期刊论文详细信息
BMC Complementary and Alternative Medicine
Efficacy of modified LiuJunZi decoction on functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: a randomized controlled trial
Tao Zhou2  Lin Tao2  Wei Wei3  Hong Shen4  Suiping Huang5  Chuijie Wang1  Hongbing Wang2  Luqing Zhao2  Shengsheng Zhang2 
[1] The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, No. 33 Beiling Street, Huanggu District, Shenyang, 110033, China;Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, No. 23 Meishuguan Back Street, Dongcheng District, Beijing, 100010, China;Wangjing Hospital, Huajiadi Street, Chaoyang District, Beijing, 100102, China;The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, No. 155 Hanzhong Street, Jianye District, Nanjing, 210029, China;The Second Affiliated Hospital of Guangdong University of Traditional Chinese Medicine, No. 111 Dade Street, Baiyun District, Guangzhou, 510120, China
关键词: Randomized controlled trial;    Modified LiuJunZi decoction;    Chinese herbal medicine;    Functional dyspepsia;   
Others  :  1230288
DOI  :  10.1186/1472-6882-13-54
 received in 2012-06-07, accepted in 2013-02-26,  发布年份 2013
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【 摘 要 】

Background

Chinese herbal medicine (CHM) has been used in China and some other countries for the treatment of patients with functional dyspepsia (FD). However, controlled studies supporting the efficacy of such treatments in patients with FD are lacking. In this trial, we aimed to assess the efficacy and safety of modified LiuJunZi decoction in patients with FD of spleen-deficiency and qi-stagnation syndrome.

Methods

We performed a randomized, double-blind, placebo-controlled trial with patients from five centers. Patients with FD of spleen-deficiency and qi-stagnation syndrome (n = 160) were randomly assigned to groups given CHM modified LiuJunZi decoction or placebo in a 2:1 ratio. Herbal or placebo granules were dissolved in 300 ml of boiled water cooled to 70°C. Patients in both groups were administered 150 ml (50°C) twice daily. The trial included a 4-week treatment period and a 4-week follow-up period. The primary outcomes were dyspepsia symptom scores, measured by the total dyspepsia symptom scale and the single dyspepsia symptom scale at weeks 0, 1, 2, 3, 4 and 8. The secondary outcome was the change of radiopaque barium markers emptied from the stomach between week 0 and week 4 of treatment.

Results

Compared with patients in the placebo group, patients in the CHM group showed significant improvements according to the scores of total dyspepsia symptoms and single dyspepsia symptoms obtained from patients (P < 0.01) and investigators (P < 0.01). They also showed an improvement in the number of radiopaque barium markers emptied from the stomach (P < 0.05).

Conclusions

CHM modified LiuJunZi decoction appears to offer symptomatic improvement in patients with FD of spleen-deficiency and qi-stagnation syndrome.

