It was a Saturday night when I called my parents, both of whom are doctors, to report the intermittent epigastric pain I’d had throughout the day. Since starting medical school a few months earlier, I had a penchant for self-diagnosing ailments that just happened to coincide with the topic of the week. I thus felt certain it was stomach cancer. Yet I was still surprised when my parents said they’d stop by—an offer they never made when I thought I had Ehlers-Danlos or Marfan syndrome.

A quick physical exam left them debating whether I had a peptic ulcer (Mom) or cholecystitis (Dad). I sided with my mom, having just learned that my description fit only 2 of the “4 Fs” and not yet knowing anything about ulcers. When I noted that an ultrasound would have to wait until after an exam early next week, Dad handed me a pint of Haagen-Dazs from the freezer. I happily indulged while he explained that the ice cream would either soothe my ulcerated stomach lining or further aggravate my gallbladder. A half-pint (and a half-hour) later, my parents headed home.

I awoke at 5:30 am with a horrendous pain in the right upper quadrant. I called home and managed to communicate that I was headed to the emergency department, where I underwent the very imaging studies I’d hoped to avoid. After a normal ultrasound, an unremarkable computed tomography (CT), and a good bit of Dilaudid, I was admitted for observation.

On Monday, I was sent for a hepatobiliary iminodiacetic acid (HIDA) scan. A few hours later I felt the same excruciating pain that had brought me to the hospital, and was told that my ejection fraction was 23%. On Tuesday, I was in the operating room having my inflamed and sludge-filled gall bladder excised.

One lesson to take away from this anecdote is that it may be worth exploring low-cost, low-tech means of investigating illness. Although Dad’s affectionately named “Haagen-Dazs test” did not yield a definitive diagnosis, it certainly helped to narrow the differential. In view of the increasing pressure on physicians to curb health care costs and respond to patient complaints about depersonalized treatment, low-tech, low-cost measures are a win for everyone. After all, what patient wouldn’t love being told to eat dessert first?

Karen L. Rolston
Buffalo, NY

It was a Saturday night when I called my parents, both of whom are doctors, to report the intermittent epigastric pain I’d had throughout the day. Since starting medical school a few months earlier, I had a penchant for self-diagnosing ailments that just happened to coincide with the topic of the week. I thus felt certain it was stomach cancer. Yet I was still surprised when my parents said they’d stop by—an offer they never made when I thought I had Ehlers-Danlos or Marfan syndrome.

A quick physical exam left them debating whether I had a peptic ulcer (Mom) or cholecystitis (Dad). I sided with my mom, having just learned that my description fit only 2 of the “4 Fs” and not yet knowing anything about ulcers. When I noted that an ultrasound would have to wait until after an exam early next week, Dad handed me a pint of Haagen-Dazs from the freezer. I happily indulged while he explained that the ice cream would either soothe my ulcerated stomach lining or further aggravate my gallbladder. A half-pint (and a half-hour) later, my parents headed home.

I awoke at 5:30 am with a horrendous pain in the right upper quadrant. I called home and managed to communicate that I was headed to the emergency department, where I underwent the very imaging studies I’d hoped to avoid. After a normal ultrasound, an unremarkable computed tomography (CT), and a good bit of Dilaudid, I was admitted for observation.

On Monday, I was sent for a hepatobiliary iminodiacetic acid (HIDA) scan. A few hours later I felt the same excruciating pain that had brought me to the hospital, and was told that my ejection fraction was 23%. On Tuesday, I was in the operating room having my inflamed and sludge-filled gall bladder excised.

One lesson to take away from this anecdote is that it may be worth exploring low-cost, low-tech means of investigating illness. Although Dad’s affectionately named “Haagen-Dazs test” did not yield a definitive diagnosis, it certainly helped to narrow the differential. In view of the increasing pressure on physicians to curb health care costs and respond to patient complaints about depersonalized treatment, low-tech, low-cost measures are a win for everyone. After all, what patient wouldn’t love being told to eat dessert first?

Karen L. Rolston
Buffalo, NY

It was a Saturday night when I called my parents, both of whom are doctors, to report the intermittent epigastric pain I’d had throughout the day. Since starting medical school a few months earlier, I had a penchant for self-diagnosing ailments that just happened to coincide with the topic of the week. I thus felt certain it was stomach cancer. Yet I was still surprised when my parents said they’d stop by—an offer they never made when I thought I had Ehlers-Danlos or Marfan syndrome.

A quick physical exam left them debating whether I had a peptic ulcer (Mom) or cholecystitis (Dad). I sided with my mom, having just learned that my description fit only 2 of the “4 Fs” and not yet knowing anything about ulcers. When I noted that an ultrasound would have to wait until after an exam early next week, Dad handed me a pint of Haagen-Dazs from the freezer. I happily indulged while he explained that the ice cream would either soothe my ulcerated stomach lining or further aggravate my gallbladder. A half-pint (and a half-hour) later, my parents headed home.

I awoke at 5:30 am with a horrendous pain in the right upper quadrant. I called home and managed to communicate that I was headed to the emergency department, where I underwent the very imaging studies I’d hoped to avoid. After a normal ultrasound, an unremarkable computed tomography (CT), and a good bit of Dilaudid, I was admitted for observation.

On Monday, I was sent for a hepatobiliary iminodiacetic acid (HIDA) scan. A few hours later I felt the same excruciating pain that had brought me to the hospital, and was told that my ejection fraction was 23%. On Tuesday, I was in the operating room having my inflamed and sludge-filled gall bladder excised.

One lesson to take away from this anecdote is that it may be worth exploring low-cost, low-tech means of investigating illness. Although Dad’s affectionately named “Haagen-Dazs test” did not yield a definitive diagnosis, it certainly helped to narrow the differential. In view of the increasing pressure on physicians to curb health care costs and respond to patient complaints about depersonalized treatment, low-tech, low-cost measures are a win for everyone. After all, what patient wouldn’t love being told to eat dessert first?

Karen L. Rolston
Buffalo, NY

I read Dr. Susman’s editorial on PSA screening (J Fam Pract. 2011;60:319) with great personal interest.

I am 43 years old; I have no family history of prostate cancer and had no symptoms. Yet my Gleason 7 prostate cancer was found by a PSA test. You can argue that statistically, it would be better that I be allowed to die so that 722 others could be spared the stress of testing, some subset of those could be spared a biopsy, and some still smaller subset could be spared overtreatment. But my PSA test wasn’t “screening nonsense,” as Dr. Susman laments. It was ordered by a wise and caring physician and it saved my life.

Go ahead and take a position based on statistics. But please don’t dismiss the judgment of other knowledgeable professionals as “nonsense.”

Scott Orwig
Saline, MI

I read Dr. Susman’s editorial on PSA screening (J Fam Pract. 2011;60:319) with great personal interest.

I am 43 years old; I have no family history of prostate cancer and had no symptoms. Yet my Gleason 7 prostate cancer was found by a PSA test. You can argue that statistically, it would be better that I be allowed to die so that 722 others could be spared the stress of testing, some subset of those could be spared a biopsy, and some still smaller subset could be spared overtreatment. But my PSA test wasn’t “screening nonsense,” as Dr. Susman laments. It was ordered by a wise and caring physician and it saved my life.

Go ahead and take a position based on statistics. But please don’t dismiss the judgment of other knowledgeable professionals as “nonsense.”

Scott Orwig
Saline, MI

I read Dr. Susman’s editorial on PSA screening (J Fam Pract. 2011;60:319) with great personal interest.

I am 43 years old; I have no family history of prostate cancer and had no symptoms. Yet my Gleason 7 prostate cancer was found by a PSA test. You can argue that statistically, it would be better that I be allowed to die so that 722 others could be spared the stress of testing, some subset of those could be spared a biopsy, and some still smaller subset could be spared overtreatment. But my PSA test wasn’t “screening nonsense,” as Dr. Susman laments. It was ordered by a wise and caring physician and it saved my life.

Go ahead and take a position based on statistics. But please don’t dismiss the judgment of other knowledgeable professionals as “nonsense.”

Scott Orwig
Saline, MI

Evidence summary

Lumbar disc disease is the most common cause of sciatica.¹ In the absence of red flags, the initial approach to treatment is conservative and includes physical therapy and analgesic medications. In 90% of patients, acute attacks of sciatica improve within 4 to 6 weeks without surgical intervention.^1,2

Experts agree that cauda equina syndrome is an absolute indication for urgent surgical intervention.³ Most also would consider surgery for patients with progressive or severe neuromotor deficit, although no controlled studies exist to support this recommendation.³ If surgery is necessary, discectomy to relieve nerve compression is the current standard of care.³

Surgery provides relief, at least in the short term
A Cochrane review of 4 RCTs compared open and microdiscectomy with nonoperative management of lumbar disc disease in patients with sciatica.¹ All the studies showed a tendency toward improved early outcomes with surgery. However, the results of the studies were limited by lack of adherence to treatment, with high crossover rates from conservative treatment to surgical intervention.

Microdiscectomy produced comparable results to standard open discectomy. The reviewers concluded that, for patients with sciatica caused by lumbar disc prolapse, surgery provides faster relief from the acute attack than conservative management; long-term differences in outcome are unclear.¹

A more recent systematic review of 5 studies that compared surgery with conservative management of sciatica concluded that early surgery provides better short-term relief of sciatica but no benefit after 1 or 2 years.⁴

Despite faster recovery with surgery, questions remain
A subsequent study randomized 283 patients with severe sciatica for 6 to 12 weeks to early surgery or prolonged conservative treatment with surgery if needed.⁵ Primary outcomes were functional disability, intensity of leg pain, and the patient’s self-perceived recovery. Of patients in the early surgery group, 89% (125/141) underwent microdiscectomy after a mean of 2.2 weeks.

At 1 year, intention-to-treat analysis showed no significant difference in disability, pain, or perceived recovery between the 2 groups. However, patients who underwent early surgery reported faster relief of leg pain and a faster rate of perceived recovery. The median time to perceived recovery was 4 weeks (95% confidence interval [CI], 3.7-4.4) for early surgery and 12.1 weeks (95% CI, 9.5-14.9) for prolonged conservative treatment. Both groups had a 95% recovery rate at 52 weeks.

Thirty-nine percent (55/142) of patients randomized to conservative management underwent surgery after a mean of 18.7 weeks, and this lack of adherence to intention to treat may limit the validity of the results. A follow-up study at 2 years continued to show no difference in outcomes between surgery and conservative treatment.⁶

Recommendations

The Institute for Clinical Systems Improvement (ICSI) recommends conservative management initially for acute low back pain with sciatica/radiculopathy because the condition usually improves in 4 to 6 weeks. Surgery is indicated in the following cases:

• cauda equina syndrome
• progressive or significant neuromotor deficit
• neuromotor deficit that persists after 4 to 6 weeks of conservative treatment
• chronic sciatica with positive straight leg raise longer than 6 weeks or uncontrolled pain.

The ICSI recommends that patients being considered for nonemergent surgery have an epidural steroid injection, which may allow them to advance in a nonoperative treatment program.²

The American College of Physicians guidelines agree that most patients with lumbar disc herniation will improve within the first month with conservative management. They recommend discectomy or epidural steroid injections as potential treatment options for patients whose symptoms persist despite conservative therapy.⁷

Evidence summary

Lumbar disc disease is the most common cause of sciatica.¹ In the absence of red flags, the initial approach to treatment is conservative and includes physical therapy and analgesic medications. In 90% of patients, acute attacks of sciatica improve within 4 to 6 weeks without surgical intervention.^1,2

Experts agree that cauda equina syndrome is an absolute indication for urgent surgical intervention.³ Most also would consider surgery for patients with progressive or severe neuromotor deficit, although no controlled studies exist to support this recommendation.³ If surgery is necessary, discectomy to relieve nerve compression is the current standard of care.³

Surgery provides relief, at least in the short term
A Cochrane review of 4 RCTs compared open and microdiscectomy with nonoperative management of lumbar disc disease in patients with sciatica.¹ All the studies showed a tendency toward improved early outcomes with surgery. However, the results of the studies were limited by lack of adherence to treatment, with high crossover rates from conservative treatment to surgical intervention.

Microdiscectomy produced comparable results to standard open discectomy. The reviewers concluded that, for patients with sciatica caused by lumbar disc prolapse, surgery provides faster relief from the acute attack than conservative management; long-term differences in outcome are unclear.¹

A more recent systematic review of 5 studies that compared surgery with conservative management of sciatica concluded that early surgery provides better short-term relief of sciatica but no benefit after 1 or 2 years.⁴

Despite faster recovery with surgery, questions remain
A subsequent study randomized 283 patients with severe sciatica for 6 to 12 weeks to early surgery or prolonged conservative treatment with surgery if needed.⁵ Primary outcomes were functional disability, intensity of leg pain, and the patient’s self-perceived recovery. Of patients in the early surgery group, 89% (125/141) underwent microdiscectomy after a mean of 2.2 weeks.

At 1 year, intention-to-treat analysis showed no significant difference in disability, pain, or perceived recovery between the 2 groups. However, patients who underwent early surgery reported faster relief of leg pain and a faster rate of perceived recovery. The median time to perceived recovery was 4 weeks (95% confidence interval [CI], 3.7-4.4) for early surgery and 12.1 weeks (95% CI, 9.5-14.9) for prolonged conservative treatment. Both groups had a 95% recovery rate at 52 weeks.

