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Inflammatory bowel disease (IBD) is now recognised as a global disease, with incidence rapidly increasing in newly industrialised countries in South America, Asia, and Africa. Trials in IBD, therefore, should adequately represent diverse groups with respect to gender, age, place of residence, race, and ethnicity to ensure the global applicability and generalisability of their findings. In this systematic review, we searched PubMed and Embase for randomised controlled trials (RCTs) published in English from Jan 1, 1995, to Jan 13, 2023, evaluating the efficacy of any pharmacological intervention in patients with IBD. Of 7543 records yielded in the search, we included 617 records reporting data from 627 RCTs and 108 986 participants. The results show a paucity of adequate representation of diverse groups in these RCTs. This finding was true for various groups, including racially and ethnically diverse populations, older (aged >65 years) and younger (aged <18 years) populations, those who identify outside of the gender binary, and people from South America and Africa. Also, some regions had an apparent scarcity of funding sources for trials. Pharmaceutical companies and clinical trial organisations should aim to ensure adequate representation of such under-represented groups in future IBD trials.

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BACKGROUND: The role of ascitic and serum levels of various tumour biomarkers in the discrimination of cause of ascites is not well established. OBJECTIVE: To evaluate the role of serum and ascitic levels of tumor biomarkers (CA 72-4, CA 19-9, CEA and CA 125) in discrimination of cause of ascites. METHODS: A prospective study was conducted in consecutive patients presenting with ascites. Serum and ascitic levels of CA 19-9, CA 125, CA 72-4 and carcinoembryonic antigen (CEA) were determined at the presentation. The patients with cirrhotic ascites, tuberculous peritonitis (TBP) and peritoneal carcinomatosis (PC) were eventually included in analysis. RESULTS: Of the 93 patients (58 males, mean age 47 years) included, the underlying cause was cirrhosis in 31, PC in 42 and peritoneal tuberculosis in 20. The best cutoff for discriminating benign and malignant ascites for serum CEA, CA 19-9 and CA 72-4 were 6.7 ng/mL, 108 IU/mL and 8.9 IU/mL, respectively. The best cutoff for discriminating benign and malignant ascites for ascitic CA 125, CEA, CA 19-9 and CA 72-4 were 623 IU/mL, 8.7 ng/mL, 33.2 IU/mL and 7 IU/mL, respectively. CONCLUSION: The performance of single biomarker for the prediction of underlying PC is low but a combination of serum CA 19-9 and CA 72-4 best predicted the presence of peritoneal carcinomatosis.

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BACKGROUND: Acute cholangitis (AC) is a gastro-intestinal emergency associated with significant mortality. Role of change in the levels of inflammatory markers post drainage in predicting outcome in acute cholangitis is uncertain. OBJECTIVE: To evaluate the predictive value of changes in C-reactive protein (CRP) and procalcitonin levels after biliary drainage in relation to outcomes (survival or mortality) at 1 month. METHODS: A prospective observational study of consecutive adults presenting with AC was performed. At admission and at 48 hours post biliary drainage, procalcitonin and CRP were sent. RESULTS: Between August 2020 till December 2020 we recruited 72 consecutive patients of AC. The median age of the patients was 55 years (range 43-62 years) and 42 (58.33%) were females. Although the delta change in serum procalcitonin (P value<0.001) and CRP (P value<0.001) was significant, it had no bearing on the outcome. Altered sensorium and INR were independently associated with mortality at 1 month. The 30-day mortality prediction of day 0 procalcitonin was measured by receiver operating characteristic analysis which resulted in an area under the curve of 0.697 with a 95% confidence interval (95%CI) of 0.545-0.849. The optimal cut-off of procalcitonin would be 0.57ng/mL with a sensitivity and specificity of 80% and 60% respectively to predict mortality. CONCLUSION: Change in serum procalcitonin and CRP levels at 48 hours post drainage although significant, had no impact on the outcome of acute cholangitis.

