Connie Kraus, PharmD

EVIDENCE SUMMARY

A systematic review featured a single RCT (n=185) comparing the effect of a 12-month vs 24-month interval between dental visits on dental caries in low-risk 3- to 5-year-old children with primary teeth and young adults, ages 16 to 20 years, with permanent teeth.¹ The outcomes of caries (ie, decayed, missing, filled surfaces increment) between the 12- and 24-month visits both in younger children (mean difference [MD]= -0.90; 95% confidence interval [CI], -1.96 to 0.16) and young adults (MD= -0.86; 95% CI, -1.75 to 0.03) did not differ.

Gingivitis: Not an issue when visits were delayed in healthy adults

Another systematic review (3 RCTs; N=836) evaluated the benefits associated with scaling and polishing in the prevention of gingivitis (primary outcome measure).² One RCT (n=207) compared scaling and polishing at 6- and 12-month intervals to no treatment for 24 months in adults with healthy dental histories. There was no difference in the percentage of index teeth with bleeding in the 6-month or 12-month treatment groups compared to the group that received no treatment for 24 months (MD= -2%; 95% CI, -10% to 6% and MD= -1%; 95% CI, -9% to 7%, respectively).

2 visits/year prevents tooth loss in high-risk patients

A retrospective cohort study (N=5117) using 16 years of data evaluated the association between one or 2 preventive dental visits per year and tooth extraction events in adults at low risk and those at high risk for progressive periodontitis.³ Those at high risk had at least one of the following risk factors: smoking, diabetes, or interleukin-1 genotype. Low-risk patients had no difference in tooth loss with one visit compared to 2 visits annually (absolute risk reduction [ARR]=2.6%; 95% CI, 0.5%-5.8%; P=.092); however, high-risk patients had fewer events with 2 annual visits (number needed to treat [NNT]=19; ARR 5.2%; 95% CI, 1.8%-8.4%; P=.002).

Visits before age 3 likely benefit only those at high risk

A systematic review of 4 retrospective cohort studies (N=77,291) analyzed the impact of early preventive dental visits (EPDV) on the frequency of future preventive and non-preventive dental visits and related expenditures using data from insurance claims and a kindergarten state dental registry.⁴ One study (n=11,394) used dental disease status at kindergarten (defined as the count of decayed, missing [molar teeth only], and filled primary teeth) as an outcome measure. Children who received EPDV before age 24 months had a comparable number of caries to those who had EPDV at 24 to 36 months. The authors concluded that EPDV before age 3 years is likely to benefit only children at high risk, and that evidence for a first dental visit by age one year is weak.

RECOMMENDATIONS

The National Institute for Health and Care Excellence recommends preventive dental visit intervals based on individual risk.

The National Institute for Health and Care Excellence recommends preventive dental visit intervals based on individual risk (12 months as the longest interval under age 18 years and 24 months as the longest interval for those 18 years and older at low risk).⁵ The American Dental Association recommends preventive dental visits at intervals determined by individual risk.⁶ The American Academy of Pediatric Dentistry recommends a first exam by age one year and preventive dental visits every 6 months through adolescence or as indicated by individual risk.⁷ The US Preventive Services Task Force states there is insufficient evidence to recommend routine dental screening by primary care physicians in children up to age 5 years.⁸

EVIDENCE SUMMARY

A systematic review featured a single RCT (n=185) comparing the effect of a 12-month vs 24-month interval between dental visits on dental caries in low-risk 3- to 5-year-old children with primary teeth and young adults, ages 16 to 20 years, with permanent teeth.¹ The outcomes of caries (ie, decayed, missing, filled surfaces increment) between the 12- and 24-month visits both in younger children (mean difference [MD]= -0.90; 95% confidence interval [CI], -1.96 to 0.16) and young adults (MD= -0.86; 95% CI, -1.75 to 0.03) did not differ.

Gingivitis: Not an issue when visits were delayed in healthy adults

Another systematic review (3 RCTs; N=836) evaluated the benefits associated with scaling and polishing in the prevention of gingivitis (primary outcome measure).² One RCT (n=207) compared scaling and polishing at 6- and 12-month intervals to no treatment for 24 months in adults with healthy dental histories. There was no difference in the percentage of index teeth with bleeding in the 6-month or 12-month treatment groups compared to the group that received no treatment for 24 months (MD= -2%; 95% CI, -10% to 6% and MD= -1%; 95% CI, -9% to 7%, respectively).

