Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: Study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial

Trials

Volumn 14, Issue 1, 2013, Pages

  Zhong, Linda L D ^a   Cheng, Chung W ^a   Chan, Yawen ^b   Chan, King H ^c   Lam, Ting W ^c   Chen, Xiao R ^c   Wong, Chi T ^c   Wu, Justin C Y ^b   Bian, Zhao X ^a  

^a HONG KONG BAPTIST UNIVERSITY   (Hong Kong)

^b CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^c HOSPITAL AUTHORITY   (Hong Kong)

Author keywords

Chinese herbal medicine; Functional constipation; Ma Zi Ren Wan; Randomized controlled trial

Indexed keywords

BISACODYL; PLACEBO;

ADULT; AGED; ARTICLE; CHINESE MEDICINE; CONSTIPATION; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; FOLLOW UP; FUNCTIONAL CONSTIPATION; HERBAL MEDICINE; HUMAN; MA ZI REN WAN; MAJOR CLINICAL STUDY; MALE; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SYMPTOM ASSESSMENT; TRADITIONAL MEDICINE; TREATMENT DURATION; WESTERN MEDICINE;

CLINICAL PROTOCOLS; CONSTIPATION; DEFECATION; DOUBLE-BLIND METHOD; DRUGS, CHINESE HERBAL; GASTROINTESTINAL MOTILITY; HONG KONG; HUMANS; LAXATIVES; PROSPECTIVE STUDIES; RECOVERY OF FUNCTION; RESEARCH DESIGN; SENNA EXTRACT; TIME FACTORS; TREATMENT OUTCOME;

EID: 84886731835     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-366     Document Type: Article

References (32)

