Purpose:
To evaluate safety and efficacy of Ayurveda's anti-inflammatory and anti-oxidative natural compound Curcumin in the treatment of nonexudative AMD. Preliminary results (6-months follow-up) of the Justification for the Use of Natuaral Compounds in the Treatment of Inflammatory, Ophthalmic and Neurodegenerative diseases Study (JUNCTION Study) are presented here.
Methods:
126 patients with nonexudative AMD with large drusen in both eyes (AREDS Category 3) were randomized to the AREDS2 supplements 1000mg Omega 3 and 10mg Lutein / 2mg Zeaxanthin alone or to these supplements in addition to 1000mg CuromTM (complex of Curcumin, Omega 3 DHA/EPA and phospholipids). SD-OCT (Heidelberg Spectralis OCT) and fundus photography (Zeiss Visucam NMpro) were performed at baseline and after 6 months. Before the beginning of this study, the bioavailability of different Curcumin products have been studied.
Results:
The treatment with CuromTM shows very good 24-hours bioavailabilities. In the 66 patients treated with AREDS2 plus CuromTM, there was a highly significant reduction of drusen size between baseline and after 6 months (p<0.0001). In the 132 eyes of these 66 patients, we found a disappearing of one or more drusen in 109 eyes. There was only a non-significant change of drusen size in the eyes of the 60 patients who were treated with AREDS2 supplements alone. Tolerance of AREDS2 supplements was slightly better than of AREDS2 supplements plus CuromTM. There were 5 out of the 66 patients who were treated with AREDS2 supplements plus CuromTM, who complained about diarrhea and/or a dull stomach. Biomarkers of atherosclerosis improved significantly in patients who were treated with AREDS2 supplements plus CuromTM (p<0.05).
Conclusions:
CuromTM is a powerful natural compound (complex) to treat nonexudative AMD (high-risk dry AMD). The anti-inflammatory agent Curcumin should be part of any treatment of nonexudative AMD. Thereby, bioavailability is of major concern. Follow-up of patients in the JUNCTION Study will test the hypothesis, that (whether) CuromTM is able to reduce the risk of progression of high-risk dry AMD (AREDS Category 3) to exudative AMD and/or Geographic Atrophy (AREDS Category 4). In addition, following the guidelines for assessment of cardiovascular risk in asymptomatic adults of the American College of Cardiology Foundation/American Heart Association, the large number of patients recruited until April 30, 2012, will give insights into a possible prevention of stroke and/or congestive heart failure.
Clinical Trial:
Bavarian Medical Association, Munich, Germany, 11130
Keywords: age-related macular degeneration