A two-phased controlled study investigated the efficacy of long-term ranitidine treatment in patients with progressive systemic sclerosis (PSS) and symptomatic gastroesophageal reflux (GER).

Twenty patients with PSS and symptoms of GER were included in the study. All patients received 6-week treatment with 150 mg ranitidine twice daily (phase 1). Then, in a double-blind manner, they were randomized to receive 3 months of treatment with either 150 mg ranitidine twice daily or placebo (phase 2). The study duration was 20 weeks. Two patients were excluded during the study.

The investigators assessed heartburn and dysphagia, endoscopic appearance of the esophageal mucosa, esophageal motility, and gastroesophageal reflux.

• Changes in the estimates of heartburn and dysphagia as well as endoscopic findings were noted in 18 PSS patients treated for 6 weeks with ranitidine. In phase1, 16 patients had symptomatic relief of heartburn.
• In phase 2, 10 patients were randomized to further treatment with ranitidine. Five patients had no change in heartburn while three patients noted further improvement. Mucosal appearance was unchanged in three patients, and improved in four patients.
• No abnormal test results were noted and no side effects could be attributed to ranitidine therapy.
• The efficacy of ranitidine was maintained over the 20-week period.
• Patients recognized a shift to placebo within a few days and it was noted to cause increase in heartburn and esophageal mucosal inflammation.

To summarize, treatment with 150 mg ranitidine twice daily in patients with PSS and symptomatic GER over 20 weeks was devoid of any side effects and was associated with symptomatic relief and healing of esophageal mucosa.

Source: Hendel L, Aggestrup S, Stentoft P. Long-Term Ranitidine in Progressive Systemic Sclerosis (Scleroderma) with Gastroesophageal Reflux. Scand J Gastroenterol. 1986 Sep;21(7):799-805.