Very low dose naltrexone in opioid detoxification: a double-blind, randomized clinical trial of efficacy and safety

Reza Afshari,Majid Khadem-Rezaiyan,Hoda Khatibi Moghadam,Mahdi Talebi 한국독성학회 2020 Toxicological Research Vol.36 No.1

Withdrawal syndrome is one of the initial focuses of opioid detoxification. Very low dose naltrexone (VLNTX) has been found to reduce opioid tolerance and dependence in animal and human clinical studies. The aim of this study was to determine the safety and efficacy of VLNTX during early stages of detoxification. In a multi-arm parallel, double-blind, randomized controlled trial, 63 opioid-dependent male participants referring to Imam Reza Rehabilitation Center were allocated to three equal groups using block randomization method. They received 0.125 mg, 0.250 mg of VLNTX or placebo daily for 10 days, together with the routine clonidine-based protocol. Self-reported and observer ratings of withdrawal severity and adverse events were measured on the 1st, 4th and 10th day of treatment. Runny eyes (p = 0.006), anxiety (p = 0.031) and dehydration (p = 0.014) were reduced during the whole 10 days in the 0.125 mg VLNTX-treated group compared to placebo. Only drowsiness (p = 0.043) and dysphoric mood (p < 0.001) were reduced in the 0.250 mg VLNTX-treated group. Results of 1st, 4th, and 10th-day assessment showed that most symptoms reductions were for the 0.125 mg VLNTX and the placebo group in the 1st and 4th days, respectively. On the 10th day, there was not any significant difference between 0.250 mg VLNTX-treated group and placebo group. No adverse effect was observed. In the starting days of detoxification, VLNTX can reduce the withdrawal symptoms, but the efficacy declined by passing time. Further studies are needed to test the utility of this new therapeutic approach.

Fecal Calprotectin and Phenotype Severity in Patients with Cystic Fibrosis: A Systematic Review and Meta-Analysis

Saeedeh Talebi,Andrew S. Day,Majid Khadem Rezaiyan,Golnaz Ranjbar,Mitra Zarei,Mahammad Safarian,Hamid Reza Kianifar 대한소아소화기영양학회 2022 Pediatric gastroenterology, hepatology & nutrition Vol.25 No.1

Inflammation plays an important role in the outcome of patients with cystic fibrosis (CF). It may develop due to cystic fibrosis transmembrane conductance regulator protein dysfunction, pancreatic insufficiency, or prolonged pulmonary infection. Fecal calprotectin (FC) has been used as a noninvasive method to detect inflammation. Therefore, the aim of the current meta-analysis was to investigate the relationship between FC and phenotype severity in patients with CF. In this study, searches were conducted in PubMed, Science Direct, Scopus, and Embase databases up to August 2021 using terms such as “cystic fibrosis,” “intestine,” “calprotectin,” and “inflammation.” Only articles published in English and human studies were selected. The primary outcome was the level of FC in patients with CF. The secondary outcome was the relationship between FC and clinical severity. Statistical analysis was performed using Comprehensive Meta-Analysis software. Of the initial 303 references, only six articles met the inclusion criteria. The mean (95% confidence interval [CI]) level of FC was 256.5 mg/dL (114.1-398.9). FC levels were significantly associated with pancreatic insufficiency (mean, 243.02; 95% CI, 74.3 to 411.6; p=0.005; I2=0), pulmonary function (r=–0.39; 95% CI, –0.58 to –0.15; p=0.002; I2=60%), body mass index (r=–0.514; 95% CI, 0.26 to 0.69; p<0.001; I2=0%), and Pseudomonas colonization (mean, 174.77; 95% CI, 12.5 to 337.02; p=0.035; I2=71%). While FC is a reliable noninvasive marker for detecting gastrointestinal inflammation, it is also correlated with the severity of the disease in patients with CF.

The Effect of Glasthma Syrup in Asthma: a study protocol for a triple-blind randomized controlled trial

Derakhshan Ali Reza,Saeidinejat Shahin,Khadem-Rezaiyan Majid,Asnaashari Amir-Mohammad-Hashem,Mirsadraee Majid,Salari Roshanak,Jabbari-Azad Farahzad,Jalali Shima,Jalali Shabnam 대한약침학회 2022 Journal of pharmacopuncture Vol.25 No.3

