Pregabalin Versus Amitriptyline in the Treatment of Fibromyalgia Patients (A Double Blind Comparative Study)


ABSTRACT:BACK GROUND:Fibromyalgia is a disorder characterized by widespread musculoskeletal pain, fatigue, sleep and mood disturbances. Its etiology and treatment remain challenging. Oxidative stress may play a role in its pathogenesis.OBJECTIVE:The efficacy of pregabalin to that of amitriptyline on FM and the effect of treatment on oxidative status were examined.METHODS:123 patients fulfilling the Wolfe 2010 criteria for fibromyalgia diagnosis and assessment were randomized to receive amitriptyline (25 mg) or pregabalin (75 mg) once daily for 12 weeks. The revised fibromyalgia impact questionnaire criteria were also used. Malondialdehide and glutathaion levels were checked at the beginning and at the end of the study.RESULTS: Improvement in the pain was better with pregabalin than with amitriptyline (P=0.0001) at 4 weeks of treatment, but achieved comparable improvement at 8 and 12 weeks. The reduction in the somatic symptoms scale was significant for both drugs in favour of pregabalin. Sleep was improved significantly but pregabalin over amitriptyline (P=0.0001). Oxidative status was significantly improved.CONCLUSION:Both drugs improved the symptoms. Pregabalin was better than amitriptyline concerning SSS and sleep, but with a comparable effect on pain. Oxidative status was improved. Amitriptyline was better than pregabalin concerning patient compliance and tolerability.