Mast Cell Stabilizer (Ketotifen) in Fibromyalgia: Phase 1 Randomized Controlled Clinical Trial.

ABSTRACT:

Objectives

Compared with pain-free controls, patients with fibromyalgia (FM) have more mast cells in the skin. Whether mast cells are involved in the pathogenesis of FM is unclear. We sought to determine the effects of a mast cell stabilizer (ketotifen) on FM symptoms.

Materials and methods

Fifty-one FM patients were randomized to daily oral ketotifen 2 mg bid (n=24) for 8 weeks or placebo (N=27). Mean age of patients was 51.2 years (SD=8.4); 88% were female and 88% were white; 22% were taking concomitant opiates; and mean pressure pain sensitivity (range, 0 to 20) was 10.0 (0.4). At study entry, the weekly average pain intensity was 6.4 (1.1) and the mean score on the Revised Fibromyalgia Impact Questionnaire-Revised was 66.8 (14.0).

Results

We found no statistically

SUBMITTER: Ang DC 

PROVIDER: S-EPMC4417653 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature