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“Natural” Postmenopausal Hormones: Not so natural, not so safe

Posted by medconsumers on May 1, 2007

When a landmark clinical trial reported in 2002 that the dangers of postmenopausal hormone drugs far outweighed the benefits, many more women turned to bioidentical or natural hormones. These products are widely portrayed in the media and on the Internet as safer than prescription hormone drugs like Prempro and Premarin for the relief of hot flashes and other menopausal symptoms. The idea that these products are safer or even natural is challenged in a paper by Adriane Fugh-Berman, MD, and Jenna Bythrow of the Complementary and Alternative Medicine Master’s Program, Georgetown University School of Medicine.

Sold as topical creams and tablets over the Internet and in health food stores, bioidentical hormones are actually synthetic versions of female hormones, including estriol, estrone, estradiol, progesterone, testosterone, DHEA, thyroxine and cortisol. In their paper published recently in the Journal of General Internal Medicine, Fugh-Berman and Bythrow contend that bioidentical is a meaningless term coined by a business that knows what sells.

Compounding Pharmacies

Many of these products are prepared by compounding pharmacies that convert prescription and non-prescription drugs into different formulations. For example, converting a drug manufactured in tablet form to a syrup for people who have difficulty swallowing pills or a pet-sized dose of a drug meant for humans. In the case of bioidentical hormones, the pharmacies are reformulating the standard prescription hormone drugs, usually in weaker doses.

Because compounding pharmacies are not manufacturing facilities, they are not required by the FDA to prove safety or effectiveness. “Compounding pharmacies have their place,” said Dr. Fugh-Berman in a telephone interview. “But [with bioidentical hormones] all these pharmacies are doing are buying hormones from Upjohn or some other drug company and following a recipe.”

“Bioidentical hormones are chemically identical to hormones produced by the body,” explained Dr. Fugh-Berman, but the term bioidentical is widely misunderstood. Most women surveyed at one compounding pharmacy either thought it meant “not man-made” or plant-derived; they no doubt got that impression from advertising and/or reading the product labels which often, for example, feature wild yams as the source of progesterone.

Bioidentical hormones are sometimes derived from starting materials of plants in a lab process, Dr. Fugh-Berman said, “but, you won’t get progesterone from eating a yam. Plants have precursors in them, but not actual progesterone.”

Because compounding pharmacies are unregulated, they can make unsubstantiated claims for their products. (Legislation has been introduced.) The most dangerous to Dr. Fugh-Berman are the claims that bioidentical hormones will prevent heart disease and breast cancer, as well as improve well-being—all of which have been discredited for standard hormone drugs in the landmark 2002 Women’s Health Initiative trial.

Also, women with an intact uterus must protect it against estrogen-induced endometrial cancer with the addition of progesterone. Studies show that many bioidentical progesterone products contain much weaker doses of the standard progesterone prescription drugs, so they do not provide the level of needed protection.

For the many women who do not want to hear her message and will continue taking bioidentical hormones no matter what, Dr. Fugh-Berman has this advice, “Now we know that [the conventional prescription] hormones help only symptoms—hot flashes and vaginal dryness—they don’t prevent disease,” she said, referring to the results of the 2002 Women’s Health Initiative trial. “So symptomatic women should take the lowest possible dose for the shortest period of time. Women without symptoms shouldn’t use either bioidentical or conventional hormones for disease prevention. Bioidentical hormones should be assumed to have the same risks as conventional hormone drugs and should carry the same warning labels.”

As for the standard claim that bioidentical hormones are natural, “Ironically, the estrogen in the best-selling hormone preparations Premarin, Prempro, and Premphase is derived from pregnant mare’s urine, an inarguably natural source.”

Maryann Napoli, Center for Medical Consumers ©
May 2007

Posted in Alternative Medicine, Women's Health | Tagged: , | Comments Off

Statins and Mediterranean Diet

Posted by medconsumers on February 1, 2007

One might reasonably expect the U.S. government’s cholesterol-treatment guidelines to be firmly based on scientific evidence. Certainly, that was the claim of the National Cholesterol Education Program when it issued an updated report in 2004. What alarmed some researchers and consumer advocates at the time was the expansion of statin use to include people who do not have heart disease but are supposedly at “moderately elevated risk” for developing it.

The updated guidelines would put an additional 23 million Americans on statins for the rest of their lives. A cloud of doubt hung over the entire issue once it became known that the majority of physicians who established the guidelines had financial ties to companies that make statin drugs.

Statins, the top-selling class of drugs in history, are cholesterol-lowering drugs that include atorvastatin (Lipitor), lovastatin (Mevacor), pravastatin (Pravachol), fluvastatin (Lescol), simvastatin (Zocor) and rosuvastatin (Crestor). Their benefit to people with heart disease is proven, but there is a controversy regarding the use of these drugs by everyone else. Three-quarters of all Americans now on long-term statin therapy do not have heart disease.

In a recent issue of the medical journal, Lancet, John Abramson, MD, Harvard Medical School, and James Wright, MD, University of British Columbia, Vancouver, co-authored a commentary entitled, “Are Lipid-Lowering Guidelines Evidence-Based?” They conducted an analysis of all the major trials in which participants were randomly assigned to take either a statin or a placebo. The seven trials that included adults between 30 and 80 years old who already have heart disease clearly showed that statins lower the risk of a cardiac death as well as a death from any cause.

However, their analysis of the other trials that included healthy but high-risk people without heart disease showed that statins should not be prescribed to women of any age who do not have heart disease or diabetes, or to men older than 69 years who do not have heart disease or diabetes because no benefit was shown for them.

There is a modest benefit for men aged 30-69 years who are at high risk of developing heart disease. Out of 50 high-risk men taking a statin every day for five years, only one avoids a “cardiac event” —that is, a heart attack or heart-related death. Put another way, out of every 50 men who stay on statins for five years, 49 risk an adverse drug reaction for no benefit. “In our experience,” wrote Drs. Abramson and Wright, “many men presented with this evidence do not choose to take a statin, especially when informed of the potential benefits of lifestyle modification on cardiovascular risk and overall benefit health.”

*****

What follows is an interview with the lead author of this analysis, John Abramson, MD, who is also the author of the 2004 book entitled, “Overdosed America” and serves as an expert consultant to plaintiffs’ attorneys in litigation involving the drug industry including Pfizer and Lipitor. He is interviewed by Maryann Napoli.

MN: Whenever I write about statins, I get calls from readers that indicate many are misled about their level of risk. Typical is the healthy woman over the age of 65 pressured to take statins by her doctor who says that she is at high risk for a heart attack solely because of age and high cholesterol.

JA: 1) The evidence shows that the higher her cholesterol, the longer she will live; 2) no trial shows that statin therapy will benefit her; 3) people over 65 who exercise routinely, eat a Mediterranean-style diet, don’t smoke, drink moderately, will have a 60% lower rate of death than the people who don’t do these things.

