Frailty Predicting Health-Related Quality of Life Trajectories in Individuals with Sarcopenia in Liver Cirrhosis: Finding from BCAAS Study.

The association between frailty and health-related quality of life (HRQoL) among Asian patients with liver cirrhosis and sarcopenia remains largely unexplored. To address this knowledge gap, we conducted a cross-sectional study involving individuals aged 32 to 69 years, all diagnosed with liver cirrhosis. The chronic liver disease questionnaire (CLDQ) was used to assess HR-QoL, the CLDQ score was used as an outcome to measure the factors related to HR-QoL, and the liver frailty index (LFI) was used to assess the frailty status. The association between the frailty status and the CLDQ summary scales was investigated using the correlation coefficient and multiple regression analyses. A total of 138 patients in the frail (n = 62) and non-frail (n = 76) groups with (alcohol: 97; viral: 24; autoimmune: 17; and cryptogenic: 12) were included in the study. Age, CTP score, and model for end-stage liver disease (MELD) sodium were significantly higher in the frail group. In the CLDQ domains, there was a significant difference between the frail and non-frail groups (p value = 0.001). In health-related quality-of-life summary measures, there was a strong negative correlation between frailty and the scores for activities, emotional function, and fatigue (p value = 0.001). When comparing frail to non-frail patients, these characteristics demonstrated significantly increased odds as indicated by their adjusted odds ratios: OR 3.339 (p value = 0.013), OR 3.998 (p value = 0.006), and OR 4.626 (p value = 0.002), respectively.

Impact of Branched Chain Amino Acid on Muscle Mass, Muscle Strength, Physical Performance, Combined Survival, and Maintenance of Liver Function Changes in Laboratory and Prognostic Markers on Sarcopenic Patients With Liver Cirrhosis (BCAAS Study): A Randomized Clinical Trial.

Background: This study aimed to investigate the long-term effects of branched-chain amino acids (BCAAs) supplementations on the parameters associated with improved prognosis in sarcopenic patients with liver cirrhosis (LC) and evaluate its impact on cirrhotic-related events. Methods: A 24-week, single-center, randomized, open-label, controlled, two cohort parallel-group intervention study was carried out by comparing the efficacy of BCAAs against lactoalbumin (L-ALB) on 106 sarcopenic patients with LC. The BCAA (intervention) group was treated with 7.2 g BCAA per dose, whereas the L-ALB group was treated with 6.3 g of L-ALB. The primary outcome was to assess the effect of BCAA on the parameters of sarcopenia, such as muscle mass, muscle strength, and physical performance. The secondary outcomes were to study the combined survival and maintenance of liver function changes in laboratory and prognostic markers over the duration of 6 months. Results: The treatment with BCAA leads to the significant improvement in sarcopenic parameters, such as muscle strength, muscle function, and muscle mass. The total cirrhotic-related complications and cumulative event-free survival occurred fewer in the BCAA group than in the L-ALB group. In addition, prognostic markers improved significantly in the study. Conclusion: The current study demonstrated that long-term BCAAs supplementation improved sarcopenia and prognostic markers in patients with advanced LC.

A Prospective Multicentric Postmarketing Observational Study to Characterize the Patient Population with Reduced Gastrointestinal Motility among Indian Diabetic Patients Receiving Itopride: The Progress Study.

AIMS: This study was intended to assess the clinical profile of Indian diabetic patients with reduced gastrointestinal (GI) motility and to understand the role of itopride in addressing reduced GI motility (gastroparesis) symptoms and maintaining glycemic control. MATERIAL AND METHODS: Patients with established reduced GI motility (scintigraphy), with varying degree of GI symptoms, receiving itopride 150 mg as per physicians' discretion were enrolled. Clinical profile, changes in symptom severity, glycemic indices, tolerability, and quality of life (QoL) after 8-week therapy (Patient assessment of upper GI disorders-QoL [PAGI-QoL]) were assessed. RESULTS: Mean ± standard deviation age of enrolled population (n = 41) was 51.8 ± 12.39 years. Average duration of gastroparesis since underlying etiology was 67.7 ± 59.76 months. Common symptoms reported at baseline were bloating (68.3%), postprandial fullness (61.0%), nausea (51.2%), early satiety (41.5%), heartburn (39.0%), and vomiting (9.8%). Itopride therapy resulted in significant improvement in all symptoms (P < 0.001), which correlated with improved QoL (PAGI-QoL score reduction: 13.8 ± 11.48; P < 0.0001). Moreover, significant improvement in glycemic indicators was also evident (mean change from baseline hemoglobinA1c -0.5 ± 1.18; fasting plasma glucose -15.3 ± 43.61; postprandial plasma glucose -24.6 ± 57.20). CONCLUSIONS: Itopride showed effectiveness in addressing symptoms of reduced GI motility in diabetics, with improved QoL. Significant improvement in glycemic indices was also evident posttreatment with itopride. This study sheds light on the role of prokinetics, not only for symptom relief but also for improving glycemic control in diabetic patients with reduced GI motility, thus providing a holistic approach for the management of these patients.