Thirty-nine percent (55/142) of patients randomized to conservative management underwent surgery after a mean of 18.7 weeks, and this lack of adherence to intention to treat may limit the validity of the results. A follow-up study at 2 years continued to show no difference in outcomes between surgery and conservative treatment.⁶

Recommendations

The Institute for Clinical Systems Improvement (ICSI) recommends conservative management initially for acute low back pain with sciatica/radiculopathy because the condition usually improves in 4 to 6 weeks. Surgery is indicated in the following cases:

• cauda equina syndrome
• progressive or significant neuromotor deficit
• neuromotor deficit that persists after 4 to 6 weeks of conservative treatment
• chronic sciatica with positive straight leg raise longer than 6 weeks or uncontrolled pain.

The ICSI recommends that patients being considered for nonemergent surgery have an epidural steroid injection, which may allow them to advance in a nonoperative treatment program.²

The American College of Physicians guidelines agree that most patients with lumbar disc herniation will improve within the first month with conservative management. They recommend discectomy or epidural steroid injections as potential treatment options for patients whose symptoms persist despite conservative therapy.⁷

Evidence summary

Lumbar disc disease is the most common cause of sciatica.¹ In the absence of red flags, the initial approach to treatment is conservative and includes physical therapy and analgesic medications. In 90% of patients, acute attacks of sciatica improve within 4 to 6 weeks without surgical intervention.^1,2

Experts agree that cauda equina syndrome is an absolute indication for urgent surgical intervention.³ Most also would consider surgery for patients with progressive or severe neuromotor deficit, although no controlled studies exist to support this recommendation.³ If surgery is necessary, discectomy to relieve nerve compression is the current standard of care.³

Surgery provides relief, at least in the short term
A Cochrane review of 4 RCTs compared open and microdiscectomy with nonoperative management of lumbar disc disease in patients with sciatica.¹ All the studies showed a tendency toward improved early outcomes with surgery. However, the results of the studies were limited by lack of adherence to treatment, with high crossover rates from conservative treatment to surgical intervention.

Microdiscectomy produced comparable results to standard open discectomy. The reviewers concluded that, for patients with sciatica caused by lumbar disc prolapse, surgery provides faster relief from the acute attack than conservative management; long-term differences in outcome are unclear.¹

A more recent systematic review of 5 studies that compared surgery with conservative management of sciatica concluded that early surgery provides better short-term relief of sciatica but no benefit after 1 or 2 years.⁴

Despite faster recovery with surgery, questions remain
A subsequent study randomized 283 patients with severe sciatica for 6 to 12 weeks to early surgery or prolonged conservative treatment with surgery if needed.⁵ Primary outcomes were functional disability, intensity of leg pain, and the patient’s self-perceived recovery. Of patients in the early surgery group, 89% (125/141) underwent microdiscectomy after a mean of 2.2 weeks.

At 1 year, intention-to-treat analysis showed no significant difference in disability, pain, or perceived recovery between the 2 groups. However, patients who underwent early surgery reported faster relief of leg pain and a faster rate of perceived recovery. The median time to perceived recovery was 4 weeks (95% confidence interval [CI], 3.7-4.4) for early surgery and 12.1 weeks (95% CI, 9.5-14.9) for prolonged conservative treatment. Both groups had a 95% recovery rate at 52 weeks.

Thirty-nine percent (55/142) of patients randomized to conservative management underwent surgery after a mean of 18.7 weeks, and this lack of adherence to intention to treat may limit the validity of the results. A follow-up study at 2 years continued to show no difference in outcomes between surgery and conservative treatment.⁶

Recommendations

The Institute for Clinical Systems Improvement (ICSI) recommends conservative management initially for acute low back pain with sciatica/radiculopathy because the condition usually improves in 4 to 6 weeks. Surgery is indicated in the following cases:

• cauda equina syndrome
• progressive or significant neuromotor deficit
• neuromotor deficit that persists after 4 to 6 weeks of conservative treatment
• chronic sciatica with positive straight leg raise longer than 6 weeks or uncontrolled pain.

The ICSI recommends that patients being considered for nonemergent surgery have an epidural steroid injection, which may allow them to advance in a nonoperative treatment program.²

The American College of Physicians guidelines agree that most patients with lumbar disc herniation will improve within the first month with conservative management. They recommend discectomy or epidural steroid injections as potential treatment options for patients whose symptoms persist despite conservative therapy.⁷

A 2004 national survey of more than 3100 American physicians in 6 specialties reported that 94% had some type of relationship with the pharmaceutical industry, mostly involving the receipt of food in the workplace (83%) or free drug samples (78%).¹ Family physicians met with industry representatives more frequently, on average 16 times per month, than other specialties.¹ But at what expense?

Physician interaction with the pharmaceutical industry and acceptance of drug samples has been shown to increase prescription costs and nonevidence-based prescribing.^2-4 Furthermore, evidence suggests that samples are not distributed to the neediest of patients,⁵ and that sampled medicines may be distributed with inadequate labeling, instruction, or discussion of adverse effects.^6,7

Evidence suggests doctors receive little value from detailing visits.^8,9 Physician organizations, including the National Physicians Alliance,¹⁰ No Free Lunch,¹¹ and the American Medical Student Association,¹² have explicit policies refusing gifts from drug companies and encourage members to examine the ethical implications of interactions with drug detailers. However, little guidance or evidence exists concerning the development of individual clinic policies regarding access of pharmaceutical representatives, the use of drug samples, or how such policies might affect prescribing practices of physicians.

Concerned about the operational impact of increased detailer visits on their private practice, the 5 physicians affiliated with Madras Medical Group decided by consensus to discontinue seeing pharmaceutical representatives and accepting and distributing drug samples. At the same time, they instituted scheduled group educational meetings to review nonindustry-supported, objective pharmaceutical resources. They also participated in a qualitative study to gain insight into the impact of this policy change on physician and nurse attitudes toward the practice of pharmaceutical detailing.

Methods

The study team, which included academic researchers unaffiliated with Madras Medical Group, used semistructured interviews with clinicians and key staff members at the rural family practice office. After a detailed literature review, the team created a set of 5 open-ended questions to obtain physician and nurse perceptions in 4 areas:

1. verification of the decision process and policy change banning pharmaceutical representatives and drug samples
2. impact of the policy on patients, physicians, nursing staff, and clinic operations
3. perceived influence of pharmaceutical representatives and drug samples on the practice
4. lessons learned to share with other family medicine practices contemplating implementation of a policy excluding pharmaceutical representatives and drug samples.

On a single day about 2 years after the policy change, an out-of-town neutral interviewer (GA) unaffiliated with the practice interviewed physicians and nurses. The interviewer asked the predetermined questions of each study participant and was free to ask related questions depending on the answers. The team taped the interviews and had them transcribed. Two study investigators and a senior research associate, none of whom were associated with the practice, read each transcript and independently identified common themes, concordance, theme saturation, and unique perspectives. The study was approved by the Oregon Health & Science University Institutional Review Board.

Results

Six clinic personnel participated in the interviews: 3 family physicians with an average of 8 years of practice, and 3 nurses with an average of 20 years of service. (The other 2 practice physicians were not in the office on the day interviews were conducted.) The interviewees agreed that the practice was free of pharmaceutical representatives, sample medicines, and marketing paraphernalia (pens, note pads, etc.). Each interviewee understood and supported the policy.

The analysis of participant responses was organized into 6 themes:

1. patient flow impact
2. detailing influence on prescribing
3. appropriate use and availability of therapeutically important medications
4. relevance of information provided by a pharmaceutical representative
5. value of detailer visits
6. patient and public response.

Patient flow impact
Study participants agreed that not seeing pharmaceutical representatives improved patient flow, and they viewed this lack of interruption from detailers positively.

It’s nice not to have all the interruptions. We have enough interruptions without having to get a signature from a doctor here or try and talk them into spending 5 or 10 minutes with this rep.—(Clinic nurse)

Certainly our work flow is easier. I don’t have my office nurse coming to me saying, “You have to go to talk to this drug rep.” I can go through my day without being interrupted that way. There are already plenty of interruptions. That’s not a necessary one.—(Clinic MD)

Influence on prescribing
All interviewees, particularly the physicians, viewed pharmaceutical detailing as a negative influence on clinical prescribing. This was a major reason for the change in policy. Such influences included receiving information of questionable veracity or objectivity; prescribing sampled medications unnecessarily; choosing sampled drugs because of convenience; and possibly making unethical decisions under the sway of representative gifting.

I think we’d all like to think that the presence of the drug reps doesn’t affect the way we prescribe, but they wouldn’t be here if it didn’t.—(Clinic MD)

Not having the sample cabinet…forces me to prescribe more on cost and efficacy than on what is in the sample cabinet.—(Clinic MD)

Appropriate use and availability of therapeutically important medications
Interviewees noted that sample medications offered by drug detailers were often of questionable benefit.

Samples we had were not necessarily the medicines we’d use first line. If you…start [a person with hypertension] on any medicine that’s in your sample cabinet, you’re not practicing good medicine…what you have is…expensive brand- name medicines that shouldn’t be first line, drive up costs, are not more effective, and possibly [have more adverse effects].—(Clinic MD)

For the most part I don’t see [samples as positively] impacting patients’ care at all. …We had a cupboard full of samples but nothing that was real useful in most cases.—(Clinic nurse)

Some respondents indicated that when they looked in the sample cabinet, the medications there were not what they were looking for. This was a source of frustration. It was also noted that often the samples were not being dispensed to patients but were being used by clinic personnel and their families.

The most valuable elements were samples, so our husbands didn’t have to buy Lipitor.—(Clinic nurse)

A lot of our samples were used by our staff and some of our physicians. I know cholesterol medicines in particular, PPIs, some antidepressants.…—(Clinic MD)

Relevance of information provided by pharmaceutical representative
The physicians viewed the information distributed by pharmaceutical representatives as, at best incomplete, and, at worst, misleading.

The straw that broke the camel’s back around here was Vioxx. We were heavily detailed on Vioxx…and you know, the study that was designed to look at GI side effects—do COX-2 inhibitors have less GI risk than other NSAIDS?—found that it caused heart attacks instead. …We’d been talking about this [policy] before Vioxx, but Vioxx brought it full front.—(Clinic MD)

Staff members, though initially less enthusiastic, grew to understand the policy, embrace the philosophy, and take pride in the clinic’s stance on pharmaceutical detailing.

The philosophy of the physicians led to policy. The philosophy is, “Let’s get our information from sources that don’t have anything to gain from their reports. Let’s try to bring down the cost of drugs.” It’s not necessarily to the patient’s advantage to be given samples of the most expensive drug on the market.—(Clinic nurse)

Value of detailer visits
The study subjects did not see the value of pharmaceutical detailing other than the periodic industry-sponsored lunches. The nurses, in particular, enjoyed this perk and viewed it as important social time for clinic employees to interact outside of the clinical environment. Interviewees further noted that the physicians seldom attended these lunches, as they were busy with other tasks.

Staff liked the lunches. It was a nice treat for them. When we started [the policy change], we provided a once-a-month “pharm-free” lunch…still fun, social interaction…paid out of clinic funds.—(Clinic MD)

Now that we’ve adjusted to it, we’re pretty happy with it. Part of it was once per month someone would bring us lunch. …Rather than educational for us, it was a social gathering. So the doctors now provide a once-a-month employee lunch.—(Clinic nurse)

Although some cost was incurred to replace pens, clock, staplers, and other branded items, the gifts brought by the detailers were not viewed as a big benefit for the clinic or its staff. The ethics of gifting was raised as a conflict of interest.

Patient and public response
To explain the key reasons behind the change in policy to patients and the community, Madras Medical Group sent press releases to local news outlets, and physicians took time to discuss the issues of samples and gifting with their patients.

We submitted a press release to the Madras Pioneer [local weekly newspaper] and Bend Bulletin [regional daily newspaper]. I think patients get this issue a whole lot better than doctors do. Doctors think they’re uninfluenced. They’re wrong. The general public knows and thinks they are. If you look at public surveys and patient surveys, it will very clearly tell you that patients take a dim view of this financial entanglement.—(Clinic MD)

Anecdotal patient feedback to the policy was generally positive. Although the practice conducted no formal survey, physicians and nurses received little negative feedback from patients regarding the policy or the lack of available drug samples. Clinic members believe the policy has resulted in improved patient care and moral clarity.

The feedback I got back from patients was generally very positive…and I got a hand-written thank you note that said, “Way to take a stand.” …It seemed to me that a lot of the people who had the fewest resources and least education were the ones who seemed to understand it the most.—(Clinic MD)

Discussion

This qualitative case study contributes to the discussion about the ethics and potential negative clinical effects of the doctor-pharmaceutical industry relationship.^2,13-20 Leading ethicists have long weighed in on the subject.¹⁵ Medical and nonmedical media outlets are replete with articles outlining the practice of drug detailing and questioning its practice.^21-24

Many academic medical centers have adopted policies regulating the interaction of the pharmaceutical industry with students, residents, and faculty.²⁵ In 2008, the Association of American Medical Colleges’ (AAMC) Task Force on Industry Funding of Medical Education released a report that included “developing principles, recommendations, and guidelines to assist members in refashioning industry relationships to better conform to high standards of medical professionalism.”²⁶ However, of the approximately 800,000 physicians in the United States, only 22% practice full time at academic medical centers that would adopt the AAMC policies.²⁷

While Campbell et al reported that more than 90% of physicians interact with pharmaceutical representatives, little is known about how private practice professionals and office staff perceive this interaction, its impact on office culture and workflow, and strategies or policies for managing this interaction.¹ Our qualitative study provides insight into how a small private primary care practice views working in an environment free from direct pharmaceutical detailing.

