© 1997 by Oxford University Press
Journal Of The National Cancer Institute, Vol 89, 355-365, Copyright © 1997 by Oxford University Press
DB Thomas, DL Gao, SG Self, CJ Allison, Y Tao, J Mahloch, R Ray, Q Qin, R Presley and P Porter
BACKGROUND: The efficacy of breast self-examination in helping to reduce
mortality from breast cancer has not been rigorously demonstrated. PURPOSE:
To assess efficacy, a large, randomized trial was initiated in Shanghai,
China. METHODS: From October 1989 to October 1991, 267040 current and
retired female employees associated with 520 factories in the Shanghai
Textile Industry Bureau were randomly assigned on the basis of factory to
either a self-examination instruction group (133375 women) or a control
group (133665 women). The women were born within the period from 1925
through 1958. Women in the instruction group were given intensive training
in breast self- examination, including the use of silicone breast models
and personalized instruction, plus two subsequent reinforcement sessions
and multiple reminders to practice the technique. Women in the control
group were asked to attend training sessions on the prevention of low back
pain. All women have been followed for the development of breast diseases
and for death from breast cancer. RESULTS: A high level of participation
during the first 4-5 years of the trial was documented among women in the
instruction group. Randomly sampled women in this group demonstrated
greater proficiency in detecting lumps in breast models than did randomly
sampled women in the control group. Approximately equal numbers of breast
cancers were detected in the two groups (331 in the instruction group and
322 in the control group) through 1994, which is the last year for which
case-finding efforts have been completed. The breast cancers detected in
the instruction group were not diagnosed at an appreciably earlier stage or
smaller size than those in the control group. More benign breast lesions
were detected in the instruction group than in the control group (1457
versus 623, respectively), suggesting a higher index of suspicion for women
who received training. Cumulative breast cancer mortality rates through 5
years from entry into the study were nearly equivalent for the two groups.
CONCLUSIONS: Breast self-examination has not led to a reduction in
mortality from breast cancer in this study cohort in the first several
years since the trial began. A shift toward the diagnosis of disease at a
less advanced stage in women given instruction has also not been
demonstrated. Longer follow-up of participants in this trial is required
before final assessment can be made of the efficacy of breast
self-examination. IMPLICATIONS: At this time, there is insufficient
evidence to recommend for or against the teaching of breast
self-examination.
ARTICLES
Randomized trial of breast self-examination in Shanghai: methodology and preliminary results
Fred Hutchinson Cancer Research Center, Seattle, WA 98104, USA.
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