Urinary iodine excretion after using povidone iodine or chlorhexidine gluconate for topical disinfectant in patients undergoing thyroidectomy due to thyroid carcinoma: When to do radio active iodine therapy?

Background: Povidone Iodine (PI) is the most frequent antiseptic used as a topical disinfectant in surgery. It has been reported high transcutaneous iodine absorption due to topical PI usage, but there is a lack of data in periods of excess iodine depletion. Materials and Methods: This is a cross-sectional study designed to assess serial urinary iodine concentration (UIC) after topical administration of PI to evaluate the transcutaneous iodine absorption and the proper iodine depletion time for safe administration of Radio Active Iodine (RAI) therapy as ablative or adjuvant therapy. Results: Thirty-seven patients with papillary thyroid carcinoma undergoing total thyroidectomy were assigned to the PI group (n = 20) or chlorhexidine gluconate (CHG) group (n = 17). In the PI group, the UIC levels rose to a maximum of 2 times in the 4th week after administration and returned to pre-operative levels in the 8th week after. In the CHG group, there was a decrease in UIC levels due to a low iodine diet (LID) with a significant P-value of 0.001, <0.001, and 0.001 in the 2nd, 4th, and 8th weeks follow up respectively compared to the PI group. The urinary excretion of excess iodine lasts about 8 weeks after total thyroidectomy until iodine levels turn back to pre-operative values. Conclusion: If the thyroidectomy was prepared with PI, RAI is better to be performed 6-8 weeks after surgery rather than the standard prescription of 4 weeks.

The effect of selenium supplementation on sonographic findings of salivary glands in papillary thyroid cancer (PTC) patients treated with radioactive iodine: study protocol for a double-blind, randomized, placebo-controlled clinical trial.

BACKGROUND: Thyroid cancer is a very damaging disease. The most common treatment for this disease includes thyroidectomy and then using radioactive iodine (RAI). RAI has many side effects, including a decrease in salivary secretions, followed by dry mouth and oral and dental injuries, as well as increased inflammation and oxidative stress. Selenium can be effective in these patients by improving inflammation and oxidative stress and by modulating salivary secretions. So far, only one clinical trial has investigated the effect of selenium on thyroid cancer patients treated with radioiodine therapy (RIT) conducted on 16 patients; considering the importance of this issue, to show the potential efficacy of selenium in these patients, more high-quality trials with a larger sample size are warranted. METHODS: This is a parallel double-blind randomized controlled clinical trial that includes 60 patients aged 20 to 65 years with papillary thyroid cancer (PTC) treated with RAI and will be conducted in Seyyed al-Shohada Center, an academic center for referral of patients to receive iodine, Isfahan, Iran. Thirty patients will receive 200 µg of selenium for 10 days (3 days before to 6 days after RAI treatment) and another 30 patients will receive a placebo for the same period. Sonographic findings of major salivary glands, salivary secretions, and sense of taste will be evaluated before and 6 months after 10-day supplementation. DISCUSSION: Due to its anti-inflammatory and antioxidant effects, as well as improving salivary secretions, selenium may improve the symptoms of thyroid cancer treated with radioactive iodine. In past studies, selenium consumption has not reduced the therapeutic effects of radiation therapy, and at a dose of 300 to 500 µg/day, it has not had any significant side effects in many types of cancer under radiation therapy. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20201129049534N6 . Registered on 16 September 2021.

Antidiabetic effects of Eryngium billardieri hydrosol in the treatment of type 2 diabetic patients: A double-blind randomized clinical trial.

Objective: Medicinal plants with fewer side effects and low cost than synthetic medicines are increasingly advised to treat diseases. The present study aimed to identify Eryngium billardieri compounds and evaluate the plant's effects on hyperglycemic and hyperlipidemia indices, and liver, and kidney function. Materials and Methods: Following identification of Eryngium billardieri using GC/MS method, 72 participants were randomly divided into two groups (n=36 per group), receiving oral hypoglycemic medication (metformin) with or without 50 ml hydrosol twice a day for three months as intervention and placebo control, respectively. Body mass index (BMI), systolic and diastolic blood pressure, fasting blood sugar (FBS), glycosylated hemoglobin (HbA1c), total cholesterol, triglyceride, HDL-C, and LDL-C levels were measured at the beginning and end of the experiment. Also, aspartate transaminase, alanine transaminase, blood urea nitrogen, and creatinine levels were measured to assess adverse effects on liver and kidney functions. Results: The main components were terpenes with 46.69% of the total ingredients of E. billardieri essential oil. Other prominent compounds identified included octanoic acid (12.14 %) and isoxazole (6.72 %). Intergroup changes in blood parameters showed that E. billardieri hydrosol for three months could significantly reduce HbA1C and blood cholesterol levels but did not affect other measured parameters. Also, there were no adverse effects on kidney or liver function. Conclusion: The present findings showed that the consumption of 50 ml of E. billardieri hydrosol as a complementary treatment in diabetic patients reduced HbA1C and cholesterol levels without adverse effects on the liver or kidneys functions.

