A randomised double blind placebo controlled trial to assess the efficacy and tolerability of short course of ornidazole in diarrhoea predominant irritable bowel syndrome

Background: Irritable bowel syndrome is a common disorder affecting the general population. At present the treatment is mainly symptomatic as the pathophysiology is not clear. Abnormal flora especially small bowel bacterial over growth is considered as one of the causes. A short course of ornidazole is compared with placebo to assess its efficacy and tolerability in diarrhoea predominant irritable bowel syndrome.Methods: This was a randomised double-blind placebo controlled trial done in the Departments of Gastroenterology and Pharmacology at Government Medical College, Calicut. Patients were randomly assigned to two groups to receive either ornidazole or Placebo. The baseline symptoms were recorded and graded to get a global symptom score. Patients assigned to ornidazole group received 500mg twice daily orally for 5 days and the control group received identical looking placebo tablets. The patients were reassessed every week for four weeks. The patients subjective global assessment of relief and global symptom score was recorded. Statistical analysis was done using Wilcoxon signed Rank test and Mann Whitney U test.Results: This study was done in twenty patients with a mean age of 30 with comparable baseline characteristics and symptom scores (p=0.969). Ornidazole produced a highly significant reduction in the global symptom score (p<0.001) compared to placebo. It was maintained through the four weeks follow up. No serious adverse effects were reported. Two patients reported burning sensation in the stomach which was self limited.Conclusions: Ornidazole is efficacious than placebo in controlling the symptoms of diarrhoea predominant irritable bowel syndrome and is well tolerated.

Short-term visual performance of soft multifocal contact lenses for presbyopia / Desempenho visual de curto prazo de présbitas usando diferentes lentes de contato multifocais hidrofílicas

ABSTRACT Purpose: To compare visual acuity (VA), contrast sensitivity, stereopsis, and subjective visual performance of Acuvue® Oasys® for Presbyopia (AOP), Air Optix® Aqua Multifocal (AOMF), and Air Optix® Aqua Single Vision (AOSV) lenses in patients with presbyopia. Methods: A single-blinded crossover trial was conducted. Twenty patients with mild presbyopia (add ≤+1.25 D) and 22 with moderate/severe presbyopia (add ≥+1.50 D) who wore lenses bilaterally for 1 h, with a minimum overnight washout period between the use of each lens. Measurements included high- and low-contrast visual acuity (HCVA and LCVA, respectively) at a distance, contrast sensitivity (CS) at a distance, HCVA at intermediate (70 cm) and near (50 cm & 40 cm) distances, stereopsis, and subjective questionnaires regarding vision clarity, ghosting, overall vision satisfaction, and comfort. The test variables were compared among the lens types using repeated-measures ANOVA. Results: Distance variables (HCVA, LCVA, and CS) were significantly worse with multifocal lens than with AOSV lens (p≤0.008), except for AOMF lens in the mild presbyopia group in which no significant difference was observed (p>0.05). Multifocal lenses had significantly greater HCVA at 40 cm than AOSV lens (p≤0.026). AOMF lens had greater intermediate HCVA than AOP lens (p<0.03). AOP lens demonstrated greater improvements in stereopsis than AOMF and AOSV lens in the moderate/severe presbyopia group (p≤0.03). Few significant differences in subjective variables were observed, with no significant difference in the overall vision satisfaction observed between lens types (p>0.05). The proportions of patients willing to buy AOSV, AOMF, and AOP lenses were 20%, 40%, and 50%, respectively, in the mild presbyopia group and 14%, 32%, and 23%, respectively, in the moderate/severe presbyopia group; however, these differences were not statistically significant (p≥0.159). Conclusions: Further development of multifocal lenses is required before significant advantages of multifocal lenses over single vision lens are observed in patients with presbyopia.