Chronic hepatitis C virus infection in India: Regional demographics and distribution of viral genotypes.

BACKGROUND AND AIMS: Although chronic hepatitis C virus (HCV) infection affects millions of people in India, few studies have assessed host, viral, and disease characteristics of chronically infected patients at national and regional levels. Such information is critical to support large scale screening and treatment initiatives for chronic HCV infection in India. METHODS: Patients with known chronic HCV infection making routine or for-cause visits to the participating study centers were enrolled in this observational study. Patients attended a single outpatient visit during which demographics and medical history were collected, a physical examination was performed, and blood and urine samples were collected for laboratory assessments. Samples were analyzed to determine HCV genotypes and subtypes, and genotypes of interferon lambda 3 (IFNL3) single nucleotide polymorphism. No therapeutic interventions were administered. RESULTS: We enrolled 500 patients at 19 centers, categorized into four geographic regions (North, South, East, and West). All patients self-identified as Indian, and most (66 %) were male. Genotype 3 was the most common genotype overall (54 %); however, its prevalence varied greatly by region, ranging from 34 % in the South to 69 % in the East. Genotypes 1 (24 %) and 4 (6 %) were the next most common, and HCV genotype could not be determined for 16 % of patients. CONCLUSIONS: This prospective survey suggests that demographics, viral, and host factors in patients with chronic HCV infection are highly variable in India and pose significant challenges for the implementation of broad-scale screening and treatment initiatives.

Etiology, clinical profile, and inhospital mortality of acute-on-chronic liver failure: a prospective study.

BACKGROUND: The causes of acute injury in acute-on-chronic liver failure (ACLF) are variable. There may be simultaneous presence of more than one acute insult. We describe the clinical profile of ACLF and the effect of dual acute insult on the natural history. METHODS: Patients with jaundice diagnosed to have ACLF were prospectively enrolled. Patients were evaluated for the clinical presentation, etiology of acute decompensation and underlying chronic liver disease, and inhospital mortality. We compared the clinical profile of patients who had dual acute insult with those of single/unknown insult. RESULTS: Fifty-two patients with ACLF (mean age 38.6 ± 16.7 years; M/F 41:11) were included. Hepatitis virus infection (46.1 %) and bacterial infection (36.5 %) were the most common acute insults. Hepatitis virus infections were the sole acute insult in 34.6 % and associated with another injury in 11.5 %. Bacterial infections were identified as acute insult in 19 patients (sole acute insult in 13). Drugs, autoimmune disease, surgery, malaria, and dengue were other acute injuries identified. The cause of acute decompensation was unknown in 11.5 %. Mortality (66.6 % vs. 51.1 %) was higher in patients with dual insult (n=9) as compared with single/unknown insult (n=43). CONCLUSIONS: Hepatitis virus and bacterial infection/sepsis were the common acute insults in ACLF. Dual acute insult is not uncommon, poses diagnostic dilemma, and may increase mortality in these patients. Plasmodium falciparum infection and dengue fever may be associated with ACLF.

Phylogenetic analysis of hepatitis e virus in northwest India.

Genotyping and subtyping are important to understand epidemiology of the hepatitis E virus so as to improve control measures to prevent transmission of virus in the community. Hence, the aim of the current study was to identify the prevalent HEV genotypes in Rajasthan in acute sporadic hepatitis E cases with varying degree of liver failure. We studied hepatitis E virus (HEV) isolates from hospitalized patients in Rajasthan, western India. In a total of seventeen HEV sequences, six acute viral hepatitis, seven acute liver failure, and 4 acute- on-chronic cases were analyzed. Subtypes 1a and 1c of HEV are prevalent in Northwest India.

Contribution of hepatitis E virus in acute sporadic hepatitis in north western India.

