Robin Holtedahl1. 1. Avdeling for fysikalsk medisin og rehabilitering, Sykehuset Buskerud, 3004 Drammen, Norway. robi-hol@online.no
Abstract
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.
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.
Authors: Mary-Ann Fitzcharles; Peter A Ste-Marie; Don L Goldenberg; John X Pereira; Susan Abbey; Manon Choinière; Gordon Ko; Dwight E Moulin; Pantelis Panopalis; Johanne Proulx; Yoram Shir Journal: Pain Res Manag Date: 2013 May-Jun Impact factor: 3.037