Multicenter, 4-Week, Double-Blind, Randomized, Placebo-Controlled Trial of Sodium Picosulfate in Patients With Chronic Constipation

Mueller–Lissner, Stefan; Kamm, Michael A.; Wald, Arnold; Hinkel, Ulrika; Koehler, U; Richter, Erika; Bubeck, Juergen

doi:10.1038/ajg.2010.41

Cited by 179 publications

(154 citation statements)

References 12 publications

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“…As already published in one of our individual papers the improvement in symptoms of constipation was reflected in all of the dimensions of the global SF-36v2 assessment [8]. Generic questionnaires as the SF-36v2 focus on broader aspects of QoL, and are intended for use in general populations or across a wider range of disorders.…”

Section: Discussionmentioning

confidence: 90%

“…The methodology of the trials has been described in detail previously [7] [8]. In brief, a randomized, double-blind, placebo-controlled, parallel-group design to assess the efficacy and safety of treatment with either bisacodyl tablets or SPS drops, respectively, was followed.…”

Section: Methodsmentioning

confidence: 99%

“…Only minor amounts are systemically absorbed but are not considered to contribute to the laxative action since the laxative effect of bisacodyl or SPS does not correlate with the plasma level of BHPM. The clinical efficacy of bisacodyl and SPS is generally not questioned and was further confirmed by recently conducted stateof-the-art trials [7] [8]. In these randomized, double-blind, placebo-controlled, parallel-group clinical trials, measures of quality of life (QoL) were obtained by the PAC-QoL questionnaire in addition to the bowel movement frequency, which is commonly used as objective outcome parameter in clinical trials to assess the efficacy of laxative treatment.…”

Section: Introductionmentioning

confidence: 99%

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Bisacodyl and Sodium Picosulfate Improve Bowel Function and Quality of Life in Patients with Chronic Constipation—Analysis of Pooled Data from Two Randomized Controlled Trials

Müller-Lissner¹,

Richter²,

Eberlin³

et al. 2017

OJGas

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Background: Quality of life (QoL) is impaired in chronic constipation. Among nonprescription laxatives QoL data out of randomized controlled trials are available only for bisacodyl and sodium picosulfate (SPS). Methods: In two randomized, double-blind, placebo-controlled, parallel-group trials, the efficacy and safety of treatment with either bisacodyl or SPS, respectively, were assessed. After a 2-week baseline period patients with functional constipation were randomized to a 4-week treatment with either bisacodyl (2 tablets = 10 mg), SPS (18 drops = 10 mg), or matching placebo in a ratio of active drug to placebo of 2:1. Dose reduction as well as resuming the original dose was permitted. Patients who did not experience a bowel movement for more than 72 h were allowed to use a bisacodyl suppository. The primary endpoint was the mean number of Complete Spontaneous Bowel Movements (CSBMs) per week during the trial. QoL was assessed using the Patient Assessment of Constipation (PAC)-QoL questionnaire. Results: Active treatment led to a greater improvement of PAC-QoL scores for every domain. Active treatment was also superior to placebo for all individual questions of the questionnaire. Of note, SPS or bisacodyl not only improved satisfaction with stool patterns ("quite a bit/extremely satisfied" in 12.8% of patients on placebo and 50.3% on active treatment) but bloating was also considerably ameliorated ("not at all feeling bloated" in 24.5% on placebo and 41.4% on active treatment). Conclusion: Bisacodyl and SPS not only improve stool variables but also quality of life in patients with chronic functional constipation.

