Book Review: A New IBS Solution

In November I wrote about an important study in the Annals of Internal Medicine that demonstrated the effectiveness of an antibiotic for the symptoms of irritable bowel syndrome (IBS).  Dr. Mark Pimentel, the author of the study, is the director of the Cedars-Sinai Medical Center Gastrointestinal Motility Program.  Last year he published a book outlining his theories about the cause and treatment of IBS:  A New IBS Solution.  After reading my post about the Annals article, he kindly asked me to review his book.

The cause of IBS remains mysterious.  Dr. Pimentel makes the astute point that when the cause of a disease is unknown, it is very frequently initially presumed to be psychological.  A generation ago, stomach ulcers were thought to be due to emotional stress.  (They are not.  They are almost always due to a specific bacterium or to anti-inflammatory pain medicine.)  Heart attacks were thought to be more common in patients with the type A-personality.  (They are not.)  The assumption that IBS has primarily psychological causes has stigmatized IBS patients, and has misdirected researchers away from potentially useful diagnostic tests and treatments.

Dr. Pimentel’s central theme is that bacterial overgrowth is a major cause of IBS.  Bacterial overgrowth is a condition that occurs when bacteria that normally live in the colon (large intestine) move into and colonize the small intestine which is normally free of bacteria.  Small intestine bacterial overgrowth can be diagnosed by testing for specific gasses in exhaled breath, and can be treated with antibiotics.  In language aimed for the general public, Dr. Pimentel summarizes the evidence supporting this theory, and details the protocol used at Cedars-Sinai to manage IBS.  The book is also peppered with patient testimonials which help put a human face on a medical problem that is frequently very miserable.

The ideas in A New IBS Solution are an important breakthrough in a very common disease for which treatments up until now have been only marginally effective.  I will certainly recommend the book to all of my patients with IBS.

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Growth Hormone Doesn’t Help Healthy Older Adults

I’ve written before about the popular antiaging trend in healthcare.  Another medication that has been widely touted as an antiaging remedy is growth hormone (GH).  It has been shown to be beneficial in certain diseases (especially GH deficiency) but has also been recommended by some to healthy older people to increase muscle mass, improve bone density, and “reverse aging”.

A systematic review of randomized studies of GH in healthy older adults in today’s issue of the Annals of Internal Medicine examines this issue.  The results have been widely reported in the general press, including this L.A. Times article, and this article in Forbes.

The study found no significant benefit from GH, but several serious side effects, including soft tissue fluid retention, carpal tunnel syndrome, joint pain, and, in men, breast tissue enlargement.

The authors of the study conclude:

“Use of GH as an antiaging therapy is widespread and has been advocated in the lay press and in scientific literature. Our analysis shows that this practice is not supported by a robust evidence base, offers little clinical benefit to the healthy elderly, and is associated with high rates of adverse events.”

This week there are three brief items of Tangential Miscellany:

There will not be a medical news post next week.  The posts will resume the week of January 29.

The Pedometer Project starts on February 1.  Folks are still signing up.  Send me an email if you’d like to join.

Finally, a year ago this week I posted my first weekly medical news post.  I’m very grateful for all the helpful feedback and encouragement about the posts that many of you have given me.  I’ll try to continue to keep you informed, motivated, and healthy in the next year.

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Caution Urged When Giving Infants Cough and Cold Medications

I never write about children’s health, since I have no training in pediatrics and my patients are adults. Nevertheless, I thought this story deserves your attention, particularly since many of my patients have young children.

The Centers for Disease Control released a warning today in their Morbidity and Mortality Weekly Report about adverse events in infants taking cough and cold medications. If you have a child less than two years of age, I urge you to read the entire brief article.

The issue seems to be that infants occasionally receive inappropriately high doses of these medications, leading to about 1,500 emergency department visits in 2004 and 2005, and three identified deaths. The packaging does not have dosing recommendations for children < 2 years, since the FDA has never tested appropriate doses in this age group. The bottom line is that the CDC advises parents to check with the child’s physician before giving cough and cold medications to a child younger than two, and to follow those instructions meticulously.

The part of the caution that surprised me most was that the medical literature has not demonstrated that cough and cold medications reduce cold symptoms better than placebo in children aged < 2. Perhaps in this age group we’re better off using humidifiers, saline nasal drops, nasal suctioning, and some patience.

Tangential Miscellany:

The pedometers have arrived! Dozens of patients and their friends have joined the Pedometer Project, which will start on February 1. It’s not too late to sign up!

