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The shortcomings of clinical trials assessing the efficacy of probiotics in irritable bowel syndrome.

Abstract

BACKGROUND

Multiple clinical trials within the past decade have aimed to study the safety and efficacy of various probiotic strains in treating patients with irritable bowel syndrome (IBS). However, there exists much heterogenicity in study design among these trials, namely, in bacterial strain, dose, dosage form, sample size, study duration, and population demographics.

AIM

The aim of this study was to identify the shortcomings of clinical trials using probiotic treatments in subjects with IBS, so that researchers may realize where limitations exist, allowing them to curtail these limitations in future trials.

METHODS

An extensive PubMed search was conducted using the following keywords: probiotics in irritable bowel syndrome, probiotic pharmacokinetics, Lactobacillus, Bifidobacterium, Alosetron, Tegaserod, Alosetron, and Tegaserod safety profile. A total of 62 articles were used in constructing this review, with 20 original articles.

RESULTS

Stark differences in study design existed among the 20 original articles analyzed, as well as an outstandingly high "placebo effect," making the ability to compare these articles as a means for evidence-based treatment therapy in IBS very difficult.

CONCLUSIONS

Future large, randomized, double-blind, placebo-controlled clinical trials must be conducted, embodying minimal variability in study designs, to appropriately assess the efficacy of specific probiotic strains over placebo.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Pharmaceutical Research Institute at Albany College of Pharmacy and Health Sciences, Rensselaer, NY 42101, USA.

    Source

    MeSH

    Bacteria
    Clinical Trials as Topic
    Humans
    Irritable Bowel Syndrome
    Placebo Effect
    Probiotics
    Research Design
    Treatment Outcome

    Pub Type(s)

    Journal Article
    Review

    Language

    eng

    PubMed ID

    22339099

    Citation

    Rogers, Nathan J., and Shaker A. Mousa. "The Shortcomings of Clinical Trials Assessing the Efficacy of Probiotics in Irritable Bowel Syndrome." Journal of Alternative and Complementary Medicine (New York, N.Y.), vol. 18, no. 2, 2012, pp. 112-9.
    Rogers NJ, Mousa SA. The shortcomings of clinical trials assessing the efficacy of probiotics in irritable bowel syndrome. J Altern Complement Med. 2012;18(2):112-9.
    Rogers, N. J., & Mousa, S. A. (2012). The shortcomings of clinical trials assessing the efficacy of probiotics in irritable bowel syndrome. Journal of Alternative and Complementary Medicine (New York, N.Y.), 18(2), pp. 112-9. doi:10.1089/acm.2011.0015.
    Rogers NJ, Mousa SA. The Shortcomings of Clinical Trials Assessing the Efficacy of Probiotics in Irritable Bowel Syndrome. J Altern Complement Med. 2012;18(2):112-9. PubMed PMID: 22339099.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - The shortcomings of clinical trials assessing the efficacy of probiotics in irritable bowel syndrome. AU - Rogers,Nathan J, AU - Mousa,Shaker A, PY - 2012/2/21/entrez PY - 2012/2/22/pubmed PY - 2012/7/28/medline SP - 112 EP - 9 JF - Journal of alternative and complementary medicine (New York, N.Y.) JO - J Altern Complement Med VL - 18 IS - 2 N2 - BACKGROUND: Multiple clinical trials within the past decade have aimed to study the safety and efficacy of various probiotic strains in treating patients with irritable bowel syndrome (IBS). However, there exists much heterogenicity in study design among these trials, namely, in bacterial strain, dose, dosage form, sample size, study duration, and population demographics. AIM: The aim of this study was to identify the shortcomings of clinical trials using probiotic treatments in subjects with IBS, so that researchers may realize where limitations exist, allowing them to curtail these limitations in future trials. METHODS: An extensive PubMed search was conducted using the following keywords: probiotics in irritable bowel syndrome, probiotic pharmacokinetics, Lactobacillus, Bifidobacterium, Alosetron, Tegaserod, Alosetron, and Tegaserod safety profile. A total of 62 articles were used in constructing this review, with 20 original articles. RESULTS: Stark differences in study design existed among the 20 original articles analyzed, as well as an outstandingly high "placebo effect," making the ability to compare these articles as a means for evidence-based treatment therapy in IBS very difficult. CONCLUSIONS: Future large, randomized, double-blind, placebo-controlled clinical trials must be conducted, embodying minimal variability in study designs, to appropriately assess the efficacy of specific probiotic strains over placebo. SN - 1557-7708 UR - https://www.unboundmedicine.com/medline/citation/22339099/The_shortcomings_of_clinical_trials_assessing_the_efficacy_of_probiotics_in_irritable_bowel_syndrome_ L2 - https://www.liebertpub.com/doi/full/10.1089/acm.2011.0015?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -