The content of herbal products varies a great deal. How the plant is grown, harvested, and stored; the plant parts selected; the extraction process used; and other factors can have an effect. The ingredients of some herbal products can vary from 0 to 10 times the label amount. There is now an effort by some manufacturers to "standardize" products. Standardization of herbal products means the manufacturer identifies one or a few ingredients of the herb and makes sure that each batch contains the same amount. The problem with this is that it is not always known what ingredients cause the desired effect (if there is one). For instance, most believe that hypericin is the active ingredient in St. John's wort, but recently hyperforin and other active compounds have been identified. Pharmaton, Inc. is marketing Movana claiming that it is more potent because it contains hyperforin. Further, if an herb exerts its effects due to a number of components working in concert, and standardization doesn't include all of the important ingredients, the results would be varied still. Also, standardized products could still vary from one manufacturer to another. Standardizing herbal products is an improvement, but these products still are not as predictable as regular medications.
The Pharmacist's Letter, Nov. 1998]
Leading researchers with a history of favorable attitudes toward manipulative therapy expressed disappointment in their results of a well-designed consumer study of different approaches to managing low back pain (LBP). 321 adults with LBP (excluding sciatica patients) that persisted for seven days after a primary care visit were randomly assigned to either: (1) the McKenzie method of physical therapy or chiropractic manipulation, or (2) an educational booklet to read. Therapy was provided for one month. The number of visits was determined by the practitioner but was limited to a maximum of 9. Patients were followed for two years. Symptoms were measured on an 11-point scale and the level of dysfunction was measured on the 24-point Roland Disability Scale.
After adjustment for baseline differences, the chiropractic group had less severe symptoms than the booklet group at four weeks (P=0.02), and there was a trend toward less severe symptoms in the PT group (P=0.06). However, these differences were small and not significant after adjusting the data for non-normal distribution. Differences in the extent of dysfunction were small and approached .05 significance only at one year with the booklet group doing worst. For all outcomes, there were no significant differences among the groups in the number of days of reduced activity or lost work, or in recurrences of back pain. Patient satisfaction was higher in the treatment groups (75%) than the booklet group (30%)(P=<0.001) The mean costs of care were $437 for the PT group, $429 for the chiropractic group, and $153 for the booklet group. The authors conclude that the limited benefits of the treatments may not be worth their additional costs. The researchers expressed disappointment with their findings.
[Cherkin, et al, "A comparison of physical therapy, chiropractic manipulation, and provision of an educational booklet for the treatment of patients with low back pain," New Engl J Med, 1998;339:1021-9]
Comment. This was a good study in every aspect except one. Chiropractors would not exclude sciatica patients in the real world (there's no reason to believe that this would have improved the outcomes; in fact, it may have made matters worse). The study shows that LBP eventually takes care of itself, but that patients are happier if a hands-on method of treatment is employed along the way. Temporary relief was not reported, but may have been important to the patients themselves. The additional costs were small by health care standards and may be worth the difference in terms of patient satisfaction. Here again, however, there is a real world problem. Chiropractors have a notorious history of over-treating. They are not likely to limit care to nine sessions. Managed care may be able to hold the line on costs, but patients can be conned into additional out-of-pocket costs. The method taught by chiropractic practice builders is to get patients to sign long-term contracts. Chiros are taught to state confidently that "it will take 55* treatments to correct the underlying causes of the problem." The bottom line is that the results are consistent with other studies, to wit: chiro care adds to costs but does not improve clinical outcomes.
*The number will vary.
Researchers conducted a randomized, controlled clinical trial of chiropractic spinal manipulation (CSM) for children with mild or moderate asthma. After a 3-week base-line evaluation period, 91 children who had continuing symptoms of asthma despite usual medical therapy were assigned to receive either active or simulated CSM for 4 months by one of eleven participating chiros, selected by the family according to location. None had previously received chiro care. The primary outcome measure was the change from base-line in the peak expiratory flow, measured in the morning before the use of a bronchodilator, at 2 and 4 months. Assessors were blinded to treatment assignment throughout the study. Eighty children had outcome data that could be evaluated. There were no significant differences found between the groups.
