Tongxiening Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome （ Stagnation of the Liver-Qi Attacking the Spleen）：A Prospective, Randomized, Placebo-controlled, Double-blind Clinical Trial_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Gang , LI Tingqian , WANG Loi , XIA Qin , CHENG Yan , ZHANG Ruiming

Department of Integrated Chinese ＆Western Medicine, West China Hospital, Siehuan University, Chengdu 610041, China;

Corresponding author：

Keywords：

Tongxiening granule; Randomized controlled trials; Double-blind; Irritable bowel syndrome

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Objective　 To evaluate the efficacy and safety of Tongxiening granule （TXNG） in the treatment of diarrhea-predominant irritable bowel syndrome （IBS）（stagnation of the liver-qi attacking the spleen）.
Methods 　In a prospective, randomized, placebo-controlled, double-blind clinical trial, 60 patients with diarrhea-predominant IBS were randomly divided into the TXNG group （TXNG, 5.0g, 3 times daily; n =30） and the placebo group （placebo, 5. 0g, 3 times daily; n =30）. The treatment was administered for 3 weeks, and the follow-up was conducted for 4 weeks.
Results　（1）Abdominal pain： The cure rates were 57. 7% vs. 16. 0% （ by per-protocol analysis, PP） and 31.0% vs. 7.1% （ by intention-to-treat analysis （ITT） ; and the overall improvement rates were 92.3% vs. 44.0% （PP） and 82.7% vs. 39.3% （ITT） in the TXNG and the placebo groups respectively （ P 〈0. 05）. （2） Diarrhea ： the cure rates were 46. 2% vs. 20. 0% （PP） and 41.4% vs. 17. 9% （ITT） , and the overall improvement rates were 96. 2% vs 48. 0% （PP） and 86. 2% vs 42.9% （ITT） in the two groups respectively （P 〈0.05）. （3）Traditional Chinese medicine symptoms： the cure rates were 30.8% vs. 4.0% （PP） and 27.6% vs. 3.6% （ITT） ; and the overall improevment rates were 92.3% vs. 48.0% （PP） and 82.7% vs 42.9% （ITT） in the two groups respectively （P 〈0. 05）. The pain duration after treatment in the TXNG group was significantly shortened compared with the placebo group （7.6 ±4. 6d vs 14. 4 ±4. 3d, P =0. 0125）. After 4-week follow-up, it suggested that the recrudescent duration in symptoms related to IBS in the TXNG group was longer than that in the placebo group （11.5 ±5.3 d vs 6.2 ±6.9 d, P = 0. 019）. No adverse effects were found in the TXNG group.
Conclusion 　It was demonstrated that TXNG is effective and safe in the treatment of diarrhea-predominant ms （stagnation of the liver-qi attacking the spleen）.

Citation： WANG Gang,LI Tingqian,WANG Loi,XIA Qin,CHENG Yan,ZHANG Ruiming. Tongxiening Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome （ Stagnation of the Liver-Qi Attacking the Spleen）：A Prospective, Randomized, Placebo-controlled, Double-blind Clinical Trial. Chinese Journal of Evidence-Based Medicine, 2006, 06(2): 84-89. doi: Copy