RESUMO Objetivo: Comparar a acuidade visual, sensibilidade ao contraste, estereopsia e desempenho visual subjetivo de présbitas usando lentes de contato Acuvue Oasys para presbiopia (AOP), Air Optix Aqua Multifocal (AOMF) e Air Optix Aqua Single Vision (AOSV). Método: Foi realizado estudo mascarado simples, cruzado. Vinte pacientes com presbiopia baixa (adição ≤+1,25 D) e 22 com presbiopia média/alta (adição ≥+1,50 D) usaram cada lente bilateralmente durante 1 hora, com descanso mínimo de uma noite entre as diferentes lentes. As medições incluíram acuidade visual para distância em alto e baixo contraste (HCVA, LCVA), sensibilidade ao contraste para distância (CS), HCVA para distância intermediária (70 cm) e para perto (50 cm e 40 cm), estereopsia e questionários subjetivos sobre nitidez visual, fantasmas, satisfação visão geral e conforto. As variáveis foram comparadas entre os tipos de lentes, utilizando medidas repetidas ANOVA. Resultados: As variáveis para distância (HCVA, LCVA, CS) foram significativamente piores com as multifocais em relação a AOSV (p≤0,008), exceto para AOMF no grupo de baixa adição, que não foi significativamente diferente (p>0,05). As multifocais foram significativamente melhores do que a AOSV para HCVA em 40 cm (p≤0,026). AOMF superou AOP para HCVA intermediária (p<0,03). AOP superou AOMF e AOSV em relação à estereopsia no grupo de presbiopia médio/alto (p≤0,03). Houve poucas diferenças significativas nas variáveis subjetivas, mas a satisfação visual global não foi significativamente diferente entre as lentes (p>0,05). A disposição para comprar lentes AOSV, AOMF e AOP foi: 20%, 40%, 50%, respectivamente, no grupo de presbiopia baixa; 14%, 32%, 23% no grupo de presbiopia média/alto, mas essas diferenças não foram estatisticamente significativas (p≥0,159). Conclusões: Melhorias futuras parecem ser necessárias para produção de uma lente multifocal que forneça aos présbitas uma vantagem significativa sobre a lente de visão única.

Rate and risk of all cause mortality among people with known hypertension in a rural community of southern Kerala, India: the results from the prolife cohort

Hypertension is one of the most important determinants of death due to vascular damage and is fast emerging as a high burden disease in India. However, its documentation is poor in the country. This study aims to estimate the rate and the causal pattern of mortality in a cohort of people with high blood pressure as compared to normotensives. The study setting is Varkkala, a rural village in southern Kerala, India, and the study design was that of a prospective cohort. A total of 77,881 participants of age 20 years and above were considered for analysis. The rate and risk of all cause mortality [death due to any cause] among hypertensives were quantified and compared against the normotensives. The causes of death were also analyzedin both the groups. Cox proportional hazard models were created to estimate the hazard ratios of death among hypertensives adjusted for sociodemographic factors, behaviors, and comorbidities. The incidence proportion of deaths in the study was 4.28% during the follow-up period of 6 years. The relative risk of mortality was 3.13 [CI: 2.91-3.37] in the high BP group. The age-adjusted hazard ratio of all cause mortality for the high BP group was 2.96 [2.56-3.42]. Coronary artery disease was the major cause of death among the subjects with high BP. The study revealed high prevalence of hypertension in the study population. A person with hypertension is at three times higher risk of death due to any cause compared to a normotensive individual even after adjustment for age

A randomized double blind placebo controlled trial of probiotics in minimal hepatic encephalopathy.

Background and aim: Hepatic encephalopathy (HE) is a common and serious complication of liver disease. Minimal HE has major impact on all aspects of a patient’s life. The aim of this study was to asses the efficacy of probiotics in minimal hepatic encephalopathy in patients with cirrhosis of the liver. Methods: Stable cirrhotics with minimal hepatic encephalopathy diagnosed by number connection test and evoked responses were recruited for the study. The patients were randomized to two groups and the drugs were administered in a double blind fashion. Improvement in number connection test score, evoked response time and arterial ammonia levels were noted. Results: 43 patients were recruited for the study; 21 in the probiotics group and 22 in the placebo group. There was no statistically significant change in the parameters like arterial ammonia, evoked responses and number connection test before and after treatment with probiotics when compared to placebo. Conclusion: Short term administration of probiotics did not produce any significant improvement in the various parameters assessed in patients with minimal hepatic encephalopathy when compared with placebo.

Evaluation of leucocyte esterase reagent strip test for the rapid bedside diagnosis of spontaneous bacterial peritonitis.