BACKGROUND & OBJECTIVES: Hepatitis E virus (HEV) causes acute viral hepatitis. Majority of the documented studies on hepatitis E have been focused on the incidence of this disease in northern and south central India. Limited data are available on HEV infection among acute sporadic hepatitis cases in north western India. The present study was undertaken to investigate the contribution of hepatitis E virus infection in sporadic hepatitis cases in Rajasthan and neighbouring States. METHODS: Seven hundred and thirty six patients suspected to have viral hepatitis were screened for the hepatotropic viral markers, hepatitis A, B, C and E by using commercial enzyme immunoassay kits with a high sensitivity and specificity. The acute nature of HEV infection was also confirmed by the detection of HEV RNA by nested RT-PCR. RESULTS: Hepatitis E was found to be the major cause of acute sporadic viral hepatitis (49.7%) in this region of India. Mixed infections of HEV-HAV (1.2%), HEV-HBV (6.1%), and HEV-HCV (1.7%) were also detected. No viral marker was detected in 32 per cent cases. INTERPRETATION & CONCLUSION: HEV was found as the major aetiological agent of acute sporadic viral hepatitis in Rajasthan (north western India). It is important to screen primarily for all the common enterically and parenterally transmitted hepatotropic viral markers in acute sporadic viral hepatitis. There is a need to do additional serological and molecular tests to identify the aetiological agent in the cases of acute hepatitis.

Barium meal follow through with pneumocolon: screening test for chronic bowel pain.

AIM: To study the sensitivity, specificity and cost effectiveness of barium meal follow through with pneumocolon (BMFTP) used as a screening modality for patients with chronic abdominal pain of luminal origin in developing countries. METHODS: Fifty patients attending the Gastroenterology Unit, SMS Hospital, whose clinical evaluation revealed chronic abdominal pain of bowel origin were included in the study. After routine testing, BMFT, BMFTP, contrast enhanced computed tomography (CECT) of the abdomen, barium enema and colonoscopy were performed. The sensitivity, specificity and cost effectiveness of these imaging modalities in the detection of small and/or large bowel lesions were compared. RESULTS: Out of fifty patients, structural pathology was found in ten. Nine out of these ten patients had small bowel involvement while seven had colonic involvement alone or in combination with small bowel involvement. The sensitivity of BMFTP was 100% compared to 88.89% with BMFT when detecting small bowel involvement (BMFTP detected one additional patient with ileocecal involvement). The sensitivity and specificity of BMFTP for the detection of colonic pathology were 85.71% and 95.35% (41/43), respectively. Screening a patient with chronic abdominal pain (bowel origin) using a combination of BMFT and barium enema cost significantly more than BMFTP while their sensitivity was almost comparable. CONCLUSION: BMFTP should be included in the investigative workup of patients with chronic abdominal pain of luminal origin, where either multiple sites (small and large intestine) of involvement are suspected or the site is unclear on clinical grounds. BMFTP is an economical, quick and comfortable procedure which obviates the need for colonoscopy in the majority of patients.

Chronic pancreatitis. A prospective nationwide study of 1,086 subjects from India.

CONTEXT: Chronic pancreatitis is common in India. However, its risk factors are not clear. There is sparse data on the current prevalence of tropical pancreatitis in India. OBJECTIVE: To undertake a prospective nationwide study of the risk factors and clinical profile of chronic pancreatitis. SETTING: Thirty-two major centers from different regions of India contributed data on 1,086 patients to a common online website (www.ipans.org). MAIN OUTCOME MEASURES: Risk factors, clinical features complications and treatment of chronic pancreatitis. RESULTS: Of the 1,086 subjects, complete data on risk factors were available for 1,033 subjects. Idiopathic pancreatitis was the most common form of pancreatitis (n=622; 60.2%) and alcoholic chronic pancreatitis accounted for about a third of the cases (n=400; 38.7%); the rest (n=11; 1.1%) had rare risk factors. Smoking and cassava intake were documented in 292 (28.3%) and 189 (18.3%) subjects, respectively. Using well-defined criteria, only 39 (3.8%)cases could be labeled as 'tropical pancreatitis'. Pain occurred in 971 patients (94.0%). Four hundred and eighteen (40.5%) subjects had diabetes mellitus. Of alcohol consumers, alcoholism and female gender were independent risk factors for diabetes in subjects with chronic pancreatitis (OR=1.48, P=0.003; and OR=1.75, P<0.001, respectively). The most common complications were pseudocysts (15.8%) and biliary obstruction (8.2%). Pancreatic cancer occurred in 42 subjects (4.1%). Ultrasound detected calculi in 69.7%, ductal dilatation in 63.4% and atrophy in 27.3%. The majority of patients were on medical therapy (n=849; 82.2%); endotherapy and surgery accounted for the rest. About 50% percent of the patients with diabetes required insulin (198/418). CONCLUSIONS: In this first nationwide prospective survey of chronic pancreatitis in India, idiopathic pancreatitis was the most common form, followed by alcoholic pancreatitis. The classical form of tropical chronic pancreatitis is becoming less common.

