RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES



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|RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES |

|BANGALORE, KARNATAKA |

|ANNEXURE II |

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|PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION |

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|1 |Name of the candidate & address |Dr. KRISTIN GEORGE |

| | |POST GRADUATE IN GENERAL MEDICINE, |

| | |BANGALORE MEDICAL COLLEGE & RESEARCH INSTITUTE, BANGALORE- 560002 |

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|2 |Name of the institution |BANGALORE MEDICAL COLLEGE & RESEARCH INSTITUTE, BANGALORE-560002 |

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|3 |Course of study and subject |M.D. IN GENERAL MEDICINE |

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|4 |Date of admission to the course |29th JULY 2013 |

| | |“A COMPARATIVE STUDY OF ALCOHOLIC LIVER DISEASE IN MEN AND WOMEN |

|5 |Title of topic |ATTENDING MEDICINE DEPARTMENT IN TWO LARGE PUBLIC HOSPITALS IN |

| | |BANGALORE, KARNATAKA” |

|6 |Brief resume of intended work: |

| |Need for study: |

| |Alcohol is a socially accepted substance abuse in most of the societies. Alcohol induced hepatotoxicity is a well established fact |

| |and alcohol remains the leading cause of liver disease worldwide; India being no different. Alcoholic liver disease (ALD) ranges from|

| |fatty liver to alcoholic hepatitis (AH), cirrhosis.1,2 Mechanism of alcohol induced liver damage has been proposed to be chiefly |

| |mediated by pro- inflammatory cytokines (TNF alpha, IL-6 and IL-8), oxidative stress, lipid peroxidation and acetaldehyde toxicity |

| |causing hepatocyte inflammation, apoptosis and eventually fibrosis.3,4 Not all persons drinking alcohol develop cirrhosis and |

| |additional factors affecting the development of liver disease like- sex, ethnicity, obesity and genetic factors have been described.5|

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| |In recent times there has been an increasing trend of female alcoholics. Although the amount and pattern of alcohol consumption is a |

| |well recognized predisposing factor for the development of serious liver pathology, environmental factors and the host’s genetic |

| |makeup may also play significant roles that have not yet been entirely explored.2 With female gender independently considered a poor |

| |prognostic factor in ALD, there is a need to study this population of female ALD patients. |

| |Hence this is proposed as a pioneer study to scientifically establish the difference in presentation, complications, prognosis of |

| |alcoholic liver disease in females compared with males. |

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| |Review of Literature: |

| |Sex-related differences among patients with alcoholic liver disease were first described by Marsha Y Morgan, Sheila Sherlock6. This |

| |study for the first time compared the mode of presentation, complications including liver biopsy findings in male and female |

| |alcoholics. |

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| |A study by J B Saunders, M Davis, Roger Williams-‘do women develop alcoholic liver disease more readily than men?’ found that women |

| |with cirrhosis were found to be eight years younger at death than male patients.7 |

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| |A retrospective study of the clinical profile and prognostic indicators in patients of alcoholic liver disease admitted to a tertiary|

| |care teaching hospital in Nepal showed that female sex is significantly associated with increased mortality with a p-value of 0.001.6|

| |this could be due to the gender-dependent differences in the gastric and hepatic metabolism of alcohol added by hormonal factors |

| |along with the delayed health care seeking practice among female patients.8 |

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| |‘Women and hepatitis: the estrogen connection’ by Tina M. st. john, md originally published in hepatitis magazine, 2004 showed-that |

| |estrogen had detrimental effects on the progression of alcoholic liver disease.9 |

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| |A study by Frezz et al- ‘the role of decreased gastric alcohol dehydrogenase activity and first pass metabolism’ found that the |

| |decreased activity of the enzyme responsible for first pass metabolism of alcohol in females was the reason for high blood alcohol |

| |levels in women.10 |

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| |Objectives of study: |

| |1. To study the demographic, clinical profile, laboratory parameters, complications among female patients of alcoholic liver disease |

| |and compare the same with male alcoholic liver disease patients. |

| |2. To study the quantity and duration of alcohol intake with severity of alcoholic liver disease in patients of female gender and |

| |compare the same in male alcoholics with alcoholic liver disease . |

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| |7. MATERIALS AND METHODS: |