[Balon et al. "A comparison of active and simulated chiropractic manipulation as an adjunctive treatment for childhood asthma," New Engl J Med, 1998;339:1013-20]
Comment. Those who are familiar with chiropractic theory know that chiros claim to be able to help almost any condition. The theory asserts that the body's innate healing capacity is mediated through the nervous system which is improved if the spine is in proper "adjustment." The president of a chiropractic college told William Jarvis that if he was bitten by a poisonous snake the first thing he would do is have his spine adjusted. He would then go to an emergency room for antivenom. He sincerely believed that he would be giving his body an advantage by assuring a better functioning "Innate" healing capacity. As nutty as this may sound to nonbelievers, it is the essence of the chiropractic paradigm. Although true believers in the chiro theory would adhere to its mechanism if an improvement had been found, others might explain such findings as psychological or due to some somatic reflex. Asthma attacks can have a functional basis* and relief can be due to behavioral factors. However, relief by CSM is more likely to be immediate and not something that would be measured on succeeding days, in the morning, and before a bronchodilator is used. It is not difficult to imagine that a patient could experience temporary relief at the time of treatment, but that the treatment would not have a lasting effect on the condition.
*A classic tale attributed to psychologist William James involved an asthma patient who arrived at an inn after dark. He was escorted to his room by candlelight. He experienced an asthma attack in the night. Believing fresh air to be absolutely necessary for relief, he fumbled in the dark for the latch to open his window. He finally found the latch, swung open the glass, and inhaled to his relief. The next morning he was surprised to find the window still closed but the face of the grandfather's clock opened! Upon hearing this story, a LLU faculty member told of a similar experience. He opened an unfamiliar window in the dark and obtained asthma relief, only to find the next morning that a storm window blocked air from the opening.
The California Department of Health Services, Food and Drug Branch, initiated a study to screen imported Asian patent medicines for undeclared pharmaceuticals and heavy metal contamination, using gas chromatography-mass spectrometry and atomic absorption methods. 17 (7%) of 243 products analyzed contained undeclared pharmaceuticals. The most common undeclared ingredients were ephedrine, chlorpheniramine, methyltestosterone, and phenacetin.
Out of 251 analyzed for lead, arsenic and mercury, 24 contained at least 10 ppm lead (range 10 to 319 ppm; median, 29.8; mean, 54.9); 36 contained arsenic (range 20.4 to 114,000 ppm; median 180.5; mean 14,553); and, 35 contained mercury (range 22.4 to 5070 ppm; median 329, mean 1046). The U.S. Pharmacopoeia limits heavy metals in most pharmaceuticals to 30 ppm with lower limits for lead, arsenic, and mercury. Of 260 products investigated, at least 83 (32%) contained undeclared pharmaceuticals or heavy metals, and 23 had more than one adulterant.
[Ko RJ, "Adulterants in Asian patent medicines," New Engl J Med, 1998;339:847]
Nearly one-fourth (23.7%) of 2,609 samples of traditional Chinese medicines were found to be adulterated with synthetic therapeutic substances in Taiwan. More than half of the adulterated products contained two or more adulterants. Four samples with either a rheumatoid or anti-inflammatory indication contained six different kinds of adulterants.
[Huang WF, Kuo-Ching W, Mei-Ling H. "Adulteration by synthetic therapeutic substances of traditional Chinese medicines in Taiwan," J Clin Pharmacol, 1997;37:344-50]
History is being repeated with the promotion of ozone devices as air purifiers. At least 30 years ago ozone device promoters were prosecuted for false claims about making air more healthful. Now again, the California Department of Health Services warns consumers about false claims being made for ozone devices as "air purifiers" for people sensitive to indoor pollution. The shocking reality is that they can readily produce unsafe levels of ozone levels in a room. Ozone is toxic. It can irritate the eyes, nose, throat, and lungs. Low level exposures have been shown to cause significant temporary decreases in lung capacity in healthy, exercising adults. Some asthmatic individuals are especially susceptible to ozone toxicity, which includes constricting airways. Long term exposures to low-level ozone indicate that it may lead to permanent reduction in lung capacity. Children, especially asthmatics, are most at risk from exposure to ozone. The ozone layer protects from the sun's harmful UV light, but ground level ozone is a harmful pollutant. Ozone can be used in water purification because it kills microbes in water. It does not kill microbes (eg, bacteria, fungi) in the air except at extremely high, unsafe levels.
["Health hazards of ozone-generating air cleaning devices," Calif Morbidity, March, 1998]
According to the Centers for Disease Control and Prevention, of 285 reported cases of illness from E. coli O157:H7, 108 were caused by alfalfa sprouts, 20 by tainted ground beef, 52 from person to person contact, and 17 from wading pools. The FDA and USDA are working together to identify possible interventions, including irradiation.
Also consider how many more consume ground beef than alfalfa sprouts.
