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Research: BELL and co-workers,
Listed in Issue 108
Abstract
BELL and co-workers, Department of Medicine, University of Arizona, Tucson, AZ, USA, ibell@u.arizona.edu, have investigated individual differences in response to randomly assigned active individualized homeopathic treatment in fibromyalgia.
Background
The aim of the study was to assess individual differences in subgroups of patients with fibromyalgia with respect to the decision to stay in or switch from randomly-assigned verum or placebo treatment during an optional crossover phase of a double-blinded homeopathy study.
Methodology
In this double-blinded, randomized, placebo-controlled, optional crossover clinical trial, 53 patients with a confirmed diagnosis of fibromyalgia were enrolled. They were prescribed an individualized homeopathic remedy by a team of two homeopaths. Some patients received the remedy and some received a placebo. After 4 months, they were offered an opportunity to crossover for another 2 months. Patients completed self-report questionnaires on mood, childhood neglect and abuse, and trait absorption, global health (whole person-centred) and tender point pain on physical examination at baseline, 3 months, and 6 months.
Results
Rates of optional crossover from verum to placebo or placebo to verum were comparable (p = 0.6; 31%, and 41%, respectively). The switch subgroups had greater baseline psychological issues (emotional neglect in placebo-switch; depression and anger in verum-switch). The verum-stay subgroup scored highest on treatment helpfulness and included all six exceptional responders who fell, prior to crossover, into the top tertile for improvement in both global health and pain. Patients staying in their randomly assigned groups, active or placebo (n = 34), scored significantly higher in trait absorption than did those who switched groups (n = 19).
Conclusion
Individual difference factors may predict better and poorer responders with fibromyalgia to homeopathic and placebo treatment.
References
Bell IR, Lewis DA 2nd, Brooks AJ, Schwartz GE, Lewis SE, Caspi O, Cunningham V, Baldwin CM. Individual differences in response to randomly assigned active individualized homeopathic and placebo treatment in fibromyalgia: implications of a double-blinded optional crossover design. Journal of Alternative and Complementary Medicine 10(2): 269-283, Apr 2004.