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Efficacy of dioctahedral smectite in treating patients of diarrhea-predominant irritable bowel syndrome.
J Gastroenterol Hepatol 2007; 22(12):2266-72JG

Abstract

BACKGROUND AND AIM

Dioctahedral smectite (DS) is natural adsorbent clay useful in treating acute diarrhea. The aim of this study was to determine DS efficacy on patients with diarrhea-predominant irritable bowel syndrome (D-IBS in a phase III-, 8-week-randomized, double-blind, placebo-controlled trial.

METHODS

The 104 patients who met the D-IBS Rome II criteria were randomized to receive either DS (n = 52) or placebo (n = 52) treatment for 8 weeks (three sachets daily). The primary efficacy endpoint was the changes of the visual analog scale (VAS) score of IBS overall disorder and pain/discomfort-related symptoms after treatment on days 28 and 56, respectively. Other outcome measures included improvement of bowel movement disorders. The therapeutic global response was assessed by the patients and investigators at each visit, as was drug safety.

RESULTS

Both treatments diminished overall disorder at each visit (P < 0.01), with respect to primary efficacy. This effect was further observed in DS-treated patients on day 56 (P = 0.0167). Placebo had no effect on the VAS score of pain/discomfort at any visit, whereas DS improved this score on days 28 and 56, respectively (P < 0.05). DS and placebo similarly diminished bowel disorders at each visit; however, only DS improved abdominal bloating (P < 0.01). The global therapeutic responses evaluated by the patients and investigators were similarly distributed. The study drug was well tolerated during the 8-week period.

CONCLUSION

DS seems acceptable to treat D-IBS patients, particularly for pain-related symptoms.

Authors+Show Affiliations

Division of Gastroenterology, Taipei Veterans General Hospital and School of Medicine, National Yang-Ming University, Taipei, Taiwan. changfy@vghtpe.gov.twNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17559369

Citation

Chang, Full-Young, et al. "Efficacy of Dioctahedral Smectite in Treating Patients of Diarrhea-predominant Irritable Bowel Syndrome." Journal of Gastroenterology and Hepatology, vol. 22, no. 12, 2007, pp. 2266-72.
Chang FY, Lu CL, Chen CY, et al. Efficacy of dioctahedral smectite in treating patients of diarrhea-predominant irritable bowel syndrome. J Gastroenterol Hepatol. 2007;22(12):2266-72.
Chang, F. Y., Lu, C. L., Chen, C. Y., & Luo, J. C. (2007). Efficacy of dioctahedral smectite in treating patients of diarrhea-predominant irritable bowel syndrome. Journal of Gastroenterology and Hepatology, 22(12), pp. 2266-72.
Chang FY, et al. Efficacy of Dioctahedral Smectite in Treating Patients of Diarrhea-predominant Irritable Bowel Syndrome. J Gastroenterol Hepatol. 2007;22(12):2266-72. PubMed PMID: 17559369.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of dioctahedral smectite in treating patients of diarrhea-predominant irritable bowel syndrome. AU - Chang,Full-Young, AU - Lu,Ching-Liang, AU - Chen,Chih-Yen, AU - Luo,Jiing-Chyuan, Y1 - 2007/06/07/ PY - 2007/6/15/pubmed PY - 2008/3/28/medline PY - 2007/6/15/entrez SP - 2266 EP - 72 JF - Journal of gastroenterology and hepatology JO - J. Gastroenterol. Hepatol. VL - 22 IS - 12 N2 - BACKGROUND AND AIM: Dioctahedral smectite (DS) is natural adsorbent clay useful in treating acute diarrhea. The aim of this study was to determine DS efficacy on patients with diarrhea-predominant irritable bowel syndrome (D-IBS in a phase III-, 8-week-randomized, double-blind, placebo-controlled trial. METHODS: The 104 patients who met the D-IBS Rome II criteria were randomized to receive either DS (n = 52) or placebo (n = 52) treatment for 8 weeks (three sachets daily). The primary efficacy endpoint was the changes of the visual analog scale (VAS) score of IBS overall disorder and pain/discomfort-related symptoms after treatment on days 28 and 56, respectively. Other outcome measures included improvement of bowel movement disorders. The therapeutic global response was assessed by the patients and investigators at each visit, as was drug safety. RESULTS: Both treatments diminished overall disorder at each visit (P < 0.01), with respect to primary efficacy. This effect was further observed in DS-treated patients on day 56 (P = 0.0167). Placebo had no effect on the VAS score of pain/discomfort at any visit, whereas DS improved this score on days 28 and 56, respectively (P < 0.05). DS and placebo similarly diminished bowel disorders at each visit; however, only DS improved abdominal bloating (P < 0.01). The global therapeutic responses evaluated by the patients and investigators were similarly distributed. The study drug was well tolerated during the 8-week period. CONCLUSION: DS seems acceptable to treat D-IBS patients, particularly for pain-related symptoms. SN - 0815-9319 UR - https://www.unboundmedicine.com/medline/citation/17559369/Efficacy_of_dioctahedral_smectite_in_treating_patients_of_diarrhea_predominant_irritable_bowel_syndrome_ L2 - https://doi.org/10.1111/j.1440-1746.2007.04895.x DB - PRIME DP - Unbound Medicine ER -