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

• Published in: International journal of rheumatic diseases 2020-11, Vol.23 (11), p.1474-1480
• Main Authors: Abdel Fattah, Yousra Hisham, Elnemr, Rehab
• Format: Article
• Language: English
• Subjects: Fibromyalgia; fibromyalgia impact questionnaire; Leeds Sleep Evaluation Questionnaire; milancipran; Pain; pregabalin; Questionnaires; Sleep; Statistical analysis
• ISSN: 1756-1841; 1756-185X
• DOI: 10.1111/1756-185X.13953

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