The policy change evaluated in this study did not occur overnight. What began as a theoretical and abstract discussion of the potential conflicts of interest in the doctor-pharmaceutical company relationship evolved into a more thorough look at this practice’s habits. Practice staff recorded the number of visits and lunches sponsored by drug companies and were surprised by the high frequency of these contacts. In response, the practice set limits on the number of such lunches and, later, on the number of detailing visits. Some doctors in the practice demanded that, during these visits, only peer-reviewed literature be cited by the representatives. After the rofecoxib (Vioxx) situation hit the press, the practice’s physicians became convinced that these limited interventions were not strong enough and developed the stringent policy change.

Before implementing the policy, the physicians discussed their rationale with the staff. Staff feedback was incorporated into the policy and, to date, there has been no staff turnover either related or unrelated to the policy. Recognizing the need for timely and accurate medication information, the practice began a structured and participatory monthly educational meeting using unbiased, evidence-based materials that were previously available to the doctors but reviewed with varying frequency by different providers.

Pharmaceutical gifts were acknowledged as valuable to the staff (lunches, pens, samples, etc.) and lunches in particular offered important social time. Overcoming the pushback from staff on the elimination of sponsored lunches was remedied by providing a monthly lunch with protected time for staff socialization. Interruptions in the busy clinical day decreased after the policy implementation, thereby improving patient flow. Without the frequent detailing visits, the nurses related that they were better able to focus on their clinical responsibilities. Additionally, the practice’s physicians and nurses observed that sample medications were often taken for personal use. The use of prescription drug samples by clinic staff has been documented elsewhere.²⁸

The practice’s physicians viewed the discontinuation of pharmaceutical representative visits and the elimination of samples through both clinical and ethical eyes. The detailing policy was changed to disentangle physicians from a relationship they believed adversely affected patient care. While gifts given in this practice consisted of lunches and trivial items, the physicians remained concerned about the subconscious impact of these gifts. This sentiment is echoed by research in social sciences documenting the powerful effect on human behavior through the receiving of gifts, even those of little value.²⁹

Other concerns surrounded the veracity and objectivity of the commercial materials. Recent scandals in drug marketing were among the issues that drove these concerns.³⁰ The practice’s physicians wanted prescribing decisions to be based on scientific information obtained from unbiased sources. The policy change resulted in a marked decrease in interaction with drug detailers, but direct mail from pharmaceutical companies continued to arrive. Although the physicians’ report of patient support for the new policy is anecdotal, it is consistent with other research showing that patients are aware of the influence of the pharmaceutical industry on prescribing behavior.³¹

Study limitations. This qualitative study occurred in a single rural family practice with a small number of study participants and may not be universally applicable across all practice locations, sizes, and specialties. Furthermore, qualitative studies in general do not offer rigorous statistical findings seen with other scientific methods.

This exploration does offer some structured insight into the complex relationship between the drug industry and practicing clinicians. Because a significant proportion of physicians practice individually or in small groups, this study may be useful for others who are considering adopting similar policies.

CORRESPONDENCE
David V. Evans, MD, Madras Medical Group, 76 NE 12th St., Madras, OR 97741; madrasdse@gmail.com

A 2004 national survey of more than 3100 American physicians in 6 specialties reported that 94% had some type of relationship with the pharmaceutical industry, mostly involving the receipt of food in the workplace (83%) or free drug samples (78%).¹ Family physicians met with industry representatives more frequently, on average 16 times per month, than other specialties.¹ But at what expense?

Physician interaction with the pharmaceutical industry and acceptance of drug samples has been shown to increase prescription costs and nonevidence-based prescribing.^2-4 Furthermore, evidence suggests that samples are not distributed to the neediest of patients,⁵ and that sampled medicines may be distributed with inadequate labeling, instruction, or discussion of adverse effects.^6,7

Evidence suggests doctors receive little value from detailing visits.^8,9 Physician organizations, including the National Physicians Alliance,¹⁰ No Free Lunch,¹¹ and the American Medical Student Association,¹² have explicit policies refusing gifts from drug companies and encourage members to examine the ethical implications of interactions with drug detailers. However, little guidance or evidence exists concerning the development of individual clinic policies regarding access of pharmaceutical representatives, the use of drug samples, or how such policies might affect prescribing practices of physicians.

Concerned about the operational impact of increased detailer visits on their private practice, the 5 physicians affiliated with Madras Medical Group decided by consensus to discontinue seeing pharmaceutical representatives and accepting and distributing drug samples. At the same time, they instituted scheduled group educational meetings to review nonindustry-supported, objective pharmaceutical resources. They also participated in a qualitative study to gain insight into the impact of this policy change on physician and nurse attitudes toward the practice of pharmaceutical detailing.

Methods

The study team, which included academic researchers unaffiliated with Madras Medical Group, used semistructured interviews with clinicians and key staff members at the rural family practice office. After a detailed literature review, the team created a set of 5 open-ended questions to obtain physician and nurse perceptions in 4 areas:

1. verification of the decision process and policy change banning pharmaceutical representatives and drug samples
2. impact of the policy on patients, physicians, nursing staff, and clinic operations
3. perceived influence of pharmaceutical representatives and drug samples on the practice
4. lessons learned to share with other family medicine practices contemplating implementation of a policy excluding pharmaceutical representatives and drug samples.

On a single day about 2 years after the policy change, an out-of-town neutral interviewer (GA) unaffiliated with the practice interviewed physicians and nurses. The interviewer asked the predetermined questions of each study participant and was free to ask related questions depending on the answers. The team taped the interviews and had them transcribed. Two study investigators and a senior research associate, none of whom were associated with the practice, read each transcript and independently identified common themes, concordance, theme saturation, and unique perspectives. The study was approved by the Oregon Health & Science University Institutional Review Board.

Results

Six clinic personnel participated in the interviews: 3 family physicians with an average of 8 years of practice, and 3 nurses with an average of 20 years of service. (The other 2 practice physicians were not in the office on the day interviews were conducted.) The interviewees agreed that the practice was free of pharmaceutical representatives, sample medicines, and marketing paraphernalia (pens, note pads, etc.). Each interviewee understood and supported the policy.

The analysis of participant responses was organized into 6 themes:

1. patient flow impact
2. detailing influence on prescribing
3. appropriate use and availability of therapeutically important medications
4. relevance of information provided by a pharmaceutical representative
5. value of detailer visits
6. patient and public response.

Patient flow impact
Study participants agreed that not seeing pharmaceutical representatives improved patient flow, and they viewed this lack of interruption from detailers positively.

It’s nice not to have all the interruptions. We have enough interruptions without having to get a signature from a doctor here or try and talk them into spending 5 or 10 minutes with this rep.—(Clinic nurse)

Certainly our work flow is easier. I don’t have my office nurse coming to me saying, “You have to go to talk to this drug rep.” I can go through my day without being interrupted that way. There are already plenty of interruptions. That’s not a necessary one.—(Clinic MD)

Influence on prescribing
All interviewees, particularly the physicians, viewed pharmaceutical detailing as a negative influence on clinical prescribing. This was a major reason for the change in policy. Such influences included receiving information of questionable veracity or objectivity; prescribing sampled medications unnecessarily; choosing sampled drugs because of convenience; and possibly making unethical decisions under the sway of representative gifting.

I think we’d all like to think that the presence of the drug reps doesn’t affect the way we prescribe, but they wouldn’t be here if it didn’t.—(Clinic MD)

Not having the sample cabinet…forces me to prescribe more on cost and efficacy than on what is in the sample cabinet.—(Clinic MD)

Appropriate use and availability of therapeutically important medications
Interviewees noted that sample medications offered by drug detailers were often of questionable benefit.

Samples we had were not necessarily the medicines we’d use first line. If you…start [a person with hypertension] on any medicine that’s in your sample cabinet, you’re not practicing good medicine…what you have is…expensive brand- name medicines that shouldn’t be first line, drive up costs, are not more effective, and possibly [have more adverse effects].—(Clinic MD)

For the most part I don’t see [samples as positively] impacting patients’ care at all. …We had a cupboard full of samples but nothing that was real useful in most cases.—(Clinic nurse)

Some respondents indicated that when they looked in the sample cabinet, the medications there were not what they were looking for. This was a source of frustration. It was also noted that often the samples were not being dispensed to patients but were being used by clinic personnel and their families.

The most valuable elements were samples, so our husbands didn’t have to buy Lipitor.—(Clinic nurse)

A lot of our samples were used by our staff and some of our physicians. I know cholesterol medicines in particular, PPIs, some antidepressants.…—(Clinic MD)

Relevance of information provided by pharmaceutical representative
The physicians viewed the information distributed by pharmaceutical representatives as, at best incomplete, and, at worst, misleading.

The straw that broke the camel’s back around here was Vioxx. We were heavily detailed on Vioxx…and you know, the study that was designed to look at GI side effects—do COX-2 inhibitors have less GI risk than other NSAIDS?—found that it caused heart attacks instead. …We’d been talking about this [policy] before Vioxx, but Vioxx brought it full front.—(Clinic MD)

Staff members, though initially less enthusiastic, grew to understand the policy, embrace the philosophy, and take pride in the clinic’s stance on pharmaceutical detailing.

The philosophy of the physicians led to policy. The philosophy is, “Let’s get our information from sources that don’t have anything to gain from their reports. Let’s try to bring down the cost of drugs.” It’s not necessarily to the patient’s advantage to be given samples of the most expensive drug on the market.—(Clinic nurse)

Value of detailer visits
The study subjects did not see the value of pharmaceutical detailing other than the periodic industry-sponsored lunches. The nurses, in particular, enjoyed this perk and viewed it as important social time for clinic employees to interact outside of the clinical environment. Interviewees further noted that the physicians seldom attended these lunches, as they were busy with other tasks.

Staff liked the lunches. It was a nice treat for them. When we started [the policy change], we provided a once-a-month “pharm-free” lunch…still fun, social interaction…paid out of clinic funds.—(Clinic MD)

Now that we’ve adjusted to it, we’re pretty happy with it. Part of it was once per month someone would bring us lunch. …Rather than educational for us, it was a social gathering. So the doctors now provide a once-a-month employee lunch.—(Clinic nurse)

Although some cost was incurred to replace pens, clock, staplers, and other branded items, the gifts brought by the detailers were not viewed as a big benefit for the clinic or its staff. The ethics of gifting was raised as a conflict of interest.

Patient and public response
To explain the key reasons behind the change in policy to patients and the community, Madras Medical Group sent press releases to local news outlets, and physicians took time to discuss the issues of samples and gifting with their patients.

We submitted a press release to the Madras Pioneer [local weekly newspaper] and Bend Bulletin [regional daily newspaper]. I think patients get this issue a whole lot better than doctors do. Doctors think they’re uninfluenced. They’re wrong. The general public knows and thinks they are. If you look at public surveys and patient surveys, it will very clearly tell you that patients take a dim view of this financial entanglement.—(Clinic MD)

Anecdotal patient feedback to the policy was generally positive. Although the practice conducted no formal survey, physicians and nurses received little negative feedback from patients regarding the policy or the lack of available drug samples. Clinic members believe the policy has resulted in improved patient care and moral clarity.

The feedback I got back from patients was generally very positive…and I got a hand-written thank you note that said, “Way to take a stand.” …It seemed to me that a lot of the people who had the fewest resources and least education were the ones who seemed to understand it the most.—(Clinic MD)

Discussion

This qualitative case study contributes to the discussion about the ethics and potential negative clinical effects of the doctor-pharmaceutical industry relationship.^2,13-20 Leading ethicists have long weighed in on the subject.¹⁵ Medical and nonmedical media outlets are replete with articles outlining the practice of drug detailing and questioning its practice.^21-24

Many academic medical centers have adopted policies regulating the interaction of the pharmaceutical industry with students, residents, and faculty.²⁵ In 2008, the Association of American Medical Colleges’ (AAMC) Task Force on Industry Funding of Medical Education released a report that included “developing principles, recommendations, and guidelines to assist members in refashioning industry relationships to better conform to high standards of medical professionalism.”²⁶ However, of the approximately 800,000 physicians in the United States, only 22% practice full time at academic medical centers that would adopt the AAMC policies.²⁷

While Campbell et al reported that more than 90% of physicians interact with pharmaceutical representatives, little is known about how private practice professionals and office staff perceive this interaction, its impact on office culture and workflow, and strategies or policies for managing this interaction.¹ Our qualitative study provides insight into how a small private primary care practice views working in an environment free from direct pharmaceutical detailing.

The policy change evaluated in this study did not occur overnight. What began as a theoretical and abstract discussion of the potential conflicts of interest in the doctor-pharmaceutical company relationship evolved into a more thorough look at this practice’s habits. Practice staff recorded the number of visits and lunches sponsored by drug companies and were surprised by the high frequency of these contacts. In response, the practice set limits on the number of such lunches and, later, on the number of detailing visits. Some doctors in the practice demanded that, during these visits, only peer-reviewed literature be cited by the representatives. After the rofecoxib (Vioxx) situation hit the press, the practice’s physicians became convinced that these limited interventions were not strong enough and developed the stringent policy change.

Before implementing the policy, the physicians discussed their rationale with the staff. Staff feedback was incorporated into the policy and, to date, there has been no staff turnover either related or unrelated to the policy. Recognizing the need for timely and accurate medication information, the practice began a structured and participatory monthly educational meeting using unbiased, evidence-based materials that were previously available to the doctors but reviewed with varying frequency by different providers.

