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Ibuprofen Compared to Acetazolamide for the Prevention of Acute Mountain Sickness: A Randomized Placebo-Controlled
Srinivasa Bhattachar1,2, Vineet K Malhotra2, Uday Yanamandra3
1Physiology, High Altitude Medical Research Centre, Leh, IND.
Introduction:
Acetazolamide is recommended for the prevention of acute mountain sickness (AMS); however, its use is limited in some areas because of side effects. Previous studies report ibuprofen to be similar to or slightly inferior to acetazolamide. This randomized, triple-blinded, parallel-group, placebo-controlled trial was designed to compare ibuprofen with acetazolamide for the prevention of AMS.
Methods:
Four hundred forty-three healthy Asian Indian men with a mean age of 29 (range: 20-49) years were randomized into three groups A, B, and P at 350m (SL). Acetazolamide (A): 85 mg; ibuprofen (B): 600 mg; or placebo (P): calcium carbonate was administered thrice daily, starting one day prior and continuing for three days after arrival at 3500m (HA). Participants were evaluated for AMS using the Lake Louise Questionnaire and for pulse, BP, SpO2, and respiratory rate twice daily for the first two days during rest and once a day for days three to six at HA.
Results:
Of the 443 participants recruited at SL, 139 could not be airlifted due to logistical limitations, and 304 were available for follow-up at HA. Among these, 254 had ascended as per protocol. By intent to treat (IT) (N = 304; A = 99, B = 102, P = 103), the incidence of AMS (LLQS>/=3) was 12%, 5%, and 13%, and the incidence of severe AMS was 1%, 2%, and 6%, in groups A, B, and P, respectively. Using per protocol analysis (PP) (N = 254; A = 83, B = 87, P = 84), the incidence of AMS was 12%, 6%, and 13% in groups A, B, and P, respectively. The relative risk for developing AMS vs. placebo was A-0.96 (CI:0.46-2.0, p=0.91), B-0.39 (CI:0.14-1.04, p=0.06), A-0.94 (CI:0.42-2.1, p=0.88), and B-0.45 (0.16-1.24, p=0.12) by IT and PP, respectively.
Conclusion:
Ibuprofen is effective in males for the prevention of AMS with rapid ascent to 3500 m-rest for the first two days. Acetazolamide was superior to ibuprofen in the prevention of moderate-to-severe AMS.
Insights
Ibuprofen effectively prevents acute mountain sickness (AMS) in men during rapid ascent. While acetazolamide is better for severe AMS, ibuprofen offers a viable alternative with fewer side effects.
Area of Science:
- Altitude Medicine
- Pharmacology
- Preventive Medicine
Background:
- Acetazolamide is a common AMS preventative, but side effects limit its use.
- Previous research suggests ibuprofen is comparable or slightly less effective than acetazolamide for AMS prevention.
Purpose of the Study:
- To compare the efficacy of ibuprofen versus acetazolamide in preventing acute mountain sickness (AMS).
- To evaluate the safety and effectiveness of ibuprofen as an alternative AMS prophylaxis.
Main Methods:
- A randomized, triple-blinded, placebo-controlled trial involving 304 healthy Asian Indian men rapidly ascending to 3500m.
- Participants received acetazolamide (85 mg), ibuprofen (600 mg), or placebo thrice daily, starting one day prior to ascent.
- AMS incidence was assessed using the Lake Louise Questionnaire, with vital signs monitored.
Main Results:
- The incidence of AMS was 5% for ibuprofen versus 12% for acetazolamide and 13% for placebo (intent-to-treat analysis).
- Ibuprofen showed a trend towards preventing AMS (relative risk 0.39 vs. placebo, p=0.06).
- Acetazolamide demonstrated superiority in preventing moderate-to-severe AMS.
Conclusions:
- Ibuprofen is effective in preventing AMS in males undergoing rapid ascent to 3500m.
- Acetazolamide remains superior for preventing moderate-to-severe AMS.
- Ibuprofen presents a potentially useful alternative for AMS prophylaxis, particularly when acetazolamide is contraindicated.
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