ED and Low T: Testosterone Therapy

June is Men’s Health Month. CHP blog posts in June will focus on health care for problems unique to men. Men’s Health Week was designated by an act of the US Congress in 1994 and signed into law by President Bill Clinton. Expanded now to Men’s Health Month, the 30 days of June include Father’s Day and the designated month is to “heighten the awareness of preventable health problems and encourage early detection and treatment of disease among men and boys.”

“ED” and “Low T” have entered the public vocabulary as shorthand for clinical conditions that were formerly the domain of urology and endocrinology medical specialties. As pharmacologic treatments became available, the market was quick to “educate” the public (men) about clinical conditions involving erectile dysfunction, loss of muscle mass, diminished sex drive, and others that formerly were the topics of discussions between men and their physicians.

In 1998 Pfizer, the maker of Viagra, hired former Senator and presidential contender, Bob Dole, as a spokesperson to promote the drug. “ED” firmly entered American’s vocabulary. With increased direct to consumer advertising, the failure of men to “perform in the bedroom” became a rich market to pursue. Since then, sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra) and their generic equivalents have become a significant piece of the market place.

More recently, “men’s health” has become focused on a wider variety of things that men notice, like loss of muscle mass, declining energy, aches, and pains that extend beyond concerns that emerge in the “bedroom.” While these symptoms are common and expected as men grow older, it has not slowed the rapidly expanding “medicalization” of normal aging. “Low T” is now the topic of public discussion in the media and a source of an overload of personal anecdotes. Male menopause and late-onset hypogonadism have joined low T as popular diagnostic shorthand, the solutions for which testosterone medication and non-prescription “natural” treatments are marketed. But what does the evidence tell us about Low T.

The hormone testosterone occurs naturally in both men and women. The effects of the hormone in males begin early in gestation and proceeds throughout life affecting the development of typical male characteristics like facial hair, muscle mass, sex drive, and behavior (competitiveness, aggression). Testosterone levels in men peak in early adulthood and gradually decline, about 1% a year past age 30. And with this decline other typical features of aging (e.g. wrinkles, arthritis, grey hair) combine and have been linked to “Low T.” However, differentiating normal changes of aging from effects specific to low levels of testosterone is clinically challenging. While these changes occur as age increases, there is little evidence that declining testosterone levels cause the other declines of aging in men.

These complex and uncertain clinical correlations however have not slowed the marketing successes of various Low T treatments. Prescriptions for testosterone drugs have tripled over the past few years. Specialty clinics focused on low T have proliferated. The drugs are available widely over the internet. The nutritional supplement and natural medicine industries have flourished.

Testosterone replacement therapy (TRT) is applied in oral, dermal, and injectable formulations. In cases of a clear-cut clinical presentation and laboratory-confirmed abnormally low levels of the hormone, medication has real value. Testosterone deficiency due to genetic anomalies such a Klinefelter Syndrome, toxicity from chemotherapy, injury, and disorders of testicular development like undescended testis clearly can benefit from careful diagnosis and therapeutic interventions.

However, it has been estimated that upward of 25% of testosterone prescriptions have been made without testing the level of testosterone beforehand, half of men taking testosterone do not have regular follow-up assessments of hormone levels, and about 1/3 of men receiving medications do not meet accepted clinical criteria for testosterone deficiency. This suggests that a significant number of men using these drugs are doing so inappropriately.

Testosterone medication is not without risk of adverse effects. Some side effects are fairly benign such as hair loss and acne, while others have much more dire consequences. Hypertension, elevated cholesterol, increased risk of cardiovascular disease, behavioral changes such as anxiety, aggression, hostility, and depression have all been associated with drug treatment.

The evidence supporting TRT for the conditions for which it is most heavily promoted (ED, loss of virility, declining muscle mass, etc.) is contradictory and weak. Most clinical studies are within men who have confirmed low testosterone. In those men, TRT “may” improve sexual function. It has not been studied among those diagnosed with “Low T” in typical Low T clinics. TRT has not demonstrated improvement in sexual satisfaction and may only “slightly” improve sexual function in men over 65. TRT does increase muscle mass in otherwise healthy (i.e. normal testosterone level) subjects.

The most robust clinical trial evidence is from the National Institutes of Health-sponsored Testosterone Trials. Study participants were all over 65. The primary outcomes measured were related to sexual function, physical function, and vitality. The results show that TRT did help some patients. However, TRT is not a panacea for older men.

