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Efficacy of Gastrosis No.1 compound on functional dyspepsia of spleen and stomach deficiency-cold syndrome: A multi-center, double-blind, placebo-controlled clinical trial

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Abstract

Objective

To assess the efficacy and safety of Gastrosis No.1 compound in the treatment of functional dyspepsia with Spleen (Pi) and Stomach (Wei) deficiency-cold syndrome.

Methods

A randomized, double-blind, placebo-controlled trial was performed in 5 centers. Patients with functional dyspepsia (FD) of Spleen-deficiency and qi-stagnation syndrome (162 cases) were randomly assigned to groups given Chinese herbal medicine (CHM) Gastrosis No.1 compound or placebo in a 2:1 ratio. This trial included a 4-week treatment period and a 4-week follow-up period. The outcomes were the dyspepsia symptom scores (measured by total dyspepsia symptom scale and single dyspepsia symptom scale) and syndromes of traditional Chinese medicine score (measured by traditional Chinese medicine syndrome scale). The outcomes were noted at weeks 0, 4 and 8.

Results

Compared with patients in the placebo group, patients in the CHM group showed significant improvement in the dyspepsia symptom scores as rated by patients and investigators (P <0.01), and also showed improvement in syndromes of traditional Chinese medicine score (P <0.01). No serious adverse event was reported. Safety tests obtained after 4 weeks of treatment showed no abnormal values.

Conclusion

CHM Gastrosis No.1 compound was effective and safe in the treatment of functional dyspepsia with Spleen and Stomach deficiency-cold syndrome

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References

  1. Shaib Y, El-Serag HB. The prevalence and risk factors of functional dyspepsia in a multiethnic population in the United States. Am J Gastroenterol 2004;99:2210–2216.

    Article  PubMed  Google Scholar 

  2. Bernersen B, Johnsen R, Straume B. Non-ulcer dyspepsia and peptic ulcer: the distribution in a population and their relation to risk factors. Gut 1996;38:822–825.

    Article  PubMed  CAS  Google Scholar 

  3. Hirakawa K, Adachi K, Amano K, Katsube T. Prevalence of non-ulcer dyspepsia in the Japanese population. J Gastroenterol Hepatol 1999;14:1083–1087.

    Article  PubMed  CAS  Google Scholar 

  4. Lu CL, Lang HC, Chang FY. Prevalence and health/social impacts of functional dyspepsia in Taiwan: a study based on the Rome criteria questionnaire survey assisted by endoscopic exclusion among a physical check-up population. Scand J Gastroenterol 2005;40:402–411.

    Article  PubMed  Google Scholar 

  5. Brook RA, Kleinman NL, Choung RS. Excess comorbidity prevalence and cost associated with functional dyspepsia in an employed population. Dig Dis Sci 2011;13:109–118.

    Google Scholar 

  6. Brook RA, Kleinman NL, Choung RS. Functional dyspepsia impacts absenteeism and direct and indirect costs. Clin Gastroenter Hepatol 2010;8:498–503.

    Article  Google Scholar 

  7. Tack J, Lee KJ. Pathophysiology and treatment of functional dyspepsia. J Clin Gastroenterol 2005;39(5 Suppl 3):S211–216.

    Article  PubMed  Google Scholar 

  8. Lee KJ, Tack J. Duodenal implications in the pathophysiology of functional dyspepsia. J Neurogastroenterol Motil 2010;16:251–257.

    Article  PubMed  Google Scholar 

  9. Zeng F, Qin W, Liang F. Abnormal resting brain activity in patients with functional dyspepsia is related to symptom severity. Gastroenterology 2011;141:499–506.

    Article  PubMed  Google Scholar 

  10. Savarino E, Zentilin P, Dulbecco P. The role of acid in functional dyspepsia. Am J Gastroenterol 2011;106:1168.

    Article  PubMed  Google Scholar 

  11. Zhang SS, Su DM, Zhao LQ. Systematic review on the efficacy of TCM in the treatment of functional dyspepsia. Chin J Integr Tradit West Med Digestion (Chin) 2011;23:32–34.

    Google Scholar 

  12. Rome Foundation. Guidelines-Rome III diagnostic criteria for functional gastrointestinal disorders. J Gastrointestin Liver Dis 2006;15:307–312.

    Google Scholar 

  13. Zheng XY. Guiding principle of clinical research on new drugs of Chinese medicine in the treament of stuffiness and fullness. In guiding principle of clinical research on new drugs of Chinese medicine (trial implementation). Edited by: Yu XH. Bejing: Chinese Medical Science and Technology Press; 2002:54–58.