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Studies You Should Ignore

The media constantly bombards us with studies purporting to show new evidence about medicines we should avoid, or foods we should eat, or behaviors that either protect us or harm us. Many of these studies, because of their design, actually tell us absolutely nothing. Nevertheless, the media is not in the business of downplaying the news, so the studies are inevitably announced in the mainstream press with much fanfare and little scientific scrutiny.

So that leaves us, the consumers of the news stories, with the responsibility of figuring out whether or not a study deserves our attention. A great example was a study last week in the Journal of the American Medical Association that linked use of proton pump inhibitors (PPIs, antacids such as Prevacid, Prilosec, Aciphex and others) to the risk of hip fractures. The most important thing to understand about this research is that it was what scientists call an observational study, and not a randomized trial. That means that the researchers followed many people who were taking a PPI and many who weren’t. They then counted how frequently hip fractures occurred in the two groups. They did not assign subjects to either take a PPI or not. They simply observed. A randomized trial, in contrast, would have been one in which each patient is randomly assigned to take either a PPI or a placebo (preferably without the patient or his doctors knowing which he is taking), and then the patients are followed and the number of hip fractures are counted.

Observational studies have very frequently given us misleading conclusions. For a generation we believed that estrogen protected women from heart attacks and strokes until finally a randomized study showed us that the opposite was true. Observational studies also suggested that lowering homocysteine might prevent heart attacks, and that dietary fiber might decrease cancer risk. None of these conclusions withstood randomized trials. Why do these trials give us flawed information? Because individual people are different from each other in myriad ways that can never be fully accounted for by the designers of the study. A generation ago, the women who chose to take estrogen were clearly healthier than those who didn’t, but it wasn’t because of the estrogen. Similarly, the patients on PPIs may be frailer or sicker than those not on them. Only a randomized trial will tell us for sure.

I think observational studies are very useful to help scientists generate ideas for large randomized trials. But patients and doctors are better off ignoring them.

Tangential Miscellany:

The response to the Pedometer Project has been very encouraging. I expect to receive the pedometers in about two weeks, so it’s not too late to sign up or to persuade a loved one to do so. Email me if you want to join. (Click on the link if you didn’t read about the Pedometer Project last week.)

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The Pedometer Project: Steps that Make a Difference

With the end of 2006 a few days away many of us turn our thoughts to the New Year and seize the opportunity to rededicate ourselves to healthier habits. I personally know all too well how easy it is to stop exercising and how hard it is to start again. I also know how insidious inactivity can be. In the last month alone, I’ve had to tell three of my patients that they were in the earliest stages of developing diabetes. For them, the need to exercise and to pay compulsive attention to their diet has suddenly become mandatory.

So I’ve decided to encourage all my patients to become more physically active in 2007 by organizing a contest called the Pedometer Project. Here’s how it works.

I will provide a pedometer (a little device that you keep in your pocket that counts how many steps you walk) for all of my patients. Several patients have told me that using a pedometer has made them much more aware of how much they are walking, and that they found themselves walking more even when they didn’t deliberately set out to do so. Non-patients are welcomed to join the contest if they are referred by patients. Periodically contestants will email me the number of steps they’ve walked. (This is obviously done on the honor system. You can cheat, but why would you?) Every month I’ll announce new winners in three different categories.

  • The Walker of the Month — whoever accumulates the most steps that month
  • Most Improved — whoever increases his / her walking the most from the first week to the last week of the month
  • Weight Loss — anyone who is overweight and loses at least 10 pounds

What do winners get? In honor of every winner I will either donate platelets at Cedars-Sinai Medical Center or donate an afternoon at the Simms/Mann Clinic, a clinic that cares for indigent patients. I’ll inform each winner when their donation happens, and if I have their permission, will congratulate them by name on my web site. Winners can only win once, so that everyone else has a chance the following months.

So by becoming more active, your steps make a difference to your health, to blood recipients at Cedars-Sinai, and to patients who could otherwise afford no healthcare at all.

Let me know if you’d like to participate.

I wish all of you a happy, healthy and active 2007!

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Black Cohosh, Other Herbs, or Soy for Symptoms of Menopause

I know I wrote about menopause only three weeks ago (and received some joking complaints from a few male patients about covering irrelevant topics) but I don’t write the medical literature; I just report it.

A great study was published this week in the Annals of Internal Medicine, and the summary for patients is free without a subscription. It’s brief and informative. The study enrolled menopausal women who were having at least two episodes of hot flashes per day and randomized them to five treatment groups, each of which received one of the following treatments: black cohosh (an herb frequently marketed for the treatment of menopausal symptoms), a multibotanical herbal product, a multibotanical herbal product and counseling to increase dietary soy intake, estrogen hormone therapy, or a placebo pill. The group receiving estrogen had fewer hot flashes and night sweats; the other four groups all had similar symptom frequency. Black cohosh, herbs, and soy did no better than placebo.

