Quality of life in Indian patients with functional dyspepsia: Translation and validation of the Hindi version of Short-Form Nepean Dyspepsia Index.

BACKGROUND/PURPOSE: Patients with functional dyspepsia (FD) have poor health-related quality of life (HRQOL), but Indian data are  lacking. Also, there is non-availability of validated disease-specific questionnaire to assess HRQOL in Hindi-speaking patients with dyspepsia. We aimed to develop and validate a reliable translation of Short-Form Nepean Dyspepsia Index (SF-NDI) in Hindi, and assess the impact of FD on HRQOL in Indian patients. METHODS: Cross-cultural adaptation of English version of SF-NDI, translation to Hindi, and adaptation of Hindi version were performed using standard procedures. English and Hindi versions were assessed against Short Form-36 (SF-36), examining for internal consistency, test-retest reliability, and validity. RESULTS: Total 211 FD patients (144 Hindi speaking, 67 English speaking) were enrolled (mean age 40.8 ± 11.7 years; male:female = 115:96). Median total SF-NDI scores for both languages were 38.75 and 40.0, respectively. Test-retest reliability intraclass correlation coefficients were 0.85 (Hindi) and 0.89 (English). Internal consistency evaluation revealed Cronbach's α coefficient of 0.79-0.86 (Hindi) and 0.78-0.89 (English). SF-NDI sub-scales showed moderate to good correlation with various domains of SF-36 (content validity). There was significant (p < 0.001) decline of HRQOL in patients with severe dyspepsia relative to those with mild dyspepsia (construct validity). On multivariate analysis, factors independently associated with HRQOL were duration of symptoms and dyspepsia severity. CONCLUSION: Both English and Hindi versions of SF-NDI are reliable and valid for HRQOL assessment in Indian FD patients, and will be useful in future epidemiological and clinical studies. Indian FD patients have poor HRQOL, being worse in those with severe dyspepsia and longer duration of symptoms.

Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet versus traditional dietary advice for functional dyspepsia: a randomized controlled trial.

BACKGROUND AND AIM: Prospective trials evaluating efficacy of specific diet restriction in functional dyspepsia (FD) are scarce. We aimed to assess efficacy of low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet in FD, compared with traditional dietary advice (TDA). METHODS: In this prospective, single-blind trial, patients with FD (Rome IV) were randomized into low FODMAP diet (LFD) and TDA groups, for 4 weeks (phase I). In phase II (4-12 weeks), LFD group was advised systematic re-introduction of FODMAPs. Symptom severity and quality of life were assessed using "Short-Form Nepean Dyspepsia Index (SF-NDI)." Primary outcome was symptomatic response (symptom score reduction of ≥ 50%), at 4 weeks. Study was registered with CTRI (2019/06/019852). RESULTS: Of 184 patients screened, 105 were randomized to LFD (n = 54) and TDA (n = 51) groups. At 4 weeks, both groups showed significant reduction in SF-NDI symptom scores compared with baseline, with no significant difference in inter-group response rates [LFD: 66.7% (36/54); TDA: 56.9% (29/51); P = 0.32]. On sub-group analysis, patients with postprandial distress syndrome or bloating had significantly better symptomatic response with LFD (P = 0.04). SF-NDI quality of life scores improved significantly in both groups. On multivariate analysis, factors predicting response to LFD were bloating and male gender. Incidences of adverse events (minor) were similar in both groups. CONCLUSIONS: In patients with FD, LFD and TDA lead to significant symptomatic and quality of life improvement. Patients with postprandial distress syndrome or bloating respond significantly better to LFD. Therefore, dietary advice for FD should be individualized according to FD subtype.

Low fermentable oligosaccharide, disaccharide, monosaccharide, and polyol diet in patients with diarrhea-predominant irritable bowel syndrome: A prospective, randomized trial.

BACKGROUND AND AIM: Low fermentable oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) diet improves irritable bowel syndrome (IBS) symptoms. Data on long-term "modified" FODMAP diet are emerging. We aimed to assess efficacy and acceptability of short-term "strict" low FODMAP diet (LFD) and long-term "modified" FODMAP diet in patients with diarrhea-predominant IBS (IBS-D). METHODS: This prospective randomized trial included patients with IBS-D (Rome IV) and IBS severity scoring system (IBS-SSS) ≥ 175. In phase I (4 weeks), patients were randomized to strict LFD and traditional dietary advice (TDA) groups. From 4 to 16 weeks, LFD group was advised systematic reintroduction of FODMAPs ("modified" FODMAP diet). Response was defined as > 50-point reduction in IBS-SSS. RESULTS: Of the total 166 patients with IBS-D screened, 101 (mean age 41.9 ± 17.1 years, 58% male) were randomized to LFD (n = 52) and TDA (n = 49) groups. Both at 4 and 16 weeks, total IBS-SSS and IBS quality of life score reduced significantly in both groups, but there was significantly greater reduction in LFD group. By intention-to-treat analysis, responders in LFD group were significantly higher than TDA group (4 weeks-62.7% [32/51] vs 40.8% [20/49], respectively, P = 0.0448; 16 weeks-52.9% [27/51] vs 30.6% [15/49], respectively; P = 0.0274). Compliance to LFD was 93% at 4 weeks and 64% at 16 weeks. Energy, carbohydrate, fat, and fiber intake showed reduction in LFD group at 4 weeks, which improved till 16 weeks. CONCLUSIONS: Strict LFD for short-term and "modified" LFD for long term in IBS-D patients is acceptable and leads to significant improvement in symptoms and quality of life.

