Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement

The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.

A Randomized, Double-Blind, Placebo-Controlled Trial of Dolasetron, a 5-HT(3) Receptor Antagonist, in Patients with Fibromyalgia

Vergne-Salle1,  Pascale, Bertin1,  Philippe, Dufauret-Lombard1,  Carine, Bonnet1,  Christine, Treves2,  Richard

University Hospital, Limoges, France,
Chu Dupuytren, Limoges Cedex, France


the purpose of the study was to evaluate the efficacy and safety of dolasetron for symptomatic relief of pain associated with fibromyalgia (FM) meeting the American College of Rheumatology criteria.


This prospective, double-blind, placebo-controlled trial randomly assigned 60 patients with FM to receive placebo (n=31) or dolasetron (n=29) at the dose of 12.5 mg/d to intravenous route for 4 days in a intermittent way at month 0 (M0), one month (M1), two months (M2) and three months (M3) with a follow-up until 12 months. The primary outcome variable was the reduction of pain intensity measured by visual analog scale (VAS) between M0 and M3. The secondary outcome variables were reduction of pain intensity between M0 and the follow-up visits at M4, M6 and M12, the patient global impression of change (PGIC), the fibromyalgia impact questionnaire, assessments of quality of life (SF-36), the hospital anxiety and depression scale, the manual tender point count and the functional symptoms associated with FM.


reduction in pain intensity at M3 was significantly greater in dolasetron-treated patients (p=0.04, -21.3 on a 0–100 scale) compared with placebo-treated patients (-5.9). More patients in the dolasetron group had >=30% and >=50% improvement in pain (42.5% and 28% respectively in the dolasetron group versus 25% and 16% in the placebo group). The pain intensity measured by VAS more decreased in the follow-up visits M4, M6 and M12 in the dolasetron group compared with placebo. The PGIC was significantly greater in the dolasetron group at M3 (p=0.02). The other secondary outcomes failed to reach statistical significance. The most common adverse events were constipation, nausea, dizziness and headache without difference between the two groups.


dolasetron to intermittent intravenous route was safe and efficacious for the treatment of pain associated with FM at three months with persistence of beneficial effects after treatment.

To cite this abstract, please use the following information:
Vergne-Salle, Pascale, Bertin, Philippe, Dufauret-Lombard, Carine, Bonnet, Christine, Treves, Richard; A Randomized, Double-Blind, Placebo-Controlled Trial of Dolasetron, a 5-HT(3) Receptor Antagonist, in Patients with Fibromyalgia [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1420
DOI: 10.1002/art.26494

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