(By the way, a brewing controversy that I have not seen addressed is that the New England Journal of Medicine calls them “hot flushes”, while the Annals calls them “hot flashes”.)

An editorial in the same issue of Annals ends with some words of encouragement.

“The good news from [this study] has to do with the natural history of vasomotor symptoms. Women in the placebo group experienced an approximately 30% reduction in the severity and frequency of vasomotor symptoms during the 12-month follow-up period. Therefore, if a woman is not severely bothered by her vasomotor symptoms, it is important to reassure her that she has a good chance of having fewer symptoms within 6 to 12 months. Indeed, she may not need treatment at all.”

So female patients should take heart — your symptoms will likely be mild and temporary. And male patients should be patient until I write about prostate problems, or football.

Tangential Miscellany:

I wish all of my patients and readers who are celebrating a very merry Christmas!

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Reclaiming the Q Word

A generation ago, in the bad old days, physicians were thought of as unquestioned experts who dispensed orders rather than advice, and expected dutiful compliance from their patients.  Fortunately those days are long gone, and today the patient and the physician see each other as partners in the patient’s healthcare, with the patient able to question and even challenge the doctor’s recommendations.  This keeps doctors smart and honest and keeps patients ultimately in control of their health.  But with the loss of our perceived infallibility of a generation ago, physicians also seem to have lost the ability to loudly and with confidence distinguish between good medicine and quackery.  Myriad ineffective supplements and health-related gizmos are advertised and sold to our patients constantly, but we mostly say nothing, afraid that we’ll offend our patients, or be thought of as narrow minded.  We end up thinking something like “Our patients want magnetic bracelets (or Echinacea, or vitamins) so who are we to stand in their way?”  Even the word “quackery” has fallen into disuse, replaced now by less judgmental terms like “alternative medicine” or “homeopathic” (a word that used to mean something specific, but no longer does).  In a culture in which “judgmental” is a pejorative adjective, how can we continue to dispense sound judgment?

So I was delighted to read in this week’s LA Times health section an article warning us of the many shady, useless, and even potentially hazardous health products being sold to us every day: Step right up, folks!  (The LA Times site requires registration, but it’s free.)  If you have a few minutes, please read it.

Another valuable resource that I found recently is Quackwatch, a website dedicated to exposing quackery and health fraud.

Please, help me revive the word “quackery”.  Use it the next time you’re driving and hear an ad for a weight loss product, or your neighbor tells you about the herbs he takes for his cold.  The next generation of physicians will thank you.

Tangential Miscellany:

I wish all my Jewish patients and readers a bright and joyous Chanukah!

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Medication Options in Newly Diagnosed Type 2 Diabetes

Over a dozen years ago, when I was a medical student, treatment of type 2 diabetes was very simple. There was only one family of oral diabetes medicine — sulfonylureas. In patients for whom the sulfonylureas failed, the only option was insulin injections. Sulfonylureas suffer from two serious side effects. They cause weight gain, an especially frustrating problem since weight loss is so important in diabetes. They can also cause blood sugar levels to become too low (hypoglycemia) which can have uncomfortable and dangerous consequences.

In 1994 metformin (Glucophage) was approved in the US, providing the first non-sulfonylurea oral treatment for diabetes. Glucophage does not cause weight gain, and, by itself, does not cause hypoglycemia. Its most common side effect is annoying but not dangerous — diarrhea and stomach upset. The most serious side effect, lactic acidosis, is rare and usually preventable. Glucophage was a boon for diabetics.

More recently, a third group of oral diabetes medications became available — the thiazolidinediones (TZDs) which include Avandia (rosiglitazone) and Actos (pioglitazone). The TZDs also do not cause hypoglycemia, but they cause fluid retention (edema) which can be dangerous in patients with heart failure or kidney disease. They can also cause weight gain, but I’ve always believed (perhaps incorrectly) that this was fluid weight, not a gain in fat, like with sulfonylureas.

Diabetes is a progressive disease, meaning that even with optimal treatment sugar levels slowly increase and more medication must be used to achieve adequate control. Many diabetics therefore eventually need more than one medication, and some eventually need all three of the above classes.

A large trial in this week’s New England Journal of Medicine helps doctors and patients decide which of these three classes of medications are best used first in newly diagnosed diabetics. Over four thousand recently diagnosed patients were randomly assigned to receive Avandia, Glucophage, or glyburide (a sulfonylurea). They were followed for an average of four years to see which medication, when used alone, would control their diabetes longest, and to follow side effects.

