Results of a single blind, randomized, placebo-controlled clinical trial to study the effect of intravenous L-carnitine supplementation on health-related quality of life in Indian patients on maintenance hemodialysis.

BACKGROUND: Carnitine insufficiency is responsible for various co-morbid conditions in maintenance hemodialysis (MHD) patients. L-carnitine supplementation is expected to improve the quality of life (QoL) of patients on MHD. AIMS: To study the effect of L-carnitine supplementation on QoL of Indian patients on MHD. SETTING AND DESIGN: This was a single (patient) blind, randomized, placebo-controlled clinical trial conducted on patients on MHD attending hemodialysis unit of the study center. MATERIALS AND METHODS: Twenty patients on MHD suffering from hemodialysis-related symptoms were randomly assigned to receive intravenous L-carnitine 20 mg/kg or placebo after every dialysis session for 8 weeks. SF36 (Short Form with 36 questions) score for QoL, laboratory investigations and dialysis related symptoms were recorded at baseline and after 8 weeks. Improvement in QoL, laboratory parameters and dialysis related symptoms in the two groups after 8 weeks was compared. STATISTICAL ANALYSIS USED: Depending on normality of data, unpaired T test or Mann Whitney U test was used for comparison of change (8 weeks-baseline) in SF36 scores and laboratory parameters observed in the two groups. RESULTS: L-carnitine supplementation increased total SF36 score by 18.29 +/- 12.71 (95% CI: 10.41 to 26) while placebo resulted in reduction in total SF36 score by 6.4 +/- 16.39 (95% CI: -16.59 to 3.73). L-carnitine also resulted in significant increase in hemoglobin and serum albumin and decrease in serum creatinine as compared to placebo. More patients were relieved of dialysis related symptoms in L-carnitine group. CONCLUSION: Intravenous L-carnitine supplementation improves QoL in patients on MHD.

Prevalence of short segments of specialized columnar epithelium in distal esophagus: association with gastroesophageal reflux.

BACKGROUND AND AIMS: Recent studies have reported high prevalence rates of short segments of specialized columnar epithelium (SCE) in the distal esophagus. The association of SCE with gastroesophageal reflux disease is not well established. We studied the prevalence and associations of short segments of SCE in the distal esophagus amongst Indians. METHODS: 271 patients (mean age 36 [14] y; 160 men) undergoing diagnostic upper gastrointestinal endoscopy were interviewed regarding symptoms of gastroesophageal reflux, and history of medications, smoking or chewing tobacco and alcohol ingestion. At endoscopy, presence and grade of esophagitis and hiatus hernia were recorded. One biopsy each was taken from the squamocolumnar junction and 2 cm proximal to it. Biopsies were stained with hematoxylin/eosin and alcian blue/periodic acid-Schiff. The pathologist was blinded to the clinical and endoscopic data. RESULTS: Short segments of SCE in the distal esophagus were present in 16/271 (6%; CI 5.03-6.97) patients. Increasing age (p<0.01), and endoscopic (p<0.01) and histologic (p<0.001) esophagitis were associated with its presence, whereas symptoms of gastroesophageal reflux, smoking, tobacco chewing, use of alcohol or non-steroidal anti-inflammatory drugs, and hiatus hernia were not. One patient with SCE had dysplasia. CONCLUSION: Prevalence of short segments of SCE in the distal esophagus amongst Indians is low and is usually associated with inflammation in the esophagus.

High frequency of bacteremia with endoscopic treatment of esophageal varices in advanced cirrhosis.

OBJECTIVES: The fregency of bacteremia after endoscopic variceal band ligation (EVL) is reported to be lower when compared to that after endoscopic variceal sclerotherapy (EVS). However, there are conflicting reports on the infectious sequelae after EVL. AIM: To compare the frequency on bacteremia and infectious sequelae after EVL and EVS in patients with cirrhosis of liver. METHODS: Bacteremia and infectious sequelae were studied in 32 sessions of EVL in 18 cirrhotic patients (Child-Pugh class A-6, B-5, C-7), 30 sessions of EVS in 22 cirrhotic patients (Child-Pugh class A-2, B-5, C-15) and 14 diagnostic upper gastrointestinal endoscopies. Blood cultures were collected before, during and 30 minutes after the procedure. Patients were observed for infectious sequelae during subsequent hospitalization. RESULTS: Before the procedure, bacteremia was present in 7/62 (11%) sessions. Significant bacteremia during and 30 min post-procedure developed in 8/32 (25%) and 12/30 (40%) of EVL and EVS sessions, respectively (p = ns), and in 1/14 (7%) upper gastrointestinal endoscopy sessions. There was more frequent bacteremia with severe liver disease (Child-Pugh class A-0/6, B-1/5. C-7/21; p = 0.09) in the EVL but not in the EVS group (Child-Pugh class A-1/3, B-2/5, C-9/22; p = ns). The incidence was higher with emergency sclerotherapy compared to elective sclerotherapy (6/8 [75%] vs 6/22 [27%]; p <0.01). One patient in the EVS group developed spontaneous bacterial peritonitis. CONCLUSIONS: Bacteremia occurs frequently following EVL and EVS in patients with advanced liver diseases. In the EVS group it is more common after emergency sclerotherapy. This bacteremia is rarely associated with significant infectious sequelae.