1.	Thompson WG,Longstreth GF,Drossman DA,et al.Funtional bowel disorders and functional abdominal pain.Gut,1999; 45 (suppl2):43 -47.
2.	Talley NJ,Zinsmeister AR,Melton LJ 3rd.Irritable bowel syn drome in a community:symptom subgroups,risk factors,and health care utilization.Am J Epidemiol,1995; 142 (1):76-83.
3.	Heaton KW,ODonnell LJ,Braddon FE,et al.Symptoms of irritable bowel syndrome in a Brithish urban community:consulters and nonconsulters.Gastroenterology,1992; 102(6):1962-1927.
4.	Heaton KW,Radvan J,Cripps H,et al.Defection frequency and timing,and stool form in the general population:a prospective stud y.Gut,1992; 33(6):818 -824.
5.	Chen LY,Ho kY,Phua kH.Normal bowel habits and prevalence of functional bowel disorders in Singaporean adults-findings from a community based study in Bishan.Community Medicine GI Study Group.Singapore Med J,2000; 41(6):255-258.
6.	Chang L.Review article:epidemiology and quality of life in func tional gastrointestinal disorders.Aliment Pharmacol Ther,2004; 20(Suppl 7):31-33.
7.	Pan GZ,Lu SC,Ke MY,et al.An epidemiologic study of irritable bowel syndrome in Beijing-As tratified randomized study by clustering sampling.Chinese Journal of Epidemiology,2000; 21 (1):26 -29.潘国宗,鲁素彩,柯美云,等北京地区肠易激综合征的流行病学研究:一个整群、分层、随机调查中华流行病学杂志,2000;21(1):26～29.
8.	Quartero AO,Meineche-Schmidt V,Muris J,et al.Bulking a gents,antispasmodic and antidepressant medication for the treatment of irritable bowel syndrome[M/CD].Cochrane Database Syst Rev,2005; (2):CD003460.
9.	Evans BW,Clark WK,Moore DJ,et al.Tegaserod for the treat ment of irritable bowel syndrome[M/CD].Cochrane Database Syst Rev,2004; (1):CD003960.
10.	LacknerJM,Mesmer C,Morley S,et al.Psychological treatments for irritable bowel syndrome:a systematic review and meta-analysis.J Consult Clin Psychol,2004; 72 (6):1100-1113.
11.	Lesbros-Pantoflichova D,Michetti P,Fried M,et al.Meta-analysis:the treatment of irritable bowel syndrome.Aliment Pharmacol Ther,2004; 20(11 -12):1253 -1269.
12.	Talley NJ.Evaluation of drug treatment in irritable bowel syndrome.Br J Clin Pharmacol,2003; 56 (4):362-369.
13.	Spanier JA,Howden CW,Jones MP.A systematic review of alternative therapies in the irritable bowel syndrome.Arch Intern Med,2003; 163(3):265 -274.
14.	Tan S,Tillisch K,Bolus SR,et al.Traditional Chinese medicine based subgrouping of irritable bowel syndrome patients.Am J Chin Med,2005; 33(3):365-379.
15.	Sung JJ,Leung WK,ChingJY,et al.Agreements among traditional Chinese medicine practitioners in the diagnosis and treatment of irritable bowel syndrome.Aliment Pharmacol Ther,2004; 20 (10):1205-1210.
16.	Bensooussan A,Talley NJ,Hing M,et al.Treatment of irritable bowel syndrome with Chinese herbal medicine:a randomized conrolled trial.JAMA,1998; 280(18):1585 -1589.
17.	Yuan R,Lin Y.Traditional Chinese medicine:an approach to scientific proof and clinical validation.Pharmacol Ther,2000; 86 (2):191-198.
18.	Chinese Society of Grstroenerology.The uniform on irritable bowel syndrome.Chinese Journal of Internal Medicine,2003; 42 (9):669-670.中华医学会消化病学分会.肠易激综合征诊治的共识意见.中华内科杂志,2003;42(9):669～670.
19.	Cheng ZS,Zhang WD,Wei BH.Schedule for Diagnosis and Treatment of Irritable Bowel Syndrome with Integrative Chinese and Western Medicine (Draft).Chinese Journal of Integrated Traditional and Western Medicine,2005; 25 (3):282-284.陈治水,张万岱,危北海.肠易激综合征中西医结合诊治方案(草案).中国中西医结合杂志,2005;25(3):282 284.
20.	World Medical Association Declaration of Helsinki:ethical principles for medical research involving human subjects.JAMA,2000; 284:3043-3045.
21.	Pittler MH,Ernst E.Peppermint oil for irritable bowel syndrome:a critical review and meta-analysis.Am J Gastroenterol,1998; 93 (7):1131 -1135.
22.	Grigoleit HG,Grigoleit P.Peppermint oil in irritable bowel syndrome.Phytomedicine,2005; 12 (8):601-606.
23.	Brinkhaus B,Hentschel C,Von Keudell C,et al.Herbal medicine with curcuma and fumitory in the treatment of irritable bowel syndrome:a randomized,placebo-controlled,double-blind clinical trial.Scand J Gastroenterol,2005; 40 (8):936-943.
24.	Bundy R,Walker AF,Middleton R W,et al.Artichoke leaf extract reduces reduces symptoms of irritable bowel syndrome and improves quality of life in otherwise healthy volunteers suffering from concomitant dyspepsia:a subset analysis.J Altern Complenent Med,2004; 10(4):667-669.
25.	Madisch A,Holtmann G,Plein K,et al.Treatment of irritable bowel syndrome with herbal preparations:results of a double-blind,randomized,placebo-controlled,multi-centre trial.Aliment Pharma col Ther,2004; 19(3):271 -279.
26.	Baer N.Debate about placebos points to issue surrounded by many shades of grey.CMA J,1996; 155 (10):1475-1476.
27.	Patel SM,Stason WB,Legedza A,et al.The placebo effect in irri table bowel syndrome trials:a meta-analysis.Neurogastroenterol Motil,2005; 17 (3):332-340.
28.	Moher D,Schulz KF,Altman D,et al.The CONSORT statement:revised recommendations for improving the quality of reports of parallel-group randomized trials.JAMA,2001; 285 (15):1987-1991.

