Pharmacological dependency in chronic treatment of gastroesophageal reflux disease: a randomized controlled clinical trial

Digestion. 2010;81(1):43-52. doi: 10.1159/000236025. Epub 2009 Dec 22.

Abstract

Background: Despite evidence of the overuse of acid suppressive medication for gastroesophageal reflux disease (GERD), a transfer to noncontinuous therapy after long-term treatment proves difficult.

Aim: To quantify the effect of blinded dosage reduction after long-term therapy on symptom control and quality of life while assessing pharmacological and placebo needs.

Methods: Primary care patients with a history of GERD and long-term treatment were randomized to daily placebo with pantoprazole rescue (n = 141) or daily pantoprazole with placebo rescue (n = 62) upon relief after 4 weeks pantoprazole 20 mg. The number of rescue tablets, symptom control and generic quality of life were analyzed.

Results: Measured from the daily placebo arm, 19% of the patients terminated treatment, 33% managed with 2-6 tablets/week, 38% needed a daily dosage and 10% needed more than a daily dosage in the long run. At these final dosages, symptom control and quality of life were dosage-independent and, furthermore, equal to values of patients on fixed daily pantoprazole. A temporal decrease in well-being was seen in 24% of the patients.

Conclusion: A significant placebo response is apparent in long-term users of acid suppressive medication and pharmacological dependency is overestimated. Despite their history of long-term treatment, the majority of GERD patients can be switched from daily to on-demand treatment without impairing symptom control and quality of life.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles / administration & dosage
  • 2-Pyridinylmethylsulfinylbenzimidazoles / adverse effects*
  • 2-Pyridinylmethylsulfinylbenzimidazoles / therapeutic use*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Gastroesophageal Reflux / drug therapy*
  • Gastroesophageal Reflux / physiopathology
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Pantoprazole
  • Proton Pump Inhibitors / administration & dosage
  • Proton Pump Inhibitors / adverse effects*
  • Proton Pump Inhibitors / therapeutic use*
  • Quality of Life
  • Substance-Related Disorders / epidemiology
  • Substance-Related Disorders / etiology*

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Proton Pump Inhibitors
  • Pantoprazole