Letter to the Editor Response- Body and Soul: A Dietary Intervention Conducted Through African-American Churches

The paper, “Body and Soul: A Dietary Intervention Conducted Through African-American Churches,” raises serious and important issues. First, an effectiveness study should be based on proven efficacy, usually from clinical trials. There are no clinical trials to date that show any benefit from the modest increase in fruits and vegetables.1 There has been a negative study, the Polyp Prevention Trial (PPT).2 The Women’s Health Initiative (WHI) will report shortly on whether increased fruits and vegetables in the diet arm have reduced cancer and cardiovascular disease. The National Cancer Institute and other governmental agencies can recommend increases in fruits and vegetables to the population.3 However, it is unethical to push an unproven intervention in a demonstration project, that is, that an increase in fruits and vegetables will decrease the risk of cancer, especially in potentially vulnerable populations. Did they explain carefully to the population that there is no evidence that the intervention will reduce the risk of cancer? You could argue that there is no downside from the intervention. We have learned from the betacarotene and vitamin E trials, for example, that even so-called benign interventions result, sometimes, in increased risk of disease. 4,5,6,7,8 It would be important to review the consent forms.