170 Background: Aromatase inhibitors are widely used in treatment of estrogen receptor positive breast cancer. Many patients experience significant arthralgias, which may lead to early cessation of therapy. Blue Citrus, a mix of Chinese herbs formulated in our community, had anecdotal reports of success in alleviating these symptoms. We objectively evaluated its activity in symptomatic patients. Methods: Breast cancer patients with significant arthralgia on aromatase inhibitors were enrolled in a prospective fashion to a double blind crossover placebo controlled trial. Each patient received either Blue Citrus (BC+P) or a placebo (P+BC) for three months and then crossed over to the opposite treatment for an additional three months. Symptoms were measured over the course of treatment. Results: A total of 37 patients enrolled on the study. There were 6 early withdrawals, which left 31 evaluable patients. Visual Analogue Score (VAS) for both groups was similar at baseline at 4.9 and 5.1 for the BC+P and P+BC groups, respectively. At 30 days the BC+P score was 3.4 vs. the P+BC of 4.7 showing clearly improved symptom control in the BC+P group. The P+BC group did however approach the BC+P group by 90 days. At crossover the BC+P group experienced a spike in symptomology when changed to placebo that didn’t appear for the P+BC group. When compared to baseline, mean VAS score on Blue Citrus was 2.98 (p=0.001) versus mean VAS score on placebo 3.92 (p=0.0203). By study end (180 days) the VAS scores for both groups were closer at 2.6 BC+P vs. 3.0 for P+BC but BC+P still maintained lower VAS scores. Conclusions: Blue Citrus improved symptoms associated with aromatase inhibitor use. Patients who received Blue Citrus in the first arm had rapid improvement in symptoms and experienced return of symptoms when converted to placebo. All patients averaged lower VAS scores on Blue Citrus however at 6 months the difference between the arms became less pronounced.
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