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.

To assess the effect of medicine-qi intake type of Bigu in healthy people using real-world data.

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.

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) .

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.

辟谷是我国一种历史悠久的、以减少食物摄入为主要思想的养生理念，现代研究证实其在部分疾病的治疗中能发挥良好效果。但因不能强行控制受试者饮食摄入，辟谷人体试验的可行性较差。

探究"服药-服气"辟谷试验对真实世界健康人群的影响。

于2018年11月至2020年9月选择四川护理职业学院招募的280例健康受试者，记录其一般资料后采用真实世界研究中的倾向性评分匹配法（PSM）对受试者进行1∶1最近邻匹配并均分为A、B组，每组140例，随后采用"隔日限食"方案进行两轮试验。首轮试验A组单纯辟谷限食10 d，B组"服药-服气"辟谷限食10 d。首轮试验结束后，经1个月的间隔洗脱期再进行次轮试验。次轮试验A组"服药-服气"辟谷限食10 d，B组单独辟谷限食10 d。统计两组在两轮试验中的不良反应出现情况及中止试验人数，记录两组完成两轮试验的受试者在辟谷开始前及辟谷结束时的自觉饥饿强度评分、体质量、体质指数（BMI）、晨起血压（收缩压、舒张压）和空腹血糖。

经PSM匹配后A组男72例、女80例；B组男61例、女67例。首轮试验A组不良反应发生率为65.7%（92/140），试验中止率为48.6%（68/140）；B组不良反应发生率为42.9%（60/140），试验中止率为20.0%（28/140）。首轮试验A组不良反应发生率、试验中止率高于B组（P<0.05）。次轮试验A组不良反应发生率为29.2%（41/140），试验中止率为13.6%（19/140）；B组不良反应发生率为60.0%（84/140），试验中止率为42.1%（59/140）。次轮试验A组不良反应发生率、试验中止率低于B组（P<0.05）。首轮试验A组辟谷结束时自觉饥饿强度评分高于辟谷开始前，B组辟谷结束时自觉饥饿强度评分低于辟谷开始前（P<0.05）。次轮试验A组辟谷结束时自觉饥饿强度评分低于辟谷试验开始前（P<0.05）。A、B组在两轮试验辟谷结束时的体质量、BMI、收缩压、舒张压、空腹血糖均低于辟谷开始前（P<0.05）。

传统辟谷养生术的"服药-服气"法作用于真实世界的健康人群能有效减少饥饿感和不良反应发生率，提高辟谷完成率，这为辟谷的推广提供了一定借鉴。