Zanette Simone de Azevedo, Born Ilca Greca, Brenol João Carlos Tavares, Xavier Ricardo Machado
Serviço de Reumatologia, Hospital de Clínicas de Porto Alegre, Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.
Clin Rheumatol. 2008 May;27(5):627-35. doi: 10.1007/s10067-007-0759-y. Epub 2007 Nov 8.
We evaluated the efficacy of acupuncture as a useful adjuvant treatment in the management of rheumatoid arthritis (RA). A pilot, randomized, double-blind, and controlled clinical trial was conducted. Forty RA patients with active disease despite stable therapy for at least the preceding 1 month were randomized to receive a standard protocol of acupuncture (AC) or superficial acupuncture at non-acupuncture points (controlAC) for 9 weeks. The primary outcome was achievement of 20% improvement according to the American College of Rheumatology (ACR) 20 criteria after five and ten treatment sessions and after 1 month of follow-up. Secondary measures included Disease Assessment Scale (DAS), tender and swollen joint count, morning stiffness, Health Assessment Questionnaire (HAQ), visual analogue scale (VAS) of pain, physician global assessment of activity disease, physician and patient global assessment of treatment, and inflammatory markers (erythrocyte sedimentation rate and C-reactive protein). There was not significant difference between the groups regarding the number of patients that reached ACR20 at the end of the treatment (p=0.479). However, after 1 month of follow-up, there was a trend in favor of the AC group, with p=0.068. Compared with the controlAC, the AC group also demonstrated significant improvement in the patient and physician global assessment of treatment and physician global assessment of disease activity, but there was no difference on other clinical and laboratorial measures. On the other hand, only the AC patients had within group improvement on the variables DAS, HAQ, morning stiffness, patient and physician global assessment of treatment, and physician global assessment of disease activity in comparison to baseline visit. Despite the improvement of some studied variables, there was no significant difference in the proportion of patients that reached ACR20 between the AC and controlAC groups. This negative result can be related to the small sample size, selection of patients, type of acupuncture protocol applied, and difficulties in establishing an innocuous and trustworthy placebo group to studies involving acupuncture.
我们评估了针灸作为类风湿性关节炎(RA)管理中一种有用辅助治疗方法的疗效。开展了一项初步的随机双盲对照临床试验。40例尽管在至少前1个月接受稳定治疗但仍患有活动性疾病的RA患者被随机分为两组,一组接受标准针灸方案(AC组),另一组接受非穴位浅刺(对照AC组),为期9周。主要结局是根据美国风湿病学会(ACR)20条标准,在治疗5次和10次后以及随访1个月后实现20%的改善。次要指标包括疾病评估量表(DAS)、压痛和肿胀关节计数、晨僵、健康评估问卷(HAQ)、疼痛视觉模拟量表(VAS)、医生对疾病活动的整体评估、医生和患者对治疗的整体评估以及炎症标志物(红细胞沉降率和C反应蛋白)。在治疗结束时达到ACR20的患者数量在两组之间没有显著差异(p = 0.479)。然而,在随访1个月后,有倾向于AC组的趋势,p = 0.068。与对照AC组相比,AC组在患者和医生对治疗的整体评估以及医生对疾病活动的整体评估方面也显示出显著改善,但在其他临床和实验室指标上没有差异。另一方面,与基线访视相比,只有AC组患者在DAS、HAQ、晨僵、患者和医生对治疗的整体评估以及医生对疾病活动的整体评估等变量上有组内改善。尽管一些研究变量有所改善,但AC组和对照AC组之间达到ACR20的患者比例没有显著差异。这一阴性结果可能与样本量小、患者选择、所应用的针灸方案类型以及在涉及针灸的研究中建立无害且可信的安慰剂组的困难有关。
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