Pharmaceutical gifts were acknowledged as valuable to the staff (lunches, pens, samples, etc.) and lunches in particular offered important social time. Overcoming the pushback from staff on the elimination of sponsored lunches was remedied by providing a monthly lunch with protected time for staff socialization. Interruptions in the busy clinical day decreased after the policy implementation, thereby improving patient flow. Without the frequent detailing visits, the nurses related that they were better able to focus on their clinical responsibilities. Additionally, the practice’s physicians and nurses observed that sample medications were often taken for personal use. The use of prescription drug samples by clinic staff has been documented elsewhere.²⁸

The practice’s physicians viewed the discontinuation of pharmaceutical representative visits and the elimination of samples through both clinical and ethical eyes. The detailing policy was changed to disentangle physicians from a relationship they believed adversely affected patient care. While gifts given in this practice consisted of lunches and trivial items, the physicians remained concerned about the subconscious impact of these gifts. This sentiment is echoed by research in social sciences documenting the powerful effect on human behavior through the receiving of gifts, even those of little value.²⁹

Other concerns surrounded the veracity and objectivity of the commercial materials. Recent scandals in drug marketing were among the issues that drove these concerns.³⁰ The practice’s physicians wanted prescribing decisions to be based on scientific information obtained from unbiased sources. The policy change resulted in a marked decrease in interaction with drug detailers, but direct mail from pharmaceutical companies continued to arrive. Although the physicians’ report of patient support for the new policy is anecdotal, it is consistent with other research showing that patients are aware of the influence of the pharmaceutical industry on prescribing behavior.³¹

Study limitations. This qualitative study occurred in a single rural family practice with a small number of study participants and may not be universally applicable across all practice locations, sizes, and specialties. Furthermore, qualitative studies in general do not offer rigorous statistical findings seen with other scientific methods.

This exploration does offer some structured insight into the complex relationship between the drug industry and practicing clinicians. Because a significant proportion of physicians practice individually or in small groups, this study may be useful for others who are considering adopting similar policies.

CORRESPONDENCE
David V. Evans, MD, Madras Medical Group, 76 NE 12th St., Madras, OR 97741; madrasdse@gmail.com

A 2004 national survey of more than 3100 American physicians in 6 specialties reported that 94% had some type of relationship with the pharmaceutical industry, mostly involving the receipt of food in the workplace (83%) or free drug samples (78%).¹ Family physicians met with industry representatives more frequently, on average 16 times per month, than other specialties.¹ But at what expense?

Physician interaction with the pharmaceutical industry and acceptance of drug samples has been shown to increase prescription costs and nonevidence-based prescribing.^2-4 Furthermore, evidence suggests that samples are not distributed to the neediest of patients,⁵ and that sampled medicines may be distributed with inadequate labeling, instruction, or discussion of adverse effects.^6,7

Evidence suggests doctors receive little value from detailing visits.^8,9 Physician organizations, including the National Physicians Alliance,¹⁰ No Free Lunch,¹¹ and the American Medical Student Association,¹² have explicit policies refusing gifts from drug companies and encourage members to examine the ethical implications of interactions with drug detailers. However, little guidance or evidence exists concerning the development of individual clinic policies regarding access of pharmaceutical representatives, the use of drug samples, or how such policies might affect prescribing practices of physicians.

Concerned about the operational impact of increased detailer visits on their private practice, the 5 physicians affiliated with Madras Medical Group decided by consensus to discontinue seeing pharmaceutical representatives and accepting and distributing drug samples. At the same time, they instituted scheduled group educational meetings to review nonindustry-supported, objective pharmaceutical resources. They also participated in a qualitative study to gain insight into the impact of this policy change on physician and nurse attitudes toward the practice of pharmaceutical detailing.

Methods

The study team, which included academic researchers unaffiliated with Madras Medical Group, used semistructured interviews with clinicians and key staff members at the rural family practice office. After a detailed literature review, the team created a set of 5 open-ended questions to obtain physician and nurse perceptions in 4 areas:

1. verification of the decision process and policy change banning pharmaceutical representatives and drug samples
2. impact of the policy on patients, physicians, nursing staff, and clinic operations
3. perceived influence of pharmaceutical representatives and drug samples on the practice
4. lessons learned to share with other family medicine practices contemplating implementation of a policy excluding pharmaceutical representatives and drug samples.

On a single day about 2 years after the policy change, an out-of-town neutral interviewer (GA) unaffiliated with the practice interviewed physicians and nurses. The interviewer asked the predetermined questions of each study participant and was free to ask related questions depending on the answers. The team taped the interviews and had them transcribed. Two study investigators and a senior research associate, none of whom were associated with the practice, read each transcript and independently identified common themes, concordance, theme saturation, and unique perspectives. The study was approved by the Oregon Health & Science University Institutional Review Board.

Results

Six clinic personnel participated in the interviews: 3 family physicians with an average of 8 years of practice, and 3 nurses with an average of 20 years of service. (The other 2 practice physicians were not in the office on the day interviews were conducted.) The interviewees agreed that the practice was free of pharmaceutical representatives, sample medicines, and marketing paraphernalia (pens, note pads, etc.). Each interviewee understood and supported the policy.

The analysis of participant responses was organized into 6 themes:

1. patient flow impact
2. detailing influence on prescribing
3. appropriate use and availability of therapeutically important medications
4. relevance of information provided by a pharmaceutical representative
5. value of detailer visits
6. patient and public response.

Patient flow impact
Study participants agreed that not seeing pharmaceutical representatives improved patient flow, and they viewed this lack of interruption from detailers positively.

It’s nice not to have all the interruptions. We have enough interruptions without having to get a signature from a doctor here or try and talk them into spending 5 or 10 minutes with this rep.—(Clinic nurse)

Certainly our work flow is easier. I don’t have my office nurse coming to me saying, “You have to go to talk to this drug rep.” I can go through my day without being interrupted that way. There are already plenty of interruptions. That’s not a necessary one.—(Clinic MD)

Influence on prescribing
All interviewees, particularly the physicians, viewed pharmaceutical detailing as a negative influence on clinical prescribing. This was a major reason for the change in policy. Such influences included receiving information of questionable veracity or objectivity; prescribing sampled medications unnecessarily; choosing sampled drugs because of convenience; and possibly making unethical decisions under the sway of representative gifting.

I think we’d all like to think that the presence of the drug reps doesn’t affect the way we prescribe, but they wouldn’t be here if it didn’t.—(Clinic MD)

Not having the sample cabinet…forces me to prescribe more on cost and efficacy than on what is in the sample cabinet.—(Clinic MD)

Appropriate use and availability of therapeutically important medications
Interviewees noted that sample medications offered by drug detailers were often of questionable benefit.

Samples we had were not necessarily the medicines we’d use first line. If you…start [a person with hypertension] on any medicine that’s in your sample cabinet, you’re not practicing good medicine…what you have is…expensive brand- name medicines that shouldn’t be first line, drive up costs, are not more effective, and possibly [have more adverse effects].—(Clinic MD)

For the most part I don’t see [samples as positively] impacting patients’ care at all. …We had a cupboard full of samples but nothing that was real useful in most cases.—(Clinic nurse)

Some respondents indicated that when they looked in the sample cabinet, the medications there were not what they were looking for. This was a source of frustration. It was also noted that often the samples were not being dispensed to patients but were being used by clinic personnel and their families.

The most valuable elements were samples, so our husbands didn’t have to buy Lipitor.—(Clinic nurse)

A lot of our samples were used by our staff and some of our physicians. I know cholesterol medicines in particular, PPIs, some antidepressants.…—(Clinic MD)

Relevance of information provided by pharmaceutical representative
The physicians viewed the information distributed by pharmaceutical representatives as, at best incomplete, and, at worst, misleading.

The straw that broke the camel’s back around here was Vioxx. We were heavily detailed on Vioxx…and you know, the study that was designed to look at GI side effects—do COX-2 inhibitors have less GI risk than other NSAIDS?—found that it caused heart attacks instead. …We’d been talking about this [policy] before Vioxx, but Vioxx brought it full front.—(Clinic MD)

Staff members, though initially less enthusiastic, grew to understand the policy, embrace the philosophy, and take pride in the clinic’s stance on pharmaceutical detailing.

The philosophy of the physicians led to policy. The philosophy is, “Let’s get our information from sources that don’t have anything to gain from their reports. Let’s try to bring down the cost of drugs.” It’s not necessarily to the patient’s advantage to be given samples of the most expensive drug on the market.—(Clinic nurse)

Value of detailer visits
The study subjects did not see the value of pharmaceutical detailing other than the periodic industry-sponsored lunches. The nurses, in particular, enjoyed this perk and viewed it as important social time for clinic employees to interact outside of the clinical environment. Interviewees further noted that the physicians seldom attended these lunches, as they were busy with other tasks.

Staff liked the lunches. It was a nice treat for them. When we started [the policy change], we provided a once-a-month “pharm-free” lunch…still fun, social interaction…paid out of clinic funds.—(Clinic MD)

Now that we’ve adjusted to it, we’re pretty happy with it. Part of it was once per month someone would bring us lunch. …Rather than educational for us, it was a social gathering. So the doctors now provide a once-a-month employee lunch.—(Clinic nurse)

Although some cost was incurred to replace pens, clock, staplers, and other branded items, the gifts brought by the detailers were not viewed as a big benefit for the clinic or its staff. The ethics of gifting was raised as a conflict of interest.

Patient and public response
To explain the key reasons behind the change in policy to patients and the community, Madras Medical Group sent press releases to local news outlets, and physicians took time to discuss the issues of samples and gifting with their patients.

We submitted a press release to the Madras Pioneer [local weekly newspaper] and Bend Bulletin [regional daily newspaper]. I think patients get this issue a whole lot better than doctors do. Doctors think they’re uninfluenced. They’re wrong. The general public knows and thinks they are. If you look at public surveys and patient surveys, it will very clearly tell you that patients take a dim view of this financial entanglement.—(Clinic MD)

Anecdotal patient feedback to the policy was generally positive. Although the practice conducted no formal survey, physicians and nurses received little negative feedback from patients regarding the policy or the lack of available drug samples. Clinic members believe the policy has resulted in improved patient care and moral clarity.

The feedback I got back from patients was generally very positive…and I got a hand-written thank you note that said, “Way to take a stand.” …It seemed to me that a lot of the people who had the fewest resources and least education were the ones who seemed to understand it the most.—(Clinic MD)

Discussion

This qualitative case study contributes to the discussion about the ethics and potential negative clinical effects of the doctor-pharmaceutical industry relationship.^2,13-20 Leading ethicists have long weighed in on the subject.¹⁵ Medical and nonmedical media outlets are replete with articles outlining the practice of drug detailing and questioning its practice.^21-24

Many academic medical centers have adopted policies regulating the interaction of the pharmaceutical industry with students, residents, and faculty.²⁵ In 2008, the Association of American Medical Colleges’ (AAMC) Task Force on Industry Funding of Medical Education released a report that included “developing principles, recommendations, and guidelines to assist members in refashioning industry relationships to better conform to high standards of medical professionalism.”²⁶ However, of the approximately 800,000 physicians in the United States, only 22% practice full time at academic medical centers that would adopt the AAMC policies.²⁷

While Campbell et al reported that more than 90% of physicians interact with pharmaceutical representatives, little is known about how private practice professionals and office staff perceive this interaction, its impact on office culture and workflow, and strategies or policies for managing this interaction.¹ Our qualitative study provides insight into how a small private primary care practice views working in an environment free from direct pharmaceutical detailing.

The policy change evaluated in this study did not occur overnight. What began as a theoretical and abstract discussion of the potential conflicts of interest in the doctor-pharmaceutical company relationship evolved into a more thorough look at this practice’s habits. Practice staff recorded the number of visits and lunches sponsored by drug companies and were surprised by the high frequency of these contacts. In response, the practice set limits on the number of such lunches and, later, on the number of detailing visits. Some doctors in the practice demanded that, during these visits, only peer-reviewed literature be cited by the representatives. After the rofecoxib (Vioxx) situation hit the press, the practice’s physicians became convinced that these limited interventions were not strong enough and developed the stringent policy change.

Before implementing the policy, the physicians discussed their rationale with the staff. Staff feedback was incorporated into the policy and, to date, there has been no staff turnover either related or unrelated to the policy. Recognizing the need for timely and accurate medication information, the practice began a structured and participatory monthly educational meeting using unbiased, evidence-based materials that were previously available to the doctors but reviewed with varying frequency by different providers.

Pharmaceutical gifts were acknowledged as valuable to the staff (lunches, pens, samples, etc.) and lunches in particular offered important social time. Overcoming the pushback from staff on the elimination of sponsored lunches was remedied by providing a monthly lunch with protected time for staff socialization. Interruptions in the busy clinical day decreased after the policy implementation, thereby improving patient flow. Without the frequent detailing visits, the nurses related that they were better able to focus on their clinical responsibilities. Additionally, the practice’s physicians and nurses observed that sample medications were often taken for personal use. The use of prescription drug samples by clinic staff has been documented elsewhere.²⁸

The practice’s physicians viewed the discontinuation of pharmaceutical representative visits and the elimination of samples through both clinical and ethical eyes. The detailing policy was changed to disentangle physicians from a relationship they believed adversely affected patient care. While gifts given in this practice consisted of lunches and trivial items, the physicians remained concerned about the subconscious impact of these gifts. This sentiment is echoed by research in social sciences documenting the powerful effect on human behavior through the receiving of gifts, even those of little value.²⁹

Other concerns surrounded the veracity and objectivity of the commercial materials. Recent scandals in drug marketing were among the issues that drove these concerns.³⁰ The practice’s physicians wanted prescribing decisions to be based on scientific information obtained from unbiased sources. The policy change resulted in a marked decrease in interaction with drug detailers, but direct mail from pharmaceutical companies continued to arrive. Although the physicians’ report of patient support for the new policy is anecdotal, it is consistent with other research showing that patients are aware of the influence of the pharmaceutical industry on prescribing behavior.³¹

Study limitations. This qualitative study occurred in a single rural family practice with a small number of study participants and may not be universally applicable across all practice locations, sizes, and specialties. Furthermore, qualitative studies in general do not offer rigorous statistical findings seen with other scientific methods.

