Document Detail


OTC laxative use of sodium picosulfate â results of a pharmacy-based patient survey (cohort study).
MedLine Citation:
PMID:  18218289     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: Constipation is one of the most frequent gastrointestinal symptoms. Traditionally, drug therapy for constipation is not prescribed and controlled by physicians. Instead, laxatives are sold by pharmacists as over-the-counter (OTC) medication. The aim of this study was to explore the safety and usage pattern of the OTC laxative sodium picosulfate use by collecting data from patients at their pharmacies. The study describes how self-treatment of constipation is practiced. In addition, the characteristics of patients buying the contact laxative, sodium picosulfate, for self-treatment of constipation were analyzed. METHODS: The survey was a pharmacy-based observational study (PHOBS) in community pharmacies in Germany. Participating pharmacists asked customers requesting a specific contact laxative to participate in the study. Customers gave verbal informed consent to study participation before receiving a structured questionnaire to be completed at home and then returned to the pharmacy. RESULTS: Data from 1,845 patients recruited by 243 pharmacies were collected. Compliance with the recommended dosage of 5 â 10 mg/day was 96%, compliance with the indication of constipation was 99%. More than 90% rated the efficacy as "very good" to "good". There was no weakening of the efficacy rating with increasing duration of use. 8% of patients reported mild-to-moderate adverse events. Nearly 60% of respondents reported to be satisfied with less than 1 bowel movement per day. Therefore, users appear to have a rational way of using OTC laxatives. CONCLUSIONS: Self-medication of constipation with sodium picosulfate is efficacious and considered to be safe.
Authors:
U Hinkel; C Schuijt; J F Erckenbrecht
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  International journal of clinical pharmacology and therapeutics     Volume:  46     ISSN:  0946-1965     ISO Abbreviation:  Int J Clin Pharmacol Ther     Publication Date:  2008 Feb 
Date Detail:
Created Date:  2008-01-25     Completed Date:  2008-05-22     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  9423309     Medline TA:  Int J Clin Pharmacol Ther     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  89-95     Citation Subset:  IM    
Affiliation:
Boehringer Ingelheim GmbH, Ingelheim, Germany. ulrika.hinkel@ing.boehringer-ingelheim.com
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MeSH Terms
Descriptor/Qualifier:
Age Factors
Body Mass Index
Cohort Studies
Community Pharmacy Services / statistics & numerical data*
Constipation / drug therapy
Diarrhea / chemically induced
Dose-Response Relationship, Drug
Female
Flatulence / chemically induced
Germany
Health Care Surveys / statistics & numerical data
Humans
Laxatives / adverse effects,  pharmacology,  therapeutic use*
Male
Nausea / chemically induced
Nonprescription Drugs / adverse effects,  pharmacology,  therapeutic use*
Patient Compliance / statistics & numerical data
Patient Satisfaction / statistics & numerical data
Picolines / adverse effects,  pharmacology,  therapeutic use*
Product Labeling / standards
Questionnaires
Self Medication / statistics & numerical data
Sex Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Laxatives; 0/Nonprescription Drugs; 0/Picolines; 10040-45-6/picosulfate sodium

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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