Interest in osteopathy continues to rise in this country. Currently, more than 20% of medical students in the United States are training to be osteopathic physicians.¹ In addition, the 2007 National Health Interview Survey found that spinal manipulation was among the most common complementary and alternative medicine (CAM) therapies used; with 8.6% of US adults reporting that they used it within the previous 12 months.²

With the growing number of DOs and the high utilization of osteopathic manipulative treatment (OMT), it is important for all physicians to understand the role OMT can play in the treatment of conditions ranging from low back pain to irritable bowel syndrome so that patients may be offered, or referred for, the treatment when appropriate.

To clarify when OMT may be most beneficial, we performed a literature review. Our findings are summarized here. But first, a word about osteopathic medicine and what OMT entails.

Osteopathic physicians view the body as a whole

According to the American Osteopathic Association, “the osteopathic philosophy of medicine sees an interrelated unity in all systems of the body, with each working with the other to heal in times of illness."³ This “whole-person approach to medicine” focuses on looking beyond symptoms alone to understand how lifestyle and environmental factors impact well-being.

As part of their education, DOs receive special training in the musculoskeletal system and in OMT. OMT is the process by which DOs use their hands to diagnose illness and injury and then mobilize a patient’s joints and soft tissues using techniques that include muscle activation, stretching, joint articulation, and gentle pressure to encourage the body’s natural tendency to heal itself.

These patients with low back pain will likely benefit

In the past, studies with small sample sizes, blinding issues, differing controls, and subjective outcome measurements have marred research efforts to demonstrate the effectiveness of OMT. More recently, researchers have attempted to minimize these issues, particularly when evaluating the efficacy of OMT for low back pain.

Meta-analyses show decreased pain and improved function in patients who received osteopathic manipulative treatment for low back pain.

In addition to increasing sample size, studies have compared OMT to usual care, to sham manipulation, and more recently to other manual modalities including ultrasound to equalize the subjective effects of interventions.⁴ With improved study designs, there has been increased awareness of the effectiveness of spinal manipulation by organizations that develop guidelines for the care of patients with low back pain. The most recent clinical practice guideline from the American College of Physicians includes spinal manipulation as a treatment modality that should be considered by clinicians for patients who have acute, subacute, or chronic low back pain.⁵

Chronic nonspecific low back pain. Looking at OMT vs other interventions for chronic nonspecific low back pain, a 2014 meta-analysis found moderate quality evidence for clinically relevant effects of OMT on low back pain and function. In 6 studies that evaluated 769 patients with chronic nonspecific low back pain, there was a significant difference in pain—equivalent to a 1.5-point improvement (mean difference [MD]= -14.93; 95% confidence interval [CI], -25.18 to -4.68)—in favor of OMT compared with controls, as measured on a 10-point visual analogue scale (VAS).⁶ In all of the studies in this meta-analysis, the treating examiner used clinical judgment to determine which manipulation techniques would be most appropriate for each patient—an approach that best represents "real-world" osteopathic practice.⁶

Acute and chronic nonspecific low back pain. Similarly, in the same 2014 meta-analysis, 1141 participants with acute and chronic nonspecific low back pain in 10 studies had the equivalent of 1.3 points more pain relief with OMT compared with controls (MD= -12.91; 95% CI, -20.00 to -5.82). The authors used the standardized mean difference (SMD), which is the difference in means divided by the standard deviation, to interpret the magnitude of difference in function between participants who received OMT and those in the control groups. Further, 1046 participants with acute and chronic nonspecific low back pain in 9 studies had a small improvement in functional status using the Roland-Morris Disability Questionnaire (RMDQ) or Oswestry-Disability Index (SMD= -0.36; 95% CI, -0.58 to -0.14).⁶

A 2005 meta-analysis that evaluated 6 randomized controlled trials (RCTs) involving 549 patients with low back pain found that 318 patients who received OMT had significantly less low back pain compared with 231 controls (effect size= -0.30; 95% CI, -0.47 to -0.13; P=.001).⁷ Although significant, an effect size of this magnitude is characterized as small.⁸

Other benefits of OMT include increased patient satisfaction, fewer meds

A randomized double-blind, sham-controlled study involving 455 patients with chronic low back pain compared outcomes of OMT to sham OMT applied in 6 treatment sessions over 8 weeks.⁹ Intention-to-treat analysis was performed to measure moderate and substantial improvements in low back pain at Week 12 (≥30% and ≥50% pain reductions from baseline, respectively). Based on the Cochrane Back Review Group criteria for effect sizes, response ratios were calculated to determine if the differences seen were considered clinically relevant.¹⁰

Patients receiving OMT were more likely to achieve moderate (response ratio=1.38; 95% CI, 1.16-1.64; P<.001) and substantial (response ratio=1.41; 95% CI, 1.13-1.76; P=.002) improvements in low back pain at Week 12. The calculated number needed to treat (NNT) for moderate and significant improvement in pain at 12 weeks was 6 and 7, respectively. In addition, patients in the OMT group were more likely to be very satisfied with their care (P<.001) with an NNT of 5, and used fewer medications than did patients in the sham group during the 12 weeks of the study (use ratio=0.66; 95% CI, 0.43-1.00; P=.048; NNT=15).⁹

Pregnant women may benefit from OMT in the third trimester

A 2013 RCT involving 144 patients randomized to OMT, sham ultrasound, or usual obstetric care found that 68 patients (47%) experienced back-specific dysfunction during their third trimester of pregnancy (defined by a ≥2-point increase in the RMDQ).¹¹

OMT reduced the risk of back-specific dysfunction by 40% vs the ultrasound group (relative risk [RR]=0.6; 95% CI, 0.3-1; P=.046) and 60% vs the usual obstetric care group (RR=0.4; 95% CI, 0.2-0.7; P<.001). The corresponding NNTs were 5.1 (95% CI, 2.7-282.2) for the OMT group vs the ultrasound group and 2.5 (95% CI, 1.8-4.9) vs the usual care group. The outcomes of this study were not conclusive because the initial RMDQ score was 1.8 points worse for the OMT group than for the usual care group.¹¹

Subsequently, the PROMOTE (Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects) study involving 400 patients demonstrated that a standard OMT protocol was effective for decreasing pain and function deterioration compared with usual obstetric care.¹² However, results from the OMT group did not differ significantly from those of the ultrasound group, which were labeled as subtherapeutic in the study.¹²

The most recent Cochrane Review on low back pain in pregnancy noted that there was moderate quality evidence (due to study design limitations or imprecision) that OMT significantly reduced low back pain and function disability.¹³

OMT for other conditions? The evidence is limited

To date, studies on conditions other than low back pain have not demonstrated the same robust improvements in design as have those concerning low back pain (ie, larger sample sizes, comparisons to usual care and other treatments, etc.), and available data are not sufficiently significant to compel a change in clinical practice. Despite this, patients seek out, and receive, OMT as an alternative or adjunctive treatment for many conditions other than low back pain,² and family physicians should be aware of the current evidence for OMT in those conditions.

OMT for acute neck pain: A comparison with ketorolac

Researchers randomized 58 patients presenting to 3 emergency departments with neck pain of less than 3 weeks’ duration to receive either OMT or 30 mg IM ketorolac.¹⁴ OMT techniques were provided at the discretion of the physician based on patient needs. Patients rated their pain intensity on an 11-point numerical scale at the time of presentation and one hour after treatment. Patients receiving ketorolac or OMT had significant reductions in pain intensity with improvements of 1.7 +/- 1.6 (95% CI, 1.1-2.3; P<.001) and 2.8 +/- 1.7 (95% CI, 2.1-3.4; P<.001), respectively.

Patients who received osteopathic manipulative treatment for low back pain used fewer medications.

Although the pain reduction changes were statistically significant in both groups, the improvements were small enough to question if they were functionally significant. Compared to those receiving ketorolac, those receiving OMT reported a significantly greater decrease in their pain intensity (2.8 vs 1.7; 95% CI, 0.2-1.9; P=.02), but it’s worth noting that the dose of ketorolac was half the recommended dose for moderate or severe pain.¹⁴

Patients may have more headache-free days with OMT

To assess the use of OMT to treat chronic migraine, researchers conducted a prospective, single-blind RCT in which 105 chronic migraine sufferers (average of 22.5 migraine days/month) were split into 3 treatment groups: OMT plus medications, sham OMT plus medications, and medications alone.¹⁵

OMT led to fewer days with migraines compared with the medication group (MD= -21.06; 95% CI, -23.19 to -18.92; P<.001) and sham OMT group (MD= -17.43; 95% CI, -19.57 to -15.29; P<.001), resulting in less functional disability (P<.001).¹⁵ Caution should be taken in interpreting the results of this small trial, however, as an effect of this size has not been replicated in other studies.

A small (N=29) single-blind RCT looked at progressive muscular relaxation with and without OMT for the treatment of tension headache. Patients who completed relaxation exercises plus 3 sessions of OMT experienced significantly more headache-free days (1.79 vs 0.21; P=.016).¹⁶ Despite this finding, headache intensity and headache diary ratings were not different between the 2 groups in this study.

Postoperative OMT may decrease length of stay

In a retrospective study evaluating the effect of OMT on postoperative outcomes in 55 patients who underwent gastrointestinal surgery, a total of 17 patients who received a single OMT session within 48 hours of surgery had a mean time to flatus of 3.1 days compared with 4.7 days in the usual care control group (P=.035).¹⁷ The mean length of stay was 6.1 days in the OMT group and 11.5 days in the non-OMT group (P=.006).

Major limitations of this study include that it was retrospective in design and that only 17 of 55 patients had OMT performed, indicating a possible selection bias.

Pneumonia: OMT may reduce LOS and duration of antibiotic usage

The Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE), a double-blind RCT, looked at 406 patients ≥50 years hospitalized with pneumonia. Researchers randomized the group to receive either conventional care (CC; antibiotic treatment only), OMT and antibiotic therapy, or light-touch sham therapy with antibiotics.¹⁸ The researchers found no significant differences between the groups for any outcomes in the intention-to-treat analysis.

Patients who received osteopathic manipulative treatment for acute neck pain had greater pain relief than those who received a small dose of IM ketorolac.

In results obtained from the per protocol analysis, however, the median length of stay for those in the OMT group was 3.5 days, compared with 4.5 days for those in the CC group (95% CI, 3.2-4.0; P=.01). Multiple comparisons also indicated a reduction in mean duration of intravenous antibiotic use of 3 days in the OMT group (95% CI, 2.7-3.5) vs 3.5 days in the CC group (95% CI, 3.2-3.9). The treatment end-points of either death or respiratory failure occurred significantly less frequently in the OMT group compared with the CC group (P=.006).¹⁸

A Cochrane review of RCTs assessing the efficacy of adjunctive techniques compared with conventional therapy for patients with pneumonia revealed a reduction in hospital stay of 2 days (95% CI, -3.5 to -0.6) for patients who received OMT and positive expiratory pressure vs those who received neither intervention.¹⁹ Additionally, the duration of IV antibiotics and total duration of all (IV and oral) antibiotic treatment required in those treated adjunctively with OMT was shorter (MD for IV antibiotics= -2.1 days; 95% CI, -3.4 to -0.9 and MD for all antibiotics= -1.9 days; 95% CI, -3.1 to -0.7).¹⁹ The review was notable for a small sample size, with only 79 patients assessed.

OMT may improve IBS symptoms

A crossover study of 31 patients that compared visceral manipulation and sacral articulation OMT with sham therapy for the treatment of irritable bowel syndrome (IBS) demonstrated that OMT significantly decreased self-reported diarrhea (P=.016), abdominal distention (P=.043), abdominal pain (P=.013), and rectal sensitivity (P<.001), but did not significantly affect constipation.²⁰

In another study, researchers randomized 30 patients with IBS in a 2:1 distribution to OMT vs sham treatment.²¹ OMT included abdominal visceral techniques and direct and indirect spine techniques. All of the patients received 2 treatment sessions, and the researchers evaluated them at 7 and 28 days. At 7 days, both groups demonstrated a significant reduction in IBS symptoms, although the OMT group had significantly greater improvement (P=.01). At 28 days, however, neither group showed a significant reduction in symptoms.²¹

The lack of a control group (in the first study due to the crossover design), small sample sizes, and self-reported symptoms are major limitations to applying these studies to IBS treatment recommendations.

CORRESPONDENCE
Andrew H. Slattengren, DO, Broadway Family Medicine Clinic, 1020 West Broadway Avenue, Minneapolis, MN 55411; aslatten@umn.edu.

Interest in osteopathy continues to rise in this country. Currently, more than 20% of medical students in the United States are training to be osteopathic physicians.¹ In addition, the 2007 National Health Interview Survey found that spinal manipulation was among the most common complementary and alternative medicine (CAM) therapies used; with 8.6% of US adults reporting that they used it within the previous 12 months.²

With the growing number of DOs and the high utilization of osteopathic manipulative treatment (OMT), it is important for all physicians to understand the role OMT can play in the treatment of conditions ranging from low back pain to irritable bowel syndrome so that patients may be offered, or referred for, the treatment when appropriate.

To clarify when OMT may be most beneficial, we performed a literature review. Our findings are summarized here. But first, a word about osteopathic medicine and what OMT entails.

Osteopathic physicians view the body as a whole

According to the American Osteopathic Association, “the osteopathic philosophy of medicine sees an interrelated unity in all systems of the body, with each working with the other to heal in times of illness."³ This “whole-person approach to medicine” focuses on looking beyond symptoms alone to understand how lifestyle and environmental factors impact well-being.

As part of their education, DOs receive special training in the musculoskeletal system and in OMT. OMT is the process by which DOs use their hands to diagnose illness and injury and then mobilize a patient’s joints and soft tissues using techniques that include muscle activation, stretching, joint articulation, and gentle pressure to encourage the body’s natural tendency to heal itself.

These patients with low back pain will likely benefit

In the past, studies with small sample sizes, blinding issues, differing controls, and subjective outcome measurements have marred research efforts to demonstrate the effectiveness of OMT. More recently, researchers have attempted to minimize these issues, particularly when evaluating the efficacy of OMT for low back pain.

Meta-analyses show decreased pain and improved function in patients who received osteopathic manipulative treatment for low back pain.