2 visits/year prevents tooth loss in high-risk patients

A retrospective cohort study (N=5117) using 16 years of data evaluated the association between one or 2 preventive dental visits per year and tooth extraction events in adults at low risk and those at high risk for progressive periodontitis.³ Those at high risk had at least one of the following risk factors: smoking, diabetes, or interleukin-1 genotype. Low-risk patients had no difference in tooth loss with one visit compared to 2 visits annually (absolute risk reduction [ARR]=2.6%; 95% CI, 0.5%-5.8%; P=.092); however, high-risk patients had fewer events with 2 annual visits (number needed to treat [NNT]=19; ARR 5.2%; 95% CI, 1.8%-8.4%; P=.002).

Visits before age 3 likely benefit only those at high risk

A systematic review of 4 retrospective cohort studies (N=77,291) analyzed the impact of early preventive dental visits (EPDV) on the frequency of future preventive and non-preventive dental visits and related expenditures using data from insurance claims and a kindergarten state dental registry.⁴ One study (n=11,394) used dental disease status at kindergarten (defined as the count of decayed, missing [molar teeth only], and filled primary teeth) as an outcome measure. Children who received EPDV before age 24 months had a comparable number of caries to those who had EPDV at 24 to 36 months. The authors concluded that EPDV before age 3 years is likely to benefit only children at high risk, and that evidence for a first dental visit by age one year is weak.

RECOMMENDATIONS

The National Institute for Health and Care Excellence recommends preventive dental visit intervals based on individual risk.

The National Institute for Health and Care Excellence recommends preventive dental visit intervals based on individual risk (12 months as the longest interval under age 18 years and 24 months as the longest interval for those 18 years and older at low risk).⁵ The American Dental Association recommends preventive dental visits at intervals determined by individual risk.⁶ The American Academy of Pediatric Dentistry recommends a first exam by age one year and preventive dental visits every 6 months through adolescence or as indicated by individual risk.⁷ The US Preventive Services Task Force states there is insufficient evidence to recommend routine dental screening by primary care physicians in children up to age 5 years.⁸

EVIDENCE SUMMARY

A systematic review featured a single RCT (n=185) comparing the effect of a 12-month vs 24-month interval between dental visits on dental caries in low-risk 3- to 5-year-old children with primary teeth and young adults, ages 16 to 20 years, with permanent teeth.¹ The outcomes of caries (ie, decayed, missing, filled surfaces increment) between the 12- and 24-month visits both in younger children (mean difference [MD]= -0.90; 95% confidence interval [CI], -1.96 to 0.16) and young adults (MD= -0.86; 95% CI, -1.75 to 0.03) did not differ.

Gingivitis: Not an issue when visits were delayed in healthy adults

Another systematic review (3 RCTs; N=836) evaluated the benefits associated with scaling and polishing in the prevention of gingivitis (primary outcome measure).² One RCT (n=207) compared scaling and polishing at 6- and 12-month intervals to no treatment for 24 months in adults with healthy dental histories. There was no difference in the percentage of index teeth with bleeding in the 6-month or 12-month treatment groups compared to the group that received no treatment for 24 months (MD= -2%; 95% CI, -10% to 6% and MD= -1%; 95% CI, -9% to 7%, respectively).

2 visits/year prevents tooth loss in high-risk patients

A retrospective cohort study (N=5117) using 16 years of data evaluated the association between one or 2 preventive dental visits per year and tooth extraction events in adults at low risk and those at high risk for progressive periodontitis.³ Those at high risk had at least one of the following risk factors: smoking, diabetes, or interleukin-1 genotype. Low-risk patients had no difference in tooth loss with one visit compared to 2 visits annually (absolute risk reduction [ARR]=2.6%; 95% CI, 0.5%-5.8%; P=.092); however, high-risk patients had fewer events with 2 annual visits (number needed to treat [NNT]=19; ARR 5.2%; 95% CI, 1.8%-8.4%; P=.002).

Visits before age 3 likely benefit only those at high risk

A systematic review of 4 retrospective cohort studies (N=77,291) analyzed the impact of early preventive dental visits (EPDV) on the frequency of future preventive and non-preventive dental visits and related expenditures using data from insurance claims and a kindergarten state dental registry.⁴ One study (n=11,394) used dental disease status at kindergarten (defined as the count of decayed, missing [molar teeth only], and filled primary teeth) as an outcome measure. Children who received EPDV before age 24 months had a comparable number of caries to those who had EPDV at 24 to 36 months. The authors concluded that EPDV before age 3 years is likely to benefit only children at high risk, and that evidence for a first dental visit by age one year is weak.

RECOMMENDATIONS

The National Institute for Health and Care Excellence recommends preventive dental visit intervals based on individual risk.

