Modification of Sexual Hormones in Rheumatoid Arthritis Patients by M2000 (β-D-mannuronic Acid) as a Novel NSAID with Immunosuppressive Property

Background: Based on in-vitro, in-vivo and human studies, the β-D-mannuronic acid (M2000) has been introduced as a novel non-steroidal anti-inflammatory drug (NSAID) with immunosuppressive properties. Objective: This study aimed to evaluate the efficacy of this drug on serum level of sex hormones (Estradiol, Progesterone, and DHEAS) in rheumatoid arthritis (RA) patients. Methods: The present research was performed on 10 RA patients who had an inadequate response to conventional treatments (clinical trial identifier: IRCT2014011213739N2). During this trial, the patients were permitted to continue the conventional therapy along with adding M2000 orally at a dose of 500 mg twice daily for 12 weeks. Serum samples were collected in a normal group, patient group (at baseline) and treatment group (after 12 weeks). The samples were tested for evaluating the serum level of Estradiol, Progesterone, and DHEAS using chemiluminescent microparticle immunoassay. Results: Data showed that the serum level of estradiol was reduced (both in men and women) during the treatment with M2000 (after 12 weeks), but there was no significant difference in the non-treated group with M2000 (p > 0.05). In addition, the serum level of progesterone and DHEAS significantly increased following the 12-week administration of M2000 in both male and female patients, compared to the non-treated group with M2000 (p < 0.001, p < 0.05, p < 0.05, p < 0.01, respectively). Conclusion: The present research showed that the sex hormones might be modified by M2000 therapy in RA patients by increasing the serum level of progesterone and DHEAS compared to healthy individuals.