In addition to increasing sample size, studies have compared OMT to usual care, to sham manipulation, and more recently to other manual modalities including ultrasound to equalize the subjective effects of interventions.⁴ With improved study designs, there has been increased awareness of the effectiveness of spinal manipulation by organizations that develop guidelines for the care of patients with low back pain. The most recent clinical practice guideline from the American College of Physicians includes spinal manipulation as a treatment modality that should be considered by clinicians for patients who have acute, subacute, or chronic low back pain.⁵

Chronic nonspecific low back pain. Looking at OMT vs other interventions for chronic nonspecific low back pain, a 2014 meta-analysis found moderate quality evidence for clinically relevant effects of OMT on low back pain and function. In 6 studies that evaluated 769 patients with chronic nonspecific low back pain, there was a significant difference in pain—equivalent to a 1.5-point improvement (mean difference [MD]= -14.93; 95% confidence interval [CI], -25.18 to -4.68)—in favor of OMT compared with controls, as measured on a 10-point visual analogue scale (VAS).⁶ In all of the studies in this meta-analysis, the treating examiner used clinical judgment to determine which manipulation techniques would be most appropriate for each patient—an approach that best represents "real-world" osteopathic practice.⁶

Acute and chronic nonspecific low back pain. Similarly, in the same 2014 meta-analysis, 1141 participants with acute and chronic nonspecific low back pain in 10 studies had the equivalent of 1.3 points more pain relief with OMT compared with controls (MD= -12.91; 95% CI, -20.00 to -5.82). The authors used the standardized mean difference (SMD), which is the difference in means divided by the standard deviation, to interpret the magnitude of difference in function between participants who received OMT and those in the control groups. Further, 1046 participants with acute and chronic nonspecific low back pain in 9 studies had a small improvement in functional status using the Roland-Morris Disability Questionnaire (RMDQ) or Oswestry-Disability Index (SMD= -0.36; 95% CI, -0.58 to -0.14).⁶

A 2005 meta-analysis that evaluated 6 randomized controlled trials (RCTs) involving 549 patients with low back pain found that 318 patients who received OMT had significantly less low back pain compared with 231 controls (effect size= -0.30; 95% CI, -0.47 to -0.13; P=.001).⁷ Although significant, an effect size of this magnitude is characterized as small.⁸

Other benefits of OMT include increased patient satisfaction, fewer meds

A randomized double-blind, sham-controlled study involving 455 patients with chronic low back pain compared outcomes of OMT to sham OMT applied in 6 treatment sessions over 8 weeks.⁹ Intention-to-treat analysis was performed to measure moderate and substantial improvements in low back pain at Week 12 (≥30% and ≥50% pain reductions from baseline, respectively). Based on the Cochrane Back Review Group criteria for effect sizes, response ratios were calculated to determine if the differences seen were considered clinically relevant.¹⁰

Patients receiving OMT were more likely to achieve moderate (response ratio=1.38; 95% CI, 1.16-1.64; P<.001) and substantial (response ratio=1.41; 95% CI, 1.13-1.76; P=.002) improvements in low back pain at Week 12. The calculated number needed to treat (NNT) for moderate and significant improvement in pain at 12 weeks was 6 and 7, respectively. In addition, patients in the OMT group were more likely to be very satisfied with their care (P<.001) with an NNT of 5, and used fewer medications than did patients in the sham group during the 12 weeks of the study (use ratio=0.66; 95% CI, 0.43-1.00; P=.048; NNT=15).⁹

Pregnant women may benefit from OMT in the third trimester

A 2013 RCT involving 144 patients randomized to OMT, sham ultrasound, or usual obstetric care found that 68 patients (47%) experienced back-specific dysfunction during their third trimester of pregnancy (defined by a ≥2-point increase in the RMDQ).¹¹

OMT reduced the risk of back-specific dysfunction by 40% vs the ultrasound group (relative risk [RR]=0.6; 95% CI, 0.3-1; P=.046) and 60% vs the usual obstetric care group (RR=0.4; 95% CI, 0.2-0.7; P<.001). The corresponding NNTs were 5.1 (95% CI, 2.7-282.2) for the OMT group vs the ultrasound group and 2.5 (95% CI, 1.8-4.9) vs the usual care group. The outcomes of this study were not conclusive because the initial RMDQ score was 1.8 points worse for the OMT group than for the usual care group.¹¹

Subsequently, the PROMOTE (Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects) study involving 400 patients demonstrated that a standard OMT protocol was effective for decreasing pain and function deterioration compared with usual obstetric care.¹² However, results from the OMT group did not differ significantly from those of the ultrasound group, which were labeled as subtherapeutic in the study.¹²

The most recent Cochrane Review on low back pain in pregnancy noted that there was moderate quality evidence (due to study design limitations or imprecision) that OMT significantly reduced low back pain and function disability.¹³

OMT for other conditions? The evidence is limited

To date, studies on conditions other than low back pain have not demonstrated the same robust improvements in design as have those concerning low back pain (ie, larger sample sizes, comparisons to usual care and other treatments, etc.), and available data are not sufficiently significant to compel a change in clinical practice. Despite this, patients seek out, and receive, OMT as an alternative or adjunctive treatment for many conditions other than low back pain,² and family physicians should be aware of the current evidence for OMT in those conditions.

OMT for acute neck pain: A comparison with ketorolac

Researchers randomized 58 patients presenting to 3 emergency departments with neck pain of less than 3 weeks’ duration to receive either OMT or 30 mg IM ketorolac.¹⁴ OMT techniques were provided at the discretion of the physician based on patient needs. Patients rated their pain intensity on an 11-point numerical scale at the time of presentation and one hour after treatment. Patients receiving ketorolac or OMT had significant reductions in pain intensity with improvements of 1.7 +/- 1.6 (95% CI, 1.1-2.3; P<.001) and 2.8 +/- 1.7 (95% CI, 2.1-3.4; P<.001), respectively.

Patients who received osteopathic manipulative treatment for low back pain used fewer medications.

Although the pain reduction changes were statistically significant in both groups, the improvements were small enough to question if they were functionally significant. Compared to those receiving ketorolac, those receiving OMT reported a significantly greater decrease in their pain intensity (2.8 vs 1.7; 95% CI, 0.2-1.9; P=.02), but it’s worth noting that the dose of ketorolac was half the recommended dose for moderate or severe pain.¹⁴

Patients may have more headache-free days with OMT

To assess the use of OMT to treat chronic migraine, researchers conducted a prospective, single-blind RCT in which 105 chronic migraine sufferers (average of 22.5 migraine days/month) were split into 3 treatment groups: OMT plus medications, sham OMT plus medications, and medications alone.¹⁵

OMT led to fewer days with migraines compared with the medication group (MD= -21.06; 95% CI, -23.19 to -18.92; P<.001) and sham OMT group (MD= -17.43; 95% CI, -19.57 to -15.29; P<.001), resulting in less functional disability (P<.001).¹⁵ Caution should be taken in interpreting the results of this small trial, however, as an effect of this size has not been replicated in other studies.

A small (N=29) single-blind RCT looked at progressive muscular relaxation with and without OMT for the treatment of tension headache. Patients who completed relaxation exercises plus 3 sessions of OMT experienced significantly more headache-free days (1.79 vs 0.21; P=.016).¹⁶ Despite this finding, headache intensity and headache diary ratings were not different between the 2 groups in this study.

Postoperative OMT may decrease length of stay

In a retrospective study evaluating the effect of OMT on postoperative outcomes in 55 patients who underwent gastrointestinal surgery, a total of 17 patients who received a single OMT session within 48 hours of surgery had a mean time to flatus of 3.1 days compared with 4.7 days in the usual care control group (P=.035).¹⁷ The mean length of stay was 6.1 days in the OMT group and 11.5 days in the non-OMT group (P=.006).

Major limitations of this study include that it was retrospective in design and that only 17 of 55 patients had OMT performed, indicating a possible selection bias.

Pneumonia: OMT may reduce LOS and duration of antibiotic usage

The Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE), a double-blind RCT, looked at 406 patients ≥50 years hospitalized with pneumonia. Researchers randomized the group to receive either conventional care (CC; antibiotic treatment only), OMT and antibiotic therapy, or light-touch sham therapy with antibiotics.¹⁸ The researchers found no significant differences between the groups for any outcomes in the intention-to-treat analysis.

Patients who received osteopathic manipulative treatment for acute neck pain had greater pain relief than those who received a small dose of IM ketorolac.

In results obtained from the per protocol analysis, however, the median length of stay for those in the OMT group was 3.5 days, compared with 4.5 days for those in the CC group (95% CI, 3.2-4.0; P=.01). Multiple comparisons also indicated a reduction in mean duration of intravenous antibiotic use of 3 days in the OMT group (95% CI, 2.7-3.5) vs 3.5 days in the CC group (95% CI, 3.2-3.9). The treatment end-points of either death or respiratory failure occurred significantly less frequently in the OMT group compared with the CC group (P=.006).¹⁸

A Cochrane review of RCTs assessing the efficacy of adjunctive techniques compared with conventional therapy for patients with pneumonia revealed a reduction in hospital stay of 2 days (95% CI, -3.5 to -0.6) for patients who received OMT and positive expiratory pressure vs those who received neither intervention.¹⁹ Additionally, the duration of IV antibiotics and total duration of all (IV and oral) antibiotic treatment required in those treated adjunctively with OMT was shorter (MD for IV antibiotics= -2.1 days; 95% CI, -3.4 to -0.9 and MD for all antibiotics= -1.9 days; 95% CI, -3.1 to -0.7).¹⁹ The review was notable for a small sample size, with only 79 patients assessed.

OMT may improve IBS symptoms

A crossover study of 31 patients that compared visceral manipulation and sacral articulation OMT with sham therapy for the treatment of irritable bowel syndrome (IBS) demonstrated that OMT significantly decreased self-reported diarrhea (P=.016), abdominal distention (P=.043), abdominal pain (P=.013), and rectal sensitivity (P<.001), but did not significantly affect constipation.²⁰

In another study, researchers randomized 30 patients with IBS in a 2:1 distribution to OMT vs sham treatment.²¹ OMT included abdominal visceral techniques and direct and indirect spine techniques. All of the patients received 2 treatment sessions, and the researchers evaluated them at 7 and 28 days. At 7 days, both groups demonstrated a significant reduction in IBS symptoms, although the OMT group had significantly greater improvement (P=.01). At 28 days, however, neither group showed a significant reduction in symptoms.²¹

The lack of a control group (in the first study due to the crossover design), small sample sizes, and self-reported symptoms are major limitations to applying these studies to IBS treatment recommendations.

CORRESPONDENCE
Andrew H. Slattengren, DO, Broadway Family Medicine Clinic, 1020 West Broadway Avenue, Minneapolis, MN 55411; aslatten@umn.edu.

Interest in osteopathy continues to rise in this country. Currently, more than 20% of medical students in the United States are training to be osteopathic physicians.¹ In addition, the 2007 National Health Interview Survey found that spinal manipulation was among the most common complementary and alternative medicine (CAM) therapies used; with 8.6% of US adults reporting that they used it within the previous 12 months.²

With the growing number of DOs and the high utilization of osteopathic manipulative treatment (OMT), it is important for all physicians to understand the role OMT can play in the treatment of conditions ranging from low back pain to irritable bowel syndrome so that patients may be offered, or referred for, the treatment when appropriate.

To clarify when OMT may be most beneficial, we performed a literature review. Our findings are summarized here. But first, a word about osteopathic medicine and what OMT entails.

Osteopathic physicians view the body as a whole

According to the American Osteopathic Association, “the osteopathic philosophy of medicine sees an interrelated unity in all systems of the body, with each working with the other to heal in times of illness."³ This “whole-person approach to medicine” focuses on looking beyond symptoms alone to understand how lifestyle and environmental factors impact well-being.

As part of their education, DOs receive special training in the musculoskeletal system and in OMT. OMT is the process by which DOs use their hands to diagnose illness and injury and then mobilize a patient’s joints and soft tissues using techniques that include muscle activation, stretching, joint articulation, and gentle pressure to encourage the body’s natural tendency to heal itself.

These patients with low back pain will likely benefit

In the past, studies with small sample sizes, blinding issues, differing controls, and subjective outcome measurements have marred research efforts to demonstrate the effectiveness of OMT. More recently, researchers have attempted to minimize these issues, particularly when evaluating the efficacy of OMT for low back pain.

Meta-analyses show decreased pain and improved function in patients who received osteopathic manipulative treatment for low back pain.

In addition to increasing sample size, studies have compared OMT to usual care, to sham manipulation, and more recently to other manual modalities including ultrasound to equalize the subjective effects of interventions.⁴ With improved study designs, there has been increased awareness of the effectiveness of spinal manipulation by organizations that develop guidelines for the care of patients with low back pain. The most recent clinical practice guideline from the American College of Physicians includes spinal manipulation as a treatment modality that should be considered by clinicians for patients who have acute, subacute, or chronic low back pain.⁵

Chronic nonspecific low back pain. Looking at OMT vs other interventions for chronic nonspecific low back pain, a 2014 meta-analysis found moderate quality evidence for clinically relevant effects of OMT on low back pain and function. In 6 studies that evaluated 769 patients with chronic nonspecific low back pain, there was a significant difference in pain—equivalent to a 1.5-point improvement (mean difference [MD]= -14.93; 95% confidence interval [CI], -25.18 to -4.68)—in favor of OMT compared with controls, as measured on a 10-point visual analogue scale (VAS).⁶ In all of the studies in this meta-analysis, the treating examiner used clinical judgment to determine which manipulation techniques would be most appropriate for each patient—an approach that best represents "real-world" osteopathic practice.⁶

Acute and chronic nonspecific low back pain. Similarly, in the same 2014 meta-analysis, 1141 participants with acute and chronic nonspecific low back pain in 10 studies had the equivalent of 1.3 points more pain relief with OMT compared with controls (MD= -12.91; 95% CI, -20.00 to -5.82). The authors used the standardized mean difference (SMD), which is the difference in means divided by the standard deviation, to interpret the magnitude of difference in function between participants who received OMT and those in the control groups. Further, 1046 participants with acute and chronic nonspecific low back pain in 9 studies had a small improvement in functional status using the Roland-Morris Disability Questionnaire (RMDQ) or Oswestry-Disability Index (SMD= -0.36; 95% CI, -0.58 to -0.14).⁶

A 2005 meta-analysis that evaluated 6 randomized controlled trials (RCTs) involving 549 patients with low back pain found that 318 patients who received OMT had significantly less low back pain compared with 231 controls (effect size= -0.30; 95% CI, -0.47 to -0.13; P=.001).⁷ Although significant, an effect size of this magnitude is characterized as small.⁸

Other benefits of OMT include increased patient satisfaction, fewer meds

A randomized double-blind, sham-controlled study involving 455 patients with chronic low back pain compared outcomes of OMT to sham OMT applied in 6 treatment sessions over 8 weeks.⁹ Intention-to-treat analysis was performed to measure moderate and substantial improvements in low back pain at Week 12 (≥30% and ≥50% pain reductions from baseline, respectively). Based on the Cochrane Back Review Group criteria for effect sizes, response ratios were calculated to determine if the differences seen were considered clinically relevant.¹⁰

Patients receiving OMT were more likely to achieve moderate (response ratio=1.38; 95% CI, 1.16-1.64; P<.001) and substantial (response ratio=1.41; 95% CI, 1.13-1.76; P=.002) improvements in low back pain at Week 12. The calculated number needed to treat (NNT) for moderate and significant improvement in pain at 12 weeks was 6 and 7, respectively. In addition, patients in the OMT group were more likely to be very satisfied with their care (P<.001) with an NNT of 5, and used fewer medications than did patients in the sham group during the 12 weeks of the study (use ratio=0.66; 95% CI, 0.43-1.00; P=.048; NNT=15).⁹

Pregnant women may benefit from OMT in the third trimester

A 2013 RCT involving 144 patients randomized to OMT, sham ultrasound, or usual obstetric care found that 68 patients (47%) experienced back-specific dysfunction during their third trimester of pregnancy (defined by a ≥2-point increase in the RMDQ).¹¹

OMT reduced the risk of back-specific dysfunction by 40% vs the ultrasound group (relative risk [RR]=0.6; 95% CI, 0.3-1; P=.046) and 60% vs the usual obstetric care group (RR=0.4; 95% CI, 0.2-0.7; P<.001). The corresponding NNTs were 5.1 (95% CI, 2.7-282.2) for the OMT group vs the ultrasound group and 2.5 (95% CI, 1.8-4.9) vs the usual care group. The outcomes of this study were not conclusive because the initial RMDQ score was 1.8 points worse for the OMT group than for the usual care group.¹¹

Subsequently, the PROMOTE (Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects) study involving 400 patients demonstrated that a standard OMT protocol was effective for decreasing pain and function deterioration compared with usual obstetric care.¹² However, results from the OMT group did not differ significantly from those of the ultrasound group, which were labeled as subtherapeutic in the study.¹²

The most recent Cochrane Review on low back pain in pregnancy noted that there was moderate quality evidence (due to study design limitations or imprecision) that OMT significantly reduced low back pain and function disability.¹³

OMT for other conditions? The evidence is limited

To date, studies on conditions other than low back pain have not demonstrated the same robust improvements in design as have those concerning low back pain (ie, larger sample sizes, comparisons to usual care and other treatments, etc.), and available data are not sufficiently significant to compel a change in clinical practice. Despite this, patients seek out, and receive, OMT as an alternative or adjunctive treatment for many conditions other than low back pain,² and family physicians should be aware of the current evidence for OMT in those conditions.

