The efficacy and safety of oral low dose naltrexone versus placebo in the patients with lichen planopilaris: a randomized controlled clinical trial.

BACKGROUND AND OBJECTIVES: Lichen planopilaris (LPP) is one of the important causes of cicatricial alopecia. We aimed to evaluate the efficacy and safety of low-dose naltrexone (LDN) in the setting of a clinical trial in patients with LPP. METHODS: We included patients with LPP between 2018 and 2020. Patients were allocated to two groups. The first group received topical clobetasol plus oral low dose naltrexone (3 mg) while the second received topical clobetasol plus placebo. The assessment was made for the disease severity by lichen planopilaris activity index (LPPAI) instrument and the safety of the drug in 2-month intervals up to 6 months. To compare both groups, we used the ANOVA test for repeated measures. Clinical trials registry code: IRCT20180809040747N1. RESULTS: Thirty-four patients were analyzed in an intention-to-treat fashion. There was a decrescendo pattern on LPPAI scores that was statistically significant within the LDN (p = .001) but almost significant within the placebo group (p = .060) and non-significant between the groups (p = .813). The side effects attributable to the low dose naltrexone was not statistically different between studied groups. CONCLUSION: Low-dose naltrexone (3 mg) failed to improve the severity of the LPP more than what is achievable with topical clobetasol.

Is there an independent association between metabolic syndrome and smoking in Iranian adults? Results of a large multicenter national survey.

BACKGROUND: Theoretically, smoking status should be associated with metabolic syndrome. This relationship has not been studied in Iranian population so far. This study aimed to explore the association among cigarette smoking, metabolic syndrome (MetS) and its domains in a nationally representative sample of Iranians aged 25-64. METHODS: Information of participants regarding demographic data and smoking habits gathered through WHO STEPS questionnaires in the frame of fourth national surveillance of the risk factors of non-communicable diseases in 2011 across the country. The fasting plasma glucose, triglyceride level, high-density lipoprotein cholesterol (HDL-C) level, blood pressure, and anthropometric indices in each patient were measured. Data of 4000 subjects were analyzed with complex sample survey method. The prevalence of metabolic syndrome was assessed according to two definitions: International Diabetes Federation (IDF) and Iranian definition. RESULTS: Herein, 38.4% of smoker participants and 36.6% of non-smokers met the IDF criteria for MetS (P=0.67). Similarly, 31.1% of smokers and 34.1% of non-smokers had MetS according to Iranian-IDF (P=0.427). Only in univariate analysis, using IDF criteria female smokers had lower prevalence of MetS than non-smokers (13.9% vs. 36.5%, P=0.01). Multivariate analysis determined the following odds ratios for the association of smoking with MetS defined by IDF and Iranian-IDF criteria, respectively: OR= 0.89 (0.53-1.47), P=0.638 and OR= 0.97 (0.59-1.58), P=0.901. CONCLUSION: There was no significant association between smoking and MetS overall and among men. However, smoking was associated with lower prevalence of MetS among women.

Autoimmune Bullous Disease Quality of Life (ABQoL) questionnaire: Validation of the translated Persian version in pemphigus vulgaris.