Prospective evaluation of medication-induced esophageal injury and its relation to esophageal function.

BACKGROUND: Few prospective studies are available on the incidence of medication-induced esophageal injury (MIEI). AIMS: To prospectively study the occurrence of MIEI with indomethacin and doxycycline and the predictive factors for its development. METHODS: In an operator-blinded study, 51 patients (age 16-65 y) requiring indomethacin (n = 24) or doxycycline (27) underwent symptom evaluation, endoscopy and scintigraphy before and after 7 days of therapy. MIEI was defined as de novo occurrence or worsening of pre-existing esophagitis or development of esophageal ulcer. RESULTS: Pre-therapy endoscopy was normal in 32 patients and revealed esophagitis in 19 (grade I--11, grade II--8). Post-therapy, 16 patients developed esophageal symptoms, which appeared earlier with doxycycline (2.0 [0.8] vs 4.1 [1.7] days, p = 0.016). MIEI developed in 23 patients--de novo esophagitis in 16, worsening of esophagitis in 6; 5 patients developed ulcer. Seven of 12 patients with hiatus hernia developed MIEI. Presence of pre-therapy gastroesophageal reflux disease did not predict MIEI. There was no difference in pre- or post-therapy transit values between patients with and without MIEI; patients who developed ulcers had significantly slower esophageal transit (p < 0.05). There was no difference in esophageal transit or occurrence of MIEI between patients who received indomethacin or doxycycline; however, 5 of 8 patients with hiatus hernia who received doxycycline developed MIEI (p = 0.02; relative risk 3.96 [CI 1.2-12.7]). CONCLUSIONS: 40% of patients receiving doxycycline or indomethacin developed MIEI; 10% developed ulcers. Hiatus hernia increased the risk for MIEI.

Long-term anti-inflammatory drug use and Helicobacter pylori infection: a clinical, endoscopic and histological study.

BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs) and Helicobacter pylori are independent risk factors for gastroduodenal damage and peptic ulcer. OBJECTIVE: To study the frequency and effect of H pylori infection on gastroduodenal mucosa in patients on long-term NSAID use. METHODS: A total of 125 subjects were studied: 65 patients (Group 1) on NSAID therapy (> 6 months), 30 patients (Group 2) with arthritic disorders prior to starting NSAID therapy, and 30 healthy volunteers (Group 3). Dyspeptic symptoms were evaluated using a questionnaire. All patients underwent endoscopy and antral and duodenal biopsies were obtained to assess the extent of gastroduodenal damage and H pylori status. RESULTS: H pylori infection was less frequent in Group 1 (37%) compared to Group 2 (57%, p = ns) and 3 (60%, p < 0.05). Among Group 1 patients, H pylori infection did not increase the risk of gastroduodenal damage (52% vs 45%) or ulceration (32% vs 27%). Group 1 patients with H pylori infection were more likely to be symptomatic (48% vs 27%) and have chronic active gastritis (76% vs 12%) and chronic active duodenitis (68% vs 5%). Gastric metaplasia was seen only in patients with H pylori infection, chronic active gastritis and duodenitis. Chemical gastritis was observed more commonly in Group 1 (34% vs 3%) compared to Group 2; its was not seen in Group 3. H pylori infection was less commonly observed in patients with chemical gastritis (8% vs 50%). CONCLUSION: Patients on long-term NSAIDs are not at increased risk of H pylori infection. Presence H pylori infection is not associated with increased risk of gastroduodenal damage in these patients. H pylori infection correlated with presence of chronic active gastritis, and NSAID with presence of chemical gastritis.

Percutaneous renal biopsy using Monopty needle.

Forty six percutaneous renal biopsies (thirty one native and fifteen transplant kidneys) were performed using the Monopty needle, compared with equal number of biopsies performed using the Travenol Tru-cut needle. The core length of samples obtained ranged from 3-16 mm using Monopty and 5-13 mm using Tru-cut. Adequate tissue was obtained in 65.5% and 80.4% of cases with the use of Monopty and Tru-cut respectively. Both the needles gave equal number of reuses. The use of Tru-cut needle was associated with serious complications like gross haematuria requiring blood transfusions and perinephric haematoma in ten cases whereas only two cases developed haematuria when the Monopty needle was used. In view of its greater safety we have switched over to using the Monopty needle for percutaneous renal bipsies.