OMT for acute neck pain: A comparison with ketorolac

Researchers randomized 58 patients presenting to 3 emergency departments with neck pain of less than 3 weeks’ duration to receive either OMT or 30 mg IM ketorolac.¹⁴ OMT techniques were provided at the discretion of the physician based on patient needs. Patients rated their pain intensity on an 11-point numerical scale at the time of presentation and one hour after treatment. Patients receiving ketorolac or OMT had significant reductions in pain intensity with improvements of 1.7 +/- 1.6 (95% CI, 1.1-2.3; P<.001) and 2.8 +/- 1.7 (95% CI, 2.1-3.4; P<.001), respectively.

Patients who received osteopathic manipulative treatment for low back pain used fewer medications.

Although the pain reduction changes were statistically significant in both groups, the improvements were small enough to question if they were functionally significant. Compared to those receiving ketorolac, those receiving OMT reported a significantly greater decrease in their pain intensity (2.8 vs 1.7; 95% CI, 0.2-1.9; P=.02), but it’s worth noting that the dose of ketorolac was half the recommended dose for moderate or severe pain.¹⁴

Patients may have more headache-free days with OMT

To assess the use of OMT to treat chronic migraine, researchers conducted a prospective, single-blind RCT in which 105 chronic migraine sufferers (average of 22.5 migraine days/month) were split into 3 treatment groups: OMT plus medications, sham OMT plus medications, and medications alone.¹⁵

OMT led to fewer days with migraines compared with the medication group (MD= -21.06; 95% CI, -23.19 to -18.92; P<.001) and sham OMT group (MD= -17.43; 95% CI, -19.57 to -15.29; P<.001), resulting in less functional disability (P<.001).¹⁵ Caution should be taken in interpreting the results of this small trial, however, as an effect of this size has not been replicated in other studies.

A small (N=29) single-blind RCT looked at progressive muscular relaxation with and without OMT for the treatment of tension headache. Patients who completed relaxation exercises plus 3 sessions of OMT experienced significantly more headache-free days (1.79 vs 0.21; P=.016).¹⁶ Despite this finding, headache intensity and headache diary ratings were not different between the 2 groups in this study.

Postoperative OMT may decrease length of stay

In a retrospective study evaluating the effect of OMT on postoperative outcomes in 55 patients who underwent gastrointestinal surgery, a total of 17 patients who received a single OMT session within 48 hours of surgery had a mean time to flatus of 3.1 days compared with 4.7 days in the usual care control group (P=.035).¹⁷ The mean length of stay was 6.1 days in the OMT group and 11.5 days in the non-OMT group (P=.006).

Major limitations of this study include that it was retrospective in design and that only 17 of 55 patients had OMT performed, indicating a possible selection bias.

Pneumonia: OMT may reduce LOS and duration of antibiotic usage

The Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE), a double-blind RCT, looked at 406 patients ≥50 years hospitalized with pneumonia. Researchers randomized the group to receive either conventional care (CC; antibiotic treatment only), OMT and antibiotic therapy, or light-touch sham therapy with antibiotics.¹⁸ The researchers found no significant differences between the groups for any outcomes in the intention-to-treat analysis.

Patients who received osteopathic manipulative treatment for acute neck pain had greater pain relief than those who received a small dose of IM ketorolac.

In results obtained from the per protocol analysis, however, the median length of stay for those in the OMT group was 3.5 days, compared with 4.5 days for those in the CC group (95% CI, 3.2-4.0; P=.01). Multiple comparisons also indicated a reduction in mean duration of intravenous antibiotic use of 3 days in the OMT group (95% CI, 2.7-3.5) vs 3.5 days in the CC group (95% CI, 3.2-3.9). The treatment end-points of either death or respiratory failure occurred significantly less frequently in the OMT group compared with the CC group (P=.006).¹⁸

A Cochrane review of RCTs assessing the efficacy of adjunctive techniques compared with conventional therapy for patients with pneumonia revealed a reduction in hospital stay of 2 days (95% CI, -3.5 to -0.6) for patients who received OMT and positive expiratory pressure vs those who received neither intervention.¹⁹ Additionally, the duration of IV antibiotics and total duration of all (IV and oral) antibiotic treatment required in those treated adjunctively with OMT was shorter (MD for IV antibiotics= -2.1 days; 95% CI, -3.4 to -0.9 and MD for all antibiotics= -1.9 days; 95% CI, -3.1 to -0.7).¹⁹ The review was notable for a small sample size, with only 79 patients assessed.

OMT may improve IBS symptoms

A crossover study of 31 patients that compared visceral manipulation and sacral articulation OMT with sham therapy for the treatment of irritable bowel syndrome (IBS) demonstrated that OMT significantly decreased self-reported diarrhea (P=.016), abdominal distention (P=.043), abdominal pain (P=.013), and rectal sensitivity (P<.001), but did not significantly affect constipation.²⁰

In another study, researchers randomized 30 patients with IBS in a 2:1 distribution to OMT vs sham treatment.²¹ OMT included abdominal visceral techniques and direct and indirect spine techniques. All of the patients received 2 treatment sessions, and the researchers evaluated them at 7 and 28 days. At 7 days, both groups demonstrated a significant reduction in IBS symptoms, although the OMT group had significantly greater improvement (P=.01). At 28 days, however, neither group showed a significant reduction in symptoms.²¹

The lack of a control group (in the first study due to the crossover design), small sample sizes, and self-reported symptoms are major limitations to applying these studies to IBS treatment recommendations.

CORRESPONDENCE
Andrew H. Slattengren, DO, Broadway Family Medicine Clinic, 1020 West Broadway Avenue, Minneapolis, MN 55411; aslatten@umn.edu.

The care of women with female sexual disorders has made great strides since Masters and Johnson first began their study in 1957. In 2000, the Sexual Function Health Council of the American Foundation for Urologic Disease defined the classification system for female sexual dysfunction, which was eventually published and officially defined in the Diagnostic and Statistical Manual of Mental Disorders-IV-TR.¹ There are now definitions for sexual desire disorders, sexual arousal disorders, orgasmic disorder, and sexual pain disorders.

Female sexual dysfunction (FSD) has complex physiologic and psychological components that require a detailed screening, history, and physical examination. Our goal in this review is to provide family physicians with insights and practical advice to help screen, diagnose, and treat female sexual dysfunction, which can have a profound impact on patients’ most intimate relationships.

Understanding the types of female sexual dysfunction

Most women consider sexual health an important part of their overall health.² Factors that can disrupt normal sexual function include aging, socioeconomics, and other medical comorbidities. FSD is common in women throughout their lives and refers to various sexual dysfunctions including diminished arousal, problems achieving orgasm, dyspareunia, and low desire. Its prevalence is reported as high as 20% to 43%.^3,4

The World Health Organization and the US Surgeon General have released statements encouraging health care providers to address sexual health during a patient’s annual visits.⁵ Unfortunately, despite this call to action, many patients and providers are initially hesitant to discuss these problems.⁶

The Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) provides the definition and diagnostic guidelines for the different components of FSD. Its classification of sexual disorders was simplified and published in May 2013.⁷ There are now only 3 female dysfunctions as opposed to 5 in DSM-IV.

• Female hypoactive desire dysfunction and female arousal dysfunction were merged into a single syndrome labeled female sexual interest/arousal disorder.
• The formerly separate dyspareunia (painful intercourse) and vaginismus are now called genitopelvic pain/penetration disorder.
• Female orgasmic disorder remains as a category and is unchanged.

To qualify as a dysfunction, the problem must be present more than 75% of the time, for more than 6 months, causing significant distress, and must not be explained by a nonsexual mental disorder, relationship distress, substance abuse, or a medical condition.

Substance- or medication-induced sexual dysfunction falls under “Other Dysfunctions” and is defined as a clinically significant disturbance in sexual function that is predominant in the clinical picture. The criteria for substance- and medication-induced sexual dysfunction are unchanged and include neither the 75% nor the 6-month requirement. The diagnosis of sexual dysfunction due to a general medical condition and sexual aversion disorder are absent from the DSM-5.⁷

A common symptom. Female sexual disorders can be caused by several complex physiologic and psychological factors. A common symptom among many women is dyspareunia. It is seen more often in postmenopausal women, and its prevalence ranges from 8% to 22%.⁸ Pain on vaginal entry usually indicates vaginal atrophy, vaginal dermatitis, or provoked vestibulodynia. Pain on deep penetration could be caused by endometriosis, interstitial cystitis, or uterine leiomyomas.⁹

The physical examination will reproduce the pain when the vulva or vagina is touched with a cotton swab or when you insert a finger into the vagina. The differential diagnosis is listed in the TABLE.^9-11

Evaluating the patient

Initially, many patients and providers may hesitate to discuss sexual dysfunction, but the annual exam is a good opportunity to broach the topic of sexual health.

Screening and history

Clinicians can screen all patients, regardless of age, with the help of a validated sex questionnaire or during a routine review of systems. There are many validated screening tools available. A simple, integrated screening tool to use is the Brief Sexual Symptom Checklist for Women (BSSC-W), created by the International Consultation in Sexual Medicine.¹² Although recommended by the American Congress of Obstetricians and Gynecologists,⁹ the BSSC-W is not validated. The questionnaire includes 4 questions that ascertain personal information regarding an individual’s overall sexual function satisfaction, the problem causing dysfunction, how bothersome the symptoms are, and if the patient is interested in discussing it with her provider.¹²

The prevalence of female sexual dysfunction is as high as 43%.

It’s important to obtain a detailed obstetric and gynecologic history that includes any sexually transmitted diseases, sexual abuse, urinary and bowel complaints, or surgeries. In addition, you’ll want to differentiate between various types of dysfunctions. A thorough physical examination, including an external and internal pelvic exam, can help to rule out other causes of sexual dysfunction.

General examination: What to look for

The external pelvic examination begins with visual inspection of the vulva, labia majora, and labia minora. Often, this is best accomplished gently with a gloved hand and a cotton swab. This inspection may reveal changes in pubic hair distribution, vulvar skin disorders, lesions, masses, cracks, or fissures. Inspection may also reveal redness and pain typical of vestibulitis, a flattening and pallor of the labia that suggests estrogen deficiency, or pelvic organ prolapse.

The internal pelvic examination begins with a manual evaluation of the muscles of the pelvic floor, uterus, bladder, urethra, anus, and adnexa. Make careful note of any unusual tenderness or pelvic masses. Pelvic floor muscles (PFMs) should voluntarily contract and relax and are not normally tender to palpation. Pelvic organ prolapse and/or hypermobility of the bladder may indicate a weakening of the endopelvic fascia and may cause sexual pain. The size and flexion of the uterus, tenderness in the vaginal fornix possibly indicating endometriosis, and adnexal fullness and/or masses should be identified and evaluated.

Neurologic exam of the pelvis will involve evaluation of sensory and motor function of both lower extremities and include a screening lumbosacral neurologic examination. Lumbosacral examination includes assessment of PFM strength, anal sphincter resting tone, voluntary anal contraction, and perineal sensation. If abnormalities are noted in the screening assessment, a complete comprehensive neurologic examination should be performed.

It’s important to assess pelvic floor muscle strength

Sexual function is associated with normal PFM function.^13,14 The PFMs, particularly the pubococcygeus and iliococcygeus, are responsible for involuntary contractions during orgasm.¹³ Orgasm has been considered a reflex, which is preceded by increased blood flow to the genital organs, tumescence of the vulva and vagina, increased secretions during sexual arousal, and increased tension and contractions of the PFMs.¹⁵

Systemic estrogen in oral form, transdermal preparations, and topical formulations may increase sexual arousal and decrease dyspareunia.

Lowenstein et al found that women with strong or moderate PFM contractions scored significantly higher on both orgasm and arousal domains of the female sexual function index (FSFI) compared with women with weak PFM contractions.¹⁶ Orgasm and arousal functions may be associated with PFM strength, with a positive association between pelvic floor strength and sexual activity and function.^17,18

The function and dysfunction of the PFMs have been characterized as normal, overactive (high tone), underactive (low tone), and non-functioning.

• Normal PFMs are those that can voluntarily and involuntary contract and relax.^19,20
• Overactive (high-tone) muscles are those that do not relax and possibly contract during times of relaxation for micturition or defecation. This type of dysfunction can lead to voiding dysfunction, defecatory dysfunction, and dyspareunia.¹⁹
• Underactive, or low-tone, PFMs cannot contract voluntarily. This can be associated with urinary and anal incontinence and pelvic organ prolapse.
• Nonfunctioning muscles are completely inactive.¹⁹

How to assess. There are several ways to assess PFM tone and strength.²⁰ The first is intravaginal or intrarectal digital palpation, which can be performed when the patient is in a supine or standing position. This examination evaluates PFM tone, squeeze pressure during contraction, symmetry, and relaxation. However, there is no validated scale to quantify PFM strength. Contractions can be further divided into voluntary and involuntary.¹⁹

During the examination, the physician should ask the patient to contract as much as she can to evaluate the maximum strength and sustained contraction for endurance. This measurement can be done with digital palpation or with pressure manometry or dynamometry.

