Abstract
OBJECTIVES: Disease-modifying anti-rheumatic drugs (DMARDs) are conventionally used in rheumatoid arthritis (RA). The role of spironolactone as add on therapy to DMARDs in RA patients was evaluated. MATERIAL AND METHODS: A total of 100 patients with rheumatoid arthritis diagnosed as per 1987 criteria having evidence of active disease despite ongoing DMARD therapy were enrolled in this study. Patients were assigned randomly to two groups. Group I (n = 50) patients were treated with 50 mg/day of spironolactone along with their maintenance DMARD and NSAID therapy. Group II (n = 50) patients continued their maintenance DMARD therapy without spironolactone. Disease activity was assessed using the Disease Activity Score-28 (DAS28) and the Clinical Disease Activity Index (CDAI) in each patient of each group was evaluated monthly for the next three months. RESULTS: All patients completed the study. Mean age of group I was 46.44 ±11.67 and of group II 44.52 ±11.82. DAS28 assessed in time according to the schedule was for group I 6.78 ±0.74, 5.34 ±0.74, 3.98 ±0.7, 3.00 ±0.75, while in group II it was 6.61 ±0.82, 5.49 ±0.90, 4.58 ±0.81, 3.55 ±0.93 at baseline, 4, 8, and 12 weeks respectively. CDAI in group I was 41.68 ±11.14, 24.36 ±8.13, 12.34 ±5.73, 6.42 ±4.4 and in group II 37.84 ±11.12, 24.54 ±9.4, 16.38 ±6.81, 9.62 ±6.1 at baseline, 4, 8, and 12 weeks respectively. Group I showed significant improvement in disease activity in the form of tender joint count (p = 0.001), swollen joint count (p = 0.023), patient global assessment (p = 0.001), physician global health (p = 0.001), DAS28 (p < 0.001) and CDAI (p = 0.001) but other parameters showed non-significant improvement compared to group II. No serious adverse events were observed in either group during the course of the study. CONCLUSIONS: Spironolactone as an adjuvant therapy can improve the effect of conventional DMARD treatment of patients with RA.