Lessons learned: Chronic idiopathic constipation patient experiences with over-the-counter medications

Abstract

Introduction: Chronic idiopathic constipation (CIC) is a prevalent functional gastrointestinal disorder diagnosed based on patient-reported symptoms and the absence of structural gastrointestinal abnormalities. Individuals with CIC typically institute dietary changes and use stool softeners or over-the-counter (OTC) laxatives, possibly at the direction of a healthcare provider, before prescription medications for CIC are initiated. Although highly prevalent, there is limited information regarding CIC patient experiences with OTC medications.

Methods: This post-hoc analysis used patient-reported data from a questionnaire administered during patient screening for a prospective linaclotide Phase 3b clinical trial in patients with CIC (N = 1482 screened). The questionnaire asked patients to report their experiences with OTC CIC medications over the preceding 6 months.

Results: Among patients with screening responses (N = 1423), most were female (85%) and white (66%), with a mean age of 48.9 years. A high proportion of patients had used one or more OTC medications (70% had ≥1 OTC; 19% had ≥3 OTCs), with the majority being bisacodyl (33%) and polyethylene glycol (30%). The most commonly cited reason for stopping an OTC medication was insufficient symptom relief (17-40%). The majority of patients taking OTC medications reported no or little satisfaction with the medication's effect on their constipation (62%) and CIC-specific abdominal symptoms (78%). Many patients had little to no confidence in bowel movement (BM) frequency after taking OTC medications and their confidence in their ability to predict BM timing was also low (49-81% not at all confident).

Conclusions: Treatment effects on individual CIC symptoms, predictability of bowel habits, and satisfaction with treatment are all important factors for healthcare providers and patients to consider when establishing an effective treatment regimen for CIC.

Trial registration number: NCT01642914.

Conflict of interest statement

I have read the journal’s policy and the authors of this manuscript have the following competing interests: Brian E. Lacy is a participant on the scientific advisory boards of Allergan plc (prior to acquisition by AbbVie Inc.), Ironwood Pharmaceuticals, Inc., Salix, and Takeda. Elizabeth P. Shea and Douglas C.A. Taylor are employees of Ironwood Pharmaceuticals, Inc. and hold stock and stock options. Hancheng Jiang and Machelle Manuel are former employees of Ironwood Pharmaceuticals, Inc. and may hold stock. Jessica L. Abel is an employee of AbbVie Inc. and holds stock and stock options. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Patient satisfaction with OTC medication’s ability to relieve symptoms.

Abbreviation: OTC = over-the-counter.

Fig 2

Patient satisfaction with relief of (a) constipation, (b) abdominal bloating, and (c) abdominal discomfort, by treatment. Abbreviation: PEG = polyethylene glycol.

Fig 3. Patient confidence in having a bowel movement at least once every other day while taking an OTC medication.

Abbreviations: OTC = over-the-counter, PEG = polyethylene glycol.

Fig 4. Patient confidence in predicting the timing of bowel movements after taking an OTC medication.

Abbreviations: OTC = over-the-counter, PEG = polyethylene glycol.