Pharmacological Dependency in Chronic Treatment of Gastroesophageal Reflux Disease: A Randomized Controlled Clinical Trial

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.

Evidence-based clinical practice guidelines for gastroesophageal reflux disease 2015

“…Therefore, the dose of PPI should be limited to as minimal as required in the long-term management of GERD, especially in the viewpoint of medical economics [105][106][107][108][109]. Furthermore, consideration of the patient's view on treatment efficacy, safety, cost, preference of medication, and frequency should be taken in long-term strategies.…”

Patient Selection for Therapy Reduction after Long-Term Daily Proton Pump Inhibitor Treatment for Gastro-Oesophageal Reflux Disease: Trial and Error

“…The design and methodology of the trial have been described previously [12]. In short, primary care patients with a history of symptoms due to pyrosis, reflux, GORD, hiatus hernia or oesophagitis using chronic PPI for at least a year were eligible.…”

“…Earlier, we showed that 52% of GORD patients on long-term, continuous acid suppression were able to switch to less than daily therapy without losing symptom control [12]. As this is the first step towards therapy reduction by applying on-demand or intermittent therapies, it would be helpful to be able to identify eligible patients.…”

Prescription of Proton Pump Inhibitors in Elderly Subjects in Real Life: A Retrospective Study in a Gastroenterology Department

“…To the naive subjects for the pylori helicobacter, this effect rebound seems to be proportional in the rise of pH during the treatment, while it tends to be masked by the persistent hypochlorhydria observed at the infected patients by the pylori helicobacter [63]. Other multicentral trials, randomized, in double blind showed that less than a third of patients receiving a long-term IPP, succeeded to stop the treatment without an effect on the control of the symptoms and the quality of life, whereas another third passed to a treatment "in the request" [65,66]. Several pathophysiological hypotheses were envisaged to explain this rebound effect on the acid gastric secretion, such as a hypergastrinemia [61] or a hypertrophy and a hyperplasia of the cells of the gastric wall [63].…”