Efficacy of Meclofenamate Sodium versus Placebo in Headache and Craniofacial Pain

SYNOPSIS Twenty patients were enrolled in a double‐blind, placebo‐controlled crossover study of meclofenomate sodium in headache and craniofacial pain. There were four observation periods of 15 days each: Period I was a wash‐out period. In period 2, subjects were randomly assigned to a 15‐day regimen of taking two capsules a day of 100mg meclofenamate sodium (group 1) or placebo (group 2). In period 3, group I was switched to placebo and group 2 to meclofenamate sodium for the next 15 days. Lastly, the patients took no medication for a further 15 days (period 4). A thermographic record of the craniofacial and neck areas was taken at the end of periods 1 and 4. A record of the pressure threshold and tissue compliance at different sites of the craniofacial, neck and shoulder areas was taken at the end of each period. During the trial, number and duration of painful events were recorded daily by the patients, and the level of pain evaluated on a visual analog scale. Mean data were analyzed for significant difference by ANOVA and paired t‐test. During the meclofenamate sodium period, there was a significant decrease of days with painful events compared to the wash‐out period in group I and compared to the placebo period in group 2. In the majority of patients, the meclofenamate sodium period scored lowest or second‐lowest after the follow‐up period in mean pain intensity. Data for pressure threshold, although not significant, were indicative of a possible increase during and after intake of meclofenamate sodium. An improvement of thermal symmetry was recorded at the second thermogram in a majority of patients. It is concluded that meclofenamate sodium showed a consistent analgesic effect in our patients, compared to the placebo.