Normal limit for serum alanine aminotransferase level and distribution of metabolic factors in old population of Kalaleh, Iran

Backgrounds: Normal or elevated values of serum alanine aminotransferase level (ALT) vary in different studies mostly related to characteristics of reference population including age, gender, body mass index, nonalcoholic fatty liver disease (NAFLD), and metabolic syndrome prevalence. Objectives: To measure upper normal limit (UNL) for serum ALT in an apparently healthy Iranian old population (which we had not sufficient data before this study), and its modulating factors. Patients and Methods: All inhabitants (> 50 years old) of Kalaleh, Golestan, Iran (N = 1986) were invited to the study. ALT measurements were performed for all subjects using the same laboratory method. Upper limit of normal (ULN) ALT was calculated based on its 95th percentile in normal weight subjects. Modulating factors of ALT were determined by multivariate analysis. Results: A total of 1309 subjects, with the mean age of 61.5 ± 7.5 years were included. UNL of ALT was 18.8 U/L and 21.4 U/L in women and men, respectively. Based on univariate analysis, waist circumference (r = 0.124, P = 0.01), body mass index (r = 0.118, P = 0.01), triglyceride (r = 0.143, P = 0.01), and having metabolic syndrome (OR = 2.04) modulate ALT levels in men. Also triglyceride (r = 0.119, P = 0.01) modulates ALT levels in women. Conclusions: The calculated level for UNL of ALT is considerably far lower than previous accepted value. Age, gender, ethnicity, and metabolic factors should be accounted in future studies to determine normal ALT level. © 2013, Kowsar Corp.; Published by Kowsar Corp

Endoscopic screening for esophageal squamous cell carcinoma

Esophageal cancer (EC) is the eighth common cancer and the sixth most common cause of death from cancer worldwide. Esophageal squamous cell carcinoma (ESCC) remains the most common type of EC in the developing world and an important health problem in high-risk areas. Most of ESCC cases present in late stages, resulting in delayed diagnosis and poor prognosis. Prevention is the most effective strategy to control ESCC. Primary and secondary preventive methods may be considered for ESCC. In primary prevention, we try to avoid known risk factors. The aim of the secondary preventive method (ESCC screening programs) is to detect and eliminate premalignant precursor lesion of ESCC, preventing its progression into advanced stages. Similar to all population-based screening programs, any screening for early detection of ESCC must be cost-effective; otherwise, screening may not be indicated in that population. Endoscopy with iodine staining has been accepted as a population-level ESCC screening program in some high-risk areas including parts of China. This method may be too expensive and invasive in other high-risk communities. Nonendoscopic methods may be more applicable in these populations for population-based screenings. The limitations (questionable validity and costs) of new endoscopic imaging modalities, including narrow-band imaging (NBI), made them inappropriate to be used in population-level ESCC screening programs. Low-cost, less-invasive endoscopic imaging methods with acceptable diagnostic performance may make screening of ESCC in high-risk areas cost-effective

The impact of illicit drug use on Spontaneous Hepatitis C Clearance: Experience from a large cohort population study

Background and Aims: Acute hepatitis C infection usually ends in chronic infection, while in a minority of patients it is spontaneously cleared. The current population-based study is performed on a large cohort in Golestan province of Iran to examine the demographic correlates of Spontaneous Hepatitis C Clearance. Methods: Serum samples used in this study had been stored in biorepository of Golestan Cohort Study. These samples were evaluated for anti hepatitis C Virus by third generation Enzyme-linked immunosorbent assay (ELISA). Subjects who tested positive were then invited and tested by Recombinant Immunoblot Assay (RIBA) and Ribonucleic Acid Polymerase Chain Reaction test (PCR). If tested positive for RIBA, subjects were recalled and the two tests were re-done after 6 months. Those subjects who again tested positive for RIBA but negative for PCR were marked as cases of spontaneous clearance. Results: 49,338 serum samples were evaluated. The prevalence of Chronic Hepatitis C Virus (CHCV) infection based on PCR results was 0.31. Among those who had acquired hepatitis C, the rate of SC was 38. In multivariate analysis, illicit drug use both Injecting Use (OR = 3.271, 95 CI: 1.784-6.000, p-value<0.001) and Non-Injecting Use (OR = 1.901, 95 CI: 1.068-3.386, p-value = 0.029) were significant correlates of CHCV infection versus SC. Conclusions: Illicit drug use whether intravenous or non-intravenous is the only significant correlate of CHCV, for which several underlying mechanisms can be postulated including repeated contacts with hepatitis C antigen. © 2011 Poustchi et al

The upper normal limit of serum alanine aminotransferase in Golestan Province, Northeast Iran

