Natreon's Ayuric hyperuricemia study published

Published: 30-Jun-2016

Standardised aqueous extract of Terminalia bellerica can significantly decrease serum uric acid levels


Natreon's Ayuric, a clinically studied and standardized aqueous extract of Terminalia bellerica, significantly reduced serum uric acid levels in subjects with hyperuricemia according to a clinical study just published in Clinical Pharmacology: Advances and Applications.

Asymptomatic hyperuricemia is common and serum uric acid levels greater than 10mg/dL may lead to symptoms of gout. Gout is a form of inflammatory arthritis that is caused by hyperuricemia and can lead to the deposition of uric acid crystals in tissues and fluids within the body.

Hyperuricemia is caused by an overproduction or under-excretion of uric acid, and is not only a risk factor for renal disease progression, but may also affect patient survival by inducing or aggravating cardiovascular disease.

The prevalence of gout among adults in the US was 3.9% in 2007-2008 (8.3 million individuals) with men being affected more than women. Owing to the increasing prevalence of gout and the adverse effects associated with prescription gout medications, consumers are searching for a natural alternative to help lower serum uric acid levels.

This randomised, double-blind, placebo-controlled study evaluated the effects of Ayuric, a natural xanthine oxidase inhibitor, and the prescription gout medication febuxostat on uric acid levels in subjects with hyperuricemia. Subjects were randomised to receive Ayuric (250mg) twice daily, 500mg twice daily, febuxostat (40mg) once daily (with a placebo dose given in the evening) and a placebo for 24 weeks.

The primary outcome measure of the study was the absolute change in serum uric acid levels from baseline to the end of 24 weeks of treatment. Secondary outcome measures included the percentage of subjects whose serum uric acid levels have decreased to <6.0mg/dL and measurements of tolerability following treatment at the end of 24 weeks.

A total of 88 subjects completed the study. At the end of 24 weeks, the mean percentage decrease in serum uric acid levels with Ayuric was dose-dependent at 28% in the 500mg group (p<0.001) and 14% in the 250mg group, while febuxostat decreased uric acid levels by 48%. The reduction in serum uric acid levels in the Ayuric group was observed as early as 4 weeks after starting therapy and maximum results were seen after 4 months. With the placebo group, there was in fact an increase of 7% in uric acid levels.

The percentage of subjects who achieved the target serum uric acid level <6mg/dL at the end of 24 weeks was the secondary outcome measure. All the subjects in the febuxostat group achieved the target serum uric acid level, whereas 88% of the Ayuric 500mg group reached this target.

Measurement of tolerability was assessed at the end of 24 weeks as 'good' because no serious side-effects were observed in either of the study groups. However, two subjects in the febuxostat group had mildly elevated bilirubin levels and one subject reported nausea and vomiting.

There were no reports of adverse effects in the Ayuric treatment groups. Owing to its positive safety profile, and ability to decrease serum uric acid levels, Ayuric may be a good choice for preventing gout attacks, especially in subjects who may be at higher risk for gastrointestinal or renal complications from the current prescription gout medications.

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