Advertisement

Tongxie Formula Reduces Symptoms of Irritable Bowel Syndrome

      Background & Aims

      Irritable bowel syndrome (IBS) is the most common chronic gastrointestinal disorder, yet few drugs are effective in reducing symptoms. Approximately 50% of patients with IBS attempt herbal therapy at least once. We performed a randomized controlled trial to compare the efficacy of the herb formulation tongxie vs placebo or pinaverium (an antispasmodic agent) in reducing symptoms of IBS.

      Methods

      We performed a trial of 1044 adult patients with IBS (based on Rome III criteria) at 5 hospitals in China, from August 2012 through January 2015. Subjects were randomly assigned (1:1:1) to groups given tongxie (a combination of A macrocephalae, P lactiflora, C reticulata, S divaricata, C pilosula, C wenyujin, C medica, and P cocos, along with other herbs, based on patient features), placebo, or pinaverium (50 mg tablets) 3 times daily for 4 weeks. Primary end points were significantly greater reductions in abdominal pain and Bristol stool score (before vs after the 4-week study period) in patients given tongxie compared with patients given placebo or pinaverium. Secondary end points were reductions in pain and stool frequencies and abdominal discomfort and its frequency.

      Results

      Subjects given tongxie had significant reductions, before vs after the study period, in all 6 symptoms assessed, compared to patients given placebo (P < .001). A significantly higher proportion of patients given tongxie had increased stool consistency (75.6%) than patients given pinaverium (50.6%), and a significantly higher proportion of patients given tongxie had fewer daily stools (72.7%) than subjects given pinaverium (58.3%) (P < .001 for both). However, significantly higher proportions of patients given pinaverium had reduced pain (63.5%) and pain frequency (69.5%) than patients given tongxie (51.4% and 58.6%, respectively; P < .005 for both).

      Conclusions

      In a randomized controlled trial of patients with IBS in China, we found 4 weeks of tongxie to produce significantly greater reduction in symptoms than placebo, and greater increases in stool consistency and reductions in stool frequency, than patients given pinaverium. Tongxie can therefore be considered an effective alternative therapy for patients with IBS who do not respond well to conventional therapies. Clinicaltrials.gov no: NCT01641224.

      Keywords

      Abbreviations used in this paper:

      IBS (irritable bowel syndrome), MOA (mechanism of action), TCM (Traditional Chinese Medicine), TEAE (treatment-emergent adverse effect)
      To read this article in full you will need to make a payment
      AGA Member Login
      Login with your AGA username and password.

      Purchase one-time access:

