INTRODUCTION:

The liver is an important part of the body located on the right side of the abdomen. It plays a crucial role in a wide range of metabolic, detoxification, and digestive functions in the body. The epidemiology of alcoholic liver disease (ALD) in India is a growing concern. India is known to have a high prevalence of alcohol consumption, and it is estimated that alcohol consumption accounts for a significant proportion of liver disease in the country. According to a study conducted in 2019, the prevalence of ALD in India ranges from 30% to 50% of all liver diseases¹. The study also reported that ALD is responsible for approximately 45% of all liver-related deaths in India. Another study conducted in 2016 found that the prevalence of alcohol consumption in India is around 21% among men and 2% among women². The study also reported that alcohol consumption in India is increasing, especially among young adults and women. The burden of ALD in India is also reflected in the number of liver transplants performed. A study conducted in 2019 reported that ALD is the most common indication for liver transplantation in India, accounting for approximately 40% of all liver transplantations³.

Structure of the Liver:

The liver is a large, reddish-brown organ that weighs around 1.5kg in an adult. It is composed of two main lobes, the right and the left, which are divided into smaller lobules. Each lobule is made up of hepatic cells, bile ducts, and blood vessels⁴.

Functions of the Liver:

1. Metabolism: The liver plays a central role in the metabolism of carbohydrates, fats, and proteins. It is responsible for regulating blood glucose levels, producing and storing glycogen, and synthesizing and breaking down lipids and amino acids.

2. Detoxification: The liver filters and detoxifies harmful substances from the bloodstream, including drugs, alcohol, and toxins produced by the body. It converts them into less harmful compounds that can be eliminated by the kidneys or intestines.

3. Bile production: The liver produces bile, a greenish-yellow fluid that helps in the digestion and absorption of fats. Bile is stored in the gallbladder and released into the small intestine when it required.

4. Storage: The liver stores important nutrients such as vitamins, minerals, and iron, as well as glycogen, which is used to maintain blood glucose levels.

5. Blood clotting: The liver produces clotting factors that are essential for the formation of blood clots and preventing excessive bleeding.

6. Immune function: The liver is involved in the immune response by filtering and removing bacteria, viruses, and other foreign particles from the bloodstream⁵.

Diseases of the Liver:

Several diseases can affect the liver, including:

1. Hepatitis: Liver inflammation is caused by infection, alcohol consumption, or exposure to certain toxins.

2. Cirrhosis: Chronic diseases in which scarring replaces healthy tissue and impairs liver function.

3. Liver cancer: A type of cancer that develops in the cells of the liver or bile ducts.

4. Fatty liver disease: A condition in which excess fat accumulates in the liver, leading to inflammation and scarring.

5. Autoimmune hepatitis: A condition in which the immune system invasion the liver, causing inflammation and damage.

6. Wilson's disease: A genetic disorder in which the liver cannot eliminate excess copper, leading to its accumulation and damage to the liver⁶.

ALD is a condition that results from chronic, excessive alcohol consumption that causes damage to the liver. ALD includes a variety of diseases, including fatty liver, alcoholic hepatitis, and cirrhosis, which can eventually lead to liver failure and death⁷. The exact mechanisms by which alcohol damages the liver are complex and not fully understood, but it is believed that alcohol can directly injure liver cells, as well as trigger inflammation and oxidative stress, which can further damage liver tissue. Additionally, chronic alcohol consumption can lead to the accumulation of fat in the liver, which can progress to inflammation and scarring. ALD is a major public health concern as it is one of the leading causes of liver disease and related mortality worldwide. According to the World Health Organization (WHO), alcohol-related liver disease accounts for approximately 75% of all liver disease deaths worldwide⁸. Diagnosis of ALD usually involves a combination of blood tests, imaging tests such as ultrasound or MRI, and a liver biopsy to evaluate the extent of liver damage.

ALD treatment includes alcohol abstinence, nutritional support, and drugs to treat complications such as ascites or hepatic encephalopathy⁹.

The pathophysiology of ALD is complex and multifactorial, involving multiple mechanisms that lead to liver injury and dysfunction. The following is an overview of the key mechanisms involved:

Alcohol metabolism plays an important role in the pathogenesis of ALD. Ethanol is mainly metabolized in the liver by two pathways: alcohol dehydrogenase (ADH) and cytochrome P450 2E1 (CYP2E1). The metabolism of ethanol by these enzymes generates reactive oxygen species (ROS) and acetaldehyde, which are toxic to hepatocytes and can cause oxidative stress and lipid peroxidation¹⁰.

1. Alcohol metabolism: The liver is responsible for metabolizing alcohol. When alcohol is consumed, It is metabolized to acetaldehyde by the enzyme alcohol dehydrogenase (ADH) and then to acetate by the enzyme aldehyde dehydrogenase (ALDH). Acetaldehyde is a highly reactive and toxic compound that can cause liver damage by causing cell damage and oxidative stress.

2. Oxidative stress: Chronic alcohol use can lead to an imbalance between reactive oxygen species (ROS) production and the liver's ability to detoxify them. ROS can cause damage to cellular structures including proteins, lipids and DNA, leading to inflammation and apoptosis of liver cells.

