Topiramate in treatment of patients with chronic low back pain: a randomized, double-blind, placebo-controlled study.

Objective: Chronic low back pain (CLBP) is a widespread ailment. The aim of this study was to assess the efficacy of topiramate in the treatment of CLBP and the changes in anger status and processing, body weight, subjective pain-related disability and health-related quality of life during the course of treatment.

Methods: We conducted a 10-week, randomized, double-blind, placebo-controlled study of topiramate in 96 (36 women) patients with CLBP. The subjects were randomly assigned to topiramate (n=48) or placebo (n=48). Primary outcome measures were changes on the McGill Pain Questionnaire, State-Trait Anger Expression Inventory, Oswestry Low Back Pain Disability Questionnaire and SF-36 Health Survey scales, and in body weight.

Results: In comparison with the placebo group (according to the intent-to-treat principle), significant changes on the pain rating index of McGill Pain Questionnaire (Ps<0.001), State-Trait Anger Expression Inventory Scales (all Ps<0.001), Oswestry Low Back Pain Disability Questionnaire (P<0.001), and SF-36 Health Survey scales (all P<0.001, except on the role-emotional scale) were observed after 10 weeks in the patients treated with topiramate. Weight loss was also observed and was significantly more pronounced in the group treated with topiramate than in those treated with placebo (P<0.001). Most patients tolerated topiramate relatively well but 2 patients dropped out because of side effects.

Discussion: Topiramate seems to be a relatively safe and effective agent in the treatment of CLBP. Significantly positive changes in pain sensitivity, anger status and processing, subjective disability, health-related quality of life, and loss of weight were observed.