Trial registration

Chinese Clinical Trial Registry (ChiCTR): http://ChiCTR-TRC-10001074 webcite

【 授权许可】

   
2013 Zhang et al; licensee BioMed Central Ltd.

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【 参考文献 】
  • [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.
  • [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.
  • [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.
  • [4]Lu CL, Lang HC, Chang FY, Chen CY, Luo JC, Wang SS, Lee SD: 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.
  • [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.
  • [6]Brook RA, Kleinman NL, Choung RS, Melkonian AK, Smeeding JE, Talley NJ: Functional dyspepsia impacts absenteeism and direct and indirect costs. Clin Gastroenterol Hepatol 2010, 8:498-503.
  • [7]Tack J, Lee KJ: Pathophysiology and treatment of functional dyspepsia. J Clin Gastroenterol 2005, 39(5 Suppl 3):S211-S216.
  • [8]Lee KJ, Tack J: Duodenal implications in the pathophysiology of functional dyspepsia. J Neurogastroenterol Motil 2010, 16:251-257.
  • [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.
  • [10]Savarino E, Zentilin P, Dulbecco P: The role of Acid in functional dyspepsia. Am J Gastroenterol 2011, 106:1168.
  • [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 Dig 2011, 23:32-34.
  • [12]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.
  • [13]Zhang SS, Chen Z, Xu WJ: Study on distribution characteristic of syndrome of 565 cases of functional dyspepsia by twice differentiation of symptoms and signs based on the “cold, heat, deficiency, excess”. Chin J Tradit Chin Med Pharm 2008, 23:833-834.
  • [14]Zhang SS, Wang HB, Li QG: Chinese consensus on diagnosis and treatment of functional dyspepsia. Chin J Integr Tradit West Med Dig 2010, 30:533-537.
  • [15]Kido T, Nakai Y, Kase Y: Effects of rikkunshi-to, a traditional Japanese medicine, on the delay of gastric emptying induced by N(G)-nitro-L-arginine. J Pharmacol Sci 2005, 98:161-167.
  • [16]Takeda H, Sadakane C, Hattori T: Rikkunshi-to, an herbal medicine, suppresses cisplatin-induced anorexia in rats via 5-HT2 receptor antagonism. Gastroenterology 2008, 134:2004-2013.
  • [17]Oyachi N, Takano K, Hasuda N: Effects of Rikkunshi-to on infantile hypertrophic pyloric stenosis, refractory to atropine. Pediatr Int 2008, 50:581-583.
  • [18]Gokhale AB, Damre AS, Kulkami KR: Preliminary evaluation of anti-inflammatory and anti-arthritic activity of S.lappa, A.speciosa and A.aspera. Phytomedicine 2002, 9:433-437.
  • [19]Yang L, Chen X, Qiang Z: In vitro anti-Helicobacter pylori action of 30 Chinese herbal medicines used to treat ulcer diseases. J Ethnopharmacol 2005, 98:329-333.
  • [20]Zhou XM, Zhang LM, Cao YL: Effect of Muxiang Dynamics Capsules inclusion (MDCI) on gastric emptying in mice. J Shenyang Pharm Univ 2003, 20:207-210.
  • [21]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.
  • [22]Liu X: Experimental design and data processing (fourth). Chin J Difficult Complicated Cases 2003, 2:55-57.
  • [23]Liu W, Zhang SS, Tang BX: Multi-center double-blind and double-simulation research on treatment of functional dyspopepsia with Jianpixiaozhang Granules. J Beijing Univ Tradit Chin Med (Clinical Medicine) 2006, 13:3-5.
  • [24]Holtmann G: A placebo-controlled trial of itopride in functional dyspepsia [J]. N Engl J Med 2006, 354:832-840.
  • [25]Oshima T, Miwa H: Treatment of functional dyspepsia: where to go and what to do. J Gastroenterol 2006, 41:647-653.
  • [26]Mönkemüller K, Malfertheiner P: Drug treatment of functional dyspepsia. World J Gastroenterol 2006, 12:2694-2700.
  • [27]Hojo M, Miwa H, Yokoyama : Treatment of functional dyspepsia with antianxiety or antidepressive agents: systematic review. J Gastroenterol 2005, 40:1036-1042.
  • [28]Talley NJ, Locke GR, Lahr BD: Predictors of the placebo response in functional dyspepsia. Aliment Pharmacol Ther 2006, 23:923-936.
  • [29]Kusunoki H, Haruma K, Hata J, Ishii M, Kamada T, Yamashita N, Honda K, Inoue K, Imamura H, Manabe N, Shiotani A, Tsunoda T: Efficacy of Rikkunshito, a traditional Japanese medicine (Kampo), in treating functional dyspepsia. Intern Med 2010, 49:2195-2202.
  • [30]Arai M, Matsumura T, Tsuchiya N, Sadakane C, Inami R, Suzuki T, Yoshikawa M, Imazeki F, Yokosuka O: Rikkunshito improves the symptoms in patients with functional dyspepsia, accompanied by an increase in the level of plasma ghrelin. Hepatogastroenterology 2012, 59:62-66.
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