3. Inflammation: Chronic alcohol consumption can activate inflammatory cells in the liver, including Kupffer cells, which produce cytokines and chemokines that recruit immune cells to the liver. This results in the release of additional ROS and activation of pro-inflammatory signaling pathways, leading to further liver damage.

4. Gut microbiota dysbiosis: Chronic alcohol consumption can disrupt the balance of the gut microbiota, leading to an increase in harmful bacteria and a decrease in beneficial bacteria. This can result in increased intestinal permeability, allowing bacterial products to enter the liver and further exacerbating inflammation and liver injury.

5. Immune dysregulation: Chronic alcohol consumption can also lead to immune dysregulation, including alterations in T-cell function and impaired natural killer cell activity, which can further contribute to liver injury and impairment of liver function¹¹.

ALD is a spectrum of liver diseases caused by excessive alcohol consumption. The different types of ALD include:

· Fatty liver disease (steatosis): This is the earliest stage of ALD and is characterized by the accumulation of fat in liver cells.

· Alcoholic hepatitis: It is an inflammatory liver disease that occurs in people who drink heavily over a long period of time. Alcoholic hepatitis can range from mild to severe and can be life threatening.

· Alcoholic cirrhosis: This is a progressive liver disease that occurs in people with a history of alcohol abuse. Cirrhosis is characterized by scarring of liver tissue, which can lead to liver failure¹².

In addition to the types of alcoholic liver disease mentioned previously, there are a few other types of ALD that are less common. These include:

1. Hepatocellular carcinoma (HCC): This is a type of liver cancer that can occur in people who abuse alcohol and have cirrhosis of the liver. HCC is a serious and potentially life-threatening condition that requires immediate treatment.

2. Alcoholic cardiomyopathy: This is a type of heart disease that can develop in people who drink too much over a long period of time. Alcoholic cardiomyopathy is characterized by weakness of the heart muscle and can lead to heart failure if not treated quickly.

3. Alcoholic neuropathy: It is a neurological disorder that can occur in people who drink excessively over a long period of time. Alcoholic neuropathy is characterized by numbness, tingling, and pain in the arms and legs and can cause muscle weakness and difficulty walking¹³.

ALD is a progressive disease caused by chronic and excessive alcohol consumption. Clinical symptoms of ALD can vary depending on the stage and severity of the disease, but some common symptoms and signs include¹⁴.

1. Fatigue and weakness: Individuals with ALD may feel tired and weak due to the liver's reduced ability to produce energy. This is because alcohol consumption can interfere with the liver's ability to convert nutrients into energy.

2. Loss of appetite and weight loss: People with ALD may experience a loss of appetite, leading to weight loss. This can occur because of damage to the liver, which can affect the digestive process and lead to malnutrition.

3. Abdominal pain and swelling: Pain and swelling in the upper right quadrant of the abdomen are common symptoms of ALD. This can occur because of inflammation or damage to the liver.

4. Nausea and vomiting: Individuals with ALD may experience nausea and vomiting due to the liver's reduced ability to process toxins. This can occur because of damage to the liver, which can result in a buildup of toxins in the body.

5. Jaundice: Yellowing of the skin and eyes (jaundice) is a common symptom of ALD and is caused by the buildup of bilirubin in the blood. This can occur when the liver is not functioning properly and is unable to process bilirubin.

6. Itchy skin: ALD can cause the skin to become dry and itchy. This can occur due to a buildup of toxins in the blood, which can lead to skin irritation.

7. Dark urine and pale stools: ALD can cause changes in the color of urine and stool due to the liver's reduced ability to process bilirubin. Bilirubin is a waste product that is normally excreted in the urine and stool. When the liver is not functioning properly, bilirubin can build up in the body and cause changes in urine and stool color.

8. Swelling in the legs and ankles: Swelling in the legs and ankles (edema) can occur due to fluid retention. This can occur because of liver damage, which can lead to changes in blood pressure and fluid balance in the body.

9. Mental confusion and difficulty concentrating: In severe cases of ALD, individuals may experience confusion, difficulty concentrating, and memory problems due to the buildup of toxins in the brain. This can occur because the liver is unable to process toxins effectively, leading to a buildup of toxins in the body¹⁵.

It is important to note that the clinical symptoms of ALD may vary depending on individual characteristics and stage of the disease. Some people may not experience symptoms until the disease has progressed to a more severe stage. Here are some diagnostic tests commonly used for alcohol liver disease (ALD).

1. Liver function tests (LFTs): LFTs such as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are commonly used to evaluate liver function in patients with suspected ALD. Elevated levels of these enzymes may indicate liver damage caused by alcohol use¹⁶.

2. Imaging studies: Imaging studies, such as ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI), provide information about the size and structure of the liver and can detect abnormalities such as cirrhosis or liver tumors¹⁷.

3. Fibro Scan: The Fibro Scan is a non-invasive test that uses ultrasound to measure liver stiffness. This test may be useful in assessing the severity of liver fibrosis due to alcohol use¹⁸.

4. CDT and GGT levels: Carbohydrate-deficient transferrin (CDT) and gamma-glutamyltransferase (GGT) levels can be used to screen for excessive alcohol consumption and are commonly used in conjunction with other tests to diagnose ALD¹⁹.

5. Liver biopsy: A liver biopsy is the removal of a small sample of liver tissue for examination under a microscope. This test can provide information about the severity of liver damage from alcohol use and the presence of cirrhosis or other liver disease²⁰.

These tests can be used in combination to diagnose ALD and assess its severity.

METHODS:

A single-center, prospective, observational study was conducted on 150 prescriptions of patients diagnosed with alcoholic liver disease in the general medicine department of a tertiary clinical hospital over a 6-month period.

Inclusion criteria:

Patient of any gender 18 year above.

Patient with alcoholic liver disease who had willing to participate in the study.

Exclusion criteria:

Below 18 years of age.

Patient’s file with missing data.

DESIGNING OF PATIENT DATA FORM:

A specially designed patient data collection and informed consent form is prepared and validated. It was used to collect right information from general Medicine department. It includes demographic details of the patients; age, sex, date of admission, reason for admission, medical history, social history, treatment history; dose, route, frequency, other information, etc.

RESULTS:

A total of 150 patients diagnosed with ALD and hospitalized within 6 months were included in the study.

Distribution According To Age (Year)

Age	No. of Patients (n= 150)	Percentage (%)
18-25yr	6	4 %
26-35yr	28	18.67%
36-45yr	55	36.67 %
46-55yr	40	26.67 %
56-65yr	14	9.33 %
65yr and Above	7	4.67%
Total	150	100%

This table indicates that maximum number of ALD patients was found to be in criteria of age of 18-25year (4%), 26-35year (18.67%), 36-45year (36.67%), 46-55year (26.67%), 56-65year (9.33%) and 65year and Above (4.7%). Majority of the patient’s were found in the age group of 36-45yearr (36.67%).

Gender wise distribution:

Gender	No. of Patients (n=150)	Percentage (%)
Male	143	95.33%
Female	07	4.67%
Total	150	100

This table indicates of total of 150 patients were enrolled in the study, out of them 143 patients (95.33%) were found to be of male gender of the total population and females were found to be 07 (4.67%) after analyzing this data it was found that majority of the patients belonged to male gender.

This Figure number 01 shows the distribution of patients based on according their region of residence, among a total of 150 patients. Out of the total patients, 98 (or 65.33%) belong to rural areas, while the remaining 52 (or 34.67%) were from urban areas. This indicates that a larger proportion of patients were from rural areas compared to urban areas.

Figure 1: Distributions based on Regions wise

The figure number 2 shows the distribution of 150 participants based on their frequency of drinking alcohol-containing drinks. Out of the total participants, 102(or 68%) drinks alcohol daily, making it the most common frequency of alcohol intake. 31 participants (or 20.67%) drink alcohol 2 or 3 times a week, while 13 participants (or 8.67%) drinks alcohol occasionally. Only 1 participant (or 0.67%) drinks alcohol on a weekly basis. In addition, 3 participants (or 2%) drinks alcohol monthly. Therefore, it can be concluded that a majority of the participants in this dataset consume alcohol daily.

Figure 2: Distributions cases according to containing alcohol

The figure number 3 shows the distribution of participants based on the number of years they have been consuming alcohol, along with the corresponding percentages for each category. Out of a total of 150 participants, the largest group (30 participants, or 20%) has been consuming alcohol for 5-7 years. This is followed by 22 participants (or 14.67%) who have been consuming alcohol for 4-5 years, and 24 participants (or 16%) who have been consuming alcohol for 7-10 years. The smallest groups are those who have been consuming alcohol for 0-1 year (6 participants, or 4%) and those who have been consuming alcohol for more than 20 years (13 participants, or 8.67%). Overall, the data suggests that a majority of the participants have been consuming alcohol for a period ranging from 5-10 years.

Figure 3: Distributions cases according to year of consumption of alcohol

The figure number 4 shows the distribution of participants based on the category of alcohol they consume, along with the corresponding percentages for each category. Out of a total of 150 participants, the largest group (94 participants, or 62.67%) consume CML (country-made liquor), followed by 32 participants (or 21.33%) who consume wine, and 22 participants (or 14.67%) who consume malted liquors. Only one participant consumes whiskey (0.67%) and one consumes beer (0.67%). Overall, the data suggests that a majority of the participants consume CML, with wine and malted liquors being the second and third most popular categories, respectively.

Figures 4: Distributions cases according to Category of Alcohol

The figure number 5 shows the distribution of participants based on the amount of alcohol they consume daily, measured in milliliters (ml). Out of 150 participants, 71(or 47.33%) consume between 250 to 400ml of alcohol per day, which is the highest number of participants in any category. The next most popular category is 400 to 800ml per day, with 56 participants (or 37.33%), followed by 100 to 250ml per day with 22 participants (or 14.67%). Only two participants consume more than 800ml of alcohol per day. Overall, the data suggests that a majority of the participants consume between 250 to 800ml of alcohol per day.