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ABSTRACT Background: Acute cholangitis (AC) is a gastro-intestinal emergency associated with significant mortality. Role of change in the levels of inflammatory markers post drainage in predicting outcome in acute cholangitis is uncertain. Objective: To evaluate the predictive value of changes in C-reactive protein (CRP) and procalcitonin levels after biliary drainage in relation to outcomes (survival or mortality) at 1 month. Methods A prospective observational study of consecutive adults presenting with AC was performed. At admission and at 48 hours post biliary drainage, procalcitonin and CRP were sent. Results: Between August 2020 till December 2020 we recruited 72 consecutive patients of AC. The median age of the patients was 55 years (range 43-62 years) and 42 (58.33%) were females. Although the delta change in serum procalcitonin (P value<0.001) and CRP (P value<0.001) was significant, it had no bearing on the outcome. Altered sensorium and INR were independently associated with mortality at 1 month. The 30-day mortality prediction of day 0 procalcitonin was measured by receiver operating characteristic analysis which resulted in an area under the curve of 0.697 with a 95% confidence interval (95%CI) of 0.545-0.849. The optimal cut-off of procalcitonin would be 0.57ng/mL with a sensitivity and specificity of 80% and 60% respectively to predict mortality. Conclusion: Change in serum procalcitonin and CRP levels at 48 hours post drainage although significant, had no impact on the outcome of acute cholangitis.

RESUMO Contexto: A colangite aguda (CA) é uma emergência gastro-intestinal associada à significativa mortalidade. O papel da mudança nos níveis de marcadores inflamatórios pós drenagem na previsão do desfecho em CA é incerto. Objetivo: Avaliar o valor preditivo das alterações nos níveis de proteína reativa C (PCR) e procalcitonina após drenagem biliar em relação aos desfechos (sobrevida ou mortalidade) em um mês. Métodos Realizou-se estudo observacional prospectivo de adultos consecutivos que apresentam CA. Na admissão e após 48 horas de drenagem biliar, foram analisadas a procalcitonina e a PCR. Resultados Entre agosto de 2020 e dezembro de 2020, foram recrutados 72 pacientes consecutivos de CA. A idade mediana dos pacientes foi de 55 anos (faixa de 43 a 62 anos) e 42 (58,33%) do sexo feminino. Embora a variação delta no soro procalcitonina (valor P<0,001) e PCR (valor P<0,001) tenha sido significativa, não houve influência sobre o resultado. Sensório alterado e INR foram independentemente associados à mortalidade em 1 mês. A previsão de mortalidade de 30 dias no dia 0 da procalcitonina foi medida pela análise característica operacional receptora que resultou em uma área sob a curva de 0,697 com intervalo de confiança de 95% (IC95%) de 0,545-0,849. O corte ideal de procalcitonina seria de 0,57ng/mL com sensibilidade e especificidade de 80% e 60% respectivamente para prever a mortalidade. Conclusão: A mudança nos níveis de procalcitonina sérica e PCR em 48 horas após a drenagem, embora significativa, não teve impacto no resultado da colangite aguda.

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ABSTRACT Background: The role of ascitic and serum levels of various tumour biomarkers in the discrimination of cause of ascites is not well established. Objective: To evaluate the role of serum and ascitic levels of tumor biomarkers (CA 72-4, CA 19-9, CEA and CA 125) in discrimination of cause of ascites. Methods: A prospective study was conducted in consecutive patients presenting with ascites. Serum and ascitic levels of CA 19-9, CA 125, CA 72-4 and carcinoembryonic antigen (CEA) were determined at the presentation. The patients with cirrhotic ascites, tuberculous peritonitis (TBP) and peritoneal carcinomatosis (PC) were eventually included in analysis. Results: Of the 93 patients (58 males, mean age 47 years) included, the underlying cause was cirrhosis in 31, PC in 42 and peritoneal tuberculosis in 20. The best cutoff for discriminating benign and malignant ascites for serum CEA, CA 19-9 and CA 72-4 were 6.7 ng/mL, 108 IU/mL and 8.9 IU/mL, respectively. The best cutoff for discriminating benign and malignant ascites for ascitic CA 125, CEA, CA 19-9 and CA 72-4 were 623 IU/mL, 8.7 ng/mL, 33.2 IU/mL and 7 IU/mL, respectively. Conclusion: The performance of single biomarker for the prediction of underlying PC is low but a combination of serum CA 19-9 and CA 72-4 best predicted the presence of peritoneal carcinomatosis.