  14. Liu X. Experimental design and data processing (fourth). Chin J Difficult Complicated Cases (Chin) 2003;2:55–57.

    Google Scholar 

  15. Zhang YP, Luo JH, Zhou C. The clinical curative effect of Jianpi Oral Liquid on 87 cases of Spleen and Stomach deficiency-weakness syndrome. Chin Tradit Patent Med (Chin) 1999;21:239–242.

    Google Scholar 

  16. Holtmann G, Talley NJ, Liebregts T, Adam B, Parow C. A placebo-controlled trial of itopride in functional dyspepsia. New Engl J Med 2006;354:832–840.

    Article  PubMed  CAS  Google Scholar 

  17. Oshima T, Miwa H. Treatment of functional dyspepsia: where to go and what to do. J Gastroenterol 2006;41:647–653.

    Article  Google Scholar 

  18. Mönkemüller K, Malfertheiner P. Drug treatment of functional dyspepsia. World J Gastroenterol 2006;12:2694–2700.

    PubMed  Google Scholar 

  19. Hojo M, Miwa H, Yokoyama. Treatment of functional dyspepsia with antianxiety or antidepressive agents: systematic review. J Gastroenterol 2005;40:1036–1042.

    Article  PubMed  CAS  Google Scholar 

  20. Talley NJ, Locke GR, Lahr BD. Predictors of the placebo response in functional dyspepsia. Aliment Pharmacol Ther 2006;23:923–936.

    Article  PubMed  CAS  Google Scholar 

  21. Zhao BG, Sun QF. Modern pharmacological studies and clinic application of Lizhong Bolus. Chin Tradit Patent Med (Chin) 2010;32:1957–1960.

    Google Scholar 

  22. Guo JC, Zhang AJ, Zheng XH, Zhou QF. Experimental study of complex Dangshen ventilation oral solution on intestinal function recovery after operation on abdominal region. J Emerg Tradit Chin Med (Chin) 2007;16:1238–1240.

    Google Scholar 

  23. Song D, Wang ZT, Li LY, Zhong GY. Protective effect of lobetyolin on gastric mucosa of experimental gastric ulcer in rats. J Emerg Tradit Chin Med (Chin) 2008;17:963–964.

    Google Scholar 

  24. Chan LW, Cheah EL, Saw CL. Antimicrobial and antioxidant activities of Cortex Magnoliae Officinalis and some other medicinal plants commonly used in south-east Asia. Chin Med 2008;28:3–15.

    Google Scholar 

  25. Liu CB, Zhang SC, Li QT. The development of modern pharmacological research of rhizoma cyperi. Guangming J Chin Med (Chin) 2009;24:787–788.

    Google Scholar 

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Authors and Affiliations

  1. Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, 100010, China

    Sheng-sheng Zhang  (张声生), Lu-qing Zhao  (赵鲁卿), Hong-bing Wang  (汪红兵) & Bing Wu  (吴 兵)

  2. The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, 110033, China

    Chui-jie Wang  (王垂杰)

  3. The Second Affiliated Hospital of Guangdong University of Traditional Chinese Medicine, Guangzhou, 510120, China

    Sui-ping Huang  (黄穗平)

  4. The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing, 210029, China

    Hong Shen  (沈 洪)

  5. Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China

    Wei Wei  (魏 玮)

  6. Beijing Xuanwu Hospital of Traditional Chinese Medicine, Beijing, 100050, China

    Yao-liang Lai  (来要良)

Authors
  1. Sheng-sheng Zhang  (张声生)
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  2. Lu-qing Zhao  (赵鲁卿)
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  3. Hong-bing Wang  (汪红兵)
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  4. Bing Wu  (吴 兵)
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  5. Chui-jie Wang  (王垂杰)
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  6. Sui-ping Huang  (黄穗平)
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  7. Hong Shen  (沈 洪)
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  8. Wei Wei  (魏 玮)
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  9. Yao-liang Lai  (来要良)
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Corresponding author

Correspondence to Sheng-sheng Zhang  (张声生).

Additional information

Supported by the Eleventh Five-Year National Key Technology R&D Program (No. 2007BAI20B092)

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Zhang, Ss., Zhao, Lq., Wang, Hb. et al. Efficacy of Gastrosis No.1 compound on functional dyspepsia of spleen and stomach deficiency-cold syndrome: A multi-center, double-blind, placebo-controlled clinical trial. Chin. J. Integr. Med. 19, 498–504 (2013). https://doi.org/10.1007/s11655-013-1503-x

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  • DOI: https://doi.org/10.1007/s11655-013-1503-x

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