Abstracts: FUNCTIONAL BOWEL DISORDERS
Purpose: Constipation-predominant irritable bowel syndrome (IBS-C) is a commonly encountered condition in clinical setting with few effective treatment options. Recent randomized controlled trials (RCTs) suggest that linaclotide may improve IBS-C symptoms. We systematically reviewed the available evidence and conducted meta-analysis to evaluate the efficacy and safety of linaclotide in treatment of IBS-C.
Methods: We searched the following database resources: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, SCOPUS, CINAHL, and gastroenterology conference proceedings and abstracts. Study eligibility criteria: RCTs comparing linaclotide with placebo in adult patients with study period of at least 12 weeks. Study appraisal and synthesis methods: Articles were independently assessed by two investigators. Standardized forms were used for blinded duplicate data extraction of study participants, quality, methods, and outcomes, including adequate relief of IBS-C symptoms and adverse events from eligible articles.
Results: Of 110 identified citations, 3 RCTs enrolling 1,773 patients met the inclusion criteria. The metaanalysis revealed that in comparison to placebo, fewer patients on linaclotide failed to achieve adequate IBS symptom relief (RR=0.73; 95% CI 0.65-0.82). Diarrhea was the most common side effect. Incidence of diarrhea leading to discontinuation of treatment was significantly higher in the linaclotide group (3 RCTs; 1,773 patients; RR=14.75; 95% CI 4.04-53.81). The quality of evidence was moderate for adequate relief response and high for significant diarrhea.
Conclusion: Few studies were available at the time of this analysis. All the included studies involved highly selective patient population, which limits generalizability. Conclusions: Linaclotide appears to be moderately effective in providing adequate relief of IBS-C symptoms with diarrhea being the major side effect. Further studies are needed to evaluate efficacy and safety of linaclotide with longer treatment periods.