RESUMO Contexto: O papel dos níveis ascíticos e séricos de vários biomarcadores de tumores na discriminação da causa das ascites não está bem estabelecido. Objetivo: Avaliar o papel dos níveis séricos e ascíticos de biomarcadores tumorais (CA 72-4, CA 19-9, CEA e CA 125) na discriminação da causa das ascites. Métodos: Estudo prospectivo foi realizado em pacientes consecutivos que apresentaram ascite. Foram determinados níveis do soro e ascítico de CA 19-9, CA 125, CA 72-4 e antígeno carcinoembrínico (CEA). Os pacientes com ascites cirróticas, peritonite tuberculosa e carcinomatose peritoneal (CP) foram eventualmente incluídos na análise. Resultados: Dos 93 pacientes (58 homens, média de idade 47 anos) incluídos, a causa básica foi cirrose em 31, CP em 42 e tuberculose peritoneal em 20. O melhor corte para discriminação de ascites benignas e malignas para soro CEA, CA 19-9 e CA 72-4 foram 6,7 ng/mL, 108 UI/mL e 8,9 UI/mL, respectivamente. O melhor corte para discriminação de ascites benignas e malignas para CA 125 ascitico, CEA, CA 19-9 e CA 72-4 foram 623 UI/mL, 8,7 ng/mL, 33,2 UI/mL e 7 UI/mL, respectivamente. Conclusão: O desempenho do biomarcador único para a previsão do CP subjacente é baixo, mas uma combinação de soro CA 19-9 e CA 72-4 melhor previu a presença de carcinomatose peritoneal.

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BACKGROUND: Procalcitonin may be increased in active ulcerative colitis (UC). We investigated the role of procalcitonin in predicting response in acute severe UC (ASUC). METHODS: Consecutive patients with ASUC diagnosed on basis of Truelove and Witts criteria were enrolled. Serum procalcitonin levels for consecutive patients were measured at admission and day 3. We assessed role of procalcitonin values at presentation and at day 3 in assessing response on day 3 (Oxford's criteria) and need for second line therapy (day 28). RESULTS: Of fifty patients (23 males, mean age: 35.98±13.8 years), 16 did not respond (day 3). Ten (20%) patients required second-line therapy. Baseline procalcitonin was significantly associated with response on day 3 (P=0.016). There was no association between day 1 or day 3 procalcitonin and need for second-line rescue therapy. CONCLUSION: Serial procalcitonin is not an effective biomarker for predicting outcomes or need for second line therapy in ASUC.

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BACKGROUND: Variceal hemorrhage (VH) is a medical emergency. Prompt endoscopic variceal ligation (EVL) is therapeutic. Terlipressin is used in VH and continued for 2-5 days even after EVL. As hemostasis is primarily achieved by EVL, the benefit of continuing trelipressin after EVL is unknown. OBJECTIVE: To evaluate the efficacy of continuing terlipressin after EVL to prevent re-bleed and mortality. METHODS: In this pilot study, after EVL 74 patients of VH were randomized into two treatment groups TG2 & TG5, received terlipressin (1 mg IV bolus q 4 hourly) for 2 days and 5 days respectively and one control group (TG0), received 0.9% normal saline (10 mL IV bolus q 4 hourly) and followed up for 8 weeks. RESULTS: A total of 9 (12.6%) patients had re-bleed with maximum 4 (5.6%) patients in TG5 group followed by 3 (4.2%) in TG2 and 2 (2.8%) in TG0 groups (P=0.670). The overall mortality was 15 (21.1%) patients, 6 (8.5%) patients in TG0 group, followed by 5 (7.0%) in TG5 and 4 (5.6%) in TG2 group (P=0.691). Adverse drug reactions were significantly higher in treatment groups with maximum 18 (24.32%) patients in TG5, followed by 8 (10.8%) in TG2 and 2 (2.7%) in TG0 groups (P=0.00). Duration of hospital stay was also significantly higher in treatment group, 6.63 (±0.65) days in TG5 followed by 3.64 (±0.57) in TG2 and 2.40 (±0.50) days in TG0 groups (P=0.00). CONCLUSION: The rational for continuing terlipressin after EVL is doubtful as it didn't have any benefit for the prevention of re-bleed or mortality; rather it increased the risk of adverse drug reactions and duration of hospital stay. Further randomized clinical trials are encouraged to generate more evidence in support or against continuing terlipressin after EVL.