Epidemiological and clinical profile of irritable bowel syndrome in India: report of the Indian Society of Gastroenterology Task Force.

AIMS: To study the profile of irritable bowel syndrome (IBS), and the frequency of such symptoms among the general population, in India. METHODS: In this prospective, multi-center study, data were obtained from 2785 patients with chronic lower gastrointestinal symptoms (complainants) with no alarm feature and negative investigations for organic causes visiting physicians at 30 centers, and from 4500 community subjects (non-complainants), using separate questionnaires. RESULTS: Most complainants were middle-aged (mean age 39.4 years) and male (1891; 68%). The common symptoms were: abdominal pain or discomfort (1958; 70%), abdominal fullness (1951; 70%); subjective feeling of constipation (1404 of 2656; 53%), or diarrhea (1252 of 2656, 47%), incomplete evacuation (2134; 77%), mucus with stools (1506; 54%), straining at stools (1271; 46%), epigastric pain (1364; 49%) and milk intolerance (906; 32%). Median stool frequency was similar in patients who felt they had constipation or those who felt they had diarrhea. Information to subtype symptoms using standard criteria was available in 1301 patients; of these, 507 (39%) had constipation-predominant IBS ( 3 3 stools/day) and 744 (57%) had indeterminate symptoms. Among non-complainants, most subjects reported daily defecation frequency of one (2520 [56%]) or two (1535 [34%]). Among non-complainants, 567 (12.6%) reported abdominal pain, 503 (11%) irregular bowel, 1030 (23%) incomplete evacuation, 167 (4%) mucus and 846 (18%) straining at stools; a combination of abdominal pain or discomfort relieved by defecation, and incomplete evacuation was present in 189/4500 (4.2%) community subjects. CONCLUSIONS: Most patients with IBS in India are middle-aged men, and have a sense of incomplete evacuation and mucus with stools. Abdominal pain or discomfort is frequent but not universal. Importantly, stool frequency was similar irrespective of whether the patients felt having constipation or diarrhea. Most (90%) non-complainant subjects had 1 or 2 stools per day; symptoms complex suggestive of IBS was present in 4.2% of community subjects.

Seroepidemiology and role of polymerase chain reaction to detect viremia in an epidemic of hepatitis E in Western India.

AIM: In an outbreak of hepatitis E affecting 859 individuals, we evaluated the titres of serological markers (IgM anti-HEV and IgG anti-HEV) and hepatitis E virus (HEV) RNA by reverse transcriptase polymerase chain reaction. METHODS: Serological markers for acute hepatitis were evaluated in 294 icteric patients (Group A) and 300 apparently healthy controls (Group B). HEV RNA was measured by RT nPCR in 19 patients in the first week of illness in patients with negative IgM anti-HEV. FINDINGS: None of the patients were positive for hepatitis A or B. In Group A, IgM anti-HEV was positive in 80.2%, 71.4% and 26.8% and IgG anti-HEV was positive in 58.3%, 77.1% and 86% of patients who were in their first, second and third weeks of illness, respectively. In Group A, amongst the 19 IgM anti-HEV negative patients in their first week of illness, 16 were positive for HEV RNA. In Group B 63.6% cases were positive for IgM anti-HEV. In the same village there had been a similar epidemic 4 years ago; none of the 93 patients traced from that time developed acute hepatitis during the present epidemic and all demonstrated the presence of IgG anti-HEV. This suggests that IgG anti-HEV was perhaps protective. CONCLUSION: During the first week of illness patients may display HEV viremia while testing negative for IgM and IgG anti-HEV. The presence of IgG anti-HEV may play a protective role against HEV infection and in the absence of IgM may help in diagnosing acute hepatitis E. Over 3 weeks of illness the IgM anti-HEV titres fall progressively whilst IgG anti-HEV titres gradually rise.

Acute pancreatitis in acute viral hepatitis.