MN: That one trial with people over 70, called PROSPER (PROspective Study of Pravastatin in Elderly at Risk), is often misrepresented.

JA: This trial clearly showed the limited benefit of statins in the elderly. For those who already have cardiovascular disease, taking a statin reduces the risk of heart attack or cardiac death. But it also showed that people in this age range who are at increased risk of, but do not have, cardiovascular disease do not benefit from taking a statin. Importantly, the study also found that at four years, there was one extra new cancer for every 70 people taking a statin. No reduced risk of stroke and no benefit for people without cardiovascular disease and an increased risk of cancer, yet millions of elderly Americans without heart disease or diabetes are taking these drugs because they and their doctors are misled into believing that clinical trials have shown that statins are beneficial.

MN: And people who have had a heart attack?

JA: Statins are definitely helpful for people who have already had a heart attack. Still, the Lyon Diet Heart Study shows how much more effective a healthy diet is in reducing the risk of heart attack for these folks. The participants were randomly assigned to receive counseling about a Mediterranean-style diet (see end of article) or a standard post-heart attack diet. Those who went on the Mediterranean-style diet developed 72% less heart disease than those in the control group. There was also a 56% lower death rate and 61% less cancer than the people in the control group. Simply eating a Mediterranean-style diet is nearly three times more effective at preventing recurrent heart disease and death in post-heart attack patients than is taking a statin. Even more surprising, those on the Mediterranean-style diet did not have lower cholesterol than those eating the standard post-heart attack diet. So when your doctor tells you to get your cholesterol down…keep that in mind.

MN: Lifestyle changes aren’t given much attention.

JA: The vast majority of communication about heart disease is influenced by the drug companies. They focus on cholesterol, rather than diet, exercise, and not smoking because their primary responsibility is to maximize the financial return to their investors, and that’s where the money is. All but one of the major statin trials was funded by a company that makes statins.

MN: That should make us all wary—studies show that the majority of drug company-funded studies produce results favorable to their product.

JA: The ALLHAT [Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial] was the only one of the 14 major statin trials included in the most recent review [published in the Lancet in October 2005] not funded by a drug company. It included a good mix of people: men and women with and without heart disease and/or diabetes. Half of the participants were randomly assigned to be treated with a statin and half to go to their regular doctor and do whatever he or she thought was right. By the end of the study, 26% of the people assigned to “usual care” had been put on a statin by their doctors and 77% of those in the statin group were still taking the statin (the others discontinued because of side effects, other medical conditions, etc.). But the results showed that there was no less heart disease or death in the group with three times as many people taking statins.

MN: These results seem to be widely misperceived.

JA: One of the reasons is a misleading editorial that accompanied the publication of ALLHAT in the Journal of the American Medical Association. It stated: “Physicians might be tempted to conclude that this large study demonstrates that statins do not work; however, it is well known that they do.” That’s not quite what I think of as evidence-based medicine. The editorialist actually had the chutzpah to suggest that statins may be less effective when they are prescribed by primary care physicians, as they were in the ALLHAT, than by cardiologists. At the time of the editorial, the writer had financial relationships with at least seven drug companies. He is now employed by Merck, which makes Zocor.

MN: All but two of the statin trials failed to report their serious adverse events, defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, requires prolongation of hospitalization, or results in significant disability.

JA: The statin trials that report only the drug’s effects on heart disease are not presenting what we all really need to know. The most important question is: What is the overall effect of taking the drug? In other words, if a statin decreases the risk of heart disease but does not reduce the overall risk of serious illness or death unrelated to heart disease, is it worth taking? And the difficulty of answering this question ought to lead people to wonder if there are alternative ways to reduce the risk of heart disease.

MN: Why do journals allow drug companies to publish only heart-related results of their trials?

JA: Medical journals are not fulfilling their responsibilities when they publish trial results and omit all serious adverse events and deaths from all causes.

MN: Any parting thoughts?

JA: People ask, “Why can’t I just take a pill, eat what I want and forget about going to the gym?” And I say to them: If the pill worked, that would be a good question, but there just isn’t any evidence from clinical trials showing that statins are beneficial for women or older men who don’t already have heart disease or diabetes. Healthy lifestyle changes are a more effective, less expensive, and safer way to reduce your risk of heart disease and improve your chances of staying healthy overall.

For information on the Mediterranean-style diet: go to www.americanheart.org and type into the search box: Lyon Diet Heart Study.

Maryann Napoli, Center for Medical Consumers ©

Posted in Alternative Medicine, Diet & Exercise, Drugs, Heart, Men's Health, Women's Health | Tagged: , , , , , , , , | Comments Off

Women’s Health Advice Falls Short

Posted by medconsumers on March 1, 2006

Prevention Advice to Women Doesn’t Hold Up

This is not the first time we’re seen medical dogma upended. Remember breast self-examination? It was proven to have no life-saving benefit and an increased risk of unnecessary breast biopsies. Now it is calcium supplements and a low-fat diet that will not save your life.

February 2006 was a banner month for disproving medical dogma. First, the public learned that the low-fat diet does not prevent heart disease. The next week, another study found that calcium does not protect against fractures or colon cancer. And in between, yet another study provided the surprising news that estrogen might lower the risk of heart disease in some women. (This last one actually reconstituted a previously disproved medical belief. For over ten years, women had been told that estrogen will save them from heart disease, but a major clinical trial was stopped early several years ago when it found that this hormone caused heart-related problems.) In each case, the findings were strongly contested.

Women’s Health Initiative

All these newsworthy announcements came from the same landmark clinical trial called the Women’s Health Initiative (WHI), an $18 million government-funded project, which involves thousands of healthy women over age 50. It is designed to test the prevailing health advice about how to prevent the chief causes of death and disability in older women.

Medical research is constantly evolving and we should expect health advice to change as more studies are published. But how is it that so many recommendations based on uncertain evidence can become orthodoxy? Recall how women were made to feel negligent by their doctors for not doing breast self-exams. A similar guilt was laid on those who refused to take postmenopausal hormones or were doubtful about high-dose calcium.

Surrogate Endpoints

Physician acceptance of the preventive measures was nearly universal, though they were based on a less reliable type of study called population, or observational studies. In this type of study, for example, the women who chose to take estrogen (as opposed to being randomly assigned to take it in a clinical trial) tended to have lower rates of heart disease. A closer look at these less reliable studies showed that women in the higher income brackets were more likely to take estrogen, and a high income is known to be associated with better health and a longer life.

Often, health recommendations are based on what researchers call surrogate endpoints—plus a heavy dose of assumptions. Estrogen lowers cholesterol in women; therefore it must save them from heart disease. Calcium improves bone density; therefore it must cut the risk of hip fracture. Long-term  trials that follow participants until they have a heart attack or a hip fracture are expensive and take many years to produce answers, which is why so much health advice is based on surrogate endpoints.