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Section: Discussionmentioning

confidence: 90%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Bisacodyl and Sodium Picosulfate Improve Bowel Function and Quality of Life in Patients with Chronic Constipation—Analysis of Pooled Data from Two Randomized Controlled Trials

Müller-Lissner¹,

Richter²,

Eberlin³

et al. 2017

OJGas

Self Cite

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“…132,138,139 A senna-fiber combination was more effective than lactulose in treating constipation in geriatric long-stay patients. 116,140 A meta-analysis found that stimulant laxatives provided superior efficacy for chronic idiopathic constipation (relative risk, 0.54; 95% confidence interval [CI], 0.42-0.69).…”

mentioning

confidence: 99%

Guidelines for the Diagnosis and Treatment of Chronic Functional Constipation in Korea, 2015 Revised Edition

Shin

Jung

Lee

et al. 2016

J Neurogastroenterol Motil

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The Korean Society of Neurogastroenterology and Motility first published guidelines for chronic constipation in 2005 and was updated in 2011. Although the guidelines were updated using evidence-based process, they lacked multidisciplinary participation and did not include a diagnostic approach for chronic constipation. This article includes guidelines for diagnosis and treatment of chronic constipation to realistically fit the situation in Korea and to be applicable to clinical practice. The guideline development was based upon the adaptation method because research evidence was limited in Korea, and an organized multidisciplinary group carried out systematical literature review and series of evidence-based evaluations. Six guidelines were selected using the Appraisal of Guidelines for Research & Evaluation (AGREE) II process. A total 37 recommendations were adopted, including 4 concerning the definition and risk factors of chronic constipation, 8 regarding diagnoses, and 25 regarding treatments. The guidelines are intended to help primary physicians and general health professionals in clinical practice in Korea, to provide the principles of medical treatment to medical students, residents, and other healthcare professionals, and to help patients for choosing medical services based on the information. These guidelines will be updated and revised periodically to reflect new diagnostic and therapeutic methods.

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“…62 The described correlation between improved pain ratings were not only reported in studies of the newly introduced agents for IBS-C, [63][64][65][66][67] but were also observed in many other trials, which did not meet inclusion criteria for this analysis and examined the effects of interventions ranging from fiber supplements, 68,69 to herbal preparations, 70 biofeedback, 71 bisacodyl, 72 or osmotic laxatives. [73][74][75] While not the focus of this analysis, we noted some statistically significant, but clinically minor, differences in the endpoints between patient cohorts with constipation and IBS-C. Moderate pain levels and low stool frequencies characterized both disorders.…”

Section: Discussionmentioning

confidence: 95%

Effective Constipation Treatment Changes More Than Bowel Frequency: A Systematic Review and Meta-Analysis

Bielefeldt

Levinthal

Nusrat

2015

J Neurogastroenterol Motil

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Background/AimsThe marketing of newer agents for treatment of constipation and irritable bowel syndrome with constipation (IBS-C) emphasize improvements in abdominal pain. However, it is not clear whether this observation reflects a unique visceral analgesic effect of these agents or is a general feature of effective laxation. We sought to determine the relationship between improvements in bowel frequency and decreases in abdominal pain in clinical trials of patients with constipation or IBS-C. MethodsWe searched "PubMed" and "Embase" databanks for clinical trials in patients with constipation or IBS-C, targeting publications that provided detailed data on bowel movement frequency and pain intensity before and after an intervention. We abstracted the results and performed meta-analytic and meta-regression analyses. Results Twenty

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Multicenter, 4-Week, Double-Blind, Randomized, Placebo-Controlled Trial of Sodium Picosulfate in Patients With Chronic Constipation

Abstract: Treatment of chronic constipation with SPS improves bowel function, symptoms, and QoL and is well tolerated. The dose can be adjusted individually while maintaining benefit.

Cited by 179 publications

References 12 publications

Bisacodyl and Sodium Picosulfate Improve Bowel Function and Quality of Life in Patients with Chronic Constipation—Analysis of Pooled Data from Two Randomized Controlled Trials

Bisacodyl and Sodium Picosulfate Improve Bowel Function and Quality of Life in Patients with Chronic Constipation—Analysis of Pooled Data from Two Randomized Controlled Trials

Guidelines for the Diagnosis and Treatment of Chronic Functional Constipation in Korea, 2015 Revised Edition

Effective Constipation Treatment Changes More Than Bowel Frequency: A Systematic Review and Meta-Analysis

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