SEPTEMBER-OCTOBER 2016 NEWS

Best of the blogs, September – on Science-Based Medicine, Jann Bellamy critiqued the National Acupuncture Detoxification Association (NADA) protocol, noting that “…more rigorous trials failed to support the initial weak evidence in its favor, either as a primary or adjunctive treatment for addiction itself or related symptoms. It is an elaborate placebo masquerading as an effective adjunct treatment for addiction.” She also discussed studies (funded by the National Center for Complementary and Integrative Health (NCCIH)) of sauna "detoxification", performed at naturopathic Bastyr University. Sweating does not accomplish anything useful as far as “detoxification,” and can even “impair your body’s natural detoxification system.” While leeches “have legitimate medical uses, primarily to aid in reattachment of digits,” Mark Crislip found little evidence in support of leech therapy for treatment of osteoarthritis or other uses. Scott Gavura provided an analysis of oxygen water; he noted that “The amount of oxygen in just one breath is vastly higher than the theoretical oxygen supplied by any oxygenated water.” David Gorski criticized a review by the NCCIH on complementary methods for pain. He found that the evidence for the “non-pharmacological approaches” was far from convincing; “this review is most consistent with none of them working for chronic pain.” Moreover, the proposal to do pragmatic trials of methods that have not been shown to work in more rigorous trials is “putting the cart before the horse.” Harriet Hall noted that Alternative Medicine Is Infiltrating Veterinary Continuing Education. “This is a horrible proposal. It would allow veterinarians to get 2/3 of their continuing education credits from courses based on fantasy rather than on science.” She also discussed "glyconutrients", as marketed by Mannatech and promoted by Dr. Ben Carson: “There is no credible evidence behind the claims for ‘glyconutrients.’ ‘Glyconutrients’ is not even an accepted scientific category. Mannatech is marketing a myth.” Clay Jones discussed Belly Button Healing, “acupressure with a gimmick device and a silly underlying philosophy that attempts to connect the magic of TCM with the science of the enteric nervous system…there is no reason to believe that manipulation of the belly button would yield systemic benefits as described on the products website.” Steven Novella criticized ultraviolet blood treatment. “Here we have practitioners who are charging thousands of dollars for a treatment without evidence that it is safe or effective, making claims not backed by evidence, and conducting worthless research without proper oversight or transparency, but this is all somehow alright because they are ‘alternative’ or ‘natural’."

On Respectful Insolence, “Orac” discussed “Right to Try” legislation in two posts. On Sept. 8, he noted that “Their purpose is not…to help patients, but rather to weaken and ultimately neuter the FDA’s power to regulate drug approval and thereby help to usher in a libertarian utopia in which drugs don’t need approval and the free market magically guarantees safety and efficacy through various ‘independent’ testing labs.” On Sept. 30, he reported signing of the law in California but blockage of a federal bill. He provided a critique of Vitastiq, which is claimed to be able to measure electrical conductance at acupuncture points and “measure the levels of 30 different nutrients, vitamins, and minerals.” As part of a series of posts on “quackademic medicine,” he criticized the promotion of unscientific methods by Stanford University. He found serious flaws with the newly funded second Trial to Assess Chelation Therapy (TACT2). A later post (Oct. 4), as well as a story by Salzberg in Forbes, also discussed the trial.

Edzard Ernst dismissed the idea of homeopathy as a substitute for immunizations: “Let’s be blunt: homeopathy is bogus - but homeoprophylaxis is worse, much worse!” He critiqued two studies supposedly showing the value of the homeopathic anti-viral agent Engystol®. Two other studies, including Deepak Chopra as one of the authors, purported to show the benefits of Ayurvedic-based interventions on well-being and gene expression; these were found to be highly flawed. He applauded the Royal Australian and New Zealand College of Obstetricians and Gynaecologists for recommending that chiropractic not be used to treat unborn children, such as for breech correction or to reduce the risk of caesarean delivery. In summarizing a recent review, he found “no reason why OMT [osteopathic manipulative treatment] should work for gynaecological conditions, and I am not in the least surprised to read that there is no clinical evidence for this notion.”