The WHI is a massive research effort that involves multiple clinical trials. As researchers continue to sift through the data generated by the WHI, they will be publishing results for years to come. What follows is a summary of the evidence (or gaps in the research) that led the WHI to study the low-fat diet, high-dose calcium, and estrogen in younger women; the doubts that long surrounded each preventive measure; and the questions that remain unanswered.

LOW-FAT DIET AND HEART DISEASE

The supporting evidence:

No long-term trial had ever been conducted to support the idea that a low-fat diet (below 20% of total calories) reduces the risk of heart attack in healthy older people. While the WHI was still underway, a 2001 Cochrane review on this topic was published in the British medical journal, BMJ. Lee Hooper, PhD, and colleagues assessed all clinical trials in which healthy older men and women had been randomly assigned to continue on their normal diet or go on a low-fat or a reduced-fat diet.

This review exposed the difficulty in finding definitive answers as heart disease takes years to develop and few of the trials lasted more than six months. Results were predictably unimpressive: There was no reduction in heart attacks or cardiac deaths, but the few trials that lasted two years hinted at a lower risk of heart  disease.

Flaws in the WHI:

The most valid criticism of the WHI/diet trial centers on the fact that it made no distinctions in the types of fat, as in: olive oil is good; trans-fatty acids (partially hydrogenated vegetable oils) are bad. Participants were simply instructed to keep their total fat intake below 20%. Because the WHI was designed 15 years ago, it reflects the general thinking among nutrition scientists at the time, said nutrition scientist Sharon Akabas, PhD, in a telephone interview. “As recently as 12 to 15 years ago, you still had people [in the nutrition field] who thought trans-fatty acids were OK and omega-3 fatty acids were seen as fringe—olive oil and other monosaturated oils were thought to be neutral.”

The Mediterranean-type diet is favored by many nutritionists today and that is a glaring omission of the WHI, according to Dr. Akabas, who is associate director of education at the Institute of Human Nutrition, Columbia University in New York City. “If I could design the WHI now, I would have had a group whose fat intake was 40% of calories with a significant contribution from olive oil. The Mediterranean diet also puts more emphasis on omega-3 fatty acids; it is high in plant food; low in animal foods; has more whole food; and less processed foods,” she said, adding that there is more to healthful living than dietary choices. Referring to the numerous population studies that showed the Mediterranean diet to be one of the most healthful in the world, Dr. Akabas continued, “People eating the Mediterranean diet at the time of these studies were taking a nap in the afternoon, they didn’t snack all day; they were physically active. And they are on the diet by choice, as opposed to have it imposed on them during a study.”

Doubters Have Reason to Remain Doubtful:

Even the highly motivated women who volunteered for the WHI could not get their fat intake under 20% of calories. (Many critics of the WHI saw this as a sign that a low-fat diet is impossible for Americans.) The best the WHI participants could do was 24% in the first year and 29% in the subsequent years. Since that narrowed the difference between them and the other women who had been assigned to remain on their usual diet, the WHI results were seen by some critics as not proving anything one way or another about the value of the low-fat diet.

The most steadfast proponent of the low-fat diet is Dean Ornish, MD, president of Preventive Medicine Research Institute and clinical professor of medicine at the University of California, San Francisco. The author of several books about reversing heart disease, Dr. Ornish has also co-authored a study that showed regression of severe coronary atherosclerosis after only one year, without the use of cholesterol-lowering drugs. In addition to a low-fat vegetarian diet, the study participants took part in a program of comprehensive lifestyle changes that included smoking cessation, stress management training, and moderate exercise. As yet, Dr. Ornish has not published a clinical trial that proves his program results in lower rates of heart attack or cardiac death.

Other Potential Benefits to Low-Fat Diet

The WHI produced a hint that even small reductions in dietary fat might reduce the risk of developing breast cancer. There was a 9% reduced rate of breast cancer in the women who attempted a low-fat diet, but this was not regarded as statistically significant, though it came close. Dr. Jacques Rossouw, the project officer for the WHI has stated that this finding might have become statistically significant had the trial lasted longer.

CALCIUM AND HIP FRACTURES

Supporting Evidence:

The body needs calcium for strong teeth and bones. That’s a fact. A controversy, however, surrounds the question whether anyone (including children) has to get it from milk or other dairy foods. It was also unclear whether massive increases in calcium intake in middle  age will make any difference in fracture reduction.

Many population or observational studies show an increase in calcium intake in middle age improves bone density, but others show that women with high intake of calcium from diet or supplements actually have higher rates of fractures. Until, the WHI published its results last month, no well-designed clinical trial followed women long enough to prove increased calcium intake in middle age will reduce the rate of hip fractures.

The WHI Findings:

The WHI/calcium plus vitamin D trial involved 36,282 women. The hip fracture rate in those taking calcium plus vitamin D was the same as that of the women taking inactive placebos. One benefit shown in the calcium/vitamin D3 group was a 1% increase in bone density at the hip. Another is a slightly lower risk of hip fracture in one subgroup—women over the age of 60 years at the start of the trial.

Only 70% of the women in the calcium/vitamin D group took their assigned supplements regularly. When the investigators looked solely at this group, they found that these women had 29% fewer hip fractures than those taking placebo. In other words, there were 10 compared to 14 hip fractures per 10,000 women each year.

Furthermore, the supplements did not prevent colon cancer as originally thought, but they slightly raised the risk of developing kidney stones. There were an additional five cases of kidney stones per 10,000 women per year among those on supplements.

Doubts That Remain:

Since the WHI was planned, researchers have begun to view the recommended dose of vitamin D3 (400 international units) as inadequate and the recommended dose of calcium (1200 milligrams) as excessive. The WHI chose to use a daily dose of 1,000 milligrams of calcium and 400 international units of vitamin D3 (cholecalciferol). Last year, an analysis of all clinical trials that looked at the relationship between fractures and vitamin D was published in the Journal of the American Medical Association. It concluded: “Oral vitamin D supplementation between 700 to 800 IU a day appears to reduce the risk of hip and any non-spinal fractures in ambulatory or institutionalized elderly persons. An oral vitamin D dose of 400 IU/day is not sufficient for fracture prevention.”

Doubters Proven Correct (so far):

The two high-profile doubters about the relevance of calcium intake to hip fracture are Walter Willett, MD, Harvard School of Public Health, and T. Colin Campbell, PhD, professor emeritus of nutritional biochemistry at Cornell, who have, respectively, conducted numerous studies on the topic. Both argue that there is too much focus on calcium and too little focus on exercise and vitamin D. Both cite the excessive protein intake in the American diet, primarily from meat as a probable cause of hip fracture (though this was not factored into the WHI).

For the last 25 years, Dr. Willett has been one of the principle investigators of the Nurses’ Health Study, which has spawned scores of nutrition and health related studies including one that found the highest rates of hip fracture among women with the highest calcium intake.

