Rajiv Gandhi University of Health Sciences Karnataka Bangalore PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION 1 Name of candidate and address Dr Nitin S Kunnoor by gz5cmbsE

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									       Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

  1. Name of candidate and address: Dr. Nitin S Kunnoor

                                             Post graduate student,
                                             Department of Pharmacology,
                                             St. John’s Medical College
                                             Bengaluru -34



  2. Name of Institution: St. John’s Medical College and Hospital, Bengaluru-34

  3. Course of study and subject: M.D., Pharmacology

  4. Date of admission to course: 20/04/2011

  5. Title: Evaluation of use and effect of Complementary and Alternative Medicine (CAM)

             among patients with selected chronic disease (CVD, DM, COPD, Asthma, RA).



  6. Brief resume of the intended work:

     6.1 Need for study

            Currently, chronic diseases are the leading cause of death in the world and their impact
     is steadily growing. About 36 million people died from heart disease, strokes, chronic lung
     disease, cancers and diabetes in 20081. Nearly 80% of these deaths (29 million people)
     occurred in low- and middle-income countries. The global epidemic of chronic diseases is
     projected to kill 52 million people annually by 2030.1

            According to the 2005 WHO statistics, deaths due to chronic diseases in India account
     for 53% of all deaths. Out of these, 28% are from cardiovascular disease, 8% from cancer, 8%
     from other chronic disease, 7% from chronic respiratory disease, and 2% from diabetes. WHO




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                        Pharmacology PG dissertation synopsis; SJMC 2011
projects that over the next 10 years deaths from chronic diseases will increase by 18%, and
deaths due to diabetes will escalate by 35%.2 As a result our country stands to lose around 10.6
lakh crore rupees from premature deaths due to heart disease, stroke and diabetes.2

       Awareness about the risks of Cardiovascular diseases (CVD) including hypertension
(HTN), coronary artery disease (CAD), peripheral vascular disease (PVD), strokes, diabetes
mellitus (DM), chronic obstructive lung diseases (COPD and asthma) and rheumatoid arthritis
(RA) is increasing. Patients are adopting different ways to handle the problem. Apart from
taking appropriate allopathic medications, patients are also looking at alternative ways to
control their chronic illness. Some of them include, ayurveda, homeopathy, naturopathy. These
options are collectively called complementary and alternative medicine (CAM).

       CAM has been used increasingly over the past decade where long-term treatment is
required. Most allopathic physicians are unaware or ill-informed that their patients use CAM.
Complex psycho-social and cultural factors promote patients to use CAM. Some reasons
include their dissatisfaction with allopathic treatments and perceptions that allopathic
medications are ineffective, have unpleasant side effects, be impersonal or too costly.

       Understanding the use of CAM among patients with chronic diseases is therefore
becoming important. This may explain non-adherence to allopathic treatment, and affect the
outcome in patients using CAM therapy along with allopathic medication.


       Allopathic medical practitioners are ill-prepared to deal with the rapid proliferation of
CAM therapies, many of which are being used by their patients in conjunction with allopathic
treatments. Allopathic practitioners are hesitant to begin an integrated practice as they do not
have adequate knowledge about alternative approaches to health care.


       Few studies have been done in India on the prevalence, pattern, and frequency of CAM
use in chronic diseases. There are however, no data on CAM use, factors influencing adherence
to medication and clinical outcomes in most of the common chronic diseases. Hence, the
present study intends to evaluate the use of CAM on selected chronic diseases including
hypertension (HTN), coronary artery disease (CAD), peripheral vascular disease (PVD),
strokes, diabetes mellitus (DM), asthma, chronic obstructive pulmonary disease (COPD) and



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                   Pharmacology PG dissertation synopsis; SJMC 2011
  rheumatoid arthritis (RA). We will also evaluate the factors influencing adherence to allopathic
  medication and clinical outcomes in patients using CAM therapy along with allopathic
  medication.



6.2 Objectives of the study

       1. To determine the rates of use of CAM among patients with selected chronic diseases
           (CVD, DM, COPD, Asthma, RA)
       2. To assess factors affecting adherence to allopathic medication among patients using
           CAM.
       3. To evaluate the clinical outcomes in patients using allopathic medication with and
           without CAM therapy.