This exploration does offer some structured insight into the complex relationship between the drug industry and practicing clinicians. Because a significant proportion of physicians practice individually or in small groups, this study may be useful for others who are considering adopting similar policies.

CORRESPONDENCE
David V. Evans, MD, Madras Medical Group, 76 NE 12th St., Madras, OR 97741; madrasdse@gmail.com

CASE When Joan C, a 35-year-old patient whom you’ve known for years, comes in for a physical, you notice that she’s coughing frequently. Upon questioning, Joan says she first noticed the cough several months ago; she also reports that she’s frequently hoarse, but has no other symptoms. Joan is a former smoker, and quit 4 years ago.

If Joan were your patient, would you suspect that she had an upper respiratory infection and prescribe an antibiotic such as azithromycin? Would you include laryngopharyngeal reflux disease in the differential diagnosis?

Laryngopharyngeal reflux disease (LPRD) is a common condition that most primary care physicians encounter frequently. It is also frequently misdiagnosed by clinicians who are unfamiliar with the differences between LPRD and gastroesophageal reflux disease (GERD).

The American Academy of Otolaryngology–Head and Neck Surgery defines laryngopharyngeal reflux as the retrograde movement of gastric contents into the laryngopharynx.¹ Common symptoms include hoarseness/dysphonia, chronic throat clearing, dysphagia, globus pharyngeus, and chronic cough, as well as postnasal drip, paroxysmal laryngospasm, odynophagia, excessive throat mucus, and a strange taste in the mouth.²

The diversity and vagueness of these symptoms, as well as the lack of a gold standard diagnostic test for LPRD, make it difficult to estimate its prevalence. In addition, signs of gastroesophageal reflux can be found in the laryngopharynx of up to 86% of healthy individuals, further complicating the clinical picture.³ To avoid missing this often overlooked reflux disease, you need to know how it develops, what signs and symptoms to look for, and which distinguishing features to keep in mind.

Pathophysiology and distinguishing features

The precise way in which LPRD develops is not known, but there are 2 proposed means of laryngeal injury—direct and indirect. In the first case, chemical irritants in the gastric refluxate enter the laryngopharynx and cause local mucosal injury. In the second, gastric reflux irritates the esophageal tissue enough to evoke laryngeal reflexes without ever reaching the larynx—a vagally mediated response associated with symptoms such as chronic cough, throat-clearing sensations, and bronchoconstriction.⁴

Unlike the esophageal lining, laryngeal epithelium is not protected against chemical injury from gastric acid, as it lacks both the stripping motion of esophageal peristalsis and the neutralizing bicarbonate in saliva.⁴ Thus, while far smaller amounts of gastric reflux make it into the laryngopharynx, the acid remains there longer and may cause greater injury.⁵ In some cases, this occurs as often as 50 times a day, although as few as 3 episodes per week have been known to cause LPRD.⁵

Heartburn is not the rule
Heartburn is a primary complaint of patients with GERD. It is reported by little more than a third (35%) of those with LPRD,^5,6 however, (which is why it is sometimes called the “silent” reflux disease). This is because heartburn is caused by esophagitis due to esophageal dysmotility and lower esophageal sphincter dysfunction,³ while most patients with LPRD have normal esophageal motor function and upper esophageal sphincter dysfunction. The fact that only a minimal amount of reflux enters the laryngopharynx may be part of the reason heartburn is less likely in patients with LPRD.

Onset of symptoms. When reflux occurs is another thing that distinguishes LPRD and GERD. Symptoms of GERD typically worsen when the individual is supine, while laryngopharyngeal reflux usually occurs when he or she is upright.⁷ The frequency with which these 2 conditions overlap is debatable, as there are few studies differentiating LPRD and GERD based on standardized signs and symptoms.⁷

Making sense of signs and symptoms

Most patients with LPRD seek treatment from their primary care physician, typically reporting symptoms that they don’t associate with gastric reflux, such as hoarseness, a chronic cough or sore throat, or the sensation of a lump in the throat (TABLE 1). Less common manifestations include “water brash”—excessive mucus in the mouth caused by a release of salivary bicarbonate to help neutralize acidity⁸—otitis media, sinus disease, and dental caries.⁵

Laryngeal endoscopy may reveal many changes from diffuse irritation. Diffuse erythema, edema, and interarytenoid hypertrophy/cobblestoning are the most useful findings for an LPRD diagnosis.^9,10 But in most cases, only a few nonspecific signs with a number of possible causes (infection, environmental irritants, allergies, temperature/climate change, among others) are seen on endoscopic examination, with little correlation with symptom severity. In fact, 74% of otolaryngologists responding to a recent survey said they relied more on patient symptoms than on laryngeal signs for an LPRD diagnosis.¹⁰

The Reflux Finding Score (RFS), available at http://www.nature.com/gimo/contents/pt1/fig_tab/gimo46_T3.html, is a clinical tool developed to quantify laryngeal inflammation and standardize objective endoscopic findings. The RFS incorporates the following endolaryngeal signs:

• subglottic edema
• ventricular obliteration
• erythema/hyperemia
• vocal cord edema
• diffuse laryngeal edema
• posterior commissure hypertrophy
• granuloma/granulation tissue
• thick endolaryngeal mucus.

A numeric value is assigned to each, based on whether it is present or absent; partial or complete; local or diffuse; or mild or severe. However, the RFS, too, is an imperfect tool. Clinicians who have used the RFS report that a score higher than 7 identifies LPRD with 95% sensitivity.¹¹ But laryngeal findings may be due to other causes, such as infection, autoimmune reaction, or even allergies, and studies have found the RFS to have poor specificity and inter-rater reliability.^12-14

Ambulatory dual probe pH monitoring was considered to be the gold standard test for LPRD at one time, but newer studies have raised questions about its validity and usefulness, especially in patients taking proton-pump inhibitors (PPIs).^1,5,7 Newer advanced probes featuring less invasive data collection and greater sensitivity are under development. Ambulatory 24-hour multichannel intraluminal impedance with pH monitoring is the most promising new diagnostic tool, as it can monitor both acidic and nonacidic reflux and distinguish between gas and liquid.¹⁵

TABLE 1
When to suspect laryngopharyngeal reflux disease^1,5,24

Treatment, like diagnosis, is not clear-cut

LPRD is often called a diagnosis of exclusion, because of the nonspecific nature of its signs and symptoms and the importance of considering a range of other etiologies. The differential diagnosis includes excessive voice use, postnasal drip, upper respiratory infection, habitual throat clearing, allergic rhinitis, environmental irritants, temperature/climate change, chronic or episodic use of alcohol and/or tobacco, and psychological problems related to tics, such as habitual throat clearing or coughing.⁵

Diagnosis is often based on an empiric trial of high-dose PPIs, with confirmation dependent on symptom relief. Because there have been few placebo-controlled trials with PPIs and those that have been completed had conflicting results, diagnosis based on a combination of medical history and endoscopic laryngeal examination may be a better approach.^16,17

Acid suppression therapy with either PPIs or histamine-2 (H2) receptor blockers such as ranitidine or famotidine is the mainstay of treatment for LPRD. But medical societies offer conflicting advice. The American Gastroenterological Association cautions clinicians not to prescribe acid-suppression therapy for patients with LPRD unless they also have GERD.⁶ The American Academy of Otolaryngology–Head and Neck Surgery recommends twice-daily PPI use for ≥6 months.^1,13 The general consensus, based on clinical experience alone, is that patients should be treated with high doses of PPIs (eg, 40 mg omeprazole twice a day) for ≥6 months, with the addition of an H2 receptor blocker to help reduce overnight acid production.^1,18 Prophylactic antacid use is also recommended in anticipation of reflux, such as before exercising and right after a meal.

Symptoms should start to improve within 6 to 8 weeks, and patients should be reassessed in about 3 months. To avoid a rebound effect from the abrupt cessation of medications, we suggest a gradual taper over 16 weeks. For the first 8 weeks, the H2 blocker should be discontinued and the PPI decreased from twice a day to once. If symptoms are still controlled, the PPI dose can be reduced to once every other day for another 8 weeks, then stopped if symptoms do not recur.¹⁸

Lifestyle and dietary changes (TABLE 2), such as smoking cessation, weight loss, and avoidance of alcohol, are an important part of LPRD treatment, and may be used as a first-line therapy before prescribing medication.¹⁹ In fact, some studies have found PPI therapy to be inferior to behavioral/lifestyle modifications.¹⁷

Fundoplication surgery, a procedure in which the gastric fundus of the stomach is wrapped around the lower end of the esophagus and stitched in place to prevent reflux, may be an option for patients who do not respond to, or cannot tolerate, aggressive medical treatment for LPRD. A 2006 prospective controlled study found that surgical fundoplication did not consistently relieve laryngeal symptoms.²⁰ But other studies have found that a carefully selected population with medically unresponsive laryngopharyngeal symptoms can benefit from this procedure.^21,22 One study showed a significant improvement within one month of fundoplication, with continued improvement observed during a 3-year follow-up.²¹ In another prospective study, researchers showed that while LPRD-related laryngeal symptoms such as coughing and throat-clearing improved with both medical therapy and laparoscopic fundoplication, voice quality and endoscopic laryngeal/pharyngeal findings improved significantly only with the surgical procedure.²³

TABLE 2
Recommend these lifestyle modifications¹⁹

CORRESPONDENCE
Shoib Sana, DO, Detroit Medical Center, Otolaryngology-Head and Neck Surgery, 6533 East Jefferson Avenue, Apartment 316, Detroit, MI 48207; ssana@dmc.org

CASE When Joan C, a 35-year-old patient whom you’ve known for years, comes in for a physical, you notice that she’s coughing frequently. Upon questioning, Joan says she first noticed the cough several months ago; she also reports that she’s frequently hoarse, but has no other symptoms. Joan is a former smoker, and quit 4 years ago.

If Joan were your patient, would you suspect that she had an upper respiratory infection and prescribe an antibiotic such as azithromycin? Would you include laryngopharyngeal reflux disease in the differential diagnosis?

Laryngopharyngeal reflux disease (LPRD) is a common condition that most primary care physicians encounter frequently. It is also frequently misdiagnosed by clinicians who are unfamiliar with the differences between LPRD and gastroesophageal reflux disease (GERD).

The American Academy of Otolaryngology–Head and Neck Surgery defines laryngopharyngeal reflux as the retrograde movement of gastric contents into the laryngopharynx.¹ Common symptoms include hoarseness/dysphonia, chronic throat clearing, dysphagia, globus pharyngeus, and chronic cough, as well as postnasal drip, paroxysmal laryngospasm, odynophagia, excessive throat mucus, and a strange taste in the mouth.²

The diversity and vagueness of these symptoms, as well as the lack of a gold standard diagnostic test for LPRD, make it difficult to estimate its prevalence. In addition, signs of gastroesophageal reflux can be found in the laryngopharynx of up to 86% of healthy individuals, further complicating the clinical picture.³ To avoid missing this often overlooked reflux disease, you need to know how it develops, what signs and symptoms to look for, and which distinguishing features to keep in mind.

Pathophysiology and distinguishing features

The precise way in which LPRD develops is not known, but there are 2 proposed means of laryngeal injury—direct and indirect. In the first case, chemical irritants in the gastric refluxate enter the laryngopharynx and cause local mucosal injury. In the second, gastric reflux irritates the esophageal tissue enough to evoke laryngeal reflexes without ever reaching the larynx—a vagally mediated response associated with symptoms such as chronic cough, throat-clearing sensations, and bronchoconstriction.⁴

Unlike the esophageal lining, laryngeal epithelium is not protected against chemical injury from gastric acid, as it lacks both the stripping motion of esophageal peristalsis and the neutralizing bicarbonate in saliva.⁴ Thus, while far smaller amounts of gastric reflux make it into the laryngopharynx, the acid remains there longer and may cause greater injury.⁵ In some cases, this occurs as often as 50 times a day, although as few as 3 episodes per week have been known to cause LPRD.⁵

Heartburn is not the rule
Heartburn is a primary complaint of patients with GERD. It is reported by little more than a third (35%) of those with LPRD,^5,6 however, (which is why it is sometimes called the “silent” reflux disease). This is because heartburn is caused by esophagitis due to esophageal dysmotility and lower esophageal sphincter dysfunction,³ while most patients with LPRD have normal esophageal motor function and upper esophageal sphincter dysfunction. The fact that only a minimal amount of reflux enters the laryngopharynx may be part of the reason heartburn is less likely in patients with LPRD.