Figure 5: Distribution based on Amount of daily consumption (ml)

The figure no 6 represents the distribution of participants based on their diagnosed liver conditions related to alcohol consumption. Out of 150 participants, 84 participants (or 56%) were diagnosed with alcoholic fatty liver, which is the most common condition among the participants. The second most common condition is liver cirrhosis with 24 participants (or 16%), followed by haptic encephalopathy with 13 participants (or 8.67%) and alcoholic hepatitis with 12 participants (or 8%). The rest of the diagnosed conditions such as liver fibrosis, ALD and ascites, chronic alcoholic liver disease, portal hypertension, ALD with liver abscess, and liver failure make up the remaining percentage of participants. Overall, the table suggests that alcoholic fatty liver is the most prevalent liver condition among the participants.

Figures 6: Distribution based on Diagnoses

The figures 7 shows the distribution of patients based on their diet types among a total of 150 patients. Out of the total patients, 23(or 15.33%) followed a vegetarian diet, while 19(or 12.67%) followed a non-vegetarian diet. The majority of the patients (109 or 72%) followed a mixed diet. This indicates that most patients had a diet that included both vegetarian and non-vegetarian components.

Figures 07: Distribution based on Diet Types

Distribution based on Psychological effects:

Total number of patients 150 and 145 patient showing psychological changes due to alcohol abuse Based on the given data, the distribution of psychological effects of the substance in question is as follows: difficulty focusing (37.42%), problems with memory (14.72%), affected vision, coordination and reflexes (19.63%), increased depression and anxiety (11.66%), reduced inhibitions (6.13%), relaxation and diminished stress (5.52%), and other effects such as convulsions, slurred speech, drowsiness, and speech problems (2.33%). These findings suggest that the substance can negatively impact cognitive and psychological functioning, as well as physical coordination and reflexes. It is important to note that this data represents a limited sample and further research may be necessary to fully understand the effects of this substance.

Prescribing indicators:

The prescribing indicators, which can provide insights into the prescribing practices of healthcare professionals. According to the data, a total of 150 prescriptions were analyzed, which included a total of 1314 drugs, resulting in an average of 8 drugs per prescription. The data also shows that 48% of drugs were prescribed by their generic name, which is a positive indicator as it can help reduce healthcare costs and improve access to affordable medication. Additionally, the high percentage (90%) of prescriptions with an injection prescribed may suggest that healthcare providers are using injectable medications for treatment when appropriate. However, the data also reveals some potential areas of concern. For instance, the high percentage (71%) of prescriptions with an antibiotic prescribed indicates that antibiotics may be over-prescribed, which can contribute to the development of antibiotic resistance. Furthermore, while 81% of the drugs prescribed were from the National List of Essential Medicines (NLEM)-2015, it is unclear whether the remaining 19% of drugs prescribed were necessary or appropriate for the patients' conditions. Overall, the data suggests that there may be opportunities to optimize prescribing practices, particularly with respect to reducing antibiotic use and ensuring appropriate use of non-NLEM drugs.

Sr. No.	Indicator	Value
1	Total number of prescriptions	150
2	Total number of medications prescribed	1314
3	Average number of drugs per prescription	9
4	Percentage of drugs prescribed by generic name	48%
5	Percentage of prescriptions with an injection prescribed	90%
6	Percentage of prescriptions with an antibiotic prescribed	71%
7	Percentage of drugs prescribed in NLEM-2015	81%

Distribution of prescribed drugs based on their category:

Drugs class	Total no. of drugs	Percentage (%)
Antibiotics	270	20.55%
Diuretics	200	15.23%
Antacids	141	10.74%
Analgesic	2	0.15%
Nutritional supplements	90	6.85%
Laxatives	150	11.42%
Antihypertensive	12	0.91%
Anti diarrheal	1	0.08%
Anti emetics	80	6.09%
Anti psychotics	13	0.99%
Anti amoebic	48	3.65%
Cholagogues	55	4.19%
Pancreatic enzymes	48	3.65%
Vitamin supplement	194	14.77%
Steroids	10	0.76%
Total	1314	100%

The based on distribution of prescribed drugs based on their category. The drug categories, including antibiotics, diuretics, antacids, analgesics, vitamin supplements, laxatives, antihypertensive drugs, anti-diarrheal drugs, anti-emetics, anti-psychotics, anti-amoebic drugs. Out of these categories, vitamin supplements and antibiotics have the highest count, accounting for 22.31% and 22.06% of the total respectively. Diuretics and antacids follow closely, with 13.33% and 18.90%, respectively. Other categories, such as laxatives, anti-emetics, and anti-amoebic drugs, have a moderate number of counts. Analgesics, anti-diarrheal drugs, anti-psychotics have the lowest count, each contributing less than 1% to the total. In summary, the table provides a clear picture of the prescription drug distribution based on their category, with antibiotics and vitamin supplements being the most commonly prescribed drugs.

