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A Multicenter,Randomized,Placebo-Controlled Clinical Study on Clinical Efficacy of Simo Decoction(四磨汤口服液)Oral Liquid in Treatment of Functional Bloating
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Ping WANG1, Qian YANG2, Yongli HUO2, Haiqing LIANG3, Yiran LI3, Tao HE4, Weiguang KONG4, Hua YANG5, Hongxia LYU6, Xudong TANG1
Chinese Archives of Traditional Chinese Medicine | 2025, 43(3) : 13 - 18
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Chinese Archives of Traditional Chinese Medicine | 2025, 43(3): 13-18
• New Opinion of Ph.D. Supervisor •
A Multicenter,Randomized,Placebo-Controlled Clinical Study on Clinical Efficacy of Simo Decoction(四磨汤口服液)Oral Liquid in Treatment of Functional Bloating
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Ping WANG1, Qian YANG2, Yongli HUO2, Haiqing LIANG3, Yiran LI3, Tao HE4, Weiguang KONG4, Hua YANG5, Hongxia LYU6, Xudong TANG1
Affiliations
  • 1.Institute of Spleen and Stomach Diseases,Xiyuan Hospital,Chinese Academy of Traditional Chinese Medicine,Beijing 100091,China
  • 2.Hebei Provincial Hospital of Traditional Chinese Medicine,Shijiazhuang 050013,Hebei,China
  • 3.Dezhou Hospital,Qilu Hospital of Shandong University,Dezhou 253075,Shandong,China
  • 4.Inner Mongolia Hospital of Traditional Chinese Medicine,Hohhot 010020,Inner Mongolia,China
  • 5.Hunan Hansen Pharmaceutical Co.,Ltd.,Yiyang 413000,Hunan,China
  • 6.Beijing Kangzhong Times Medical Technology Group Co.,Ltd.,Beijing 100071,China
Published: 2025-03-10 doi: 10.13193/j.issn.1673-7717.2025.03.003
Outline
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Objective

To evaluate the clinical efficacy of Simo Decoction Oral Liquid(四磨汤口服液)in the treatment of functional bloating(FB).

Method

Sixty cases of FB patients included in four hospitals from March 2022 to May 2023 were randomly divided into two groups,30 cases in the treatment group were given oral administration of Simo Decoction Oral Liquid,and the other 30 cases in the control group were treated with Simo Decoction Oral Liquid simulant for a period of 8 weeks. The response rate of visual analogue scale(VAS),gastrointestinal symptoms rating scales(GSRS),each individual symptom score,overall disease effectiveness rate,hospital anxiety and depression scale(HAD)score and adverse reactions were observed in the two groups.

Result

The bloat VASresponse rate[Full Analysis Set(FAS):80.00%;Per Protocol Set(PPS):82.10%]and GSRSeffective rate(FAS:96.67%;PPS:96.40%)in the treatment group were higher than those of the control group[the bloat VASresponse rate(FAS:23.33%;PPS:24.1%)and GSRSeffective rate(FAS:86.67%;PPS:86.20%),and the difference was statistically significant(P<0.05). The change value of abdominal distension VASscore in the treatment group(FAS:-4.37±2.08;PPS:-4.27±2.07)was greater than that in the control group(FAS:-1.34±1.32;PPS:-1.34±1.32),and the difference was statistically significant(P<0.05). The GSRSscores and change values of the treatment group before and after treatment,the scores and change values of each single symptom of FB(severity and frequency of episodes of bowel sounds,bowel irregularity,bloating,nausea,and flatulences),the effective rate of overall evaluation of the disease,as well as the change values of the anxiety of the HAD scores(FAS and PPS)were better than those of the control group,and the differences were statistically significant(P<0.05). No adverse reactions related to the study drug occurred in either group.

Conclusion

Simo Decoction Oral Liquid can improve the symptoms of abdominal distension and other symptoms of FB patients,the efficacy is exact,and the medication is safe. At the same time,to a certain extent,it can relieve the patient's anxiety and depression,and improve the patient's quality of life.

Simo Decoction Oral Liquid(四磨汤口服液)  /  functional bloating  /  clinical randomized controlled trial  /  efficacy evaluation
王萍, 杨倩, 霍永利, 梁海清, 李一然, 贺涛, 孔伟光, 杨华, 吕红霞, 唐旭东. 评价四磨汤口服液治疗功能性腹胀临床疗效的多中心、随机、安慰剂对照临床研究. 中华中医药学刊, 2025 , 43 (3) : 13 -18 . DOI: 10.13193/j.issn.1673-7717.2025.03.003
Ping WANG, Qian YANG, Yongli HUO, Haiqing LIANG, Yiran LI, Tao HE, Weiguang KONG, Hua YANG, Hongxia LYU, Xudong TANG. A Multicenter,Randomized,Placebo-Controlled Clinical Study on Clinical Efficacy of Simo Decoction(四磨汤口服液)Oral Liquid in Treatment of Functional Bloating[J]. Chinese Archives of Traditional Chinese Medicine, 2025 , 43 (3) : 13 -18 . DOI: 10.13193/j.issn.1673-7717.2025.03.003
Year 2025 volume 43 Issue 3
42
19
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doi: 10.13193/j.issn.1673-7717.2025.03.003
  • Online Date:2026-10-30
  • Published:2025-03-10
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Affiliations
    1.Institute of Spleen and Stomach Diseases,Xiyuan Hospital,Chinese Academy of Traditional Chinese Medicine,Beijing 100091,China
    2.Hebei Provincial Hospital of Traditional Chinese Medicine,Shijiazhuang 050013,Hebei,China
    3.Dezhou Hospital,Qilu Hospital of Shandong University,Dezhou 253075,Shandong,China
    4.Inner Mongolia Hospital of Traditional Chinese Medicine,Hohhot 010020,Inner Mongolia,China
    5.Hunan Hansen Pharmaceutical Co.,Ltd.,Yiyang 413000,Hunan,China
    6.Beijing Kangzhong Times Medical Technology Group Co.,Ltd.,Beijing 100071,China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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属
Genus
种数
Number of
species
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Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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