Dr. Campbell directed the Cornell-China-Oxford Project, the most comprehensive project on diet and disease ever conducted. He has observed: “Most of the world’s peoples do not consume cow’s milk, and yet most of the world does not experience the high rates of osteoporosis found in the West. In Asian countries, for example, where consumption of dairy foods is low (and where women tend to be thin and small-boned, universally accepted risk factors for osteoporosis), fracture rates are much lower than they are in the United States and in Scandinavian countries, where consumption of dairy products is considerably higher.”

ESTROGEN AND HEART DISEASE

New Evidence for Women Without a Uterus:

One component of the WHI was designed to test several assumptions about the health effects of hormone therapy by comparing it to a placebo. This trial made international headlines in 2002 because it had to be stopped early. There was a higher rate of heart disease, breast cancer, blood clots, and stroke among the participants who had been taking combination hormones, estrogen and progestin (the latter hormone is necessary only for women with an intact uterus due to estrogen’s ability to increase the risk of uterine cancer). Though the hormone combination was also associated with decreased risk of colon cancer and hip fracture, it is no longer universally recommended as a preventive measure because the risks clearly outweigh the benefits.

Another “arm” of the WHI/hormone study continued to follow the 10,739 participants who had undergone a hysterectomy. All had been randomly assigned to take daily doses of estrogen (0.625 milligrams) or a placebo. Their mean age at entry into the WHI was 63 years. In February 2003, this arm of the WHI was also stopped early due to a higher stroke rate among women on estrogen.

The WHI Findings:

A study that looked at the heart-related WHI findings for the hysterectomy group was published last month in the Archives of Internal Medicine. After about seven years, the rate of heart attack and cardiac death was exactly the same for both the estrogen and the placebo groups. But there was “a suggestion” of a lower heart disease risk only among the women who had started taking estrogen while in their fifties. There was no suggestion of benefit in women who were 60 years or older when they started taking estrogen. Stroke was not taken into account in this particular study.

Doubts that Remain:

Whenever researchers use the word suggestion to describe their results, as in “a suggestion of lower heart disease risk,” they are saying that the findings aren’t clearly established. Despite the breathless headlines that went out across the country heralding the results of this study (“Estrogen May Help Heart”), they could be due to chance, which is how the WHI Web site (see below) describes them. A co-author of this study, quoted frequently in the media, saw the lack of an increased risk of heart disease as reassuring to women who want to take hormones on a short-term basis to alleviate hot flashes.

For More Information:

The WHI is a 15-year project that includes 161,000 women. It is paid for by taxpayer money, and as such, the WHI has been entirely open—via its Web site (www.whi.org)—about its findings both good and bad. The WHI has two major components: a randomized clinical trial (RCT) and an observational study. The RCT section is divided into three additional components: hormones, dietary modification and calcium/vitamin D.

Maryann Napoli, Center for Medical Consumers ©
March 2006

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Probiotics: Research is Promising, But Few Products Can Be Trusted

Posted by medconsumers on January 1, 2006

Many people eat yogurt to protect themselves from antibiotics-induced diarrhea. Others swallow probiotic supplements for the same reason. Either way, the idea is to consume “good” bacteria in order to overcome the tendency of antibiotics to kill good, as well as harmful, bacteria in the gut, throat, and vagina. The public has caught on to the importance of eating microbe-containing foods, especially yogurt, as a way to prevent illness, such as traveler’s diarrhea, and as a way to maintain health. Now many yogurt containers proclaim the presence of “live active cultures,” and it is common to see probiotic capsules side by side with vitamins on the shelves of pharmacies and health food stores. Unfortunately, consumers may be wasting money because most of these products are untested and unproven to contain the necessary amounts of live microorganisms.

Consumer Reports

The problem was highlighted last year in the aftermath of a July 2005 Consumer Reports article featuring probiotics. It described several exciting areas of preliminary research that indicate probiotics could be beneficial to people with digestive disorders like irritable bowel syndrome and food allergies like atopic eczema. Other studies have suggested that probiotics may prevent respiratory infections, urinary tract infections, and precancerous changes that commonly occur in the large intestine. Such studies, however, prove only that one particular microorganism or a specific combination of microorganisms can provide this benefit. Unfortunately, some companies post these research findings on their Web sites implying that their untested products confer the same benefits.

As with all subjects taken on by Consumer Reports, the article ended with a list of products that passed the test-in this case, a list of yogurts, yogurt drinks, and supplements purportedly proven to contain the appropriate amounts of probiotics. But doubts were raised by Mary Ellen Sanders, PhD, president of the International Scientific Association for Probiotics and Prebiotics, in a letter to Consumer Reports (posted on www.isapp.net).

She objected to the article’s conclusion that 18 supplements and nine yogurt products actually contain one billion probiotic units, or colony forming units, the minimum needed for any meaningful health benefit, according to most researchers in this field. Furthermore, just having the right viable count doesn’t mean the product has been shown in a well-designed study to provide a health benefit.

While Consumer Reports was congratulated by Dr. Sanders for highlighting the potential value of consuming the right types of live bacteria and the importance of the dose delivered per serving, its testing methods were questioned. Dr. Sanders’s letter stated that many yogurts and probiotic supplements contain more than one type of bacterium and reporting the total may be misleading to consumers.

Consumer Reports had instructed readers “to pick a product with at least one billion probiotics units,” but that is actually the minimum for each strain of live bacterium in a product. Moreover, the magazine provided only sketchy information about the microbiological methods used to reach their conclusions about the recommended products. Unfortunately, this letter to the editor was not printed by Consumer Reports.

In a telephone interview, Dr. Sanders explained her frustrations with the products on the market that bill themselves as probiotics and/or carry the Live & Active Cultures seal of the National Yogurt Association (NYA). “The problem, in short, is this: with current labeling practices, consumers have no way of knowing if products contain the right number of efficacious probiotic strains. Even if the types are listed on the label, the names used may be inaccurate and the numbers may not sufficient or be what is claimed.”

In an effort to rectify the matter, Dr. Sanders met with officials at the U.S. Pharmacopeia (USP) in May, 2005 to see whether this public standards-setting authority would set the standards for probiotics. “As I understood it, the way the USP functions, it can only respond to a request from industry,” explained Dr. Sanders, “The USP needs a company to come to them and request verification.”

At this point, there is no incentive for a company to make such a request because they claim that consumers are not questioning what is written on the product label. “Things are not going to change until there is a demand from the marketplace,” she said. “What is needed is one or two companies to come forward and have their claims verified independently,” Dr. Sanders continued, suggesting that properly tested products might have a market advantage that would force all competitors to have their products tested.

Similar sentiments were expressed by researcher Gregor Reid, PhD, at the Canadian Research and Development Centre for Probiotics, University of Western Ontario . In a telephone interview he said, “The problem is the majority of the so-called probiotics products out there are unproven, though not harmful.” Even if companies meet the viable count standards that would allow them to be called yogurt, explained Dr. Reid, this would not be enough to call them probiotics. Rather, the specific live bacteria identified on the label must have been proven in a clinical trial to prevent or treat an illness or confer a defined health benefit, he explained. The live bacteria must also be at the same amounts used in the clinical trial.