Prevalence, overlap, and risk factors for Rome IV functional gastrointestinal disorders among college students in northern India.

BACKGROUND/PURPOSE: There is scarcity of data on prevalence, overlap, and risk factors for functional gastrointestinal disorders (FGID) by Rome IV criteria. We evaluated these factors among medical, nursing, and humanities students. METHODS: Rome IV Diagnostic Questionnaire (for all FGIDs), Rome III questionnaire (for irritable bowel syndrome [IBS], functional diarrhea [FDr], and functional constipation [FC]), and questionnaires assessing demography, physical activity, anxiety, and depression were used. RESULTS: A total of 1309 college students were included (medical 425, nursing 390, humanities 494; mean age 20.5 ± 2.1 years; 36.5% males). Prevalence of Rome IV FGIDs was 26.9% (n = 352), significantly higher among females compared with males (32.3% vs. 17.6%; p < 0.001) and significantly higher among medical (34.4%) and nursing students (29.2%) compared with humanities students (18.6%) (p < 0.05). Most common FGIDs were functional dyspepsia (FD) (15.2%), IBS (6.2%), reflux hypersensitivity (3.5%), FDr (2.9%), FC (2.1%), and unspecified functional bowel disorder (2.1%). FGID overlap was present in 9.3%, most common being FD-IBS overlap (4.4%). With Rome III criteria, prevalence of IBS was higher (9.5%), while that of FDr (0.92%) and of FC (1.3%) were lower. On multivariate analysis, independent predictors for FGIDs were female gender, medical student, non-vegetarian diet, junk food, tea/coffee, poor physical activity, anxiety, and insomnia. CONCLUSION: Rome IV FGIDs were present among one-fourth of college students with preponderance among females and medical students. FD, IBS, and reflux hypersensitivity were the most common FGIDs. Rome IV criteria led to a reduction in IBS prevalence and increase in FDr and FC prevalence. Dietary factors, physical activity, anxiety, and insomnia affected FGID prevalence.

Saroglitazar in patients with non-alcoholic fatty liver disease and diabetic dyslipidemia: a prospective, observational, real world study.

Saroglitazar, a dual peroxisome proliferator activated receptor α/γ agonist, approved for diabetic dyslipidemia (DD), is potential therapeutic option for non-alcoholic fatty liver disease (NAFLD). This prospective, observational, real-world study aimed to determine efficacy and safety of Saroglitazar in patients with NAFLD and DD. We included patients with DD and NAFLD who received Saroglitazar 4 mg once daily for 24 weeks. Blood investigations, liver stiffness measurement (LSM) and controlled attenuation parameter (CAP) (FibroScan) were compared at baseline and 24 weeks. Of 163 patients screened, 107 were included, and 101 completed 24 weeks treatment (mean age 50.4 ± 12.3 years, 78.5% males, mean body mass index 28.8 ± 4.2). After 24 weeks, alanine transaminase (ALT) reduced significantly from 94 (47-122) to 39 (31-49) (p < 0.0001) and aspartate aminotransferase (AST) (U/L) from 89 (43-114) to 37 (30-47) (p < 0.0001) and LSM (kPa) from 8.4 (7.1-9.3) to 7.5 (6.4-8.4) (p = 0.0261). CAP, glycated hemoglobin and lipid parameters also improved significantly. On linear regression, there was significant association between percent change in ALT and AST with TG reduction after treatment (p = 0.024 and 0.037 respectively).We conclude that Saroglitazar leads to significant improvement in transaminases, LSM, and CAP in NAFLD patients with DD.

Emphysematous Gastritis with Air in Portal Venous System.

Emphysematous gastritis is a rare but severe form of phlegmonous gastritis caused by gastric mucosal disruption and infection of stomach wall by gas-forming bacteria. Ingestion of corrosive substances is the most common predisposing factor, followed by alcohol abuse, abdominal surgery, diabetes and immunosuppression. Patients usually present with abdominal pain, vomiting, diarrhea, constipation and/or gastro-intestinal hemorrhage. Characteristic radiological findings include presence of gas in the gastric wall. Management of this condition includes broad-spectrum antibiotics and supportive therapy. Outcome of emphysematous gastritis is frequently fatal due to septic shock and multi-organ failure. We report a case of a 65 years old male who presented with fever and upper abdominal tenderness. He had history of uncontrolled diabetes and chronic alcohol intake. Radiological investigations revealed air within the gastric wall, portal vein, liver and spleen. Despite initial improvement with conservative management, patient succumbed due to sepsis and shock.

Skin and soft tissue infections in cirrhotics: a prospective analysis of clinical presentation and factors affecting outcome.