Onset of symptoms. When reflux occurs is another thing that distinguishes LPRD and GERD. Symptoms of GERD typically worsen when the individual is supine, while laryngopharyngeal reflux usually occurs when he or she is upright.⁷ The frequency with which these 2 conditions overlap is debatable, as there are few studies differentiating LPRD and GERD based on standardized signs and symptoms.⁷

Making sense of signs and symptoms

Most patients with LPRD seek treatment from their primary care physician, typically reporting symptoms that they don’t associate with gastric reflux, such as hoarseness, a chronic cough or sore throat, or the sensation of a lump in the throat (TABLE 1). Less common manifestations include “water brash”—excessive mucus in the mouth caused by a release of salivary bicarbonate to help neutralize acidity⁸—otitis media, sinus disease, and dental caries.⁵

Laryngeal endoscopy may reveal many changes from diffuse irritation. Diffuse erythema, edema, and interarytenoid hypertrophy/cobblestoning are the most useful findings for an LPRD diagnosis.^9,10 But in most cases, only a few nonspecific signs with a number of possible causes (infection, environmental irritants, allergies, temperature/climate change, among others) are seen on endoscopic examination, with little correlation with symptom severity. In fact, 74% of otolaryngologists responding to a recent survey said they relied more on patient symptoms than on laryngeal signs for an LPRD diagnosis.¹⁰

The Reflux Finding Score (RFS), available at http://www.nature.com/gimo/contents/pt1/fig_tab/gimo46_T3.html, is a clinical tool developed to quantify laryngeal inflammation and standardize objective endoscopic findings. The RFS incorporates the following endolaryngeal signs:

• subglottic edema
• ventricular obliteration
• erythema/hyperemia
• vocal cord edema
• diffuse laryngeal edema
• posterior commissure hypertrophy
• granuloma/granulation tissue
• thick endolaryngeal mucus.

A numeric value is assigned to each, based on whether it is present or absent; partial or complete; local or diffuse; or mild or severe. However, the RFS, too, is an imperfect tool. Clinicians who have used the RFS report that a score higher than 7 identifies LPRD with 95% sensitivity.¹¹ But laryngeal findings may be due to other causes, such as infection, autoimmune reaction, or even allergies, and studies have found the RFS to have poor specificity and inter-rater reliability.^12-14

Ambulatory dual probe pH monitoring was considered to be the gold standard test for LPRD at one time, but newer studies have raised questions about its validity and usefulness, especially in patients taking proton-pump inhibitors (PPIs).^1,5,7 Newer advanced probes featuring less invasive data collection and greater sensitivity are under development. Ambulatory 24-hour multichannel intraluminal impedance with pH monitoring is the most promising new diagnostic tool, as it can monitor both acidic and nonacidic reflux and distinguish between gas and liquid.¹⁵

TABLE 1
When to suspect laryngopharyngeal reflux disease^1,5,24

Treatment, like diagnosis, is not clear-cut

LPRD is often called a diagnosis of exclusion, because of the nonspecific nature of its signs and symptoms and the importance of considering a range of other etiologies. The differential diagnosis includes excessive voice use, postnasal drip, upper respiratory infection, habitual throat clearing, allergic rhinitis, environmental irritants, temperature/climate change, chronic or episodic use of alcohol and/or tobacco, and psychological problems related to tics, such as habitual throat clearing or coughing.⁵

Diagnosis is often based on an empiric trial of high-dose PPIs, with confirmation dependent on symptom relief. Because there have been few placebo-controlled trials with PPIs and those that have been completed had conflicting results, diagnosis based on a combination of medical history and endoscopic laryngeal examination may be a better approach.^16,17

Acid suppression therapy with either PPIs or histamine-2 (H2) receptor blockers such as ranitidine or famotidine is the mainstay of treatment for LPRD. But medical societies offer conflicting advice. The American Gastroenterological Association cautions clinicians not to prescribe acid-suppression therapy for patients with LPRD unless they also have GERD.⁶ The American Academy of Otolaryngology–Head and Neck Surgery recommends twice-daily PPI use for ≥6 months.^1,13 The general consensus, based on clinical experience alone, is that patients should be treated with high doses of PPIs (eg, 40 mg omeprazole twice a day) for ≥6 months, with the addition of an H2 receptor blocker to help reduce overnight acid production.^1,18 Prophylactic antacid use is also recommended in anticipation of reflux, such as before exercising and right after a meal.

Symptoms should start to improve within 6 to 8 weeks, and patients should be reassessed in about 3 months. To avoid a rebound effect from the abrupt cessation of medications, we suggest a gradual taper over 16 weeks. For the first 8 weeks, the H2 blocker should be discontinued and the PPI decreased from twice a day to once. If symptoms are still controlled, the PPI dose can be reduced to once every other day for another 8 weeks, then stopped if symptoms do not recur.¹⁸

Lifestyle and dietary changes (TABLE 2), such as smoking cessation, weight loss, and avoidance of alcohol, are an important part of LPRD treatment, and may be used as a first-line therapy before prescribing medication.¹⁹ In fact, some studies have found PPI therapy to be inferior to behavioral/lifestyle modifications.¹⁷

Fundoplication surgery, a procedure in which the gastric fundus of the stomach is wrapped around the lower end of the esophagus and stitched in place to prevent reflux, may be an option for patients who do not respond to, or cannot tolerate, aggressive medical treatment for LPRD. A 2006 prospective controlled study found that surgical fundoplication did not consistently relieve laryngeal symptoms.²⁰ But other studies have found that a carefully selected population with medically unresponsive laryngopharyngeal symptoms can benefit from this procedure.^21,22 One study showed a significant improvement within one month of fundoplication, with continued improvement observed during a 3-year follow-up.²¹ In another prospective study, researchers showed that while LPRD-related laryngeal symptoms such as coughing and throat-clearing improved with both medical therapy and laparoscopic fundoplication, voice quality and endoscopic laryngeal/pharyngeal findings improved significantly only with the surgical procedure.²³

TABLE 2
Recommend these lifestyle modifications¹⁹

CORRESPONDENCE
Shoib Sana, DO, Detroit Medical Center, Otolaryngology-Head and Neck Surgery, 6533 East Jefferson Avenue, Apartment 316, Detroit, MI 48207; ssana@dmc.org

CASE When Joan C, a 35-year-old patient whom you’ve known for years, comes in for a physical, you notice that she’s coughing frequently. Upon questioning, Joan says she first noticed the cough several months ago; she also reports that she’s frequently hoarse, but has no other symptoms. Joan is a former smoker, and quit 4 years ago.

If Joan were your patient, would you suspect that she had an upper respiratory infection and prescribe an antibiotic such as azithromycin? Would you include laryngopharyngeal reflux disease in the differential diagnosis?

Laryngopharyngeal reflux disease (LPRD) is a common condition that most primary care physicians encounter frequently. It is also frequently misdiagnosed by clinicians who are unfamiliar with the differences between LPRD and gastroesophageal reflux disease (GERD).

The American Academy of Otolaryngology–Head and Neck Surgery defines laryngopharyngeal reflux as the retrograde movement of gastric contents into the laryngopharynx.¹ Common symptoms include hoarseness/dysphonia, chronic throat clearing, dysphagia, globus pharyngeus, and chronic cough, as well as postnasal drip, paroxysmal laryngospasm, odynophagia, excessive throat mucus, and a strange taste in the mouth.²

The diversity and vagueness of these symptoms, as well as the lack of a gold standard diagnostic test for LPRD, make it difficult to estimate its prevalence. In addition, signs of gastroesophageal reflux can be found in the laryngopharynx of up to 86% of healthy individuals, further complicating the clinical picture.³ To avoid missing this often overlooked reflux disease, you need to know how it develops, what signs and symptoms to look for, and which distinguishing features to keep in mind.

Pathophysiology and distinguishing features

The precise way in which LPRD develops is not known, but there are 2 proposed means of laryngeal injury—direct and indirect. In the first case, chemical irritants in the gastric refluxate enter the laryngopharynx and cause local mucosal injury. In the second, gastric reflux irritates the esophageal tissue enough to evoke laryngeal reflexes without ever reaching the larynx—a vagally mediated response associated with symptoms such as chronic cough, throat-clearing sensations, and bronchoconstriction.⁴

Unlike the esophageal lining, laryngeal epithelium is not protected against chemical injury from gastric acid, as it lacks both the stripping motion of esophageal peristalsis and the neutralizing bicarbonate in saliva.⁴ Thus, while far smaller amounts of gastric reflux make it into the laryngopharynx, the acid remains there longer and may cause greater injury.⁵ In some cases, this occurs as often as 50 times a day, although as few as 3 episodes per week have been known to cause LPRD.⁵

Heartburn is not the rule
Heartburn is a primary complaint of patients with GERD. It is reported by little more than a third (35%) of those with LPRD,^5,6 however, (which is why it is sometimes called the “silent” reflux disease). This is because heartburn is caused by esophagitis due to esophageal dysmotility and lower esophageal sphincter dysfunction,³ while most patients with LPRD have normal esophageal motor function and upper esophageal sphincter dysfunction. The fact that only a minimal amount of reflux enters the laryngopharynx may be part of the reason heartburn is less likely in patients with LPRD.

Onset of symptoms. When reflux occurs is another thing that distinguishes LPRD and GERD. Symptoms of GERD typically worsen when the individual is supine, while laryngopharyngeal reflux usually occurs when he or she is upright.⁷ The frequency with which these 2 conditions overlap is debatable, as there are few studies differentiating LPRD and GERD based on standardized signs and symptoms.⁷

Making sense of signs and symptoms

Most patients with LPRD seek treatment from their primary care physician, typically reporting symptoms that they don’t associate with gastric reflux, such as hoarseness, a chronic cough or sore throat, or the sensation of a lump in the throat (TABLE 1). Less common manifestations include “water brash”—excessive mucus in the mouth caused by a release of salivary bicarbonate to help neutralize acidity⁸—otitis media, sinus disease, and dental caries.⁵

Laryngeal endoscopy may reveal many changes from diffuse irritation. Diffuse erythema, edema, and interarytenoid hypertrophy/cobblestoning are the most useful findings for an LPRD diagnosis.^9,10 But in most cases, only a few nonspecific signs with a number of possible causes (infection, environmental irritants, allergies, temperature/climate change, among others) are seen on endoscopic examination, with little correlation with symptom severity. In fact, 74% of otolaryngologists responding to a recent survey said they relied more on patient symptoms than on laryngeal signs for an LPRD diagnosis.¹⁰

The Reflux Finding Score (RFS), available at http://www.nature.com/gimo/contents/pt1/fig_tab/gimo46_T3.html, is a clinical tool developed to quantify laryngeal inflammation and standardize objective endoscopic findings. The RFS incorporates the following endolaryngeal signs:

• subglottic edema
• ventricular obliteration
• erythema/hyperemia
• vocal cord edema
• diffuse laryngeal edema
• posterior commissure hypertrophy
• granuloma/granulation tissue
• thick endolaryngeal mucus.

A numeric value is assigned to each, based on whether it is present or absent; partial or complete; local or diffuse; or mild or severe. However, the RFS, too, is an imperfect tool. Clinicians who have used the RFS report that a score higher than 7 identifies LPRD with 95% sensitivity.¹¹ But laryngeal findings may be due to other causes, such as infection, autoimmune reaction, or even allergies, and studies have found the RFS to have poor specificity and inter-rater reliability.^12-14

Ambulatory dual probe pH monitoring was considered to be the gold standard test for LPRD at one time, but newer studies have raised questions about its validity and usefulness, especially in patients taking proton-pump inhibitors (PPIs).^1,5,7 Newer advanced probes featuring less invasive data collection and greater sensitivity are under development. Ambulatory 24-hour multichannel intraluminal impedance with pH monitoring is the most promising new diagnostic tool, as it can monitor both acidic and nonacidic reflux and distinguish between gas and liquid.¹⁵

TABLE 1
When to suspect laryngopharyngeal reflux disease^1,5,24

Treatment, like diagnosis, is not clear-cut

LPRD is often called a diagnosis of exclusion, because of the nonspecific nature of its signs and symptoms and the importance of considering a range of other etiologies. The differential diagnosis includes excessive voice use, postnasal drip, upper respiratory infection, habitual throat clearing, allergic rhinitis, environmental irritants, temperature/climate change, chronic or episodic use of alcohol and/or tobacco, and psychological problems related to tics, such as habitual throat clearing or coughing.⁵

Diagnosis is often based on an empiric trial of high-dose PPIs, with confirmation dependent on symptom relief. Because there have been few placebo-controlled trials with PPIs and those that have been completed had conflicting results, diagnosis based on a combination of medical history and endoscopic laryngeal examination may be a better approach.^16,17

Acid suppression therapy with either PPIs or histamine-2 (H2) receptor blockers such as ranitidine or famotidine is the mainstay of treatment for LPRD. But medical societies offer conflicting advice. The American Gastroenterological Association cautions clinicians not to prescribe acid-suppression therapy for patients with LPRD unless they also have GERD.⁶ The American Academy of Otolaryngology–Head and Neck Surgery recommends twice-daily PPI use for ≥6 months.^1,13 The general consensus, based on clinical experience alone, is that patients should be treated with high doses of PPIs (eg, 40 mg omeprazole twice a day) for ≥6 months, with the addition of an H2 receptor blocker to help reduce overnight acid production.^1,18 Prophylactic antacid use is also recommended in anticipation of reflux, such as before exercising and right after a meal.

