By: Walter Alexander
One of the real impediments to wider acceptance of alternative and anthroposophical medications and approaches to treatment has been the nearly utter lack of high standard randomized clinical trials showing benefit. In the world of conventional medicine, the randomized controlled trial (or RCT) is the Holy Grail of validity. Without RCTs, claims for benefits based on individual experience have not been taken seriously.
In such trials, one group gets a specific treatment and a similar randomly chosen other group gets a sugar pill or placebo. To attain the highest level of scientific acceptance, an RCT needs also to be both prospective and double-blind, as well. That means that the question to be tested has to be explicitly stated before the start of the trial (no fishing for favorable effects afterwards allowed!), and neither the physicians nor the patients know who got the real treatment until after the trial has been completed and “unblinded.”
With that, there are serious impediments to launching and carrying out RCTs. They are enormously expensive to conduct, such that often only the huge pharmaceutical companies with colossal research budgets can afford them. Furthermore, only those drugs or procedures likely to produce the immense profits needed to offset those costs get tested.
In addition, as the author of the first study below points out, patients may not want to be randomized. Asked whether or not they would submit to randomization and subject themselves to the 50-50 odds of getting a placebo, 97 percent of the patients in the anthroposophical treatment group said no. The first serious rebellion against RCTs occurred early in the HIV/AIDS crisis when legions of HIV positive individuals agreed to enter them in order to get the latest treatments, only to run to friendly chemists to have their pills tested. If they were sugar, they dropped out of the trial and explored new treatments elsewhere.
All this amounts to a “Catch-22” of the first order. David Riley, MD, University of New Mexico School of Medicine and Integrative Medicine Institute, Sante Fe, New Mexico, has long been an advocate of alternative clinical trial designs that would allow smaller clinical practices to participate in valid research at lesser expense, and help overcome the very serious lack of supportive data for alternative and complementary therapies. He was a secondary author in the first trial reported below. This trial, rather than testing a drug against a placebo, prospectively tests two approaches to treatment for the same extremely common ailments: acute respiratory tract infections (RTI) and acute ear infections (otitis media, or AOM).
The author, Harald H. J. Hamre, MD, of the Institute for Applied Epistemology and Medical Methodology, Freiburg, Germany, points out in his introduction that RTI and AOM are very common in primary care practice and that most patients are prescribed an antibiotic. The use of antibiotics for RTI/AOM, however, is not supported by clinical trial experience. In fact, large data reviews show that compared to their potential to produce undesirable side effects, the benefits of antibiotics in AOM, sinusitis, tonsillitis, common cold and bronchitis are small or negligible. Beyond side effects, their indiscriminate use promotes bacterial resistance. Hamre explains also that in anthroposophic medicine, RTI/AOMs are treated with an array of medications supported by external herbal and hydrotherapeutic applications. Antibiotics are avoided unless “strongly needed,” and fever is not routinely suppressed with analgesics.
The non-randomized study, entitled “Anthroposophic versus Conventional Therapy of Acute Respiratory and Ear Infections” (Wien Klin Wochenschr, 2005, 117/7-8: 256-268), evaluated treatment in “real-world” clinical practices in Austria, Germany, Netherlands, UK and the United States. Practices were either anthroposophic or conventional. Specific treatments were left to the physicians’ discretion. The study objective was to compare clinical outcomes, medication use and patient satisfaction, testing the hypothesis that clinical outcomes would not be worse with anthroposophic treatment than with conventional. The primary endpoint was response, defined as a complete recovery or major improvement, after 14 days.
The analysis included 1016 patients treated by 36 physicians (715 treated by anthroposophic doctors and 301 by conventional). The response rate for anthroposophic treatment was not only non-inferior to conventional therapy (89.7 percent versus 84.4 percent for conventional), it was significantly superior. Responses and complete recovery were more frequent and faster. Subanalysis, however, showed that the differences were accounted for by stronger results in children receiving anthroposophic treatment, with comparable findings for both therapies in adults. Also, significantly more anthroposophical patients were satisfied with their treatment. Adverse drug reactions were reported in 2.7 percent of anthroposophic patients and in 6.0 percent of conventionally treated patients.
The study showed, Hamre concluded, that anthroposophic treatment of primary care patients with acute respiratory and ear infections is safe and at least as effective as conventional treatment. “In addition,” he wrote, “anthroposophic treatment allows for a very low use of antibiotics, analgesics and anti-inflammatory drugs.” In fact, about 36 percent of conventionally treated patients took antibiotics as compared with about 6 percent of anthroposophically treated patients.
Some caution is called for in interpreting the data. Anthroposophically treated patients may well have been more motivated. Hamre noted that such treatment often calls for more frequent dosing and intensive nursing, and it has to be allowed that the self-selection by patients treated via the anthroposophic approach may invite a bias in their own reporting.
The second clinical trial report, Anthroposophic therapies in chronic disease: the Anthroposophic Medicine (AM) Outcomes Study (AMOS) (Eur J Med Res, 2004 9:351-360), also conducted as a “real world” observational study under Hamre, included the wider, multi-modal range of anthroposophical remedies, encompassing both anthroposophical medicines and art, movement (eurythmy) and massage therapies. There were no comparator groups. The primary comparisons were internal, assessing aspects of status at entry and at specific time periods thereafter (i.e., disease severity and health-related quality of life). Secondary outcomes included costs and therapy and health utilization, where the prior years were compared with the first AM treatment year.
The most common diagnoses were mood disorders, fatigue, low back pain, headache, cervical spine disease, asthma, malignancies and attention deficit/hyperkinetic/conduct disorders. Analysis at 24 months of data from 811 patients (age 1-75) showed “substantial, consistent and stable improvements of disease symptoms and health-related quality of life.” Therapy costs were outweighed by savings attributed to reduced hospital stays. Adverse reactions to therapies were few (2.7 percent) and rarely caused dropout (0.5 percent).
Hamre concluded, “Anthroposophic therapies were associated with substantial long-term reduction of disease severity and improvement of health-related quality of life.” He said also, “Considering the long disease duration before enrollment (average 6.5 years), these results are encouraging.” In his discussion of the implications of the study, Hamre pointed out that patients often gave as their reason for consulting an AM physician, aside from perceived shortcomings of conventional therapies, a desire to contribute actively to therapy. “Anthroposophic counseling and therapy for chronic disease aims to affect underlying causes of the patient’s condition, which may not be addressed adequately through passive therapies,” Hamre observed.
Dr. Hamre’s final comment here is important. Conventional research design strives mightily to overcome the problem of “the placebo effect,” that often huge component of outcomes seemingly caused by the patient’s awareness that she or he is receiving treatment. Conventional medical researchers are often chagrined that placebo effects greater than 20 percent are frequently documented as confounding factors in their analyses. The further element of active engagement by the patient is another dimension that refuses to remain ignored. Highly regarded conventional research into the impact of support groups for women treated for breast cancer has shown remarkable benefits. Acceptance of the notion that when patients activate their own will forces in relation to their medical condition, they can set in motion powerful physiologic changes, has not truly arrived. But resistance to it is weakening, and serious consideration of it is implied in these studies of anthroposophic approaches to treatment.