Volume 1, Issue 1, January–June 2015, Pages 44–46
Commentary
Herbal remedies and traditional medicines in reproductive health care practices and their clinical evaluation
Keywords
- Clinical evaluation;
- Reproductive health;
- Traditional medicines
Traditional
medicine refers to health practices, knowledge and beliefs that
incorporate plant, animal and mineral based medicines, spiritual
therapies, manual techniques and exercises, applied alone or in
combination to treat, diagnose and prevent illnesses or maintain
physical well-being. In many developing countries traditional medicine
is often the main source of health care especially in the rural sector.
In some countries in Asia and Africa, 80% of the population uses
traditional medicine for primary health care needs. In many developing
nations, there are more traditional healers than there are allopathic
practitioners, and the population of allopathic practitioners is often
concentrated in urban areas, further reducing rural access to medical
care. Traditional medicine also termed as “Complementary” or
“Alternative” medicine. In industrialized nations over 50% of the
population have used complementary or alternative medicine at least
once, while ∼75% of people living with HIV/AIDS use traditional
medicine/complimentary or alternative medicine. In the United States,
158 million of the adult population use complementary medicines and
according to the USA Commission for Alternative and Complementary
medicines, in the US $17 billion was spent on traditional remedies in
2000. The global market for herbal medicines currently stands at over US
$60 billion annually and is growing steadily.
Infertility
affects ∼15% of couples with most progressing to fertility clinics for
treatment. Women experiencing infertility or difficulty of viable
pregnancy seek Traditional Medicine therapy. Information derived from
various systems of traditional medicine (ethnomedicine) and its utility
for drug discovery purposes has been reviewed by Fabricant and
Farnsworth.1
One hundred and twenty two (122) compounds of defined structure were
obtained from ninety four (94) species of plants, used globally as drugs
and demonstrated that 80% of these have ethnomedical use identical or
related to the current use of the active elements of the plant. The
authors identify and discuss the advantages and disadvantages of using
plants as starting points for drug development, specifically those used
in traditional medicine. Traditional herbal medicine is predominantly
practiced by the rural people of India. Local traditional healers have
been found to play an important role in the management of reproductive
health problems due to socio-economical and geographical factors. Hedge
et al2
interviewed 92 traditional medicine practitioners/healers from various
regions of Uttara Kannada district of India to collect information on
the use of herbal treatments for a range of female and male reproductive
disorders. A total of 18 formulations from 25 plant species belonging
to 17 families were identified commonly used to treat twelve (12)
different reproductive ailments. Additionally, Hedge et al2
highlighted that there was a need to retain and explore the rich
biodiversity associated with Indian rain forests that might result in
the discovery of new medical treatments. Reid and Alfred3
applied mixed methods and used questionnaires based on those framed by
the Tuebingen Quality of Life and the Committee on Publication Ethics
(COPE), as well as, in-depth interviews with women with primary or
secondary infertility, recurrent miscarriages or unexplained stillbirth
study to examine women's experiences of Traditional Chinese Medicine
therapy that encompassed herbal medicines, acupuncture and lifestyle
counseling for infertility and viable pregnancy. Women sought Chinese
Traditional Medicine on their own accord at any stage of their quest for
a child, some in conjunction with IVF. A survey has revealed
significant disparities exist in access to infertility treatment based
on race and ethnicity, household income, and level of education, even in
US states with mandated insurance coverage. Given the steep costs of
assisted reproductive technologies, many infertility patients augment
traditional medical treatment with Complimentary Alternative Medicine.
Acupuncture and herbal supplements are the most studied therapies,
although dietary supplements may enhance fertility, the use of other
more expensive forms of Complimentary Alternative Medicine such as
acupuncture has had mixed results.4
Based on an investigation of Chinese herbal medicine for primary
dysmenorrhea from a nation-wide database in Taiwan, Chen and colleagues5 discovered the potential importance of Corydalis yanhusuo, Cyperus rotundus and Dang-Gui-Shao-Yao-San
(DGSYS) in treating primary dysmenorrhea though have cautioned that
based on their results further clinical trials or bench studies are
warranted.