Symptoms should start to improve within 6 to 8 weeks, and patients should be reassessed in about 3 months. To avoid a rebound effect from the abrupt cessation of medications, we suggest a gradual taper over 16 weeks. For the first 8 weeks, the H2 blocker should be discontinued and the PPI decreased from twice a day to once. If symptoms are still controlled, the PPI dose can be reduced to once every other day for another 8 weeks, then stopped if symptoms do not recur.¹⁸

Lifestyle and dietary changes (TABLE 2), such as smoking cessation, weight loss, and avoidance of alcohol, are an important part of LPRD treatment, and may be used as a first-line therapy before prescribing medication.¹⁹ In fact, some studies have found PPI therapy to be inferior to behavioral/lifestyle modifications.¹⁷

Fundoplication surgery, a procedure in which the gastric fundus of the stomach is wrapped around the lower end of the esophagus and stitched in place to prevent reflux, may be an option for patients who do not respond to, or cannot tolerate, aggressive medical treatment for LPRD. A 2006 prospective controlled study found that surgical fundoplication did not consistently relieve laryngeal symptoms.²⁰ But other studies have found that a carefully selected population with medically unresponsive laryngopharyngeal symptoms can benefit from this procedure.^21,22 One study showed a significant improvement within one month of fundoplication, with continued improvement observed during a 3-year follow-up.²¹ In another prospective study, researchers showed that while LPRD-related laryngeal symptoms such as coughing and throat-clearing improved with both medical therapy and laparoscopic fundoplication, voice quality and endoscopic laryngeal/pharyngeal findings improved significantly only with the surgical procedure.²³

TABLE 2
Recommend these lifestyle modifications¹⁹

CORRESPONDENCE
Shoib Sana, DO, Detroit Medical Center, Otolaryngology-Head and Neck Surgery, 6533 East Jefferson Avenue, Apartment 316, Detroit, MI 48207; ssana@dmc.org

CASE 1 A 31-year-old African American woman sought treatment at her local emergency department (ED) for nausea, vomiting, and diarrhea. She reported passing more than 6 yellowish-brown, watery, nonbloody stools during the previous 2 days. She felt weak, feverish, and light-headed and showed signs of dehydration.

The patient had Crohn’s disease and had undergone a partial colectomy 5 years earlier. She told the ED physician that 2 days before visiting the ED she had gone to a “cleansing center” for a colonic cleansing, but was unable to complete the process because she developed cramps 15 minutes into the procedure. Less than an hour later, she developed diarrhea, nausea, and vomiting.

In the ED, her serum potassium was 2.9 mEq/L, blood urea nitrogen was 26 mg/dL, and creatinine was 1.9 mg/dL. She was afebrile, with a blood pressure of 135/75 mm Hg and a heart rate of 113 beats per minute. After receiving 2 liters of normal saline and 90 mEq of potassium chloride replacement, the patient felt better and was later discharged from the ED.

Three days later, the patient came to our residency clinic. She described her stools as being loose, but not watery or bloody, and passed in small amounts, about 4 times daily. She still had some abdominal cramping just before passing stool, but bowel movements relieved that. Her vital signs were within normal limits, and her physical exam was benign. The patient was instructed to follow her normal diet, as tolerated, and drink plenty of fluids to maintain good hydration. Her symptoms resolved by the following week.

CASE 2 A 49-year-old African American man came to our community hospital because of vomiting, diarrhea, and abdominal pain he had been experiencing for 4 days. He linked the symptoms to eating a large fast-food breakfast, followed by a big lunch the day before. He described having multiple episodes of nonbloody, nonbilious vomiting, nonbloody watery diarrhea, and “twisting” abdominal pain that was constant but temporarily relieved with a warm compress or positional maneuvers. He had never had a similar episode and had not taken any antibiotics recently.

Upon further questioning, the patient revealed that he had used a colon cleanser a few days earlier. A review showed that he had lost 24 pounds in 10 days. Vitals were within normal limits. Serum potassium was 2.9 mEq/L, and creatinine was 2.1 mg/dL. A computed tomography scan of the abdomen revealed moderate to moderately severe dilatation of multiple small bowel loops with multiple air fluid levels, suggesting an early or partial small bowel obstruction. We obtained a surgical consultation, but surgery was not required. He was discharged after 2 days.

The patient returned to the hospital 3 days later with similar symptoms and severe weakness associated with dizziness. At that time his serum potassium was 2.4 mEq/L and creatinine was 4.0 mg/dL. Aspartate aminotransferase was 29 U/L, alanine aminotransferase was 80 U/L, lipase was 418 U/L, and amylase was 94 U/L.

The patient was readmitted for dehydration, hypokalemia, and pancreatitis and, following a colonoscopy and biopsy that revealed chronic and acute inflammation, a gastroenterologist made a diagnosis of “herbal intoxication.” The patient was hydrated, his electrolytes were replaced, and his diet was slowly returned to normal. He was discharged after 5 days.

An old practice rediscovered

Colon cleansing has been around since ancient times, when its purported benefits were based on the belief that intestinal waste can poison the body (“autointoxication”).¹ The procedure became popular in the early 1900s, but in a 1919 paper, the American Medical Association discounted the autointoxication theory and condemned the practice.¹ The procedure then fell out of favor, albeit temporarily.² Colon cleansing has staged a comeback in recent years.

Colon cleansing basics
Colon cleansing, also called colonic irrigation or colonic hydrotherapy, is performed by colonic hygienists or colon therapists, or can be self-administered. The procedure works like an enema. The patient generally lies on a table and water (with or without additional herbs or compounds) is pumped through the rectum via a tube.

Unlike enemas, for which a small amount of fluid is used, however, colon cleansing calls for a large volume of fluid—up to 60 liters—to be introduced into the rectum.^3,4 Fluids and waste are expelled through another tube. The procedure may be repeated several times.

Products go by many names
Most colon cleansing products come in the forms of laxatives, teas, powders, and capsules. They can be taken by mouth or inserted into the rectum. They often contain sodium phosphate, coffee, probiotics, enzymes, or any of a variety of herbs.⁵ Some products contain fiber preparations, including psyllium, flaxseed, and laxatives such as cascara, magnesium oxide, cat’s claw, artichoke leaves, burdock root, licorice, and milk thistle.²

With names such as Nature’s Bounty Colon Cleanser Natural Detox Formula, Health Plus Inc. Colon Cleanse, and 7-Day Miracle Cleanse, as well as endorsements by movie stars, these colon cleansing products are actively promoted as a natural way to enhance one’s well-being. Advertisements promising that colon cleansing will alleviate fatigue, headache, weight gain, and low energy are ubiquitous on the Internet and in newspapers and magazines. The ads tout the safety of “herbal” and “natural” preparations. These materials also provide anecdotal support for claims that colon cleansing improves the immune and circulatory systems, enhances cognitive abilities, and aids weight loss through “detoxification.”⁶

Individuals who want to cleanse their own colons can choose among home kits, some of which include disposable tubing, while others have components that can be reused if they are sterilized after each use.^5,7 But many people turn to a “hydrotherapist” for colon irrigation. The services are also increasingly being offered by practitioners who describe themselves as “colon hygienists.”

These individuals sometimes belong to organizations such as the National Board for Colon Hydrotherapy (NBCH) or the International Association for Colon Hydrotherapy (I-ACT).^8,9 These practitioners are not licensed, but they are required to have a high school or equivalent degree plus 3 semesters of postsecondary education and to be certified in cardiopulmonary resuscitation. They also take various seminars and continuing education courses from the NBCH and I-ACT.

How many individuals have used colon cleansing is unclear, although one study suggested that in the United Kingdom, registered practitioners carry out an estimated 5600 procedures every month.¹⁰

Where’s the evidence?

Despite colon cleansing’s long history and current popularity, the literature does not support its purported benefits. Historically, colon cleansing was thought to prevent autointoxication from toxins originating in the colon, but the evidence for this claim is limited.¹¹ A search of the literature using the terms “colon cleansing,” “herbal colon cleanse,” “colon detoxification,” and “colon irrigation,” yielded no scientifically robust studies in support of this practice. One study suggested that lymphocytes might migrate from the gut into the circulation after the procedure, which may “improve colon and immune system function.”¹²

Even though colon cleansing is touted as a commonly used form of holistic, complementary and alternative medicine, the Natural Standard Professional Database concluded in a monograph that there is “limited clinical evidence validating colon therapy as a health promotion practice” and noted a “lack of sufficient evidence” for most of its prescribed uses.¹³

Adverse effects: From cramping to renal failure
Most reports in the literature note a variety of adverse effects of colon cleansing that range from mild (eg, cramping, abdominal pain, fullness, bloating, nausea, vomiting, perianal irritation, and soreness) to severe (eg, electrolyte imbalance and renal failure).^11,14-17 Some herbal preparations have also been associated with aplastic anemia and liver toxicity.¹⁸

Case reports also have noted back and pelvic abscesses after colonic hydrotherapy, fatal aeroportia (gas accumulation in the mesenteric veins) with air emboli, rectal perforations, perineal gangrene, acute water intoxication, coffee enema-associated colitis and septicemia, and deaths due to amebiasis.^2,3,19-21

The FDA has issued many warning letters
The preparations used for colon cleansing are considered dietary supplements, and the US Food and Drug Administration (FDA) requires that they be labeled as such; the FDA does not preapprove these substances, however. The FDA also requires that colonic hydrotherapy and irrigation system devices meet certain requirements, but the agency has never approved any system for general nonmedical purposes, such as colon cleansing.

The devices have an FDA Class III designation, indicating that if a device is used for purposes beyond what is medically indicated (preparation for radiologic and endoscopic procedures), the manufacturer must obtain premarket approval from the FDA, which is based on evaluation of the safety and effectiveness of the device as shown by available scientific evidence and current regulations.²² During the past decade the FDA has issued numerous warning letters to manufacturers for unapproved use of the devices for colon cleansing.^23-26

Raise the issue with patients
Given the current popularity of colon cleansing, it’s important to recognize that some of your patients may engage in, or be thinking about, the practice. (See “4 things to tell patients about colon cleansing”.) Be sure to tell patients about the potential consequences of colon cleansing and to emphasize that there is a lack of evidence to back up supporters’ claims.

CORRESPONDENCE
Ranit Mishori, MD, MHS, Georgetown University School of Medicine, 3900 Reservoir Road, NW, Washington, DC 20007; mishorir@georgetown.edu

CASE 1 A 31-year-old African American woman sought treatment at her local emergency department (ED) for nausea, vomiting, and diarrhea. She reported passing more than 6 yellowish-brown, watery, nonbloody stools during the previous 2 days. She felt weak, feverish, and light-headed and showed signs of dehydration.

The patient had Crohn’s disease and had undergone a partial colectomy 5 years earlier. She told the ED physician that 2 days before visiting the ED she had gone to a “cleansing center” for a colonic cleansing, but was unable to complete the process because she developed cramps 15 minutes into the procedure. Less than an hour later, she developed diarrhea, nausea, and vomiting.

In the ED, her serum potassium was 2.9 mEq/L, blood urea nitrogen was 26 mg/dL, and creatinine was 1.9 mg/dL. She was afebrile, with a blood pressure of 135/75 mm Hg and a heart rate of 113 beats per minute. After receiving 2 liters of normal saline and 90 mEq of potassium chloride replacement, the patient felt better and was later discharged from the ED.

Three days later, the patient came to our residency clinic. She described her stools as being loose, but not watery or bloody, and passed in small amounts, about 4 times daily. She still had some abdominal cramping just before passing stool, but bowel movements relieved that. Her vital signs were within normal limits, and her physical exam was benign. The patient was instructed to follow her normal diet, as tolerated, and drink plenty of fluids to maintain good hydration. Her symptoms resolved by the following week.

CASE 2 A 49-year-old African American man came to our community hospital because of vomiting, diarrhea, and abdominal pain he had been experiencing for 4 days. He linked the symptoms to eating a large fast-food breakfast, followed by a big lunch the day before. He described having multiple episodes of nonbloody, nonbilious vomiting, nonbloody watery diarrhea, and “twisting” abdominal pain that was constant but temporarily relieved with a warm compress or positional maneuvers. He had never had a similar episode and had not taken any antibiotics recently.

Upon further questioning, the patient revealed that he had used a colon cleanser a few days earlier. A review showed that he had lost 24 pounds in 10 days. Vitals were within normal limits. Serum potassium was 2.9 mEq/L, and creatinine was 2.1 mg/dL. A computed tomography scan of the abdomen revealed moderate to moderately severe dilatation of multiple small bowel loops with multiple air fluid levels, suggesting an early or partial small bowel obstruction. We obtained a surgical consultation, but surgery was not required. He was discharged after 2 days.

The patient returned to the hospital 3 days later with similar symptoms and severe weakness associated with dizziness. At that time his serum potassium was 2.4 mEq/L and creatinine was 4.0 mg/dL. Aspartate aminotransferase was 29 U/L, alanine aminotransferase was 80 U/L, lipase was 418 U/L, and amylase was 94 U/L.

The patient was readmitted for dehydration, hypokalemia, and pancreatitis and, following a colonoscopy and biopsy that revealed chronic and acute inflammation, a gastroenterologist made a diagnosis of “herbal intoxication.” The patient was hydrated, his electrolytes were replaced, and his diet was slowly returned to normal. He was discharged after 5 days.

An old practice rediscovered

Colon cleansing has been around since ancient times, when its purported benefits were based on the belief that intestinal waste can poison the body (“autointoxication”).¹ The procedure became popular in the early 1900s, but in a 1919 paper, the American Medical Association discounted the autointoxication theory and condemned the practice.¹ The procedure then fell out of favor, albeit temporarily.² Colon cleansing has staged a comeback in recent years.

