Consumer Health Digest, Issue #47 (original) (raw)

Consumer Health Digest is a free weekly e-mail newsletter edited by William M. London, Ed.D., M.P.H., with help from Stephen Barrett, M.D., It summarizes scientific reports; legislative developments; enforcement actions; other news items; Web site evaluations; recommended and nonrecommended books; research tips; and other information relevant to consumer protection and consumer decision-making. The Digest’s primary focus is on health, but occasionally it includes non-health scams and practical tips. Items posted to this archive may be updated when relevant information becomes available. To subscribe, cli ck here.

High-quality evidence for acupuncture still lacking. Researchers have systematically reviewed systematic reviews, published from 2013 to 2021, on the use of acupuncture in adult health conditions. They identified 434 systematic reviews of which 82 assessed the certainty or quality of evidence of their conclusion and could be included in “evidence maps” to depict the evidence for acupuncture’s safety and effectiveness for particular health conditions. Evidence maps for 19 adult health conditions were created. [Allen J. and others. Use of acupuncture for adult health conditions, 2013 to 2021: A systematic review. JAMA Network Open, Nov 23, 2022] The researchers concluded:

There is a vast literature of original randomized trials and systematic reviews of randomized trials of acupuncture as a treatment for dozens of health conditions. Despite this, the number of conditions for which authors of systematic reviews have concluded that there is at least moderate-certainty evidence regarding health outcomes associated with acupuncture was modest, and most of these involved comparisons of acupuncture with sham or control acupuncture and mostly for painful conditions. The evidence that acupuncture causes adverse health effects was rare, and reviews that compared acupuncture with usual care and included conclusions about adverse effects all concluded that acupuncture was at least as safe or safer than usual care.

Edzard Ernst, M.D., has blogged repeatedly about why acupuncture research reports originating in China should be regarded with great skepticism. Among other things, investigations have found many such reports are based on faked data. [Ernst E. More compelling reasons for distrusting Chinese research papers. Edzard Ernst Blog, Dec 3, 2022]

American Heart Association evaluates “alternative” treatments for heart failure. A new American Heart Association scientific statement outlines research on complementary and alternative therapies for heart failure. It estimates that more than 30% of people with heart failure in the U.S. use federally unregulated complementary and alternative medicine products. [Chow S. and others. Complementary and alternative medicines in the management of heart failure: A scientific statement from the American Heart Association. Circulation, Dec 8, 2022] Some findings were discussed in a news release. [Some benefits, potential risks with alternative medicines for heart failure. American Heart Association news release, Dec 8, 2022] These include:

Vitamin D supplementation hasn’t shown benefit and may be harmful when taken with heart-failure drugs.
Blue cohosh might cause a fast heart rate (tachycardia), high blood pressure, chest pain, and increased blood sugar.
Lily of the valley may cause irregular heartbeat, confusion, and tiredness; it may cause very low potassium levels when taken with digoxin.
Thiamine supplementation in the absence of thiamine deficiency isn’t shown to be effective.
Coenzyme Q10 supplementation is of uncertain value.
It’s not clear whether the potential benefit of vitamin E or Hawthorn exceeds the potential for harm.
“Yoga and Tai Chi, in addition to standard treatment, may help improve exercise tolerance and quality of life and decrease blood pressure.”
“Omega-3 polyunsaturated fatty acids (PUFA, fish oil) have the strongest evidence among complementary and alternative agents for clinical benefit in people with heart failure and may be used safely, in moderation, in consultation with their health care team. Omega-3 PUFA is associated with a lower risk of developing heart failure and, for those who already have heart failure, improvements in the heart’s pumping ability. There appears to be a dose-related increase in atrial fibrillation (an irregular heart rhythm), so doses of 4 grams or more should be avoided.”

Ban on naturopath treating autism with fecal transplants upheld. A British Columbia Supreme Court judge has upheld a ban that prevents naturopath Jason Klop from manufacturing, advertising, and selling pills and enemas made from human feces for use on autistic children. [Lindsay B. Judge upholds order banning B.C. naturopath from making fecal transplants for autistic kids. CBC News, Dec 6, 2022] Klop was the subject of an August 2021 action from the College of Naturopathic Physicians of B.C. that prohibits him from producing and marketing fecal microbiota transplants (FMT) while he is under investigation because of complaints about his business. Klop had been charging parents about $15,000 US for autistic children as young as two years old to receive the unproven treatments, mainly at a clinic in the Mexican city of Rosarito. His services later became available in Hungary, Australia, and Panama. FMT is approved in Canada and the U.S. but only for the treatment of recurrent C. difficile infection that hasn’t responded to other therapies. FMT can lead to serious infection or even death if not performed under the strictest of conditions.

FDA announces enforcement priorities for homeopathic products. The U.S. Food and Drug Administration has issued a final guidance describing the agency’s approach to prioritizing regulatory actions for homeopathic products marketed in the United States. [Homeopathic drug products: Guidance for FDA staff and industry. FDA Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, December 2022] The FDA has developed a risk-based approach to enforcement that gives priority to homeopathic products that potentially pose a higher risk to public health. These are products that:

have reports of injury that, after evaluation, raise potential safety concerns
contain or purport to contain ingredients associated with potentially significant safety concerns
are not intended for oral or topical use, such as injectable products or products to be administered to eyes
are intended for prevention or treatment of serious and/or life-threatening diseases or conditions
are intended for vulnerable populations such as immunocompromised individuals, infants, children, the elderly, and pregnant women
have significant quality issues such as contamination with foreign materials or objectionable microorganisms and/or are made in facilities with significant deviations from Current Good Manufacturing Practice requirements

Most homeopathic products fall outside of these categories. No homeopathic products are FDA-approved, and there is no reason to believe they are effective. [Barrett S. Homeopathy: The ultimate fake. Quackwatch, Aug 25, 2016] Previously, the FDA warned the public about certain homeopathic products that contained a toxic substance or were recalled due to contamination. Instructions for public comment on the guidance document are available in the Federal Register.

Nonsurgical body sculpting spotlighted. The U.S. Food and Drug Administration (FDA) has published a consumer information page describing the uses and risks of several nonsurgical body-contouring or body-sculpting procedures that are offered to change the shape of various areas of the body: (a) fat freezing (cryolipolysis), (b) radiofrequency energy heating, (c) laser or intense pulsed light (IPL) to heat tissue, (c) ultrasound, (d) photobiomodulation (low-level light), (e) pulsed magnetic fields, and (f) massage or vibration. [Non-invasive body contouring technologies. FDA, Dec 7, 2022] The page offers tips to consumers considering these procedures.

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