Dr. Reid, a Professor of Microbiology and Immunology, and Surgery, is also concerned about the lack of incentive for companies to put out a high-quality product. Two companies in Canada pulled their products off the shelf, despite the fact that they had a proven benefit in clinical trials, Dr. Reid said, explaining that one company found it was cheaper to sell an inferior version of its own product. Can consumers trust any probiotic products that have been proven in studies to confer a health benefit? Dr. Reid answered in the affirmative, but the list* is short and none made it into the Consumer Reports article:

  • Culturelle with Lactobacillus GG , a supplement made by ConAgra, prevents and treats diarrhea;
  • VSL#3, made by VSL Pharmaceuticals, Inc. Fort Lauderdale , FL, keeps ulcerative colitis in remission;
  • Activia with Bifidus Regularis TM yogurt, made by Dannon, maintains regularity;
  • Florastor capsules and powder, made by Biocodex , France , maintains intestinal health and normal bowel function in infants, children, and adults;
  • Lactobacillus reuteri (capsules), made by Nature’s Way, treats diarrhea;
  • and Align containing Bifantis TM , made by Procter & Gamble, Cincinnati, Ohio, relieves abdominal pain/discomfort, bloating/distention, and bowel problems.

Dr. Reid has published numerous studies and commentaries about probiotics and owns patents on Lactobacillus strains GR-1 and RC-14. (Both strains are marketed in Europe to maintain the “balance of vaginal flora” under the brand name, Ombe, but this product is not yet available in the U.S. ) He has been working to improve quality and standards for products that claim to be probiotics. For example, the live bacteria in the products should be present for the length of shelf life. And the products should specify the exact strain of live bacteria, for example Lactobacillus acidophilus NCFM TM , as opposed to simply listing Lactobacillus acidophilus on the label.

It should be noted, however, that uncertainties about quality apply to all dietary supplements, including vitamins and herbal products, because this is an unregulated industry. One cannot be sure that any of these products contain what it says on the label because products classified as dietary supplements are not required by the FDA to undergo testing for safety or effectiveness.

When Dr. Sanders was asked what products currently on the market could be expected to be truly probiotics, she prefaced her answer by saying, “I’m not in any better position to answer that question than consumers because there is no third party verification.” Dr. Sanders did, however, single out three products-Culturelle supplements , DanActive TM yogurt drink, and Stonyfield Farm organic yogurt. (The last two products got the highest ratings by Consumer Reports.)

By way of disclosure, Dr. Sanders said that she serves on the scientific advisory board for Dannon, the company that makes DanActive TM , which claims to “naturally strengthen your body’s defense system.” Dr. Sanders points out that DanActive TM appropriately identifies the presence of 10 billion Lactobacillus casei cultures per serving on its label. [Editorial note: two other strains are listed on the label of DanActive TM without mention of the amount of cultures.] Dr. Sanders is not only a consultant for the probiotics industry but also an adjunct research professor at California Polytechnic State University .

While Stonyfield yogurt is one of Dr. Sanders’s three picks for products that appear to be probiotics, she expressed dissatisfaction about companies that do not inform consumers about the amount of live bacteria. “Stonyfield lists the six live active cultures on the label, but the company will not reveal the level of each strain or whether they are still active at the end of shelf life,” she said. “The company says it is proprietary information.”

Probiotics Research at a Turning Point

While there are plenty of reasons to be skeptical about the majority of probiotics on the market, there are also reasons to be optimistic. Dr. Reid spoke of a mindset in the mainstream research establishment that is dismissive of probiotics research and of his frustration about where the lion’s share of the research funding goes. “It’s drugs, drugs, drugs.” But he also reports a sea change in the last few years, much of it related to concerns about antibiotics. “Until a few years ago, we [probiotics researchers] were laughed at by our peers-both scientists and physicians. Now with the problem of resistant antibiotics, there is patient demand, and physicians are starting to pay attention.

” There are a number of reasons why probiotic research has become a hot topic. Despite over 50 years of antibiotics, infectious diseases remain a major cause of death, with gastroenteritis killing a child every 15 seconds. Antibiotics kill normal bacteria as well as good bacteria; hospital-borne infections are not declining; multiple-drug-resistant bacteria continue to emerge as the antibiotic pipeline dries up; pathogenic microbes are being linked with the induction or worsening of many chronic diseases.

“Add to this the pending threat of a deadly flu pandemic. All this has led to consideration of probiotics as one of the possible anti-disease countermeasures. Worried consumers, governments, scientists and industries are looking for new approaches to health restoration and retention. Probiotics have already been shown to alleviate some disease processes, so we need to explore their true potential, as well as understand their limitations.”

* All products can be purchased in the U.S. without a prescription. VSL #3 is available only at www.vslpharma.com or by calling 1(866-GET-VSL3).

Maryann Napoli, Center for Medical Consumers ©
January 2006

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Insomnia Treatments: What Works?

Posted by medconsumers on December 1, 2005

When the U.S. National Institutes of Health convened a State-of-the-Science Conference on insomnia last June, it came down hard on the drugs most people use for this common affliction. The independent panel of experts chosen months before the conference had been given the task of assessing the supporting scientific evidence for the full range of treatments. It concluded that the drugs most often used to treat insomnia—antihistamines and antidepressants—have never been proven effective for this purpose. And though insomnia can persist for decades, the panel found that most prescription drugs approved for this condition have not been carefully evaluated for long-term use. The panel advised greater use of one non-drug approach to sleeplessness, a technique called cognitive-behavioral therapy.

Still, most insomniacs continue to turn to drugs in greater numbers. And the ubiquitous drug advertising campaigns encourage them to do so.

Ambien CR and Lunesta

Eight prescription drugs are approved by the Food and Drug Administration (FDA) for insomnia. Two of them have dominated recently in terms of advertising to the public. Ambien CR is a new extended-release version of Ambien, which has been on the market for 12 years. Ambien is so well known that full-page ads for its new extended-release version are appearing in magazines without mention of what the drug is for. The manufacturer, Sanofi-Aventis, is aggressively selling this new version to hold on to its market share as Ambien is due to go off patent next year. (Ambien was the world’s most popular prescription sleep drug in 2004, accounting for $2.1 billion in sales.)  The full-page ads announce a “Free 7-Day Trial Offer” for Ambien CR. An accompanying coupon falls out of the magazine that people are encouraged to bring to their doctors for a starter kit of free pills.