Distribution of diuretics agents: The distribution based on diuretic agents with the total number of drugs being 200. The diuretic agents are classified into four categories namely Furosemide, Spirolactone, Lasilactone, and Aldectone. Furosemide is the most commonly used diuretic agent with a percentage of 43.5% and a total of 87 drugs. Spirolactone is the second most commonly used diuretic with a percentage of 43% and a total of 86 drugs. Lasilactone is the least used diuretic with only one drug representing 0.5%. Aldectone has a percentage of 13% with a total of 26 drugs. In summary, the majority of diuretic agents used in this dataset are Furosemide and Spirolactone, accounting for more than 86% of the total diuretic drugs used. Aldectone is also commonly used but to a lesser extent, while Lasilactone is rarely used.

Distribution based on Antibiotics: The represents the distribution of antibiotics based on the total number of drugs, which is 245. The antibiotics are classified into five categories: Ceftraxone, Refaximine, Norfloxacin, Amikacin, and Piperacillin+Tazobactum. Ceftraxone is the most commonly used antibiotic with a percentage of 48.98% and a total of 120 drugs. Refaximine is the second most commonly used antibiotic with a percentage of 45.71% and a total of 112 drugs. Amikacin and Norfloxacin are less commonly used antibiotics, representing 3.67% and 1.22% respectively, with a total of 9 and 3 drugs. Piperacillin+Tazobactum is the least used antibiotic, with only one drug, representing 0.41% of the total. In summary, Ceftraxone and Refaximine are the most commonly used antibiotics, accounting for more than 94% of the total antibiotics used. The remaining antibiotics, including Norfloxacin, Amikacin, and Piperacillin+Tazobactum, are used less frequently.

Distribution based on antacids: This distribution represents of antacids based on the total number of drugs, which is 141. The antacids are classified into two categories: Pantoprazole and Rabeprozole. Pantoprazole is the most commonly used antacid with a percentage of 93.62% and a total of 132 drugs. Rabeprozole is used less frequently, representing 6.38% of the total antacids used with a total of 9 drugs. In summary, Pantoprazole is the most commonly used antacid, accounting for the vast majority of antacids used. Rabeprozole is used less frequently in comparison.

Distribution of vitamin supplements: The distribution of vitamin supplements based on the total number of drugs, which is 194. The vitamin supplements are classified into four categories: Vitamin K, Multivitamin B complex, Vitamin A and D, and Vitamin C. Vitamin K is the most commonly used vitamin supplement with a percentage of 50% and a total of 97 drugs. Multivitamin B complex is the second most used supplement, representing 33.51% of the total vitamin supplements used with a total of 65 drugs. Vitamin A and D represent 7.73% of the total vitamin supplements used with a total of 15 drugs, and Vitamin C represents 8.76% of the total vitamin supplements used with a total of 17 drugs. In summary, Vitamin K is the most commonly used vitamin supplement, followed by Multivitamin B complex, while Vitamin A and D, and Vitamin C are used less frequently in comparison.

Distribution of anti hypertensives: The antihypertensive drugs based on the total number of drugs, which is 12. The antihypertensive drugs are classified into four categories: Carvedilol, Clonidine, Propranolol, and Amlodipine. Propranolol is the most commonly used antihypertensive drug, representing 50% of the total antihypertensive drugs used with a total of 6 drugs. Clonidine is the second most used drug, representing 25% of the total antihypertensive drugs used with a total of 3 drugs. Carvedilol represents 16.67% of the total antihypertensive drugs used with a total of 2 drugs, while Amlodipine represents 8.33% of the total antihypertensive drugs used with a total of 1 drug. In summary, Propranolol is the most commonly used antihypertensive drug, followed by Clonidine, while Carvedilol and Amlodipine are used less frequently in comparison.

Distribution based on Laxatives, pancreatic enzymes, Nutritional supplements, Steroids, Anti emetics, Anti psychotics, anti ameobic, Analgesics, Cholagogues, Anti fungal, and Anti diarrheal:

The drugs from various classes such as laxatives, pancreatic enzymes, nutritional supplements, steroids, anti-emetics, antipsychotics, anti-ameobic, analgesics, cholagogues, anti-fungal, and anti-diarrheal. The distribution of drugs in each class is as follows: Laxatives: Lactulose is the only drug in this class with a total of 150 drugs. Pancreatic enzyme: L-Orinithine-L-Aspartate is the only drug in this class with a total of 48 drugs, Nutritional supplements: This class includes two drugs, Folic acid with a total of 80 drugs and Iron sucrose with a total of 10 drugs, Steroids: Prednisolone is the only drug in this class with a total of 10 drugs, Anti emetics: Ondansetron is the only drug in this class with a total of 89 drugs, Antipsychotic: This class includes four drugs, Midazolam with a total of 10 drugs, Lorazepam, Diazepam, and Oxazepam with a total of 1 drug each, Anti ameobic: Metronidazole is the only drug in this class with a total of 48 drugs, Analgesics: This class includes two drugs, Naltrexone with a total of 2 drugs and Tramadol with a total of 1 drug, Cholagogues: Ursodeoxycholic acid is the only drug in this class with a total of 55 drugs, Anti fungal: Fluconazole is the only drug in this class with a total of 1drug and Anti diarrheal: This class includes two drugs, Lactic Acid Bacillus and Racecadotril with a total of 1 drug each.

