[Questionable documentation of the effect of pregabalin in fibromyalgia]. [Article in Norwegian]
Author(s): Holtedahl R.
Affiliation(s): Avdeling for fysikalsk medisin og rehabilitering, Sykehuset Buskerud, 3004
Drammen, Norway. email@example.com
Publication date & source: 2010, Tidsskr Nor Laegeforen. , 130(10):1032-6
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.
MATERIAL AND 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.
INTERPRETATION: 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.