September – Nahin et al. examined complementary approaches for pain management (Mayo Clin. Proc. 91(9):1292-1306 (2016) Paper). They concluded that “current evidence suggests that the following complementary approaches may help some patients manage their painful health conditions: acupuncture and yoga for back pain; acupuncture and tai chi for OA [osteoarthritis] of the knee; massage therapy for neck pain with adequate doses and for short-term benefit; and relaxation techniques for severe headaches and migraine. Weaker evidence suggests that massage therapy, SM [spinal manipulation], and osteopathic manipulation might also be of some benefit to those with back pain, and relaxation approaches and tai chi might help those with fibromyalgia.” The paper was discussed by Abasi (JAMA 2016; 316(22)2343-2344 Abstract).

September – Heidemann and others described seven patients suffering liver injury as a result of taking OxyELITE Pro, “a multi-ingredient nutritional supplement used by many individuals as a weight loss and energy-enhancing aid” (Dig. Disc. Sci. 61(9):2741-2748 (2016) Abstract).

September – A review of dietary supplements for treatment of tinnitus (Coelho et al., Am J Audiol. 2016 Sep 1;25(3):184-205 Abstract) concluded, “The use of dietary supplements to treat tinnitus is common, particularly with Ginkgo biloba, lipoflavonoids, magnesium, melatonin, vitamin B12, and zinc. It is likely that some supplements will help with sleep for some patients. However, they are generally not effective, and many produced adverse effects. We concluded that dietary supplements should not be recommended to treat tinnitus but could have a positive outcome on tinnitus reactions in some people.”

September – Eichner and others investigated “Banned and discouraged-use ingredients found in weight loss supplements” (J Am Pharm Assoc (2003). 2016 Sep-Oct;56(5):538-43 Abstract). They purchased weight loss supplements in retail stores near Denver. “At least one banned ingredient was found to be listed on the product labels in 17 of the 51 studied supplements (33%). At least one discouraged-use ingredient was found in 46 of the 51 products (90%). Retail outlet stores dedicated to supplements and sports nutrition alone were found to have the greatest number of weight loss supplements that included banned and discouraged-use ingredients.”

September 1 – Greenlee and others studied “Association Between Complementary and Alternative Medicine Use and Breast Cancer Chemotherapy Initiation” (JAMA Oncol. 2016 Sep 1;2(9):1170-6 Paper). They found that users of dietary supplements were less likely to begin recommended chemotherapy. “Orac” discussed the study on Respectful Insolence.

September 1 – Kligler, Teets, and Quick published “Complementary/Integrative Therapies That Work: A Review of the Evidence” (Am Fam Physician. 2016 Sep 1;94(5):369-374 Abstract). They concluded that “Acupuncture is effective in the management of chronic low back pain. Mind-body interventions such as cognitive behavior therapy, yoga, tai chi, qi gong, and music therapy may be helpful for treating insomnia. Exercise can reduce anxiety symptoms. Herbal preparations and nutritional supplements can be useful as first-line therapy for certain conditions, such as fish oil for hypertriglyceridemia, St. John's wort for depression, and Ginkgo biloba extract for dementia, or as adjunctive therapy, such as coenzyme Q10 for heart failure. Probiotic supplementation can significantly reduce the likelihood of antibiotic-associated diarrhea.”

September 2 – Apaydin and others published “A systematic review of St. John’s wort for major depressive disorder” (Syst Rev. 2016 Sep 2;5(1):148 Paper). They concluded that “SJW monotherapy for mild and moderate depression is superior to placebo in improving depression symptoms and not significantly different from antidepressant medication. However, evidence of heterogeneity and a lack of research on severe depression reduce the quality of the evidence.” Edzard Ernst commented on the review, referring to St. John’s wort as “the biggest success story of alternative medicine.” However, he cautioned that “we need to keep an eye on the interaction issue. As a sole treatment, SJW is much safer than conventional antidepressants. But if a patient takes other medicines, we ought to be very careful.”

September 6 – An article by Belluz was entitled "Amazon is a giant purveyor of medical quackery". Among the questionable offerings are treatments for cancer, “immune system boosters,” and oxytocin products.

September 8 – A Story by Ledford described proposed FDA guidelines “to rein in rogue stem-cell clinics” (Nature. 2016 Sep 8;537(7619):148). Steven Novella discussed the issue on Science-Based Medicine. “The current rise of dubious stem cell clinics is a serious problem, but it is also a symptom of a far deeper and more serious problem – a destructive yet alluring narrative that there are many miraculous cures out there waiting for you, once the pesky government regulations are out of the way.”

