Efficacy and safety of nitazoxanide and escitalopram as adjuvant therapies in patients with rheumatoid arthritis: a randomized controlled study

Abstract

Objective This research aimed at evaluating the effectiveness and safety of nitazoxanide and escitalopram as adjuvant therapies in patients with rheumatoid arthritis (RA). Methods In this randomized controlled parallel study, 90 patients with active RA were randomized into three groups; group 1 (control group; n = 30) which received traditional therapy, group 2 (Nitazoxanide group; n = 30) which received traditional therapy plus 1 gm/day oral nitazoxanide, and group 3 (Escitalopram group; n = 30) which received traditional therapy plus 10 mg/day oral escitalopram for three months. At baseline and 3 months after treatment, clinical and functional assessments were done through the 28-joint count disease activity score using C-reactive protein (DAS28-CRP), the health assessment questionnaire-disability index (HAQ-DI), and the patient’s global assessment (PGA). Also, serum levels of high-sensitivity C-reactive protein (hs-CRP), signal transducer and activator of transcription-3 (STAT-3), Janus kinase-2 (JAK-2), toll-like receptors 4 (TLR-4), interleukin-1 beta (IL-1β), and malondialdehyde (MDA) were assessed. Data were analyzed using paired t -test and one-way analysis of variance, followed by Tukey’s HDS test. Results Three months after treatment and as compared to the control group, the nitazoxanide group showed a significant decline in PGA ( P = 0.042), and serum levels of STAT-3 ( P < 0.001), JAK-2 ( P < 0.001), TLR-4 ( P < 0.001), and IL-1β ( P < 0.001). On the other hand, the escitalopram group produced a significant decrease in DAS28-CRP score ( P = 0.029), HAQ-DI score ( P = 0.001), and serum levels of JAK-2 ( P = 0.001), TLR-4 ( P < 0.001), IL-1β ( P < 0.001), and MDA ( P < 0.001). As compared to nitazoxanide group, the escitalopram group produced a significant decline in fatigue score ( P < 0.001) and serum levels of both IL-1β ( P = 0.023) and MDA ( P < 0.001). Both medications were safe; however, chromaturia was the only significant nitazoxanide-related adverse effect. Conclusion Nitazoxanide and escitalopram could serve as potential adjuvant therapies for patients with RA based on their effectiveness and safety data.

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