Tritermenos en Centellea

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POSTER PRESENTATION Open Access P02.186. CAST (Centella asiatica selected triterpenes): stability, safety, and effect on diabetic neuropathy (DN) A Soumyanath * , D Dimitrova, G Arnold, H Belding, N Seifer, N Le, J Lou From International Research Congress on Integrative Medicine and Health 2012 Portland, Oregon, USA. 15-18 May 2012 Purpose The Ayurvedic nerve tonic herb Centella asiatica demon- strates potential neuro-regenerative properties in in vitro and in vivo models. The aims of the present study were to evaluate the safety and therapeutic effects of CAST (Indena ® , Milan, Italy) in humans with DN, while moni- toring the stability of CAST during the trial period. Methods The stability of CAST was monitored throughout the study using reversed phase high performance liquid chro- matography. CAST or placebo capsules were administered to 33 DN subjects, in a randomized double-blind, placebo- controlled study. The dose of CAST was escalated from 60 mg to 240 mg/day over the first 12 weeks, followed by a stable dose of 240 mg/day for the remaining 40 weeks. The primary outcome was total symptom score (TSS), while secondary outcomes were nerve conduction studies, neurological disability score (NDS) and qualitative sensory testing (QST). Results CAST was stable (<10% change from starting values) at room temperature for the duration of the study. At base- line, there was no difference in outcome measures between treatment (n=15, 3F/12M) and placebo (n=18, 6F/12M) groups (TSS: 8.4±2.9 vs 8.3±2.5; combined sen- sory nerve action potential amplitude of sural and radial (SNAP): 18.8±8.9 vs 17.7±15.4 μV). At week 52, subjects in the treatment group had significantly lower TSS scores (6.4±0.4 vs 7.5±0.4, p<0.05) and higher SNAP (20.3±2.4 vs 14.8±2.2 μV, p<0.05) than the placebo group. Other outcome measures did not differ significantly between the two groups. Conclusion CAST was stable and well tolerated by subjects at up to 240 mg per day. Compared to placebo, CAST significantly improved subjective DN symptoms (TSS score) and pre- vented deterioration in an objective measure of nerve con- duction (SNAP). Current treatments for DN provide symptomatic relief rather than ameliorating disease pro- gression. Multicenter trials are clearly warranted to further evaluate the role of CAST as a novel disease-modifying agent for DN. Published: 12 June 2012 doi:10.1186/1472-6882-12-S1-P242 Cite this article as: Soumyanath et al.: P02.186. CAST (Centella asiatica selected triterpenes): stability, safety, and effect on diabetic neuropathy (DN). BMC Complementary and Alternative Medicine 2012 12(Suppl 1):P242. Submit your next manuscript to BioMed Central and take full advantage of: Convenient online submission Thorough peer review No space constraints or color figure charges Immediate publication on acceptance Inclusion in PubMed, CAS, Scopus and Google Scholar Research which is freely available for redistribution Submit your manuscript at www.biomedcentral.com/submit Oregon Health & Science University, Portland, USA Soumyanath et al. BMC Complementary and Alternative Medicine 2012, 12(Suppl 1):P242 http://www.biomedcentral.com/1472-6882/12/S1/P242 © 2012 Soumyanath et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Transcript of Tritermenos en Centellea

POSTER PRESENTATION Open Access

P02.186. CAST (Centella asiatica selectedtriterpenes): stability, safety, and effect ondiabetic neuropathy (DN)A Soumyanath*, D Dimitrova, G Arnold, H Belding, N Seifer, N Le, J Lou

From International Research Congress on Integrative Medicine and Health 2012Portland, Oregon, USA. 15-18 May 2012

PurposeThe Ayurvedic nerve tonic herb Centella asiatica demon-strates potential neuro-regenerative properties in in vitroand in vivo models. The aims of the present study were toevaluate the safety and therapeutic effects of CAST(Indena®, Milan, Italy) in humans with DN, while moni-toring the stability of CAST during the trial period.

MethodsThe stability of CAST was monitored throughout thestudy using reversed phase high performance liquid chro-matography. CAST or placebo capsules were administeredto 33 DN subjects, in a randomized double-blind, placebo-controlled study. The dose of CAST was escalated from60 mg to 240 mg/day over the first 12 weeks, followed bya stable dose of 240 mg/day for the remaining 40 weeks.The primary outcome was total symptom score (TSS),while secondary outcomes were nerve conduction studies,neurological disability score (NDS) and qualitative sensorytesting (QST).

ResultsCAST was stable (<10% change from starting values) atroom temperature for the duration of the study. At base-line, there was no difference in outcome measuresbetween treatment (n=15, 3F/12M) and placebo (n=18,6F/12M) groups (TSS: 8.4±2.9 vs 8.3±2.5; combined sen-sory nerve action potential amplitude of sural and radial(SNAP): 18.8±8.9 vs 17.7±15.4 μV). At week 52, subjectsin the treatment group had significantly lower TSS scores(6.4±0.4 vs 7.5±0.4, p<0.05) and higher SNAP (20.3±2.4 vs14.8±2.2 μV, p<0.05) than the placebo group. Other

outcome measures did not differ significantly between thetwo groups.

ConclusionCAST was stable and well tolerated by subjects at up to240 mg per day. Compared to placebo, CAST significantlyimproved subjective DN symptoms (TSS score) and pre-vented deterioration in an objective measure of nerve con-duction (SNAP). Current treatments for DN providesymptomatic relief rather than ameliorating disease pro-gression. Multicenter trials are clearly warranted to furtherevaluate the role of CAST as a novel disease-modifyingagent for DN.

Published: 12 June 2012

doi:10.1186/1472-6882-12-S1-P242Cite this article as: Soumyanath et al.: P02.186. CAST (Centella asiaticaselected triterpenes): stability, safety, and effect on diabetic neuropathy(DN). BMC Complementary and Alternative Medicine 2012 12(Suppl 1):P242.

Submit your next manuscript to BioMed Centraland take full advantage of:

• Convenient online submission

• Thorough peer review

• No space constraints or color figure charges

• Immediate publication on acceptance

• Inclusion in PubMed, CAS, Scopus and Google Scholar

• Research which is freely available for redistribution

Submit your manuscript at www.biomedcentral.com/submit

Oregon Health & Science University, Portland, USA

Soumyanath et al. BMC Complementary and AlternativeMedicine 2012, 12(Suppl 1):P242http://www.biomedcentral.com/1472-6882/12/S1/P242

© 2012 Soumyanath et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the original work is properly cited.