Non-prescription treatments include a wide range of nutraceutical and other interventions. Promoted by the likes of Dr. Oz and Dr. Weil as well as countless nutrition practitioners, evidence supporting these treatments is generally sparse. Two supplements (acetyl-L-carnitine and propionyl-L-carnitine) may have results similar to that of TRT.

While some TRTs are outside the scope of practice for some IH clinicians, the subject is so topical that it can come up in any clinical setting where IH is practiced. Knowing the evidence about pharmacologic and natural treatments may help IH clinicians to better inform their patients.

Prostate cancer screening: PSA (Prostate Specific Antigen) Testing

Prostate cancer is common in men. About 1 in 6 men (16%) will develop prostate cancer at some point in their lives. Events during Men’s Health Month often encourage men to be screened for prostate cancer. In the recent past cancer screening was recommended to include prostate-specific antigen (PSA) testing and a digital rectal examination (DRE). This post will focus on PSA testing and, next time, the DRE.

The test for a “prostate specific antigen” was developed in the 1970s and approved by the FDA in 1986 as a method to monitor the progress of cancer treatment or the recurrence of prostate cancer. Heralded as a screening breakthrough, PSA testing was FDA approved for screening purposes in 1994 and since then an estimated 1 billion PSA tests have been performed. However recent research has quelled some of the enthusiasm of this screening test.

Prostate cancer is common, and while about 16% of men develop identifiable disease, autopsies show that upward of 60% of men over 80 have evidence of unrecognized “disease,” but have died of other causes. It is becoming increasingly clear that prostate disease is slow to progress and may not present a threat to life.

The prostate-specific antigen is a normal product of prostate function. It is increased in a number of circumstances other than cancer such as benign prostatic hypertrophy (BPH) and prostatitis. PSA is also elevated post-ejaculation and may be affected by bike riding. Elevated PSA has been shown to precede identification of disease by 10-15 years. So elevated PSA identified at screening may indicate many things other than cancer.

The positive predictive value of elevated PSA, that is the number of men with a high PSA who actually have cancer, is about 30%. Evidence from randomized clinical trials, observational, and modeling studies have tried to evaluate the effectiveness of PSA screening to prevent death from prostate cancer. Overall, screening of men at ordinary risk of prostate cancer results in only small reductions in mortality.

Any medical procedure involves a balance of risk and benefit. The risks associated with prostate cancer screening include overdiagnosis, risks of biopsy, and risks of treatment.

Overdiagnosis is detection of conditions such as a slow-growing prostate cancer that will not cause serious disease or death. The associated harms are caused by further diagnostic procedures such as biopsy, unnecessary treatments and their side effects for cancers that are unlikely to cause death, and the psychological impacts of being “diagnosed with cancer.”

Prostate biopsy often is performed in follow up for elevated PSA. Biopsy bears the real risk of infection, bleeding and other complications in addition to the discomfort and anxiety that the procedure often entails.

Treatment of prostate cancer can be very effective in ideal circumstances and has been life-saving for many men. However, many men diagnosed with prostate cancer can have years of problem-free life. Interventions commonly proposed include surgical removal of the prostate (prostatectomy) and radiation.  Both of these procedures, while usually effective for cancer, do involve high rates of erectile dysfunction, urinary and bowel incontinence, and pain. So treatment of otherwise benign prostate “cancer” can produce a lifetime of trouble.

High-risk individuals may benefit from enhanced screening. Increased risk may be indicated by a family history of prostate cancer, a previous history of prostate cancer, and men who have the genetic risk factors of the BRCA1 or BRCA2 gene mutations.

Given the uncertainty of PSA screening of men at average risk for prostate cancer and the potential for untoward side effects of further testing and treatments for cancer, it is important that men and their caregivers make informed decisions about screening.  This is where integrative health (IH) providers can have an impact. While PSA testing and prostate cancer treatment may be outside the scope of practice for some IH clinicians, the personal and powerful relationships that most IH providers engender with their patients creates an ideal environment for information sharing and can set the stage for informed decision-making.

