A community-based RCT for oral cancer screening with toluidine blue.
Early detection of oral premalignant lesions (OPMLs) by visual inspection with toluidine blue has not been addressed. We conducted a community-based randomized controlled trial to assess whether using toluidine blue as an adjunctive tool for visual screening had a higher detection rate of OPMLs and could further reduce the incidence of oral cancer. In 2000, in Keelung, we randomly assigned a total of 7975 individuals, aged 15 years or older and with high-risk oral habits, to either the toluidine-blue-screened (TBS) group or the visual screening group. Results showed 5% more oral premalignant lesions and 79% more oral submucous fibrosis detected in the TBS group than in the control group. After a five-year follow-up ascertaining oral cancer development through linkage to the National Cancer Registry, the incidence rate in the TBS group (28.0 x 10(-5)) was non-significantly 21% lower than that in the control group (35.4 x 10(-5)).
Division of Biostatistics, Graduate Institute of Epidemiology/Centre of Biostatistics Consultation, College of Public Health, National Taiwan University, Room 533, No. 17, Hsu-chow Road, Taipei, 100, Taiwan.
W W-Y
WW
Su
A M-F
AM
Yen
S Y-H
SY
Chiu
T H-H
TH
Chen
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001114:Areca; D016009:Chi-Square Distribution; D004396:Coloring Agents; D016001:Confidence Intervals; D055088:Early Detection of Cancer; D006801:Humans; D007972:Leukoplakia, Oral / Q000175:diagnosis*; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000175:diagnosis*; D009914:Oral Submucous Fibrosis / Q000175:diagnosis*; D011230:Precancerous Conditions / Q000175:diagnosis*; D012907:Smoking; D014048:Tolonium Chloride; D055815:Young Adult
D004396:Coloring Agents; D014048:Tolonium Chloride