Breast self-examination (BSE) is widely recommended for breast cancer prevention. Following recent controversy over the efficacy of mammography, it may be seen as an alternative. We present a meta-analysis of the effect of regular BSE on breast cancer mortality. From a search of the medical literature, 20 observational studies and three clinical trials were identified that reported on breast cancer death rates or rates of advanced breast cancer (a marker of death) according to BSE practice. A lower risk of mortality or advanced breast cancer was only found in studies of women with breast cancer who reported practising BSE before diagnosis (mortality: pooled relative risk 0.64, 95% CI 0.56 -0.73; advanced cancer, pooled relative risk 0.60, 95% CI 0.46 -0.80). The results are probably due to bias and confounding. There was no difference in death rate in studies on women who detected their cancer during an examination (pooled relative risk 0.90, 95% CI 0.72 -1.12). None of the trials of BSE training (in which most women reported practising it regularly) showed lower mortality in the BSE group (pooled relative risk 1.01, 95% CI 0.92 -1.12). They did show that BSE is associated with considerably more women seeking medical advice and having biopsies. Regular BSE is not an effective method of reducing breast cancer mortality. British Journal of Cancer (2003) For many years, women have been taught methods of breast selfexamination (BSE) and it is recommended that they practise this regularly (Boyle et al, 1995; Shapiro et al, 1998), usually every month. There is a belief that among women who practise BSE, those who develop breast cancer are more likely to find it at an earlier stage and this is expected to lead to earlier treatment and hence decrease their risk of dying from the disease. Breast selfexamination is appealing as a routine screening method because the examination has no financial cost (apart from the initial instruction sessions) and can be conducted in private. Most studies on the effectiveness of BSE have been observational. They suggest that women who practise BSE are more likely to find their breast tumour themselves, that the tumour tends to be smaller and that these women have an increased survival (Hackshaw, 1996; International Agency for Research on Cancer (IARC), 2002). However, survival time as an outcome measure can be misleading because of lead-time bias, in which BSE only identifies cancers at an earlier stage but has no effect on prognosis. Using mortality rates instead of survival time can overcome much of this bias.Recently, the International Agency for Research on Cancer (2002) published a review on breast-cancer screening that reported the individual results from observational studies of BSE in relation to survival and stage of cancer, and those from randomised trials and cohort studies in relation to mortality. We here, however, present a meta-analysis of BSE and breast-cancer mortality by reviewing the published evidence from both observational studies and randomised trials, including t...