[Questionable documentation of the effect of pregabalin in fibromyalgia].
BACKGROUND
Use of Pregabalin has increased considerably in Norway during the last years. One explanation is prescription to patients with diffuse musculo-skeletal pain. The aim of the article is to clarify the effect of pregabalin in fibromyalgia.


METHODS
This article is based on literature identified through searches in Medline and public trial registries.


RESULTS
Six randomized, double-blind clinical trials were identified (three of them in peer-reviewed journals) and Pfizer had initiated and sponsored them all. The three trials published in peer-reviewed journals used a numerical rating scale for pain as the primary endpoint, and all trials reported statistically significant improvements on mean pain scores in relation to placebo. The mean pain reduction was between 9 % and 15 %. Effects on secondary endpoints varied considerably, both within and between the studies. Negative results were seldom mentioned in the abstracts, and secondary endpoints were reported incompletely. All 19 reviews referred to one or more of the clinical trials, and were generally limited to describing main results.


CONCLUSIONS
Recommendations for pregabalin in treatment of patients with fibromyalgia are based on rather weak evidence. Until trials independent of industry-funding are published, the role of pregabalin in treatment of fibromyalgia remains unclear.
Holtedahl
Robin
R
Avdeling for fysikalsk medisin og rehabilitering, Sykehuset Buskerud, 3004 Drammen, Norway. robi-hol@online.no
D000700:Analgesics / Q000627:therapeutic use*; D016265:Conflict of Interest; D004282:Documentation; D004345:Drug Industry; D019317:Evidence-Based Medicine; D005356:Fibromyalgia / Q000188:drug therapy*; D006801:Humans; D000069583:Pregabalin; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000700:Analgesics; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid