For review on vitamin D: Michael F Holick, Professor of Medicine, Physiology and Biophysics
and Molecular Medicine. Director, Vitamin D, Skin, and Bone Research Laboratory. Programme
Director General Clinical Research Unit. Director, Biologic Effects of Light Research
Centre, Director, Bone Healthcare, Boston.
External Review Board: A Muruganathan, Anil K Jain, Dinesh K Dhanwal, G R Sridhar,
Hema Divakar, K V Radha Krishna, Prof Nihal Thomas, N S Neki, P K Shah, S K S Marya,
Sandhya Kamath, Sarita Bajaj, Thomas Paul.
Advisory Board: Asha Kapadia, Atul Munshi, Duru Shah, Rama Vaidya, Saroj Srivastava,
Sonia Malik, Sunila Khandelwal, Urvashi Prasad Jha. External Review Board: A Muruganathan,
Anil K Jain, Dinesh K Dhanwal, G R Sridhar, Hema Divakar, K V Radha Krishna, Prof
Nihal Thomas, N S Neki, P K Shah, S K S Marya, Sandhya Kamath, Sarita Bajaj, Thomas
Paul.
Resource Faculty: Alap Shah, Amita Pandey, Anil Mahajan, Ashok Vaidya, Beena Bansal,
Bharti Kalra Prof. Dr C.V. Harinarayan, Dilip Mehta, Hemant Tiwari, I.V. Reddy, Jyothi
Unni, Ketan Mehta, Manisha Sahay, Meeta, Nagamani, Neelam Agarwal, Rabindera Nath
Mehrotra, Raghava Dutt Mulukutla, Rakesh Sahay, Major General (Dr) Raman Kumar Marwaha,
Ram Prabhoo, Rama Vaidya, Ranu Patni, Rashmi Shah, Sanjay Bhadada, Sanjay Kalra, Sailesh.
B, Seema Puri, Sharad Kumar, Shashank Joshi, Shushrut Babhulkar, Siddharth Sarkar,
Sudha Sharma, Sunila Khandelwal, Sushil Gupta, Vishal R. Tandon, Vivek Arya, U.R.K.
Rao, Yatan Pal Singh Balhara.
INTRODUCTION
Guidelines are a method of translating the best available evidence into clinical,
communicable, organizational, and policy making statements in the hope of improving
health care and or policies. Do we need country specific guidelines? Yes, we do. Given
the fact that the model of health-care delivery system and the prevailing environment
of one country may not be extrapolated to that of another.
“Working with what you have, where you are and not with what you wish for” – is the
principle each one of us follow in the clinical practice to give the best to our patients.
This guideline hopes to bridge the gap between evidence based practice, backed by
scientific evidence and experience based practice based on the published and unpublished
Indian data and expert opinions. Unlike protocols, guidelines are meant to aid the
clinician in decision making. The target readers of this guideline are the adult women,
members of the Indian Menopause Society (IMS), allied professionals, health-care providers,
and policy makers.
India is a land of rich and diverse cultural heritage. It is a land of diversity in
terms of, socioeconomic, religion, culture, beliefs, education, nutrition urban, rural,
and geographical regions. The dilemmas and challenges are unique to different regions
and solutions need to be planned accordingly. The specific issues pertaining to Indian
women are an early age of natural menopause, genetic and environmental influences,
nutritional deficiencies, and excesses resulting in physiologic differences. These
factors contribute significantly to an increased incidence of diabetes, cardiovascular
disease, osteoporosis, and thyroid dysfunction. Genetic components are likely to play
a prominent role in these disorders for example, polymorphisms in estrogen receptors
alpha and vitamin D receptor has been implicated in the pathogenesis of osteoporosis.
The burden of morbidity from osteoporosis has significant medical, social, and financial
implications. Osteoporotic fractures are preventable, yet diagnosed only after the
event; a situation similar to the diagnosis of hypertension after myocardial infarction
or stroke. It has a long incubation period and cost- effective treatment strategies
currently available for this disease mandate that osteoporosis be diagnosed and treated
early.
OBJECTIVES
To recognize post-menopausal osteoporosis (PMO) as a major health issue among health-care
professionals, policy makers, and the public.
To assist health-care practitioners in providing optimal care to post-menopausal women
with the available resources. Osteoporosis is a costly debilitating disease, hence
it is important to instill preventive measures, diagnose early, encourage modifications
of risk factors associated with osteoporosis. Counseling on nutritional factors, abuse
of tobacco, heavy alcohol consumption, and on life-style should be mandatory. Treat
with pharmacologic agents only when indicated.
To fill the lacunae of medical care after managing fragility fracture.
To aid primary care physicians to decide when to refer patients with difficult problems
to the relevant specialists.
To stimulate interest in research on osteoporosis.
METHODS
The planning to publishing of the document took 24 months. The core committee was
formed and a broad based multi-disciplinary list of experts were invited to write
on the topic of their expertise. Majority of the reviews and deliberations wear by
E-mail. A two day intensive contact program of the contributors was convened at Hyderabad
on December 8th and 9th 2012. Each topic was presented and deliberated upon, and the
consensus obtained by an automated response system. Later one day contact meeting
of the Editorial Board was convened on January 11th, 2013. Finally, the document was
validated by an External Review Board.
Data were sourced from the electronic database PubMed, MEDLINE, Cochrane Database
of Systematic Reviews and published guidelines on PMO management. The appraisal of
Guidelines Research and Evaluation,[1] instrument was used to appraise published guidelines.
Abstracts from papers and posters presented at the National Indian Menopause Society
Meetings, published and unpublished studies, expert opinion was considered. Cost-effectiveness
of diagnosis and treatment is based on the available market value.
SYSTEM FOR GRADING: EVIDENCE USED IN THE DOCUMENT
The quality of evidence and the level of recommendation was carried out using the
grades of recommendation, assessment, development, and evaluation (GRADE),[2] system.
Recommendations are based on strong evidence, suggestions on experience based evidence,
this method is adapted to unite the diverse conditions of India with the best available
data and the rich experience based evidence from the experts.
GRADE: Grades of evidence:
High quality – GRADE A: Further research is very unlikely to change our confidence
in the estimate of effect.
Moderate quality – GRADE B: Further research is likely to have an important impact
on our confidence in the estimate of effect and may change the estimate.
Low quality – GRADE C: Further research is very likely to have an important impact
on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality – GRADE D: We are very uncertain about the estimate.
In terms of the strength of the recommendation, strong recommendations use the phrase
“recommend,” and weak recommendations use the phrase “suggest.”
Research questions are placed at the end of each chapter in the monogram of the book.
BENEFITS OF USING THE GUIDELINE
Benefits of using these guidelines are: (i) Improved early identification and better
management of women at risk for fragility fractures; (ii) down grading the disease
burden after an episode of fragility fracture by improving the assessment, management
and follow-up of these women; (iii) understanding the urgent need of conducting preventive
health programs by all stake holders related to women’s health; and (iv) in addition,
in view of the paucity of Indian data it is hoped that this guideline will help stimulate
interest in research in various aspects of PMO.
CONCLUSIONS
Osteoporosis has significant medical, social, and financial implications.
The onus is on the Government and Non-Government Organizations to develop specialty
menopause and osteoporosis clinics akin to antenatal clinics in the private and public
sectors besides developing management of menopause as a medical specialty within obstetrics
and gynecology care. The aim of the guideline is to provide a resource documentss
to aid the busy clinician to give optimal care to the ageing woman. Limitations are
the paucity of robust research evidence in India. This is one of the endeavors of
the Indian Menopause Society to work toward the slogan “Fit @ Forty, Strong @ Sixty,
Independent @ Eighty”.
ACKNOWLEDGEMENTS
We thank the experts who took time out of their busy family life, academics, and work
to contribute to the document on PMO in India. A special thanks to Dr. Hemant Zaveri
for sourcing the data.
DISSEMINATION OF THE GUIDELINES
A free copy of the guideline is for the members of the IMS and Jaypee Publishers are
making the monogram available widely for purchase by the health-care providers and
policy makers. The Guideline is available on the IMS website www.indianmenopausesociety.org.com
and is published in the Journal of Midlife, official publication of the IMS.
REVISION OF THE GUIDELINES
It is recommended that the guidelines are upgraded every 2 years.
EDITORIAL INDEPENENCE
The views expressed are independent of any extraneous influences.