CAMDA Data Set No. 03

The Evaluation of the Efficacy, Safety, and Tolerability of Moxibustion on Acupuncture Point Zhiyin (67 UB) for Correction of Abnormal Presentation, 1995-1996
Francesco Cardini and Huang Weixin

The Evaluation of the Efficacy, Safety, and Tolerability of Moxibustion on Acupuncture Point Zhiyin (67 UB) for Correction of Abnormal Presentation was conducted between 1995 and 1996 at two women's hospitals in the Jiangxi Province of the People's Republic of China. The study was conducted to evaluate the efficacy and safety of moxibustion (burning herbs to stimulate acupuncture points) on acupuncture point Zhiyin (beside the outer corner of the fifth toenail) as a means of promoting inversion of fetuses in breech presentation, by way of increasing fetal activity. The study was a randomized, controlled, open clinical trial that lasted two weeks. The study involved 260 women, pregnant for the first time, in the 33rd week of gestation, and with breech presentation, diagnosed by ultrasound. Patients were randomly assigned to receive either one or two 30-minute moxibustion sessions per day or to receive routine care. All patients were evaluated at baseline, during examinations in the 35th week, and during an after-birth appointment. Patients receiving moxibustion were also evaluated during examinations in the 34th week and if breech presentation persisted, moxibustion was administered for another week. In addition, patients monitored active fetal movements during their duration in the trial. The primary outcome variables are number of cephalic presentations at the 35th week of gestation and at birth and fetal motor activity. Secondary outcome variables include compliance with treatment, adverse effects experienced, cephalic presentations at the 34th week, cephalic presentations for different dosages of moxibustion, number of cesarean deliveries, number of spontaneous and induced vaginal deliveries, and Apgar scores at 5 minutes. The dataset contains 145 variables collected from 260 patients.

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