A single-blind, randomized clinical trial of 56 female subjects was conducted to determine whether decreased consumption of
caffeine decreases
breast pain/tenderness or nodularity in patients with suspected benign proliferative
breast disease. The subjects were randomly assigned to one of three groups--a control group (no
dietary restrictions), a placebo group (
cholesterol-free diet), and an experimental group (
caffeine-free diet). At the initial examination, the subjects reported on the presence of
breast pain, the degree to which
pain affects daily activities, the frequency of
pain, the degree of
pain associated with breast examinations, and the degree of
pain associated with close-fitting clothing. Subjects were then examined and the four quadrants of each breast were rated on a scale of 0 to 3 (0 = normal, fatty tissue, 1 = little seedy bumps or fine nodularity, 2 = discrete nodules or ropy tissue, 3 = confluent areas, hard or soft masses). Subjects in all three groups returned for 2- and 4-month follow-up examinations. Total nodularity scores, degree of
pain/tenderness, and compliance with
dietary restrictions were analyzed. The data showed that decreased
caffeine consumption did not result in a significant reduction of palpable breast nodules or in a lessening of
breast pain/tenderness.