The efficiency and safety of Hou Gu Mi Xi for patients with spleen qi deficiency nonorganic gastrointestinal disorders: 1-year follow-up results in a multicenter, randomized, double blind, controlled trial_Chinese Journal of Evidence-Based Medicine

Authors：

CHEN Xiaofan ¹ , ZHOU Xu ¹ , LIU Wenjun ² , SUN Xin ^1,3 , NIE Heyun ¹ , YAN Dongmei ¹ , FANG Jianhe ¹ , WANG Fei ¹ , NIE Jianhua ¹ , YU Jianwei ⁴ , JIANG Yiping ⁴ , ZHANG Kunhe ⁵ , FU Ying ⁶ , YANG Deping ⁷ , XIONG Yan ⁸ , XU Tielong ¹ ,  ZHU Weifeng ¹

1. Evidence-Based Medicine Research Center, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, P.R.China;
2. School of Food Science and Engineering, Inner Mongolia Agricultural University, Huhehaote 010018, P.R.China;
3. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Sichuan 610041, P.R.China;
4. The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang 330000, P.R.China;
5. Department of Gastroenterology, the First Affiliated Hospital of Nanchang University, Nanchang 330000, P.R.China;
6. Department of Traditional Chinese Medicine, the Second Affiliated Hospital of Nanchang University, Nanchang 330000, P.R.China;
7. Department of Gastroenterology, Nanchang Hospital of Integrated Traditional Chinese and Western Medicine, Nanchang 330000, P.R.China;
8. Department of Internal Medicine, Nanchang Hongdu Hospital of Traditional Chinese Medicine, Nanchang 330000, P.R.China;

Corresponding author：

ZHU Weifeng, Email: zwf0733@163.com

Keywords：

Hou Gu Mi Xi; Spleen qi deficiency; Nonorganic gastrointestinal disorder; Dietary therapy; Randomized controlled trial

DOI：

10.7507/1672-2531.202002097

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Objectives To investigate the efficacy and safety of Hou Gu Mi Xi (HGMX) in patients with nonorganic gastrointestinal disorders (NOGD) from the aspect of dietary therapy.Methods A randomized, double-blind, parallel, placebo-controlled trial was performed. Patients with NOGD and spleen qi deficiency (SQD) syndrome were randomly assigned into HGMX or placebo group. Each received 30 g/day HGMX or placebo for one year. The outcomes included SQD scores, body weight, body mass index (BMI), gastrin-17, and adverse events (AEs) between HGMX and placebo groups, or subgroups divided by NOGD type or helicobacter pylori (Hp) infection, at the 0^th, 2^nd, 4^th, 8^th, 26^th, or 52^nd weeks’ follow-up.Results The reduction of SQD scale score was found in the HGMX group compared with the placebo group at 4^th week (MD=−9.40, 95%CI −18.53 to −0.27, P=0.044), 8^th week (MD=−10.07, 95%CI −19.66 to −0.48, P=0.04), 26^th week (MD=−12.45, 95%CI −22.31 to −2.59, P=0.014) and 52^th week (MD=−17.25, 95%CI −28.53 to −5.97, P=0.003), respectively. In the subgroup analyses, HGMX showed significant efficacy in Hp-negative patients with the detailed reduction of SQD scale score being (MD=−15.20, 95%CI −28.16 to −2.24, P=0.022), (MD=−17.91, 95%CI −31.22 to −4.59, P=0.009) and (MD=−20.38, 95%CI −35.43 to −5.32, P=0.008) at the 8^th, 26^th and 52^nd week, respectively, and in patients with chronic nonatrophic gastritis with the detailed reduction being (MD=−13.02, 95%CI −24.75 to −1.29, P=0.03), (MD=−12.43, 95%CI −24.36 to −0.5, P=0.041) and (MD=−15.90, 95%CI −30.72 to −1.08, P=0.036) at the 2^nd, 26^th and 52^nd week, respectively, and in patients with functional gastrointestinal disease with the reduction being (MD=−18.22, 95%CI −35.75 to −0.69, P=0.042) at the 52^nd week. However, no significant efficacy was found in Hp-positive patient at any time. HGMX was not associated with changes in weight, BMI, or gastrin-17. No AEs were reported in the HGMX group.Conclusions HGMX improves SQD symptoms in patients with NOGD, especially Hp-negative patients, and has a good safety profile.

Citation： CHEN Xiaofan, ZHOU Xu, LIU Wenjun, SUN Xin, NIE Heyun, YAN Dongmei, FANG Jianhe, WANG Fei, NIE Jianhua, YU Jianwei, JIANG Yiping, ZHANG Kunhe, FU Ying, YANG Deping, XIONG Yan, XU Tielong, ZHU Weifeng. The efficiency and safety of Hou Gu Mi Xi for patients with spleen qi deficiency nonorganic gastrointestinal disorders: 1-year follow-up results in a multicenter, randomized, double blind, controlled trial. Chinese Journal of Evidence-Based Medicine, 2020, 20(10): 1142-1149. doi: 10.7507/1672-2531.202002097 Copy

