title: OTC laxative use of sodium picosulfate â results of a pharmacy-based patient survey (cohort study).
abstract: OBJECTIVE
  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.affiliation: Boehringer Ingelheim GmbH, Ingelheim, Germany. ulrika.hinkel@ing.boehringer-ingelheim.com
authors.forename: U
authors.initials: U
authors.lastname: Hinkel
authors.forename: C
authors.initials: C
authors.lastname: Schuijt
authors.forename: J F
authors.initials: JF
authors.lastname: Erckenbrecht
mesh_terms: D000367:Age Factors; D015992:Body Mass Index; D002951:Citrates; D015331:Cohort Studies; D003157:Community Pharmacy Services / Q000706:statistics & numerical data*; D003248:Constipation / Q000188:drug therapy; D003967:Diarrhea / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D005260:Female; D005414:Flatulence / Q000139:chemically induced; D005858:Germany; D019538:Health Care Surveys / Q000706:statistics & numerical data; D006801:Humans; D054368:Laxatives / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D009325:Nausea / Q000139:chemically induced; D004366:Nonprescription Drugs / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D009942:Organometallic Compounds; D010349:Patient Compliance / Q000706:statistics & numerical data; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D010847:Picolines / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D011356:Product Labeling / Q000592:standards; D012651:Self Medication / Q000706:statistics & numerical data; D012737:Sex Factors; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D002951:Citrates; D054368:Laxatives; D004366:Nonprescription Drugs; D009942:Organometallic Compounds; D010847:Picolines; C005701:picosulfate sodium