6.3 Review of literature

         Cardiovascular diseases (CVD) are the leading causes of death worldwide, most
  commonly coronary heart disease and stroke. Low and middle-income countries suffer more
  than 80% of the global burden of cardiovascular disease. By 2020, deaths from CVD will rise
  to 4 million per year in China and almost 5 million in India.3


         Hypertension (HTN) is a global health problem affecting 65 million persons in the
  United States (US) and about 1 billion persons worldwide.4 Epidemiological studies show that
  HTN is present in 25% urban and 10% rural subjects in India. HTN is responsible for 57% of
  all stroke deaths and 24% of all coronary heart disease deaths. Hence its control can lead to
  prevention of 0.3 million of the 1.5 million annual deaths from CVD in India.5


         Diabetes affects around 250 million people worldwide. There are about 7 million new
  cases every year. Almost 80% of deaths associated with diabetes occur in low- and middle-
  income countries. There are 40 million people with diabetes in India. This number is expected
  to rise to 70 million by 2025. Half of the deaths occur in people below the age of 70 years and
  half of it occurs in women.6



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       Chronic obstructive lung disease which includes asthma and chronic obstructive
pulmonary disease (COPD), is present in 100 million individuals in India. The Phase I of the
Indian study on Epidemiology of Asthma, Respiratory symptoms and Chronic bronchitis
(INSEARCH) reported population -prevalence of ever-asthma in adults of over 15 years of age
is 2.4 percent, and of other respiratory symptoms is 4.3-10.5%. Prevalence of chronic
bronchitis in the adult population of over 35 years of age was diagnosed in 4.1% individuals.


       Centre for disease control and prevention (CDC) combined data from the National
Health Interview Survey 2007–2009 estimated average annual arthritis prevalence of 22.2% in
the civilian, non-institutionalized U.S. population age 18 years or older. Age-adjusted
prevalence in women than in men (24.3%, vs. 18.3%) was significantly higher.


       Complementary and alternative medicine (CAM) use is common in chronic illnesses
such as: diabetes mellitus, hypertension, coronary artery disease, stroke, COPD, asthma,
arthritis, gout and other musculoskeletal conditions, such as chronic backache.


       CAM is defined by the National Center for Complementary and Alternative Medicine
(NCCAM) as a group of diverse medical and health care systems, products, and practices that
are not presently considered part of conventional medical care and are consequently not taught
as part of medical education curriculum. It is generally assumed that complementary medicine
is used in conjunction with allopathic medicine whereas alternative medicine is used in place
of allopathic medicine; however.7


 The National Institute of Health (NIH) classifies CAM into five major categories7 -


1) Alternative medical systems ( traditional oriental medicine, acupuncture, Ayurveda,
   naturopathy, homeopathy, Native American healing, Tibetan medicine)

2) Mind-body interventions (meditation, hypnosis, dance, art and music therapy, spiritual
   healing, and prayer)




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                   Pharmacology PG dissertation synopsis; SJMC 2011
3) Biologic – based therapies (herbal medicine and dietary supplements, special diets and
   orthomolecular medicine)

4) Manipulative and body-based methods (chiropractic, massage, the Feldenkrais method,
   other "body work" systems, and aspects of osteopathic medicine such as craniosacral work)

5) Energy therapies (reiki, therapeutic touch, and other methods of affecting the "bioelectric
   field" of the body)

       A study done in primary out-patient care in Singapore over a one week period reported
one year prevalence of CAM use in chronic disease was 22.7%. Among those patients who
were dissatisfied/very dissatisfied with the cost of treatment and waiting time were more likely
to use CAM. Patients who were very satisfied with the benefit from treatment were much less
likely to use CAM.8


       A large study done in Cohort Study of Medication Adherence among Older Adults
[CoSMO] regarding Adverse effects of CAM use on Antihypertensive Medication Adherence
in older blacks and white adults in USA, it was observed that in managing blood pressure,
30.5% of black and 24.7% of white participants used CAM in the previous year and 18.4% of
black and 12.3% of white participants reported low adherence to antihypertensive medication.9


       A 3 month survey of asthmatic inpatients and outpatients in Australia was undertaken,
which showed that 51% used CAM in their lifetime. 62% were currently using CAM. 47.8% of
parents informed doctors about the use of CAM. Cost ranged around $A2-$A200/month.10
A study done in Malaysia on use of CAM among patient with chronic diseases reported around
64% utilization rate. Patients with Diabetes were more common (35.5%). Vitamin supplements
and herbal medicine most commonly used.11


       Results from National health Interview Survey on use of CAM by Asian Americans
(AA) showed 42% utilization rate. Mind/body therapies were used more often by Asian
Indians (31%) Among AA, CAM use was associated with being female, having higher
education, and having a chronic medical condition.12




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       A study on prevalence and pattern of use of CAM in Hypertensive patients,
conducted in PGI, Chandigarh, India, it was observed that 63.9% used CAM. Ayurveda was
most commonly used. 59% cited reason of adverse drug reaction to allopathic medicine.
5.4% informed their consultants about usage of CAM.13 In another study of association
between use of CAM and non-compliance with modern medicine in patients presenting to
emergency depatment, over 3 months in 2004, was found that 33% were noncompliant,
among which 41% were using CAM. Among the patient admitted, COPD and Asthma were
common CAM using non-complier.14