Prostate Cancer Screening: Digital Rectal Examination

June is Men's Health Month
CHP blog posts in June will focus on health care for problems unique to men. Men’s Health Week was designated by an act of the US Congress in 1994 and signed into law by President Bill Clinton. Expanded now to Men’s Health Month, the 30 days of June include Father’s Day and the designated month is to “heighten the awareness of preventable health problems and encourage early detection and treatment of disease among men and boys.”
Perhaps no routine medical examination procedure prompts more dread among patients and anxiety for clinicians than the digital rectal examination (DRE). IH providers, especially naturopathic and chiropractic physicians, have as a part of their training in physical examination, learned the procedures for DRE. Most men have experienced a DRE as a part of the annual physical. This very personal and intimate procedure has been an accepted ritual in health care for generations.

The procedure gives the physician-examiner access to the posterior portion of the prostate. Palpation allows assessment of size, tenderness, lumps, hardness, and other abnormalities that indicate cancer. Public awareness campaigns promote screening for prostate cancer, including the DRE, for men over 50. And DRE has been a routine part of a complete physical examination. The American Cancer Society promotes DRE as part of early detection of prostate cancer as well.

However, when the DRE has been studied in light of the evidence of validity and effectiveness, its clinical value has come to be questioned. As long ago as 1995, a study assessed inter-examiner agreement on DRE among urologists and found only “fair” agreement. Different experts performing the DRE on the same patient came to different conclusions from the exam.

A clinical study over 15 years ago looked at men who had prostate cancer that had been confirmed by a biopsy. They then underwent DRE by 2 experienced urology consultants. The study found no correlation between rectal examination findings and the presence of cancer. Cancer was present in men with a “normal” DRE and many who were cancer free had “abnormal” DRE findings.

More recently, a systematic review and meta-analysis published in 2018 found almost no support in the medical literature for the DRE. Sensitivity of DRE performed by primary care clinicians was 0.51. Sensitivity is the ability of a test to detect disease correctly. Sensitivity of .51 is basically a 50:50 chance of finding cancer. Specificity, which is the ability to correctly identify men who are cancer-free was 0.59. This means that nearly ½ of men with “normal” DRE had cancer. Positive and negative predictive values (PPV and NPV) were similarly disappointing.  PPV was 0.41, meaning only about 40% of men with abnormal DRE had cancer. NPV was 0.64 showing almost 2/3 of men with a “normal” DRE actually had cancer.

Closer inspection of DRE’s effect on outcomes that really matter, i.e. death from prostate cancer, show little value. Having a DRE performed does not improve a man’s chances of dying from prostate cancer. Medical and chiropractic schools still teach the procedure and DRE continues to be performed in clinical practice. But the evidence shown by these dismal results in controlled trials have caused a gradual shift in clinical recommendations.

What this means for your patients, whether or not you actually perform the test, is that informed clinical decision making is critical in deciding about DRE. Providing information about DRE may assist your patients in making this decision.

Hormone Therapy Over Age 65

Although using hormone therapy in women over age 65 remains controversial, based on a 2016 statement from North American Menopause Society (NAMS) & National Institute for Health (NIH) there are some guidelines providers can follow when advising this population. Most insurance will deny hormone therapy after age 65, however, there are medical standards for using hormone therapy after age 65. This article discusses an 80-year-old patient with clinically justified diagnostic findings that allowed for hormone Rx. Providers will often need to send a letter of clinical justification when patients over 65 meet the medical standards for hormone therapy. NAM’s stance is that age should NOT dictate whether a woman receives hormone therapy, but rather a checklist of genetics, past history, and symptoms should guide the need.

The following populations show greater risk with hormone therapy: https://www.nia.nih.gov/health/hot-flashes-what-can-i-do#risks

Current or past history of:

  • Breast or uterine cancer or family history of same
  • Stroke or heart disease, or family history of same
  • Smokers
  • Blood clots
  • Bleeding disorders
  • Liver disease
  • Allergic reactions to hormones
  • Currently pregnant or considering pregnancy

Risks of taking hormones include:

  • Heart attack
  • Stroke
  • Blood clots
  • Breast cancer
  • Gallbladder disease
  • Dementia

Providers are encouraged to discuss hormone options and discuss risks with patients before prescribing.

Acupuncture for menopause

The most troublesome symptoms for women during menopause are hot flashes and night sweats. Also known in the literature as hot “flushes,” these vasomotor symptoms are the most frequent cause of women to seek clinical care during menopause. Upward of 75-80% of women experience these troublesome symptoms and they can persist for several years as the changes of menopause proceed. For women who want to forgo hormone replacement treatment (HRT) or are concerned about the long-term effects of HRT, acupuncture has become increasingly recognized as a valuable and valid non-drug treatment.