Stem cell clinics were also discussed in two articles by Wagner of San Diego’s KPBS. Part 1 was entitled “Patients Turn To San Diego Stem Cell Companies For Costly, Unproven Treatments” and focused on Stemedica. Stem cell scientist Jeanne Loring, a critic of the clinics, was quoted: “’It’s not a terrific idea to be putting stuff that you don’t know very much about into people and expecting it to work.’…if a stem cell company truly is helping patients make remarkable recoveries, they should prove it by publishing their results.” But “Stemedica could not provide published data from any of its human trials.” Part 2 examined Stemedica’s leadership and found some claimed credentials could not be verified. Moreover, three of its executives were previously involved in selling Penta water, for which absurd claims were made. David Gorsky also revisited the topic on Science-Based Medicine (see our Aug. 4 item in July-August 2016 News). “It just takes more than what I’ve seen so far to convince me that stem cells are indeed the miracle that Stemedica and other companies doing the stem cell hard sell tell us they are.”

September 20 - An article in the New York Post by Ridley was entitled “I was an anti-vax crackpot – until this happened,” telling the story of a mother whose daughters came down with rotavirus. This led her to research the benefits of vaccination.

September 22 – Opar wrote “The Dangers of Snake-Oil Treatments for Autism” for The Atlantic. “Parents are enticed by alternative therapies that promise to do everything from improving social interactions to restoring speech. But there’s no scientific evidence to support these purported benefits. Few of these therapies have been adequately tested for safety or efficacy, many come with a hefty price tag, and some are downright dangerous.” (See also June, 2016 item below.)

September 26 – Hermes published an article on UVLrx, a device that “delivers an illuminated cocktail of red, green and ultraviolet wavelengths directly into the bloodstream that is claimed to improve circulation and oxygen saturation, reduce pain, modulate the immune system and lessen inflammation.” She notes that Edzard Ernst “reaffirmed that the UVLrx system is based on flimsy science: ‘The implication that it cures any condition is not supported by good evidence.’ He went on to caution that “we cannot even be sure that the treatment is safe.” Also, “What is true, however, is that ultraviolet light damages the DNA of healthy cells. Dr. David Palma, M.D., a clinical scientist and radiation oncologist at the Ontario Institute for Cancer Research, stressed that ‘it seems unwise to start delivering something directly into the bloodstream that is known to cause cancer’.”

September 29 – UK’s Advertising Standards Authority and Committee of Advertising Practice (CAP) have issued Advertising standards for homeopathy. “…neither we nor CAP has seen robust evidence that homeopathy works. Practitioners should therefore avoid making direct or implied claims that homeopathy can treat medical conditions.”

September 30 – The FDA warned against the use of homeopathic teething tablets after reports of seizures and other adverse events. Although homeopathic products normally contain so little active ingredient that they cannot produce harm, it appears that in this case some products contained harmful amounts of belladonna, a toxic plant. Steven Novella discussed the issue on Science-Based Medicine.

Best of the blogs, October – on Science-Based Medicine, David Gorski responded to an editorial by Journal of Complementary and Alternative Medicine editor John Weeks, accusing writers for Science-Based Medicine and other critics of “polarization-based medicine.” But, according to Gorski, “nowhere does he actually convincingly rebut on substance anything that any of us has written.” To silence the critics, “All it would take would be consistent good science from well-designed, well-executed preclinical laboratory and animal experiments and clinical trials on CAM to demonstrate their value, something he is now in a position to provide. I won’t hold my breath waiting…After all, you can’t publish what doesn’t exist.” He attacked German alternative cancer clinics for combining “unapproved and experimental drugs” with quackery, while failing to publish any data in support of their methods. Harriet Hall reviewed Plavinol and other natural remedies for diabetes. Without further proper testing, we cannot know if these are safe and effective treatments. She also reviewed Richard Rawlins’ book, Real Secrets of Alternative Medicine: An Expose. Steven Novella discussed a debate on whether it is worth doing research on homeopathic vaccines (nosodes). Novella feels that we already have enough evidence; “There is a strong consensus that homeopathy is nonsense, the problem is that most academics don’t care.” Orac also provided commentary. Novella provided an "Update on CCSVI and Multiple Sclerosis". Chronic cerebrospinal venous insufficiency (CCSVI) was claimed by Zamboni to be a cause of MS, which he thought could be reversed with the “Liberation treatment.” Continued research shows that this is incorrect.

