Clinical trial: the effects of adding ranitidine at night to twice daily omeprazole therapy on nocturnal acid breakthrough and acid reflux in patients with systemic sclerosis--a randomized controlled, cross-over trial

Background  Gastro-oesophageal reflux disease (GERD) is an important problem in systemic sclerosis due to impaired salivation and oesophageal function.
Aim  To determine the efficacy of adding ranitidine at bedtime to control nocturnal acid breakthrough (NAB) and GERD in patients with systemic sclerosis already prescribed high-dose omeprazole.
Methods  Patients with systemic sclerosis and GERD symptoms ( n  = 14) were treated with omeprazole 20 mg b.d. and either placebo or ranitidine 300 mg at bedtime for 6 weeks in a randomized, cross-over, placebo controlled study. At the end of each period a 24 h pH-study with intragastric and oesophageal pH measurement was performed.
Results  Pathological acid reflux occurred in eight patients with omeprazole/placebo and in seven with omeprazole/ranitidine ( P  = ns) with technically adequate oesophageal pH-studies ( n  = 13). NAB was present in eight patients with omeprazole/placebo and six with omeprazole/ranitidine ( P  = ns) in whom technically adequate gastric pH-studies were obtained ( n  = 10). The addition of ranitidine had no consistent effect on patient symptoms or quality of life.
Conclusion  Many patients with systemic sclerosis experienced NAB and pathological oesophageal acid exposure despite high-dose acid suppression with omeprazole b.d. Adding ranitidine at bedtime did not improve NAB, GERD or quality of life in this population.