Monday, November 28, 2011

ACR2011 and Fibromyalgia (2)

Quite a lot of posters on fibromyalgia! I’ve taken a couple of abstracts as a couple of things might be new to one or another. It’s a very private selection. I won’t advocate some of the wonderdrugs the pharma industry is eager to promote.
Here is the first study.

Nocebo in Fibromyalgia drug trials

DD Mitsikostas and colleagues were interested in the question of nocebo in fibromyalgia drug trials. “In medicine, a nocebo reaction or response refers to harmful, unpleasant, or undesirable effects a subject manifests after receiving an inert dummy drug or placebo. Nocebo responses are not chemically generated and are due only to the subject's pessimistic belief and expectation that the inert drug will produce negative consequences.” [Look up the whole article on Wikipedia: ] The background for this meta-analysis has been poor medication adherence. The hypothesis is that treatment failure and/or increased total healthcare costs may be partly related to nocebo. “Nocebo dropouts in fibromyalgia trials were 4-fold and 2-fold higher than in RCT’s for multiple
sclerosis treatment and migraine preventive treatment, respectively.” The authors see nocebo as a serious confounding factor.
I would be more concerned about the high rate of AEs in drug studies, in the 450 mg pregabalin treated fibromyalgia patients 65% complained about dizziness alone (LJ Crofford et al., Arthritis rheum. 2005; 52: 1264-1273).

[SUN] 739
Nocebo in Fibromyalgia: Meta-Analysis of Placebo-Controlled Clinical
Trials and Implications for Practice. DD Mitsikostas1, NG Chalarakis1, LI Mantonakis1, E. Delicha2 and PP Sfikakis2.
1Naval Hospital, Athens, Greece, Athens, Greece, 2First Department of Propaedeutic and Internal Medicine, Laiko, Athens University Medical School, Greece, Athens, Greece
Conclusion: Nocebo is remarkably prevalent in fibromyalgia patients participating in RCTs probably being a serious confounding factor. Since nocebo contributes to drug intolerance and treatment failure in clinical practice, identification of predisposing factors and efforts to prevent nocebo by educating these patients appropriately seems to be important for fibromyalgia outcome.

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