       Study done in south India regarding CAM use in arthritis showed 43% pt used CAM
and 50% of they used more than two modalities. Ayurveda was most commonly used.
Majority believed CAM better in terms of cure and less adverse reactions. Family income,
urban and rural living did not influence usage of CAM.15 A similar study on prevalence and
usage characteristics of CAM in patients with rheumatoid arthritis (RA) at a tertiary care
centre in northern India, showed 39% patient with RA were using CAM. As many as 82%
reported having tried CAM during the course of their disease. Ayurveda was the commonest
(28% courses) followed by homoeopathy (20%). 87% did not reveal their use to the
physicians, because the physician did not enquire about it.16


       A cross-sectional study in Uttar Pradesh, India, on 493 diabetes mellitus (DM) patients,
reported 68% used CAM. Acupressure followed by naturopathy were the most beneficial to
them.17 A similar study regarding knowledge, attitude and practice of CAM for DM, revealed
that 71% awareness of CAM among 493 participants selected by systemic sampling from a
population of 6094 patients with DM. There was no significant gap (p>0.10) between
knowledge and practice in different categories. Only 42.2% perceived some relief by CAM.18


       In a systematic review study conducted in UK, to know the efficacy of CAM in
management of RA, reported that there was no consistent evidence available for any of the 18
reviewed substances to suggest that they were efficacious as CAM to standard treatment.19


       Many CAM utilization studies have been done internationally and nationally under
different settings. They are undertaken to explore the use of CAM or assess the overall



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                   Pharmacology PG dissertation synopsis; SJMC 2011
  prevalence, pattern and frequency of use of CAM in particular chronic diseases. Details
  about studies directed towards exploring CAM use in patients suffering from different
  chronic diseases are lacking in Indian setting. So this study intends to evaluate the use of
  CAM among patients with selected chronic diseases, the factors influencing adherence to
  allopathic medication and clinical outcomes in patients using CAM therapy along with
  allopathic medication.



7. Materials and Methods

 7.1 Source of data

  a. Study site: Study will be conducted at the out-patient Dept of Gen. Medicine, Cardiology,
                 Neurology and Endocrinology in a tertiary care hospital.

  b. Study subjects: Patients with hypertension (HTN), coronary artery disease (CAD),
                     peripheral vascular disease (PVD), stroke, diabetes mellitus (DM), Asthma,
                     chronic obstructive pulmonary disease (COPD), rheumatoid arthritis (RA)
  c.   Sample size: Previous studies reported between 42% and 69 % of CAM utilization in
                     different chronic diseases. Two studies which evaluated use of CAM in all
                     major chronic diseases showed 22% and 42% utilization rate. For our study
                     we assume a prevalence of 32% with a relative precision of 10% and desired
                     confidence level (1-alpha) of 95% and evaluated need for 816 patients.
                     Based on these data, we plan to recruit about 900 patients with selected
                     chronic disease in the 6-8 month period (accounting for the patients who
                     refuse consent or those fulfilling exclusion criteria)..

  c. Study design: Prospective, observational hospital based out-patient study.

  d. Duration of study: Two and a half years. (preparation 6 months, recruitment 6-8 months,

                           follow up 6 months, data cleanup and analysis 6-8 months)

  e. Inclusion criteria:

       1. Patients with any one or more of the following chronic diseases:




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                      Pharmacology PG dissertation synopsis; SJMC 2011
          Hypertension (HTN), coronary artery disease (CAD), peripheral vascular disease
         (PVD), stroke, diabetes mellitus (DM), asthma, chronic obstructive pulmonary
         disease (COPD) and rheumatoid arthritis (RA)

     2. Attending the hospital out-patient department (OPD) for at least 3 months
     3. Using any one CAM therapy (ayurveda, homeopathy, naturopathy, meditation, yoga,
        massage, special diet/supplements, acupuncture, spiritual healing/prayer and others)
     4. Taking CAM in the last 3 months or have used CAM for at least 3 months anytime in
        the past one year for the selected chronic disease(s).

f. Exclusion criteria:

     1. Patients without adequate and reliable information on prior treatments received.
     2. Using CAM for a condition other than the selected chronic diseases
     3. Patients with cognitive impairment or unable to follow up for 6 months.



7.2 Method of collection of data

  The following data will be collected in detail with written consent from patient/attendant on
 a standardized case record form.

     1. Demographic and Socio-economic data of patient
     2. Medical history
     3. Allopathic treatment received in hospital for the chronic illness
     4. Complementary and Alternative Medicine (CAM) use for the same chronic illness

7.3 On follow-up
    At One month
        a. To estimate rates of medication adherence
        b. Patient outcome (improvement, complications, adverse effects or other events)

    At Six month
       a. To estimate rates of medication adherence
       b. Patient outcome (improvement, complications, adverse effects or other events)




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                   Pharmacology PG dissertation synopsis; SJMC 2011
         7.4 Statistical analysis:
                We will summarise descriptive data and present unadjusted rates. We will compare
        categorical data using Chi squared tests and parametric data using Student’s t tests. Where
        appropriate we will use regression analysis to evaluate outcomes using univariate and
        multivariate models. We will consider a p-value less than 0.05 as significant for all tests. All
        statistical analyses will be performed using commercially available software Statistics
        Package for the Social Sciences (SPSS).
.