The National Institute for Health and Care Excellence recommends preventive dental visit intervals based on individual risk (12 months as the longest interval under age 18 years and 24 months as the longest interval for those 18 years and older at low risk).⁵ The American Dental Association recommends preventive dental visits at intervals determined by individual risk.⁶ The American Academy of Pediatric Dentistry recommends a first exam by age one year and preventive dental visits every 6 months through adolescence or as indicated by individual risk.⁷ The US Preventive Services Task Force states there is insufficient evidence to recommend routine dental screening by primary care physicians in children up to age 5 years.⁸

EVIDENCE SUMMARY

A systematic review of 22 trials (13 case series, 8 prospective, nonrandomized studies, and one randomized controlled trial; 12,407 patients) conducted in Europe, Asia, and the Americas evaluated the likelihood of pregnancy with repeated use of precoital and postcoital hormonal contraception.¹ Some trials used more than one dose or medication. Many had inadequate reporting of research methods. Results were reported using the Pearl Index (PI)—the number of pregnancies per 100 woman-years.

In 11 studies (2700 patients), women took 750 mcg of levonorgestrel from 24 hours before to 24 hours after intercourse for an average duration of 5 cycles or months. Coital frequency varied from 1 to 15 times per month. The PI ranged from 0 to 18.6, with a pooled PI of 5.4 (95% confidence interval [CI], 4.1-7.0). Three of the trials (915 patients), with research methods reported as good, had a pooled PI of 8.9 (95% CI, 5.1-14.4). No serious adverse effects were reported in 10 of the 11 studies, but menstrual irregularity was commonly observed. In one of the largest studies (1315 patients), only 3% of women discontinued treatment because of adverse effects.

Six other trials (5785 patients) of levonorgestrel taken at doses ranging from 150 mcg to 1 mg for a mean duration of 9.2 cycles reported PIs of 0 to 9. Breakthrough bleeding was the most common adverse event. When all 17 studies of levonorgestrel were combined, the PI was 4.9 (95% CI, 4.3-5.5). The remaining studies in the systematic review described medicines not commonly used for emergency contraception or not available in the United States.

Other reported adverse effects: Headache, nausea, abdominal pain

A prospective, open-label study enrolled 321 women 18 to 45 years of age from Asia, Europe, and South America to evaluate the safety and efficacy of levonorgestrel 1.5 mg taken before or within 24 hours of intercourse as the exclusive means of contraception.² Women who were lactating or recently postpartum were excluded; condoms were permitted for women who had concerns about risk of sexually transmitted illness. Data analysis included estimates of perfect use (consistent and correct use of levonorgestrel only) and typical use (use of other contraceptive methods in addition to levonorgestrel).

At baseline, weight, blood pressure, and hemoglobin were documented, and follow-up visits occurred at 2.5, 4.5, and 6.5 months. Pregnancy tests, blood pressure, and adverse effects were assessed at each visit; weight and hemoglobin were evaluated at the final visit. The primary outcome measure was the PI in women younger than 35 years who used only levonorgestrel for contraception.

In women younger than 35 years (208 patients), the PI was 11 (95% CI, 5.7-13.1) with perfect use and 10.3 (95% CI, 5.4-19.9) with typical use. In all ages 18 to 45 years, the PI was 7.1 (95% CI, 3.8-13.1) for typical use and 7.5 (95% CI, 4-13.9) for perfect use. Most women took 4 to 6 doses per month.

The most commonly reported adverse effects were headache (29%), nausea or abdominal pain (16%), influenza (11%), and acne or candidiasis (8%). Bleeding patterns varied with a tendency toward longer bleeding initially and lighter menstrual periods and less anemia in some patients at the end of the study.

RECOMMENDATIONS

The Office of Population Research at Princeton University suggests that moderate repeat use of emergency contraceptives is unlikely to cause serious harm, but estimates that women using progestin-only emergency contraception on a regular basis would have a 20% chance of pregnancy in a year.³

The American College of Obstetricians and Gynecologists states that long-term use of emergency contraception is less effective than other methods and may result in higher hormone levels and more adverse effects than other established means.⁴

The International Consortium for Emergency Contraception concluded that there is no basis for limiting the number of times that emergency contraceptives may be used in a menstrual cycle, that emergency contraceptives are safe, and that, although they are less effective than other forms of long-term contraception, using them repeatedly is more effective than using no method.⁵

The Society of Obstetricians and Gynecologists of Canada states that emergency contraception is intended for occasional use as a backup method.⁶ The Society also notes that repeat use isn’t as effective as regular use of other forms of contraception.

Annual pregnancy rates in women using pericoital levonorgestrel 150 mcg to 1 mg range from 4.9% to 8.9%.

The Faculty of Sexual & Reproductive Healthcare of the (British) Royal College of Obstetricians and Gynaecologists says that use of levonorgestrel can be considered even if previously used one or more times in a menstrual cycle (SOR: D, based on non-analytical studies and expert opinion).⁷ The organization also recommends that emergency contraceptive providers share with patients that oral emergency contraceptive methods should not be used for long-term contraception (SOR: Good Practice Point, based on clinical experience of the guideline development group).

