Year : 2016 | Volume
: 36 | Issue : 1 | Page : 1--2
Improving Quality of Research on Herbals and its Reporting
CSO, Ayurvidye Trust, 1101/927, 1F Main, 2nd Stage, Girinagar, Bengaluru - 560 085, Karnataka, India
CSO, Ayurvidye Trust, 1101/927, 1F Main, 2nd Stage, Girinagar, Bengaluru - 560 085, Karnataka
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Narayana D. Improving Quality of Research on Herbals and its Reporting.Ancient Sci Life 2016;36:1-2
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Narayana D. Improving Quality of Research on Herbals and its Reporting. Ancient Sci Life [serial online] 2016 [cited 2017 Apr 27 ];36:1-2
Available from: http://www.ancientscienceoflife.org/text.asp?2016/36/1/1/195413
Having been involved in research on herbals and reviewing documentation of the same for all most two decades has been a great learning experience. It is befitting the grandeur of Ayurveda that more informative and meaningful research on herbals takes place. The term “herbals” used here is most commonly adopted in India involving any scientific work on botanicals/medicinal plants and its parts/herbs/processed herbs and formulations/products made using the “herbals” as ingredients. The origin or basis of selection of the herbals for research could be those that grow near or around the areas of the investigators and/or those that are known in cultural usage/grandmother remedies and/or those that are documented in traditional authoritative text of Ayurveda, Unani, Siddha or even traditional Chinese medicine and similar traditional knowledge of Asian origin. Often one also finds studies on herbals of South African origin or Western nations.
Rising popularity of traditional medicines, interest of consumers to use what is commonly referred to as “Complimentary or alternative medicines” and a drive to go back to nature have all promoted interest in undertaking contemporary scientific studies – referred to commonly as research. Such research normally comprises of pharmacognostic, botanical, chemistry, Phytochemistry, qualitative and quantitative analyses for either components or activities. Activities span across anti-microbial, pharmacological, toxicological, clinical studies on efficacy for one or more therapeutic activity or health benefits. Interest in DNA barcode analysis is the current trend. Though not reported in contemporary scientific journals, studies on Ayurveda as documented in authoritative texts also happen. Research in this area is conducted mainly by the following communities – (i) academic post graduate courses as part of dissertation/thesis (which are all very short term undertaken by beginners in research), (ii) PG research leading to doctoral thesis, (iii) research funded by national organizations on specific areas, (iv) research undertaken by private R and D organizations involved in food, pharmaceutical, traditional medicine, nutraceutical and cosmetic products. The last basket of research mostly focuses on herbal products being developed adopting reverse pharmacology approach – herbals developed adopting drug development approach – primarily aimed at innovating a stable good quality product with safety profile known and claims supporting data.
The research as stated above revolve around a number of deficiencies. Any scientific research needs to be logical, as per the scientific method and needs adequate planning and rationale. Any deficiency in any of these components makes the research unscientific and illogical. Research papers should not only honestly report data but also have fact based interpretation to adequately support others who wish to undertake further work on the same lines. Efforts need to be focused on making research papers of greater utility to the scientific community. It will be pertinent here to point to some of the non-negotiable short comings seen in and often leading to rejection of papers submitted for publication in Ayurveda journals:
Improper botanical identity confirmation of the herb under study Inadequate or almost nil reportage of passport data Absence of a photograph of the part of the herb studied in the paper (one may refer to Indian Pharmacopoeia to get an Idea about how such photographs are to be taken Inadequate description of the processing of the herb for study – batch sizes, solvents used, temperatures involved during processing, volumes or weight of resultant material, yields obtained stage wise and at the last stage forming the study material Rationality of the processing of the herb selected for study. While the investigators may select any process, most often no reasons or explanations are given for such selection. Even if it is arbitrary it should be mentioned so Most often, processes are selected for study without any application of thought merely following some conventional method Often investigators use solvents like chloroform, carbon tetra chloride for extraction, in biological experimentation on lab animals disregarding safety and a consensus against their use Hardly investigators prepare (i) a study material detailing the cultural/traditional processes documented in traditional medicine books, and as per such processes, along with (ii) whatever novel pharmaceutical processing methods adopted by them. Comparative and concurrent evaluation of these two processes for the same battery of studies would actually add great value to the data and understanding with marginal additional cost. In the absence of such comparative evaluation, potential to generate false negative or false positive data is high Inadequate planning and application of statistics and sample sizes. Often there arises a feeling that the data generated was fitted to a statistical tool post its generation Arbitrary selection of levels of study material for testing especially in pharmacological, animal and human studies: Often, investigators state testing at 100, 250, 500, 1000 mg-quoting accurate round figures of the levels without any supporting rationale or data. In a few studies it is stated that dose selections were done on the basis of maximum tolerated dose. We also find that the level found to be nontoxic in an acute toxicity testing being a few thousand milligrams Arbitrary and unscientific selection of dose at which studies are performed is a common issue. Unlike synthetic drugs where doses are known as approved by regulatory authorities, for herbals one need to provide a basis for dose selection. This can be based on: Reference to traditional authoritative texts/materia medica/compendiums or traditional pharmacopoeiae Reference to authoritative books such as British Herbal Compendium/pharmacopoeiae Decisions based on a study of any marketed product containing the herb under study that is already available Decision based on interviewing a few traditional medicine physicians or herbalists to elicit information on the dose they adopt for treating patients and computing an average dose Other Innovative data generation for the usage level.
Even in those cases where the dose of the herb at which studies are performed is determined reasonably, there is inadequate application of scientific tools to compute the dose to be used for each animal in the study design. There are a number of computing models and formulae, many of which are even approved by regulatory authorities to calculate the dosage administration based on adult human dosage. Most investigators do not report this aspect properly and often it is seen that studies are conducted normally at high levels of dose and sometimes at sub potent levels Nonuse of negative and positive controls in biological experimentation Inadequate chemical characterization of study material is most common feature of deficiency. Very preliminary testing for presence or absence of group of compounds like alkaloids, tannins etc., (borrowing from Sherlock Holmes phrase - “Elementary my dear Watson” – any lab technician can do this test) is reported as chemistry. Most often repeated preparation of samples would have been undertaken and they would have been tested/studied without any quality control or characterization. Authors fail to report as to whether studies were done using partly characterized or uncharacterized material Results and conclusions are written in a way that is not based on the data of the study reported. Often these tend to be unobjective and lean towards exaggeration. A fact based reportage should be the norm which it does not. Instead of reporting “the study material showed or did not show – effect when tested by a method applied at a particular dose level”. Often the concluding sentence states that the particular herb showed or did not show any activity at all.
Due to constraints of length, a number of other aspects in the design of study, especially design of animal experimentation, human clinical or human intervention studies, variables measured in such studies, duration of pretreatment or treatment with the study material have not dealt with here.
More and more contemporary chemical and biological scientists are undertaking research on herbals, perhaps more than research on synthetic molecules (this itself can be a research topic). Value addition can happen if such researches involve in dialogue and discussions with traditional medicine scientists/physicians or herbalists while undertaking herbal research.