DISCUSSION:

Alcoholic liver disease (ALD) is a major public health problem worldwide with a significant impact on morbidity and mortality. ALD covers a spectrum of liver diseases from steatosis to alcoholic hepatitis and cirrhosis and is caused by chronic and excessive alcohol consumption. The prevalence of ALD depends on the population studied and the amount and duration of alcohol consumption. In the United States, ALD accounts for up to 50% of liver-related deaths, making it a significant public health issue²¹.

The pathogenesis of ALD is multifactorial and complex, involving a combination of genetic, environmental, and lifestyle factors. Chronic alcohol consumption leads to generation of reactive oxygen species (ROS) and the activation of inflammatory pathways, leading to oxidative stress, inflammation, and cellular damage. Alcohol metabolism generates ROS and promotes lipid accumulation in hepatocytes, leading to the development of fatty liver disease, the earliest stage of ALD. With continued alcohol consumption, fatty liver disease can development to alcoholic hepatitis, characterized by inflammation and necrosis of hepatocytes. In severe cases, alcoholic hepatitis can development to cirrhosis, a condition characterized by fibrosis and disruption of usual hepatic architecture²². Diagnosis of ALD is usually based on a combination of clinical signs, laboratory tests, and imaging studies. Hematological tests such as liver function test, complete blood count, and coagulation profile can provide important information on liver function and the presence of inflammation. Imaging studies, such as ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI), can detect the presence of liver damage and assess the severity of the disease. In some cases, a liver biopsy may be needed to confirm the diagnosis and evaluate the extent of liver damage²².

The World Health Organization recommends limiting alcohol Consume no more than 2 standard servings per day for men and 1 standard serving per day for women ²³. Several factors contribute to the development of ALD, including genetic susceptibility, environmental factors, and lifestyle factors such as alcohol consumption. In one study found that the genetic variant PNPLA3 was associated with an increased risk of developing ALD, independent of alcohol consumption ²⁴. The management of ALD involves abstinence from alcohol, nutritional support, and treatment of complications. Abstinence from alcohol is the cornerstone of therapy and can lead to significant improvements in liver function and histology. Nutritional support, including vitamin and mineral supplementation, is important in patients with ALD, as they may have nutritional deficiencies due to poor dietary intake and impaired nutrient absorption.

Treatment of complications such as ascites, hepatic encephalopathy, and portal hypertension is also important in patients with ALD. Severe ALD may require a liver transplant²⁵. Prevention of ALD involves reducing Alcohol consumption or complete abstinence from alcohol. The World Health Organization recommends limiting alcohol intake to two drinks per day for men and one drink per day for women. In addition, education and public health campaigns aimed at reducing alcohol consumption and promoting healthy lifestyles can play a role in preventing ALD²⁶.

A prescription written by a physician can be seen as an indicator of the physician's attitude toward the disease and the role of the drug in treatment. Therefore, each doctor's prescription system will be different from others. Because there is no specific treatment for ALD and treatment decisions are based on symptoms and complications, drug use will be a problem for doctors. This study describes a prescription regimen for drugs used in patients with ALD.

A prospective observational study was conducted over a period of 6 months at the Department of General Medicine, Parul Sevashram Hospital. A total of 150 patients were included in the study. Of the total study population, 144 patients were male and 7 patients were female. This shows that the male population predominates over the female population. This may be because males consume more alcohol than females in the Indian scenario^27-36.

