June 13, 2012 — The latest systematic review of randomized, controlled trials (RCTs) of complementary and alternative medicine (CAM) therapies for rheumatoid arthritis (RA) provides little support for the use of some of the more popular CAM treatments to reduce inflammation or pain from this chronic condition. The analysis by Gary J. Macfarlane, MD, and colleagues on behalf of the Arthritis Research UK Working Group on Complementary and Alternative Therapies for the Management of the Rheumatic Diseases was published online June 1 in Rheumatology.
Coauthor Edzard Ernst, MD, PhD, told Medscape Medical News that the study's key finding was the lack of good evidence of efficacy for any therapy included in the analysis.
Dr. Ernst, who emphasized that he was speaking as a coauthor, not on behalf of the working group, holds the Laing Chair in Complementary Medicine at the University of Exeter's Peninsula Medical School, Exeter, United Kingdom.
The researchers identified 11 eligible RCTs that covered 7 therapies: acupuncture (4 trials), meditation (2 studies), autogenic training (1 trial), healing therapy (1 trial), progressive muscle relaxation (1 study), static magnets (1 trial), and tai chi (1 study). These trials met the following eligibility criteria: English-language RCT of human patients with RA that involved a complementary therapy not taken orally or applied topically; comparison with sham therapy or any other established treatment, or with waiting-list control or usual care; and results reported as the difference between the treatment and the comparator group by using a statistical test of significance or a confidence interval. The main outcomes of interest were pain relief and patient global assessment.
With regard to acupuncture, the authors write, "Three trials that compared acupuncture with sham acupuncture reported no significant difference in pain reduction between the groups but one out of two reported an improvement in patient global assessment. Except for reduction in physician's global assessment of treatment and disease activity reported in one trial, no other comparative benefit of acupuncture was seen."
They add, "None of the trials of other therapies reported positive comparative effects on pain reduction."
Most of the trials were small and thus were not likely to be able to detect small effect differences between study groups. The authors note that few of the studies reported calculations of the effect size they were powered to detect.
The authors also note other methodologic issues: "All studies reported on multiple outcome measures and several over multiple time points. It is likely that such multiple testing will give rise to some positive outcomes even if there is no true difference between groups being tested (Type I error). Most studies did not specify their primary (or secondary) outcome measure of the study to allow positive results to be set in this context. Finally, many studies focused on changes from baseline to end-of-study scores within treatment groups. These often showed improvements, and this would be expected if only as a result of placebo or contextual response. It is likely, however, that if there were between-group differences that these would have been reported. Therefore, to allow future evaluations of the effectiveness or efficacy of complementary therapies for RA, it is essential that standards such as CONSORT [Consolidated Standards of Reporting Trials] are followed in the reporting of trials (https://www.consort-statement.org/)."
Study Quality Poor, Outcomes Not Convincing, but CAM May Still Have Value
Dr. Ernst said, "With regard to the quality of the studies, such studies are often under-funded, thus they are too small. Another frequent problem is insufficient control for nonspecific effects."
With regard to clinical implications, Dr. Ernst is also cautious. He said, "Honesty is important ethically and otherwise. So, patients need to be told that the evidence is far from convincing and that the many claims being made are misleading at best and fraudulent at worst."
Robert Bonakdar, MD, from the Scripps Clinic Center for Integrative Medicine, La Jolla, California, reviewed the study for Medscape Medical News.
Dr. Bonakdar said, "I think for the evidence-based exercise that was performed, that is a systematic review of controlled trials, they did a fine job. However as previous researchers have emphasized, it is hard to do evidence-based summaries when there is less than adequate evidence. Unfortunately, when a study comes out, we jump to the conclusions and don't read the drawbacks, which even the authors point out. This may have several unintended consequences. For example, I often recommend mindfulness meditation or MBSR [mindfulness-based stress reduction] for RA patients who are having issues related to the condition, including insomnia, depression and difficulty with coping. Because many studies have hard primary end points, such as decrease in inflammatory markers, they may have negative conclusions. If a patient struggling with RA or their busy provider were to only read the summary and say "Well it doesn't work," that would be unfortunate. There is strong evidence that several mind-body therapies, for example, help the larger picture of dealing with chronic disease."
This work was supported by Arthritis Research UK. The study authors and Dr. Bonakdar have disclosed no relevant financial relationships.
Rheumatology. Published online June 1, 2012. Abstract
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Cite this: Rheumatoid Arthritis: Doubt Cast on Alternative Therapies - Medscape - Jun 13, 2012.