      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Hungin A.
        • Chang L.
        • Locke G.
        • et al.
        Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact.
        Aliment Pharmacol Ther. 2005; 21: 1365-1375
        • Quigley E.
        • Fried M.
        • Gwee K.
        • et al.
        Irritable bowel syndrome: a global perspective.
        World Gastroenterology Organisation Global Guideline, Milwaukee, WI2009: 3
        • Paré P.
        • Gray J.
        • Lam S.
        • et al.
        Health-related quality of life, work productivity, and health care resource utilization of subjects with irritable bowel syndrome: baseline results from LOGIC (Longitudinal Outcomes Study of Gastrointestinal Symptoms in Canada), a naturalistic study.
        Clin Ther. 2006; 28: 1726-1735
        • Maxion-Bergemann S.
        • Thielecke F.
        • Abel F.
        • et al.
        Costs of irritable bowel syndrome in the UK and US.
        PharmacoEconomics. 2006; 24: 21-37
        • Sandler R.
        • Everhart J.E.
        • Donowitz M.
        • et al.
        The burden of selected digestive diseases in the United States.
        Gastroenterology. 2002; 122: 1500-1511
        • Hulisz D.
        The burden of illness of irritable bowel syndrome: current challenges and hope for the future.
        J Manag Care Pharm. 2004; 10: 299-309
        • Camilleri M.
        • Prather C.M.
        The irritable bowel syndrome: mechanisms and a practical approach to management.
        Ann Intern Med. 1992; 116: 1001-1008
        • Kellow J.
        • Azpiroz F.
        • Delvaux M.
        • et al.
        Applied principles of neurogastroenterology: physiology/motility sensation.
        Gastroenterology. 2006; 130: 1412-1420
        • Serra J.
        • Azpiroz F.
        • Malagelada J.
        Impaired transit and tolerance of intestinal gas in the irritable bowel syndrome.
        Gut. 2001; 48: 14-19
        • Kellow J.
        • Eckersley G.
        • Jones M.
        Enhanced perception of physiological intestinal motility in the irritable bowel syndrome.
        Gastroenterology. 1991; 101: 1621-1627
        • Ritchie J.
        Pain from distension of the pelvic colon by inflating a balloon in the irritable bowel syndrome.
        Gut. 1973; 6: 105-112
        • Mertz H.
        • Naliboff B.
        • Munakata J.
        • et al.
        Altered rectal perception is a biological marker of patients with irritable bowel syndrome.
        Gastroenterology. 1995; 109: 40-52
        • Hiatt R.
        • Katz L.
        Mast cells in inflammatory conditions of the gastrointestinal tract.
        Am J Gastroenterol. 1962; 37: 541-545
        • Weston A.
        • Biddle W.
        • Bhatia P.
        • et al.
        Terminal ileal mucosal mast cells in irritable bowel syndrome.
        Dig Dis Sci. 1993; 38: 1590-1595
        • O’Sullivan M.
        • Clayton N.
        • Breslin N.
        • et al.
        Increased mast cells in the irritable bowel syndrome.
        Neurogastroenterol Motil. 2000; 12: 449-457
        • Aggarwal A.
        • Cutts T.
        • Abell T.
        • et al.
        Predominant symptoms in irritable bowel syndrome correlate with specific autonomic nervous system abnormalities.
        Gastroenterology. 1994; 106: 945-950
        • Silverman D.
        • Munakata J.
        • Ennes H.
        • et al.
        Regional cerebral activity in normal and pathologic perception of visceral pain.
        Gastroenterology. 1997; 112: 64-72
        • Whitehead W.
        • Crowell M.
        • Robinson J.
        • et al.
        Effects of stressful life events on bowel symptoms: subjects with irritable bowel syndrome compared to subjects without bowel dysfunction.
        Gut. 1992; 33: 825-830
        • Whitehead W.
        • Bosmajian L.
        • Zonderman A.
        • et al.
        Symptoms of psychologic distress associated with irritable bowel syndrome. Comparison of community and medical clinic samples.
        Gastroenterology. 1988; 95: 709-714
        • Brandt L.
        • Chey W.
        • Foxx-Orenstein A.
        • et al.
        An evidence-based position statement on the management of irritable bowel syndrome.
        Am J Gastroenterol. 2009; 104: S1-S35
        • Ford A.
        • Moayyedi P.
        • Lacy B.
        • et al.
        American College of Gastroenterology monograph on the management of irritable bowel syndrome and chronic idiopathic constipation.
        Am J Gastroenterol. 2014; 109: S2-S26
        • Hussain Z.
        • Quigley E.
        Systematic review: complementary and alternative medicine in the irritable bowel syndrome.
        Aliment Pharmacol Ther. 2006; 23: 465-471
        • Shen Y.
        • Nahas R.
        Complementary and alternative medicine for treatment of irritable bowel syndrome.
        Can Fam Physician. 2009; 55: 143-148
        • Kong S.
        • Hurlstone D.
        • Pocock C.
        • et al.
        The incidence of self-prescribed oral complementary and alternative medicine use by patients with gastrointestinal diseases.