Background Spontaneous bacterial peritonitis (SBP) is a common serious complication of cirrhosis, and carries a high morbidity and mortality. Rapid diagnosis and prompt treatment of this condition may improve survival of such patients. Objective To validate the diagnostic efficacy of a leukocyte esterase reagent (LER) strip test for rapid, bedside diagnosis of SBP. Methods We prospectively studied 175 patients with liver cirrhosis and ascites [mean age 48 (SD 16.4) years; 146 men] between August 2007 and December 2008. Alcohol was the most common (124 of 175; 70.8%) cause of liver cirrhosis. All patients underwent abdominal paracentesis, and the ascitic fluid was processed for cell count, LER strip (Magistik 10) test and culture. Two different cut-offs for calling the LER strip test positive were tried, namely when the color turned light blue [grade 2: >125 polymorphonuclear leucocytes (PMNL)/ μL] or it turned purple (grade 3: >500 PMNL/μL). Sensitivity, specificity, positive predictive value, negative predictive value were calculated, using PMN count by microscopy exceeding 250 PMNL/μL. Results LER strip using the more stringent purple-color cut off to diagnose SBP had a sensitivity of 92% and specificity of 100%. The corresponding figures using the light-blue color cut-off were 97% and 89%, respectively. Conclusions LER strip testing of ascitic fluid is a rapid, cheap and sensitive bed side tool for the diagnosis of SBP.

Natural history of bleeding after esophageal variceal eradication in patients with extrahepatic portal venous obstruction; a 20-year follow-up.

Background Long-term follow-up studies of patients with extrahepatic portal venous obstruction (EHPVO) after eradication of esophageal varices using endoscopic sclerotherapy (EST) are limited. Methods Between 1985 and 1994, 223 patients with bleeding esophageal varices due to EHPVO underwent variceal eradication using EST. Regular annual clinical and endoscopic follow-up data were available for 198 of these patients for a mean period of 19.8 (range: 14–23) years. These data were analyzed retrospectively. Results Of the 198 patients, 34 (17.2%) had rebleeding after variceal eradication. The mean duration from variceal eradication to recurrence of bleeding was 5.4 years. The causes of rebleeding were: recurrent esophageal varices in 21 patients, fundal varices in eight, portal gastropathy in three, and ectopic varices in two patients. Esophageal varices reappeared in 39 (19.7%) patients. Fundal varices appeared in 19 (9.5%) patients during follow-up. Conclusions EST is an effective treatment modality for bleeding esophageal varices due to EHPVO. During a follow- up of nearly 20 years after variceal eradication, only about one-sixth of the patients had recurrence of gastrointestinal bleeding. Bleeding was unusual after 10 years had passed since initial variceal eradication.

Isolated rectal tuberculosis in an AIDS patient masquerading as malignancy.

Tuberculosis may involve any region of the gastrointestinal tract but involvement of the rectum is rare. The literature concerning rectal tuberculosis in AIDS patients is limited. We report the case of rectal tuberculosis mimicking malignancy, both clinically and endoscopically, in an AIDS patient. Histopathology confirmed the diagnosis. Treatment was initiated with antituberculous drugs and highly active antiretroviral therapy (HAART). The patient developed drug-induced hepatitis, his general condition deteriorated and he finally succumbed to his illness.

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 <or= stools/week), 50 (4%) had diarrhea-predominant IBS (>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.

Randomized controlled trial of DOTS versus conventional regime for treatment of ileocecal and colonic tuberculosis.

There is limited information regarding the efficacy of 'directly observed treatment short course' (DOTS) in the treatment of intestinal tuberculosis. We randomized patients with ileocecal or colonic tuberculosis to receive daily tuberculosis chemotherapy (Group A) or DOTS (Group B). Patients received isoniazid, rifampicin, pyrazinamide and ethambutol daily for two months in group A and thrice weekly for 2 months in group B, followed by isoniazid and rifampicin daily for 7 months in group A and thrice weekly for 4 months in group B. Patients were followed up at 2 and 4 weeks and monthly thereafter until the end of treatment. Follow up colonoscopy was done at 2 and 6 months after starting treatment. The improvement in clinical symptoms was not different between Groups A (24) and B (23) at 2 and 6 months. Mean increase in weight was 5.1 (0.5) Kg and 5.7 (0.6) Kg at 2 months and 7.1 (1.7) Kg and 6.9 (1.9) Kg at 6 months in Group A and B, respectively. Complete healing of ulceration was noted in 75% of Group A patients and 79% of Group B patients at 2 months and in all patients in both groups at 6 months. We conclude that DOTS and daily chemotherapy are equally effective for treating ileocecal and colonic tuberculosis.

Non-familial juvenile polyposis in prolapsed rectum.

Juvenile polyposis located solely on prolapsed rectal mucosa is very unusual. We report the case of a 17-year old boy who presented to us with a history of passage of blood and mucus per rectum of a mass protruding through the anus during defecation. Per rectal and colonoscopic examinations revealed numerous polyps located solely on the prolapsed rectal mucosa. Histopathology was consistent with juvenile polyposis. He was managed with repeated sessions of endoscopic polypectomy. Family screening was negative for colonic polyps.

