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Efficacy of Non-pharmacologic Auxiliary Treatments in Improving Defecation Function in Children With Chronic Idiopathic Constipation: A Systematic Review and Network Meta-analysis.

ABSTRACT: Background: Non-pharmacologic auxiliary treatments have been considered crucial therapies for treating chronic idiopathic constipation (CIC) during the past decades worldwide. Several treatment patterns are available, but their relative efficacy is obscure because there are no head-to-head randomized controlled trials, especially in children. We conducted this network meta-analysis to evalute the effectiveness of these therapies in improving defecation function based on their direct comparisons with standard medical care. Methods: Medline, Embase, and Cochrane Central were searched for randomized controlled trials (RCTs) published in English from inception to October 2020, assessing the efficacy of auxiliary therapies (behavior therapy, physiotherapy, biofeedback, or anorectal manometry) in children with CIC. We extracted data for endpoints, risk of bias, and evidence quality. Eligible studies in the meta-analysis reported the data of a dichotomous assessment of overall response to treatment (response or not) or defecation frequency per week after treatment. The hierarchical Bayesian network meta-analysis was used in the study. We chose a conservative methodology, random effects model, to pool data which could handle the heterogeneity well. The relative risk (RR) with 95% confidence intervals (CIs) was calculated for dichotomous outcomes. For continuous results, weighted mean difference (WMD) with related CIs was calculated. The included treatments were ranked to define the probability of being the best treatment. Results: Seven RCTs (838 patients) met inclusion and endpoint criteria. Based on an endpoint of the absence of constipation (Rome criteria) with laxatives allowed, physiotherapy plus standard medical care (SMC) had the highest probability (84%) to bethe most effective therapy. When the treatment response was defined as an absence of constipation with not laxatives allowed, biofeedback plus SMC ranked first (probability 52%). Physiotherapy plus SMC ranked first when the endpoint was based on defecation frequency per week with laxatives allowed (probability 86%). Conclusion: Almost all auxiliary therapies are effective complementary therapies for treating CIC, but they needed to be used simultaneously with SMC. Nevertheless, because of the small number of eligible studies and their small sample sizes, the differences in treatment duration and the endpoints, large sample RCTs with long-term follow-up are required for further investigation.

SUBMITTER: Tang J

PROVIDER: S-EPMC8110729 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:To provide evidence for medical management of chronic idiopathic constipation (CIC) in China based on comparisons of all clinical practical interventions using Bayesian network meta-analysis. METHODS:We conducted a systematic literature review by searching PubMed, Embase, Cochrane Central, the China National Knowledge Infrastructure (CNKI), and the Wanfang Database (inception to May 2019) for randomized controlled trials (RCTs) for CIC in Chinese people. Only RCTs that recruited participants aged over 18 and diagnosed with CIC by the Rome II, III or IV criteria were included. We used three outcomes to examine efficacy. The risk ratio (RR) of the responder rate, based on ?3 spontaneous bowel movements (SBMs) per week after treatment, was the primary outcome, and the SBM count per week and the Bristol score (BS) were secondary outcomes. In addition, adverse effects (AEs) were also considered a secondary outcome to evaluate safety. We conducted Bayesian network meta-analysis with random effects, and the RR or mean difference with its 95% credible interval was calculated. In addition, we ranked all treatments via their cumulative curves (SUCRA) and assessed the quality of evidence according to the GRADE criteria. RESULTS:We included a total of 42 trials (6820 participants) of 20 grouped interventions that included pharmacological and nonpharmacological treatments. For the primary outcome, fourteen interventions were significantly better than placebo, and Probiotics plus Mosapride (PB?+?MP) appeared superior to others (GRADE quality of evidence: Moderate to Low), followed by Prucalopride (PP) (High to Low) and Electroacupuncture (EA) (High to Low). For SBM, Compound sodium bicarbonate suppository (CSBS) appeared to be best, with an SUCRA value of 90% (High to Low). For BS, Lactulose plus Probiotics (LT?+?PB) was superior to others (Moderate to Low), followed by Polyethylene glycol (PEG) (High to Moderate). Although all interventions appeared non-significant when compared with placebo in terms of adverse effects, Lactulose plus Mosapride showed greater risk than others on ranking probability. CONCLUSIONS:Given the GRADE assessment, PB?+?MP, PP and EA may be the priory options with moderate certainty in the quality of evidence for the primary outcome. For SBM, a CSBS may be the best option with moderate certainty in the quality of evidence. For BS, PEG may be the priory option with high certainty in the quality of evidence. However, due to a lack of high certainty in the quality of evidence, caution is needed when recommending the interventions. Because of the limitations, an increased number of trials are required for more accurate results.