1. Eoff JC. Optimal treatment of chronic constipation in managed care: review and roundtable discussion. J Manag Care Pharm 2008, 14:1-15.
2. Cheng C, Chan AO, Hui WM, Lam SK. Coping strategies, illness perception, anxiety and depression of patients with idiopathic constipation: a population-based study. Aliment Pharmacol Ther 2003, 18:319-326. 10.1046/j.1365-2036.2003.01663.x, 12895216.
3. Drossman DA, Corazziari E, Delvaux M, Spiller RC, Talley NJ, Thompson WG. Rome III: The Functional Gastrointestinal Disorders 2006, McLean, VA: Degnon Associates.
4. Ramkumar D, Rao SS. Efficacy and safety of traditional medical therapies for chronic constipation: systematic review. Am J Gastroenterol 2005, 100:936-971. 10.1111/j.1572-0241.2005.40925.x, 15784043.
5. Youssef NN, Sanders L, Di Lorenzo C. Adolescent constipation: evaluation and management. Adolesc Med Clin. 2004, 15:37-52. 10.1016/j.admecli.2003.11.007, 15272255.
6. Zhang BY, Dong JH, Zhou ZY. Traditional Chinese Internal Medicine 1985, Shang Hai: Shang Hai Science and Technology Press.
7. Maclean W, Lyttleton J. Clinical Handbook of Internal Medicine: the Treatment of Disease with Traditional Chinese Medicine 2002, Macarthur, Sydney: University of Western Sydney.
8. Peng B. Fang X, and Wang Y(Ed): Traditional Chinese Internal Medicine 2007, Beijing: People's Medical Publishing House, 2.
9. Bensky D. Chinese Herbal Medicine: Formulas & Strategies 1990, Washington: Eastland Press.
10. Zhu YP. Chinese Materia Medica: Chemistry, Pharmacology, and Applications 1998, Amsterdam: Harwood Academic.
11. Li X, Wei W. Chinese Materia Medica: Combinations and Applications 2002, Donica: St. Albans.
12. Cheng CW, Bian ZX, Wu TX. Systematic review of Chinese herbal medicine for functional constipation. World J Gastroenterol. 2009, 15:4886-4895. 10.3748/wjg.15.4886, 2764965, 19842218.
13. Lai TS. Clinical Handbook of Chinese Herbal Formulae 1996, Beijing: People's Medical Publishing House.
14. Cheng CW, Bian ZX, Zhu LX, Wu JC, Sung JJ. Efficacy of a Chinese herbal proprietary medicine (Hemp Seed Pill) for functional constipation. Am J Gastroenterol 2011, 106:120-129. 10.1038/ajg.2010.305, 21045817.
15. Kositchaiwat S, Suwanthanmma W, Suvikapakornkul R, Tiewthanom V, Rerkpatanakit P, Tinkornrusmee C. Comparative study of two bowel preparation regimens for colonoscopy: senna tablets vs sodium phosphate solution. World J Gastroenterol 2006, 12:5536-5539.
16. Alexande FC, Nicole SC. Effect of laxatives and pharmacological therapies in chronic idiopathic constipation: systematic review and meta-analysis. Gut 2007, 60:209-218.
17. Central Co-ordinating Committee (Medicine) Handbook of Internal Medicine 2008, Hong Kong: Hong Kong Hospital Authority, Central Co-ordinating Committee (Medicine).
18. Moher D, Schulz KF, Altman DG. CONSORT. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Med Res Methodol 2001, 1:2.
19. Lembo AJ, Kurtz CB, Macdouqall JE, Lavins BJ, Currie MG, Fitch DA, Jeqlinski BI, Johnston JM. Efficacy of linaclotide for patients with chronic constipation. Gastroenterology 2010, 138:886-895. 10.1053/j.gastro.2009.12.050, 20045700.
20. Johnston JM, Kurtz CB, Drossman DA, Lembo AJ, Jeqlinski BI, MacDouqll JE, Antonelli SM, Currie MG. Pilot study on the effect of linaclotide in patients with chronic constipation. Am J Gastroenterol 2009, 104:125-132. 10.1038/ajg.2008.59, 19098860.
21. Amato A, Radaelli F, Paggi S, Terruzzi V. Half doses of PEG-ES and senna vs. high-dose senna for bowel cleansing before colonoscopy: a randomized, investigator-blinded trial. Am J Gastroenterol 2010, 105:675-681. 10.1038/ajg.2009.598, 19844199.
22. Mueller-Lissner S, Kamm MA, Wald A, Hinkel U, Koehler U, Richter E, Bubeck J. Multicenter, 4-week, double-blind, randomized, placebo-controlled trial of sodium picosulfate in patients with chronic constipation. Am J Gastroenterol 2010, 105:897-903. 10.1038/ajg.2010.41, 20179697.
23. Chinese Pharmacopoeia Commission Pharmacopoeia of the People's Republic of China 2010, Beijing: People's Medical Publishing House, 2010, Chinese Pharmacopoeia Commission.
24. Parkman HP, Rao SS, Reynolds JC, Schiller LR, Wald A, Miner PB, Lembo AJ, Gordon JM, Drossman DA, Waltzman L, Stambler N, Cedarbaum JM. Neurotrophin-3 improves functional constipation. Am J Gastroenterol 2003, 98:1338-1347. 10.1111/j.1572-0241.2003.t01-1-07477.x, 12818279.
25. Chan AO, Hui MW, Leung G, Hu WH, Lam SK, Wong BC. Efficacy of tegaserod for functional constipation in Chinese subjects: a randomized double-blind controlled trial in a single centre. Aliment Pharmacol Ther 2007, 25:463-469.
26. Kamm MA, Müller-Lissner S, Talley NJ, Tack J, Boeckxstaens G, Minushkin ON, Kalinin A, Dzieniszewski J, Haeck P, Fordham F, Hugot-Cournez S, Nault B. Tegaserod for the treatment of chronic constipation: a randomized, double-blind, placebo-controlled multinational study. Am J Gastroenterol 2005, 100:362-372. 10.1111/j.1572-0241.2005.40749.x, 15667494.
27. Konsyl Pharmaceuticals Sitzmarks diagnostic test. [http://www.sitzmarks.com], Konsyl Pharmaceuticals.
28. Park JM, Choi MG, Choi H, Cho YK, Oh JH, Lee IS, Kim SW, Choi KY, Chung IS. Measurement of colonic transit using a delayed-release capsule containing radio-opaque markers. Scand J Gastroenterol. 2008, 43:545-550. 10.1080/00365520701850204, 18415746.
29. Wexner DS, Duthie GS. Constipation: Etiology, Evaluation, and Management 2006, London: Springer.
30. Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J. C Bombardier: Recommendations for reporting randomized controlled trials of herbal interventions: explanation and elaboration. J Clin Epidemiol 2006, 59:1134-1149. 10.1016/j.jclinepi.2005.12.020, 17027423.
31. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher DSPIRIT. Statement: Defining Standard Protocol Items for Clinical Trials. Ann Intern Med 2013, 2013:200-207.
32. Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013, 346:e7586. 10.1136/bmj.e7586, 3541470, 23303884.