Over time the evidence from clinical trials has been accumulating steadily to show that acupuncture produces significant and lasting improvement in hot flashes (as well as other symptoms) during menopause.

A 2015 meta-analysis1 of 12 studies including 869 women found significant reductions of the number and severity of hot flashes in the acupuncture treated patients. An evidence synthesis conducted by the US Dept. of Veterans Affairs similarly concluded that acupuncture helps vasomotor symptoms2. Both of these summaries however concluded that the evidence, while positive for acupuncture, is of low to moderate quality due to the quality of the underlying clinical trials.

A new randomized controlled clinical trial in Denmark was designed to address the often poor quality of earlier trials of acupuncture3. This new study was created to be of high methodological quality (with allocation concealment, adequate power, use of a validated outcome measure, excellent reporting) that would yield a valid result. As in previous studies, this short trial “produced a fast and clinically relevant reduction in moderate-to-severe menopausal symptoms during the six-week intervention.” Further, and as important, “no severe adverse effects were reported.”

Weaknesses of the study were noted.  The number of subjects (70) was relatively small, the trial proceeded over a short period and no “placebo” comparator was included in the treatment arm. However this is an important trial which lens to the strengthening evidence that acupuncture is a useful tool to assist women during this phase of life.

Pelvic Organ Prolapse, The Mesh Controversy and Integrative Health

Integrative healthcare clinicians (IH) may frequently encounter female patients with troubling symptoms of Pelvic Organ Prolapse (POP). POP is very common, more frequent among older women, but often without significant difficulty. Population based studies suggest that from 15% to 35% of women however do have symptoms, especially of stress urinary incontinence. Women often are reluctant to volunteer a medical history of POP symptoms, so sensitive and respectful inquiry about POP-related disorders may identify patients who can benefit from evidence-based treatment recommendations. Many of these treatments are non-drug/non-surgical and are within the scope of practice of IH providers.

While (POP) occurs in both women and men, it is primarily a problem for women1. POP occurs when the ligaments and muscles that normally support the organs in the lower abdomen and pelvis weaken. The pelvic organs descend into the lower pelvis where they can put pressure on the bladder, ureters, and lower bowel and produce troubling symptoms. Not all patients who exhibit POP have significant symptoms, but POP often produces pelvic and low back pain, bladder incontinence, urinary leakage, pain with sexual activity, and other problems that, while usually not life threatening, do impair a patient’s quality of life.

The primary goal of any treatment for POP is relief of symptoms and delaying the progression of prolapse. Treatment options range from “watchful waiting;” to various physical methods such as pelvic floor muscle training, physical and massage therapy, yoga, and behavioral changes; the use of a pessary; and on through to a variety of surgical procedures.

Watchful waiting is certainly appropriate for women who may have some degree of POP but few troublesome symptoms. This is an ideal time to implement preventive approaches involving education and exercises for self-management and to prevent development of advancing POP.

When symptoms of POP manifest, evidence based recommendations are for non-surgical interventions to be considered as first-line treatment. Clinical research on Kegel exercises has shown these to be helpful.2  Individualized exercise regimens have been shown to improve symptoms.4.

Exercise interventions are generally of low risk and are recommended by most clinical practice guidelines as a first-line treatment. This approach can enhance a woman’s sense of self-efficacy and control over troublesome and embarrassing symptoms and therefore should be considered first. Other self-management approaches include managing fluid intake, bladder “training,” and scheduled bathroom visits5. These recommendations are largely based on clinical consensus since none of these interventions have been investigated in clinical trials6.

Mechanical support devices, pessaries, have been in use for generations. Ancient Egyptian, Greek, and Latin medical texts describe a variety of mechanical methods intended to support pelvic organs. Contemporary use continues with a variety of devices, usually made of silicone and inserted vaginally7. Proper fitting is key to successful treatment. In one small trial (n=113) use of a pessary helped 72% of women avoid surgery.8 A 2013 Cochrane review found only one randomized trial comparing just one pessary type to another. This very weak level of evidence prompted the reviewers to conclude that there is, “No good quality evidence from randomised controlled trials …on which to base the management by pessaries of women with pelvic organ prolapse..”