| |7.1 Source of data: |

| |Patients with alcoholic liver disease admitted in the department of medicine of Victoria Hospital and Bowring and Lady Curzon |

| |Hospital, attached to Bangalore Medical College and Research Institute, Bangalore. |

| |7.2 Methods of collection of data: |

| |A .Study design: comparative case series study design. |

| |B. Study period: October 2013 to May 2015. |

| |C. Place of study: |

| |The study is planned to be conducted on in-patient basis in the department of medicine of Victoria Hospital and Bowring and Lady |

| |Curzon Hospital attached to Bangalore Medical College and Research Institute, Bangalore. |

| |D. Sample size: 50 female patients with alcoholic liver disease and |

| |50 male patients with alcoholic liver disease |

| |E. Inclusion criteria : |

| |50 female alcoholics with alcoholic liver disease admitted to Victoria and Bowring and Lady Curzon hospital willing to give written |

| |informed consent. |

| |50 male patients with alcoholic liver disease willing to give written informed consent. |

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| |F. Exclusion criteria : |

| |HbsAg positive patients |

| |Anti HCV positive patients |

| |Patients with liver disease other than ALD |

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| |G. Methodology: |

| |After obtaining clearance and approval from the institutional ethics committee and written informed consent, patients with alcoholic |

| |liver disease admitted in the above mentioned hospitals attached to BMCRI fulfilling the inclusion/exclusion criteria will be |

| |enrolled in the study. (Annexure I) |

| |A total of 50 female patients with alcoholic liver disease (ALD) and 50 male patients with ALD will be studied. |

| |Socio- demographic profile, detailed history of alcohol consumption, presenting complaints, general physical examination and systemic|

| |examination will be done on these patients. Routine laboratory investigations and additional tests like PT INR will be done in all |

| |patients. Ultrasonography and upper GI endoscopy will be done in all patients. Liver biopsy will be done if required in patients |

| |giving informed consent for the same. A |

| |comparison of all the above mentioned parameters will be done in female and male |

| |alcoholics. |

| |Assessment tools: |

| |Proforma for informed consent. (Annexure I) |

| |A detailed history taking, general physical, systemic examination, ultrasonography, endoscopy, liver biopsy (in those who give |

| |consent) will be carried out and recorded in the case proforma. (Annexure II) |

| |Clinical, biochemical and wherever needed endoscopic and histopathological parameters will be compared in the two groups. |

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| |H. Statistical analysis: |

| |The data in this study will be assessed using SPSS statistical software. |

| |7.3 Does the study require any interventions to be conducted on patients or animals specify? |

| |Animals: No |

| |Patient’s written consent will be taken. |

| |Those who give informed consent will be subjected for liver biopsy. |

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| |7.4 Has the ethical clearance been obtained from ethics committee of your Institution in case of 7.3? |

| |“YES”. Ethical clearance has been obtained from the ethics committee of our Institution. |

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| |8.LIST OF REFERENCES : |

| |Sheila Sherlock, James Dooley. Alcohol and the liver. In: Sheila Sherlock, James Dooley. Diseases of the liver and biliary system. |

| |11th edition. UK: Blackwell Science; 2002.p. 399-405 |

| |Mark E. Mailliard, Michael F. Sorrell. Alcoholic liver disease. In: Dan L. Longo, Dennis L. Kasper, J. Larry Jameson, Anthony S. |

| |Fauci, Stephen L. Hauser, Joseph Loscalzo, editors Harrison’s principles of internal medicine. 18th edition. US: Mc Graw Hill; |

| |2012.p.2589-2591 |

| |Zhou Z, Wang L, Song Z, et al. A critical involvement of oxidative stress in acute alcohol-induced hepatic TNF-alpha |

| |production. American journal of pathology 2003;163(3):1137-1146. |

| |Stewart S, Jones D, Day CP: Alcoholic liver disease: New insights into mechanisms and preventative strategies. Trends Mol |

| |Med 2001;7(9):408-413. |

| |O'Shea RS, Dasarathy S, McCullough AJ: Alcoholic Liver Disease. Hepatology 2010;51(1):307-328. |

| |M Y Morgan, S Sherlock. Sex-related differences among 100 patients with alcoholic liver disease. British medical journal 05/1977; |

| |1(6066):939-41. DOI:10.1136/bmj.1.6066.939. |

| |J B Saunders, M Davis, R Williams. Do women develop alcoholic liver disease more readily than men? British medical journal (Clinical |

| |research edition.) 05/1981; 282(6270):1140-3. |

| |Om K. Pathak, Raju Paudel, Om B. Panta, Hom P. Pant, Bishnu R. Giri, and Baikuntha Adhikari. Retrospective Study of the Clinical |

| |Profile and Prognostic Indicators in Patients of Alcoholic Liver Disease Admitted to a Tertiary Care Teaching Hospital in Western |

| |Nepal. Saudi J Gastroenterology 2009 July; 15(3): 171–175. |

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| |Tina M, St. John. Women and Hepatitis: The Estrogen Connection. Hepatitis Magazine 2004; 89-92. |

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| |Frezza M, di Padova C, Pozzato G et al. High blood alcohol levels in women-The role of decreased gastric alcohol dehydrogenase |

| |activity and first-pass metabolism. NEJM 1990; 322:95-99. |

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|9.SIGNATURE OF THE CANDIDATE | |

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| |DR.KRISTIN GEORGE |

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|10.REMARK OF THE GUIDE |With changing socioeconomic conditions in the society, alcoholism in |

| |females is also on the rise. We are treating more number of female |

| |alcoholics in our hospitals. In spite of marked difference in affection |

| |and progression of liver disease among females, scientific research done|

| |is scarce. Hence this study should throw more light to understand the |

| |liver disease among female alcoholics. |

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|11.1.NAME AND DESIGNATION OF THE GUIDE (IN BLOCK |PROF. DR. NAGARAJA B.S. |

|LETTERS) | |

| |PROFESSOR,DEPARTMENT OF GENERAL MEDICINE |

| |BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |

| |BANGALORE-560002 |

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|11.2.SIGNATURE | |

| |PROF.DR.NAGARAJA B.S. |

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| |PROF DR.PRABHAKAR.B. |

|11.3. HEAD OF THE DEPARTMENT. | |

| |PROFESSOR AND HEAD |

| |DEPARTMENT OF GENERAL MEDICINE |

| |BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE,BANGALORE 560002 |

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|11.4.SIGNATURE |PROF.DR.PRABHAKAR B. |

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|REMARKS OF THE DIRECTOR /DEAN | |

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|SIGNATURE | |

ANNEXURE I

INFORMED CONSENT

I, Mr./Mrs./Ms have been explained in a language well understood by me to my satisfaction about the study being carried out. I exercise my own will power of choice and hereby give consent for myself/ being used as an object of “ALCOHOLIC LIVER DISEASE IN FEMALES-A CASE CONTROL STUDY” conducted by Dr. KRISTIN GEORGE, Department of General Medicine, Victoria hospital/ Bowring and Lady Curzon hospital, Bangalore Medical College and Research Institute.

The attending doctors have informed me about the purpose of study, the materials to be used during the course of the study as well as complications associated with the methods/ tools to be used. I have no issues about sharing my details in case records and would co-operate for the study. I have been informed that I will not be sharing any incentives.

I am also aware of my right to opt out of the study without prejudice to further treatment at any time during the course of study without having to give reasons to do so. During the discussion with treating doctor at any time, there would be no compulsion to furnish any details and hence the willingness to take part in the study is completely voluntary.

Signature of Doctor: Signature/ Left thumb impression of Date: patient

Signature of the witness:

INFORMED CONSENT FOR LIVER BIOPSY

I, Mr./Mrs./Ms have been explained in a language well understood by me to my satisfaction about the procedure- ‘liver biopsy under local anaesthesia’ being carried out as a part of the study- “ALCOHOLIC LIVER DISEASE IN FEMALES- A CASE CONTROL STUDY” conducted by Dr. KRISTIN GEORGE, Department of General Medicine, Victoria hospital/ Bowring and Lady Curzon hospital, Bangalore Medical College and Research Institute and give my informed consent to undergo liver biopsy as a part of this study.

The attending doctors have informed me about the purpose of procedure, the materials to be used, the steps involved during the procedure as well as complications associated with the procedure.

I have been informed that I will not be sharing any incentives.

I am also aware of my right to opt out of this procedure without prejudice to further treatment at any time during the course of study without having to give reasons to do so. During the discussion with treating doctor at any time, there would be no compulsion to furnish any details and hence the willingness to undergo the procedure is completely voluntary.