1. Thompson WG,Longstreth GF,Drossman DA,et al.Funtional bowel disorders and functional abdominal pain.Gut,1999; 45 (suppl2):43 -47.
2. Talley NJ,Zinsmeister AR,Melton LJ 3rd.Irritable bowel syn drome in a community:symptom subgroups,risk factors,and health care utilization.Am J Epidemiol,1995; 142 (1):76-83.
3. Heaton KW,ODonnell LJ,Braddon FE,et al.Symptoms of irritable bowel syndrome in a Brithish urban community:consulters and nonconsulters.Gastroenterology,1992; 102(6):1962-1927.
4. Heaton KW,Radvan J,Cripps H,et al.Defection frequency and timing,and stool form in the general population:a prospective stud y.Gut,1992; 33(6):818 -824.
5. Chen LY,Ho kY,Phua kH.Normal bowel habits and prevalence of functional bowel disorders in Singaporean adults-findings from a community based study in Bishan.Community Medicine GI Study Group.Singapore Med J,2000; 41(6):255-258.
6. Chang L.Review article:epidemiology and quality of life in func tional gastrointestinal disorders.Aliment Pharmacol Ther,2004; 20(Suppl 7):31-33.
7. Pan GZ,Lu SC,Ke MY,et al.An epidemiologic study of irritable bowel syndrome in Beijing-As tratified randomized study by clustering sampling.Chinese Journal of Epidemiology,2000; 21 (1):26 -29.潘国宗,鲁素彩,柯美云,等北京地区肠易激综合征的流行病学研究:一个整群、分层、随机调查中华流行病学杂志,2000;21(1):26～29.
8. Quartero AO,Meineche-Schmidt V,Muris J,et al.Bulking a gents,antispasmodic and antidepressant medication for the treatment of irritable bowel syndrome[M/CD].Cochrane Database Syst Rev,2005; (2):CD003460.
9. Evans BW,Clark WK,Moore DJ,et al.Tegaserod for the treat ment of irritable bowel syndrome[M/CD].Cochrane Database Syst Rev,2004; (1):CD003960.
10. LacknerJM,Mesmer C,Morley S,et al.Psychological treatments for irritable bowel syndrome:a systematic review and meta-analysis.J Consult Clin Psychol,2004; 72 (6):1100-1113.
11. Lesbros-Pantoflichova D,Michetti P,Fried M,et al.Meta-analysis:the treatment of irritable bowel syndrome.Aliment Pharmacol Ther,2004; 20(11 -12):1253 -1269.
12. Talley NJ.Evaluation of drug treatment in irritable bowel syndrome.Br J Clin Pharmacol,2003; 56 (4):362-369.
13. Spanier JA,Howden CW,Jones MP.A systematic review of alternative therapies in the irritable bowel syndrome.Arch Intern Med,2003; 163(3):265 -274.
14. Tan S,Tillisch K,Bolus SR,et al.Traditional Chinese medicine based subgrouping of irritable bowel syndrome patients.Am J Chin Med,2005; 33(3):365-379.
15. Sung JJ,Leung WK,ChingJY,et al.Agreements among traditional Chinese medicine practitioners in the diagnosis and treatment of irritable bowel syndrome.Aliment Pharmacol Ther,2004; 20 (10):1205-1210.
