Efficacy of pregabalin as a monotherapy versus combined pregabalin and milnacipran in the management of fibromyalgia.

AIM To compare the efficacy and tolerability of combined pregabalin (PGB) and milnacipran (MLN) in female patients with fibromyalgia (FM) versus PGB as a monotherapy. METHODS The present randomized open study included 58 female patients diagnosed with FM (registered on 4/2/19: NCT03905486). Patients were randomly divided into 2 groups (2:2); group 1 included 29 patients who received PGB monotherapy (150 mg twice daily) and group 2 included 29 patients who received combined PGB (150 mg twice daily) and MLN (50 mg twice daily) for 3 months. At the initial visit, patients were subjected to demographic data collection and assessed by the visual analog scale (VAS) for pain and the FM impact questionnaire (FIQ). Outcome measures after 3 months: FIQ, VAS and Leeds Sleep Evaluation Questionnaire. RESULTS The median disease duration was 2 years in group 1 (6 months to 5 years) and 2 years in group 2 (6 months to 12 years). The dropout rate was 20.7% in group 1 (n = 6) and 10.3% in group 2 (n = 3). At the follow-up evaluation, a statistically significant improvement was observed in VAS and FIQ scores in both groups (P < 0.001). Although the percentage of patients demonstrating significant improvement in pain, disease impact and sleep pattern were higher in group 2, this did not reach statistical significance. CONCLUSION Although PGB as a monotherapy and in combination with MLN have both shown adequate efficacy in the treatment of patients with FM, the combined therapy did not demonstrate superiority over the monotherapy.