Aims: To study the role of combination therapies in the treatment of rheumatoid arthritis. Study Design: This an open-label, randomized 180-days clinical trial. Place and Duration of Study: This study was conducted in the Department of Pharmacology and Therapeutics, BMSI and Medical unit ward 6, after approval of JPMC ethical committee, between March 2013 and May 2014. Methodology: We included 90 patients (69 women, 21 men; age range 28-62 years) which were divided into two groups, A and B. 44 patients of group A received methotrexate (MTX) 7.5-20 mg/ week orally and Leflunomide (LEF) 10-20 mg/ day QD orally as maximally tolerated. 46 patients of group B were given MTX 7.5-20 mg/ week orally and Hydroxychloroquine (HCQ) 200 mg twice daily orally as maximally tolerated. Results: Comparing the combination of group A with group B, group A showed highly significant improvement in mean patient’s global assessment (1.4 ± 0.66) and mean pain (1.3 ± 1.11) as compared to group B (2.4 ± 1.14, 2.2 ± 1.49). The drugs of group B showed significant improvement in mean physician’s global assessment (1.7 ± 0.92) and mean morning stiffness (49.2 ± 10.59) as compared to group A (2.8 ± 0.97, 54.4 ± 10.14). Combination treatment of group B showed significantly lower adverse effects (4.3%) as compared to group A (11.4%). Statistical analysis revealed that patients receiving both the combinations responded equally in terms of effects but group B showed significantly better in terms of adverse effects. Conclusion: Both combinations of MTX & LEF and MTX & HCQ were well tolerated but the efficacy of MTX and HCQ was significantly superior in terms of adverse effects to the combination of MTX and LEF.
Aims: To study the role of two combination therapies in the treatment of rheumatoid arthritis. Study Design: This an open-label, randomized 180-days clinical trial. Place and Duration of Study: This study was conducted in the Department of Pharmacology and Therapeutics, BMSI and Medical unit ward 6. Methodology: Eighty-nine patients were enrolled (69 women, 20 men; age range 28-62 years). A and B were the groups assigned to the patients. MTX 7.5-20 mg/ week orally and SSZ 10-20 mg / day orally as maximally tolerated were prescribed to the 55 patients of group A. MTX 7.5-20 mg/ week orally and HCQ 200 mg twice daily were prescribed to the 54 patients of group B.. Results: When we compared group A with group B, group A showed major progress in mean swollen joint count (1.9 ± 0.97) as compared to group B (2.7 ± 1.78). Group B showed major progress in mean physician’s global assessment (2.7 ± 0.92) as compared to group A (3.8 ± 1.22). For that reason, our study showed that patients receiving both the combinations responded equally in terms of efficacy but the combination of MTX and HCQ is better tolerated than the combination of MTX and SSZ. Conclusion: Both combinations of MTX & SSZ and MTX & HCQ were equally effective but the combination of MTX & HCQ was superior in terms of tolerability than the combination of MTX and SSZ.
Objectives: To compare the role of low dose Theophylline and Tiotropium rotacap in improving the lung functions and day to day life of patients suffering from COPD. Study Design and Setting: A Clinical trial study was conducted at Department of Pharmacology and Therapeutics, BMSI in association with Department of Chest Medicine, JPMC. Methodology: This study was planned as an open label and parallel clinical trial study. A total of 168 patients of COPD were selected for this study and only 161 patients completed the 3 months duration of the study. The enrolled patients were grouped into 2, namely A and B. Tab. Theophylline 350 mg was given to Group A in two divided doses while Tiotropium rotacap18µg through rotahaler was given to group B once a day. Results: Mean FEV1 ± SD was improved by 0.04 ± 0.02 in Theophylline therapy group while by 0.07 ± 0.01 in the Tiotropium therapy treated group and a significant difference between the changes in the two treatment groups was evident. There was a percentage improvement in PEFR of 8.9 ± 5.8 in the Theophylline therapy treated group and of 13.2 ± 4.7 in Tiotropium therapy treated group. When Tiotropium group was compared with Theophylline group for improvement in percentage change in PEFR from day 0, a significant difference was evident between the two groups. There was a significant improvement from day 0 in CAT score in Tiotropium treated groups versus Theophylline group after 3 months of therapy. Conclusion: Tiotropium rotacap was more effective as compared to low dose Theophylline in improving pulmonary functions and CAT score in patients with COPD
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