AIM: To elucidate the frequency and characteristics of pancreatic involvement in the course of acute (nonfulminant) viral hepatitis. METHODS: We prospectively assessed the pancreatic involvement in patients with acute viral hepatitis who presented with severe abdomimanl pain. RESULTS: We studied 124 patients with acute viral hepatitis, of whom 24 presented with severe abdominal pain. Seven patients (5.65%) were diagnosed to have acute pancreatitis. All were young males. Five patients had pancreatitis in the first week and two in the fourth week after the onset of jaundice. The pancreatitis was mild and all had uneventful recovery from both pancreatitis and hepatitis on conservative treatment. The etiology of pancreatitis was hepatitis E virus in 4, hepatitis A virus in 2, and hepatitis B virus in 1 patient. One patient had biliary sludge along with HEV infection. The abdominal pain of remaining seventeen patients was attributed to stretching of Glisson's capsule. CONCLUSION: Acute pancreatitis occurs in 5.65% of patients with acute viral hepatitis, it is mild and recovers with conservative management.

Prevalence of occult hepatitis B & C in HIV patients infected through sexual transmission.

BACKGROUND: Prevalence of Hepatitis B virus (HBV) and Hepatitis C virus (HCV) markers including active and occult infection has not been described in diverse cohorts among HIV-infected patients in India. Earlier studies have explained the role of HBV/HCV co-infection in cohorts of injection drug users (IDUs) but the sexual co-transmission of HBV/ HCV is not completely understood. OBJECTIVE: The objective of this study was to assess the prevalence of occult HBV & HCV infection in HIV positive sexually acquired transmission risk group. MATERIALS AND METHODS: 58 sexually acquired HIV positive patients were taken up for the study of occult HBV/HCV co-infection. Data on demographics, sexual behaviour, sexually transmitted diseases (STD), medical history, laboratory tests viz., serum ALT and CD4 count were recorded. HBV serology included HBsAg, anti HBs, IgG anti HBc and HBV DNA (PCR). HCV serology included anti HCV & HCV RNA (RT-PCR). RESULTS: Occult HBV infection (HBV DNA) was observed in 12.2% (7/58 with HBsAg -ve and IgG anti HBc +ve subjects) while an overall prevalence of HBV DNA was 13.7% (12% occult & 1.7% in HBsAg+ve patients). Out of 58 HIV positive patients 29.3% demonstrated reactivity for any marker of past or current HBV infection. (HBsAg 1.7%, anti HBs 10.3% anti HBc IgG 17.2%). 4/58 (6.8%) revealed anti HCV positivity along with HCV RNA positivity by RT-PCR while 6/58 (10.3%) individuals revealed an occult HCV infection (anti HCV negative). The overall HCV RNA prevalence was 17.2%. 2 out of 58 (3.4%) individuals were positive for occult infection of both HBV DNA & HCV RNA (Triple infection HIV/HBV/ HCV). The HBV/HCV co-infected group (n = 18) showed a significantly high ALT (114.3 + 12.3 U/I) & low CD4 count (202.5 + 33.7 cells/mm3). The percent prevalence of HBV/ HCV co-infection was higher in the illiterate group, in men less than 30 years of age, and in those who were married and exhibited polygamous activity. CONCLUSIONS: The study demonstrated that in HIV infected patients testing only serological viral markers like HBsAg, antiHBcIgG & anti HCV, fails to identify the true prevalence of co-infection with HBV & HCV. Qualitative PCR for HBV DNA & HCV RNA detects co-infection in patients who are negative for serological markers. Also, in subjects who had only a sexual risk factor for parenterally transmitted infections, HIV may enhance the sexual transmission of HBV and HCV.

Safety and efficacy of an indigenous human recombinant interferon alpha 2b (Shanferon) in patients with chronic hepatitis B.

Interferon treatment is the established option for the treatment of patients with chronic hepatitis B without decompensated liver disease. However, such treatment is expensive. We report here our data of a multi-center, open-label trial of the use of an indigenously produced interferon in the treatment of chronic HBeAg-positive chronic hepatitis B. Adult patients with chronic HBeAg-positive hepatitis B with elevated serum transaminase activity and positive serum HBV DNA test were treated with 5 MU/day of an indigenously produced interferon (Shanferon; Shantha Biotechnics, Hyderabad, India) for 4 months, and were then followed up for 6 months. Of the 39 patients enrolled, 36 completed the treatment and 33 completed the post-treatment follow-up. Of the 33 patients who completed the study, end-of-treatment biochemical and virological responses were observed in 10 (30%) and 5 (15%) respectively. Sustained biochemical and virological responses were observed in 15 (45%) and 7 (21%), patients respectively. Adverse effects led to the discontinuation of treatment in only one patient. Our data suggest that safety and efficacy of the indigenously produced interferon were similar to those previously reported results with interferon from other sources.