Background: Hyperimmune anti-COVID-19 Intravenous Immunoglobulin (C-IVIG) is an unexplored therapy amidst the rapidly evolving spectrum of medical therapies for COVID-19 and is expected to counter the three most lifethreatening consequences of COVID-19 including lung injury by the virus, cytokine storm and sepsis. Methods: A single center, phase I/II, randomized controlled, single-blinded trial was conducted at Dow University of Health Sciences, Karachi, Pakistan. Participants were COVID-19 infected individuals, classified as either severely or critically ill with Acute Respiratory Distress Syndrome (ARDS). Participants were randomized through parallel-group design with sequential assignment in a 4:1 allocation to either intervention group with four C-IVIG dosage arms (0.15, 0.20, 0.25, 0.30 g/kg), or control group receiving standard of care only (n = 10). Primary outcomes were 28-day mortality, patient's clinical status on ordinal scale and Horowitz index (HI), and were analysed in all randomized participants that completed the follow-up period (intentionto-treat population). The trial was registered at clinicaltrials.gov (NCT04521309). Findings: Fifty participants were enrolled in the study from June 19, 2020 to February 3, 2021 with a mean age of 56.54 §13.2 years of which 22 patients (44%) had severe and 28 patients (56%) had critical COVID-19. Mortality occurred in ten of 40 participants (25%) in intervention group compared to six of ten (60%) in control group, with relative risk reduction in intervention arm I (RR, 0.333; 95% CI, 0.087À1.272), arm II (RR, 0.5; 95% CI, 0.171À1.463), arm III (RR, 0.167; 95% CI, 0.024À1.145), and arm IV (RR, 0.667; 95% CI, 0.268À1.660). In intervention group, median HI significantly improved to 359 mmHg [interquartile range (IQR) 127À400, P = 0.009)] by outcome day, while the clinical status of intervention group also improved as compared to control group, with around 15 patients (37.5%) being discharged by 7th day with complete recovery. Additionally, resolution of chest X-rays and restoration of biomarkers to normal levels were also seen in intervention groups. No drug-related adverse events were reported during the study. Interpretation: Administration of C-IVIG in severe and critical COVID-19 patients was safe, increased the chance of survival and reduced the risk of disease progression. Funding: Higher Education Commission (HEC), Pakistan (Ref no. 20-RRG-134/RGM/R&D/HEC/2020).

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Background: The abrupt rise of colorectal cancer in developing countries is raising concern in healthcare settings. Studies on assessing relationships with modifiable and non-modifiable risk factors in the Pakistani population have been limited. The present investigation was designed to examine associations of dietary practices, addictive behavior and bowel habits in developing colorectal cancer (CRC) among patients in a low-resource setup. Materials and Methods: An age-gender matched case control study was conducted from October 2011 to July 2015 in Karachi, Pakistan. Cases were from the surgical oncology department of a public sector tertiary care hospital, while their two pair-matched controls were recruited from the general population. A structured questionnaire was used which included questions related to demographic characteristics, family history, dietary patterns, addictive behavior and bowel habits. Results: A family history of cancer was associated with a 2.2 fold higher chance of developing CRC. Weight loss reduced the likelihood 7.6 times. Refraining from a high fat diet and consuming more vegetables showed protective effects for CRC. The risk of CRC was more than twice among smokers and those who consumed Asian specific addictive products as compared to those who avoid using these addictions (ORsmoking: 2.12, 95% CI: 1.08 -4.17, ORpan: 2.92, 95% CI: 1.6 -5.33, ORgutka: 2.13, 95% CI: 1.14 -3.97). Use of NSAID attenuated risk of CRC up to 86% (OR: 0.14, 95% CI: 0.07 -0.31). Conclusions: Most of the findings showed concordance with the literature elucidating protective effects of consuming vegetables and low fat diet while documenting adverse associations with family history, weight loss, constipation and hematochezia. Moreover, this study highlighted Asian specific indigenous addictive products as important factors. Further studies are needed to validate the findings produced by this research.