        J Clin Gastroenterol. 2005; 39: 138-141
        • Langmead L.
        • Rampton D.
        Herbal treatment in gastrointestinal and liver disease: benefits and dangers.
        Aliment Pharmacol Ther. 2001; 15: 1239-1252
        • Fulder S.
        • Munro R.
        Complementary medicine in the United Kingdom: patients, practitioners and consultations.
        Lancet. 1985; 7: 542-545
        • Koloski N.
        • Talley N.
        • Huskic S.
        • et al.
        Predictors of conventional and alternative health care seeking for irritable bowel syndrome and functional dyspepsia.
        Aliment Pharmacol Ther. 2003; 17: 841-851
        • van Tilburg M.
        • Palsson O.
        • Levy R.
        • et al.
        Complementary and alternative medicine use and cost in functional bowel disorders: a six month prospective study in a large HMO.
        BMC Complement Altern Med. 2008; 8: 46
        • Dossett M.
        • Davis R.
        • Lembo A.
        • et al.
        Complementary and alternative medicine use by US adults with gastrointestinal conditions: results from the 2012 National Health Interview Survey.
        Am J Gastroenterol. 2014; 109: 1705-1711
        • Bensoussan A.
        • Talley N.
        • Hing M.
        • et al.
        Treatment of irritable bowel syndrome with Chinese herbal medicine: a randomized controlled trial.
        JAMA. 1998; 280: 1585-1589
        • Bensoussan A.
        • Kellow J.
        • Bourchier S.
        • et al.
        Efficacy of a Chinese herbal medicine in providing adequate relief of constipation-predominant irritable bowel syndrome: a randomized controlled trial.
        Clin Gastroenterol Hepatol. 2015; 13: 1946-1954
        • Leung W.
        • Wu J.
        • Liang S.
        • et al.
        Treatment of diarrhea-predominant irritable bowel syndrome with traditional Chinese herbal medicine: a randomized placebo-controlled trial.
        Am J Gastroenterol. 2006; 101: 1574-1580
        • Joiner T.
        Chinese Herbal Medicine Made Easy: Natural and Effective Remedies for Common Illnesses.
        Hunter House Inc, Alameda, CA2001
        • The Spleen and Stomach Subcommittee of China Association of Traditional Chinese Medicine
        The consensus of traditional Chinese medicine diagnosis of and treatment for irritable bowel syndrome.
        Chin J Trad Chin Med Pharm. 2010; 25: 1062-1065
        • The Pharmacopoeia Committee of the Executive Committee
        The Pharmacopoeia of the People's Republic of China.
        10th ed. China Medical Science and Technology Press, Beijing, China2015
        • US Food and Drug Administration
        Guidance for industry irritable bowel syndrome—clinical evaluation of drugs for treatment. Final Guidance.
        Office of Communications, Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Springs, MD2012
        • Vincent C.
        Credibility assessment of trials in acupuncture.
        Complementary Med Res. 1990; 4: 8-11
        • Borkovec T.
        • Nau S.
        • Borkovec T.
        • et al.
        Credibility of analogue therapy rationales.
        J Behav Ther Exp Psychiatry. 1972; 3: 257-260
        • Petrie J.
        • Hazleman B.
        Credibility of placebo transcutaneous nerve stimulation and acupuncture.
        Clin Exp Rheumatol. 1985; 3: 151-153
        • Zheng L.
        • Lai Y.
        • Lu W.
        • et al.
        Pinaverium reduces symptoms of irritable bowel syndrome in a multicenter, randomized, controlled trial.
        Clin Gastroenterol Hepatol. 2015; 13: 1285-1292
        • Verhoef M.
        • Sutherland L.
        • Brkich L.
        Use of alternative medicine by patients attending a gastroenterology clinic.
        Can Med Assoc J. 1990; 142: 121-125
        • Tu Y.
        Artemisia Annua and Artemisinin Medications.
        Chemical Industry Press, Beijing, China2009: 31-33
      1. Editorial Committee of Zhonghuabencao of State Administration of Traditional Chinese Medicine of People’s Republic of China Zhonghuabencao. Volume 9. Shanghai, China: Shanghai Science and Technology Press, 1999.

        • Xu Y.
        • Liu P.
        • Yan H.
        • et al.
        Analysis of variation of monoterpene glycosides and polyhydroxy compounds in paeoniae radix alba during preliminary processing.
        J Chin Med Materials. 2014; 37 ([Article in Chinese]): 775-780
        • Jin L.
        • Zhao W.
        • Guo Q.
        • et al.
        Study on chemical components distribution in Paeoniae Radix Alba and its processing methods.
        Chin J Chin Materia Medica. 2015; 40 ([Article in Chinese]): 1953-1959
        • Tu Y.
        Artemisia annua and artemisinin medications.
        Chemical Industry Press, Beijing, China2009: 34-36
        • Wen J.
        • Zhao D.
        • Deng J.
        Influence of processing methods on the chemical composition of the essential oil from Aucklandia lappa.
        J Chin Med Materials. 2012; 35 ([Article in Chinese]): 1397-1401