Examination can be focused on the levator ani, piriformis, and internal obturator muscles bilaterally and rated by the patient’s reactions. Pelvic muscle tenderness, which can be highly prevalent in women with chronic pelvic pain, is associated with higher degrees of dyspareunia.²¹ Digital evaluation of the pelvic floor musculature varies in scale, number of fingers used, and parameters evaluated. Lukban et al has described a zero to 4 numbered scale that evaluates tenderness in the pelvic floor.²² The scale denotes “1” as comfortable pressure associated with the exam, “2” as uncomfortable pressure associated with the exam, “3” as moderate pain associated with the exam and that intensifies with contraction, and “4” indicating severe pain with the exam and inability to perform the contraction maneuver due to pain.

Effective treatment includes multiple options

Lifestyle modifications can help

Lifestyle changes may help improve sexual function. These modifications include physical activity, healthy diet, nutrition counseling, and adequate sleep.^23,24

Identifying medical conditions such as depression and anxiety will help delineate differential diagnoses of sexual dysfunction. Cardiovascular diseases may contribute to arousal disorder as a result of atherosclerosis of the vessels supplying the vagina and clitoris. Neurologic diseases such as multiple sclerosis and diabetes can affect sexual dysfunction by impairing arousal and orgasm. Identification of concurrent comorbidities and implementation of lifestyle changes will help improve overall health and may improve sexual function.²⁵

Manual therapies, including transvaginal technique, may relieve female sexual dysfunction that results from a variety of causes.

In addition, Herati et al²⁶ found food sensitivities to grapefruit juice, spicy foods, alcohol, and caffeine were more prevalent in patients with interstitial cystitis and chronic pelvic pain. Avoiding irritants such as soap and other detergents in the perineal region may help decrease dysfunction.²⁷ Finally, foods high in oxalate and other acidic items may cause bladder pain and worsening symptoms of vulvodynia.²⁸

Topical therapies worth considering

Lubricants and moisturizers may help women with dyspareunia or symptoms of vaginal atrophy.

Zestra, for instance, which is applied to the vulva prior to sexual activity, has been proven more effective than placebo for improving desire and arousal.²⁹

Neogyn is a non-hormonal cream containing cutaneous lysate and has been shown to improve vulvar pain in women with vulvodynia. A double-blind placebo-controlled randomized crossover trial followed 30 patients over 3 months and found a significant reduction in pain during sexual activity and a significant reduction in erythema.³⁰

Alprostadil is a prostaglandin E1 analogue that increases genital vasodilation when applied topically and is currently undergoing investigational trials.^31,32 Patients can also choose from many over-the-counter lubricants that contain water-based, oil-based, or silicone-based ingredients.

Don’t overlook physical therapy

Manual therapies, including the transvaginal technique, are used for female sexual dysfunction that results from a variety of causes, including high-tone pelvic floor dysfunction. The transvaginal technique can identify myofascial pain; treatment involves internal release of the PFMs and external trigger point identification and alleviation.

One pilot study, which involved transvaginal Thiele massage twice a week for 5 weeks on 21 symptomatic women with IC and high-tone pelvic floor dysfunction found it decreased hyptertonicity of the pelvic floor and generated statistically significant improvement in the Symptom and Problem Indexes of the O’Leary-Sant Questionnaire, Likert Visual Analogue Scales for urgency and pain, and the Physical and Mental Component Summary from the SF-12 Quality-of-Life Scale.³³ Transvaginal physical therapy is also an effective treatment for myofascial pelvic pain.³⁴

Biofeedback, which can be used in combination with pelvic floor physical therapy, teaches the patient to control the PFMs by visualizing the activity to achieve conscious control over contraction of the pelvic floor and ceasing the cycle of spasm.³⁵ Ger et al³⁶ investigated patients with levator spasm and found biofeedback decreased pain; relief was rated as good or excellent at 15-month follow-up in 6 out of 14 patients (43%).

Home devices such as Eros Therapy, an FDA-approved, nonpharmacologic battery-operated device, provide vacuum suction to the clitoris with vibratory sensation. Eros Therapy has been shown to increase blood flow to the clitoris, vagina, and pelvic floor and increase sensation, orgasm, lubrication, and satisfaction.³⁷

The treatment of female sexual dysfunction may require a multimodal systematic approach targeting genitopelvic pain.

Vaginal dilators allow increasing lengths and girths designed to treat vaginal and pelvic floor pain.³⁸ In our practice, we encourage pelvic muscle strengthening tools in the form of kegal trainers and other insertion devices that may improve PFM coordination and strength.

Pharmacotherapy has its place

The treatment of FSD may require a multimodal systematic approach targeting genito-pelvic pain. But before the best options can be found, it is important to first establish the cause of the pain. Several drug formulations have been effectively used including hormonal and non-hormonal options.

Conjugated estrogens are FDA approved for the treatment of dyspareunia, which can contribute to decreased desire. Systemic estrogen in oral form, transdermal preparations, and topical formulations may increase sexual desire and arousal and decrease dyspareunia.³⁹ Even synthetic steroid compounds such as tibolone may improve sexual function, although it is not FDA approved for that purpose.⁴⁰

Ospemifene (Osphena) is a selective estrogen receptor modulator that acts as an estrogen agonist in select tissues, including vaginal epithelium. It is FDA approved for dyspareunia in postmenopausal women.^41,42 A daily dose of 60 mg is effective and safe with minimal adverse effects.⁴² Studies suggest that testosterone, although not FDA approved in the United States for this purpose, improves sexual desire, pleasure, orgasm, and arousal satisfaction.³⁹ The hormone has not gained FDA approval because of concerns about long-term safety and efficacy.⁴²

Non-hormonal drugs including flibanserin (Addyi), a well-tolerated serotonin receptor 1A agonist, 2A antagonist shown to improve sexual desire, increase the number of satisfying sexual events, and reduce distress associated with low sexual desire when compared with placebo.⁴³ The FDA has approved flibanserin as the first treatment targeted for women with hypoactive sexual desire disorder (HSDD). It can, however, cause severe hypotension and syncope, is not well tolerated with alcohol, and is contraindicated in patients who take strong CYP3A4 inhibitors, such as fluconazole, verapamil, and erythromycin, or who have liver impairment.

Buproprion, a mild dopamine and norepinephrine reuptake inhibitor and acetylcholine receptor antagonist, has been shown to improve desire in women with and without depression. Although it is FDA approved for major depressive disorder, it is not approved for female sexual dysfunction and is still under investigation.

Tricyclic antidepressants such as nortriptyline and amitriptyline may be effective in treating neuropathic pain. Starting doses of both amitriptyline and nortriptyline are 10 mg/d and can be increased to a maximum of 100 mg/d.⁴⁴ Tricyclic antidepressants are still under investigation for the treatment of FSD.

Muscle relaxants in oral and topical compounded form are used to treat increased pelvic floor tension and spasticity. Cyclobenzaprine and tizanidine are FDA-approved muscle relaxants indicated for muscle spasticity.

Cyclobenzaprine, at a starting dose of 10 mg, can be taken up to 3 times a day for pelvic floor tension. Tizanidine is a centrally active alpha 2 agonist that’s superior to placebo in treating high-tone pelvic floor dysfunction.⁴⁴

Other medications include benzodiazepines such as oral clonazepam and intra-vaginal diazepam, although they are not FDA approved for high-tone pelvic floor dysfunction. Rogalski et al reviewed 26 patients who received vaginal diazepam for bladder pain, sexual pain, and levator hypertonus.⁴⁵ They found subjective and sexual pain improvement assessed on FSFI and the visual analog pain scale. PFM tone significantly improved during resting, squeezing, and relaxation phases. Multimodal therapy can be used for muscle spasticity and high-tone pelvic floor dysfunction.

Trigger point and Botox injections

Although drug therapy has its place in the management of sexual dysfunction, other modalities that involve trigger point injections or botulinum toxin injections to the PFMs may prove helpful for patients with high-tone pelvic floor dysfunction.

A prospective study investigated the role of trigger point injections in 18 women with levator ani muscle spasm with a mixture of 0.25% bupivacaine in 10 mL, 2% lidocaine in 10 mL, and 40 mg of triamcinolone in 1 mL combined and used for injection of 5 mL per trigger point.⁴⁶ Three months after injections, 13 of the 18 women improved, resulting in a success rate of 72%. Trigger point injections can be applied externally or transvaginally.

OnabotulinumtoxinA (Botox) has also been tested for relief of levator ani muscle spasm. Botox is FDA approved for upper and lower limb spasticity but is not approved for pelvic floor spasticity or tension. It may reduce pressure in the PFMs and may be useful in women with high-tone pelvic floor dysfunction.⁴⁷

In a prospective 6-month pilot study, 28 patients with pelvic pain who failed conservative treatment received up to 300 U Botox into the pelvic floor.¹¹ The study, which used needle electromyography guidance and a transperineal approach, found that the dyspareunia visual analog scale improved significantly at Weeks 12 and 24. Keep in mind, however, that onabotulinumtoxinA should be reserved for patients who fail conventional treatments.^47,48

Addressing psychological issues

Sex therapy is a traditional approach that aims to improve individual or couples’ sexual experiences and help reduce anxiety related to sex.⁴² Cognitive behavioral sex therapy includes traditional sex therapy components but puts greater emphasis on modifying thought patterns that interfere with intimacy and sex.⁴²

Three months after trigger point injections, 13 of 18 women improved, resulting in a success rate of 72%.

Mindfulness-based cognitive-behavioral treatments have shown promise for sexual desire problems. It is an ancient eastern practice with Buddhist roots. This therapy is a nonjudgmental, present-moment awareness comprised of self-regulation of attention and accepting orientation to the present.⁴⁹ Although there is little evidence from prospective studies, it may benefit women with sexual dysfunction after intervention with sex therapy and cognitive behavioral therapy.

Female sexual dysfunction is common and affects women of all ages. It can negatively impact a women’s quality of life and overall well-being. The etiology of FSD is complex, and treatments are based on the causes of the dysfunction. Difficult cases warrant referral to a specialist in sexual health and female pelvic medicine. Future prospective trials, randomized controlled trials, the use of validated questionnaires, and meta-analyses will continue to move us forward as we find better ways to understand, identify, and treat female sexual dysfunction.

CORRESPONDENCE
Melissa L. Dawson, DO, MS, Department of OB/GYN, Drexel University College of Medicine, 207 N Broad St. 4th Floor, Philadelphia, PA 19107; Melissa.Dawson.DO@gmail.com.

The care of women with female sexual disorders has made great strides since Masters and Johnson first began their study in 1957. In 2000, the Sexual Function Health Council of the American Foundation for Urologic Disease defined the classification system for female sexual dysfunction, which was eventually published and officially defined in the Diagnostic and Statistical Manual of Mental Disorders-IV-TR.¹ There are now definitions for sexual desire disorders, sexual arousal disorders, orgasmic disorder, and sexual pain disorders.

Female sexual dysfunction (FSD) has complex physiologic and psychological components that require a detailed screening, history, and physical examination. Our goal in this review is to provide family physicians with insights and practical advice to help screen, diagnose, and treat female sexual dysfunction, which can have a profound impact on patients’ most intimate relationships.

Understanding the types of female sexual dysfunction

Most women consider sexual health an important part of their overall health.² Factors that can disrupt normal sexual function include aging, socioeconomics, and other medical comorbidities. FSD is common in women throughout their lives and refers to various sexual dysfunctions including diminished arousal, problems achieving orgasm, dyspareunia, and low desire. Its prevalence is reported as high as 20% to 43%.^3,4

The World Health Organization and the US Surgeon General have released statements encouraging health care providers to address sexual health during a patient’s annual visits.⁵ Unfortunately, despite this call to action, many patients and providers are initially hesitant to discuss these problems.⁶

The Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) provides the definition and diagnostic guidelines for the different components of FSD. Its classification of sexual disorders was simplified and published in May 2013.⁷ There are now only 3 female dysfunctions as opposed to 5 in DSM-IV.

• Female hypoactive desire dysfunction and female arousal dysfunction were merged into a single syndrome labeled female sexual interest/arousal disorder.
• The formerly separate dyspareunia (painful intercourse) and vaginismus are now called genitopelvic pain/penetration disorder.
• Female orgasmic disorder remains as a category and is unchanged.

To qualify as a dysfunction, the problem must be present more than 75% of the time, for more than 6 months, causing significant distress, and must not be explained by a nonsexual mental disorder, relationship distress, substance abuse, or a medical condition.

Substance- or medication-induced sexual dysfunction falls under “Other Dysfunctions” and is defined as a clinically significant disturbance in sexual function that is predominant in the clinical picture. The criteria for substance- and medication-induced sexual dysfunction are unchanged and include neither the 75% nor the 6-month requirement. The diagnosis of sexual dysfunction due to a general medical condition and sexual aversion disorder are absent from the DSM-5.⁷

A common symptom. Female sexual disorders can be caused by several complex physiologic and psychological factors. A common symptom among many women is dyspareunia. It is seen more often in postmenopausal women, and its prevalence ranges from 8% to 22%.⁸ Pain on vaginal entry usually indicates vaginal atrophy, vaginal dermatitis, or provoked vestibulodynia. Pain on deep penetration could be caused by endometriosis, interstitial cystitis, or uterine leiomyomas.⁹

The physical examination will reproduce the pain when the vulva or vagina is touched with a cotton swab or when you insert a finger into the vagina. The differential diagnosis is listed in the TABLE.^9-11

Evaluating the patient

Initially, many patients and providers may hesitate to discuss sexual dysfunction, but the annual exam is a good opportunity to broach the topic of sexual health.

Screening and history

Clinicians can screen all patients, regardless of age, with the help of a validated sex questionnaire or during a routine review of systems. There are many validated screening tools available. A simple, integrated screening tool to use is the Brief Sexual Symptom Checklist for Women (BSSC-W), created by the International Consultation in Sexual Medicine.¹² Although recommended by the American Congress of Obstetricians and Gynecologists,⁹ the BSSC-W is not validated. The questionnaire includes 4 questions that ascertain personal information regarding an individual’s overall sexual function satisfaction, the problem causing dysfunction, how bothersome the symptoms are, and if the patient is interested in discussing it with her provider.¹²

The prevalence of female sexual dysfunction is as high as 43%.

It’s important to obtain a detailed obstetric and gynecologic history that includes any sexually transmitted diseases, sexual abuse, urinary and bowel complaints, or surgeries. In addition, you’ll want to differentiate between various types of dysfunctions. A thorough physical examination, including an external and internal pelvic exam, can help to rule out other causes of sexual dysfunction.

General examination: What to look for

The external pelvic examination begins with visual inspection of the vulva, labia majora, and labia minora. Often, this is best accomplished gently with a gloved hand and a cotton swab. This inspection may reveal changes in pubic hair distribution, vulvar skin disorders, lesions, masses, cracks, or fissures. Inspection may also reveal redness and pain typical of vestibulitis, a flattening and pallor of the labia that suggests estrogen deficiency, or pelvic organ prolapse.

