Zhongguo quanke yixue (Jun 2022)
Efficacy of Traditional Bigu Health-preserving Regimen in Healthy People: a Crossover Trial Using Real-world Data
Abstract
Background Bigu is a health-preserving regimen with a long history advocating appropriately reducing food intake in China, whose efficacy has been confirmed in practical treatment of some diseases currently. However, the applicability of Bigu in human experiments is poor due to nonforcible control of dietary intake in the participants. Objective To assess the effect of medicine-qi intake type of Bigu in healthy people using real-world data. Methods Two hundred and eighty healthy volunteers were recruited from Sichuan Nursing Vocational College from November 2018 to September 2020, and equally divided into two groups (A and B, with 140 cases in each) after being matched using k-nearest neighbor propensity score approach based on their demographics, and received a two-round Bigu trial: in the first round, group A received 10-day diet-restriction type of Bigu, while group B received 10-day medicine-qi intake in combination with diet-restriction type of Bigu. Then, after one-month washout period, the second round was conducted, during which group A received 10-day medicine-qi intake in combination with diet-restriction type of Bigu, while group B received 10-day diet-restriction type of Bigu. Comparisons were performed between two groups in terms of incidence of adverse reactions and number of dropouts in two rounds of Bigu, and subjective hunger sensation, weight, BMI, morning blood pressure, and fasting fingerstick glucose on the first and 10th days of two rounds of Bigu. Results After being assigned by PSM, there were 72 males and 80 females in group A; 61 males and 67 females in group B. In the first round, the incidence of adverse reactions in group A was 65.7% (92/140) , and the trial discontinuation rate was 48.6% (68/140) ; the incidence of adverse reactions in group B was 42.9% (60/140) , and the trial discontinuation rate was 20.0% (28/140) . The incidence of adverse reactions and trial discontinuation rate in group A were higher than those in group B, and the difference was statistically significant (P<0.05) . In the second round, the incidence of adverse reactions in group A was 29.2% (41/140) , and the trial discontinuation rate was 13.6% (19/140) ; the incidence of adverse reactions in group B was 60.0% (84/140) , and the trial discontinuation rate was 42.1% (59/140) . The incidence of adverse reactions and trial discontinuation rate in group A were lower than those in group B, and the difference was statistically significant (P<0.05) . The subjective hunger sensation score at the end of the first round was higher than that before the beginning, and the subjective hunger sensation score in group B at the end was lower than that before the beginning, and the difference was statistically significant (P<0.05) . The subjective hunger sensation score at the end in the second round of group A was lower than that before the beginning, and the difference was statistically significant (P<0.05) . The body weight, BMI, systolic blood pressure, diastolic blood pressure, and fasting blood glucose of groups A and B at the end of the 2-round test were all lower than those before the start of the test, and the difference was statistically significant (P<0.05) . Conclusion This real-world trial demonstrates that the medicine-qi intake type of Bigu may reduce the subjective hunger sensation, and incidence of adverse reactions as well as enhanced the completion rate of Bigu in healthy population, which may be used as a recommended scheme for the promotion of Bigu.
Keywords