External resection of a giant sigmoid lipoma causing colonic intussusception and prolapse through the anal canal.

We depict the case of an 80-year-old female patient who presented to us with a history of protruding mass per anum. Sigmoidoscopy revealed a large globular pedunculated polyp at 22 cm from the anal verge resulting in a sigmoidorectal intussusception. Endoscopic polypectomy was not technically possible due to the large size of the polyp. At the time of prolapse the polyp was tied at its pedicle with thread and resected surgically. The patient is asymptomatic on follow-up.

Time trends and pathological profile of carcinoma lower oesophagus and gastro-oesophageal junction over the last 20 years--an experience from South India.

There is an upward trend in the incidence of adenocarcinoma lower oesophagus in western countries. However there is only limited comparable data from Asian countries. We conducted a retrospective analysis of our data compiled over a twenty-year period (1985-2004). All lesions diagnosed as either squamous cell carcinoma or adenocarcinoma involving the oesophagus with or without involvement of the gastro-oesophageal junction were included in the study. 476 cases with biopsy proven malignancy (either adeno or squamous) of lower oesophagus were studied. The pattern of change in frequency and histology over twenty years was analysed using the chi square test for trend. There was a consistent increase in the frequency of cancer involving the gastro-oesophageal junction though it did not reach statistical significance (p = 0.15). Out of 476 lower oesophageal cancers, 249 were adeno-carcinomas and 227 were squamous cell carcinomas. Adenocarcinoma involving the gastro-oesophageal junction showed consistent increase even though the p value was not significant (p = 0.09) and this therefore requires further longitudinal studies. There was no change in trend for pattern and frequency of squamous cell carcinoma oesophagus involving different sub-sites during the study period.

Profile of colonic polyps in a southern Indian population.

BACKGROUND: In Western countries, colonic polyps are usually adenomatous in nature, are evenly distributed along the entire colon in asymptomatic per-sons and show a left-sided predominance in symptomatic patients. There is dearth of such literature from India. METHODS: We retrospectively analyzed reports of colonoscopies done in our institution during the period 2001 to 2005. Clinical features, colonoscopic description and histologic findings of all patients with polyps were noted. Association of the degree of dysplasia with the size, site and type of polyps and the person's age was assessed. RESULTS: Polyps were seen in 124 (5.1%) of 2412 complete colonoscopies. Mean age of patients with polyps was 58.1 (SD 19.9) years; ninety were men. A majority of polyps (92%) were located in the left colon. They were adenomatous in 99 (79.8%), juvenile in 12 (9.8%), hyperplastic in 11 (8.8 %), inflammatory in 1 (0.8%) and Peutz-Jegher's polyp in 1 (0.8%). Dysplasia was severe in large (>2 cm) polyps compared to small (< 1 cm) ones (p< 0.001). Age of patient and location of polyp had no association with degree of dysplasia. CONCLUSIONS: In southern Indian adults, most colonic polyps are adenomatous and are in the left colon. Large polyps are associated with severe dysplasia.

Endoscopic abnormalities in the oesophagus after variceal sclerotherapy--a long-term follow up study.

Endoscopic sclerotherapy is a well-established treatment modality for oesophageal varices. Various local, regional and systemic complications occur after sclerotherapy. Altered endoscopic appearances of the oesophagus have been observed on follow-up of patients after sclerotherapy. 171 consecutive patients with extra-hepatic portal venous obstruction on follow up after achieving variceal eradication by sclerotherapy during the period from January 2004 to June 2005 were enrolled in this study. The oesophagus was closely observed for mucosal abnormalities and the endoscopic findings were recorded. Out of 171 patients, 95 (55.5%) patients had no specific endoscopic changes in the oesophagus. The most common finding was mucosal neovascularization which was seen in 56 (32.7%) patients. Oval or oblong depressed areas were seen in 41 (23.9%) patients. Mucosal tags and polypoidal lesions were seen in 37 (21.6%) patients. 25 (15.6%) patients had stenosis of the lower oesophagus and 3 (1.7%) patients had mucosal bridges. On multivariate analysis, these abnormal endoscopic findings in the oesophagus correlated with the total volume of sclerosant injected when compared with those patients without similar findings on endoscopy (p value < 0.001). Endoscopic sclerotherapy leads to various abnormalities at the injection sites like neovascularization, oval or oblong depressed areas, mucosal tags, polypoidal lesions, stenosis and mucosal bridges. Endoscopic abnormalities correlated with the total volume of sclerosant used. The long-term significance of these changes is not known at present and further follow-up studies will be required.