Signature of Doctor: Signature/ Left thumb impression of Date: patient

Signature of the witness:

Date:

ANNEXURE III

STUDY PROFORMA

IP NO:

NAME:

AGE:

SEX:

ADDRESS:

EDUCATION STATUS:

SOCIOECONOMIC STATUS:

DRINKING HISTORY:

1. Type of beverage:

2. Quantity: ______________ml/day

3. Equivalent amount of alcohol: ___________g/day

4. Duration:

PRESENTING COMPLAINTS:

|SYMPTOM |YES |NO |DURATION |

|Jaundice | | | |

|Abdominal distension | | | |

|Upper GI bleed- hematemesis/malena | | | |

|Lower GI bleed | | | |

|Altered sensorium | | | |

|others | | | |

PAST HISTORY :

|SYMPTOM |YES |NO |DURATION |

|Jaundice | | | |

|Abdominal distension | | | |

|Upper GI bleed- hematemesis/malena | | | |

|Lower GI bleed | | | |

|Altered sensorium | | | |

|others | | | |

FAMILY HISTORY:

PERSONAL HISTORY:

1. diet

2. appetite

3. sleep

4. bowel and bladder habits

MENSTRUAL HISTORY

GENERAL PHYSICAL EXAMINATION

Height-

Weight-

BMI-

|SIGN |YES |NO |

|pallor | | |

|icterus | | |

|edema | | |

|clubbing | | |

|Parotid enlargement | | |

|Spider naevi | | |

|Palmar erythema | | |

|Dupuytren’s contracture | | |

|Flapping tremor | | |

|Diminished body hair(male) | | |

|Gynaecomastia(male) | | |

|Testicular atrophy(male) | | |

|Menstrual irregularities(female) | | |

|Signs of virilisation(female) | | |

|Breast atrophy(female) | | |

SYSTEMIC EXAMINATION

PER ABDOMEN

| |YES |NO |

|Ascites | | |

|Splenomegaly | | |

|Hepatomegaly | | |

|Liver span |--------------cm |

RESPIRATORY SYSTEM

CARDIOVASCULAR SYSTEM

CENTRAL NERVOUS SYSTEM

Hepatic encephalopathy grading-1/2/3/4

|Grade 1 |Mild confusion, euphoria, anxiety or depression |

| |Shortened attention span |

| |Slowing of ability to perform mental tasks |

| |(addition/subtraction) |

| |Reversal of sleep rhythm |

| |Mild asterixis |

|GRADE 2 |Drowsiness, lethargy, gross deficits in ability to perform |

| |mental tasks |

| |Obvious personality changes |

| |Inappropriate behaviour |

| |Intermittent disorientation of time (and place) |

| |Lack of sphincter control |

| |Asterixis |

|GRADE 3 |Somnolent but rousable |

| |Persistent disorientation of time and place |

| |Pronounced confusion |

| |Unable to perform mental tasks |

|GRADE 4 |Coma with (IVa) or without (IVb) response to painful stimuli |

LABORATORY INVESTIGATIONS

|PARAMETER |VALUE |

|Hb% | |

|TLC | |

|Platelet count | |

|Peripheral smear | |

|Total bilirubin | |

|Direct bilirubin | |

|Total protein | |

|Albumin | |

|ALT | |

|AST | |

|ALP | |

|PT INR | |

ULTRASONOGRAPHY

Liver- size-

Echotexture-

Portal vein- size-

Velocity-

Spleen- size-

Ascites- minimal

Moderate

Massive

UPPER GI ENDOSCOPY

Esophageal varices- YES/NO

Grading-1/2/3

Grade1- small, straight esophageal varices

Grade 2- enlarged, tortuous esophageal varices occupying less than one third of the lumen

Grade 3- large, coil-shaped esophageal varices occupying more than one third of the lumen

LIVER BIOPSY

CHILD PUGH SCORE

|PARAMETER |1 |2 |3 |

|Encephalopathy(grade) |None |1-2 |1-3 |

|Ascites |None |Mild or controlled with |Moderate despite diuretics |

| | |diuretics | |

|Prolongation of prothrombin |6 |

|time(seconds) | | | |

|Serum albumin(g/dl) |>3.5 |2.8-3.5 |9

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