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Effect of Laxatives and Pharmacological Therapies in Gut: First Published As 10.1136/Gut.2010.227132 on 4 January 2011

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Effect of Laxatives and Pharmacological Therapies in Gut: First Published As 10.1136/Gut.2010.227132 on 4 January 2011 Neurogastroenterology Effect of laxatives and pharmacological therapies in Gut: first published as 10.1136/gut.2010.227132 on 4 January 2011. Downloaded from chronic idiopathic constipation: systematic review and meta-analysis Alexander C Ford,1,2 Nicole C Suares1 1Leeds Gastroenterology ABSTRACT Institute, Leeds General Background There has been no definitive systematic Significance of this study Infirmary, Great George Street, review and meta-analysis to date examining the effect of Leeds, UK 2 laxatives and pharmacological therapies in chronic Leeds Institute of Molecular What is already known about this subject? idiopathic constipation (CIC). Medicine, University of Leeds, < Chronic idiopathic constipation is a common Leeds, UK Objective To assess efficacy of these therapies functional disorder of the gastrointestinal tract. systematically in CIC. < The condition is difficult to treat. Correspondence to Design Systematic review and meta-analysis of Dr Alex Ford, Leeds < Evidence for any benefit of laxatives is randomised controlled trials (RCTs). Gastroenterology Institute, conflicting, and there has been no definitive Data sources MEDLINE, EMBASE, and the Cochrane Room 230, D Floor, Clarendon summary of the evidence for efficacy of newer Wing, Leeds General Infirmary, central register of controlled trials were searched (up to pharmacological agents. Great George Street, Leeds, September 2010). LS1 3EX, UK; [email protected] Eligibility criteria for selecting studies Placebo- What are the new findings? controlled trials of laxatives or pharmacological therapies < Polyethylene glycol, sodium picosulfate, bisa- Revised 1 October 2010 in adult CIC patients were eligible. Minimum duration of codyl, prucalopride, lubiprostone and linaclotide Accepted 26 October 2010 therapy was 1 week. Trials had to report either were all more effective than placebo for treating a dichotomous assessment of overall response to chronic idiopathic constipation, but data to therapy at last point of follow-up in the trial, or mean support efficacy of lactulose were limited. number of stools per week during therapy. < Diarrhoea was significantly more common in Study appraisal and synthesis methods Symptom patients assigned to both laxatives and phar- data were pooled using a random effects model. Effect macological therapies. of laxatives or pharmacological therapies compared to placebo was reported as RR of failure to respond to How might it impact on clinical practice in the therapy, or a weighted mean difference (WMD) in mean foreseeable future? http://gut.bmj.com/ number of stools per week, with 95% CIs. < Guidelines for the management of chronic Results Twenty-one eligible RCTs were identified. idiopathic constipation should be updated to Laxatives (seven RCTs, 1411 patients, RR¼0.52; 95% CI include this useful information. 0.46 to 0.60), prucalopride (seven trials, 2639 patients, RR¼0.82; 95% CI 0.76 to 0.88), lubiprostone (three RCTs, 610 patients, RR¼0.67; 95% CI 0.56 to 0.80), and 267 lower educational level, and older individuals. linaclotide (three trials, 1582 patients, RR¼0.84; 95% CI on September 29, 2021 by guest. Protected copyright. Up to 20% of sufferers consult a physician with 0.80 to 0.87) were all superior to placebo in terms of 2 their symptoms, and the impact of CIC on quality a reduction in risk of failure with therapy. Treatment of life for patients is comparable with that for effect remained similar when only RCTs at low risk of organic conditions, such as chronic obstructive bias were included in the analysis. Diarrhoea was 8 pulmonary disease, diabetes and depression. significantly more common with all therapies. Traditionally, individuals with CIC are told to Limitations Only two RCTs were conducted in primary increase dietary fibre intake in order to alleviate care, and total adverse events data for laxatives and symptoms, but there is little evidence from rando- linaclotide were sparse. mised controlled trials (RCTs) that this approach Conclusions Laxatives, prucalopride, lubiprostone and is of any benefit, even in the short-term treatment linaclotide are all more effective than placebo for the 9 10 of the condition. In a recent multi-national treatment of CIC. survey of CIC patients, between 16% and 40% reported that they used laxatives, with almost two- thirds using them on at least a monthly basis.6 INTRODUCTION However, levels of dissatisfaction with laxatives Chronic idiopathic constipation (CIC) is a func- are high, primarily due to concerns about efficacy tional disorder of the gastrointestinal tract, charac- and safety.11 In addition, laxatives do not target terised