["Sprout safety-high risk groups warned: don't eat alfalfa sprouts," FDA Consumer, 11-12/98]
The herbal remedy saw palmetto has been found useful in controlling lower urinary tract symptoms presumed to be secondary to benign prostatic hyperplasia. There was significant improvement in the International Prostate Symptom Score (IPSS--Yes, Virginia, that's what they call it!) of the 46 men who completed the 6-month trial. There was no improvement in peak urinary flow rate, postvoid residual urine volume, or detrusor pressure at peak flow. No significant change in PSA was noted (worth knowing because concern has been stated that SP may lower PSA and give a false feeling of security in patients with prostate cancer.) Recalling the dramatic finding of a Canadian study in which placebo (white flour) capsules achieved significant improvement in symptoms, a great weakness in the saw palmetto study's design was the absence of a placebo control group. Recall that Canadian men taking placebo therapy alone for prostate problems achieved significant improvement in another study.
[NCAHF Newsletter, Jul-Aug, 1997, p.2].
[Gerber, et al. Urology, 1998;51:1003-7]
The hot item being touted for weight loss is pyruvate (aka pyruvic acid), a compound generated as the end product of glycolysis--one of the body's energy-generating pathways. Chief proponent is Ronald Stanko, a University of Pittsburgh researcher, who is responsible for practically all of the studies on pyruvate, and who also holds the U.S. Patent on "Pyruvate+". Pyruvate is also touted as a muscle-builder, but evidence is nonexistent. Pyruvate is also promoted as an "antioxidant," but has no human studies to support this claim. A full critique of pyruvate appeared in the Sept-Oct Nutrition Forum, "Pyruvate: just the facts," by exercise physiologist Joseph Cannon.
PC-SPES, a commercially available combination of 8 herbs, is used as a nonestrogenic treatment for cancer of the prostate. Since some herbal medicines have estrogenic effects in vitro, researchers tested PC-SPES in yeast, mice and eight men with prostate cancer and found it to have "potent estrogenic activity." This means that the use of the unregulated mixture could confound the results of standard or experimental therapies, or produce clinically significant adverse effects.
[DiPaola et al. "Clinical and biologic activity of an estrogenic herbal combination (PC-SPES) in prostate cancer," New Engl J Med, 1998;339:785-91]
A 15-yr-old boy with stage IA nodular, sclerosing Hodgkin's disease was offered multiagent chemotherapy. In April, 1998, despite lengthy discussion with the treatment team, the patient, with the approval of his mother, elected to use Matol Bioimmune OSF Plus. According to the manufacturer's promotional literature, the product would "create a synergistic effect on the immune system, resulting in the elevation of natural killer (NK) cell activity." Case reports provided by Matol Botanical International indicate that the compound has beneficial effects on a wide range of disorders, including environmental illness, a variety of cancers, AIDS, hepatitis C, and chronic fatigue syndrome. In early August, both clinical and radiologic evidence of marked disease progression was seen. Two weeks later severe night sweats developed and the patient requested the previously offered chemotherapy. On restaging, it was determined that the disease had progressed to stage IIB, thus requiring more intensive therapy.
[Coppes et al. "Alternative therapy for the treatment of childhood cancer," New Engl J Med, 1998;339:846]
Androstenedione, the testosterone-boosting supplement made famous by St. Louis Cardinals slugger Mark McGwire is alleged to have produced an increased libido in East German female athletes "bordering on nymphomania" in the 1980s. Met-Rx Engineered Nutrition of Irvine, CA, will begin selling androstenedione chewing gum in 1999. Among its targets are post-menopausal women who often experience a decreased sex drive.
[McGraw D. "A pink Viagra?" US News & World Report, 10/5/98:54]
Candy bars touted as healthy nutrition bars are aimed at health conscious consumers. One brand, Weider Nutrition Group's Steel Bars, has been the target of a class action lawsuit. WNG's own testing during the time period involved showed that the bars had more "bad" and fewer "good" ingredients than promised on the labels. Coconut bar labels claimed 4 grams of fat and 35 mgs of sodium, but lab tests found 16 grams of fat and 235 mgs of sodium. The labels touted "healthy" fractionated canola oil but there was none in the product. A settlement agreement was reached in September, 1998, that set aside $750,000 for consumer refunds ($1 per bar up to 5 bars) for those who purchased Steel Bars between 12/20/94 and 4/24/98. WNG also will donate 1 million bars to the Contra Costa County food bank, pay plaintiff's attorney fees, and comply with labeling laws in the future.
