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Use of Prucalopride for Chronic Constipation: A Systematic Review and Meta-analysis of Published Randomized, Controlled Trials.

Sajid MS, Hebbar M, Baig MK, Li A, Philipose Z - J Neurogastroenterol Motil (2016)

Bottom Line: Prucalopride successfully increased the frequency of spontaneous bowel movements per week in all variable doses of 1 mg (standardized mean difference [SMD], 0.42 [95% CI, 0.18-0.66; P = 0.006]), 2 mg (SMD, 0.34 [95% CI, 0.11-0.56; P = 0.003]), and 4 mg (SMD, 0.33 [95% CI, 0.22-0.44; P = 0.00001]).The risks of adverse events or side effects such as headache, abdominal cramps, excessive flatulence, dizziness, diarrhea, and rash were higher (odds ratio, 1.70 [95% CI, 1.27 to -2.27; P = 0.0004]) in prucalopride group.Prucalopride is clinically a beneficial pharmacotherapy for chronic constipation and its routine use may be considered in patients with chronic simple laxative-resistant constipation.

View Article: PubMed Central - PubMed

Affiliation: Department of General, Endoscopic and Laparoscopic Colorectal Surgery, Western Sussex Hospitals NHS Foundation Trust, Worthing Hospital, Worthing, UK.

ABSTRACT
This article highlights the role of prucalopride in the management of chronic constipation based upon the principles of meta-analysis using data reported in the published randomized, controlled trials. Sixteen randomized, controlled trials on 3943 patients reported the effectiveness of prucalopride in patients with chronic constipation. Prucalopride successfully increased the frequency of spontaneous bowel movements per week in all variable doses of 1 mg (standardized mean difference [SMD], 0.42 [95% CI, 0.18-0.66; P = 0.006]), 2 mg (SMD, 0.34 [95% CI, 0.11-0.56; P = 0.003]), and 4 mg (SMD, 0.33 [95% CI, 0.22-0.44; P = 0.00001]). The risks of adverse events or side effects such as headache, abdominal cramps, excessive flatulence, dizziness, diarrhea, and rash were higher (odds ratio, 1.70 [95% CI, 1.27 to -2.27; P = 0.0004]) in prucalopride group. Prucalopride is clinically a beneficial pharmacotherapy for chronic constipation and its routine use may be considered in patients with chronic simple laxative-resistant constipation.

No MeSH data available.


Related in: MedlinePlus

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart to show study selection.
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f1-jnm-22-412: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart to show study selection.

Mentions: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart to explain the literature search strategy and trial selection is given in Figure 1. Sixteen randomized, controlled trials43–58 on 3943 patients were retrieved from the search of standard medical electronic databases. The characteristics, salient features and treatment protocols adopted in the included randomized, controlled trials are given in the Table. All trials were adequately randomized using either computer generated sequential pattern or other reliable random pattern methods. These trials varied from phase II46 to phase III,51 and were placebo-controlled43–58 with either single or double blinding. Power calculations, type I and type II errors were adequately covered in the majority of trials. The trial quality indicator Jadad score of included randomized, controlled trials was 4.3 (3.1–5.0). However, the intention-to-treat analysis was lacking in the majority of the trials. The included trials investigated the clinical effectiveness of prucalopride recruiting patients in either 1 arm47–49,51,58 or 2 arms,44,45,50,53–57 or even in some cases, 3 arms.43,46,52 There were diverse inclusion and exclusion criteria in reported randomized, controlled trials and duration of prucalopride use ranged from 1–12 weeks. Although several primary and secondary outcome measures were reported in included trials, in order to get uniform data and uniform combined outcome, this article analysed the frequency of spontaneous bowel movements (SBMs) per week and adverse events including cardiac complications. The combined outcomes following use of 1, 2, and 4 mg doses of prucalopride is given in the following 6 subheadings. The short summary of resulting evidence is given in Figure 2 in tabulated form.