Background: The objective of this study was to determine the upper normal limit of serum alanine aminotransferase level in a population-based study in Golestan Province, northeast Iran. Methods: From the randomly invited individuals (2,292), 698 out of the 916 males and 1,351 out of the 1,376 females participated in the study (participation rate: 76.2 and 98.1, respectively). One hundred and twenty-one participants were excluded due to positive hepatitis B surface antigen or hepatitis C virus antibody and/or drinking more than 20 grams of alcohol per day. A total of 1,928 participants (1300 females) were included. The upper normal limit of serum alanine aminotransferase level was defined as the 95th percentile. Results: The upper normal limit of serum alanine aminotransferase level in normal weight and nondiabetics was significantly lower than the total study group (36 versus 45 U/L). Serum alanine aminotransferase level was independently associated with male gender, body mass index, and diabetes mellitus (OR=2.05; 95Cl: 1.44 - 2.94, OR=2.76; 95Cl: 1.84 - 4.13, and OR=2.96; 95Cl: 1.56-5.61, respectively). Conclusion: Considering the lower calculated upper normal limit in normal weight nondiabetic participants in this study, we recommend setting new upper normal limit for serum alanine aminotransferase level, It seems reasonable to set upper normal limit for serum alanine aminotransferase level in males and females separately

The upper normal limit of serum alanine aminotransferase in Golestan Province, Northeast Iran

Background: The objective of this study was to determine the upper normal limit of serum alanine aminotransferase level in a population-based study in Golestan Province, northeast Iran. Methods: From the randomly invited individuals (2,292), 698 out of the 916 males and 1,351 out of the 1,376 females participated in the study (participation rate: 76.2 and 98.1, respectively). One hundred and twenty-one participants were excluded due to positive hepatitis B surface antigen or hepatitis C virus antibody and/or drinking more than 20 grams of alcohol per day. A total of 1,928 participants (1300 females) were included. The upper normal limit of serum alanine aminotransferase level was defined as the 95th percentile. Results: The upper normal limit of serum alanine aminotransferase level in normal weight and nondiabetics was significantly lower than the total study group (36 versus 45 U/L). Serum alanine aminotransferase level was independently associated with male gender, body mass index, and diabetes mellitus (OR=2.05; 95Cl: 1.44 - 2.94, OR=2.76; 95Cl: 1.84 - 4.13, and OR=2.96; 95Cl: 1.56-5.61, respectively). Conclusion: Considering the lower calculated upper normal limit in normal weight nondiabetic participants in this study, we recommend setting new upper normal limit for serum alanine aminotransferase level, It seems reasonable to set upper normal limit for serum alanine aminotransferase level in males and females separately

Endoscopic screening for precancerous lesions of the esophagus in a high risk area in northern Iran

Background: Esophageal squamous cell carcinoma (ESCC) is a major health problem in many developing countries, including Iran. ESCC has a very poor prognosis, largely due to late diagnosis. As a first step in developing an early detection and treatment program, we conducted a population-based endoscopic screening for ESCC and its precursor lesion, esophageal squamous dysplasia (ESD), in asymptomatic adults from Golestan Province, northern Iran (a high-risk area for ESCC) to evaluate the feasibility of such a program and to document the prevalence and risk factor correlates of ESD. Methods: This cross-sectional study was conducted among participants of the Golestan Cohort Study (GCS), a population-based cohort of 50,000 adults in eastern Golestan Province. Randomly selected GCS participants were invited by telephone. Those who accepted were referred to a central endoscopy clinic. Eligible subjects who consented were asked to complete a brief questionnaire. Detailed information about selected risk factors was obtained from the GCS main database. Endoscopic examination with was performed with Lugol's iodine staining; biopsies were taken from unstained lesions as well as the normally stained mucosa of the esophagus, and the biopsies were diagnosed by expert pathologists according to previously described criteria. Results: In total, 1906 GCS subjects were invited, of whom only 302 (15.8%) were successfully enrolled. Esophagitis (29.5%) and ESD (6.0%) were the most common pathological diagnoses. Turkmen ethnicity (adjusted OR = 8.61; 95%CI: 2.48-29.83), being older than the median age (OR = 7.7; 95% CI: 1.99-29.87), and using deep frying cooking methods (OR = 4.65; 95%CI: 1.19-18.22) were the strongest predictors for ESD. There were significant relationships between esophagitis and smoking (p-value<0.001), drinking hot tea (P value = 0.02) and lack of education (P value = 0.004). Conclusion: We observed a low rate of participation in endoscopic screening. The overall prevalence of ESD was 6.0%. Developing non-endoscopic primary screening methods and screening individuals with one or more risk factors may improve these rates

The prevalence of hepatitis B surface antigen and anti-hepatitis B core antibody in Iran: A population-based study

