Randomized Double Masked Trial of Zhi Byed 11, a Tibetan Traditional Medicine, Versus Misoprostol to Prevent Postpartum Hemorrhage in Lhasa, Tibet

Abstract

The objective of this study was to compare a Tibetan traditional medicine (the uterotonic Zhi Byed 11 [ZB11]) to oral misoprostol for prophylaxis of postpartum hemorrhage (PPH). We conducted a double-blind randomized controlled trial at three hospitals in Lhasa, Tibet, People’s Republic of China. Women (N = 967) were randomized to either ZB11 or misoprostol groups. Postpartum blood loss was measured in a calibrated blood collection drape. The primary combined outcome was incidence of PPH, defined as measured blood loss (MBL) ≥ 500 mL, administration of open label uterotonics, or maternal death. We found that the rate of the combined outcome was lower among the misoprostol group (16.1% versus 21.8% for ZB11; P = .02). Frequency of PPH was lower with misoprostol (12.4% versus 17.4%; P = .02). There were no significant differences in MBL > 1000 mL or mean or median MBL. Fever was significantly more common in the misoprostol group (P = .03). The rate of combined outcome was significantly lower among women receiving misoprostol. However, other indices of obstetric hemorrhage were not significantly different.

Community‐based distribution of misoprostol for treatment or prevention of postpartum hemorrhage: Cost‐effectiveness, mortality, and morbidity reduction analysis

“…Further, if the prophylactic dose was associated with pyrexia or marked shivering, then at least 6 hours should pass between doses [15,16]. The exact percentage of women who hemorrhage despite misoprostol prophylaxis is unknown; rates range from 6% [6] to 12% [17].…”

Tibetan Medicine: A Systematic Review of the Clinical Research Available in the West

“…A whole medical system approach with a complex traditional TM intervention was applied in 3 studies on diabetes mellitus [43], arthritis, [58] or hepatitis B [59]. Tibetan yoga in lymphoma patients [60] and a single TM preparation (Zhi Byed 11) for postpartum haemorrhage [44] were each the subject of 1 RCT. One study [61] was declared an RCT but lacked randomization.…”

“…From those publications including herbal medicines, four did not provide details on the used medication [42, 58, 59, 62], two provided the name of the preparations but not the ingredients [43, 48], and two provided the name of the preparation and ingredients, but no information on the quantity of the ingredients [44, 63]. Data on both ingredients and their quantity was only available for Padma 28 and Padma Lax.…”

Tibetan medicine: a unique heritage of person-centered medicine

“…The leading research regarding multi-ingredient formulas come from the Padma Company who produce standardized herbal formulas developed from Tibetan medical knowledge [42][43][44][45]. In addition there has been research focusing on pregnancy and birth, in particular using the fomula Zhi Byed 11 [46][47][48]. It is important that companies such as these and others interested in research be supported by Governments.…”