Amisulpride in the treatment of fibromyalgia: an uncontrolled study
Rico–Villademoros F et al. – Despite its promising results in some chronic painful conditions and in a related illness, such as chronic fatigue syndrome, amisulpride does not seem to provide any benefit to patients with fibromyalgia. Amisulpride was poorly tolerated by the participants. Methods
- In this open–label, 12–week study, the authors explored the efficacy and tolerability of amisulpride in patients with fibromyalgia.
- They recruited 40 patients, 1 male and 39 females, aged 46.2±6.8 years, who met the ACR criteria for fibromyalgia and had a score equal to or greater than 4 in the pain severity item of the Fibromyalgia Impact Questionnaire (FIQ).
- Amisulpride was added to their current treatment regimen at an initial dose of 25 mg/day and titrated according to the clinical response and tolerability (mean final dose, 87.5±41.3 mg/day).
- In the intent–to–treat analysis (i.e., all recruited patients), using a baseline–observation–carried–forward approach, the mean score in the FIQ decreased from 75.7±10.6 to 73.2±15.4, but this change was not statistically significant.
- Pain severity, as measured with the visual analogue scale from the FIQ, remained unchanged.
- Nonsignificant improvements were observed in depressive or anxiety symptoms using the Beck Depression Inventory and the State–Trait Anxiety Inventory, respectively.
- Twenty–six patients either withdrew from the study, mainly due to adverse reactions, or were lost to follow–up (n = 11, 27.5 %, for each category).