Efficacy of dioctahedral smectite in treating patients of diarrhea-predominant irritable bowel syndrome.
OBJECTIVE
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.


CONCLUSIONS
DS seems acceptable to treat D-IBS patients, particularly for pain-related symptoms.
Chang
Full-Young
FY
Division of Gastroenterology, Taipei Veterans General Hospital and School of Medicine, National Yang-Ming University, Taipei, Taiwan. changfy@vghtpe.gov.tw
Lu
Ching-Liang
CL
Chen
Chih-Yen
CY
Luo
Jiing-Chyuan
JC
D015746:Abdominal Pain / Q000150:complications / Q000188:drug therapy; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003710:Demography; D003967:Diarrhea / Q000150:complications* / Q000188:drug therapy*; D023381:Endpoint Determination; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010919:Placebos; D017640:Silicates / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D010919:Placebos; D017640:Silicates; C033214:Smectite