On Respectful Insolence, “Orac” criticized Medscape for its interview with Mark Hyman, in which the pseudoscientific ideas of functional medicine went unchallenged. He refuted the claim that placebo effects can be brought about without deception. He provided an update on the case of the Texas Medical Board vs. Stanislaw Burzynski. He also reported on an expose of Miracle Mineral Solution (which is essentially bleach), claimed to be a cure for autism and other conditions.

Edzard Ernst refuted seven claims about acupuncture. In another post, he noted a review of acupuncture trials published in China found that 99.8% of them reported positive results. Taking into account another finding that over 80% of the data in Chinese clinical trials is fabricated, he concludes that “we have little choice but to distrust the evidence that originates from China.” In a third post, he attacked the idea that acupuncture could be useful for stable angina; the meta-analysis suggesting utility is highly flawed. Acupuncture is “the last thing a patient needs in this condition.” He described a study of homeopathy for otitis media; homeopathy provided no benefit. On the other hand, a positive study of homeopathy for upper respiratory tract infections was flawed by the lack of controls for the placebo effect; “the paper turns out to be much more of a marketing exercise than a research effort.” Using homeopathy as an example, he described 12 “pseudo-arguments” of charlatans. He reported on a study that found no benefit of chiropractic manipulation for migraine. He also noted an Australian study showing only 50% of chiropractors are aware of current radiographic guidelines for low back pain, leading them to “grossly over-use X-rays.”

October 11 – Kantor and others published “Trends in Dietary Supplement Use Among US Adults From 1999-2012” (JAMA. 2016 Oct 11;316(14):1464-1474 Paper). Usage remained stable over this time period, with about 50% using supplements. An editorial by Cohen (JAMA. 2016 Oct 11;316(14):1453-1454 Preview) referred to this as a paradox, since increasing evidence showed risks but little benefit from the supplements. Gavura commented on the paper on Science-Based Medicine, noting the need for “better education and more effective regulation.” “There is a place for, and even a need for, dietary supplements as part of good health. But widespread access and a lack of good advice is contributing to billions in waste.”

October 13 – Hermes discussed the use of ozone therapy, an ineffective and dangerous approach promoted by some naturopaths. Hermes, a former naturopath turned critic of the profession, was profiled in an article in Stat.

October 17 – A report by English on NPR’s Morning Edition was entitled “Skeptics Question The Value Of Hydration Therapy For The Healthy.” The intravenous treatments, which cost more than $100 and include vitamins and minerals, have not been shown to provide any benefits.

Additions to Earlier Months

October 1, 2015 – Patrick and others studied patients with so-called “chronic Lyme disease” (Clin Infect Dis. 2015 Oct 1;61(7):1084-91 Paper). Unlike true Lyme disease, these patients have not been diagnosed based on recognized testing procedures. The authors found that the patients had characteristics indistinguishable from chronic fatigue syndrome. They concluded that “false-positive serological results from an alternative Lyme specialty laboratory represent the most likely reason for different labels for what is clearly debilitating illness.”

February, 2016 – An article by Homola discussed pediatric chiropractic care (Bioethics. 2016 Feb;30(2):63-8 Abstract). “I do not know of any credible evidence to support chiropractic subluxation theory. Any attempt to manipulate the immature, cartilaginous spine of a neonate or a small child to correct a putative chiropractic subluxation should be regarded as dangerous and unnecessary.”

May 16, 2016 – Crothers and others compared spinal manipulative therapy, the Graston technique® (“an instrument-assisted soft tissue therapy”), and placebo for treatment of thoracic spine pain (Chiropr Man Therap. 2016 May 16;24:16 Paper). Neither type of treatment provided benefits beyond placebo.

June, 2016 – Klein and Kemper reviewed “Integrative Approaches to Caring for Children with Autism” (Curr Probl Pediatr Adolesc Health Care. 2016 Jun;46(6):195-201 Abstract). They concluded that “Given their risks, costs, and limited evidence of efficacy, chelation, secretin, and hyperbaric oxygen should be avoided.”

June 1, 2016 – Sarris and others reviewed the adjunctive use of nutraceuticals for depression (Am J Psychiatry. 2016 Jun 1;173(6):575-87 Paper). They concluded that “Current evidence supports adjunctive use of SAMe, methylfolate, omega-3, and vitamin D with antidepressants to reduce depressive symptoms.”