It’s good to keep in mind when reading such ads that omitting the purpose of the drug allows the manufacturer to avoid identifying the harms associated with the drug and the warning that it is only for short-term use. One would have to read the packet insert, or what the FDA calls the label (for access, see page 3) to learn about adverse effects that include abnormal thinking, behavior changes, anxiety, memory loss, and addiction. Companies that make sleeping pills assert that these reactions can occur in a small number of people who take any drug in this class known as sedative/hypnotics. All drugs in this class are also known to cause what the manufacturers prefer to call “dependency,” when taken for more than a few weeks.

Ambien CR purportedly has the advantage of keeping people asleep longer. Although short-term use is never spelled out, the packet insert indicates just how brief the FDA-required trials were. Only two trials were performed to demonstrate efficacy. Both were only three weeks in duration, and assessments were conducted after two weeks of treatment.

Lunesta, which came on the market last April, is the strongest rival to Ambien. So far, it is the only prescription sleep medication approved by the FDA for long-term use. Even so, its manufacturer, Sepracor, is explicit in the fine print of its magazine and newspaper ads, stating, “It [insomnia] usually requires treatment for only a short time, usually 7 to 10 days. If your insomnia does not improve after 7 to 10 days of treatment, see your doctor, because it may be a sign of an underlying condition.”

The packet insert for Lunesta has this summary of clinical trial findings without quantifying how much sleep improvement people can expect from this drug: “Lunestra significantly improved sleep latency and improved measures of sleep maintenance (objectively measured as wake time after sleep onset and subjectively measured a total sleep time).”  And here’s a key warning that might be overlooked “Be aware that you may have more sleeping problems the first night or two after stopping any sleep medication.”

Lunesta and Ambien CR  pose the risk of a form of memory loss known as “traveler’s amnesia.” This can occur during an airplane flight when the person wakes up before the effect of the medicine is gone. The drug should be avoided in such a circumstance when it is impossible to get a full night of sleep. Both Lunesta and Ambien CR carry the warning not to drink alcohol. And both drugs should be taken in the smallest effective dose by people over age 65 years.

Short-Term Use of Prescription Sleep Drugs

Suppose you are one of those rare older people who use sleep medicines appropriately—no more than ten days. What are the benefits and harms of short-term use? A team of Canadian researchers led by Jennifer Glass, PhD, University of Toronto, conducted an analysis of all studies in which people over the age of 60 years had been given one of the standard prescription drugs for insomnia, including Ativan, Xanax, Restoril, Dalmane, Ambien, and Sonata. Altogether, the analysis included 24 studies involving 2,417 participants who had taken either a placebo (sugar pill) or one of the above prescription drugs. To be included, the studies had to assess any of the above drugs taken for at least five consecutive nights for insomnia. Findings were published last month in the British medical journal, BMJ.

  • The drugs were associated with harms that are particularly detrimental to older people, such as cognitive effects, falls, and ataxia (inability to coordinate the muscles in voluntary movement);
  • adverse cognitive effects were five times more common in people on a drug than in those on the placebo;
  • daytime fatigue was nearly three times more common in people taking a drug;
  • and the drugs provided only marginal improvements.

Dr. Glass and colleagues concluded that the short-term benefits of these drugs may not justify the increased harm, especially to older people who are already at risk for adverse cognitive reactions.

Other Approaches to Sleeplessness

The panel of experts at the State-of-the-Science Conference identified antihistamines as the most commonly used over-the-counter treatment for insomnia. But there is no systematic evidence to demonstrate effectiveness and there are significant concerns about risks, according to the panel. The adverse effects include “residual daytime sedation, diminished cognitive function, and delirium, the latter being of particular concern to the elderly.”

Alcohol does reduce the time it takes to fall asleep, but large amounts will result in poorer quality sleep and awakening during the night. Melatonin, a natural hormone that can be purchased over the counter, is better for jet lag than insomnia. Furthermore, there is no information about the safety of long-term use.

The panel also assessed alternatives to drugs, such as tai chi, yoga, acupuncture, and light therapy. All were deemed potentially useful, but inadequately evaluated. Only one non-pharmacological approach to sleeplessness, called cognitive-behavioral therapy (CBT), was judged to have been proven effective in moderate to high-quality trials that compared it to drug therapy. This form of therapy was shown to be as effective as prescription drugs are for short-term treatment of insomnia minus the risks.

CBT was described by the panel as “cognitive restructuring in which anxiety-producing beliefs and erroneous beliefs about sleep and sleep loss are specifically targeted.” The treatment involves a series of visits to a therapist trained in this method, a prospect that might be  out of reach for many people.

To explore a lower cost, self-help version of CBT that involves $35 and access to the Internet, go to www.myselfhelp.com, which describes itself as funded in part through a series of Small Business Innovative Research Grants from the National Institute of Mental Health, National Institutes of Health, Department of Health and Human Services.

How to Obtain the Packet Insert, aka Drug Label

The packet insert, also known as the drug label, is produced by the drug’s manufacturer with FDA oversight. It is intended for the prescribing physician and is entirely different from the pharmacy-generated drug information.  Only the packet insert has complete information on the drug, including what was proven in the FDA-required clinical trials. It is distinctive in its fine print and length (@20-40 pages), as opposed to the consumer friendly format of the usual pharmacy-generated drug information. The packet inserts of many drugs contain both a professional and a patient version. Read both.

There are several ways to obtain the packet insert. Ask  the pharmacist for a copy when purchasing the drug; go to the public library and consult the Physicians’ Desk Reference; visit the FDA’s Web site (www.fda.gov) and  click into the following sections: drugs,  drugs@FDA, the drug’s name, and finally, drug label. And sometimes this works best: perform a google search with the drug’s name plus the word label.

Maryann Napoli, Center for Medical Consumers ©
December 2005

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Colds & Flu: What Works?

Posted by medconsumers on October 1, 2003

By Maryann Napoli

We took this question to the Cochrane Library and found positive results for high doses of vitamin C, the herbal remedy called Echinacea, and enough evidence to suggest that zinc lozenges merit more research. The Cochrane Collaboration (CC) is an international network of experts from different fields who examine the quality of medical research to help consumers determine which treatments have scientific evidence of efficacy.

Vitamin C
The CC reviewed 30 trials; most of them tested both the preventive effect of maintenance doses (10-30 mg/daily) of vitamin C as well as the therapeutic effect of taking high doses once a cold developed. In all of the trials, adults and children had been randomly assigned to take vitamin C or a placebo. Though the combined results of these trials showed no preventive benefit to vitamin C, the CC reviewers did find an exception. People who were malnourished and/or under heavy physical stress did, in fact, had a lower number of colds taking maintenance daily doses of C.