Avandia controlled sugars longest, keeping the glycated hemoglobin (a long-term measure of sugar control) normal for an average of 60 months, compared to 45 months with Glucophage, and 33 months with glyburide. This benefit, however, came with increased side effects. Avandia caused the most weight gain, 10.6 lbs on average. The patients on glyburide surprisingly gained only an average of 3.5 lbs in the first year, and then did not gain more. The group on Glucophage actually lost weight. As expected, patients on glyburide also had occasional hypoglycemia.

The authors conclude

Our findings confirm the value of metformin (Glucophage) as an initial treatment for type 2 diabetes and the greater efficacy of metformin than of glyburide.

Tangential Miscellany:

Some ideas are so preposterous, they never go away. The purported link between cell phone use and cancer always struck me as such an idea. This Forbes article cites a recent large Danish study showing no connection between cell phone use and the risk of malignancy. I hope this will be the last word on the topic. So go ahead and use your cell phone. It won’t give you cancer, though you might drive into a tree.

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Management of Menopausal Symptoms

Yesterday’s issue of the New England Journal of Medicine had a very helpful review article: Management of Menopausal Symptoms. (The full text is available even to non-subscribers.) The article reviews the existing evidence about the prevalence of symptoms related to menopause and the risks and benefits of various treatments. I summarize the article below.

The symptoms most associated with menopause are vasomotor symptoms (hot flushes and night sweats), vaginal symptoms, and trouble sleeping. About 65% of women have hot flushes during menopause. In most women, the hot flushes resolve within 4 to 5 years. Vaginal symptoms, including dryness, discomfort, itching, and discomfort during intercourse, are reported by about half of women during menopause. Unlike hot flushes, these symptoms do not resolve with time, and they sometimes worsen. Vaginal symptoms are most effectively and safely treated with vaginal estrogen cream.

A great number of treatments have been used for vasomotor symptoms, many without strong evidence. Many women find relief with simple measures such as dressing in layers and lowering the temperature of their room. In regard to the many alternative medications used for hot flushes, the author states:

There is no convincing evidence that acupuncture, yoga, Chinese herbs, dong quai, evening primrose oil, ginseng, kava, or red clover extract improve hot flushes. One trial of vitamin E found a statistically significant effect, but the benefit was only one hot flush per day less with treatment, as compared with placebo. Evidence regarding black cohosh is mixed but primarily negative.

Estrogen has been proven to improve hot flushes, but it has also been proven to increase the risk of stroke (a risk I wrote about in April). Antidepressants have also been tested with mixed results. Gabapentin (Neurontin) is modestly effective but has some bothersome side effects. Most expert groups therefore recommend that if a woman is having severe enough hot flushes that simple environmental measures (i.e. dressing in layers, cooling the room) don’t bring relief, the lowest dose of estrogen necessary to relieve the symptoms be used. (Progesterone should be added in a woman who has not had a hysterectomy.) The woman should understand the potential risks of estrogen and that her hot flushes will likely resolve in a few years. Attempts should be made every 6 months or so to wean off the estrogen, thereby attempting to use the lowest dose of estrogen for the shortest duration necessary.

Tangential Miscellany:

Two patients pointed out to me the two recent studies and the editorial in the New England Journal of Medicine regarding the use of epoetin (or EPO, marketed under the brand names Procrit and Epogen) in patients with kidney disease. The Los Angeles Times published an article that covered the issue well. If you or someone you know takes EPO, please read these articles and discuss them with your doctor.

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DHEA and Testosterone Don’t Help Elderly Patients

Antiaging is the latest wellness craze, with many supplements promising to turn back the clock and help people feel younger.  Very few antiaging supplements have received rigorous attention.

Dehydroepiandrosteone (DHEA) and testosterone are two hormones widely promoted as antiaging supplements which were investigated in a randomized double-blind study published last month in the New England Journal of Medicine.  The study randomized elderly men who had low levels of testosterone and sulfated DHEA into three groups.  One group received DHEA; one group received testosterone; and one group received placebo.  The study also randomized women with low levels of sulfated DHEA to a group that received DHEA, and a placebo group.  The patients were followed for two years.  Their physical performance, bone mineral density, percent body fat, glucose tolerance and quality of life were measured.

The study concluded

Neither DHEA nor low-dose testosterone replacement in elderly people has physiologically relevant beneficial effects on body composition, physical performance, insulin sensitivity, or quality of life.

I guess I’m “pro-aging”.  I figure the better I do my job, the older my patients get!

Tangential Miscellany:

My staff and I wish you a very happy Thanksgiving.  May we all enjoy time with loved ones, and may we remember to express gratitude for our abundant blessings.

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