The Guttmacher Institute reports that without contraception, approximately 85% of sexually active women become pregnant each year.⁸ Long-acting reversible methods, such as implants and intrauterine devices, have annual pregnancy rates of 0.05% to 0.8%. With perfect (consistent and correct) use, combined oral contraceptives have a 0.3% annual pregnancy rate, but the rate rises to 9% with typical use. Condoms, when used perfectly, are associated with a 2% annual rate of pregnancy compared with an 18% rate with typical use.

EVIDENCE SUMMARY

A systematic review of 22 trials (13 case series, 8 prospective, nonrandomized studies, and one randomized controlled trial; 12,407 patients) conducted in Europe, Asia, and the Americas evaluated the likelihood of pregnancy with repeated use of precoital and postcoital hormonal contraception.¹ Some trials used more than one dose or medication. Many had inadequate reporting of research methods. Results were reported using the Pearl Index (PI)—the number of pregnancies per 100 woman-years.

In 11 studies (2700 patients), women took 750 mcg of levonorgestrel from 24 hours before to 24 hours after intercourse for an average duration of 5 cycles or months. Coital frequency varied from 1 to 15 times per month. The PI ranged from 0 to 18.6, with a pooled PI of 5.4 (95% confidence interval [CI], 4.1-7.0). Three of the trials (915 patients), with research methods reported as good, had a pooled PI of 8.9 (95% CI, 5.1-14.4). No serious adverse effects were reported in 10 of the 11 studies, but menstrual irregularity was commonly observed. In one of the largest studies (1315 patients), only 3% of women discontinued treatment because of adverse effects.

Six other trials (5785 patients) of levonorgestrel taken at doses ranging from 150 mcg to 1 mg for a mean duration of 9.2 cycles reported PIs of 0 to 9. Breakthrough bleeding was the most common adverse event. When all 17 studies of levonorgestrel were combined, the PI was 4.9 (95% CI, 4.3-5.5). The remaining studies in the systematic review described medicines not commonly used for emergency contraception or not available in the United States.

Other reported adverse effects: Headache, nausea, abdominal pain

A prospective, open-label study enrolled 321 women 18 to 45 years of age from Asia, Europe, and South America to evaluate the safety and efficacy of levonorgestrel 1.5 mg taken before or within 24 hours of intercourse as the exclusive means of contraception.² Women who were lactating or recently postpartum were excluded; condoms were permitted for women who had concerns about risk of sexually transmitted illness. Data analysis included estimates of perfect use (consistent and correct use of levonorgestrel only) and typical use (use of other contraceptive methods in addition to levonorgestrel).

At baseline, weight, blood pressure, and hemoglobin were documented, and follow-up visits occurred at 2.5, 4.5, and 6.5 months. Pregnancy tests, blood pressure, and adverse effects were assessed at each visit; weight and hemoglobin were evaluated at the final visit. The primary outcome measure was the PI in women younger than 35 years who used only levonorgestrel for contraception.

In women younger than 35 years (208 patients), the PI was 11 (95% CI, 5.7-13.1) with perfect use and 10.3 (95% CI, 5.4-19.9) with typical use. In all ages 18 to 45 years, the PI was 7.1 (95% CI, 3.8-13.1) for typical use and 7.5 (95% CI, 4-13.9) for perfect use. Most women took 4 to 6 doses per month.

The most commonly reported adverse effects were headache (29%), nausea or abdominal pain (16%), influenza (11%), and acne or candidiasis (8%). Bleeding patterns varied with a tendency toward longer bleeding initially and lighter menstrual periods and less anemia in some patients at the end of the study.

RECOMMENDATIONS

The Office of Population Research at Princeton University suggests that moderate repeat use of emergency contraceptives is unlikely to cause serious harm, but estimates that women using progestin-only emergency contraception on a regular basis would have a 20% chance of pregnancy in a year.³

The American College of Obstetricians and Gynecologists states that long-term use of emergency contraception is less effective than other methods and may result in higher hormone levels and more adverse effects than other established means.⁴

The International Consortium for Emergency Contraception concluded that there is no basis for limiting the number of times that emergency contraceptives may be used in a menstrual cycle, that emergency contraceptives are safe, and that, although they are less effective than other forms of long-term contraception, using them repeatedly is more effective than using no method.⁵

The Society of Obstetricians and Gynecologists of Canada states that emergency contraception is intended for occasional use as a backup method.⁶ The Society also notes that repeat use isn’t as effective as regular use of other forms of contraception.

Annual pregnancy rates in women using pericoital levonorgestrel 150 mcg to 1 mg range from 4.9% to 8.9%.