Background: Hepatitis B virus infection is a very common cause of chronic liver disease worldwide. It is estimated that 3 of Iranians are chronically infected with hepatitis B virus. Current population-based studies on both rural and urban prevalence of hepatitis B virus infection in Iran are sparse with results that do not always agree. We performed this study to find the prevalence of hepatitis B surface antigen, anti-hepatitis B core antibody, and associated factors in the general population of three provinces of Iran. Methods: We randomly selected 6,583 subjects from three provinces in Iran, namely Tehran, Golestan, and Hormozgan. The subjects were aged between 18 and 65 years. Serum samples were tested for hepatitis B surface antigen and anti-hepatitis B core antibody. Various risk factors were recorded and multivariate analysis was performed. Results: The prevalence of hepatitis B surface antigen and anti-hepatitis B core antibody in Iran was 2.6 and 16.4, respectively. Predictors of hepatitis B surface antigen or anti-hepatitis B core antibody in multivariate analysis included older age, not having high-school diploma, living in a rural area, and liver disease in a family member. We did not find any significant differences between males and females. Conclusion: In spite of nationwide vaccination of newborns against hepatitis B virus since 1992, hepatitis B virus infection remains a very common cause of chronic liver disease in Iran which should be dealt with for at least the next 30-50 years

Reliability and validity of opiate use self-report in a population at high risk for esophageal cancer in Golestan, Iran

Objective: To assess the reliability and validity of self-reported opium use in a rural Iranian population at high risk for esophageal cancer in preparation for a large cohort study. Method: 1,057 subjects ages 33 to 84 years were recruited from Gonbad city and three surrounding villages in Golestan province of Iran and completed a questionnaire and provided biological samples. The history and duration of using opium, smoking tobacco, chewing nass, and drinking alcohol were measured by questionnaire in the entire cohort. A subgroup of 130 people was reinterviewed after 2 months to assess reliability. Validity of the opium question was assessed by comparing the questionnaire responses with the presence of codeine and morphine in the urine of 150 selected subjects. Results: Self-reported opiate use is reliable and valid in this population. The reliability of ever opium use and duration of opium use had κ′s of 0.96 and 0.74, respectively. The validity of self-reported opium use was also high. Using urine codeine or morphine as the gold standard for use of opium, self-report had a sensitivity of 0.93 and a specificity of 0.89. Conclusions: The self-reported use of opium can provide a reliable and valid measurement in this population and will be useful for studying associations between opium use and occurrence of esophageal cancer and other diseases

Mortality and cancer in relation to ABO blood group phenotypes in the Golestan Cohort Study

Background: A few studies have shown an association between blood group alleles and vascular disease, including atherosclerosis, which is thought to be due to the higher level of von Willebrand factor in these individuals and the association of blood group locus variants with plasma lipid levels. No large population-based study has explored this association with overall and cause-specific mortality. Methods: We aimed to study the association between ABO blood groups and overall and cause-specific mortality in the Golestan Cohort Study. In this cohort, 50,045 people 40- to 70-years old were recruited between 2004 and 2008, and followed annually to capture all incident cancers and deaths due to any cause. We used Cox regression models adjusted for age, sex, smoking, socioeconomic status, ethnicity, place of residence, education and opium use. Results: During a total of 346,708 person-years of follow-up (mean duration 6.9 years), 3,623 cohort participants died. Non-O blood groups were associated with significantly increased total mortality (hazard ratio (HR) = 1.09; 95% confidence interval (CI): 1.01 to 1.17) and cardiovascular disease mortality (HR = 1.15; 95% CI: 1.03 to 1.27). Blood group was not significantly associated with overall cancer mortality, but people with group A, group B, and all non-O blood groups combined had increased risk of incident gastric cancer. In a subgroup of cohort participants, we also showed higher plasma total cholesterol and low-density lipoprotein (LDL) in those with blood group A. Conclusions: Non-O blood groups have an increased mortality, particularly due to cardiovascular diseases, which may be due to the effect of blood group alleles on blood biochemistry or their effect on von Willebrand factor and factor VIII levels. \ua9 Etemadi et al

Sample size calculations for cluster randomised controlled trials with a fixed number of clusters

Background\ud Cluster randomised controlled trials (CRCTs) are frequently used in health service evaluation. Assuming an average cluster size, required sample sizes are readily computed for both binary and continuous outcomes, by estimating a design effect or inflation factor. However, where the number of clusters are fixed in advance, but where it is possible to increase the number of individuals within each cluster, as is frequently the case in health service evaluation, sample size formulae have been less well studied. \ud \ud Methods\ud We systematically outline sample size formulae (including required number of randomisation units, detectable difference and power) for CRCTs with a fixed number of clusters, to provide a concise summary for both binary and continuous outcomes. Extensions to the case of unequal cluster sizes are provided. \ud \ud Results\ud For trials with a fixed number of equal sized clusters (k), the trial will be feasible provided the number of clusters is greater than the product of the number of individuals required under individual randomisation ($n_i$) and the estimated intra-cluster correlation ($\rho$). So, a simple rule is that the number of clusters ($\kappa$) will be sufficient provided: \ud \ud $\kappa$ > $n_i$ x $\rho$\ud \ud Where this is not the case, investigators can determine the maximum available power to detect the pre-specified difference, or the minimum detectable difference under the pre-specified value for power. \ud \ud Conclusions\ud Designing a CRCT with a fixed number of clusters might mean that the study will not be feasible, leading to the notion of a minimum detectable difference (or a maximum achievable power), irrespective of how many individuals are included within each cluster. \ud \u