The given results present the distribution of participants based on various parameters. The first parameter is the age-wise distribution, where the study found that 37.1% of the patients were aged between 36-45 years, and the majority of the patients were in this age group. The second parameter is gender-wise distribution, where the study found that 95.4% of the participants were male, and only 4.6% were female. The third parameter is region-wise distribution, where the study found that 65.6% of the patients were from rural areas, while the remaining 34.4% were from urban areas. The fourth parameter is distribution based on drinks containing alcohol, where the study found that 68.2% of the participants consumed alcohol daily, and only 0.7% consumed alcohol on a weekly basis. The fifth parameter is distribution based on the year of consumption of alcohol, where the study found that a majority of the participants have been consuming alcohol for a period ranging from 5-10 years. The sixth parameter is distribution based on the category of alcohol, where the study found that beer was the most commonly consumed category of alcohol. The given results show the distribution of participants based on their daily alcohol consumption, diagnosed liver conditions related to alcohol consumption, diet types, and psychological effects of alcohol abuse. Regarding the amount of daily alcohol consumption, the data suggests that a majority of the participants consume between 250 to 800ml of alcohol per day. The highest number of participants falls within the range of 250 to 400 ml per day, followed by 400 to 800ml per day. Only two participants consume more than 800ml of alcohol per day. Concerning diagnosed liver conditions related to alcohol consumption, alcoholic fatty liver is the most prevalent condition among the participants, with 56.29% of the total number of participants diagnosed with this condition. The second most common condition is liver cirrhosis, followed by haptic encephalopathy and alcoholic hepatitis. As for diet types, the majority of the participants followed a mixed diet that included both vegetarian and non-vegetarian components, while 15.20% followed a vegetarian diet, and 12.60% followed a non-vegetarian diet. Finally, the data indicates that the substance in question can negatively impact cognitive and psychological functioning, as well as physical coordination and reflexes. The most common psychological effect is difficulty focusing, followed by problems with memory and affected vision, coordination, and reflexes. The given results present the distribution of drugs based on their types, including antibiotics, antacids, vitamin supplements, and antihypertensives. The tables provide the total number of drugs for each type along with the percentage of each drug. The figures represent the distribution graphically. According to the results, Ceftraxone is the most commonly used antibiotic, accounting for 48.98% of the total antibiotics used, followed by Refaximine, which represents 45.71% of the total antibiotics used. The remaining antibiotics, including Norfloxacin, Amikacin, and Piperacillin+Tazobactum, are used less frequently. Pantoprazole is the most commonly used antacid, accounting for 93.62% of the total antacids used, while Rabeprozole is used less frequently, representing 6.38% of the total antacids used. Vitamin K is the most commonly used vitamin supplement, accounting for 50% of the total vitamin supplements used, followed by Multivitamin B complex, representing 33.51% of the total vitamin supplements used. Vitamin A and D and Vitamin C are used less frequently. Propranolol is the most commonly used antihypertensive drug, accounting for 50% of the total antihypertensive drugs used, followed by Clonidine, representing 25% of the total antihypertensive drugs used. Carvedilol and Amlodipine are used less frequently.

CONCLUSION:

The study findings indicate that there is a deviation from standard values in the prescription of drugs listed in NLEM-2015 (81%) for the treatment of ALD. To obtain more accurate and reliable results regarding prescribing patterns in ALD, it is advisable to conduct multi-centered studies. The main goal of treatment in patients with ALD is to stop drinking alcohol as it reduces the risk of complications and death. Currently, there is no specific drug therapy proven to be effective in ALD. In order to increase the quality of treatment, it is recommended to increase the participation of doctors in the hospital in order to promote the effective use of drugs and compliance. Continuing education for physicians is essential, with a particular focus on adherence to ALD treatment guidelines and appropriate medication use for ALD patients. These measures help improve patient outcomes and improve health outcomes in the management of ALD.

CONFLICT OF INTEREST:

None declared.

ETHICAL APPROVAL:

The study was approved by the Institutional Ethics Committee.

REFERENCES:

1. Singh SP, Misra D, Singh A, Misra A. Alcoholic liver disease in India: current status and future directions. J Clin Exp Hepatol. 2019; 9(5): 716-724.

2. Rehm J, Samokhvalov AV, Shield KD. Global burden of alcoholic liver diseases. J Hepatol. 2013; 59(1): 160-168.

3. National Family Health Survey (NFHS-4), 2015-16: India Fact Sheet. International Institute for Population Sciences. Accessed March 11, 2023. https://rchiips.org/nfhs/pdf/NFHS4/India.pdf

4. Vetriselvan Subramaniyan et.al. Alcohol-associated liver disease: A review on its pathophysiology, diagnosis and drug therapy, Toxicology Reports 2021: 8; 376-385.

5. Liver Anatomy and Functions. Johns Hopkins Medicine, Accessed on 11 March 2023, https://www.hopkinsmedicine.org/health/conditions-and-diseases/liver-anatomy-and-functions

6. "Liver Diseases." National Institute of Diabetes and Digestive and Kidney Diseases, Accessed on 11 March 2023, https://www.niddk.nih.gov/health-information/liver-disease

7. National Institute on Alcohol Abuse and Alcoholism. (2019). Alcohol’s Effects on the Body. Retrieved from https://www.niaaa.nih.gov/alcohols-effects-body.

8. Singal AK, Bataller R, Ahn J, Kamath PS, Shah VH. ACG Clinical Guideline: Alcoholic Liver Disease. Am J Gastroenterol. 2018; 113(2): 175-194. doi:10.1038/ajg.2017.469

9. World Health Organization. Global status report on alcohol and health 2018. Retrieved from https://www.who.int/publications/i/item/9789241565639

10. Gao, B., and Bataller, R. Alcoholic liver disease: pathogenesis and new therapeutic targets. Gastroenterology. 2011; 141(5): 1572-1585.

11. Louvet, A., and Mathurin, P. Alcoholic liver disease: mechanisms of injury and targeted treatment. Nature Reviews Gastroenterology and Hepatology, 2011; 12(4): 231-242. https://doi.org/10.1038/nrgastro.2015.35

12. Rehm, J., Samokhvalov, A. V., and Shield, K. D. Global burden of alcoholic liver diseases. Journal of Hepatology. 2013; 59(1): 160-168.

13. Singal, A. K., and Kamath, P. S. Alcoholic hepatitis: current challenges and future directions. Clinical Gastroenterology and Hepatology. 2013; 11(7): 777-783.

14. Alcoholic Liver Disease: Pathogenesis and Current Management. Journal of Clinical and Translational Hepatology, 2016; 4(2): 113-123.