The Faculty of Sexual & Reproductive Healthcare of the (British) Royal College of Obstetricians and Gynaecologists says that use of levonorgestrel can be considered even if previously used one or more times in a menstrual cycle (SOR: D, based on non-analytical studies and expert opinion).⁷ The organization also recommends that emergency contraceptive providers share with patients that oral emergency contraceptive methods should not be used for long-term contraception (SOR: Good Practice Point, based on clinical experience of the guideline development group).

The Guttmacher Institute reports that without contraception, approximately 85% of sexually active women become pregnant each year.⁸ Long-acting reversible methods, such as implants and intrauterine devices, have annual pregnancy rates of 0.05% to 0.8%. With perfect (consistent and correct) use, combined oral contraceptives have a 0.3% annual pregnancy rate, but the rate rises to 9% with typical use. Condoms, when used perfectly, are associated with a 2% annual rate of pregnancy compared with an 18% rate with typical use.

EVIDENCE SUMMARY

A systematic review of 22 trials (13 case series, 8 prospective, nonrandomized studies, and one randomized controlled trial; 12,407 patients) conducted in Europe, Asia, and the Americas evaluated the likelihood of pregnancy with repeated use of precoital and postcoital hormonal contraception.¹ Some trials used more than one dose or medication. Many had inadequate reporting of research methods. Results were reported using the Pearl Index (PI)—the number of pregnancies per 100 woman-years.

In 11 studies (2700 patients), women took 750 mcg of levonorgestrel from 24 hours before to 24 hours after intercourse for an average duration of 5 cycles or months. Coital frequency varied from 1 to 15 times per month. The PI ranged from 0 to 18.6, with a pooled PI of 5.4 (95% confidence interval [CI], 4.1-7.0). Three of the trials (915 patients), with research methods reported as good, had a pooled PI of 8.9 (95% CI, 5.1-14.4). No serious adverse effects were reported in 10 of the 11 studies, but menstrual irregularity was commonly observed. In one of the largest studies (1315 patients), only 3% of women discontinued treatment because of adverse effects.

Six other trials (5785 patients) of levonorgestrel taken at doses ranging from 150 mcg to 1 mg for a mean duration of 9.2 cycles reported PIs of 0 to 9. Breakthrough bleeding was the most common adverse event. When all 17 studies of levonorgestrel were combined, the PI was 4.9 (95% CI, 4.3-5.5). The remaining studies in the systematic review described medicines not commonly used for emergency contraception or not available in the United States.

Other reported adverse effects: Headache, nausea, abdominal pain

A prospective, open-label study enrolled 321 women 18 to 45 years of age from Asia, Europe, and South America to evaluate the safety and efficacy of levonorgestrel 1.5 mg taken before or within 24 hours of intercourse as the exclusive means of contraception.² Women who were lactating or recently postpartum were excluded; condoms were permitted for women who had concerns about risk of sexually transmitted illness. Data analysis included estimates of perfect use (consistent and correct use of levonorgestrel only) and typical use (use of other contraceptive methods in addition to levonorgestrel).

At baseline, weight, blood pressure, and hemoglobin were documented, and follow-up visits occurred at 2.5, 4.5, and 6.5 months. Pregnancy tests, blood pressure, and adverse effects were assessed at each visit; weight and hemoglobin were evaluated at the final visit. The primary outcome measure was the PI in women younger than 35 years who used only levonorgestrel for contraception.

In women younger than 35 years (208 patients), the PI was 11 (95% CI, 5.7-13.1) with perfect use and 10.3 (95% CI, 5.4-19.9) with typical use. In all ages 18 to 45 years, the PI was 7.1 (95% CI, 3.8-13.1) for typical use and 7.5 (95% CI, 4-13.9) for perfect use. Most women took 4 to 6 doses per month.

The most commonly reported adverse effects were headache (29%), nausea or abdominal pain (16%), influenza (11%), and acne or candidiasis (8%). Bleeding patterns varied with a tendency toward longer bleeding initially and lighter menstrual periods and less anemia in some patients at the end of the study.

RECOMMENDATIONS

The Office of Population Research at Princeton University suggests that moderate repeat use of emergency contraceptives is unlikely to cause serious harm, but estimates that women using progestin-only emergency contraception on a regular basis would have a 20% chance of pregnancy in a year.³

The American College of Obstetricians and Gynecologists states that long-term use of emergency contraception is less effective than other methods and may result in higher hormone levels and more adverse effects than other established means.⁴

The International Consortium for Emergency Contraception concluded that there is no basis for limiting the number of times that emergency contraceptives may be used in a menstrual cycle, that emergency contraceptives are safe, and that, although they are less effective than other forms of long-term contraception, using them repeatedly is more effective than using no method.⁵

The Society of Obstetricians and Gynecologists of Canada states that emergency contraception is intended for occasional use as a backup method.⁶ The Society also notes that repeat use isn’t as effective as regular use of other forms of contraception.

