Cardini Francesco, Lombardo Pietro, Regalia Anna Laura, Regaldo Giuseppe, Zanini Alberto, Negri Maria Grazia, Panepuccia Lea, Todros Tullia
Istituto Superiore di Sanità, Roma, Italy.
BJOG. 2005 Jun;112(6):743-7. doi: 10.1111/j.1471-0528.2005.00634.x.
To evaluate the efficacy of moxibustion for the correction of fetal breech presentation in a non-Chinese population.
Single-blind randomised controlled trial (RCT).
Six obstetric departments in Italy.
Healthy non-Chinese nulliparous pregnant women at 32-33 weeks + 3 days of gestational age with the fetus in breech presentation.
Random assignment to treatment or observation. Treatment consisted of moxibustion (stimulation with heat from a stick of Artemisia vulgaris) at the BL 67 acupuncture point (Zhiyin) for one or two weeks. Two weeks after recruitment, each participant was subjected to an ultrasonic examination of the fetal presentation.
Number of participants with cephalic presentation in the 35th week.
The study was interrupted when 123 participants had been recruited (46% of the planned sample). Intermediate data monitoring revealed a high number of treatment interruptions. At this point no difference was found in cephalic presentation in the 35th week (treatment group: 22/65, 34%; control group: 21/58, 36%; RR 0.95; 99% CI 0.59-1.5).
The results underline the methodological problems evaluating of a traditional treatment transferred from a different cultural context. They do not support either the effectiveness or the ineffectiveness of moxibustion in correcting fetal breech presentation.
评估艾灸对非中国人群矫正胎位异常的疗效。
单盲随机对照试验(RCT)。
意大利的六个产科科室。
孕龄为32 - 33周+3天、胎位异常的健康非中国初产妇。
随机分为治疗组或观察组。治疗组采用艾灸(用艾条温热刺激)至阴穴(BL 67),为期一至两周。招募两周后,对每位参与者进行胎儿胎位超声检查。
第35周时头先露的参与者数量。
招募了123名参与者(占计划样本的46%)后研究中断。中期数据监测显示治疗中断的情况较多。此时,第35周时头先露情况无差异(治疗组:22/65,34%;对照组:21/58,36%;相对危险度0.95;99%可信区间0.59 - 1.5)。
结果凸显了评估从不同文化背景移植过来的传统治疗方法时存在的方法学问题。它们既不支持艾灸矫正胎位异常的有效性,也不支持其无效性。