BACKGROUND: Autoimmune bullous diseases are a group of rare, chronic, blistering diseases, with pemphigus vulgaris (PV) being the most common type in Iran. Skin and mucosal involvement and therapy may have a dismal impact on the quality of life of affected patients. OBJECTIVE: We aimed to assess the validity and reliability of the Farsi (Persian) version of the Autoimmune Bullous Quality of Life (ABQoL) index in Iranian patients with PV. METHODS: Forward and backward translation procedures were used to prepare the Persian version of the ABQoL questionnaire. A total of 180 patients were asked to complete the questionnaires, and 24 cases repeated the test after 2 weeks. For validity and reliability, an exploratory factor analysis was performed along with a parallel analysis to determine the number of factors. The multi-trait, multi-method matrix assessed convergent and discriminant validity. To evaluate internal reliability and reliability over time, Cronbach's alpha and intraclass correlation coefficients were reported. RESULTS: Two factors explained a total variance of 54.9% in the data. The first and second factors comprised questions 1-3, 5, 7, 9, and 12-17 (symptoms-social) and questions 4, 6, 8, 10, and 11 (mucosal-psychological), respectively. The internal reliability of the Persian version of the ABQoL index was also acceptable, with a Cronbach's alpha of .855 for total items, .918 for the first factor, and .6 for the second factor. Our results suggest an acceptable convergent and discriminant validity of the Persian version of the ABQoL questionnaire. CONCLUSION: The Persian version of ABQoL index is a valid and reliable tool to monitor quality of life in patients with PV. Further studies are needed to assess the sensitivity of this instrument to changes in different disease activity and correlation with more general tools for the measurement of quality of life.

Relationship Between Level of Serum 25-Hydroxyvitamin D and Risk of Squamous Cell Carcinoma in an Iranian Population.

BACKGROUND: The relationship between vitamin D and skin squamous cell carcinoma (SCC) is not well defined. OBJECTIVE: To investigate the relationship between vitamin D levels and the incidence of skin SCC for the first time in Iran. METHODS AND STUDY DESIGN: In this case-control study, 126 subjects were enrolled (63 in each group) out of referents to Razi Skin Hospital in Tehran in 2014. The risk factors for cancer gathered by self-reported questionnaires and blood samples were obtained to measure the level of 25-hydroxyvitamin D. Multivariate logistic regression was used to neutralize the effect of confounding factors. RESULTS: Cases of SCC were more likely to be in men, older than 49 years and working in an outdoor environment, and with longtime exposure to sunlight and a personal history of skin cancers. Family history of skin cancer and of cigarette smoking were not significantly related to SCC. In the SCC and control groups, 69.8% and 31.7%, respectively, had sufficient levels of vitamin D (P < 0.001). Mean level of 25-hydroxyvitamin D was 40.99 ng/mL in the SCC group and 26.34 ng/mL in the control group (P < 0.05). In the unadjusted model, the level of vitamin D as a continuous variable was positively related to SCC risk. In the adjusted model, vitamin D did not independently predict the likelihood of SCC. CONCLUSION: Vitamin D level and SCC risk are directly related, although not in an independent fashion. Indeed, this relation is severely confounded by exposure to sunlight, which was evidenced by an increased vitamin D level in the people working outside and the higher prevalence of SCC in the same population.

Cardiovascular risk assessment by FRS and SCORE in Iranian adult population.

BACKGROUND: Handling the growing epidemic of coronary heart disease in developing nations hinges on primary prevention, which logistically requires directing preventive interventions to those at the highest risk. Therefore, implementing cardiovascular risk assessment profiles is crucial to distinguish high risk groups who truly need extensive preventive measures. We aimed to draw a picture of the cardiovascular risk profiles in the Iranian adult population for the first time. METHODS: Demographic, anthropometric, and laboratory data as well as blood pressure and smoking status of 3944 subjects participating in the 2011 national surveillance of risk factors for non-communicable diseases were used to calculate the mean estimated risk of coronary artery disease and the relative frequency of low-, medium- and high-risk subjects based on FRS and SCORE indices in general population as well as different age, sex, and residence subgroups. RESULTS: The average 10-year risk of coronary artery disease (FRS) and 10-year risk of fatal coronary and cerebrovascular accidents (SCORE) in the 25 to 64 year-old population was 13.82 and 0.72 respectively. The relative frequency of the intermediate- and high- risk subjects was 25.8 and 22.6% based on FRS and 9.2 and 1.8% based on SCORE respectively. Average FRS and SCORE were significantly higher among men than women, but were not significantly different among urban and rural residents. CONCLUSIONS: A significant proportion of the Iranian population, based on FRS model, will be at moderate to high risk of coronary events in the next 10 years. Urgent preventive plans are needed at the national level.