15. Clinical Manifestations of Alcoholic Liver Disease. Clinics in Liver Disease. 2016; 20(3): 419-429.

16. Singal AK, Kamath PS, Gores GJ, Shah VH. Alcoholic hepatitis: current challenges and future directions. Clin Gastroenterol Hepatol. 2014; 12(4): 555-564.

17. European Association for the Study of the Liver. EASL-ALEH clinical practice guidelines: non-invasive tests for evaluation of liver disease severity and prognosis. J Hepatol. 2015; 63(1): 237-264.

18. Altamirano J, Bataller R. Alcoholic liver disease: pathogenesis and new targets for therapy. Nat Rev Gastroenterol Hepatol. 2011; 8(9): 491-501.

19. European Association for the Study of the Liver. EASL clinical practical guidelines: management of alcoholic liver disease. J Hepatol. 2012; 57(2): 399-420.

20. Zeebaish S, Farooqui M, Ahmad A, et al. Prescribing pattern of drugs in alcoholic liver disease patients in a tertiary care hospital. J Basic Clin Pharma. 2017;8(Suppl 1):S017-S021. doi: 10.4103/jbcps.jbcps_34_17. PMID: 28781452; PMCID: PMC5530523.

21. Bataller R, Brenner DA. Liver fibrosis. J Clin Invest. 2005; 115(2): 209-218.

22. Singal AK, Bataller R, Ahn J, Kamath PS, Shah VH. ACG clinical guideline: alcoholic liver disease. Am J Gastroenterol. 2018; 113(2): 175-194.

23. World Health Organization. Global status report on alcohol and health 2018. Geneva: World Health Organization; 2018. Licence: CC BY-NC-SA 3.0 IGO.

24. Stickel F, Buch S. Genetic variation in the PNPLA3 gene is associated with alcoholic liver injury in caucasians. Hepatology. 2011; May; 53(5): 1637-

25. Singal AK, Bataller R, Ahn J, Kamath PS, Shah VH. ACG clinical guideline: alcoholic liver disease. Am J Gastroenterol. 2018; 113(2): 175-194. doi: 10.1038/ajg.2017.469. PMID: 29380815.

26. World Health Organization. Global status report on alcohol and health. World Health Organization. (2018). https://www.who.int/publications/i/item/978924156563.

27. Pinisetti D, Patel AB, Kakadiya J. Role of quercetin as an effective bioenhancer in curcumin absorption, In vitro Study. Research Journal of Pharmacy and Technology. 2022; 15(11): 4867-70.

28. Vadakkan K, Rajesh KS, Tarachandra S, Raj KC, Joshi H. Clinical utility of benzodiazepine in the management of alcohol withdrawal syndrome in a tertiary care teaching hospital. Research Journal of Pharmacy and Technology. 2022; 15(11): 5321-6.

29. Kumar VS, Rahaman SK, Deepika T. Prevalence and General Medications Utilization, Cost Minimization Analysis of Drugs in Hepatic Impairment Patients at A Tertiary Care Hospital. Research Journal of Pharmacy and Technology. 2019; 12(10): 4873-8.

30. Venkatalakshmi P, Ragadevi M. Protective effect of tinospora cordifolia linn., on paracetamol and alcohol induced hepatotoxicity in albino rats. Research Journal of Pharmacy and Technology. 2012; 5(2): 281.

31. Yasmeen R, Jabeen HH, Aseena R, Taneem K, Syed U. An Observational Study to Determine Severity and Complications Associated with Non-Alcoholic Fatty Liver Disease with Special Emphasis on Riskfactors. Research Journal of Pharmacy and Technology. 2021; 14(10): 5498-502.

32. Fauzi NQ, Vishnupriya V, Gayathri R. Fatty liver disease-a review. Research Journal of Pharmacy and Technology. 2016; 9(8): 1263-7.

33. Thaminee S. Prednisolone in alcoholic liver disorder. Research Journal of Pharmacy and Technology. 2016; 9(11): 2041-2.

34. Nitin M, Ifthekar S, Mumtaz M. Protective Effect of Aqueous Extract of Seeds of Vigna mungo (Linn) Hepper on Ethanol-Induced Hepatotoxicity in Albino Rats. Research Journal of Pharmacy and Technology. 2012; 5(6): 780-4.

35. Mitha KV, Yadav SJ, Rashmi KS, Bolumbu G. Neuroprotective effects of feeding Centella asiatica (L) urb.-study of hippocampal neurons in pups born to alcohol-fed female wistar rats. Research Journal of Pharmacy and Technology. 2022; 15(3): 1047-52.

36. Vadakkan K, Rajesh KS, Tarachandra S, Raj KC, Joshi H. Clinical utility of benzodiazepine in the management of alcohol withdrawal syndrome in a tertiary care teaching hospital. Research Journal of Pharmacy and Technology. 2022; 15(11): 5321-6.

Received on 19.08.2023 Modified on 26.09.2023

Research J. Pharm. and Tech 2024; 17(7):3231-3240.

DOI: 10.52711/0974-360X.2024.00506