Objective: To evaluate the research evidence on the efficacy and toler
ability of mefloquine chemoprophylaxis. Search strategy: Any potential
ly relevant trial from the Cochrane Infectious Disease Group's registe
r of controlled trials; systematic searches of Medline, Embase, Lilacs
and Science Citation Index; scanning citations; and consulting drug c
ompanies and key investigators. We considered studies in all languages
. Inclusion criteria: Trials carried out in non-immune adult traveller
s, and in non-travelling volunteers, where an attempt had been made to
conduct a randomised comparison of mefloquine against placebo or agai
nst alternative standard prophylaxis. Results: 37 potentially eligible
trials of mefloquine prophylaxis were identified, and 10 met the incl
usion criteria These 10 trials comprised a total of 2750 non-immune ad
ult participants randomised to mefloquine or to a control. One placebo
controlled trial examined malaria incidence directly and showed meflo
quine to be highly effective in preventing malaria in an area of drug
resistance. However, four placebo controlled trials showed that mefloq
uine was not well tolerated, and withdrawals were consistently higher
in mefloquine treatment arms than in placebo arms (odds ratio 3.49 (95
% confidence interval 1.42 to 8.56)). Five field trials compared meflo
quine with other chemoprophylaxis. Mefloquine was no worse tolerated t
han other chemoprophylaxis, although there was possibly a trend toward
s higher withdrawals in mefloquine arms (odds ratio 1.33 (0.75 to 2.36
)). Conclusion: One trial showed mefloquine to be effective in prevent
ing malaria, but withdrawal rates, presumably from side effects, were
high across most studies. This is likely to impair mefloquine's effect
iveness in general travellers, and it may therefore not be useful for
routine prophylaxis. Mefloquine may be useful in specific situations s
uch as for groups travelling to regions with a high risk of chloroquin
e resistant malaria and only limited access to effective medical care.