As for stopping a cold once it appeared, the CC reviewers found a “clear effect on the duration of symptoms” in people who began taking high doses of vitamin C at the first sign of a cold, as well as a reduction in severity. This finding was judged “modest but certainly not trivial.” The study participants began taking incremental doses of vitamin C in the 1-3 gram range, which would not be considered high enough by the late Linus Pauling, the leading proponent of this treatment. In a 1987 interview, Dr. Pauling told this reporter that people should begin taking vitamin C at the first sign of a cold and continue taking it to their level of tolerance. To Dr. Pauling, high doses will eventually reach the realm of 20 grams for adults. (In its powdered form, vitamin C is measured in grams, rather than milligrams.) The level of tolerance differs from person to person, but Dr. Pauling said it is reached once diarrhea begins.
The CC reviewers left the door open for the possibility that the doses were not high enough in these trials, concluding “dose response clearly requires further research…incremental doses as high as 8 grams daily may heighten the therapeutic effect.”

Echinacea
Echinacea is an herb believed to be an immune stimulant. The CC located 16 clinical trials in which people with colds had been given either this herb or a placebo. Half the trials looked at preventing colds, and the other half looked at treatment. The CC found that the majority of the trials reported positive results for both prevention and treatment. There was not enough evidence to recommend a specific Echinacea product, however. Echinacea is sold in a variety of forms, ranging from powdered root to tinctures. Many of the trials assessed by the CC combined Echinacea with vitamin C or other herbs. In Germany alone, the CC found that there are 200 different Echinacea products on the market.

Zinc
Zinc lozenges have been pitted against placebos in seven clinical trials. Though the CC found the results to be inconclusive, zinc showed enough potential to indicate that further research is warranted.

Antibiotics
Many consumers and doctors think that antibiotics are appropriate treatment for a cold because they will prevent the development of a bacterial infection. The CC found nine clinical trials with the combined total of 2,157 participants who range in age from two months to 79 years. All of the participants had been randomly assigned to take antibiotics or a placebo once a cold had been diagnosed. No benefit was found for antibiotics and they were associated with a significant increase in adverse effects, such as rash, vomiting, and diarrhea.

For More Information:
Access to the Cochrane Library is on a subscription-only basis, but the abstracts or summaries of the reviews are freely available at www.cochraneconsumer.com.

Maryann Napoli is the associate director of the Center for Medical Consumers in New York City.
October 2003

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Ultimate Fitness

Posted by medconsumers on July 1, 2003

New Book: Ultimare Fitness–The Quest for Truth about Exercise and Health By Gina Kolata

In Ultimate Fitness, Gina Kolata, a science reporter for The New York Times, applies her investigative-journalist skills to the science–and too often, the pseudoscience–behind the fitness training advice aimed at helping us look good, be healthy, and maybe even live longer.

Kolata brings us back to the early 20th century when most physicians thought “an enlarged and irregular heart with murmurs was a diseased heart.” In those days, an enlarged heart was called athlete’s heart — clear evidence of the harm caused by too much strenuous exercise. As recently as 30 years ago, heart attack patients were warned never to do anything that made their hearts beat fast, and everyone who reached middle age was advised to begin taking it easy. Physician-created fears about the dangers of running and other strenuous exercise prevailed right up to the exercise “boom” of the early 1970s.

The book covers the fitness revolution that began with jogging, and before we knew it, there were aerobics classes, health clubs, body sculpting, performance-enhancing supplements, and StairMasters. But, given the sedentary nature of most Americans, the scientific question eventually became: What is the least amount of exercise we have to do and still get a health benefit?

In time, studies showed that moderate exercise like walking for 20-30 minutes three times a week could reduce the odds of premature death in men and women. Even better, the exercise did not have to take up 20-30 consecutive minutes; it could be, for example, a couple of minutes of stair climbing in the morning and 20 minutes of walking after work. Kolata expresses her own surprise at finding that the proven health benefit of moderate exercise accrues solely to the heart. Don’t expect to lose weight, the prime reason why most people exercise.

It is the vigorous workouts that are Kolata’s personal favorites. An avid exerciser, fully qualifying as an off-the-charts gym rat, Kolata hits her stride in this book when she takes on the conventional health wisdom surrounding health clubs, performance enhancing programs, and the latest workout tools. When her daughter became certified as a fitness trainer, Kolata got a firsthand over-the-shoulder look at the process and found it to be more about paying escalating fees than actual training on the proper use of weights and health club machines.

Weight lifting, long the province of men who want strength and large muscles, has been taken up in recent years by women who also grew strong, though not large-muscled. Kolata found no evidence to support the claim that strength training will reduce the risk of osteoporosis-related fractures, though it might cut down on the hip-breaking falls by strengthening muscles and improving stability. Don’t bother trying to spot reduce your thighs on that favorite machine of women at every gym. You can’t spot reduce the fat, says one interviewed expert, though you can spot increase the size of a muscle.

Once she began wondering about those maximum heart rate charts found on the wall at every gym, Kolata might have become the first science reporter to look for the evidence to support the standard formula that is programmed into exercise machines at health clubs and is used in the standard doctor-ordered treadmill test. She found that the interpretation of heart rates to be “mired in myths and misconceptions, in pseudo-science and marketing .”Is there such a thing as a fat-burning zone?

The formula that shows you the maximum number of heartbeats per minute for someone your age seems to have been uncritically accepted ever since the exercise movement began in the early 1970s. Kolata traced its origins to an old, poorly designed study. And the first successful commercialization of the formula was attributed to a Finnish company that continues to sell heart monitors, not to professional athletes but regular people who use them while working out.

Throughout the book, Kolata’s skepticism is balanced by her obvious love of exercise, especially the test-your-limits extreme sort. She works out regularly for the pure euphoric pleasure of it all and because strenuous exercise is an invigorating antidote to the long hours spent at a sedentary job, a sentiment echoed by many of her fellow gym rats when asked about their motivations.

This book will be of interest to exercisers of all kinds…including those who plan to join them some day.

Maryann Napoli, Center for Medical Consumers(c)

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Osteoarthritis Treatments

Posted by medconsumers on May 1, 2003

By Maryann Napoli

There is no effective treatment for osteoarthritis (OA), a chronic degenerative joint disease that afflicts most people to some degree by the time they reach the age of 70. A wide range of options, however, are available to people looking for symptom relief. Most of the OA studies have concentrated on the hip and knee, the weight-bearing joints most likely to cause pain and disability.

Exercise:
People with knee OA can benefit from exercise, in terms of pain relief and improved function, according to a review of 17 studies conducted by the Cochrane Collaboration (see below). Of the combined total of 1,492 people who participated in the studies, those doing some form of exercise, be it walking or muscle-strengthening exercises, were better off than those who did not. However, the effect of exercise overall was found to be quite small. The reviewers did not find enough good quality studies to determine a benefit to people with hip OA.

After this Cochrane Review was completed, a newly published study called into question the standard thigh-muscle strengthening advice given to people with knee OA ( Annals of Internal Medicine , 4/15/03). It found that quadriceps muscle strengthening might actually be counterproductive to people whose knees are misaligned or unusually loose. Leena Sharma , MD, and colleagues at Northwestern University, Chicago, followed 230 people with knee arthritis who experienced difficulty with knee-related activities After 18 months the x-rays showed that OA progressed in the people with greater quadriceps muscle strength. Worsening of arthritis was defined as more joint space narrowing on knee x-rays. These results do not mean that exercise is bad for people with knee OA, only that the muscle-strengthening regimen for those with misaligned or loose knee joints might be reconsidered. This study did not assess the participants’ symptoms.

