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Editorial- Clinical effectiveness of Traditional Medicines
Madhu.C.Divakar
There is a general conception that, herbs are natural therefore, they are completely safe. In fact, herbs or herbal preparations can cause toxic adverse effects, serious allergic reactions and adverse drug /diet interactions.
The efficacy of a drug substance is its capacity to produce a desired therapeutic effect, or the relative ability of a drug receptor complex to produce maximum functional response. Nowadays, in health care systems the term 'clinical effectiveness' or 'clinical governance' is preferred instead of efficacy, though both are having similar meanings. The term clinical effectiveness includes the sum total of the pharmacological and the non medical effects of bioactive compounds that may act synergistically, otherwise termed as placebo effect, or sometimes antagonistically or the nocebo effect.
The meaning response
The non therapeutic function of medicines plays a major role in executing the 'meaning response'. The 'meaning response' mainly arise from the physiological or psychological perception of mind in the treatment of illness. This includes mainly the brain mechanisms like- expectation, anxiety, and reward, in addition to other learning phenomena.
In regards to traditional herbal medicines, the socio cultural aspects are likely to elicit a physiological response in addition to the intrinsic pharmacological activity of the herb, since they often exist within religious and mythical traditions creating a collaborative 'meaning response'. Meaning response plays a very important role in the clinical effectiveness of traditional herbal medicines, for e.g. traditional healer may make magical claims, gestures, chanting or prayers while giving a crude herbal extract to the needed person ,finally result in the so called meaning response .Even the packaging, shape, size, color, odor, of a herbal dosage form may affect the clinical effectiveness of the drug, a theme which can entertain many levels of pharmacy practice research.
Evidence
In an era of evidence based health care, systematic reviews of randomized control trials (RCT) are becoming increasingly important as a source of evidence for decision making. The evidence of clinical effectiveness mainly comes from the use of high quality herbal ingradients in the formulations, systematic reviews and Meta analysis of randomized controlled clinical trials.
To establish the true effectiveness of herbs as medicines, they must be tested in prospective, double blind, randomized, placebo-controlled clinical trials (RCTs).The main reliable reviews about the effectiveness of herbal drugs may be obtained from the well known Cochrane reviews and Medline reviews considered as the bench mark of high quality informations on health care systems. Cochrane reviews are systematic reviews of primary research in human health care and health policy and are internationally recognized as the highest standard in evidence based health care.
Newer scientific trends about herbal medicines
Application of novel trial designs such as Point Of Care clinical trial (POC –CT) ,a newly derived clinical trial approach developed by Dr.Philip Lavori of Stanford University, compares treatments that doctors are already using, and collects data on which treatments work best within the context of real-world, everyday practice. Enrollment and randomization of study volunteers occurs during regular care - within the framework of a patient’s visit to their usual health care provider.
It is assumed that herbal medicines interact with bacteria present in the gut flora, leading to a kind of bioprocessing inside, may result in the conversion of inactive to active medicine compounds, or sometimes improve the population of beneficial bacteria which in turn improve the immune system performance. Phytopharmaceuticals proved useful in several cases as these compounds act synergistically with the synthetic drugs and may reduce the adverse reactions to some extent.
Reports again indicated that the phytoconstituent, piperine present in Piper longum and Piper nigrum, increases the bioavailability, Cmax and AUC of several synthetic drugs amoxicillin, phenytoin, propranol and theophylline. Licorice has been shown to increase the plasma concentration of prednisolone.
Recent research on several Ayurvedic medicines indicated that, the total synergistic effect of the constituents lead to the inhibition of Stress activated Protein Kinase there by blocking the NFκB (Nuclear Factor kappa B) signal transduction pathway, finally results in apoptosis, and anti inflammatory responses. The emergence of modern standardization tools like proteomics, bioinformatics and various chemical docking studies may improve the identification of the evidence based herbal constituents and products in the future.
(Please refer the section 'Pharmaceutical updates and reviews' or click this link : complete text of the editorial with references )
For Correspondence:madhu.divakar@gmail.com
Editor-in-Chief
Hygeia :: journal for drugs and medicines,
Researcher ID: C-2923-2012 ORCID: 0000-0001-7527-3554