Quality of life during acute and intermittent treatment of gastro-oesophageal reflux disease with omeprazole compared with ranitidine. Results from a multicentre clinical trial. The European Study Group

Ital J Gastroenterol Hepatol. 1998 Feb;30(1):19-27.


Aims: To investigate quality of life in patients with gastro-oesophageal reflux disease.

Patients: A series of 704 patients were randomised to treatment with ranitidine 150 mg bd, omeprazole 10 mg om or omeprazole 20 mg om for 2 weeks. Asymptomatic/mildly symptomatic patients were followed for 12 months.

Methods: The Psychological General Well-Being index and the Gastrointestinal Symptom Rating Scale were completed before and during short-term and intermittent treatment.

Results: The quality of life response rate was > 80%. The majority of the patients receiving omeprazole 20 mg om (55%) had symptom relief after 2 weeks despite the fact that more patients on ranitidine required 4 weeks' treatment and an increased dose. There was no difference in the reflux dimension of Gastrointestinal Symptom Rating Scale between treatments in the initial treatment phase, but the total Gastrointestinal Symptom Rating Scale score improved significantly more on omeprazole 10 mg om than on ranitidine 150 mg bd (p = 0.006). Both doses of omeprazole improved the total Psychological General Well-Being score more than ranitidine (omeprazole 10 mg om versus ranitidine 150 mg bd, p = 0.005, omeprazole 20 mg om versus ranitidine 150 mg bd, p = 0.031). During follow-up, relapsing patients returned to pre-treatment symptom and well-being scores, but these dimensions were restored after treatment.

Conclusion: The quality of life is impaired in patients presenting with reflux symptoms. Irrespective of whether the patients presented with endoscopy positive or endoscopy negative reflux disease, treatment on demand improved the quality of life.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-Ulcer Agents / administration & dosage
  • Anti-Ulcer Agents / therapeutic use*
  • Double-Blind Method
  • Europe
  • Female
  • Follow-Up Studies
  • Gastroesophageal Reflux / diagnosis
  • Gastroesophageal Reflux / drug therapy
  • Gastroesophageal Reflux / psychology*
  • Humans
  • Male
  • Middle Aged
  • Omeprazole / administration & dosage
  • Omeprazole / therapeutic use*
  • Quality of Life*
  • Ranitidine / administration & dosage
  • Ranitidine / therapeutic use*
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Treatment Outcome


  • Anti-Ulcer Agents
  • Ranitidine
  • Omeprazole