Annual pregnancy rates in women using pericoital levonorgestrel 150 mcg to 1 mg range from 4.9% to 8.9%.

The Faculty of Sexual & Reproductive Healthcare of the (British) Royal College of Obstetricians and Gynaecologists says that use of levonorgestrel can be considered even if previously used one or more times in a menstrual cycle (SOR: D, based on non-analytical studies and expert opinion).⁷ The organization also recommends that emergency contraceptive providers share with patients that oral emergency contraceptive methods should not be used for long-term contraception (SOR: Good Practice Point, based on clinical experience of the guideline development group).

The Guttmacher Institute reports that without contraception, approximately 85% of sexually active women become pregnant each year.⁸ Long-acting reversible methods, such as implants and intrauterine devices, have annual pregnancy rates of 0.05% to 0.8%. With perfect (consistent and correct) use, combined oral contraceptives have a 0.3% annual pregnancy rate, but the rate rises to 9% with typical use. Condoms, when used perfectly, are associated with a 2% annual rate of pregnancy compared with an 18% rate with typical use.

EVIDENCE SUMMARY

A systematic review and meta-analysis of 15 RCTs with a total enrollment of 5540 assessed the efficacy of opioids in adults with chronic low back pain of at least 12 weeks’ duration.¹ Five low-quality studies (1378 patients) that compared tramadol with placebo found tramadol to be moderately superior to placebo for relieving pain (standard mean difference [SMD]= -0.55; 95% confidence interval [CI], -0.66 to -0.44) but only modestly better for improving function (SMD= −0.18; 95% CI, -0.29 to -0.07).

Six trials with 1887 patients compared strong opioids (morphine, hydromorphone, oxycodone, oxymorphone, and tapentadol) with placebo. The opioids were better than placebo for improving pain (SMD= -0.43; 95% CI, -0.52 to -0.33) and function (SMD= -0.26; 95% CI, -0.37 to -0.15). The general interpretation of SMD effect size is 0.2=small, 0.5=medium, 0.8=large. In this case, larger negative numbers correlate with greater improvement.

How opioids stack up against NSAIDs

Two separate double-blind, double-dummy studies randomized adults with low back pain of at least 12 weeks’ duration to receive celecoxib 200 mg twice daily (404 and 398 patients, respectively) or tramadol 50 mg 4 times daily (392 and 404 patients, respectively) for 6 weeks.² The primary outcome measure was at least a 30% improvement in pain using a 0 (no pain) to 10 (worst possible pain) scale. In both studies, more patients taking celecoxib had positive responses than patients taking tramadol (63% vs 50%, P<.001, and 64% vs 55%, P<.008, respectively).

A small RCT (36 patients who had suffered low back pain for more than 6 months) randomized patients to one of 3 treatment groups for 16 weeks: oxycodone as much as 20 mg/d (13 patients); naproxen as much as 1 g/d (12 patients); or oxycodone and sustained-release morphine (titrated up to 200 mg morphine equivalent/d (11 patients).³ After 16 weeks, patients receiving oxycodone or naproxen were treated with oxycodone and sustained-release morphine for another 16 weeks, as were patients already receiving this therapy. Pain was assessed on a 0 (none) to 100 (worst possible pain) scale.

Both opioid groups had significantly less pain on average (59.8 for oxycodone, 54.9 for titrated morphine) than the naproxen group (65.5; F=16.07; P<.001) but no significant difference in activity level. However, an independent analysis of the naproxen group and titrated morphine group found no significant difference in either pain relief (SMD= -0.58; 95% CI, -1.42 to 0.26) or disability (SMD= -0.06; 95% CI, -0.88 to 0.76) between the 2 groups.⁴

How does long-term opioid use affect pain and function?

Two prospective cohort studies have evaluated long-term opioid use. The first (715 patients) used a Roland-Morris Disability Questionnaire (RMDQ) to assess disability at 6 months in patients taking opioids compared with patients not taking opioids.⁵ Patients using opioids showed an increase in RMDQ score of 1.18 units (95% CI, 0.17-2.19) on a 0 to 24 scale, with 24 representing greatest disability.

Short-term treatment with opioids provides modest relief of chronic low back pain, but only minimal improvement in function compared with placebo.

The second study evaluated pain and function in 1843 adults with acute back injuries taking opioids for a year.⁶ Pain, rated on a 0 to 10 scale, decreased from 7.7 at baseline to 6.8 at one year (no P value). At the end of the first quarter, the RMDQ score decreased from 18.8 at baseline (the end of the first quarter) to 17.5 at one year (no P value). Clinically meaningful improvement in pain and function (30% or more) occurred in 26% (95% CI, 18%-36%) and 16% (95% CI, 10%-25%) of patients, respectively.