Project description:ImportanceMigraine is one of the most common neurologic disorders in children and adolescents. However, a quantitative comparison of multiple preventive pharmacologic treatments in the pediatric population is lacking.ObjectiveTo examine whether prophylactic pharmacologic treatments are more effective than placebo and whether there are differences between drugs regarding efficacy, safety, and acceptability.Data sourcesSystematic review and network meta-analysis of studies in MEDLINE, Cochrane, Embase, and PsycINFO published through July 2, 2018.Study selectionRandomized clinical trials of prophylactic pharmacologic treatments in children and adolescents diagnosed as having episodic migraine were included. Abstract, title, and full-text screening were conducted independently by 4 reviewers.Data extraction and synthesisData extraction was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis network meta-analysis guidelines. Quality was assessed with the Cochrane Risk of Bias tool. Effect sizes, calculated as standardized mean differences for primary outcomes and risk ratios for discontinuation rates, were assessed in a random-effects model.Main outcomes and measuresPrimary outcomes were efficacy (ie, migraine frequency, number of migraine days, number of headache days, headache frequency, or headache index), safety (ie, treatment discontinuation owing to adverse events), and acceptability (ie, treatment discontinuation for any reason).ResultsTwenty-three studies (2217 patients) were eligible for inclusion. Prophylactic pharmacologic treatments included antiepileptics, antidepressants, calcium channel blockers, antihypertensive agents, and food supplements. In the short term (<5 months), propranolol (standard mean difference, 0.60; 95% CI, 0.03-1.17) and topiramate (standard mean difference, 0.59; 95% CI, 0.03-1.15) were significantly more effective than placebo. However, the 95% prediction intervals for these medications contained the null effect. No significant long-term effects for migraine prophylaxis relative to placebo were found for any intervention.Conclusions and relevanceProphylactic pharmacologic treatments have little evidence supporting efficacy in pediatric migraine. Future research could (1) identify factors associated with individual responses to pharmacologic prophylaxis, (2) analyze fluctuations of migraine attack frequency over time and determine the most clinically relevant length of probable prophylactic treatment, and (3) identify nonpharmacologic targets for migraine prophylaxis.

Project description:INTRODUCTION:Cognitive impairment is prevalent and debilitating among persons with multiple sclerosis (MS). While many pharmacologic treatments have shown good efficacy in reducing clinical relapses, brain lesions, and improving certain physical symptoms, their efficacy for improving cognitive function is not well understood. OBJECTIVES:The current systematic review aimed to evaluate the efficacy of pharmacologic treatments for improving cognitive function among persons with MS. METHODS:A literature search was conducted through the PubMed and PsycINFO databases. Two independent reviewers assessed each paper, and a third reviewer weighed in if the two reviewers could not reach a consensus. Classification of evidence was determined using the 2017 American Academy of Neurology (AAN) criteria for therapeutic trials. Standardized effect sizes (Cohen's d) were calculated to compare across studies. RESULTS:Eighty-seven journal articles published between 1990 and January 2020 were included in the current review. Overall, there is insufficient evidence to support the use of pharmacologic treatments to improve cognitive function in persons with MS. There were many contradictory findings observed in this review, which may be due to possible unidentified moderating treatment response variables and/or lack of standardization in assessment procedures. There was also an overreliance on statistical significance (most papers did not provide sizes of treatment effects), which may not be clinically meaningful. CONCLUSIONS:Higher-quality randomized controlled trials are needed to establish the cognitive efficacy of pharmacologic treatments for MS-related cognitive dysfunction, with cognition as the primary endpoint. Researchers are urged to use standardized criteria (such as the AAN criteria) to guide their research designs. Clinicians should consider effect sizes of studies before deciding whether to prescribe certain medications to ameliorate cognitive symptoms.