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ABSTRACT Background Procalcitonin may be increased in active ulcerative colitis (UC). We investigated the role of procalcitonin in predicting response in acute severe UC (ASUC). Methods Consecutive patients with ASUC diagnosed on basis of Truelove and Witts criteria were enrolled. Serum procalcitonin levels for consecutive patients were measured at admission and day 3. We assessed role of procalcitonin values at presentation and at day 3 in assessing response on day 3 (Oxford's criteria) and need for second line therapy (day 28). Results Of fifty patients (23 males, mean age: 35.98±13.8 years), 16 did not respond (day 3). Ten (20%) patients required second-line therapy. Baseline procalcitonin was significantly associated with response on day 3 (P=0.016). There was no association between day 1 or day 3 procalcitonin and need for second-line rescue therapy. Conclusion Serial procalcitonin is not an effective biomarker for predicting outcomes or need for second line therapy in ASUC.

RESUMO Contexto A procalcitonina pode estar aumentada em colite ulcerativa ativa. Investigamos o papel da procalcitonina na previsão de resposta na colite ulcerativa aguda grave. Métodos Foram inscritos pacientes consecutivos com colite ulcerativa aguda grave diagnosticados com base nos critérios de Truelove e Witts. Os níveis de procalcitonina sérica dos pacientes foram medidos consecutivamente na internação e no terceiro dia. Avaliamos o papel dos valores procalcitonina na apresentação e na avaliação da resposta no terceiro dia (critérios de Oxford) e necessidade de terapia de segunda linha (dia 28). Resultados Dos 50 pacientes (23 homens, idade média: 35,98±13,8 anos), 16 não responderam (terceiro dia). Dez pacientes (20%) necessitaram de terapia de segunda linha. A procalcitonina de linha de base foi significativamente associada à resposta no terceiro dia (P=0,016). Não houve associação entre o primeiro dia ou o terceiro dia de procalcitonina e necessidade de terapia de resgate de segunda linha. Conclusão A procalcitonina sérica não é um biomarcador eficaz para prever desfechos ou necessidade de terapia de segunda linha em colite ulcerativa aguda grave.

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ABSTRACT Background Variceal hemorrhage (VH) is a medical emergency. Prompt endoscopic variceal ligation (EVL) is therapeutic. Terlipressin is used in VH and continued for 2—5 days even after EVL. As hemostasis is primarily achieved by EVL, the benefit of continuing trelipressin after EVL is unknown. Objective To evaluate the efficacy of continuing terlipressin after EVL to prevent re-bleed and mortality. Methods In this pilot study, after EVL 74 patients of VH were randomized into two treatment groups TG2 & TG5, received terlipressin (1 mg IV bolus q 4 hourly) for 2 days and 5 days respectively and one control group (TG0), received 0.9% normal saline (10 mL IV bolus q 4 hourly) and followed up for 8 weeks. Results A total of 9 (12.6%) patients had re-bleed with maximum 4 (5.6%) patients in TG5 group followed by 3 (4.2%) in TG2 and 2 (2.8%) in TG0 groups (P=0.670). The overall mortality was 15 (21.1%) patients, 6 (8.5%) patients in TG0 group, followed by 5 (7.0%) in TG5 and 4 (5.6%) in TG2 group (P=0.691). Adverse drug reactions were significantly higher in treatment groups with maximum 18 (24.32%) patients in TG5, followed by 8 (10.8%) in TG2 and 2 (2.7%) in TG0 groups (P=0.00). Duration of hospital stay was also significantly higher in treatment group, 6.63 (±0.65) days in TG5 followed by 3.64 (±0.57) in TG2 and 2.40 (±0.50) days in TG0 groups (P=0.00). Conclusion The rational for continuing terlipressin after EVL is doubtful as it didn't have any benefit for the prevention of re-bleed or mortality; rather it increased the risk of adverse drug reactions and duration of hospital stay. Further randomized clinical trials are encouraged to generate more evidence in support or against continuing terlipressin after EVL.