7.5 Does the study require investigations or interventions to be conducted on

       Patients or other humans or animals?

         No
7.6 Has ethical clearance been obtained from your institution?
            Applied for approval.

8. List of references


1. WHO Global status report on non-communicable diseases (NCDs) launched on 27th April. Ref Type:
     Online Source

2.   Preventing chronic diseases: a vital investment: WHO global report, Geneva, Switzerland, 2005. Ref Type:
     Online Source

3. Surveillance of mortality and cardiovascular disease (CVD) related morbidity in Industrial settings. WHO
     Country Office for India, Geneva, Switzerland.

4. Ong KL, Cheung BM, Man YB, et al. Prevalence, awareness, treatment, and control of hypertension
     among United States adults 1999–2004. Hypertension 2007;49:69–75. [PubMed:17159087]

5.   Rajeev Gupta and Gupta VP. Hypertension epidemiology in India: lessons from Jaipur Heart Watch.
     Current science. Aug 2009;97(3)

6.   International Diabetes Federation (IDF) 2006. Diabetes Atlas, 3rd Edition; International Diabetes
     Federation (IDF). Complications. Ref Type: Online Source

7. National     Centre   for    Complementary    and   Alternative   Medicine.   What    is   CAM?     2009.
     nccam.nih.gov/health/what is cam/D347.pdf. Ref Type: Online Source



                                                Page 9 of 11
                               Pharmacology PG dissertation synopsis; SJMC 2011
8. GBW Lee et al. CAM use in patients with chronic diseases in primary care is associated with perceived
    quality of care and cultural beliefs. Family Practice.2004;21:654-660

9. Marie A. et al. Adverse effects of complementary and Alternative Medicine use on antihypertensive
    medication adherence: Findings from CoSMO. J Am Geriatric Soc. Jan 2010; 58(1): 54-61.

10. Shenfield G, Allen H et al. Survey of the use of complementary medicines and therapies in children with
    asthma. J Paediatr Child Health. Jun 2002; 38(3):252-7.

11. Hassan SS, Ahmed SI et al. Use of complementary and alternative medicine among patients with
    chronic diseases at out patient clinic. Complement Ther Clin Pract Aug 2009;15(3):152-7

12. Metha DH, Davis RB et al. Use of Complementary and Alternative Therapies by Asian Americans.
    Results from National Health Interview Survey. J Gen Intern Med. June 2007;22(6):762-7

13. Shafiq N, Gupta M et al. Prevalance and pattern of use of CAM in hypertensive patients of tertiary care
    centre in India. Int J Clin Pharmacol Ther. July 2003;41(7):294-98.

14. Jose VM, Bhalla A et al. Study of association between use of complementary and alternative medicine and
    non-compliance with modern medicine in patients presenting to emergency department. J Postgrad Med.
    Apr-Jun 2007;53(2):96-101

15. Chandrashekar S et al. Complementary and Alternative drug therapy in arthritis. J Assoc Physicians India.
    Feb 2002;50:225-7.

16. Zaman T, Agarwal S et al. CAM use in rheumatoid arthritis: an audit of patients visiting a tertiary care
    centre. Natl Med J India. Sep 2007;20(5):236-9.

17. Bajaj S et al. Use of complmentary and alternative medicine by patients with diabetes mellitus. Natl Med J
    India. Sep 2004;17(5):243-5

18. Kumar D et al. Knowledge, attitude and practice of complementary and alternative medicine for diabetes.
    Public health. Aug 2006;120(8):705-11

19. Macfarlane GJ et al. Evidence for the efficacy of complementary and alternative medicines in the
    management of rheumatoid arthritis: a systematic review. Jun 2011




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                             Pharmacology PG dissertation synopsis; SJMC 2011
9. Signature of the candidate


10. Remarks of the guide:


11. Name and designation of:

       11.1 GUIDE: Dr. Denis Xavier
                        Professor and Head,
                        Department of Pharmacology,
                        St. John’s Medical College.



      11.2 Signature:


      11.3 HEAD OF DEPARTMENT:
                        Dr. Denis Xavier
                        Professor and Head,
                        Department of Pharmacology,
                        St. John’s Medical College.



      11.4 Signature:


12.
      12.1 Remarks of the Chairman and Principal




      12.2 Signature:




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                   Pharmacology PG dissertation synopsis; SJMC 2011

								
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