Based on previous observations a randomized, noncompartative, phase II trial was conducted in China to investigate effects of 2 doses of freeze dried strawberries in human patients with esophageal dysplastic lesions in high risk areas for esophageal cancer.
75 patients were randomly identified by endoscopy to have their dysplastic esophageal premalignant lesions treated with freeze dried strawberry powder mixed with water: 37 received 30 g/d; and 38 received 60 g/d for 6 months.
After 6 months changes in histologic grade of the lesions was assessed in a blinded fashion. Doses of 30 g/d were observed not to significantly affect histology or any other measured parameter; doses of 60 g/d was observed to reduce the histologic grade of dysplastic premalignant lesions in 29 of the 36 patients who were evaluated for histology (80.6%; P<0.0001). No toxic effects or serious adverse events were reported, and the strawberry powder was well tolerated.
60 g/d strawberry doses also reduced protein expression levels of inducible nitric oxide synthase by 79.5%; cyclooxygenase-2 by 62.9%; phospho-nuclear factor kappa B by 62.6%; phospho-S6 by 73.2%, and significantly inhibited Ki-67 labeling index by 37.9%. Researchers suggest that their results indicate that freeze dried strawberry powder represents potential for preventing human esophageal cancer and is supportive of further clinical testing of the natural agent in this setting.
