Paper Information

Journal:   ARCHIVES OF IRANIAN MEDICINE   JULY 2014 , Volume 17 , Number 7; Page(s) 466 To 470.
 
Paper: 

THERAPEUTIC EFFECTS, TOLERABILITY AND SAFETY OF A MULTI-STRAIN PROBIOTIC IN IRANIAN ADULTS WITH IRRITABLE BOWEL SYNDROME AND BLOATING

 
DOI: 

0141707/AIM.003

 
Author(s):  JAFARI ELHAM, VAHEDI HOMAYOON*, MERAT SHAHIN, MOMTAHEN SHABNAM, RIAHI AINA
 
* DIGESTIVE DISEASE RESEARCH CENTER, TEHRAN UNIVERSITY OF MEDICAL SCIENCES,14117-13135-NORTH KARGAR AVE., SHARIATI HOSPITAL, TEHRAN, IRAN
 
Abstract: 

Background: Irritable bowel syndrome (IBS) is a common disorder in Iran with challenging treatment. Although trials have suggested that probiotics alleviate the complaints of patients with minimal side effects, they have not been investigated in Iranian adults.
Methods: In a randomized double-blind study, 108 eligible IBS patients (Rome III Criteria) aged 20 – 70 years who referred consecutively to a clinical center in Tehran with abdominal bloating from 2010 to 2012 received a combination probiotics or placebo twice Daily for 4 weeks. The objective was to evaluate the efficacy and safety of a multi-strain probiotic combination. One week prior  and throughout the treatment, the participants recorded their abdominal symptoms on a daily basis, using visual analogue scale and reported satisfactory relief of general symptoms at the end of each week. Adverse events were evaluated by self-reporting and physical examination. Continuous variables were analyzed by independent t-test and chi-square was used for binomials.
Results: The baseline characteristics were balanced (60% female, mean age 36.7±11.5). A total of 97 (51 intervention, 46 control) completed the treatment. Intention to treat analysis was done on 108 allocated subjects. 85% of the probiotic group reported satisfactory relief of general symptoms compared with 47% in the control group (P<0.01). A reduction in abdominal bloating and pain with probiotic was superior to placebo [-13.0 vs. -3.7 (P<0.01), -8.2 vs. -2.1 (P=0.02), respectively]. No severe adverse drug reaction was seen in either group.
Conclusions: A 4-week period of treatment with the combination probiotics twice daily was safe, well tolerated, and effective in our patients. Further investigation is recommended for other subgroups of IBS. Trial Registration: IRCT.ir IRCT2012071010230N1

 
Keyword(s): ADULTS, BLOATING, IBS, IRAN, PROBIOTIC
 
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