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. 探索完善中醫藥治療功能性胃腸病的臨床結局評價方法. 中西醫結合心血管病電子雜志, 2016, 4(5): 126-127.
10.	顧華盾. 中醫藥療法與西醫療法治療功能性胃腸疾病患者的臨床效果比較. 中國藥物經濟學, 2017, 12(5): 72-74.
11.	周海新, 麥聯任, 張玲, 等. 功能性胃腸疾病治療前后抑郁與焦慮情況對比評價. 第三十一屆全國中西醫結合消化系統疾病學術會議論文集, 2019.
12.	辜沅, 舒青龍. 基于腸道微生態的參苓白術散藥理研究進展. 時珍國醫國藥, 2018, 29(3): 674-676.
13.	劉翠英, 施家希, 黃娟, 等. 參苓白術散對潰瘍性結腸炎小鼠緊密連接及MLCK/MLC通路的影響. 中藥材, 2018, 41(9): 2180-2184.
14.	湯麗娜. 參苓白術散加減聯合艾灸治療脾胃虛弱證癌因性疲乏的臨床療效觀察. 福州: 福建中醫藥大學, 2019.
15.	王梅, 于漫, 王淳, 等. 參苓白術散治療功能性消化不良的meta分析. 中國衛生統計, 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, 趙迎盼, 高蕊, 等. 中成藥治療功能性消化不良臨床試驗方案及研究病歷設計和實施. 中國新藥雜志, 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.	楊華升, 楊誠, 華鑫, 等. 新型冠狀病毒肺炎營養與中醫食療應對. 陜西中醫藥大學學報, 2020.
22.	徐煌鈺, 孫靈芝, 周立群. 先秦兩漢藥膳簡史. 中醫學報, 2020, 35(5): 1120-1125.
23.	楊黛仙. 易感冒人群食療藥膳方. 農村新技術, 2020, (2): 70.
24.	朱燕, 劉志剛, 秦晉穎. 探索藥膳食療的中醫學理論——評《中醫藥膳食療》. 中國釀造, 2020, 39(4): 228.
25.	楊閃閃, 王灼慧, 張學智, 等. 幽門螺桿菌感染與脾胃濕熱證的相關性探討. 北京中醫藥, 2018, 37(10): 938-941.
26.	杜杰. 幽門螺桿菌感染與脾胃濕熱證的相關性分析. 系統醫學, 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, 張艷春, 張麗芳, 等. 典型城市居民慢性病患病率及患者疾病負擔分析. 中國公共衛生, 2014, 30(1): 5-7.
4. 于娟. 慢性萎縮性胃炎患者的危險因素與臨床治療效果. 中國醫藥指南, 2020, 18(12): 141-142.
5. 范明明, 張嘉裕, 張湘龍, 等. 功能性消化不良造模方法的述評. 世界中醫藥, 2020, 15(7): 1080-1083.
6. 玉穎, 黃適, 岳珍珍, 等. 功能性消化不良的中醫藥研究進展. 湖南中醫雜志, 2020, 36(4): 172-174.
7. 王文, 張莎, 朱芳紅. 腸易激綜合征的中醫藥治療現狀與分析. 中國中醫急癥, 2020, 29(4): 750-752.
8. 徐晶晶, 黃柳向. 以腸道菌群為靶點治療腸易激綜合征研究進展. 湖南中醫雜志, 2020, 36(3): 165-167.
9. 莫雅冰. 探索完善中醫藥治療功能性胃腸病的臨床結局評價方法. 中西醫結合心血管病電子雜志, 2016, 4(5): 126-127.
10. 顧華盾. 中醫藥療法與西醫療法治療功能性胃腸疾病患者的臨床效果比較. 中國藥物經濟學, 2017, 12(5): 72-74.
11. 周海新, 麥聯任, 張玲, 等. 功能性胃腸疾病治療前后抑郁與焦慮情況對比評價. 第三十一屆全國中西醫結合消化系統疾病學術會議論文集, 2019.
12. 辜沅, 舒青龍. 基于腸道微生態的參苓白術散藥理研究進展. 時珍國醫國藥, 2018, 29(3): 674-676.
13. 劉翠英, 施家希, 黃娟, 等. 參苓白術散對潰瘍性結腸炎小鼠緊密連接及MLCK/MLC通路的影響. 中藥材, 2018, 41(9): 2180-2184.
14. 湯麗娜. 參苓白術散加減聯合艾灸治療脾胃虛弱證癌因性疲乏的臨床療效觀察. 福州: 福建中醫藥大學, 2019.
15. 王梅, 于漫, 王淳, 等. 參苓白術散治療功能性消化不良的meta分析. 中國衛生統計, 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, 趙迎盼, 高蕊, 等. 中成藥治療功能性消化不良臨床試驗方案及研究病歷設計和實施. 中國新藥雜志, 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. 楊華升, 楊誠, 華鑫, 等. 新型冠狀病毒肺炎營養與中醫食療應對. 陜西中醫藥大學學報, 2020.
22. 徐煌鈺, 孫靈芝, 周立群. 先秦兩漢藥膳簡史. 中醫學報, 2020, 35(5): 1120-1125.
23. 楊黛仙. 易感冒人群食療藥膳方. 農村新技術, 2020, (2): 70.
24. 朱燕, 劉志剛, 秦晉穎. 探索藥膳食療的中醫學理論——評《中醫藥膳食療》. 中國釀造, 2020, 39(4): 228.
25. 楊閃閃, 王灼慧, 張學智, 等. 幽門螺桿菌感染與脾胃濕熱證的相關性探討. 北京中醫藥, 2018, 37(10): 938-941.
26. 杜杰. 幽門螺桿菌感染與脾胃濕熱證的相關性分析. 系統醫學, 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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