The internal pelvic examination begins with a manual evaluation of the muscles of the pelvic floor, uterus, bladder, urethra, anus, and adnexa. Make careful note of any unusual tenderness or pelvic masses. Pelvic floor muscles (PFMs) should voluntarily contract and relax and are not normally tender to palpation. Pelvic organ prolapse and/or hypermobility of the bladder may indicate a weakening of the endopelvic fascia and may cause sexual pain. The size and flexion of the uterus, tenderness in the vaginal fornix possibly indicating endometriosis, and adnexal fullness and/or masses should be identified and evaluated.

Neurologic exam of the pelvis will involve evaluation of sensory and motor function of both lower extremities and include a screening lumbosacral neurologic examination. Lumbosacral examination includes assessment of PFM strength, anal sphincter resting tone, voluntary anal contraction, and perineal sensation. If abnormalities are noted in the screening assessment, a complete comprehensive neurologic examination should be performed.

It’s important to assess pelvic floor muscle strength

Sexual function is associated with normal PFM function.^13,14 The PFMs, particularly the pubococcygeus and iliococcygeus, are responsible for involuntary contractions during orgasm.¹³ Orgasm has been considered a reflex, which is preceded by increased blood flow to the genital organs, tumescence of the vulva and vagina, increased secretions during sexual arousal, and increased tension and contractions of the PFMs.¹⁵

Systemic estrogen in oral form, transdermal preparations, and topical formulations may increase sexual arousal and decrease dyspareunia.

Lowenstein et al found that women with strong or moderate PFM contractions scored significantly higher on both orgasm and arousal domains of the female sexual function index (FSFI) compared with women with weak PFM contractions.¹⁶ Orgasm and arousal functions may be associated with PFM strength, with a positive association between pelvic floor strength and sexual activity and function.^17,18

The function and dysfunction of the PFMs have been characterized as normal, overactive (high tone), underactive (low tone), and non-functioning.

• Normal PFMs are those that can voluntarily and involuntary contract and relax.^19,20
• Overactive (high-tone) muscles are those that do not relax and possibly contract during times of relaxation for micturition or defecation. This type of dysfunction can lead to voiding dysfunction, defecatory dysfunction, and dyspareunia.¹⁹
• Underactive, or low-tone, PFMs cannot contract voluntarily. This can be associated with urinary and anal incontinence and pelvic organ prolapse.
• Nonfunctioning muscles are completely inactive.¹⁹

How to assess. There are several ways to assess PFM tone and strength.²⁰ The first is intravaginal or intrarectal digital palpation, which can be performed when the patient is in a supine or standing position. This examination evaluates PFM tone, squeeze pressure during contraction, symmetry, and relaxation. However, there is no validated scale to quantify PFM strength. Contractions can be further divided into voluntary and involuntary.¹⁹

During the examination, the physician should ask the patient to contract as much as she can to evaluate the maximum strength and sustained contraction for endurance. This measurement can be done with digital palpation or with pressure manometry or dynamometry.

Examination can be focused on the levator ani, piriformis, and internal obturator muscles bilaterally and rated by the patient’s reactions. Pelvic muscle tenderness, which can be highly prevalent in women with chronic pelvic pain, is associated with higher degrees of dyspareunia.²¹ Digital evaluation of the pelvic floor musculature varies in scale, number of fingers used, and parameters evaluated. Lukban et al has described a zero to 4 numbered scale that evaluates tenderness in the pelvic floor.²² The scale denotes “1” as comfortable pressure associated with the exam, “2” as uncomfortable pressure associated with the exam, “3” as moderate pain associated with the exam and that intensifies with contraction, and “4” indicating severe pain with the exam and inability to perform the contraction maneuver due to pain.

Effective treatment includes multiple options

Lifestyle modifications can help

Lifestyle changes may help improve sexual function. These modifications include physical activity, healthy diet, nutrition counseling, and adequate sleep.^23,24

Identifying medical conditions such as depression and anxiety will help delineate differential diagnoses of sexual dysfunction. Cardiovascular diseases may contribute to arousal disorder as a result of atherosclerosis of the vessels supplying the vagina and clitoris. Neurologic diseases such as multiple sclerosis and diabetes can affect sexual dysfunction by impairing arousal and orgasm. Identification of concurrent comorbidities and implementation of lifestyle changes will help improve overall health and may improve sexual function.²⁵

Manual therapies, including transvaginal technique, may relieve female sexual dysfunction that results from a variety of causes.

In addition, Herati et al²⁶ found food sensitivities to grapefruit juice, spicy foods, alcohol, and caffeine were more prevalent in patients with interstitial cystitis and chronic pelvic pain. Avoiding irritants such as soap and other detergents in the perineal region may help decrease dysfunction.²⁷ Finally, foods high in oxalate and other acidic items may cause bladder pain and worsening symptoms of vulvodynia.²⁸

Topical therapies worth considering

Lubricants and moisturizers may help women with dyspareunia or symptoms of vaginal atrophy.

Zestra, for instance, which is applied to the vulva prior to sexual activity, has been proven more effective than placebo for improving desire and arousal.²⁹

Neogyn is a non-hormonal cream containing cutaneous lysate and has been shown to improve vulvar pain in women with vulvodynia. A double-blind placebo-controlled randomized crossover trial followed 30 patients over 3 months and found a significant reduction in pain during sexual activity and a significant reduction in erythema.³⁰

Alprostadil is a prostaglandin E1 analogue that increases genital vasodilation when applied topically and is currently undergoing investigational trials.^31,32 Patients can also choose from many over-the-counter lubricants that contain water-based, oil-based, or silicone-based ingredients.

Don’t overlook physical therapy

Manual therapies, including the transvaginal technique, are used for female sexual dysfunction that results from a variety of causes, including high-tone pelvic floor dysfunction. The transvaginal technique can identify myofascial pain; treatment involves internal release of the PFMs and external trigger point identification and alleviation.

One pilot study, which involved transvaginal Thiele massage twice a week for 5 weeks on 21 symptomatic women with IC and high-tone pelvic floor dysfunction found it decreased hyptertonicity of the pelvic floor and generated statistically significant improvement in the Symptom and Problem Indexes of the O’Leary-Sant Questionnaire, Likert Visual Analogue Scales for urgency and pain, and the Physical and Mental Component Summary from the SF-12 Quality-of-Life Scale.³³ Transvaginal physical therapy is also an effective treatment for myofascial pelvic pain.³⁴

Biofeedback, which can be used in combination with pelvic floor physical therapy, teaches the patient to control the PFMs by visualizing the activity to achieve conscious control over contraction of the pelvic floor and ceasing the cycle of spasm.³⁵ Ger et al³⁶ investigated patients with levator spasm and found biofeedback decreased pain; relief was rated as good or excellent at 15-month follow-up in 6 out of 14 patients (43%).

Home devices such as Eros Therapy, an FDA-approved, nonpharmacologic battery-operated device, provide vacuum suction to the clitoris with vibratory sensation. Eros Therapy has been shown to increase blood flow to the clitoris, vagina, and pelvic floor and increase sensation, orgasm, lubrication, and satisfaction.³⁷

The treatment of female sexual dysfunction may require a multimodal systematic approach targeting genitopelvic pain.

Vaginal dilators allow increasing lengths and girths designed to treat vaginal and pelvic floor pain.³⁸ In our practice, we encourage pelvic muscle strengthening tools in the form of kegal trainers and other insertion devices that may improve PFM coordination and strength.

Pharmacotherapy has its place

The treatment of FSD may require a multimodal systematic approach targeting genito-pelvic pain. But before the best options can be found, it is important to first establish the cause of the pain. Several drug formulations have been effectively used including hormonal and non-hormonal options.

Conjugated estrogens are FDA approved for the treatment of dyspareunia, which can contribute to decreased desire. Systemic estrogen in oral form, transdermal preparations, and topical formulations may increase sexual desire and arousal and decrease dyspareunia.³⁹ Even synthetic steroid compounds such as tibolone may improve sexual function, although it is not FDA approved for that purpose.⁴⁰

Ospemifene (Osphena) is a selective estrogen receptor modulator that acts as an estrogen agonist in select tissues, including vaginal epithelium. It is FDA approved for dyspareunia in postmenopausal women.^41,42 A daily dose of 60 mg is effective and safe with minimal adverse effects.⁴² Studies suggest that testosterone, although not FDA approved in the United States for this purpose, improves sexual desire, pleasure, orgasm, and arousal satisfaction.³⁹ The hormone has not gained FDA approval because of concerns about long-term safety and efficacy.⁴²

Non-hormonal drugs including flibanserin (Addyi), a well-tolerated serotonin receptor 1A agonist, 2A antagonist shown to improve sexual desire, increase the number of satisfying sexual events, and reduce distress associated with low sexual desire when compared with placebo.⁴³ The FDA has approved flibanserin as the first treatment targeted for women with hypoactive sexual desire disorder (HSDD). It can, however, cause severe hypotension and syncope, is not well tolerated with alcohol, and is contraindicated in patients who take strong CYP3A4 inhibitors, such as fluconazole, verapamil, and erythromycin, or who have liver impairment.

Buproprion, a mild dopamine and norepinephrine reuptake inhibitor and acetylcholine receptor antagonist, has been shown to improve desire in women with and without depression. Although it is FDA approved for major depressive disorder, it is not approved for female sexual dysfunction and is still under investigation.

Tricyclic antidepressants such as nortriptyline and amitriptyline may be effective in treating neuropathic pain. Starting doses of both amitriptyline and nortriptyline are 10 mg/d and can be increased to a maximum of 100 mg/d.⁴⁴ Tricyclic antidepressants are still under investigation for the treatment of FSD.

Muscle relaxants in oral and topical compounded form are used to treat increased pelvic floor tension and spasticity. Cyclobenzaprine and tizanidine are FDA-approved muscle relaxants indicated for muscle spasticity.

Cyclobenzaprine, at a starting dose of 10 mg, can be taken up to 3 times a day for pelvic floor tension. Tizanidine is a centrally active alpha 2 agonist that’s superior to placebo in treating high-tone pelvic floor dysfunction.⁴⁴

Other medications include benzodiazepines such as oral clonazepam and intra-vaginal diazepam, although they are not FDA approved for high-tone pelvic floor dysfunction. Rogalski et al reviewed 26 patients who received vaginal diazepam for bladder pain, sexual pain, and levator hypertonus.⁴⁵ They found subjective and sexual pain improvement assessed on FSFI and the visual analog pain scale. PFM tone significantly improved during resting, squeezing, and relaxation phases. Multimodal therapy can be used for muscle spasticity and high-tone pelvic floor dysfunction.

Trigger point and Botox injections

Although drug therapy has its place in the management of sexual dysfunction, other modalities that involve trigger point injections or botulinum toxin injections to the PFMs may prove helpful for patients with high-tone pelvic floor dysfunction.

A prospective study investigated the role of trigger point injections in 18 women with levator ani muscle spasm with a mixture of 0.25% bupivacaine in 10 mL, 2% lidocaine in 10 mL, and 40 mg of triamcinolone in 1 mL combined and used for injection of 5 mL per trigger point.⁴⁶ Three months after injections, 13 of the 18 women improved, resulting in a success rate of 72%. Trigger point injections can be applied externally or transvaginally.

OnabotulinumtoxinA (Botox) has also been tested for relief of levator ani muscle spasm. Botox is FDA approved for upper and lower limb spasticity but is not approved for pelvic floor spasticity or tension. It may reduce pressure in the PFMs and may be useful in women with high-tone pelvic floor dysfunction.⁴⁷

In a prospective 6-month pilot study, 28 patients with pelvic pain who failed conservative treatment received up to 300 U Botox into the pelvic floor.¹¹ The study, which used needle electromyography guidance and a transperineal approach, found that the dyspareunia visual analog scale improved significantly at Weeks 12 and 24. Keep in mind, however, that onabotulinumtoxinA should be reserved for patients who fail conventional treatments.^47,48

Addressing psychological issues

Sex therapy is a traditional approach that aims to improve individual or couples’ sexual experiences and help reduce anxiety related to sex.⁴² Cognitive behavioral sex therapy includes traditional sex therapy components but puts greater emphasis on modifying thought patterns that interfere with intimacy and sex.⁴²

Three months after trigger point injections, 13 of 18 women improved, resulting in a success rate of 72%.

Mindfulness-based cognitive-behavioral treatments have shown promise for sexual desire problems. It is an ancient eastern practice with Buddhist roots. This therapy is a nonjudgmental, present-moment awareness comprised of self-regulation of attention and accepting orientation to the present.⁴⁹ Although there is little evidence from prospective studies, it may benefit women with sexual dysfunction after intervention with sex therapy and cognitive behavioral therapy.

Female sexual dysfunction is common and affects women of all ages. It can negatively impact a women’s quality of life and overall well-being. The etiology of FSD is complex, and treatments are based on the causes of the dysfunction. Difficult cases warrant referral to a specialist in sexual health and female pelvic medicine. Future prospective trials, randomized controlled trials, the use of validated questionnaires, and meta-analyses will continue to move us forward as we find better ways to understand, identify, and treat female sexual dysfunction.

CORRESPONDENCE
Melissa L. Dawson, DO, MS, Department of OB/GYN, Drexel University College of Medicine, 207 N Broad St. 4th Floor, Philadelphia, PA 19107; Melissa.Dawson.DO@gmail.com.

The care of women with female sexual disorders has made great strides since Masters and Johnson first began their study in 1957. In 2000, the Sexual Function Health Council of the American Foundation for Urologic Disease defined the classification system for female sexual dysfunction, which was eventually published and officially defined in the Diagnostic and Statistical Manual of Mental Disorders-IV-TR.¹ There are now definitions for sexual desire disorders, sexual arousal disorders, orgasmic disorder, and sexual pain disorders.

Female sexual dysfunction (FSD) has complex physiologic and psychological components that require a detailed screening, history, and physical examination. Our goal in this review is to provide family physicians with insights and practical advice to help screen, diagnose, and treat female sexual dysfunction, which can have a profound impact on patients’ most intimate relationships.

Understanding the types of female sexual dysfunction

Most women consider sexual health an important part of their overall health.² Factors that can disrupt normal sexual function include aging, socioeconomics, and other medical comorbidities. FSD is common in women throughout their lives and refers to various sexual dysfunctions including diminished arousal, problems achieving orgasm, dyspareunia, and low desire. Its prevalence is reported as high as 20% to 43%.^3,4

The World Health Organization and the US Surgeon General have released statements encouraging health care providers to address sexual health during a patient’s annual visits.⁵ Unfortunately, despite this call to action, many patients and providers are initially hesitant to discuss these problems.⁶

The Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) provides the definition and diagnostic guidelines for the different components of FSD. Its classification of sexual disorders was simplified and published in May 2013.⁷ There are now only 3 female dysfunctions as opposed to 5 in DSM-IV.

• Female hypoactive desire dysfunction and female arousal dysfunction were merged into a single syndrome labeled female sexual interest/arousal disorder.
• The formerly separate dyspareunia (painful intercourse) and vaginismus are now called genitopelvic pain/penetration disorder.
• Female orgasmic disorder remains as a category and is unchanged.