Colon cleansing basics
Colon cleansing, also called colonic irrigation or colonic hydrotherapy, is performed by colonic hygienists or colon therapists, or can be self-administered. The procedure works like an enema. The patient generally lies on a table and water (with or without additional herbs or compounds) is pumped through the rectum via a tube.

Unlike enemas, for which a small amount of fluid is used, however, colon cleansing calls for a large volume of fluid—up to 60 liters—to be introduced into the rectum.^3,4 Fluids and waste are expelled through another tube. The procedure may be repeated several times.

Products go by many names
Most colon cleansing products come in the forms of laxatives, teas, powders, and capsules. They can be taken by mouth or inserted into the rectum. They often contain sodium phosphate, coffee, probiotics, enzymes, or any of a variety of herbs.⁵ Some products contain fiber preparations, including psyllium, flaxseed, and laxatives such as cascara, magnesium oxide, cat’s claw, artichoke leaves, burdock root, licorice, and milk thistle.²

With names such as Nature’s Bounty Colon Cleanser Natural Detox Formula, Health Plus Inc. Colon Cleanse, and 7-Day Miracle Cleanse, as well as endorsements by movie stars, these colon cleansing products are actively promoted as a natural way to enhance one’s well-being. Advertisements promising that colon cleansing will alleviate fatigue, headache, weight gain, and low energy are ubiquitous on the Internet and in newspapers and magazines. The ads tout the safety of “herbal” and “natural” preparations. These materials also provide anecdotal support for claims that colon cleansing improves the immune and circulatory systems, enhances cognitive abilities, and aids weight loss through “detoxification.”⁶

Individuals who want to cleanse their own colons can choose among home kits, some of which include disposable tubing, while others have components that can be reused if they are sterilized after each use.^5,7 But many people turn to a “hydrotherapist” for colon irrigation. The services are also increasingly being offered by practitioners who describe themselves as “colon hygienists.”

These individuals sometimes belong to organizations such as the National Board for Colon Hydrotherapy (NBCH) or the International Association for Colon Hydrotherapy (I-ACT).^8,9 These practitioners are not licensed, but they are required to have a high school or equivalent degree plus 3 semesters of postsecondary education and to be certified in cardiopulmonary resuscitation. They also take various seminars and continuing education courses from the NBCH and I-ACT.

How many individuals have used colon cleansing is unclear, although one study suggested that in the United Kingdom, registered practitioners carry out an estimated 5600 procedures every month.¹⁰

Where’s the evidence?

Despite colon cleansing’s long history and current popularity, the literature does not support its purported benefits. Historically, colon cleansing was thought to prevent autointoxication from toxins originating in the colon, but the evidence for this claim is limited.¹¹ A search of the literature using the terms “colon cleansing,” “herbal colon cleanse,” “colon detoxification,” and “colon irrigation,” yielded no scientifically robust studies in support of this practice. One study suggested that lymphocytes might migrate from the gut into the circulation after the procedure, which may “improve colon and immune system function.”¹²

Even though colon cleansing is touted as a commonly used form of holistic, complementary and alternative medicine, the Natural Standard Professional Database concluded in a monograph that there is “limited clinical evidence validating colon therapy as a health promotion practice” and noted a “lack of sufficient evidence” for most of its prescribed uses.¹³

Adverse effects: From cramping to renal failure
Most reports in the literature note a variety of adverse effects of colon cleansing that range from mild (eg, cramping, abdominal pain, fullness, bloating, nausea, vomiting, perianal irritation, and soreness) to severe (eg, electrolyte imbalance and renal failure).^11,14-17 Some herbal preparations have also been associated with aplastic anemia and liver toxicity.¹⁸

Case reports also have noted back and pelvic abscesses after colonic hydrotherapy, fatal aeroportia (gas accumulation in the mesenteric veins) with air emboli, rectal perforations, perineal gangrene, acute water intoxication, coffee enema-associated colitis and septicemia, and deaths due to amebiasis.^2,3,19-21

The FDA has issued many warning letters
The preparations used for colon cleansing are considered dietary supplements, and the US Food and Drug Administration (FDA) requires that they be labeled as such; the FDA does not preapprove these substances, however. The FDA also requires that colonic hydrotherapy and irrigation system devices meet certain requirements, but the agency has never approved any system for general nonmedical purposes, such as colon cleansing.

The devices have an FDA Class III designation, indicating that if a device is used for purposes beyond what is medically indicated (preparation for radiologic and endoscopic procedures), the manufacturer must obtain premarket approval from the FDA, which is based on evaluation of the safety and effectiveness of the device as shown by available scientific evidence and current regulations.²² During the past decade the FDA has issued numerous warning letters to manufacturers for unapproved use of the devices for colon cleansing.^23-26

Raise the issue with patients
Given the current popularity of colon cleansing, it’s important to recognize that some of your patients may engage in, or be thinking about, the practice. (See “4 things to tell patients about colon cleansing”.) Be sure to tell patients about the potential consequences of colon cleansing and to emphasize that there is a lack of evidence to back up supporters’ claims.

CORRESPONDENCE
Ranit Mishori, MD, MHS, Georgetown University School of Medicine, 3900 Reservoir Road, NW, Washington, DC 20007; mishorir@georgetown.edu

CASE 1 A 31-year-old African American woman sought treatment at her local emergency department (ED) for nausea, vomiting, and diarrhea. She reported passing more than 6 yellowish-brown, watery, nonbloody stools during the previous 2 days. She felt weak, feverish, and light-headed and showed signs of dehydration.

The patient had Crohn’s disease and had undergone a partial colectomy 5 years earlier. She told the ED physician that 2 days before visiting the ED she had gone to a “cleansing center” for a colonic cleansing, but was unable to complete the process because she developed cramps 15 minutes into the procedure. Less than an hour later, she developed diarrhea, nausea, and vomiting.

In the ED, her serum potassium was 2.9 mEq/L, blood urea nitrogen was 26 mg/dL, and creatinine was 1.9 mg/dL. She was afebrile, with a blood pressure of 135/75 mm Hg and a heart rate of 113 beats per minute. After receiving 2 liters of normal saline and 90 mEq of potassium chloride replacement, the patient felt better and was later discharged from the ED.

Three days later, the patient came to our residency clinic. She described her stools as being loose, but not watery or bloody, and passed in small amounts, about 4 times daily. She still had some abdominal cramping just before passing stool, but bowel movements relieved that. Her vital signs were within normal limits, and her physical exam was benign. The patient was instructed to follow her normal diet, as tolerated, and drink plenty of fluids to maintain good hydration. Her symptoms resolved by the following week.

CASE 2 A 49-year-old African American man came to our community hospital because of vomiting, diarrhea, and abdominal pain he had been experiencing for 4 days. He linked the symptoms to eating a large fast-food breakfast, followed by a big lunch the day before. He described having multiple episodes of nonbloody, nonbilious vomiting, nonbloody watery diarrhea, and “twisting” abdominal pain that was constant but temporarily relieved with a warm compress or positional maneuvers. He had never had a similar episode and had not taken any antibiotics recently.

Upon further questioning, the patient revealed that he had used a colon cleanser a few days earlier. A review showed that he had lost 24 pounds in 10 days. Vitals were within normal limits. Serum potassium was 2.9 mEq/L, and creatinine was 2.1 mg/dL. A computed tomography scan of the abdomen revealed moderate to moderately severe dilatation of multiple small bowel loops with multiple air fluid levels, suggesting an early or partial small bowel obstruction. We obtained a surgical consultation, but surgery was not required. He was discharged after 2 days.

The patient returned to the hospital 3 days later with similar symptoms and severe weakness associated with dizziness. At that time his serum potassium was 2.4 mEq/L and creatinine was 4.0 mg/dL. Aspartate aminotransferase was 29 U/L, alanine aminotransferase was 80 U/L, lipase was 418 U/L, and amylase was 94 U/L.

The patient was readmitted for dehydration, hypokalemia, and pancreatitis and, following a colonoscopy and biopsy that revealed chronic and acute inflammation, a gastroenterologist made a diagnosis of “herbal intoxication.” The patient was hydrated, his electrolytes were replaced, and his diet was slowly returned to normal. He was discharged after 5 days.

An old practice rediscovered

Colon cleansing has been around since ancient times, when its purported benefits were based on the belief that intestinal waste can poison the body (“autointoxication”).¹ The procedure became popular in the early 1900s, but in a 1919 paper, the American Medical Association discounted the autointoxication theory and condemned the practice.¹ The procedure then fell out of favor, albeit temporarily.² Colon cleansing has staged a comeback in recent years.

Colon cleansing basics
Colon cleansing, also called colonic irrigation or colonic hydrotherapy, is performed by colonic hygienists or colon therapists, or can be self-administered. The procedure works like an enema. The patient generally lies on a table and water (with or without additional herbs or compounds) is pumped through the rectum via a tube.

Unlike enemas, for which a small amount of fluid is used, however, colon cleansing calls for a large volume of fluid—up to 60 liters—to be introduced into the rectum.^3,4 Fluids and waste are expelled through another tube. The procedure may be repeated several times.

Products go by many names
Most colon cleansing products come in the forms of laxatives, teas, powders, and capsules. They can be taken by mouth or inserted into the rectum. They often contain sodium phosphate, coffee, probiotics, enzymes, or any of a variety of herbs.⁵ Some products contain fiber preparations, including psyllium, flaxseed, and laxatives such as cascara, magnesium oxide, cat’s claw, artichoke leaves, burdock root, licorice, and milk thistle.²

With names such as Nature’s Bounty Colon Cleanser Natural Detox Formula, Health Plus Inc. Colon Cleanse, and 7-Day Miracle Cleanse, as well as endorsements by movie stars, these colon cleansing products are actively promoted as a natural way to enhance one’s well-being. Advertisements promising that colon cleansing will alleviate fatigue, headache, weight gain, and low energy are ubiquitous on the Internet and in newspapers and magazines. The ads tout the safety of “herbal” and “natural” preparations. These materials also provide anecdotal support for claims that colon cleansing improves the immune and circulatory systems, enhances cognitive abilities, and aids weight loss through “detoxification.”⁶

Individuals who want to cleanse their own colons can choose among home kits, some of which include disposable tubing, while others have components that can be reused if they are sterilized after each use.^5,7 But many people turn to a “hydrotherapist” for colon irrigation. The services are also increasingly being offered by practitioners who describe themselves as “colon hygienists.”

These individuals sometimes belong to organizations such as the National Board for Colon Hydrotherapy (NBCH) or the International Association for Colon Hydrotherapy (I-ACT).^8,9 These practitioners are not licensed, but they are required to have a high school or equivalent degree plus 3 semesters of postsecondary education and to be certified in cardiopulmonary resuscitation. They also take various seminars and continuing education courses from the NBCH and I-ACT.

How many individuals have used colon cleansing is unclear, although one study suggested that in the United Kingdom, registered practitioners carry out an estimated 5600 procedures every month.¹⁰

Where’s the evidence?

Despite colon cleansing’s long history and current popularity, the literature does not support its purported benefits. Historically, colon cleansing was thought to prevent autointoxication from toxins originating in the colon, but the evidence for this claim is limited.¹¹ A search of the literature using the terms “colon cleansing,” “herbal colon cleanse,” “colon detoxification,” and “colon irrigation,” yielded no scientifically robust studies in support of this practice. One study suggested that lymphocytes might migrate from the gut into the circulation after the procedure, which may “improve colon and immune system function.”¹²

Even though colon cleansing is touted as a commonly used form of holistic, complementary and alternative medicine, the Natural Standard Professional Database concluded in a monograph that there is “limited clinical evidence validating colon therapy as a health promotion practice” and noted a “lack of sufficient evidence” for most of its prescribed uses.¹³

Adverse effects: From cramping to renal failure
Most reports in the literature note a variety of adverse effects of colon cleansing that range from mild (eg, cramping, abdominal pain, fullness, bloating, nausea, vomiting, perianal irritation, and soreness) to severe (eg, electrolyte imbalance and renal failure).^11,14-17 Some herbal preparations have also been associated with aplastic anemia and liver toxicity.¹⁸

Case reports also have noted back and pelvic abscesses after colonic hydrotherapy, fatal aeroportia (gas accumulation in the mesenteric veins) with air emboli, rectal perforations, perineal gangrene, acute water intoxication, coffee enema-associated colitis and septicemia, and deaths due to amebiasis.^2,3,19-21

The FDA has issued many warning letters
The preparations used for colon cleansing are considered dietary supplements, and the US Food and Drug Administration (FDA) requires that they be labeled as such; the FDA does not preapprove these substances, however. The FDA also requires that colonic hydrotherapy and irrigation system devices meet certain requirements, but the agency has never approved any system for general nonmedical purposes, such as colon cleansing.

The devices have an FDA Class III designation, indicating that if a device is used for purposes beyond what is medically indicated (preparation for radiologic and endoscopic procedures), the manufacturer must obtain premarket approval from the FDA, which is based on evaluation of the safety and effectiveness of the device as shown by available scientific evidence and current regulations.²² During the past decade the FDA has issued numerous warning letters to manufacturers for unapproved use of the devices for colon cleansing.^23-26

Raise the issue with patients
Given the current popularity of colon cleansing, it’s important to recognize that some of your patients may engage in, or be thinking about, the practice. (See “4 things to tell patients about colon cleansing”.) Be sure to tell patients about the potential consequences of colon cleansing and to emphasize that there is a lack of evidence to back up supporters’ claims.

CORRESPONDENCE
Ranit Mishori, MD, MHS, Georgetown University School of Medicine, 3900 Reservoir Road, NW, Washington, DC 20007; mishorir@georgetown.edu