Surgery for POP is common. 300,000 procedures occur annually in the US. Various surgical techniques include the use of “native” connective tissue grafts and over the past several years has involved the use of a “mesh” which is surgically inserted into the pelvis to suspend the prolapsing organs in their normal positions. The surgical fixes fail frequently depending on the patient, the surgeon and the technique used. One recent retrospective cohort study (n=112) found recurrence of POP symptoms in 18% of patients after about 2.6 years .

Post-surgical complications with mesh procedures are frequent and sometimes serious. Recent research across the globe however has called into the question the effectiveness and safety of this procedure. One large study in the UK found nearly 10% of surgical mesh cases had complications9. On April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately10.

Despite the frequency of occurrence and the numbers of women affected by POP, good medical evidence about which treatments are safe and effective is scarce. Treatments available in IH clinician offices have supportive clinical evidence on the same level as that which supports conventional medicine.

Adverse Childhood Experiences: ACEs in Women and Chronic Pain

The National Women’s Health Week kicks off on Mother’s Day, May 12, and is celebrated through May 18, 2019. The U.S. Department of Health and Human Services’ Office on Women’s Health leads National Women’s Health Week. The event is intended to encourage all women to be as healthy as possible at each stage of life. In honor of this goal, May will be women’s health month at the CHP Blog and we’ll focus on topics of interest to IH clinicians.

When evaluating adult pain complaints, especially chronic pain problems, obtaining a careful and respectful history of adverse childhood experiences (ACEs) in the past may shed light on the nature of the current chronic pain condition.

The effects of ACEs on a variety of health outcomes in adult life began to be examined first in a population of Kaiser Permanente members in Southern California in the late 1990’s. This retrospective analysis found correlation between ACEs (which were defined as psychological, physical, and sexual abuse; violence, mental illness, and drug abuse in the household; and imprisonment) and later-in-life risk factors for death including alcoholism, drug abuse, depression, and suicide attempt. There was an associated 2- to 4-fold increase in smoking, poor self-rated health, ≥50 sexual intercourse partners, and sexually transmitted disease; and a 1.4- to 1.6-fold increase in physical inactivity and severe obesity.

This is of course a correlation, not a cause-and-effect explanation of these health risks. The initial study was limited to KP members (~1/2 female; 74.8% white; the average age 57; 75.2% had attended college; all had jobs and good health care) and was focused on just a few ACEs and associated health outcomes (obesity, substance abuse, risky sexual behavior, depression, heart disease, cancer, etc.).

Subsequent studies have investigated relationships in other populations with other kinds of ACEs and a variety of subsequent poor health outcomes in adults. These more recent studies have correlated pain, fibromyalgia, migraine headaches, depression, anxiety, and a self-image of poor health with adverse experiences in childhood, particularly physical and sexual abuse .

While both women and men are affected by ACEs such as sexual violence, women experience many ACEs from .25 to 10 times more often than men . Further, it is recognized that women generally report more pain and more chronic pain than men . These observations strongly suggest that clinical evaluation particularly of women (and men too) with chronic pain should prompt at least an initial screening for ACEs.

Patients are often reluctant to disclose ACEs. But prompting in an open, trusting, informed, and non-judgmental clinical relationship may facilitate the potentially sensitive and awkward conversation that reveals ACEs. While the appropriate interventions to address problems associated with ACEs have not fully been determined, from the perspective of Integrative Health (IH) it is essential to consider this aspect of a patient’s history in finding a treatment plan and setting treatment goals. Taking into account physical, psychosocial and spiritual factors is a hallmark of IH.

A model of when and how to screen patients for ACEs have been proposed by the Center for Health Care Strategies. Consensus recommendations include:
• Treatment setting and patient population should guide screening. Pain patients in IH primary care would seem to be appropriate .
• Screening should benefit the patient. Providers screening for ACEs must have a clear strategy in place for utilizing the information in a way that supports patients’ health, including an established referral network.
• Sharing results across treatment settings with appropriate privacy protections may help reduce rescreening and the potential for re-traumatization.
• Ample training should precede screening. Health care professionals should be proficient in trauma screening and conducting patient follow-up in a manner that is sensitive to cultural and ethnic characteristics.

A simple, open-ended question at intake can point to possible ACEs in the past and the need for in-depth evaluation with one of the several ACE scoring tools , .
• Is there anything else about you that you would like me to know?
• Have you ever been abused?