RECOMMENDATIONS

The 2007 clinical practice guideline on low back pain from The American College of Physicians and American Pain Society recommends opioids, including tramadol, for patients with severe back pain who don’t get adequate relief from acetaminophen or NSAIDs.⁷

The 2009 National Institute for Health and Care Excellence (NICE) guidelines for early management of persistent, nonspecific low back pain recommend considering strong opioids (buprenorphine, fentanyl, and oxycodone) for short-term use in severe pain and referral to a specialist for patients requiring prolonged use of strong opioids.⁸

The 2013 British Pain Society guidelines for low back and radicular pain recommend tight restrictions on the use of strong opioids. They also recommend giving the lowest possible dose of opioids for the shortest time possible.⁹

EVIDENCE SUMMARY

A systematic review and meta-analysis of 15 RCTs with a total enrollment of 5540 assessed the efficacy of opioids in adults with chronic low back pain of at least 12 weeks’ duration.¹ Five low-quality studies (1378 patients) that compared tramadol with placebo found tramadol to be moderately superior to placebo for relieving pain (standard mean difference [SMD]= -0.55; 95% confidence interval [CI], -0.66 to -0.44) but only modestly better for improving function (SMD= −0.18; 95% CI, -0.29 to -0.07).

Six trials with 1887 patients compared strong opioids (morphine, hydromorphone, oxycodone, oxymorphone, and tapentadol) with placebo. The opioids were better than placebo for improving pain (SMD= -0.43; 95% CI, -0.52 to -0.33) and function (SMD= -0.26; 95% CI, -0.37 to -0.15). The general interpretation of SMD effect size is 0.2=small, 0.5=medium, 0.8=large. In this case, larger negative numbers correlate with greater improvement.

How opioids stack up against NSAIDs

Two separate double-blind, double-dummy studies randomized adults with low back pain of at least 12 weeks’ duration to receive celecoxib 200 mg twice daily (404 and 398 patients, respectively) or tramadol 50 mg 4 times daily (392 and 404 patients, respectively) for 6 weeks.² The primary outcome measure was at least a 30% improvement in pain using a 0 (no pain) to 10 (worst possible pain) scale. In both studies, more patients taking celecoxib had positive responses than patients taking tramadol (63% vs 50%, P<.001, and 64% vs 55%, P<.008, respectively).

A small RCT (36 patients who had suffered low back pain for more than 6 months) randomized patients to one of 3 treatment groups for 16 weeks: oxycodone as much as 20 mg/d (13 patients); naproxen as much as 1 g/d (12 patients); or oxycodone and sustained-release morphine (titrated up to 200 mg morphine equivalent/d (11 patients).³ After 16 weeks, patients receiving oxycodone or naproxen were treated with oxycodone and sustained-release morphine for another 16 weeks, as were patients already receiving this therapy. Pain was assessed on a 0 (none) to 100 (worst possible pain) scale.

Both opioid groups had significantly less pain on average (59.8 for oxycodone, 54.9 for titrated morphine) than the naproxen group (65.5; F=16.07; P<.001) but no significant difference in activity level. However, an independent analysis of the naproxen group and titrated morphine group found no significant difference in either pain relief (SMD= -0.58; 95% CI, -1.42 to 0.26) or disability (SMD= -0.06; 95% CI, -0.88 to 0.76) between the 2 groups.⁴

How does long-term opioid use affect pain and function?

Two prospective cohort studies have evaluated long-term opioid use. The first (715 patients) used a Roland-Morris Disability Questionnaire (RMDQ) to assess disability at 6 months in patients taking opioids compared with patients not taking opioids.⁵ Patients using opioids showed an increase in RMDQ score of 1.18 units (95% CI, 0.17-2.19) on a 0 to 24 scale, with 24 representing greatest disability.

Short-term treatment with opioids provides modest relief of chronic low back pain, but only minimal improvement in function compared with placebo.

The second study evaluated pain and function in 1843 adults with acute back injuries taking opioids for a year.⁶ Pain, rated on a 0 to 10 scale, decreased from 7.7 at baseline to 6.8 at one year (no P value). At the end of the first quarter, the RMDQ score decreased from 18.8 at baseline (the end of the first quarter) to 17.5 at one year (no P value). Clinically meaningful improvement in pain and function (30% or more) occurred in 26% (95% CI, 18%-36%) and 16% (95% CI, 10%-25%) of patients, respectively.