To qualify as a dysfunction, the problem must be present more than 75% of the time, for more than 6 months, causing significant distress, and must not be explained by a nonsexual mental disorder, relationship distress, substance abuse, or a medical condition.

Substance- or medication-induced sexual dysfunction falls under “Other Dysfunctions” and is defined as a clinically significant disturbance in sexual function that is predominant in the clinical picture. The criteria for substance- and medication-induced sexual dysfunction are unchanged and include neither the 75% nor the 6-month requirement. The diagnosis of sexual dysfunction due to a general medical condition and sexual aversion disorder are absent from the DSM-5.⁷

A common symptom. Female sexual disorders can be caused by several complex physiologic and psychological factors. A common symptom among many women is dyspareunia. It is seen more often in postmenopausal women, and its prevalence ranges from 8% to 22%.⁸ Pain on vaginal entry usually indicates vaginal atrophy, vaginal dermatitis, or provoked vestibulodynia. Pain on deep penetration could be caused by endometriosis, interstitial cystitis, or uterine leiomyomas.⁹

The physical examination will reproduce the pain when the vulva or vagina is touched with a cotton swab or when you insert a finger into the vagina. The differential diagnosis is listed in the TABLE.^9-11

Evaluating the patient

Initially, many patients and providers may hesitate to discuss sexual dysfunction, but the annual exam is a good opportunity to broach the topic of sexual health.

Screening and history

Clinicians can screen all patients, regardless of age, with the help of a validated sex questionnaire or during a routine review of systems. There are many validated screening tools available. A simple, integrated screening tool to use is the Brief Sexual Symptom Checklist for Women (BSSC-W), created by the International Consultation in Sexual Medicine.¹² Although recommended by the American Congress of Obstetricians and Gynecologists,⁹ the BSSC-W is not validated. The questionnaire includes 4 questions that ascertain personal information regarding an individual’s overall sexual function satisfaction, the problem causing dysfunction, how bothersome the symptoms are, and if the patient is interested in discussing it with her provider.¹²

The prevalence of female sexual dysfunction is as high as 43%.

It’s important to obtain a detailed obstetric and gynecologic history that includes any sexually transmitted diseases, sexual abuse, urinary and bowel complaints, or surgeries. In addition, you’ll want to differentiate between various types of dysfunctions. A thorough physical examination, including an external and internal pelvic exam, can help to rule out other causes of sexual dysfunction.

General examination: What to look for

The external pelvic examination begins with visual inspection of the vulva, labia majora, and labia minora. Often, this is best accomplished gently with a gloved hand and a cotton swab. This inspection may reveal changes in pubic hair distribution, vulvar skin disorders, lesions, masses, cracks, or fissures. Inspection may also reveal redness and pain typical of vestibulitis, a flattening and pallor of the labia that suggests estrogen deficiency, or pelvic organ prolapse.

The internal pelvic examination begins with a manual evaluation of the muscles of the pelvic floor, uterus, bladder, urethra, anus, and adnexa. Make careful note of any unusual tenderness or pelvic masses. Pelvic floor muscles (PFMs) should voluntarily contract and relax and are not normally tender to palpation. Pelvic organ prolapse and/or hypermobility of the bladder may indicate a weakening of the endopelvic fascia and may cause sexual pain. The size and flexion of the uterus, tenderness in the vaginal fornix possibly indicating endometriosis, and adnexal fullness and/or masses should be identified and evaluated.

Neurologic exam of the pelvis will involve evaluation of sensory and motor function of both lower extremities and include a screening lumbosacral neurologic examination. Lumbosacral examination includes assessment of PFM strength, anal sphincter resting tone, voluntary anal contraction, and perineal sensation. If abnormalities are noted in the screening assessment, a complete comprehensive neurologic examination should be performed.

It’s important to assess pelvic floor muscle strength

Sexual function is associated with normal PFM function.^13,14 The PFMs, particularly the pubococcygeus and iliococcygeus, are responsible for involuntary contractions during orgasm.¹³ Orgasm has been considered a reflex, which is preceded by increased blood flow to the genital organs, tumescence of the vulva and vagina, increased secretions during sexual arousal, and increased tension and contractions of the PFMs.¹⁵

Systemic estrogen in oral form, transdermal preparations, and topical formulations may increase sexual arousal and decrease dyspareunia.

Lowenstein et al found that women with strong or moderate PFM contractions scored significantly higher on both orgasm and arousal domains of the female sexual function index (FSFI) compared with women with weak PFM contractions.¹⁶ Orgasm and arousal functions may be associated with PFM strength, with a positive association between pelvic floor strength and sexual activity and function.^17,18

The function and dysfunction of the PFMs have been characterized as normal, overactive (high tone), underactive (low tone), and non-functioning.

• Normal PFMs are those that can voluntarily and involuntary contract and relax.^19,20
• Overactive (high-tone) muscles are those that do not relax and possibly contract during times of relaxation for micturition or defecation. This type of dysfunction can lead to voiding dysfunction, defecatory dysfunction, and dyspareunia.¹⁹
• Underactive, or low-tone, PFMs cannot contract voluntarily. This can be associated with urinary and anal incontinence and pelvic organ prolapse.
• Nonfunctioning muscles are completely inactive.¹⁹

How to assess. There are several ways to assess PFM tone and strength.²⁰ The first is intravaginal or intrarectal digital palpation, which can be performed when the patient is in a supine or standing position. This examination evaluates PFM tone, squeeze pressure during contraction, symmetry, and relaxation. However, there is no validated scale to quantify PFM strength. Contractions can be further divided into voluntary and involuntary.¹⁹

During the examination, the physician should ask the patient to contract as much as she can to evaluate the maximum strength and sustained contraction for endurance. This measurement can be done with digital palpation or with pressure manometry or dynamometry.

Examination can be focused on the levator ani, piriformis, and internal obturator muscles bilaterally and rated by the patient’s reactions. Pelvic muscle tenderness, which can be highly prevalent in women with chronic pelvic pain, is associated with higher degrees of dyspareunia.²¹ Digital evaluation of the pelvic floor musculature varies in scale, number of fingers used, and parameters evaluated. Lukban et al has described a zero to 4 numbered scale that evaluates tenderness in the pelvic floor.²² The scale denotes “1” as comfortable pressure associated with the exam, “2” as uncomfortable pressure associated with the exam, “3” as moderate pain associated with the exam and that intensifies with contraction, and “4” indicating severe pain with the exam and inability to perform the contraction maneuver due to pain.

Effective treatment includes multiple options

Lifestyle modifications can help

Lifestyle changes may help improve sexual function. These modifications include physical activity, healthy diet, nutrition counseling, and adequate sleep.^23,24

Identifying medical conditions such as depression and anxiety will help delineate differential diagnoses of sexual dysfunction. Cardiovascular diseases may contribute to arousal disorder as a result of atherosclerosis of the vessels supplying the vagina and clitoris. Neurologic diseases such as multiple sclerosis and diabetes can affect sexual dysfunction by impairing arousal and orgasm. Identification of concurrent comorbidities and implementation of lifestyle changes will help improve overall health and may improve sexual function.²⁵

Manual therapies, including transvaginal technique, may relieve female sexual dysfunction that results from a variety of causes.

In addition, Herati et al²⁶ found food sensitivities to grapefruit juice, spicy foods, alcohol, and caffeine were more prevalent in patients with interstitial cystitis and chronic pelvic pain. Avoiding irritants such as soap and other detergents in the perineal region may help decrease dysfunction.²⁷ Finally, foods high in oxalate and other acidic items may cause bladder pain and worsening symptoms of vulvodynia.²⁸

Topical therapies worth considering

Lubricants and moisturizers may help women with dyspareunia or symptoms of vaginal atrophy.

Zestra, for instance, which is applied to the vulva prior to sexual activity, has been proven more effective than placebo for improving desire and arousal.²⁹

Neogyn is a non-hormonal cream containing cutaneous lysate and has been shown to improve vulvar pain in women with vulvodynia. A double-blind placebo-controlled randomized crossover trial followed 30 patients over 3 months and found a significant reduction in pain during sexual activity and a significant reduction in erythema.³⁰

Alprostadil is a prostaglandin E1 analogue that increases genital vasodilation when applied topically and is currently undergoing investigational trials.^31,32 Patients can also choose from many over-the-counter lubricants that contain water-based, oil-based, or silicone-based ingredients.

Don’t overlook physical therapy

Manual therapies, including the transvaginal technique, are used for female sexual dysfunction that results from a variety of causes, including high-tone pelvic floor dysfunction. The transvaginal technique can identify myofascial pain; treatment involves internal release of the PFMs and external trigger point identification and alleviation.

One pilot study, which involved transvaginal Thiele massage twice a week for 5 weeks on 21 symptomatic women with IC and high-tone pelvic floor dysfunction found it decreased hyptertonicity of the pelvic floor and generated statistically significant improvement in the Symptom and Problem Indexes of the O’Leary-Sant Questionnaire, Likert Visual Analogue Scales for urgency and pain, and the Physical and Mental Component Summary from the SF-12 Quality-of-Life Scale.³³ Transvaginal physical therapy is also an effective treatment for myofascial pelvic pain.³⁴

Biofeedback, which can be used in combination with pelvic floor physical therapy, teaches the patient to control the PFMs by visualizing the activity to achieve conscious control over contraction of the pelvic floor and ceasing the cycle of spasm.³⁵ Ger et al³⁶ investigated patients with levator spasm and found biofeedback decreased pain; relief was rated as good or excellent at 15-month follow-up in 6 out of 14 patients (43%).

Home devices such as Eros Therapy, an FDA-approved, nonpharmacologic battery-operated device, provide vacuum suction to the clitoris with vibratory sensation. Eros Therapy has been shown to increase blood flow to the clitoris, vagina, and pelvic floor and increase sensation, orgasm, lubrication, and satisfaction.³⁷

The treatment of female sexual dysfunction may require a multimodal systematic approach targeting genitopelvic pain.

Vaginal dilators allow increasing lengths and girths designed to treat vaginal and pelvic floor pain.³⁸ In our practice, we encourage pelvic muscle strengthening tools in the form of kegal trainers and other insertion devices that may improve PFM coordination and strength.

Pharmacotherapy has its place

The treatment of FSD may require a multimodal systematic approach targeting genito-pelvic pain. But before the best options can be found, it is important to first establish the cause of the pain. Several drug formulations have been effectively used including hormonal and non-hormonal options.

Conjugated estrogens are FDA approved for the treatment of dyspareunia, which can contribute to decreased desire. Systemic estrogen in oral form, transdermal preparations, and topical formulations may increase sexual desire and arousal and decrease dyspareunia.³⁹ Even synthetic steroid compounds such as tibolone may improve sexual function, although it is not FDA approved for that purpose.⁴⁰

Ospemifene (Osphena) is a selective estrogen receptor modulator that acts as an estrogen agonist in select tissues, including vaginal epithelium. It is FDA approved for dyspareunia in postmenopausal women.^41,42 A daily dose of 60 mg is effective and safe with minimal adverse effects.⁴² Studies suggest that testosterone, although not FDA approved in the United States for this purpose, improves sexual desire, pleasure, orgasm, and arousal satisfaction.³⁹ The hormone has not gained FDA approval because of concerns about long-term safety and efficacy.⁴²

Non-hormonal drugs including flibanserin (Addyi), a well-tolerated serotonin receptor 1A agonist, 2A antagonist shown to improve sexual desire, increase the number of satisfying sexual events, and reduce distress associated with low sexual desire when compared with placebo.⁴³ The FDA has approved flibanserin as the first treatment targeted for women with hypoactive sexual desire disorder (HSDD). It can, however, cause severe hypotension and syncope, is not well tolerated with alcohol, and is contraindicated in patients who take strong CYP3A4 inhibitors, such as fluconazole, verapamil, and erythromycin, or who have liver impairment.

Buproprion, a mild dopamine and norepinephrine reuptake inhibitor and acetylcholine receptor antagonist, has been shown to improve desire in women with and without depression. Although it is FDA approved for major depressive disorder, it is not approved for female sexual dysfunction and is still under investigation.

Tricyclic antidepressants such as nortriptyline and amitriptyline may be effective in treating neuropathic pain. Starting doses of both amitriptyline and nortriptyline are 10 mg/d and can be increased to a maximum of 100 mg/d.⁴⁴ Tricyclic antidepressants are still under investigation for the treatment of FSD.

Muscle relaxants in oral and topical compounded form are used to treat increased pelvic floor tension and spasticity. Cyclobenzaprine and tizanidine are FDA-approved muscle relaxants indicated for muscle spasticity.

Cyclobenzaprine, at a starting dose of 10 mg, can be taken up to 3 times a day for pelvic floor tension. Tizanidine is a centrally active alpha 2 agonist that’s superior to placebo in treating high-tone pelvic floor dysfunction.⁴⁴

Other medications include benzodiazepines such as oral clonazepam and intra-vaginal diazepam, although they are not FDA approved for high-tone pelvic floor dysfunction. Rogalski et al reviewed 26 patients who received vaginal diazepam for bladder pain, sexual pain, and levator hypertonus.⁴⁵ They found subjective and sexual pain improvement assessed on FSFI and the visual analog pain scale. PFM tone significantly improved during resting, squeezing, and relaxation phases. Multimodal therapy can be used for muscle spasticity and high-tone pelvic floor dysfunction.

Trigger point and Botox injections

Although drug therapy has its place in the management of sexual dysfunction, other modalities that involve trigger point injections or botulinum toxin injections to the PFMs may prove helpful for patients with high-tone pelvic floor dysfunction.

A prospective study investigated the role of trigger point injections in 18 women with levator ani muscle spasm with a mixture of 0.25% bupivacaine in 10 mL, 2% lidocaine in 10 mL, and 40 mg of triamcinolone in 1 mL combined and used for injection of 5 mL per trigger point.⁴⁶ Three months after injections, 13 of the 18 women improved, resulting in a success rate of 72%. Trigger point injections can be applied externally or transvaginally.

OnabotulinumtoxinA (Botox) has also been tested for relief of levator ani muscle spasm. Botox is FDA approved for upper and lower limb spasticity but is not approved for pelvic floor spasticity or tension. It may reduce pressure in the PFMs and may be useful in women with high-tone pelvic floor dysfunction.⁴⁷

In a prospective 6-month pilot study, 28 patients with pelvic pain who failed conservative treatment received up to 300 U Botox into the pelvic floor.¹¹ The study, which used needle electromyography guidance and a transperineal approach, found that the dyspareunia visual analog scale improved significantly at Weeks 12 and 24. Keep in mind, however, that onabotulinumtoxinA should be reserved for patients who fail conventional treatments.^47,48

Addressing psychological issues

Sex therapy is a traditional approach that aims to improve individual or couples’ sexual experiences and help reduce anxiety related to sex.⁴² Cognitive behavioral sex therapy includes traditional sex therapy components but puts greater emphasis on modifying thought patterns that interfere with intimacy and sex.⁴²

Three months after trigger point injections, 13 of 18 women improved, resulting in a success rate of 72%.