Considering the
fact that self-collected, home-prepared herbal medicines are frequently
used and the fact that illness and traditional knowledge predict plant
use rather than poverty or a limited access to modern health care in
developing nations, it appears that the potential risks and benefits of
herbal remedies and traditional medicines should be put prominently on
the national public health agenda. The foundation of a National Ayush
Mission in India to increase our resources for research in traditional
medicine and the quest for new medicines from our age old heritage of
different systems of medicine is going to give a thrust to conducting
clinical trials to determine the efficacy of our herbal remedies. It is
important for us not to make the same mistakes that we made in carrying
out clinical trials in India for synthetic products. From being a
country with over two hundred clinical trials in India the number
plummeted down to about thirty. Only now after two years of hard and
painstaking patient work are the figures going up. The purpose of this
paper is not to describe why this happened, what measures were taken and
what is happening today in the field of clinical trials with
pharmaceutical products. This paper rather lays down some of the
measures that need to be kept in mind and implemented if good quality,
science based, transparent and ethical clinical trials are to be
undertaken in this field.
1. Clinical trials for herbal remedies and traditional medicines: Indian perspective
1.1. Design of trial
The
first point to remember is that the quality and design of our clinical
trials have to be of an order which is accepted by scientists,
regulators and clinical investigators all over the world. There can be
no two standards for clinical trials. The CONSORT organization has laid
down the criteria which needs to be followed for clinical trials with
herbal products. I had participated at those meetings and following
these guidelines should become mandatory for investigators wanting
support from the Government for carrying out clinical trials for
conditions such as hypertension, arthritis, bronchial asthma, diabetes
and cancer. In spite of all the laboratory and clinical trial research
carried out in the country over sixty years not one of our herbal
Ayurvedic or Unani plants or combinations have been accepted for use
even in our allopathic hospitals leave alone being used outside the
country. This needs to change.
The
fact that our methodology for herbal remedies is different from that
required in a clinical trial for a synthetic drug has been recognized.
Such methodology such as Observation Clinical Trials without
intervention or Trial on a Single Subject will be accepted if we apply
strict scientific criteria to such methodology. Let us take one example.
If a control group cannot be possible the Observational Study approach
presented by Chaudhury et al6
at a WHO meeting at Yangon could be used. In this type of study the
traditional medicine practitioners continues his treatment without it in
any way. The observer records the clinical response. To make this type
of trial possible, meaningful and scientific it has to fulfill some
criteria. These are:
- a)
- this approach should be used for a few conditions only and not for all conditions
- b)
- only a few herbal remedies should be studied
- c)
- the sample must be large
- d)
- careful recording of signs and symptoms of the patient before starting the trial
- e)
- training of the group of observers in assessing a therapeutic response well before the trial
The
gold standard for clinical trials of synthetic drugs – the double
blind, randomized, placebo, controlled multi-centre trial – is not the
gold standard for clinical trials. While this has been accepted today by
both the World Health Organization and the Indian Council of Medical
Research what needs to be done is to put in place a robust, science
based, validated method in place. This unfortunately has not been put in
place. This concept was brought forward by Chaudhury7
at the first World Conference of Clinical Pharmacology at London when
he stated “Challenge of the 21st century is to carry out clinical
evaluation of rigid clinical pharmacological principles without
trampling on the concepts of the traditional systems of medicine”.
1.2. Ethics
All
clinical trials have to be ethically conducted. The volunteers,
subjects and patients taking part in those trials should not be taken
advantage of either because of the non-ethical aggressiveness of the
sponsor, the ambitions of the investigator, the ignorance of the
participant or the incentives provided to the volunteer. Many cases of
unethical, illegal and criminal clinical trials have taken place both in
India and also in the developed countries in the recent past.
Fortunately such examples till now are not so common in the field of
traditional medicine. To avoid such occurrences the author in a paper
published in Tropical Medicinal Plants8
had stated, “One way to improve the quality in clinical trials is to
set up a system of Accreditation of centres of clinical trials based on
objective criteria such as the quality of the Chief Investigator and
co-investigator and evidence of functioning of a transparent and
suitably constituted Ethics Committee”. This view was reiterated by the
Dr. Ranjit Roy Chaudhury Expert Committee9
and accepted by the Government. Clinical trials for acceptance by the
drug regulatory system for the allopathic hospitals would soon only be
allowed at:
- 1)
- hospitals accredited for carrying out clinical trials
- 2)
- hospitals with accredited Ethics Committees and
- 3)
- hospitals with accredited Principal Investigators
It
is strongly recommended that this triple system of accreditation also
be used for clinical trials of traditional medicines. Only if this
system is in position will it give confidence to our clinicians,
pharmaceutical industry, regulatory authority, the NGOs, the Civil
Society, the Parliament and the Supreme Court that no unethical practice
would be possible in approved clinical trials in India. The Quality
Council of India will carry out these accreditation procedures.