Project description:BackgroundIn the 2010s, medications with new mechanisms were introduced in Japan for the treatment of chronic idiopathic constipation (CIC). A few systematic reviews have compared medications' relative efficacy, but the reviews included studies on patients from various races, even though the mechanism of CIC is considered to differ between races. The aim of this study was to use a systematic review and network meta-analysis to compare the relative efficacy of these medications in Japanese patients.MethodsWe conducted a meta-analysis and report it here according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). We identified studies by searching MEDLINE (via the PubMed interface) and the Cochrane Library and ICHUSHI databases and included randomized clinical trials that compared medications for CIC with placebo in Japanese adults. Two reviewers independently screened and assessed articles, abstracted data, and assessed the risk of bias. We pooled data by random-effects meta-analyses and also performed a Bayesian network meta-analysis to indirectly compare data.ResultsThe present systematic review and meta-analyses included 1460 patients in 6 randomized clinical trials: 2 on linaclotide, 3 on elobixibat, 2 on lubiprostone, and 1 on lactulose. The results of direct comparisons showed that linaclotide, elobixibat, and lubiprostone were superior to placebo in the change of spontaneous bowel movements (SBMs) within 1 week: linaclotide, 1.95 (95% CI, 1.51-2.39); elobixibat, 5.69 (95% CI, 3.31-8.07); and lubiprostone, 2.41 (95% CI, 0.82-4.01). The Bayesian network meta-analysis showed consistent results. Elobixibat 10 mg was ranked first for the increase in SBMs and complete SBMs within 1 week and the time to first SBM. Lubiprostone 48 μg was ranked first for the proportion of patients with SBM within 24 hours.ConclusionOur direct and indirect meta-analyses revealed that the new CIC medications available in Japan have equal efficacy but that elobixibat and lubiprostone are highly likely to be more efficacious.

Project description:OBJECTIVES:Linaclotide and plecanatide are guanylate cyclase-C (GCC) agonists for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Our objective is to evaluate the efficacy and tolerability of GCC agonists based on data from multiple randomized controlled trials (RCTs). METHODS:We searched PubMED, EMBASE, Cochrane databases, clinicaltrials.gov, major conference abstracts, Food and Drug Administration (FDA) websites, and United States Securities and Exchange Commission filings of drug sponsors to identify RCTs of CIC or IBS-C patients. We assessed efficacy based on FDA-approved composite responder endpoints, diarrhea as an adverse event, and study withdrawal owing to diarrhea for each therapy. Trial results were pooled using DerSimonian and Laird random effects model of meta-analysis and exact logistic regression when appropriate with 95% confidence intervals. Meta-regression was performed to compare outcomes between therapies adjusting for placebo event rate. RESULTS:Eight linaclotide trials (five CIC; three IBS-C) and seven plecanatide trials (four CIC; three IBS-C) evaluating 10,369 patients met inclusion criteria. FDA publications documented that different definitions for diarrhea were used in linaclotide vs. plecanatide trials. Both drugs were efficacious in treating CIC (linaclotide 72??g (Odds ratio (OR)=3.11, 95% CI 1.81-5.34); linaclotide 145??g (OR=3.25, 2.15-4.91); plecanatide 3?mg (OR=1.99, 1.57-2.51)) and IBS-C (linaclotide 290??g (OR=2.43, 1.48-3.98); plecanatide 3?mg (OR=1.87, 1.47-2.38); plecanatide 6?mg (OR=1.92, 1.48-2.48)). Diarrhea occurred in excess of placebo in treating CIC (linaclotide 72??g (OR=3.07, 1.97-4.77); linaclotide 145??g (OR=3.70, 2.69-5.10); plecanatide 3?mg (OR=3.86, 1.83-8.12)) and IBS-C (linaclotide 290??g (OR=8.02, 5.20-12.37); plecanatide 3?mg (OR=5.55, 1.62-19.00); plecanatide 6?mg (OR=4.13, 1.57-10.83)). Based on meta-regression, there were no statistically significant differences between therapies in odds ratios for efficacy, diarrhea, or diarrhea-related study withdrawals. CONCLUSIONS:Both linaclotide and plecanatide demonstrate similar efficacy and tolerability in treating IBS-C and CIC. No differences in odds of diarrhea were seen between linaclotide and plecanatide.

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Efficacy of Non-pharmacologic Auxiliary Treatments in Improving Defecation Function in Children With Chronic Idiopathic Constipation: A Systematic Review and Network Meta-analysis.

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