Meriva®, a lecithinized curcumin delivery system, in the control of benign prostatic hyperplasia: a pilot, product evaluation registry study.

ABSTRACT

INTRODUCTION: The aim of this registry evaluation study was to compare, in symptomatic BPH patients, two management plans based on a currently validated standard treatment [defined as the best standard management (BSM)] including or not curcumin (administered as Meriva®) as a further complementary adjuvant element. Signs and symptoms were evaluated using the International Prostate Symptom Score (IPSS). SUBJECTS, METHODS: The study was carried out on a total of 61 subjects. 33 subjects (mean age 58.6;5.3) completed the survey with at least 24 weeks of treatment with Meriva® in association with the BSM. The BSM-alone control group consisted of 28 volunteers of similar age (58.4 years;3.4) and severity of the condition. The range of inclusion age was 55-65. No other clinical or metabolic problems were present. Meriva® was administered at the dosage of 2 tablets/day (2 x 500 mg of Meriva®/day, corresponding to 2 x 100 mg curcumin/day) with a compliance values > 95% as evaluated by the number of tablets used according to medical recommendation. No other drugs or food supplement were used during the study. RESULTS: All IPSS scores, with the exception of the stream weakness score in the BSM group, were improved (p<0.05 vs. inclusion) in both groups. The overall results in the Meriva® group were significantly better than in the BSM-only group (p<0.05). No side effects were recorded. The quality of life improved in both groups, but was significantly better in the Meriva® group (p<0.01). There was also a significantly more important decrease in clinical and subclinical episodes of urinary infections and urinary block in the Meriva® group (p<0.01). COMMENTS: In patients with BPH, the addition of Meriva® to the standard treatment contributed to the reduction of signs and symptoms of the disease without causing any significant additional side effect. This pilot experience suggests a potential novel clinical application of curcumin, and further studies aimed at selecting the most appropriate dosages and length of treatment as well as the possibility to including longer treatments will, undoubtedly, validate and optimize the role of Meriva® in the management of BPH.