by persistently difficult, infrequent, or the pathophysiological abnormalities that may incomplete defaecation, in the absence of any contribute to the symptoms of CIC. physiological abnormality.1 The condition is As a result, novel drug therapies for the disorder common, with a prevalence of between 4% and 20% have been developed within the last 10 years. e in cross-sectional community-based surveys.2 6 Prucalopride is a selective agonist at the 5-hydroxy- Chronic idiopathic constipation is more common in tryptamine-4 (5-HT4) receptor, leading to increased females, those of lower socioeconomic status and colonic motility and transit.12 Lubiprostone and Gut 2011;60:209e218. doi:10.1136/gut.2010.227132 209 Neurogastroenterology linaclotide are drugs that act on chloride channels and guanylate senna plant, senna extract, bisacodyl, phosphates, dioctyl sulfosuccinic cyclase receptors in the intestinal enterocyte, respectively. acid, magnesium, magnesium hydroxide,sorbitol, poloxamer, serotonin Gut: first published as 10.1136/gut.2010.227132 on 4 January 2011. Downloaded from Both of these agents increase the chloride concentration of agonists, receptors, serotonin, 5-HT4,orreceptors, prostaglandin E intestinal fluid, thereby stimulating intestinal fluid secretion and (both as MeSH terms and free text terms), or the following free accelerating transit.13 14 text terms: sodium picosulphate, docusate, milk of magnesia, At present, management guidelines for CIC do not make any danthron, senna$, poloxalkol, prucalopride, lubiprostone,orlinaclotide. firm recommendations to support the use of laxatives or phar- There were no language restrictions. Abstracts of the papers e macological therapies in the condition.15 17 Part of the expla- identified by the initial search were evaluated independently by nation for this may be that there has been no recent definitive both investigators for appropriateness. All potentially relevant quantitative summary of all available evidence for their efficacy papers were obtained and evaluated in detail. Foreign language in CIC. We have therefore conducted a systematic review and papers were translated. Abstract books of conference proceed- meta-analysis of RCTs to examine this issue. ings between 2002 and 2010 were hand-searched to identify potentially eligible studies published only in abstract form. METHODS Bibliographies of all identified relevant studies were used to Search strategy and study selection perform a recursive search. Articles were assessed independently A search of the medical literature was conducted using by two investigators using pre-designed eligibility forms, fi MEDLINE (1950 to September 2010), EMBASE and EMBASE according to the pre-de ned eligibility criteria. Disagreement Classic (1947 to September 2010), and the Cochrane central between investigators was resolved by discussion. register of controlled trials (Issue 3, July 2010). Randomised placebo-controlled trials examining the effect of laxatives Outcome assessment fi (osmotic or stimulant) or pharmacological therapies (pruca- The primary outcomes assessed were the ef cacy of laxatives or lopride, lubiprostone or linaclotide) in adult patients (>90% of pharmacological therapies compared with placebo in CIC, in participants over the age of 16 years) with CIC were eligible for terms of failure to respond to therapy, or effect on mean number inclusion (box 1). The first period of cross-over RCTs were also of stools per week during treatment. Secondary outcomes eligible for inclusion. A diagnosis of CIC could be based on included effect on individual symptoms of CIC, and adverse clinical symptoms, a physician’s opinion, or the Rome I, II or III events occurring as a result of therapy (overall numbers, as well diagnostic criteria,1 18 19 supplemented by negative investiga- as individual adverse events such as nausea, vomiting, diarrhoea, tions where trials deemed this necessary. Studies that recruited abdominal pain, abdominal bloating, or headache). patients with organic constipation, drug-induced constipation, or highly selected groups of patients (such as elderly patients Data extraction who were also institutionalised) were ineligible. Duration of All data were extracted independently by two investigators on treatment had to be at least 1 week. Trials using any dose of to a Microsoft Excel spreadsheet (XP professional edition; Microsoft, Redmond, Washington, USA) as dichotomous laxative or pharmacological therapy were considered eligible. http://gut.bmj.com/ Studies had to report either a dichotomous assessment of overall outcomes (response or no response to therapy), or mean number response to therapy at the last point of follow-up in the trial, or of stools per week with a SD. In addition, the following clinical continuous data in the form of mean number of stools per week data were extracted for each trial, where available: setting during therapy. First and senior
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