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9.	莫雅冰. 探索完善中医药治疗功能性胃肠病的临床结局评价方法. 中西医结合心血管病电子杂志, 2016, 4(5): 126-127.
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15.	王梅, 于漫, 王淳, 等. 参苓白术散治疗功能性消化不良的meta分析. 中国卫生统计, 2014, 31(6): 939-942.
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17.	李博, 赵迎盼, 高蕊, 等. 中成药治疗功能性消化不良临床试验方案及研究病历设计和实施. 中国新药杂志, 2016, 25(2): 187-192.
18.	Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet, 2000, 356(9237): 1255-1259.
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22.	徐煌钰, 孙灵芝, 周立群. 先秦两汉药膳简史. 中医学报, 2020, 35(5): 1120-1125.
23.	杨黛仙. 易感冒人群食疗药膳方. 农村新技术, 2020, (2): 70.
24.	朱燕, 刘志刚, 秦晋颖. 探索药膳食疗的中医学理论——评《中医药膳食疗》. 中国酿造, 2020, 39(4): 228.
25.	杨闪闪, 王灼慧, 张学智, 等. 幽门螺杆菌感染与脾胃湿热证的相关性探讨. 北京中医药, 2018, 37(10): 938-941.
26.	杜杰. 幽门螺杆菌感染与脾胃湿热证的相关性分析. 系统医学, 2019, 4(7): 129-131.

1. Everhart JE, Ruhl CE. Burden of digestive diseases in the United States Part I: overall and upper gastrointestinal diseases. Gastroenterology, 2009, 136(2): 376-386.
2. Peery AF, Dellon ES, Lund J, et al. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology, 2012, 143(5): 1179-1187.
3. 秦江梅, 张艳春, 张丽芳, 等. 典型城市居民慢性病患病率及患者疾病负担分析. 中国公共卫生, 2014, 30(1): 5-7.
4. 于娟. 慢性萎缩性胃炎患者的危险因素与临床治疗效果. 中国医药指南, 2020, 18(12): 141-142.
5. 范明明, 张嘉裕, 张湘龙, 等. 功能性消化不良造模方法的述评. 世界中医药, 2020, 15(7): 1080-1083.
6. 玉颖, 黄适, 岳珍珍, 等. 功能性消化不良的中医药研究进展. 湖南中医杂志, 2020, 36(4): 172-174.
7. 王文, 张莎, 朱芳红. 肠易激综合征的中医药治疗现状与分析. 中国中医急症, 2020, 29(4): 750-752.
8. 徐晶晶, 黄柳向. 以肠道菌群为靶点治疗肠易激综合征研究进展. 湖南中医杂志, 2020, 36(3): 165-167.
9. 莫雅冰. 探索完善中医药治疗功能性胃肠病的临床结局评价方法. 中西医结合心血管病电子杂志, 2016, 4(5): 126-127.
10. 顾华盾. 中医药疗法与西医疗法治疗功能性胃肠疾病患者的临床效果比较. 中国药物经济学, 2017, 12(5): 72-74.
11. 周海新, 麦联任, 张玲, 等. 功能性胃肠疾病治疗前后抑郁与焦虑情况对比评价. 第三十一届全国中西医结合消化系统疾病学术会议论文集, 2019.
12. 辜沅, 舒青龙. 基于肠道微生态的参苓白术散药理研究进展. 时珍国医国药, 2018, 29(3): 674-676.
13. 刘翠英, 施家希, 黄娟, 等. 参苓白术散对溃疡性结肠炎小鼠紧密连接及MLCK/MLC通路的影响. 中药材, 2018, 41(9): 2180-2184.
14. 汤丽娜. 参苓白术散加减联合艾灸治疗脾胃虚弱证癌因性疲乏的临床疗效观察. 福州: 福建中医药大学, 2019.
15. 王梅, 于漫, 王淳, 等. 参苓白术散治疗功能性消化不良的meta分析. 中国卫生统计, 2014, 31(6): 939-942.
16. Chen X, Nie H, Liu W, et al. Efficacy and safety of Hou Gu Mi Xi on spleen qi deficiency in patients with nonorganic gastrointestinal disorders: protocol for a multicenter, randomized, placebo-controlled trial. Evid Based Complement Alternat Med, 2018: 1980491.
17. 李博, 赵迎盼, 高蕊, 等. 中成药治疗功能性消化不良临床试验方案及研究病历设计和实施. 中国新药杂志, 2016, 25(2): 187-192.
18. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet, 2000, 356(9237): 1255-1259.
19. Shen C, Pang SM, Kwong EW, et al. The effect of Chinese food therapy on community dwelling Chinese hypertensive patients with Yin-deficiency. J Clin Nurs, 2010, 19(7-8): 1008-1020.
20. Shi Z, Riley M, Taylor AW, et al. Chilli consumption and the incidence of overweight and obesity in a Chinese adult population. Int J Obes (Lond), 2017, 41(7): 1074-1079.
21. 杨华升, 杨诚, 华鑫, 等. 新型冠状病毒肺炎营养与中医食疗应对. 陕西中医药大学学报, 2020.
22. 徐煌钰, 孙灵芝, 周立群. 先秦两汉药膳简史. 中医学报, 2020, 35(5): 1120-1125.
23. 杨黛仙. 易感冒人群食疗药膳方. 农村新技术, 2020, (2): 70.
24. 朱燕, 刘志刚, 秦晋颖. 探索药膳食疗的中医学理论——评《中医药膳食疗》. 中国酿造, 2020, 39(4): 228.
25. 杨闪闪, 王灼慧, 张学智, 等. 幽门螺杆菌感染与脾胃湿热证的相关性探讨. 北京中医药, 2018, 37(10): 938-941.
26. 杜杰. 幽门螺杆菌感染与脾胃湿热证的相关性分析. 系统医学, 2019, 4(7): 129-131.

Chinese Journal of Evidence-Based Medicine

The efficiency and safety of Hou Gu Mi Xi for patients with spleen qi deficiency nonorganic gastrointestinal disorders: 1-year follow-up results in a multicenter, randomized, double blind, controlled trial

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