Omics and its potential impact on R&D and regulation of complex herbal products

Abstract

In traditional Chinese medicine (TCM), multicomponent and principally plant-derived drugs are used for disease prevention, symptom amelioration and treatment in a personalized manner. Because of their complex composition and consequent multiple targets and treatment objectives, the application of omics techniques and other integrative approaches seems inherently appropriate and even necessary for the demonstration of their potential preclinical and clinical safety and efficacy. This perspectives article provides proposals for the application of omics methods to the investigation of complex herbal products (CHP),(1) including Chinese herbal medicines (CHM), both in vitro and in vivo, for preclinical and clinical toxicity, pharmacokinetics, pharmacodynamics and efficacy tests. Ultimately, such approaches could aid regulatory scrutiny and potential acceptance, although currently there is no regulatory requirement of omics-based data in any submitted dossier to any regulatory agency, including for conventional drugs and CHP. However, it has been acknowledged that such studies are being increasingly performed, and almost surely will eventually be included into regulatory submission dossiers, possibly initially as supplementary materials. Specifically for CHM and CHP, omics can play a role both in determining product composition and its variability and in monitoring biological effects in carefully selected platforms. Predicting the future is difficult, but it seems possible that regulatory acceptance of omics techniques and a systems biology approach for the study of TCM, CHM and CHP will not be long delayed. It is expected that current studies and plans employing omics techniques and other integrative approaches will prove to be positive and informative.

Traditional Chinese medicine research in the post-genomic era: Good practice, priorities, challenges and opportunities

“…This confidence was reflected by the opinions of GP-TCM members in the "Grand Issues" survey and supported by the recent research developments reviewed in this special issue Jia et al, 2012;Pelkonen et al, 2012). Nevertheless, studies using omics and systems biology approaches should be particularly good at generating new hypotheses on mechanisms for the effects of TCM and these hypotheses would need many additional approaches to substantiate them.…”

Proteins Derived from In Vitro Culture of the Callus and Roots of Calotropis procera Ameliorate Acute Inflammation in the Rat Paw

“…One such study on the anti-arthritic efficacy of latex proteins has been reported recently [15]. Numerous studies based on the quality assessment using chemometric analysis and omics approach have reported variation in the composition of constituents in the herbal medicines which have been attributed to seasonal changes, geographical conditions, or the processing of the plant material [18,33]. The qualitative and quantitative uniformity of the phytoconstituents present in plant-derived preparations are important from the point of their safety and efficacy.…”

Quality Control for Medicinal Plants

“…• Traditional (holistic) medicines are often mixtures, which do not fit well to the general set-up of clinical (reductionistic) trials [27,28].…”