Individual differences in response to randomly assigned active individualized homeopathic and placebo treatment in fibromyalgia: implications of a double-blinded optional crossover design.
OBJECTIVE
To assess individual difference characteristics of subgroups of patients with fibromyalgia (FM) patients 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.


METHODS
Double-blinded, randomized, placebo-controlled, optional crossover clinical trial.


METHODS
Fifty-three (53) community-recruited patients with FM entered the optional crossover phase.


METHODS
Two homeopaths jointly selected an individualized homeopathic remedy for all patients. The pharmacy dispensed either verum LM remedy or indistinguishable placebo in accord with randomized assignment for 4 months and the patient's optional crossover decision for an additional 2 months.


METHODS
Patients completed a battery of baseline state/trait questionnaires, including mood, childhood neglect and abuse, and trait absorption. They rated global health (whole person-centered) and tender point pain on physical examination (disease-specific) 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 psychologic 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 terciles 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).


CONCLUSIONS
Individual difference factors may predict better and poorer responders with FM to specific and nonspecific effects of homeopathic and placebo treatment.
Bell
Iris R
IR
Department of Medicine, University of Arizona, Tucson, AZ, USA. ibell@u.arizona.edu
Lewis
Daniel A
DA
Brooks
Audrey J
AJ
Schwartz
Gary E
GE
Lewis
Sabrina E
SE
Caspi
Opher
O
Cunningham
Victoria
V
Baldwin
Carol M
CM
D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005356:Fibromyalgia / Q000628:therapy*; D006705:Homeopathy / Q000379:methods*; D006801:Humans; D008297:Male; D008419:Materia Medica / Q000008:administration & dosage* / Q000494:pharmacology*; D008875:Middle Aged; D019964:Mood Disorders / Q000188:drug therapy; D010146:Pain / Q000188:drug therapy; D010147:Pain Measurement; D011788:Quality of Life; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D008419:Materia Medica