背景:类风湿性关节炎(RA)是一种多样化的疾病,其特征是变量,与疼痛相关的关节和关节外症状的进行性过程,残疾,和死亡率。类风湿关节炎的确切原因仍在调查中,这种衰弱没有治疗方法,持久性,痛苦的疾病。Qurs-e-Mafasil,一种草药Unani制剂,被认为是对Waja\'al-Mafasil的有效治疗,临床上与类风湿性关节炎相似的情况,但是科学证据很少。
目的:本研究旨在评估Qurs-e-Mafasil与塞来昔布治疗类风湿关节炎患者的非劣效性。
方法:这项随机对照试验是对年龄在35至55岁之间的70例诊断为类风湿性关节炎的患者进行的。参与者以3:2的比例随机分配,试验组42名参与者,对照组28名参与者。试验组服用2片(每片500毫克)Qurs-e-Mafasil,对照组给予塞来昔布100mg胶囊1粒。两种药物都递送了4周。主要结局指标是基于治疗前后评估的疾病活动评分28(DAS28)的欧洲抗风湿病联盟(EULAR)反应标准。而次要结局指标是通过100mm视觉模拟量表(VAS)在基线和每次随访时确定的关节疼痛严重程度的变化.根据每次随访时的不良事件监测和实验室检查(包括血象)评估干预措施的安全性。肝功能测试(LFTs),肾功能测试(KFTs),在基线和治疗4周后进行完整的尿液检查。
结果:对完成研究持续时间的50名参与者(测试组30名,对照组20名)进行了符合方案分析。因此,在审判结束时,根据EULAR应答标准,试验组和对照组参与者有中度应答或无应答.无反应与中度反应的比值比为0.71(95%CI:0.20-2.55),p=0.744。此外,观察到的第1点的VAS评分的平均差异,2nd,3rd,最终随访为0.33(95%CI:-0.6.65至5.99,p=0.916),0.50(95%CI:-5.63至6.63,p=0.870),2.42(95%CI:-2.95至7.78,p=0.370),和3.00(95%CI:-1.82至7.84,p=0.219),分别。
结论:两组之间主要和次要结局的差异表明Qurs-e-Mafāsil,一种含有生姜的草药Unani配方,秋葵黄体,PipernigrumL.水果,和Withaniasomnifera(L.)杜纳尔。根,在治疗类风湿性关节炎方面与塞来昔布相当。
BACKGROUND: Rheumatoid arthritis (RA) is a diverse disease characterized by a variable, progressive course of articular and extra-articular symptoms that are linked with pain, disability, and mortality. The exact cause of rheumatoid arthritis is still being investigated, and there is no cure for this debilitating, persistent, painful disease. Qurs-e-Mafasil, a herbal Unani preparation, is regarded as a potent treatment for Waja\'al-Mafasil, a condition clinically similar to rheumatoid arthritis, but scientific evidence is scarce.
OBJECTIVE: This
study aimed to assess the non-inferiority of Qurs-e-Mafasil compared to celecoxib in the treatment of patients with rheumatoid arthritis.
METHODS: This randomized controlled
trial was conducted on seventy patients diagnosed with rheumatoid arthritis between the ages of 35 and 55 years. The participants were randomly allocated in a ratio of 3:2, with 42 participants in the test group and 28 participants in the control group. The test group was administered 2 tablets (each having 500 mg) of Qurs-e-Mafasil, while the control group was administered 1 capsule of Celecoxib 100 mg. Both medications were delivered for four weeks. The primary outcome measure was European League Against Rheumatism (EULAR) response criteria based on Disease Activity Score-28 (DAS28) assessed before and after therapy, whereas the secondary outcome measure was the change in joint pain severity as determined by a 100 mm Visual Analog Scale (VAS) at baseline and each follow-up. The safety of the interventions was evaluated based on adverse event monitoring at each follow-up and laboratory tests including hemogram, Liver Function Tests (LFTs), Kidney Function Tests (KFTs), and a complete urine examination performed at baseline and after four weeks of treatment.
RESULTS: The per-protocol analysis was done on 50 participants (30 in test group and 20 in control group) who completed the
study duration. Thus, at the conclusion of the
trial, participants in the test and control groups had either a moderate or no response based on EULAR response criteria. The odds ratio for no response versus moderate response between the test and the control groups was 0.71 (95% CI: 0.20-2.55) with p = 0.744. Moreover, the observed mean differences in VAS scores between the test and the control groups at 1st, 2nd, 3rd, and final follow-up were -0.33 (95% CI: -6.65 to 5.99, p = 0.916), 0.50 (95% CI: -5.63 to 6.63, p = 0.870), 2.42 (95% CI: -2.95 to 7.78, p = 0.370), and 3.00 (95% CI: -1.82 to 7.84, p = 0.219), respectively.
CONCLUSIONS: The differences in primary and secondary outcomes between the two groups indicate that Qurs-e-Mafāsil, a herbal Unani formulation containing Zingiber officinale Roscoe rhizome, Colchicum luteum Baker root, Piper nigrum L. fruit, and Withania somnifera (L.) Dunal. root, is comparable to celecoxib in the treatment of rheumatoid arthritis.