MAXILLARY SINUSITIS IN ADULTS - AN EVALUATION OF PLACEBO-CONTROLLED DOUBLE-BLIND TRIALS

Background, In general practice, acute sinusitis is frequently diagnos ed and treated with antibiotics. Objective. This study aimed to determ ine the evidence for the effectiveness of antibiotic treatment in acut e maxillary sinusitis in adults by assessing the methodological qualit y of placebo-controlled double-blind randomized trials. Method. An eva luation by four raters through a 35-item scoring-scale for internal an d external validity of all placebo-controlled double-blind randomized trials on acute sinusitis found between January 1966 and July 1996. Re sults. Eighty-five trials were excluded because they were not placebo- controlled, double-blind, randomized, or were carried out in patients with chronic sinusitis or in children. The three remaining trials were performed in different populations (one in general practice) between 1973 and 1978. Only one study claimed superiority of antibiotic treatm ent. Different inclusion criteria and major outcome measures were used by the authors. The reliablity of major outcome events was reported p oorly or not at all and in two studies outcome measures were clinicall y inappropriate. The studies scored 30-62% of the maximum attainable s core for internal validity and 10-20% for external validity. Conclusio n. The effectiveness of antibiotic treatment in acute maxillary sinusi tis in a general practice population is not based sufficiently on evid ence.