[John Psathas v Weider Nutrition Group, Inc., Superior Court for the State of California, Contra Costa County, Case No. 96-05610]
On 5/27/97 the FDA received a report of a complete heart block occurring in a previously healthy, 23-yr-old woman who had ingested a regimen of botanical products for the purpose of "internal cleansing." The patient was found to have an elevated serum digoxin level. Laboratory analysis revealed that the product Chomper (distributed by Arise and Shine of Mt. Shasta, CA) that she was using contained a digitalis-like substance.
A 46-yr-old woman was hospitalized in June, 1997, for evaluation of visual disturbances (described as "yellow scintillations"), nausea, vomiting, shortness of breath, palpitations, and chest pressure. She had begun an herbal "cleansing" program using a product found to contain cardiac glycosides.
This report tracks the sources and distribution of the contaminated products involved in these cases.
[Slifman et al. (FDA Center for Food Safety) "Contamination of botanical dietary supplements by Digitalis lanata," New Engl J Med, 1998;339:806-11]
Comment. The problem of mislabeled, adulterated, contaminated, and poorly manufactured products being sold as medications (aka "herbal remedies," "traditional medicines") looms ever larger as hucksters take advantage of the wide open marketplace created by the 1994 Dietary Supplement Health & Education Act. Consumers and health professionals must be vigilant in their watch for adverse reactions, and must report suspicious events. Detailed information on how to report adverse reactions and other product problems is available in the Nov-Dec FDA Consumer
[Henkel T, "E-mail, snail mail, phone or fax," pp 7-15].
A study of Therapeutic Touch (TT) comparing, no TT, mock TT, and TT says it found significant improvement in 8 osteoarthritis patients compared to controls. Patients were evaluated using standardized, validated instruments employed by an observer who did not know any of the patients.
[Gordon et al. J Fam Pract, 1998;47:271-7]
Comment. This study seems to have a reasonably good design, but suffers from its small number of subjects. Replication is needed and should be easy because it is well reported.
In October, 1997, NCAHF established the Task Force on Veterinary Pseudoscience (TFVP) to deal with the issues of pseudoscience, critical thinking, and health fraud in veterinary medicine. The TFVP's first order of business was to challenge the American Veterinary Medical Association's (AMVA) 1996 Guidelines for Alternative and Complementary Veterinary Medicine. These Guidelines had been quietly formulated by a secret six-member committee alleged to have been composed of a "balance" of alt med and regular practitioners. The latter, according to committee chairman Dr. Stanley Held, had no particular knowledge of, or interest in, alternative therapies. However, it is known that veterinary chiropractor, acupuncturist, prolific author, and arguably the country's leading veterinary alt med advocate, Allen Schoen, DVM, was a member of this "balanced" committee. The Guidelines were accepted and presented to the AVMA general membership as a fait accompli.
Although AVMA officials and attorneys are adamant that the Guidelines in no way constitute an endorsement of "alternative" therapies, the language used sent a different message. Regarding acupuncture, they stated: "Veterinary acupuncture and acutherapy are now considered an integral part of veterinary medicine. These techniques should be regarded as surgical and/or medical procedures under state veterinary practice acts." About chiropractic, they stated that: "sufficient research exists documenting efficacy of chiropractic in humans." On homeopathy, they stated that "Clinical and anecdotal evidence exists to indicate that veterinary homeopathy may be beneficial." The committee provided no substantiation of these accolades, and exhibited an ignorance of the scientific studies and meta-analyses indicating that these modalities are of little value.
The Guidelines also stated that "Holistic veterinary medicine is a comprehensive approach to health care employing alternative and conventional diagnostic and therapeutic modalities. In practice, holistic veterinary medicine incorporates, but is not limited to, the principles of acupuncture and acutherapy, botanical medicine, chiropractic, homeopathy, massage therapy, nutraceuticals, and physical therapy as well as conventional medicine, surgery, and dentistry." Great emphasis is placed on the need for "continuing education" in these modalities and the absolutely essential requirement that they be administered exclusively by or on the order of licensed veterinarians.
Most disturbing is that nowhere in the document is there any indication of a commitment to science- or evidence-based practices. "Alternative" and "complementary" therapies are never described as unproven, which is consistent with established definitions.
