Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
Department of Gastroenterology, Ezhou Hospital of Traditional Chinese Medicine, Ezhou 436000, China.
J Tradit Chin Med. 2023 Jun;43(3):552-558. doi: 10.19852/j.cnki.jtcm.2023.03.005.
To evaluate the effectiveness and safety of Xiangsha Liujun pills on the decreased digestive function in patients in the recovery phase of the Coronavirus disease 2019 (COVID-19).
A randomized, double blind, placebo controlled clinical trial was conducted. A total of 200 COVID-19 patients in the recovery phase were included in our study in Ezhou Hospital of Traditional Chinese Medicine. Totally 200 subjects were randomly divided into a treatment group (Xiangsha Liujun pills) and a control group (placebo), with 100 in each group. Subjects took Xiangsha Liujun pills or placebo orally three times a day for two weeks. Three visits were scheduled at week 0 (baseline), week 1 (the middle of the intervention) and week 2 (the end of the intervention) for each eligible patient. The total efficacy rates for improving the Traditional Chinese Medicine (TCM) symptoms (fatigue, poor appetite, abdominal distension and loose stools) and the disappearance rates of symptoms were observed and compared in the treatment and control groups. Adverse events were recorded during the study period. SAS 9.4 was used to analyze the data.
A total of 200 patients were included in this study, among which 4 participants withdrew because the drugs did not work. Three patients were excluded for age. Before the treatment, there was no significant difference between the TCM symptoms scores of subjects. After 1 week of treatment, the full analysis set (FAS) showed that the efficacy rates for abdominal distension and loose stools in the treatment group were significantly higher than the control group ( 0.05). There were no significant differences in the efficacy rates for fatigue and poor appetite between the two groups (0.05). In addition, the disappearance rate of fatigue in the treatment group was significantly higher than the control group (0.05); there were no significant differences between the two groups after treatment in the rates of poor appetite, abdominal distension, and loose stools (>0.05). After 2 weeks of treatment, the efficacy rates for fatigue, poor appetite, abdominal distension, and loose stools in the treatment group were significantly higher than the control group (0.05). The disappearance rate of loose stools in the treatment group was significantly higher than the control group ( 0.05). However, there were no significant differences in the disappearance rates of fatigue, poor appetite, and abdominal distension between the two groups ( 0.05). No severe adverse events were reported by subjects during the study.
This clinical study confirmed that Xiangsha Liujun pills can effectively improve the symptoms related to the decreased digestive function in COVID-19 convalescent patients.
评估香砂六君丸对新型冠状病毒肺炎（COVID-19）恢复期患者消化功能减退的疗效和安全性。
采用随机、双盲、安慰剂对照的临床试验方法。本研究共纳入 200 例在鄂州市中医医院治疗的 COVID-19 恢复期患者。将 200 例患者随机分为治疗组（香砂六君丸）和对照组（安慰剂），每组 100 例。两组患者均口服香砂六君丸或安慰剂，每日 3 次，疗程 2 周。每例合格患者分别在第 0 周（基线）、第 1 周（干预中期）和第 2 周（干预结束）进行 3 次访视。观察并比较两组患者改善中医症状（乏力、纳差、腹胀、便溏）的总有效率和症状消失率。研究期间记录不良事件。采用 SAS 9.4 进行数据分析。
本研究共纳入 200 例患者，其中 4 例因药物无效退出，3 例因年龄不符被排除。治疗前，两组患者中医症状评分无显著差异。治疗 1 周后，全分析集（FAS）显示治疗组腹胀、便溏的疗效显著高于对照组（P＜0.05）；两组患者乏力、纳差的疗效无显著差异（P＞0.05）。此外，治疗组乏力症状消失率显著高于对照组（P＜0.05）；治疗后两组患者纳差、腹胀、便溏的消失率无显著差异（P＞0.05）。治疗 2 周后，治疗组乏力、纳差、腹胀、便溏的疗效均显著高于对照组（P＜0.05）；治疗组便溏的消失率显著高于对照组（P＜0.05）。然而，两组患者乏力、纳差、腹胀的消失率无显著差异（P＞0.05）。研究期间，受试者未报告严重不良事件。
本临床研究证实，香砂六君丸可有效改善 COVID-19 恢复期患者与消化功能减退相关的症状。
