Abstract
Background It is ambiguous whether a higher dose of linaclotide provides higher efficacy for chronic constipation (CC) patients. The meta-analysis aimed to assess the efficacy and safety of linaclotide doses ranging from 62.5 μg to 600 μg for CC patients. Methods A comprehensive search was conducted, and STATA16 software was used for data analysis. Results Seven studies with 4,107 patients were eligible. A significantly enhanced number of completely spontaneous bowel movement (CSBM) responders were found in the extremely low-dose group (OR: 2.94; 95% CI: 1.98–4.34; p < 0.001), the low-dose group (OR: 3.24; 95% CI: 2.44–4.31; p < 0.001), the medium-dose group (OR: 3.08; 95% CI: 1.46–6.50; p=0.003), and high-dose group (OR: 4.79; 95% CI: 3.04–7.54; p < 0.001). Bayesian analysis showed the high-dose group obtained the maximum CSBM responder rate (OR: 4.94; 95% credible interval (CrI): 3.22–7.79; probability rank = 0.87) indirectly compared with extremely low-dose, low-dose, and medium-dose groups. However, no significant difference presented in the CSBM responder rate by pairwise comparisons of the different dose groups. Additionally, no more any adverse events occurred in the higher linaclotide dose group (RR: 0.91; 95% CrI: 0.60–1.38) indirectly compared with other dose groups. Conclusions High dose of linaclotide could be more effective and safer for CC patients, which need more trials to confirm in the future.
Highlights
Chronic constipation (CC) may be primary or secondary to several disorders or medications
chronic constipation (CC) is characterized by various bowel symptoms, including infrequent bowel movement, hard stools, excessive straining to defecate, a sense of anorectal blockage, anal digitation, and a sense of incomplete evacuation. e most widely used diagnostic criteria of CC are the Rome criteria, and the latest is Rome IV, created in 2016 [1], which distinguishes functional constipation from irritable bowel syndrome with constipation (IBS-C)
Poor quality of life can aggravate CC symptoms. e estimated incidence of CC ranges from 11% to 20% [4,5,6]
Summary
Chronic constipation (CC) may be primary (idiopathic or functional) or secondary to several disorders or medications. Up to 50% of patients report that they are not completely satisfied with current treatment due to inefficient relief from constipation, the side effects of drugs (e.g., bloating and abdominal pain), the lack of predictability of laxative action, and partial improvement of the quality of life [13]. It is ambiguous whether a higher dose of linaclotide provides higher efficacy for chronic constipation (CC) patients. It is ambiguous whether a higher dose of linaclotide provides higher efficacy for chronic constipation (CC) patients. e meta-analysis aimed to assess the efficacy and safety of linaclotide doses ranging from 62.5 μg to 600 μg for CC patients
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