IntroductionThe Oral Health Impact Profile (OHIP-14) has been used extensively to measure the impact of oral disease on oral health-related quality of life (HRQoL) but has not been validated in the Urdu language or tested in gastroenterology.AimsTo validate the OHIP-14 for use in Pakistan and its ability to assess oral health in patients with upper gastrointestinal (GI) and hepatic disorders.DesignMulticentre, cross-sectional.SettingFour major tertiary care hospitals.MethodsThe OHIP-14 was tested for reliability and validity in 700 patients referred for oesophago-gastro-duodenoscopic (OGD) investigation of the symptoms of upper GI or hepatic disease. Socio-demographic details and oral examination findings (for oral lesions and DMFT) were recorded.ResultsThe mean (±standard deviation) total OHIP-14 score (range 0–56) was estimated to be 23.38 ± 10.47, indicating a significant impact of upper gastrointestinal and hepatic disorders on oral health. The reliability coefficient of the OHIP-14 was above 0.7 threshold, and the tool had good internal consistency (α = 0.83). When associated with worsening DMFT (decayed, missed, and filled teeth) index value, the highest correlations (p < 0.01) were detected with functional limitation (rs = 0.234), physical disability (rs = 0.230), and psychological discomfort (rs = 0.221).ConclusionThe OHIP-14 is a precise and valid instrument for assessing oral-HRQoL in a gastroenterological setting amongst Pakistani population.

ObjectiveGastro-oesophageal reflux disease (GORD) is a relatively common disorder and manifests with extraoesophageal symptoms, such as dental erosions (DE), cough, laryngitis, asthma, and oral soft- and hard-tissue pathologies. This study aimed (1) to identify oral soft and hard-tissue changes in patients with GORD and (2) to evaluate these oral changes as indices for assessing GORD and its severity.SettingThis cross-sectional study was conducted at four major tertiary care government hospitals, in two metropolitan cities of Pakistan.ParticipantsIn total, 187 of 700 patients who underwent oesophago–gastro–duodenoscopy and having GORD were included in the study. Patients with GORD were divided according to the presence of DE into group A (with DE, chronic/severe GORD) and group B (without DE, mild GORD). Patients who were unconscious and had extremely limited mouth opening were excluded.Primary and secondary outcome measuresAbnormal conditions and lesions of the oral mucosa were recorded. The impact of oral hard and soft-tissue changes on the oral health-related quality of life was assessed using the Pakistani (Urdu) version of the validated Oral Health Impact Profile-14 (OHIP-14) instrument.ResultsOral submucous fibrosis (66.3%), ulceration (59.4%) and xerostomia (47.6%) were significantly more common in group A (p<0.05). The prevalence of GORD was 26.7%, within which the prevalence of DE was 35.3%. Unhealthy dietary pattern, nausea/vomiting, oesophagitis, xerostomia, ulceration, gingivitis and angular cheilitis showed a statistically significant association with chronic GORD and DE. All subscales of OHIP-14 were positively correlated (p<0.05) in patients with GORD and DE, with notable impact on psychological discomfort (rs=0.30), physical disability (rs=0.29), psychological disability (rs=0.27) and functional limitation (rs=0.20).ConclusionPatients with GORD and DE presented with more severe oral manifestations than did those with GORD and no DE. We recommend timely dental check-ups to assess the severity of both systemic and oral disease.

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To assess the effect of Ramadan fasting on blood pressure, fasting glucose, lipid profile, uric acid, HbA1c, body mass index, body adiposity index and visceral adiposity index among fasting medical students, 35 students were recorded before, during and after Ramadan (August) 2011, for their blood pressure, anthropometric measurements, questionnaire response and blood sample. A blood sample was taken at each visit for glucose, lipid profile and HbA1c. Total physical activity, weight-to-height ratio, body adiposity index and visceral adiposity index were calculated for insulin sensitivity. Changes in anthropometric measurements were not statistically significant. However, physical activities increased significantly after Ramadan. Changes in blood pressure, fasting blood sugar, total cholesterol, HbA1c, uric acid and triglyceride were not statistically significant. Mean high density lipoprotein decreased significantly in Ramadan, while low density lipoprotein increased significantly.