RESUMO Contexto A hemorragia varicosa (HV) é emergência médica. A ligadura endoscópica imediata das varizes (LEV) é terapêutica. A terlipressina é usada em HV e contínua por 2—5 dias mesmo após a LEV. Como a hemostasia é alcançada principalmente pela LEV, o benefício do uso contínuo da terlipressina após o evento é desconhecido. Objetivo Avaliar a eficácia da terlipressina contínua após a LEV para evitar o ressangramento e a mortalidade. Métodos Neste estudo piloto, após a LEV, 74 pacientes com HV foram randomizados em dois grupos de tratamento TG2 & TG5, que receberam terlipressina (1 mg EV em bolus a cada 4 horas) durante 2—5 dias, respectivamente, e um grupo controle (TG0), que receberam soro fisiológico normal de 0,9% (10 mL EV em bolus a cada 4 horas) e foram seguidos por 8 semanas. Resultados Um total de 9 (12,6%) pacientes tiveram ressangramento, 4 (5,6%) no grupo TG5, seguidos por 3 (4,2%) no TG2 e 2 (2,8%) no grupo TG0 (P=0,670). A mortalidade geral de pacientes foi de 15 (21,1%), 6 (8,5%) no grupo TG0, seguidos por 5 (7,0%) no TG5 e 4 (5,6%) no TG2 (P=0,691). As reações adversas de medicamentos foram significativamente maiores em grupos de tratamento em 18 (24,32%) pacientes no TG5, seguidos por 8 (10,8%) no TG2 e 2 (2,7%) em grupo TG0 (P=0,00). A duração da internação hospitalar também foi significativamente maior no grupo de tratamento, 6,63 (±0,65) dias no TG5, seguido por 3,64 (±0,57) em TG2 e 2,40 (±0,50) dias em grupos TG0 (P=0,00). Conclusão O uso racional para a continuação da terlipressina após a LEV é duvidoso, pois não teve qualquer benefício para a prevenção de ressangramento ou mortalidade; pelo contrário, aumentou o risco de efeitos adversos e duração da internação hospitalar. Outros ensaios clínicos randomizados são necessários para gerar mais evidências em apoio ou contra a terlipressina contínua após a LEV.

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BACKGROUND: Traditionally peptic ulcer disease was the most common cause of upper gastrointestinal (UGI) bleed but with the changing epidemiology; other etiologies of UGI bleed are emerging. Many scores have been described for predicting outcomes and the need for intervention in UGI bleed but prospective comparison among them is scarce. OBJECTIVE: This study was planned to determine the etiological pattern of UGI bleed and to compare Glasgow Blatchford score, Pre-Endoscopy Rockall score, AIMS65, and Modified Early Warning Score (MEWS) as predictors of outcome. METHODS: In this prospective cohort study 268 patients of UGI bleed were enrolled and followed up for 8 weeks. Glasgow Blatchford score, Endoscopy Rockall score, AIMS65, and MEWS were calculated for each patient, and the area under the receiver operating characteristic (AUC-ROC) curve for each score was compared. RESULTS: The most common etiology for UGI bleed were gastroesophageal varices 150 (63.55%) followed by peptic ulcer disease 29 (12.28%) and mucosal erosive disease 27 (11.44%). Total 38 (15.26%) patients had re-bleed and 71 (28.5%) patients died. Overall, 126 (47%) patients required blood component transfusion, 25 (9.3%) patients required mechanical ventilation and 2 (0.74%) patients required surgical intervention. Glasgow Blatchford score was the best in predicting the need for transfusion (cut off - 10, AUC-ROC= 0.678). Whereas AIMS65 with a score of ≥2 was best in predicting re-bleed (AUC-ROC=0.626) and mortality (AUC-ROC=0.725). CONCLUSION: Gastrointestinal bleed was most commonly of variceal origin at our tertiary referral center in Northern India. AIMS65 was the best & simplest score with a score of ≥2 for predicting re-bleed and mortality.

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