Table 6.

Breast Self-Examination clinical trials

Age group (years)	Study years	Design and Setting	Protocol	Primary outcome	Secondary outcome	Result and reference
31-65	1989-2000	RCT: Shanghai, China; women working in factories	Instruction on breast anatomy and 3-step BSE by trained factory medical worker with instruction reinforcement at 1 and 3 years and medically supervised CBE every 6 months (women practiced supervised BSE 1, 3, 6, and 9 months after initial instruction during year 1 and every 6 months for next 4 years). versus No information on breast cancer screening	Relative Risk (RR) for breast cancer mortality = 1.03 (95% CI, 0.81-1.31)	Benign biopsies: RR = 1.57 (95% CI, 1.48-1.68)	Breast cancer was 6.5/1,000 women in the BSE group and 6.7/1,000 in control group. Breast cancer mortality equivalent in both groups 43.
40-64	1985-2001	RCT, cluster randomization; Saint Petersburg, Russia; women attending clinics; n=123,748	Nurses or providers receive 3-hour training on BSE prior to instructing groups of 5-20 women. BSE instruction with reinforcement every 3 years provided by the trained personnel [CBE with review of BSE at annual clinic visits] versus no instruction;	Relative Risk (RR) for all cause mortality = 1.07 (95% CI, 0.88-1.29) Breast cancer mortality not reported.	Benign biopsies: RR 2.05 (95% CI, 1.80-2.33)	Only 18% reported performing monthly BSE within 4 years of enrollment, which prompted BSE refresher every 3 years. Even with BSE instruction reinforcement, only 58% of women performed monthly BSE. Various publications from this study have unexplained inconsistencies in data reporting 44