A randomized two-part study was conducted in order to determine the efficacy of
theophylline in the treatment of acute
mountain sickness during fast ascent to altitudes >2,500 m. Fourteen healthy male subjects participated in a randomized single-blind placebo-controlled crossover study carried out in a
decompression chamber (simulated altitude 4,500 m). A second randomized single-blind, placebo-controlled study was conducted at a high-altitude research laboratory (3,454 m) and included 21 healthy male subjects. The study medication was either 375 mg oral slow-release
theophylline (250 mg if <70 kg) or a matched placebo
tablet taken twice daily. The acute
mountain sickness score (AMSS) was assessed three times a day, beginning 18 h prior to altitude exposure and continuing for 18 h after altitude exposure. In addition, measurements of respiratory frequency, pulse rate, oxygen saturation and arterial blood gas levels were performed. Acute
mountain sickness was significantly reduced by
theophylline during the
decompression chamber study (mean+/-SD 1.2+/-0.9) with placebo versus 3.6+/-0.8 with
theophylline; p=0.03). During the high-altitude study, subjects with
theophylline showed a significantly lower AMSS on arrival and after 18 h at altitude (0.6 versus 2.3, p=0.03). Oxygenation was improved in both parts of the study. In conclusion, oral slow-release
theophylline improves acute
mountain sickness.