Acetaminophen: Guidelines and evidence

Acetaminophen (also known as APAP and in Europe and UK, paracetamol) is the most commonly used drug in the US.  It is contained in over 600 prescription and over-the-counter medications.  It is widely available in the US as the brand name Tylenol and is also provided in a wide variety of combination preparations to treat colds, flu, insomnia, fever, allergies and pain. The Tylenol brand itself is almost a $2 billion market worldwide.

Pain patients often present to integrative healthcare providers already using the drug, either by prescription or OTC. Being aware of the clinical benefits and risks of acetaminophen can help patients make informed clinical decisions. While generally considered to be safe, the toxicity of acetaminophen is well recognized. It is a leading cause of liver failure and liver transplants in the US. It causes 56,000 ER visits and 2600 hospitalizations every year.[i],[ii]  Toxicity can occur both from an acute overdose as well as prolonged chronic use.

Acetaminophen is particularly dangerous because the highest recommended therapeutic dose of 3000 mg is close to the lethal dose of 10,000 mg. Overdose is too easy.

Acetaminophen is often cited in clinical practice guidelines as a first-line pharmacotherapy for a number of pain conditions. Clinical practice guidelines for acute and chronic low back pain, osteoarthritis, hip, knee, and shoulder pain make this recommendation. However review of the clinical evidence from randomized controlled trials calls these recommendations into question.

  • Acute low back pain. A high quality RCT as reported in Lancet in 2014 found no difference in recovery time from acute LBP with acetaminophen and placebo.
  • Chronic low back pain. A 2015 systematic review and meta-analysis found high quality evidence that showed no difference in pain intensity, functional capacity and quality of life between acetaminophen and placebo.[iii]
    • This same review also looked at osteoarthritis in the knee and hip. While drug therapy produced improvement in pain, the reduction was small (3-4 point on a 100-point pain scale) and was of questionable clinical significance.
  • Shoulder pain. A 2010 systematic review of the effects of various drug treatment of shoulder pain found insufficient evidence to support or refute the benefit of paracetamol for shoulder pain.[iv]

So the next time a patient reports that they are “only taking Tylenol,” having an evidence based discussion about their healthcare choices is appropriate.

[i] Chiew AL, Gluud C, Brok J, Buckley NA. Interventions for paracetamol (acetaminophen) overdose. Cochrane Database Syst Rev. 2018 Feb 23;2:CD003328.

[ii] Ye H, Nelson LJ, Gómez Del Moral M, Martínez-Naves E, Cubero FJ. Dissecting the molecular pathophysiology of drug-induced liver injury. World J. Gastroenterol. 2018 Apr 07;24(13):1373-1385

[iii] Machado GC, Maher CG, Ferreira PH, et al. Efficacy and safety of paracetamol for spinal pain and osteoarthritis: systematic review and meta-analysis of randomised placebo controlled trials. BMJ. 2015;350:h1225. Published 2015 Mar 31. doi:10.1136/bmj.h1225

[iv] Murphy RJ, Carr AJ. Shoulder pain. BMJ Clin Evid. 2010;2010:1107. Published 2010 Jul 22.

IBS: Non-pharmacological and integrative health treatments

More than 1/3 and up to 1/2 of IBS patients opt for the drug-free and more natural interventions provided by integrative health (IH) practitioners in the hope of relief of disabling symptoms with fewer adverse outcomes.[i] ,[ii] Some of these “alternative” treatments do appear in evidence based conventional medicine treatment guidelines.  Many more have a level of evidence that is equivalent to the evidence that supports conventional medicine treatments.  In this last blog post on IBS, we will briefly survey some of them including lifestyle and behavioral interventions, natural medicines, and physical medicine treatments. (CHP providers can find a more complete review of IH treatment of IBS, on the IBS Clinical Pathway at behind the provider log-in.)

There are many prescription and OTC drug treatments for the symptoms of irritable bowel syndrome (IBS). These were surveyed in previous posts.  They are all of variable effectiveness and each has a risk of adverse side-effects. IBS patients are generally not satisfied with the outcomes of this care.  A University at Buffalo survey of 483 IBS patients found less that 20% were “very satisfied” with their medical treatments and 40% reported their treatment to be “below average.”[iii] A 2009 survey by University of North Carolina found only about 8% of patients were “very or extremely” satisfied with care and over 1/3 were “not at all” satisfied.[iv]

There unfortunately is no “gold standard” of care. Patients and their clinicians must necessarily develop treatment plans empirically based on the clinicians’ experience and “best guess” coupled with each patient’s preferences and tolerance for risk.  “Try it and see what works.”