The committee recommended that the Guidelines be reviewed "within three years." In June, 1998, the TFVP sent a letter to then-AVMA-president John Freeman, DVM, formally challenging the Guidelines on a dozen different points and requesting representation on any committee seated to review them. The letter included dozens of "endorsements," and eloquent supporting comments from veterinary practitioners, prominent academicians, scientists and concerned citizens around the world. Two follow-up letters were sent to president Freeman in June and July. Finally, on July 19, the TFVP received a response in which Dr. Freeman offered the assurance that "the concerns of the AVMA are similar to those expressed by you and your colleagues," but failed to address any of our objections in any substantial way. He also did not offer any assurance that the views of advocates of evidence-based veterinary medicine would be represented in future deliberations regarding the Guidelines.
In July, Richard C. Swanson, DVM, succeeded Dr. Freeman as AVMA president. On July 22, the TFVP sent Dr. Swanson copies of pertinent materials previously submitted to Dr. Freeman, including the request for representation in future deliberations involving the alt vet med guidelines. The TFVP learned (after the fact) that the Guidelines had been on the agenda of an Executive Board meeting at the AVMA National Convention in Baltimore (July 25-29).
Having heard nothing from Dr. Swanson or the AVMA, on Sept 5, the TFVP wrote again, asking what action had been taken at that meeting. Included in the letter were the names, credentials, and addresses of 13 prominent veterinary practitioners, academicians, and scientists, familiar with "alternative" and "complementary" modalities, who were willing to serve on a committee seated to review the Guidelines. On September 18, Dr. Craig A. Smith, AVMA officer and assistant editor of JAVMA, responded with a brief note and a clipping from the Sept 15 issue of JAVMA entitled "Board takes action on issues." Among the actions noted was that:
The board disapproved a recommendation, made by the AVMA/American Association of Veterinary Medical Colleges Joint committee, that the board clarify the legitimacy of the various components of alternative veterinary therapy discussed in the current Guidelines for Alternative and Complementary Veterinary Medicine. However, the board approved a substitute recommendation to have AVMA staff prepare a description of a committee that will review the guidelines. The board will review the committee description at its November 1998 meeting.
In response to a phone call requesting clarification, Dr. Smith wrote the TFVP stating: "During the meeting of November 12-14, 1998, the AVMA Executive Board approved a recommendation for the formation of a task force to review and recommend revisions to the AVMA Guidelines on Alternative and Complementary Veterinary Medicine. The task force will comprise 9 members who will be appointed by the AVMA Executive Board. Those members are as follows: one member of the AVMA Executive Board, one predominantly equine practitioner who practices only traditional Western medicine, one predominantly equine practitioner who uses alternative and complementary methods as well as traditional Western medicine, one small animal practitioner who practices only traditional Western medicine, one small animal practitioner who uses who uses alternative and complementary methods as well as traditional Western medicine, one food animal practitioner, one academic clinician, one representative of the Association of American Veterinary State Boards, and one representative of the Association of American Veterinary Medical Colleges." (The poverty of AVMA's insight on the issues is exposed by misidentification of evidence-based medicine as "traditional medicine" [actually a synonym for "folk medicine"], and a failure to recognize "alternative" and/or "complementary" medicine as "unproven" or "unscientific.") Dr. Smith went on to state that: "It is the policy of the AVMA to seek nominations for these positions from organizations represented in the AVMA House of Delegates. To that end, notice will soon be sent to each state veterinary medical association and all allied organizations represented in the AVMA House of Delegates requesting nominations for this task force." All nominees must be AVMA members, which excludes recognized authorities on "alternative" therapeutic claims who had offered their services. Fortunately, "Nominations will be accepted from local or state veterinary medical associations, and individual AVMA members."
The TFVP applauds the AVMA's willingness to at least reconsider the '96 Guidelines, but the inclusion of alt med advocates and practitioners is problematic. We believe the public interest, and the interests of the veterinary profession, would be best served if the members of the proposed task force were all staunch advocates of science- and evidence-based medicine. In the realm of human medicine, the New England Journal of Medicine has editorialized against the promulgation of alternative medicine, and the American Medical Association has a skeptical stance regarding unproven therapeutic modalities. The AVMA stands alone in its de facto endorsement and support of "alternative" (unproven) therapeutic claims. The TFVP continues its objections to the '96 alt vet med guidelines, and still needs all the help it can get from interested parties. We invite supporters to read the original TFVP letter to the AVMA on the internet website, the letters of support for the letter and to offer your comments. They'll be forwarded to president Swanson.
[The Aug 1 JAVMA announced that the Executive Board had "accepted an invitation from the American Chiropractic Association to explore areas of common interest."]