No effect of riboflavine, retinol, and zinc on prevalence of precancerous lesions of oesophagus. Randomised double-blind intervention study in high-risk population of China.

A randomised double-blind intervention trial was carried out in Huixian, Henan Province, People's Republic of China, to determine whether combined treatment with retinol, riboflavine, and zinc could lower the prevalence of precancerous lesions of the oesophagus. 610 subjects in the age group 35-64 were randomised to receive once a week the active treatment (15 mg [50 000 IU] retinol, 200 mg riboflavine, and 50 mg zinc) or placebo. Both at entry to the study and at the end of the treatment, 13.5 months later, the subjects were examined, with an emphasis on signs of vitamin A and riboflavine deficiences, and riboflavine, retinol, beta-carotene, and zinc levels were measured. Compliance was excellent. The final examination, on 567 (93%) subjects, included oesophagoscopy and at least two biopsies. The intervention did not affect the prevalence of oesophageal lesions: after one year, the prevalence of oesophagitis with or without atrophy or dysplasia was 45.3% in the placebo group and 48.9% in the vitamin/zinc treated group.

RCT Entities:   Population Interventions Outcomes