Welcome to the ninety-fourth issue of GP Research Review. Under-reporting of drug-induced harms appears to be widespread in trials using the frequently prescribed antibiotics amoxicillin and amoxicillin–clavulanic acid. In a systematic review of 45 controlled trials, only 25 reported harms in sufficient detail to allow meta-analysis of their data and even these rarely gave detailed information about how harms data were collected. Statistically significant results were found for just diarrhoea and candidiasis, which was unexpected, as clinical anecdotal experience and observationally derived data have primarily reported common harms as rashes (at rates
of 5%–8% of those treated and even higher, up to 20%, among those with mononucleosis treated with amoxicillin) and gastrointestinal disturbance, note the study researchers. They conclude that until the problem of under-reporting of harms in trials is addressed, under-reporting will flow to systematic reviews and other evidence syntheses such as guidelines. Poor measurement and reporting hampers the ability of clinicians and patients to make fully informed decisions about the use of
amoxicillin and amoxicillin–clavulanic acid. To read more please open the attached PDF.