Use of Prucalopride for Chronic Constipation: A Systematic Review and Meta-analysis of Published Randomized, Controlled Trials.

Sajid MS, Hebbar M, Baig MK, Li A, Philipose Z - J Neurogastroenterol Motil (2016)

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart to show study selection.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4930296&req=5

f1-jnm-22-412: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart to show study selection.
Mentions: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart to explain the literature search strategy and trial selection is given in Figure 1. Sixteen randomized, controlled trials43–58 on 3943 patients were retrieved from the search of standard medical electronic databases. The characteristics, salient features and treatment protocols adopted in the included randomized, controlled trials are given in the Table. All trials were adequately randomized using either computer generated sequential pattern or other reliable random pattern methods. These trials varied from phase II46 to phase III,51 and were placebo-controlled43–58 with either single or double blinding. Power calculations, type I and type II errors were adequately covered in the majority of trials. The trial quality indicator Jadad score of included randomized, controlled trials was 4.3 (3.1–5.0). However, the intention-to-treat analysis was lacking in the majority of the trials. The included trials investigated the clinical effectiveness of prucalopride recruiting patients in either 1 arm47–49,51,58 or 2 arms,44,45,50,53–57 or even in some cases, 3 arms.43,46,52 There were diverse inclusion and exclusion criteria in reported randomized, controlled trials and duration of prucalopride use ranged from 1–12 weeks. Although several primary and secondary outcome measures were reported in included trials, in order to get uniform data and uniform combined outcome, this article analysed the frequency of spontaneous bowel movements (SBMs) per week and adverse events including cardiac complications. The combined outcomes following use of 1, 2, and 4 mg doses of prucalopride is given in the following 6 subheadings. The short summary of resulting evidence is given in Figure 2 in tabulated form.

Bottom Line: Prucalopride successfully increased the frequency of spontaneous bowel movements per week in all variable doses of 1 mg (standardized mean difference [SMD], 0.42 [95% CI, 0.18-0.66; P = 0.006]), 2 mg (SMD, 0.34 [95% CI, 0.11-0.56; P = 0.003]), and 4 mg (SMD, 0.33 [95% CI, 0.22-0.44; P = 0.00001]).The risks of adverse events or side effects such as headache, abdominal cramps, excessive flatulence, dizziness, diarrhea, and rash were higher (odds ratio, 1.70 [95% CI, 1.27 to -2.27; P = 0.0004]) in prucalopride group.Prucalopride is clinically a beneficial pharmacotherapy for chronic constipation and its routine use may be considered in patients with chronic simple laxative-resistant constipation.

View Article: PubMed Central - PubMed

Affiliation: Department of General, Endoscopic and Laparoscopic Colorectal Surgery, Western Sussex Hospitals NHS Foundation Trust, Worthing Hospital, Worthing, UK.

ABSTRACT
This article highlights the role of prucalopride in the management of chronic constipation based upon the principles of meta-analysis using data reported in the published randomized, controlled trials. Sixteen randomized, controlled trials on 3943 patients reported the effectiveness of prucalopride in patients with chronic constipation. Prucalopride successfully increased the frequency of spontaneous bowel movements per week in all variable doses of 1 mg (standardized mean difference [SMD], 0.42 [95% CI, 0.18-0.66; P = 0.006]), 2 mg (SMD, 0.34 [95% CI, 0.11-0.56; P = 0.003]), and 4 mg (SMD, 0.33 [95% CI, 0.22-0.44; P = 0.00001]). The risks of adverse events or side effects such as headache, abdominal cramps, excessive flatulence, dizziness, diarrhea, and rash were higher (odds ratio, 1.70 [95% CI, 1.27 to -2.27; P = 0.0004]) in prucalopride group. Prucalopride is clinically a beneficial pharmacotherapy for chronic constipation and its routine use may be considered in patients with chronic simple laxative-resistant constipation.

No MeSH data available.


Related in: MedlinePlus