Objectives: Asthma is a chronic disease, and the demand for herbal medicines in this field has increased in recent years. The new findings highlight the role of the gut-lung axis in the pathophysiology of asthma. Hence, this study will evaluate the safety and efficacy of Glasthma syrup, an herbal formula based on Persian medicine, in improving asthma and regulating intestinal permeability. The formula consists of five herbal ingredients that have anti-inflammatory effects on the respiratory tract, also known as gut tonics. Methods: The study will be conducted as a placebo-controlled, triple-blind, randomized trial. It will consist of a 4-week intervention followed by a 4-week follow-up period. The target sample size is 20 patients with moderate asthma aged 18 to 60 years. Eligible participants will be randomly assigned to either the experimental group or the control group in equal numbers. Patients in the experimental group will take Glasthma syrup (7.5 mL, twice a day), while patients in the control group will take a matching placebo. Both groups will receive a 4-week combination of a long-acting beta2 agonist and a leukotriene modulator as standard of care. Inhaled corticosteroids can be used as rescue medication as needed. Results: The primary outcomes are asthma symptom scale, lung function, and intestinal permeability. Secondary outcomes include quality of life, symptom recurrence rates, and blood tests. A safety assessment will also be conducted during the trial. Conclusion: In this trial, the effects of Glasthma syrup in patients with moderate asthma will be examined. The study will also assess the effects of the formulation on the gut-lung axis by simultaneously monitoring the gut permeability index, asthma symptoms, and lung function.

Efficacy of Herbal Medicines on Lung Function in Asthma: a systematic review and meta-analysis of randomized controlled trials

Derakhshan Alireza,Sadeghi Masoumeh,Asnaashari Amir-Mohammad-Hashem,Dehghani Mohsen,Salari Roshanak,Khadem-Rezaiyan Majid,Mirsadraee Majid,Saeidinejat Shahin,Jalali Shima,Jalali Shabnam 대한약침학회 2023 Journal of pharmacopuncture Vol.26 No.2

Objectives: The present study was designed to conduct a comprehensive systematic review and meta-analysis to assess the efficacy of herbal medicines as add-on therapy on lung function in asthmatic patients. Methods: A comprehensive search of online databases was performed up to December 2021 to identify randomized controlled trials that used orally herbal preparations for asthma as add-on therapy. Studies were assessed for methodological quality using the Cochrane Collaboration’s Risk of Bias tool. The main outcome was percent predicted value of forced expiratory volume (% predicted FEV1). Pooled weighted mean difference (WMD) estimate with corresponding 95% confidence interval (CI) was calculated using inversevariance weights method while random effects meta-analysis was used, taking into account clinical and conceptual heterogeneity. Results: As a result, 1,525 studies were identified. 169 studies were reviewed in-depth and 23 studies met our systematic review inclusion criteria. Finally, nine randomized controlled trials were included in the meta-analysis. Findings indicated that use of herbal medicines in patients with asthma significantly improved % predicted FEV1 (WMD: 3.73, 95% CI: 1.76-5.70), with no evidence for significant heterogeneity (p = 0.56 [Q statistic], I 2 = 0.0%). In subgroup analysis by age, improvement in % predicted FEV1 was higher and significant in adults (WMD: 5.16; 95% CI: 2.68-7.63) compared to children (WMD = 1.27; 95% CI: −1.98-4.51). Sensitivity analysis showed the significant effect of herbal medicine consumption on improving FEV1 was consistently (range of summary WMDs: 3.27-4.59), indicating that the meta-analysis model was robust. There was no evidence of publication bias both visually and statistically. Conclusion: Findings support, the complementary use of herbal medicines resulted in significant improvement in the lung function compared to standard treatment in asthmatic patients with no considerable adverse events. This improvement is more likely to be observed amongst adults.

Macro- and Micro-nutrient Intake Adequacy in Gastric Bypass Patients after 24 Months: a Cross-sectional Study

Ostad Andisheh Norouzian,Barghchi Hanieh,Jangjoo Ali,Ranjbar Golnaz,Rezvani Reza,Bahrami Leila Sadat,Goshayeshi Ladan,Khadem-Rezaiyan Majid,Nematy Mohsen 한국임상영양학회 2021 Clinical Nutrition Research Vol.10 No.4

Decreased food intake is an effective mechanism for gastric bypass surgery (GBS) for successful weight loss. This cross-sectional study aimed to assess dietary intake, micro-and macro-nutrients in the patients undergoing GBS and determine the possible associations with weight changes. We assessed anthropometric indices and food intake at 24 month-post gastric bypass surgery. Dietary data was evaluated using three-day food records. After the 24 months of surgery, among 35 patients (mean age: 43.5 ± 11.2 years; 82.85% females), with the mean body mass index (BMI) of 30.5 ± 4.5 kg/m2, 17 cases were < 50% of their excess weight. The average daily calorie intake was 1,733 ± 630 kcal, with 14.88% of calories from protein. Consumption amounts of protein (0.82 ± 0.27 g/kg of the current weight), as well as fiber, and some micro-nutrients (vitamin B9, E, K, B5, and D3) were lower than recommended amounts. Patients were classified into three groups based on their success in weight loss after surgery. Calorie intake was not significantly different between groups, but successful groups consumed considerably more protein and less carbohydrate than the unsuccessful group (p < 0.05). Based on our findings, the patients undergoing GBS had inadequate macro- and micro-nutrient intake after 24 months. However, protein intake can affect patients' success in achieving better weight loss. Long-term cohort and clinical studies need to be conducted to comprehend this process further.