Skin and soft tissue infections (SSTI) are an important cause of morbidity and mortality in patients with cirrhosis. This prospective study aimed to analyze the clinical profile and factors affecting outcome of SSTIs in cirrhotics. All cirrhotics hospitalized between September 2007 and August 2010 were included. Frequency, site, extent, and type of SSTI were noted. Of 1,395 cirrhotics, 19.4 % (n = 271) had bacterial infections, out of which 32.8 % (89/271) had SSTI. Alcohol was the predominant etiological factor for cirrhosis; 95.2 % belonged to Child class B/C, and 67 % gave history of barefoot walking. The most common site of SSTI was the lower limbs (87.1 %), cellulitis was the most common type (61.2 %), and gram-negative bacilli (GNB) is the most common organism (86.7 %). Mortality rate was 23.5 %. Serum creatinine and model for end-stage liver disease (MELD) score were independent predictors of mortality. SSTIs in cirrhotics were common and mostly involved the lower limbs. Cellulitis was the most common type, and GNB was the most common organism. Serum creatinine and MELD score were independent predictors of mortality.

Profile of hepatocellular carcinoma in a tertiary care hospital in Punjab in northern India.

PURPOSE/AIM: Hepatocellular carcinoma (HCC) is a major cause of morbidity and mortality in all parts of the world. We analyzed the clinical presentation, etiology, and tumor characteristics of HCC presenting to our hospital. METHODS: All patients diagnosed to have HCC from September 2007 to August 2010 were prospectively enrolled. HCC was diagnosed according to EASL criteria-USG/CT/MRI of the abdomen and/or serum alpha-fetoprotein and/or histology (where indicated). Detailed clinical and laboratory parameters were noted. Barcelona Clinic Liver Cancer (BCLC) staging was done. RESULTS: One hundred and twenty-eight patients (22 females, mean ± SD; age, 49.8 ± 10.2 years) were diagnosed to have HCC. Underlying cirrhosis was present in 99.2 %. Hepatitis C virus infection, alone (21.9 %) or with alcohol (22.9 %) was the most common etiological factor, followed by alcohol alone; 33.6 % of the patients had more than one etiological factor. Most patients (83.5 %) presented with features of decompensated cirrhosis. HCC leading to decompensation of cirrhosis was the first presentation of the liver disease in nearly one third of the cases. Serum alpha-fetoprotein was >200 ng/mL in 67.2 % of the patients, while it was normal in 18.7 % of the patients. The mean ± SD size of HCC was 5.3 ± 2.9 cm. HCC was multicentric in 57 %, and portal vein thrombosis was present in 34.4 %. About 66 % of the patients belonged to BCLC stage C or D. CONCLUSIONS: Hepatitis C virus infection was the most common cause of HCC in Punjab. One-third of the patients had multiple etiological factors and almost all had underlying cirrhosis and presented at advanced stage.

Embolotherapy in massive post sphincterotomy bleed.

A 38-year-old female with obstructive jaundice underwent therapeutic ERCP. Minor self limiting bleed was observed from the ampulla during the procedure. Later she had massive bleed for which endoscopic therapy was not possible due to obscured vision of the ampulla. So immediate angiographic embolisation of the bleeding vessel using the available coronary hardware was performed and bleed was controlled. Embolotherapy is an attractive and safe therapeutic option for control of massive post-sphincterotomy bleed.

Liver function tests in patients with dengue viral infection.

To assess the frequency and degree of hepatic dysfunction in patients with dengue infection, records of214 serologically confirmed cases of dengue infection with available biochemical liver tests, admittedto our tertiary-care institute, were analysed. Patients were classified as classical dengue fever (DF) –81.3%, dengue haemorrhagic fever (DHF) – 13.6% and dengue shock syndrome (DSS) – 5.1%. Themean age was 31.6 years (male:female = 3.3:1). Deranged total bilirubin, aspartate aminotransferase(AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), albumin and prothrombin timeindex (PTI) [international normalized ratio (INR)] was present in 19.5% (29/143), 97.7% (209/214),93.9% (199/214), 32.6% (47/144), 29.1% (44/151) and 15.5% (22/156) patients respectively. Themean (± SE) total bilirubin, AST, ALT, ALP, albumin and INR values were 0.93 ± 0.09 mg/dl, 353.7 ±49.6 U/L, 218.6 ± 27.2 U/L, 135.2 ± 6.5 U/L, 3.2 ± 0.04 g/dl and 1.2 ± 0.03 respectively. The meanvalue of AST was significantly higher than ALT. The degree of rise of AST and ALP was significantly morein DHF and DSS, as compared to DF; but the frequency of rise was similar in all groups. Mean serumbilirubin, ALT and ALP values were significantly higher in patients with haemorrhage as compared tothose without haemorrhage, in patients with secondary dengue infection as compared to primary infection, and in non-survivors. Hepatic dysfunction was very common in all forms of dengue infection,with AST rising significantly more than ALT. Serum bilirubin, ALT and ALP were significantly higher inpatients with DSS, haemorrhage, sequential infection and non-survivors. While preferentially high AST may serve as an early indicator of dengue infection, high bilirubin, ALT and ALP may act as poorprognostic markers.