16. Bensooussan A,Talley NJ,Hing M,et al.Treatment of irritable bowel syndrome with Chinese herbal medicine:a randomized conrolled trial.JAMA,1998; 280(18):1585 -1589.
17. Yuan R,Lin Y.Traditional Chinese medicine:an approach to scientific proof and clinical validation.Pharmacol Ther,2000; 86 (2):191-198.
18. Chinese Society of Grstroenerology.The uniform on irritable bowel syndrome.Chinese Journal of Internal Medicine,2003; 42 (9):669-670.中华医学会消化病学分会.肠易激综合征诊治的共识意见.中华内科杂志,2003;42(9):669～670.
19. Cheng ZS,Zhang WD,Wei BH.Schedule for Diagnosis and Treatment of Irritable Bowel Syndrome with Integrative Chinese and Western Medicine (Draft).Chinese Journal of Integrated Traditional and Western Medicine,2005; 25 (3):282-284.陈治水,张万岱,危北海.肠易激综合征中西医结合诊治方案(草案).中国中西医结合杂志,2005;25(3):282 284.
20. World Medical Association Declaration of Helsinki:ethical principles for medical research involving human subjects.JAMA,2000; 284:3043-3045.
21. Pittler MH,Ernst E.Peppermint oil for irritable bowel syndrome:a critical review and meta-analysis.Am J Gastroenterol,1998; 93 (7):1131 -1135.
22. Grigoleit HG,Grigoleit P.Peppermint oil in irritable bowel syndrome.Phytomedicine,2005; 12 (8):601-606.
23. Brinkhaus B,Hentschel C,Von Keudell C,et al.Herbal medicine with curcuma and fumitory in the treatment of irritable bowel syndrome:a randomized,placebo-controlled,double-blind clinical trial.Scand J Gastroenterol,2005; 40 (8):936-943.
24. Bundy R,Walker AF,Middleton R W,et al.Artichoke leaf extract reduces reduces symptoms of irritable bowel syndrome and improves quality of life in otherwise healthy volunteers suffering from concomitant dyspepsia:a subset analysis.J Altern Complenent Med,2004; 10(4):667-669.
25. Madisch A,Holtmann G,Plein K,et al.Treatment of irritable bowel syndrome with herbal preparations:results of a double-blind,randomized,placebo-controlled,multi-centre trial.Aliment Pharma col Ther,2004; 19(3):271 -279.
26. Baer N.Debate about placebos points to issue surrounded by many shades of grey.CMA J,1996; 155 (10):1475-1476.
27. Patel SM,Stason WB,Legedza A,et al.The placebo effect in irri table bowel syndrome trials:a meta-analysis.Neurogastroenterol Motil,2005; 17 (3):332-340.
28. Moher D,Schulz KF,Altman D,et al.The CONSORT statement:revised recommendations for improving the quality of reports of parallel-group randomized trials.JAMA,2001; 285 (15):1987-1991.

Chinese Journal of Evidence-Based Medicine

Tongxiening Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome （ Stagnation of the Liver-Qi Attacking the Spleen）：A Prospective, Randomized, Placebo-controlled, Double-blind Clinical Trial

Abstract Full text Figures/Tables Video References Cited by

Format

Content