Mindfulness-based cognitive-behavioral treatments have shown promise for sexual desire problems. It is an ancient eastern practice with Buddhist roots. This therapy is a nonjudgmental, present-moment awareness comprised of self-regulation of attention and accepting orientation to the present.⁴⁹ Although there is little evidence from prospective studies, it may benefit women with sexual dysfunction after intervention with sex therapy and cognitive behavioral therapy.

Female sexual dysfunction is common and affects women of all ages. It can negatively impact a women’s quality of life and overall well-being. The etiology of FSD is complex, and treatments are based on the causes of the dysfunction. Difficult cases warrant referral to a specialist in sexual health and female pelvic medicine. Future prospective trials, randomized controlled trials, the use of validated questionnaires, and meta-analyses will continue to move us forward as we find better ways to understand, identify, and treat female sexual dysfunction.

CORRESPONDENCE
Melissa L. Dawson, DO, MS, Department of OB/GYN, Drexel University College of Medicine, 207 N Broad St. 4th Floor, Philadelphia, PA 19107; Melissa.Dawson.DO@gmail.com.

Here are 5 articles in the December issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. When Is It Really Recurrent Strep Throat?

To take the posttest, go to: http://bit.ly/2lHFh8i
Expires September 21, 2018

2. Revised Bethesda System Resets Thyroid Malignancy Risks

To take the posttest, go to: http://bit.ly/2iSLOvM
Expires August 10, 2018

3. Tips for Avoiding Potentially Dangerous Patients

To take the posttest, go to: http://bit.ly/2lH1Fi7
Expires August 10, 2018

4. Study Findings Support Uncapping MELD Score

To take the posttest, go to: http://bit.ly/2xOA7sI
Expires September 12, 2018

5. 'Motivational Pharmacotherapy' Engages Latino Patients With Depression

To take the posttest, go to: http://bit.ly/2zs2ly4
Expires August 14, 2018

Here are 5 articles in the December issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. When Is It Really Recurrent Strep Throat?

To take the posttest, go to: http://bit.ly/2lHFh8i
Expires September 21, 2018

2. Revised Bethesda System Resets Thyroid Malignancy Risks

To take the posttest, go to: http://bit.ly/2iSLOvM
Expires August 10, 2018

3. Tips for Avoiding Potentially Dangerous Patients

To take the posttest, go to: http://bit.ly/2lH1Fi7
Expires August 10, 2018

4. Study Findings Support Uncapping MELD Score

To take the posttest, go to: http://bit.ly/2xOA7sI
Expires September 12, 2018

5. 'Motivational Pharmacotherapy' Engages Latino Patients With Depression

To take the posttest, go to: http://bit.ly/2zs2ly4
Expires August 14, 2018

Here are 5 articles in the December issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. When Is It Really Recurrent Strep Throat?

To take the posttest, go to: http://bit.ly/2lHFh8i
Expires September 21, 2018

2. Revised Bethesda System Resets Thyroid Malignancy Risks

To take the posttest, go to: http://bit.ly/2iSLOvM
Expires August 10, 2018

3. Tips for Avoiding Potentially Dangerous Patients

To take the posttest, go to: http://bit.ly/2lH1Fi7
Expires August 10, 2018

4. Study Findings Support Uncapping MELD Score

To take the posttest, go to: http://bit.ly/2xOA7sI
Expires September 12, 2018

5. 'Motivational Pharmacotherapy' Engages Latino Patients With Depression

To take the posttest, go to: http://bit.ly/2zs2ly4
Expires August 14, 2018

This month we learned of the passing of Dr. Marv Sleisenger. There are few physicians who have had a greater impact on our field than Dr. Sleisenger. He was a consummate gentleman, enthusiastic teacher, great mentor, authored hundreds of research papers, and edited the most famous textbook of gastroenterology. Our thoughts and hearts are with his family and friends.

John I. Allen, MD, MBA, AGAF

Editor in Chief

This month we learned of the passing of Dr. Marv Sleisenger. There are few physicians who have had a greater impact on our field than Dr. Sleisenger. He was a consummate gentleman, enthusiastic teacher, great mentor, authored hundreds of research papers, and edited the most famous textbook of gastroenterology. Our thoughts and hearts are with his family and friends.

John I. Allen, MD, MBA, AGAF

Editor in Chief

This month we learned of the passing of Dr. Marv Sleisenger. There are few physicians who have had a greater impact on our field than Dr. Sleisenger. He was a consummate gentleman, enthusiastic teacher, great mentor, authored hundreds of research papers, and edited the most famous textbook of gastroenterology. Our thoughts and hearts are with his family and friends.

John I. Allen, MD, MBA, AGAF

Editor in Chief

Timely access to cancer care can translate into improved outcomes and quality of care, better patient quality of life, and cost savings for patients, practices, and society alike. There are many ways to facilitate such access, starting with educating patients and caregivers about its importance and that ensuring routine screening recommendations are followed to increase the likelihood of earlier-stage diagnosis and therefore earlier therapy initiation. But literal access – physically getting to the point of care – can also be an issue. For patients who live in rural or remote areas or those of low socioeconomic status, even in an urban area, the cost and logistics of getting to the point of care for treatment can be prohibitive, especially if the various components of care are not consolidated. Two articles in this issue focus on access to care and the impact on outcomes.

On page e263, Margaret Kemeny reports on the impact on outcomes and quality of care in patients of low socioeconomic status who were treated for breast cancer at a centralized cancer care center. The center was established at a public hospital in Queens, New York, to provide single-site, comprehensive care encompassing the clinical, supportive, and clerical-financial aspects of care during all phases of the disease trajectory. Kemeny compared the data of breast cancer patients treated at the hospital before the center was established with the five-year data of those treated at the cancer care center. She found that several factors changed, among them, that there was an increase in the number of patients diagnosed with earlier-stage breast cancer, an increase in the use of lumpectomies, and an increase in survival for patients with stage 3 disease. Not only are the findings of this study compelling, but the introduction and discussion sections provide a useful review of related literature as well as some practical “how-to” pointers for anyone thinking about setting up a similar center.

Gilbertson-White and colleagues continue with the theme of access to care in cancer patients, but shift the focus in their systemic literature review to supportive and palliative interventions for patients with advanced disease who live in rural communities (p. e248). Compared with urban communities, the rates of late-stage cancer and mortality are higher in rural communities, where low socioeconomic status, inadequate health coverage, and less workplace flexibility and social support hamper access to care. The findings show that the interventions resulted in a reduction in physical and emotional symptoms; improvement in patient quality of life and well-being, access to health care services, and quality of care; and cost savings for patients who received care from rural- instead of urban-based hospitals. The authors emphasize the importance of technology, especially tele- and video-conferencing, in delivering palliative and supportive care to underserved communities.

Patient-reported outcomes have been described as a picture of the patient perspective on treatment and its side effects, and they are increasingly being included in clinical trials and incorporated into the delivery of quality care. Valenti and colleagues studied the impact of cancer-therapy–related adverse events (AEs) on patient quality of life (p. e256). They compared the impact on quality of life reported by cancer patients who had experienced a particular AE with the impact envisioned by participants from the general public who had not experienced AEs and found that those who had experienced AEs perceived a lower impact on quality of life compared with the general public participants who had not experienced the AEs.

Also in this issue are a pertinent and comprehensive review of the latest in breast cancer therapies, specifically targeted therapies for multiple subtypes (p. e277); two Case Reports, one on managing tonsillar carcinoma with advanced radiation and chemotherapy techniques (p. e268), another on familial essential thrombocythemia associated with JAK2 V617F mutation in siblings (p. e274); and Community Translations articles on the approvals of atezolizumab for non–small-cell lung cancer (p. e 242)and lenlidomide for multiple myeloma in the maintenance setting (p. e245).

Timely access to cancer care can translate into improved outcomes and quality of care, better patient quality of life, and cost savings for patients, practices, and society alike. There are many ways to facilitate such access, starting with educating patients and caregivers about its importance and that ensuring routine screening recommendations are followed to increase the likelihood of earlier-stage diagnosis and therefore earlier therapy initiation. But literal access – physically getting to the point of care – can also be an issue. For patients who live in rural or remote areas or those of low socioeconomic status, even in an urban area, the cost and logistics of getting to the point of care for treatment can be prohibitive, especially if the various components of care are not consolidated. Two articles in this issue focus on access to care and the impact on outcomes.

On page e263, Margaret Kemeny reports on the impact on outcomes and quality of care in patients of low socioeconomic status who were treated for breast cancer at a centralized cancer care center. The center was established at a public hospital in Queens, New York, to provide single-site, comprehensive care encompassing the clinical, supportive, and clerical-financial aspects of care during all phases of the disease trajectory. Kemeny compared the data of breast cancer patients treated at the hospital before the center was established with the five-year data of those treated at the cancer care center. She found that several factors changed, among them, that there was an increase in the number of patients diagnosed with earlier-stage breast cancer, an increase in the use of lumpectomies, and an increase in survival for patients with stage 3 disease. Not only are the findings of this study compelling, but the introduction and discussion sections provide a useful review of related literature as well as some practical “how-to” pointers for anyone thinking about setting up a similar center.

Gilbertson-White and colleagues continue with the theme of access to care in cancer patients, but shift the focus in their systemic literature review to supportive and palliative interventions for patients with advanced disease who live in rural communities (p. e248). Compared with urban communities, the rates of late-stage cancer and mortality are higher in rural communities, where low socioeconomic status, inadequate health coverage, and less workplace flexibility and social support hamper access to care. The findings show that the interventions resulted in a reduction in physical and emotional symptoms; improvement in patient quality of life and well-being, access to health care services, and quality of care; and cost savings for patients who received care from rural- instead of urban-based hospitals. The authors emphasize the importance of technology, especially tele- and video-conferencing, in delivering palliative and supportive care to underserved communities.

Patient-reported outcomes have been described as a picture of the patient perspective on treatment and its side effects, and they are increasingly being included in clinical trials and incorporated into the delivery of quality care. Valenti and colleagues studied the impact of cancer-therapy–related adverse events (AEs) on patient quality of life (p. e256). They compared the impact on quality of life reported by cancer patients who had experienced a particular AE with the impact envisioned by participants from the general public who had not experienced AEs and found that those who had experienced AEs perceived a lower impact on quality of life compared with the general public participants who had not experienced the AEs.

Also in this issue are a pertinent and comprehensive review of the latest in breast cancer therapies, specifically targeted therapies for multiple subtypes (p. e277); two Case Reports, one on managing tonsillar carcinoma with advanced radiation and chemotherapy techniques (p. e268), another on familial essential thrombocythemia associated with JAK2 V617F mutation in siblings (p. e274); and Community Translations articles on the approvals of atezolizumab for non–small-cell lung cancer (p. e 242)and lenlidomide for multiple myeloma in the maintenance setting (p. e245).

Timely access to cancer care can translate into improved outcomes and quality of care, better patient quality of life, and cost savings for patients, practices, and society alike. There are many ways to facilitate such access, starting with educating patients and caregivers about its importance and that ensuring routine screening recommendations are followed to increase the likelihood of earlier-stage diagnosis and therefore earlier therapy initiation. But literal access – physically getting to the point of care – can also be an issue. For patients who live in rural or remote areas or those of low socioeconomic status, even in an urban area, the cost and logistics of getting to the point of care for treatment can be prohibitive, especially if the various components of care are not consolidated. Two articles in this issue focus on access to care and the impact on outcomes.

On page e263, Margaret Kemeny reports on the impact on outcomes and quality of care in patients of low socioeconomic status who were treated for breast cancer at a centralized cancer care center. The center was established at a public hospital in Queens, New York, to provide single-site, comprehensive care encompassing the clinical, supportive, and clerical-financial aspects of care during all phases of the disease trajectory. Kemeny compared the data of breast cancer patients treated at the hospital before the center was established with the five-year data of those treated at the cancer care center. She found that several factors changed, among them, that there was an increase in the number of patients diagnosed with earlier-stage breast cancer, an increase in the use of lumpectomies, and an increase in survival for patients with stage 3 disease. Not only are the findings of this study compelling, but the introduction and discussion sections provide a useful review of related literature as well as some practical “how-to” pointers for anyone thinking about setting up a similar center.

Gilbertson-White and colleagues continue with the theme of access to care in cancer patients, but shift the focus in their systemic literature review to supportive and palliative interventions for patients with advanced disease who live in rural communities (p. e248). Compared with urban communities, the rates of late-stage cancer and mortality are higher in rural communities, where low socioeconomic status, inadequate health coverage, and less workplace flexibility and social support hamper access to care. The findings show that the interventions resulted in a reduction in physical and emotional symptoms; improvement in patient quality of life and well-being, access to health care services, and quality of care; and cost savings for patients who received care from rural- instead of urban-based hospitals. The authors emphasize the importance of technology, especially tele- and video-conferencing, in delivering palliative and supportive care to underserved communities.

Patient-reported outcomes have been described as a picture of the patient perspective on treatment and its side effects, and they are increasingly being included in clinical trials and incorporated into the delivery of quality care. Valenti and colleagues studied the impact of cancer-therapy–related adverse events (AEs) on patient quality of life (p. e256). They compared the impact on quality of life reported by cancer patients who had experienced a particular AE with the impact envisioned by participants from the general public who had not experienced AEs and found that those who had experienced AEs perceived a lower impact on quality of life compared with the general public participants who had not experienced the AEs.

Also in this issue are a pertinent and comprehensive review of the latest in breast cancer therapies, specifically targeted therapies for multiple subtypes (p. e277); two Case Reports, one on managing tonsillar carcinoma with advanced radiation and chemotherapy techniques (p. e268), another on familial essential thrombocythemia associated with JAK2 V617F mutation in siblings (p. e274); and Community Translations articles on the approvals of atezolizumab for non–small-cell lung cancer (p. e 242)and lenlidomide for multiple myeloma in the maintenance setting (p. e245).

Training community health providers to treat chronic hepatitis C virus infection is a cost-effective way to expand treatment access and reduce the national burden of this prevalent condition, according to research published in the December issue of Gastroenterology (doi: 10.1053/j.gastro.2017.10.016).

The model, dubbed Project ECHO, “is the best way, to our knowledge, to cost-effectively find and treat HCV patients at scale,” wrote Thilo Rattay, MPH, of the University of Michigan School of Public Health, Ann Arbor, and his associates. “Our analysis demonstrates that fundamentally changing the care delivery model for HCV enables unparalleled reach, in contrast to simply using ever more cost-effective drugs in an inefficient system. Project ECHO can quickly reduce the burden of disease from HCV and accelerate the impact of the new generation of highly effective medications.”

 

Project ECHO (echo.unm.edu) links multidisciplinary teams of specialists (hubs) to physicians and nurse practitioners in community practice (spokes). Each hub, which is usually based at an academic medical center, holds video conferences to mentor and teach providers about best practices for managing conditions ranging from autism to Zika virus infection. Initial reports suggest that Project ECHO can improve health care quality and access as well as job satisfaction among primary care providers, the researchers noted.