A critical factor in successful management of IBS is a meaningful and supportive relationship between the IBS patient and her clinician.  Many IBS patients have been dismissed by uninformed conventional medical providers as “untreatable head cases” since no objective abnormality can be identified for this “functional” illness.  A small clinical trial of empathic clinician interaction[v] shows the benefit of exploring an IBS patient’s concerns, acknowledging the impact of the symptoms on quality of life, and providing evidence-based guidance regarding medication, diet, stress reduction, and reducing avoidance behavior is well recognized as a foundation of effective IBS therapy.

Many lifestyle interventions including diet recommendations and behavioral therapies can contribute to evidence based IH treatments. A summary of evidence in Cochrane[vi] found support for “CAM” treatments including peppermint oil, probiotics, soluble fiber, and the Chinese medicine formula, Tong xie yao fang.  Hypnotherapy, mindfulness meditation, yoga, relaxation therapy, and cognitive behavioral therapy (CBT) all have been supported by randomized controlled trials[vii],[viii],[ix],[x].

IH herbal treatments, both self-administered and clinician prescribed, are used by about ½ of IBS patients.  Of these patients, about ½ report benefit from herbal preparations, both single herbs and herbal formulas. Well designed clinical trials have shown benefit from peppermint oil, turmeric, artichoke leaf extract, and certain herbal formulas from Chinese and Tibetan medicine and Traditional Chinese Medicine.[xi]

Acupuncture trials show variable outcomes. Trials that compare sham to true acupuncture show no superiority of the real thing (there are of course many concerns with the validity of sham acupuncture). However in a head-to-head comparison trial of acupuncture and antispasmodic drugs, acupuncture recipients reported greater benefit.[xii]

Physical medicine in the form of exercise, yoga, and massage has not been studied extensively, but some clinical trials have investigated specific forms of massage traditions. IBS symptom relief has been shown form physical activity.[xiii] Twice daily yoga practice in a head-to-head trial with loperamide (Imodium) found equal benefit.

Massage itself is well known to facilitate relaxation and improve mood which in turn improves functional disturbances such as IBS. Specific abdominal massage directed to the GI tract has anecdotal evidence of effectiveness. Self-massage likely improves a sense of self-efficacy among patients.

The evidence about IBS shows it to be a most troubling clinical problem. From a clinician perspective, the lack of a clearly defined pathology, or rather a very complex set of potential pathologies involving the microbe-gut-brain axis make diagnosis and treatment planning very difficult. IH approaches, with a whole-person perspective brings all of physiology, neurology, psychology, and personality into the diagnostic picture. This view can set the stage for effective treatment planning that can bring the evidence to facilitate informed patient decision making, which is clearly the goal of effective patient care.

[i] Moayyedi P, et al. Canadian Association of Gastroenterology Clinical Practice Guideline for the Management of Irritable Bowel Syndrome (IBS). Journal of the Canadian Association of Gastroenterology, 2019, XX(X), 1–24 doi: 10.1093/jcag/gwy071
[ii] Shen YH, Nahas R. Complementary and alternative medicine for treatment of irritable bowel syndrome. Can Fam Physician. 2009;55(2):143–148.
[iii] University at Buffalo. IBS patients (can’t get no) satisfaction, study finds.  MedicalXpress. https://medicalxpress.com/news/2017-05-ibs-patients-satisfaction.html
[iv] Drossman DA, Morris CB, Schneck S, et al. International survey of patients with IBS: symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit. J Clin Gastroenterol. 2009;43(6):541–550. doi:10.1097/MCG.0b013e318189a7f9
[v] Conboy LA, Macklin E, Kelley J, et al. Which patients improve: characteristics increasing sensitivity to a supportive patient-practitioner relationship. Social Science & Medicine. 2010;70(3):479–484.
[vii] Labus J, Gupta A, Gill HK, et al. Randomised clinical trial: symptoms of the irritable bowel syndrome are improved by a psycho-education group intervention. Alimentary Pharmacology and Therapeutics. 2013;37(3):304-315.
[viii] Gaylord SA, Palsson OS, Garland EL, et al. Mindfulness training reduces the severity of irritable bowel syndrome in women: results of a randomized controlled trial. The American Journal of Gastroenterology. 2011;106(9):1678–1688.
[ix] Phillips-Moore JS, Talley NJ, Jones MP. The mind-body connection in irritable bowel syndrome: A randomised controlled trial of hypnotherapy as a treatment. Health Psychol Open. 2015;2(1):2055102914564583. Published 2015 Jan 28. doi:10.1177/2055102914564583
[x] Schumann D, Langhorst J, Dobbs G, Cramer H. Randomised clinical trial: yoga vs a low‐FODMAP diet in patients with irritable bowel syndrome. Alimentary Pharmacology & Therapeutics Volume 47, Issue 2.
[xi] Yoon S, Grundman O, Koepp L, Farrell L. Management of Irritable Bowel Syndrome (IBS) in Adults: Conventional and Complementary/Alternative Approaches. Alternative Medicine Review 2011 Volume 16, Number 2.
[xii] Manheimer E, Cheng K, Wieland LS, Min LS, Shen X, Berman BM, Lao L. Acupuncture for treatment of irritable bowel syndrome. Cochrane Database of Systematic Reviews 2012, Issue 5. Art. No.: CD005111. DOI: 10.1002/14651858.CD005111.pub3
[xiii] . Villoria A, Serra J, Azpiroz F, Malagelada JR. Physical activity and intestinal gas clearance in patients with bloating. Am J Gastroenterol 2006;101:2552-2557.