Drugs:
In the March 2003 issue of Current Opinion in Rheumatology, Bischoff and Roos noted that exercise will provide a “small to moderate benefit” in terms of pain and improved function to people with hip and/or knee arthritis. And the “small to moderate benefit,” they wrote, also applies to the non-steroidal anti-inflammatory drugs (NSAIDs) commonly prescribed for osteoarthritis. NSAIDs encompass a wide range of popular over-the-counter and prescription drugs, including aspirin, Ibuprofen, Motrin, Naprosyn, Mobic, Celebrex, and Vioxx.

Acetaminophen (Tylenol) used to be singled out as the most effective OA drug, but a recent review found NSAIDs to be superior to acetaminophen in reducing pain and overall disease activity. The review conducted by the Cochrane Collaboration involved six randomized controlled trials; it also found NSAIDs were not better than acetaminophen in improving joint function. And there is no consistent evidence to show that any one NSAID stands out among the rest. A survey, published in 2000, found that most people take many different drugs for OA. The majority found a NSAID to be more “helpful” than acetaminophen, though many reported taking a NSAID and acetaminophen.

All NSAIDs and acetaminophen (in high doses) are associated with gastrointestinal bleeding which accounts for an estimated 70,000 hospitalizations and 10-15,000 deaths each year in the U.S. Only one in five people who develop this adverse reaction will have symptoms in advance. Gastrointestinal bleeding occurs in 1% of everyone who takes NSAIDs for three to six months, and in 2-4% of those taking NSAIDs for one year. The risk increases accordingly in those who take the drugs for longer periods of time.

The newest, most expensive NSAIDs—Celebrex, Vioxx, Bextra, which are from a drug class called COX-2 inhibitors—are no more effective as painkillers than other NSAIDs, though they may lower the risk of gastrointestinal reactions. The Food and Drug Administration (FDA) ruled that uncertainties remain about this advantage because many of the study participants in the pre-approval trials were not representative of the people who typically take NSAIDs. For example, 40% of the participants in the Celebrex studies had an endoscopic examination that ruled out the presence of ulcers prior to participation. Also, many of the study participants taking COX-2 inhibitors were also taking low doses of aspirin to prevent heart attacks, thereby reducing any stomach-protective benefit. Elderly people, particularly those who are debilitated, and those with ulcers should not take these drugs for OA, nor should anyone with heart disease.

Most NSAID studies pit a drug against a placebo and follow people only about 12 weeks. Some have compared a COX-2 inhibitor with another NSAID and have found their pain-relief benefit to be equivalent. In one Vioxx study, however, the people taking COX-2 inhibitors had twice the rate of heart attacks as those taking Naproxen.

Glucosamine:
Glucosamine is a natural substance classified by the FDA as a dietary supplement, which means that it is available over-the-counter without the safety and efficacy testing required of drugs. Furthermore, there is no quality control so consumers cannot count on the supplement containing the ingredients or the amount listed on the label. Studies conducted with glucosamine in standardized doses show that it is safer than OA drugs and just as effective in alleviating pain. Most intriguing, glucosamine appears to slow the progression of OA.

The Cochrane Collaboration reviewed 16 randomized, controlled trials ( RCTs ) and evaluated the effectiveness and safety of glucosamine for people with OA. In 13 RCTs in which glucosamine is compared to a placebo, glucosamine was found to be superior in all but one trial. In the four RCTs in which glucosamine was compared to a NSAID, glucosamine was found to be superior in two and equivalent in two. This review concluded that further research is needed to confirm the long-term effectiveness and safety of glucosamine. Few of the RCTs lasted more than six weeks. Glucosamine appears to be far safer than NSAIDs and acetaminophen—based on the mostly short-term results of these RCTs .

One RCT in this review found that the people taking a placebo showed a progressive joint-space narrowing that did not occur among those taking glucosamine. Symptoms worsened slightly in the placebo group, but the significant lessening of pain and disability was sustained for three years among those taking glucosamine.

Ultrasound, Electromagnetic Fields, etc.:
Electrical stimulation therapy had a small to moderate effect on knee OA, according to three studies with a total of 259 people who had been randomly assigned to this treatment or a placebo. Transcutaneous electrical nerve stimulation, also known as TENS, was shown in seven trials to provide significant improvement in knee stiffness and pain relief. Ultrasound therapy had no benefit over placebo or short wave diathermy in three clinical trials.

Herbal Medicine:
The Cochrane Collaboration conducted a review of the evidence for herbs and plant substances and found two studies that showed avocado/soybean oil extract had beneficial effects on joint function, pain, and reduced need for NSAIDs, and general well-being. The symptomatic relief persisted even after discontinuation. Results were better with hips than knees. The former involves more chronic and continuous inflammation and pain, whereas the latter is more likely to consist of flare-ups. Avocado/soybean extract is sold as a dietary supplement in the U.S. under the brand name of AvoFlex .

Rub-on Creams:
Rubbing liniment, such as capsaicin cream, into the skin around the joint will stimulate blood flow and create warmth, which may temporarily reduce pain and improve function.

What is the Cochrane Collaboration?
The Cochrane Collaboration is an international network of over 6,000 researchers, epidemiologists, physicians, consumer advocates, scientists, and statisticians in over 60 countries. Most are based at universities and medical centers. Their work is divided into review groups, according to topic (e.g., breast cancer, pregnancy and childbirth, complementary medicine).

Each review group conducts systematic reviews of all available research on a specific treatment, such as “Glucosamine Therapy for Treating Osteoarthritis.” The goal is to help doctors and consumers make informed decisions by answering the question: Is there high-quality evidence to show that this treatment is effective and safe?

Most of the information in this article came from the Musculoskeletal Review Group whose Web site (www.cochranemsk.org) offers free access to summaries (abstracts) of existing reviews intended for health professionals. For more consumer friendly summaries, go to www.cochraneconsumer.com to read Cochrane abstracts on a range of medical topics.

Maryann Napoli is the associate director of the Center for Medical Consumers in New York City.
May 2003

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Links: Alternative Medicine & Nutrition

Posted by medconsumers on January 1, 2000

Center for Science in the Public Interest (CSPI)
CSPI is a nonprofit education and advocacy organization that focuses on improving the safety and nutritional quality of food. Their Web site offers information on food additives, substitutes and advice on improving you and your children’s diet. CSPI is the publisher of Nutrition Action Healthletter.

The National Center for Complementary and Alternative Medicine
The National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health (NIH) is dedicated to exploring complementary and alternative healing practices in the context of rigorous science; training CAM researchers; and disseminating authoritative information.

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