Objective To assess the effect and safety of Dalitong Granule in the treatment of the Piman syndrome (functional dyspepsia).
Method The double-blind, double-dummy and randomized controlled method was adopted. 120 patients were randomized to the treatment group (n=90, Dalitong Granule 6 g, tid) and the control group (n=30, treated with cisapride 5 mg, tid). The therapeutic course for both groups was 2 weeks.
Results All the results were analyzed on the basis of intention-to-treat and per-protocol population. In the treatment group, the markedly effective rates were 62.37% and 64.45% respectively. The effective rates were 99.55% and 96-67% respectively. In the control group, the markedly effective rates were 58-08% and 60.00% respectively. The effective rates were 90.33% and 93.33% respectively. There was no significant difference between two groups (P gt;0.05). For effects on Piman syndrome, in the treatment group, the markedly effective rates were 53.76% and 55.56% respectively. The effective rates were 86.02% and 88.89% respectively. In the control group, the markedly effective rates were 48.38% and 50.00% respectively. The effective rates were 80.64% and 83.33% respectively. The results showed no statistical significance difference between two groups (P gt;0.05). For effects on gastric emptying function (PP population), in the treatment group, the markedly effective rate and effective rate were 72.42% and 79.32%. In the control group those were 64.28% and 64.28%. There was no significant difference between the two groups (P gt;0.05). ITT and PP analysis revealed similar results. No adverse effect was found in the observation.
Conclusions Dalitong granule has the same clinical effect as cisapride with no obvious toxic-adverse effects.
Citation：
WANG Lei,LI Tingqian,ZHANG Ruiming,MAO Bing,CHANG Jing,ZHANG Ying. Double-Blind Randomized Controlled Trial of Dalitong Granule in the Treatment of Piman Syndrome (Functional Dyspepsia). Chinese Journal of Evidence-Based Medicine, 2004, 04(4): 239-243. doi:
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Copyright © the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
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- 1. ［1］Principle of clinical research for new traditional herbs [ R ]. 1st issue. Ministry of health P. R. China. August, 1993;88-90.
- 2. 中华人民共和国卫生部:中药新药临床研究指导原则[R].第1辑,1993年8月;88～90.
- 3. ［2］Ye RG, Chief -editor. Internal medicine [ M ]. Fifth edition.Beijing : People’ s medical publishing house, 1999 ;440 -444.
- 4. 叶仁高.内科学[M]第5版北京:人民卫生出版社,1999;440～444.
- 5. ［3］He MR, Song YG, He CR. The therapeutic effect of fluoxetine on nonuclear dyspepsia patients with delayed gastric emptying[ J ]. Clinical Medicine of China, 2002; 18 ( 9 ): 798 -799.
- 6. 何美蓉,宋于刚,何春容.氟西丁治疗胃排空延缓的非溃疡性消化不良得疗效观察[J].中国综合临床,2002;18(9):798～799.
- 7. ［4］Su BH, Chief-editor. New insights of statistics for clinical trials of new drugs [ M ]. Shanghai publishing house of science,technology and literrature , 1999 ;43-44.
- 8. 苏炳华主编.新药临床试验统计新进展[M].第2版上海:上海科技文献出版社,1999;43～44.
- 9. ［5］Fang YZ, chief-editor. Practical medicine of traditional Chinese medicine [ M ]. Shanghai publishing house of science,technology, 1985 ;211-215.
- 10. 方药中主编.实用中医内科学[M].第3版上海:上海科学技术出版社,1985;211～215.
- 11. ［6］Liu XG. Functional dyspepsia and abnormality of gastrointestinal mobility [ J ]. Chinese Journal of Digestion, 2002; 22 ( 1 ): 44 -45.
- 12. 刘新光.功能性消化不良与胃肠动力异常[J]中华消化杂志,2002;22(1):44～45.
- 13. ［7］Scott AM, Kellow JE, Shuter B. Intragastric distribution and gastric emptying of solids and liquids in functional dyspepsia[J].Dig Dis Sci, 1993;38(12) :2 247-2 254.
- 14. ［8］Rosch W. Chronic functional dyspepsia: short- and mediumterm outcome of a therapeutic trial with cisapride [J ]. Clin Ther, 1994;16(3) :437-445.