IBS: The evidence for conventional pharmacological treatment

IBS is one of the most common disorders seen in primary care and gastroenterology specialty practice. Conventional medicine approaches consist of combinations of diet advise, psychological, and drug therapies.

Current conventional medicine guidelines make a number of recommendations for treatment [i],[ii]. However most of these are consensus-based and have inadequate clinical evidence for a strong recommendation. The summary of US guidelines notes, “Despite the large number of published studies, in most cases our recommendations are weak because either (1) the quality of the available data and/or (2) the balance of risks and benefits for a particular therapy do not overwhelmingly support its use.”

Pharmacotherapy* is directed toward modifying the symptoms of IBS that ranges from IBS-C which is constipation-dominant, to IBS-D – diarrhea dominant, and IBS-M which has both. Among the suggested or recommended pharmacological interventions are antispasmodics, antidepressants, and eluxadoline (IBS-D), lubiprostone (IBS-C), and linaclotide (IBS-C).

  • Antidepressants: A 2011 Cochrane review concluded that SSRIs and tri-cyclic antidepressants have “good” evidence of effectiveness, but effectiveness may be depend on “the individual patient.”[iii]
  • Antispasmodics: Found by this same review to be effective in some patients.  About 3-7 patients need to be treated in order to produce 1 successful outcome (NNT).
  • Bulking agents: Cochrane found no evidence to support bulking agents (soluble and insoluble fiber.)
  • Psychological therapies: A recent review (2019) suggests that while the evidenced is of limited quality, psychological therapies (cognitive behavioral therapy (CBT), relaxation therapy, multi-component psychological therapy, hypnotherapy, and dynamic psychotherapy) appear to be helpful.

The website www.drugs.com lists 79 medications (Rx, OTC, off-label) used to treat IBS. Over the counter medications are used frequently. OTC bismuth and loperamide (Kayopectate, Pepto-Bismol, Imodum)have been shown to provide relief of diarrhea but have no effect on other IBS symptoms. IBS-C can be treated with a variety of drugs intended to get things moving when constipation strikes. Dietary fiber sources, osmotic laxitives, stool softeners, and stimulant laxatives have evidence of varying degrees of effectiveness and individual risk profiles for adverse events.

Our final installment covering IBS in April will look at the evidence for integrative healthcare treatment options for patients dealing with Irritable Bowel Syndrome.

[i]Canadian Assoc. of Gastroenterology. (Accessed 4/2/19 at https://www.cag-acg.org/images/publications/CAG_CPG_for_Management_of_IBS_JCAG_Jan2019.pdf)

[ii] Weinberg, David S. et al. American Gastroenterological Association Institute Guideline on the Pharmacological Management of Irritable Bowel Syndrome. Gastroenterology , Volume 147 , Issue 5 , 1146 – 1148

[iii] Ruepert  L, Quartero  AO, de Wit  NJ, van der Heijden  GJ, Rubin  G, Muris  JWM. Bulking agents, antispasmodics and antidepressants for the treatment of irritable bowel syndrome. Cochrane Database of Systematic Reviews 2011, Issue 8. Art. No.: CD003460. DOI: 10.1002/14651858.CD003460.pub3.