Bahadori Shahnaz, Ahmadzadeh Arman, Shams Ardekani Mohammad Reza, Kamalinejad Mohammad, Keshavarz Mansoor, Salamzadeh Jamshid
Faculty of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.
Department of Rheumatology, Loghman-e Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Iran J Pharm Res. 2016 Fall;15(4):933-940.
Rheumatoid arthritis (RA) patients are vulnerable to cardiovascular morbidity and mortality in which atherosclerosis plays a major role. In this study, the lipid profile and fasting blood sugar (FBS) of RA patients receiving a complementary medicine of olive and fig, as add-on therapy for routine disease-modifying antirheumatic drugs (DMARDs) regimen containing low dose methotrexate (MTX), were studied. A randomized controlled clinical trial was designed. Adult RA patients were randomly allocated in two groups receiving routine DMARDs regimen (control group) and routine DMARDs regimen plus the herbal supplementary formulation of olive oil, fig and olive fruits (intervention group). Patients were followed every 4 weeks for total study period of 16 weeks. In addition to demographic and medical history of the patients, the total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), the atherogenic index of plasma (AIP) defined as log(TG/HDL-C), and the fasting blood sugar (FBS) were determined and recorded. 56 patients (control = 27 and intervention = 29), with mean ± sd age of 50.9 ± 12.3 years completed the study. Average MTX dose received by intervention and control groups were 24.30 ± 18.39 and 17.61 ± 15.53 mg/week, respectively (p = 0.11). Repeated measures analysis of variance (ANOVA) revealed that differences between lipid profile indicators and FBS in the two study groups were not statistically significant (P>0.05). No additional substantial adverse reaction was seen in the study groups. Our findings are more reassuring for patients and their doctors to trust on the safety of the investigated complementary preparation to be used as add-on therapy to manage rheumatoid arthritis.
类风湿关节炎（RA）患者易患心血管疾病，动脉粥样硬化在其中起主要作用。在本研究中，对接受橄榄油和无花果补充药物作为含低剂量甲氨蝶呤（MTX）的常规改善病情抗风湿药物（DMARDs）方案附加治疗的RA患者的血脂谱和空腹血糖（FBS）进行了研究。设计了一项随机对照临床试验。成年RA患者被随机分为两组，一组接受常规DMARDs方案（对照组），另一组接受常规DMARDs方案加橄榄油、无花果和橄榄果的草药补充制剂（干预组）。在为期16周的总研究期间，每4周对患者进行随访。除了患者的人口统计学和病史外，还测定并记录了总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、高密度脂蛋白胆固醇（HDL-C）、甘油三酯（TG）、定义为log（TG/HDL-C）的血浆致动脉粥样硬化指数（AIP）以及空腹血糖（FBS）。56例患者（对照组 = 27例，干预组 = 29例）完成了研究，平均年龄±标准差为50.9±12.3岁。干预组和对照组接受的MTX平均剂量分别为24.30±18.39和17.61±15.53 mg/周（p = 0.11）。重复测量方差分析（ANOVA）显示，两个研究组的血脂谱指标和FBS之间的差异无统计学意义（P>0.05）。研究组未观察到额外的严重不良反应。我们的研究结果让患者及其医生更放心地相信所研究的补充制剂作为类风湿关节炎附加治疗的安全性。