Project ECHO has 127 hubs globally, including 77 in the United States, and receives support from foundations, state legislatures, and government agencies. Because patients with chronic HCV vastly outnumber gastroenterologists in the United States, Mr. Rattay and his coinvestigators used Markov models to evaluate Project ECHO’s cost-effectiveness in the HCV setting. To do so, they created a decision tree and Markov models with Microsoft Excel, PrecisionTree, and @RISK by using data from the U.S. Census Bureau, MarketScan, and an extensive literature review

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

The models yielded an incremental cost-effectiveness ratio of $10,351 per quality-adjusted life year when compared with the status quo, said the researchers. Commonly cited willingness-to-pay thresholds are $50,000 and $100,000, indicating that Project ECHO is a cost-effective way to expand HCV treatment, they added. However, insurers would pay substantially more during the first 5 years of rollout – about $708 million versus $368 million with the status quo. During the first year, ECHO would cost payers about $350.5 million more than would the status quo, but 4,446 more patients would be treated, drastically reducing prevalence in the insurance pool. Consequently, subsequent costs would drop by nearly $11 million over the first 5 years of ECHO. Nonetheless, the “high budgetary costs suggest that incremental rollout of [Project] ECHO may be best,” the investigators wrote.

They were unable to determine whether increased treatment under ECHO relates to expanded screening, treatment adherence, or access, but sensitivity analyses suggested that “results are largely independent of the cause,” the researchers wrote. “Importantly, most of the financial benefits of treating HCV are not immediate, while a majority of the costs are upfront,” they stressed. Stakeholders therefore need to adopt a long-term view and consider population-based health care models and reimbursement strategies that “capture the full benefit of this type of ecosystem.”

The investigators had no external funding sources and no conflicts of interest.

Training community health providers to treat chronic hepatitis C virus infection is a cost-effective way to expand treatment access and reduce the national burden of this prevalent condition, according to research published in the December issue of Gastroenterology (doi: 10.1053/j.gastro.2017.10.016).

The model, dubbed Project ECHO, “is the best way, to our knowledge, to cost-effectively find and treat HCV patients at scale,” wrote Thilo Rattay, MPH, of the University of Michigan School of Public Health, Ann Arbor, and his associates. “Our analysis demonstrates that fundamentally changing the care delivery model for HCV enables unparalleled reach, in contrast to simply using ever more cost-effective drugs in an inefficient system. Project ECHO can quickly reduce the burden of disease from HCV and accelerate the impact of the new generation of highly effective medications.”

 

Project ECHO (echo.unm.edu) links multidisciplinary teams of specialists (hubs) to physicians and nurse practitioners in community practice (spokes). Each hub, which is usually based at an academic medical center, holds video conferences to mentor and teach providers about best practices for managing conditions ranging from autism to Zika virus infection. Initial reports suggest that Project ECHO can improve health care quality and access as well as job satisfaction among primary care providers, the researchers noted.

Project ECHO has 127 hubs globally, including 77 in the United States, and receives support from foundations, state legislatures, and government agencies. Because patients with chronic HCV vastly outnumber gastroenterologists in the United States, Mr. Rattay and his coinvestigators used Markov models to evaluate Project ECHO’s cost-effectiveness in the HCV setting. To do so, they created a decision tree and Markov models with Microsoft Excel, PrecisionTree, and @RISK by using data from the U.S. Census Bureau, MarketScan, and an extensive literature review

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

The models yielded an incremental cost-effectiveness ratio of $10,351 per quality-adjusted life year when compared with the status quo, said the researchers. Commonly cited willingness-to-pay thresholds are $50,000 and $100,000, indicating that Project ECHO is a cost-effective way to expand HCV treatment, they added. However, insurers would pay substantially more during the first 5 years of rollout – about $708 million versus $368 million with the status quo. During the first year, ECHO would cost payers about $350.5 million more than would the status quo, but 4,446 more patients would be treated, drastically reducing prevalence in the insurance pool. Consequently, subsequent costs would drop by nearly $11 million over the first 5 years of ECHO. Nonetheless, the “high budgetary costs suggest that incremental rollout of [Project] ECHO may be best,” the investigators wrote.

They were unable to determine whether increased treatment under ECHO relates to expanded screening, treatment adherence, or access, but sensitivity analyses suggested that “results are largely independent of the cause,” the researchers wrote. “Importantly, most of the financial benefits of treating HCV are not immediate, while a majority of the costs are upfront,” they stressed. Stakeholders therefore need to adopt a long-term view and consider population-based health care models and reimbursement strategies that “capture the full benefit of this type of ecosystem.”

The investigators had no external funding sources and no conflicts of interest.

Training community health providers to treat chronic hepatitis C virus infection is a cost-effective way to expand treatment access and reduce the national burden of this prevalent condition, according to research published in the December issue of Gastroenterology (doi: 10.1053/j.gastro.2017.10.016).

The model, dubbed Project ECHO, “is the best way, to our knowledge, to cost-effectively find and treat HCV patients at scale,” wrote Thilo Rattay, MPH, of the University of Michigan School of Public Health, Ann Arbor, and his associates. “Our analysis demonstrates that fundamentally changing the care delivery model for HCV enables unparalleled reach, in contrast to simply using ever more cost-effective drugs in an inefficient system. Project ECHO can quickly reduce the burden of disease from HCV and accelerate the impact of the new generation of highly effective medications.”

 

Project ECHO (echo.unm.edu) links multidisciplinary teams of specialists (hubs) to physicians and nurse practitioners in community practice (spokes). Each hub, which is usually based at an academic medical center, holds video conferences to mentor and teach providers about best practices for managing conditions ranging from autism to Zika virus infection. Initial reports suggest that Project ECHO can improve health care quality and access as well as job satisfaction among primary care providers, the researchers noted.

Project ECHO has 127 hubs globally, including 77 in the United States, and receives support from foundations, state legislatures, and government agencies. Because patients with chronic HCV vastly outnumber gastroenterologists in the United States, Mr. Rattay and his coinvestigators used Markov models to evaluate Project ECHO’s cost-effectiveness in the HCV setting. To do so, they created a decision tree and Markov models with Microsoft Excel, PrecisionTree, and @RISK by using data from the U.S. Census Bureau, MarketScan, and an extensive literature review

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

The models yielded an incremental cost-effectiveness ratio of $10,351 per quality-adjusted life year when compared with the status quo, said the researchers. Commonly cited willingness-to-pay thresholds are $50,000 and $100,000, indicating that Project ECHO is a cost-effective way to expand HCV treatment, they added. However, insurers would pay substantially more during the first 5 years of rollout – about $708 million versus $368 million with the status quo. During the first year, ECHO would cost payers about $350.5 million more than would the status quo, but 4,446 more patients would be treated, drastically reducing prevalence in the insurance pool. Consequently, subsequent costs would drop by nearly $11 million over the first 5 years of ECHO. Nonetheless, the “high budgetary costs suggest that incremental rollout of [Project] ECHO may be best,” the investigators wrote.

They were unable to determine whether increased treatment under ECHO relates to expanded screening, treatment adherence, or access, but sensitivity analyses suggested that “results are largely independent of the cause,” the researchers wrote. “Importantly, most of the financial benefits of treating HCV are not immediate, while a majority of the costs are upfront,” they stressed. Stakeholders therefore need to adopt a long-term view and consider population-based health care models and reimbursement strategies that “capture the full benefit of this type of ecosystem.”

The investigators had no external funding sources and no conflicts of interest.

PARIS – Forty percent of patients with major depressive disorder who receive a selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor (SNRI) as their initial pharmacotherapy do not achieve the minimum therapeutic dose within 4 weeks of diagnosis, according to a real-world study of U.S. practice patterns.

This finding from a retrospective analysis of more than 60,000 adults diagnosed with major depressive disorder (MDD) during 2010-2015 and newly treated with an SSRI or SNRI as their first-line medication highlights an area where improved treatment delivery could lead to better outcomes, Rita Prieto, MD, PhD, said at the annual congress of the European College of Neuropsychopharmacology.

Brent_Davis/Thinkstock

The study was funded by Pfizer.

bjancin@frontlinemedcom.com

PARIS – Forty percent of patients with major depressive disorder who receive a selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor (SNRI) as their initial pharmacotherapy do not achieve the minimum therapeutic dose within 4 weeks of diagnosis, according to a real-world study of U.S. practice patterns.

This finding from a retrospective analysis of more than 60,000 adults diagnosed with major depressive disorder (MDD) during 2010-2015 and newly treated with an SSRI or SNRI as their first-line medication highlights an area where improved treatment delivery could lead to better outcomes, Rita Prieto, MD, PhD, said at the annual congress of the European College of Neuropsychopharmacology.

Brent_Davis/Thinkstock

The study was funded by Pfizer.

bjancin@frontlinemedcom.com

PARIS – Forty percent of patients with major depressive disorder who receive a selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor (SNRI) as their initial pharmacotherapy do not achieve the minimum therapeutic dose within 4 weeks of diagnosis, according to a real-world study of U.S. practice patterns.

This finding from a retrospective analysis of more than 60,000 adults diagnosed with major depressive disorder (MDD) during 2010-2015 and newly treated with an SSRI or SNRI as their first-line medication highlights an area where improved treatment delivery could lead to better outcomes, Rita Prieto, MD, PhD, said at the annual congress of the European College of Neuropsychopharmacology.

Brent_Davis/Thinkstock

The study was funded by Pfizer.

bjancin@frontlinemedcom.com

What will the practice of gastroenterology look like in 20 years? It is our hope that physicians will have an abundance of new tools and treatments to care for their patients suffering from digestive disorders.

How will we get there? New treatments and devices are the result of years of research.

What will the practice of gastroenterology look like in 20 years? It is our hope that physicians will have an abundance of new tools and treatments to care for their patients suffering from digestive disorders.

How will we get there? New treatments and devices are the result of years of research.

What will the practice of gastroenterology look like in 20 years? It is our hope that physicians will have an abundance of new tools and treatments to care for their patients suffering from digestive disorders.

How will we get there? New treatments and devices are the result of years of research.

After palpating the soft growths and noting more than 5 café au lait macules and axillary freckling, the FP made a diagnosis of neurofibromatosis type 1. Neurofibromatosis type 1 is an autosomal dominant genetic condition that leads to the development of tumors along the nerves in the skin, brain, and other parts of the body. The FP explained to the patient that these were neurofibromas—not skin tags—and that there can be serious health issues associated with neurofibromatosis, including tumors of the eye (optic gliomas) and nervous system. The patient was willing to see an ophthalmologist, but still wanted some of the growths removed.

The FP scheduled an appointment to remove some of the neurofibromas. He explained to the patient that he would not have time to remove them all but could take care of the ones that bothered her the most. At the patient’s next scheduled appointment, the FP removed the largest neurofibroma on the anterior neck using an elliptical excision at the base of the neurofibroma and sutured it closed using 4-0 nylon as a running suture. The FP sent the first excision to Pathology. (See a video on how to perform an elliptical excision here.)

One week later, the patient returned to have the sutures removed. The pathology report had come back and it confirmed the diagnosis of neurofibromas. The FP planned to remove some of the small neurofibromas using punch excision in the future. At follow-up one month later, the patient was happy with how her skin had healed. Her ophthalmology evaluation did not show any serious tumors.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith AM. Skin tags. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013: 922-925.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

After palpating the soft growths and noting more than 5 café au lait macules and axillary freckling, the FP made a diagnosis of neurofibromatosis type 1. Neurofibromatosis type 1 is an autosomal dominant genetic condition that leads to the development of tumors along the nerves in the skin, brain, and other parts of the body. The FP explained to the patient that these were neurofibromas—not skin tags—and that there can be serious health issues associated with neurofibromatosis, including tumors of the eye (optic gliomas) and nervous system. The patient was willing to see an ophthalmologist, but still wanted some of the growths removed.

The FP scheduled an appointment to remove some of the neurofibromas. He explained to the patient that he would not have time to remove them all but could take care of the ones that bothered her the most. At the patient’s next scheduled appointment, the FP removed the largest neurofibroma on the anterior neck using an elliptical excision at the base of the neurofibroma and sutured it closed using 4-0 nylon as a running suture. The FP sent the first excision to Pathology. (See a video on how to perform an elliptical excision here.)

One week later, the patient returned to have the sutures removed. The pathology report had come back and it confirmed the diagnosis of neurofibromas. The FP planned to remove some of the small neurofibromas using punch excision in the future. At follow-up one month later, the patient was happy with how her skin had healed. Her ophthalmology evaluation did not show any serious tumors.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith AM. Skin tags. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013: 922-925.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

After palpating the soft growths and noting more than 5 café au lait macules and axillary freckling, the FP made a diagnosis of neurofibromatosis type 1. Neurofibromatosis type 1 is an autosomal dominant genetic condition that leads to the development of tumors along the nerves in the skin, brain, and other parts of the body. The FP explained to the patient that these were neurofibromas—not skin tags—and that there can be serious health issues associated with neurofibromatosis, including tumors of the eye (optic gliomas) and nervous system. The patient was willing to see an ophthalmologist, but still wanted some of the growths removed.

The FP scheduled an appointment to remove some of the neurofibromas. He explained to the patient that he would not have time to remove them all but could take care of the ones that bothered her the most. At the patient’s next scheduled appointment, the FP removed the largest neurofibroma on the anterior neck using an elliptical excision at the base of the neurofibroma and sutured it closed using 4-0 nylon as a running suture. The FP sent the first excision to Pathology. (See a video on how to perform an elliptical excision here.)

One week later, the patient returned to have the sutures removed. The pathology report had come back and it confirmed the diagnosis of neurofibromas. The FP planned to remove some of the small neurofibromas using punch excision in the future. At follow-up one month later, the patient was happy with how her skin had healed. Her ophthalmology evaluation did not show any serious tumors.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith AM. Skin tags. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013: 922-925.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

Click here to read the supplement

Modern Day Laboring

Induction of Labor for Low-Risk Women: Is 39 the New 41?

Rohan D’Souza, MD, MSc, MRCOG; Errol R. Norwitz, MD, PhD, MBA 

Cervical Ripening in Alternative Settings: Balancing Logistics and Patient Care

Julian N. Robinson, MD; Sarah E. Little, MD

Click here to read the supplement

Click here to read the supplement

Modern Day Laboring

Induction of Labor for Low-Risk Women: Is 39 the New 41?

Rohan D’Souza, MD, MSc, MRCOG; Errol R. Norwitz, MD, PhD, MBA 

Cervical Ripening in Alternative Settings: Balancing Logistics and Patient Care

Julian N. Robinson, MD; Sarah E. Little, MD

Click here to read the supplement

Click here to read the supplement

Modern Day Laboring

Induction of Labor for Low-Risk Women: Is 39 the New 41?

Rohan D’Souza, MD, MSc, MRCOG; Errol R. Norwitz, MD, PhD, MBA 

Cervical Ripening in Alternative Settings: Balancing Logistics and Patient Care

Julian N. Robinson, MD; Sarah E. Little, MD

Click here to read the supplement