RECOMMENDATIONS

The 2007 clinical practice guideline on low back pain from The American College of Physicians and American Pain Society recommends opioids, including tramadol, for patients with severe back pain who don’t get adequate relief from acetaminophen or NSAIDs.⁷

The 2009 National Institute for Health and Care Excellence (NICE) guidelines for early management of persistent, nonspecific low back pain recommend considering strong opioids (buprenorphine, fentanyl, and oxycodone) for short-term use in severe pain and referral to a specialist for patients requiring prolonged use of strong opioids.⁸

The 2013 British Pain Society guidelines for low back and radicular pain recommend tight restrictions on the use of strong opioids. They also recommend giving the lowest possible dose of opioids for the shortest time possible.⁹

EVIDENCE SUMMARY

A systematic review and meta-analysis of 15 RCTs with a total enrollment of 5540 assessed the efficacy of opioids in adults with chronic low back pain of at least 12 weeks’ duration.¹ Five low-quality studies (1378 patients) that compared tramadol with placebo found tramadol to be moderately superior to placebo for relieving pain (standard mean difference [SMD]= -0.55; 95% confidence interval [CI], -0.66 to -0.44) but only modestly better for improving function (SMD= −0.18; 95% CI, -0.29 to -0.07).

Six trials with 1887 patients compared strong opioids (morphine, hydromorphone, oxycodone, oxymorphone, and tapentadol) with placebo. The opioids were better than placebo for improving pain (SMD= -0.43; 95% CI, -0.52 to -0.33) and function (SMD= -0.26; 95% CI, -0.37 to -0.15). The general interpretation of SMD effect size is 0.2=small, 0.5=medium, 0.8=large. In this case, larger negative numbers correlate with greater improvement.

How opioids stack up against NSAIDs

Two separate double-blind, double-dummy studies randomized adults with low back pain of at least 12 weeks’ duration to receive celecoxib 200 mg twice daily (404 and 398 patients, respectively) or tramadol 50 mg 4 times daily (392 and 404 patients, respectively) for 6 weeks.² The primary outcome measure was at least a 30% improvement in pain using a 0 (no pain) to 10 (worst possible pain) scale. In both studies, more patients taking celecoxib had positive responses than patients taking tramadol (63% vs 50%, P<.001, and 64% vs 55%, P<.008, respectively).

A small RCT (36 patients who had suffered low back pain for more than 6 months) randomized patients to one of 3 treatment groups for 16 weeks: oxycodone as much as 20 mg/d (13 patients); naproxen as much as 1 g/d (12 patients); or oxycodone and sustained-release morphine (titrated up to 200 mg morphine equivalent/d (11 patients).³ After 16 weeks, patients receiving oxycodone or naproxen were treated with oxycodone and sustained-release morphine for another 16 weeks, as were patients already receiving this therapy. Pain was assessed on a 0 (none) to 100 (worst possible pain) scale.

Both opioid groups had significantly less pain on average (59.8 for oxycodone, 54.9 for titrated morphine) than the naproxen group (65.5; F=16.07; P<.001) but no significant difference in activity level. However, an independent analysis of the naproxen group and titrated morphine group found no significant difference in either pain relief (SMD= -0.58; 95% CI, -1.42 to 0.26) or disability (SMD= -0.06; 95% CI, -0.88 to 0.76) between the 2 groups.⁴

How does long-term opioid use affect pain and function?

Two prospective cohort studies have evaluated long-term opioid use. The first (715 patients) used a Roland-Morris Disability Questionnaire (RMDQ) to assess disability at 6 months in patients taking opioids compared with patients not taking opioids.⁵ Patients using opioids showed an increase in RMDQ score of 1.18 units (95% CI, 0.17-2.19) on a 0 to 24 scale, with 24 representing greatest disability.

Short-term treatment with opioids provides modest relief of chronic low back pain, but only minimal improvement in function compared with placebo.

The second study evaluated pain and function in 1843 adults with acute back injuries taking opioids for a year.⁶ Pain, rated on a 0 to 10 scale, decreased from 7.7 at baseline to 6.8 at one year (no P value). At the end of the first quarter, the RMDQ score decreased from 18.8 at baseline (the end of the first quarter) to 17.5 at one year (no P value). Clinically meaningful improvement in pain and function (30% or more) occurred in 26% (95% CI, 18%-36%) and 16% (95% CI, 10%-25%) of patients, respectively.

RECOMMENDATIONS

The 2007 clinical practice guideline on low back pain from The American College of Physicians and American Pain Society recommends opioids, including tramadol, for patients with severe back pain who don’t get adequate relief from acetaminophen or NSAIDs.⁷

The 2009 National Institute for Health and Care Excellence (NICE) guidelines for early management of persistent, nonspecific low back pain recommend considering strong opioids (buprenorphine, fentanyl, and oxycodone) for short-term use in severe pain and referral to a specialist for patients requiring prolonged use of strong opioids.⁸

The 2013 British Pain Society guidelines for low back and radicular pain recommend tight restrictions on the use of strong opioids. They also recommend giving the lowest possible dose of opioids for the shortest time possible.⁹