1.3. Ethics Committees
Every
trial has to be approved by the Ethics Committee of the Institute where
the trials are to be carried out. This is applicable also to clinical
trials with traditional medicines. For a long time researchers who want
to carry out clinical trials with traditional medicines in allopathic
hospital have complained that the membership of the Ethics Committee, as
it is constituted now, do not understand the nuances of traditional
medicines and their proposals are rejected. This complaint needs to be
looked at and addressed. Either special Ethics Committees for
Traditional Medicines have to be created just as special Stem Cell
Ethics Committees have been set up or the existing members of the Ethics
Committees should be complemented by a group of experts experience in
clinical trial methodology of herbals or should be given essential
training in this specific area. Keeping in view the possible growth in
this area of clinical trials I would support a special Ethics Committee
for Traditional Medicines Clinical Trials. Just as in the Stem Cell
Ethics Committees their recommendations would be ratified by the main
Ethics Committee.
As clinical
trials with herbal products get more the aspect of Training members of
the Traditional Medicine Ethics Committees should be organized. The same
pattern being followed for training of Ethics Committee members today
should be followed. Two organizations Clinical Development Services
Agency (CDSA) of the Department of Biotechnology, Government of India
and CReATE composed of AIIMS (New Delhi), CMC (Vellore) and FERCI
(Mumbai) have already started training members of Institute Ethics
Committees. Sensitive issues such as Informed Consent and Causal Effect
of a Serious Adverse Event or Death are being discussed. The Department
of AYUSH could be asked for support for this very important activity.
If
these three issues of scientific design, Accreditation of Centres and
empowered Ethics Committees are instituted then the mistakes made in
clinical trials of pharmaceutical products and the troubles we have
undergone would be avoided. There is also the issue of Compensation of
Injury and Death which needs to be discussed and a formation for
compensation laid out. Again, I would suggest that the experts in
traditional medicine study the twenty five recommendations recently
notified by government and decide what is relevant to the traditional
systems of medicine and what needs to be modified.
One
thing is clear: if clinical trials of products of the traditional
system of medicine are to be recognized internationally, guidelines are
to be laid down by experts of Ayurveda, Unani, Siddha, Homeopathy and
Naturopathy. They have to make their recommendations. Outside experts
like this author can only help in technical matters, if asked.
Conflicts of interest
The author has none to declare.
References
- 1
- The value of plants used in traditional medicine for drug discovery
- Environ Health Perspect, 109 (2001), pp. 69–75
- | |
- 2
- Herbal care for reproductive health: ethno medicobotany from Uttara Kannada district in Karnataka, India
- Complement Ther Clin Pract, 13 (2007), pp. 38–45
- | | |
- 3
- Quality of life, coping strategies and support needs of women seeking Traditional Chinese Medicine for infertility and viable pregnancy in Australia: a mixed methods approach
- BMC Women Health, 13 (2013), p. 17
- 4
- Role of complementary and alternative medicine to achieve fertility in uninsured patients
- Obstet Gynecol Surv, 68 (2013), pp. 305–311
- | |
- 5
- Investigation on Chinese herbal medicine for primary dysmenorrhea: implication from a nationwide prescription database in Taiwan
- Complement Ther Med, 22 (2014), pp. 116–125
- | | |
- 6
- Traditional, complementary and alternative medicine: policy and public health perspectives
- G. Bodekar, G. Burford (Eds.), Clinical Trials Methodology, Imperial College Press, London (2007), pp. 389–402
- 7
- Controversies in the clinical evaluation of 'antifertility plants
- P. Turner (Ed.), Clinical Pharmacology and Therapeutics, Macmillan, New York (1980), pp. 474–482
- |
- 8
- Recommendations for reporting randomized controlled trials of herbal interventions: explanation and elaboration
- J Clin Epidemiol, 59 (2006), pp. 1134–1149
- 9
- Expert Committee Report of the Ministry of Health and Family Welfare
- (July 2013) http://www.cdsco.nic.in/writereaddata/Report_of_Dr_Ranjit_Roy.pdf
Copyright © 2015 Published by Elsevier, a division of Reed Elsevier India, Pvt. Ltd.
Commentary