The efficacy of curcumin-piperine co-supplementation on clinical symptoms, duration, severity, and inflammatory factors in COVID-19 outpatients: a randomized double-blind, placebo-controlled trial.

BACKGROUND: COVID-19 pandemic has made the disease a major global problem by creating a significant burden on health, economic, and social status. To date, there are no effective and approved medications for this disease. Curcumin as an anti-inflammatory agent can have a positive effect on the control of COVID-19 complications. This study aimed to assess the efficacy of curcumin-piperine supplementation on clinical symptoms, duration, severity, and inflammatory factors in patients with COVID-19. METHODS: Forty-six outpatients with COVID-19 disease were randomly allocated to receive two capsules of curcumin-piperine; each capsule contained 500 mg curcumin plus 5 mg piperine or placebo for 14 days. RESULTS: Mean changes in complete blood count, liver enzymes, blood glucose levels, lipid parameters, kidney function, and c-reactive protein (CRP) were not significantly different between the two groups. There was a significant improvement in health status, including dry cough, sputum cough, ague, sore throat, weakness, muscular pain, headache, and dyspnea at week 2 in both curcumin-piperine and placebo groups (P value < 0.05); however, the improvement in weakness was more in the curcumin-piperine group than with placebo group (P value 025). CONCLUSION: The present study results showed that curcumin-piperine co-supplementation in outpatients with COVID-19 could significantly reduce weakness. However, in this study, curcumin-piperine co-supplementation could not significantly affect the other indices, including biochemical and clinical indices. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20121216011763N46 . 2020-10-31.

The Effects of Berberis integerrima Fruit Extract on Glycemic Control Parameters in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial.

BACKGROUND: Berberis integerrima Bunge fruits have been utilized in traditional medicine to control diabetes mellitus (DM). However, no clinical survey has been done in this regard. This study was conducted to clinically evaluate the effects of fruit extract of this plant in improving glycemic control indices in patients with type 2 DM (T2DM). METHODS: In a randomized controlled clinical trial, patients with T2DM who met the inclusion criteria were randomly divided into two groups of drug (Berberis) and control to receive the extract solution 5 ml twice daily (equivalent to 1000 mg of dry extract) with standard treatment (metformin) or only standard treatment, respectively, for 8 weeks. Before and after the intervention, fasting blood sugar (FBS), serum glycosylated hemoglobin (HbA1c), serum insulin, the homeostasis assessment model for insulin resistance (HOMA-IR), body mass index (BMI), and systolic and diastolic blood pressure were determined and compared between the two groups. RESULTS: During the study, 30 and 35 patients in the drug and control groups, respectively, completed the study. Although no significant changes occurred in any parameter within each group, postintervention FBS (117.5 [107-128.8] versus 134 [120-142], P = 0.001) and HbA1c (7 [6.4-7.7] versus 7.5 [6.8-7.9], P = 0.045) were significantly lower in the drug group than in the control one. In terms of other parameters, there were no significant differences between the groups. CONCLUSION: Consumption of B. integerrima Bunge fruit extract at a dosage of 1000 mg daily decreases FBS and HbA1c but does not affect HOMA-IR in patients with type 2 diabetes mellitus.

Effect of curcumin-pipeine supplementation on clinical status, mortality rate, oxidative stress, and inflammatory markers in critically ill ICU patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial.

OBJECTIVES: This study aims to investigate the efficacy of curcumin-piperine co-supplementation on oxidative stress factors, clinical symptoms, and mortality rate in patients with coronavirus (COVID-19) admitted to the intensive care unit (ICU). TRIAL DESIGN: This study is a randomized, placebo-controlled, double-blind, parallel-arm clinical trial. PARTICIPANTS: The study participants will be recruited from patients admitted to the ICU of Al-Zahra hospital with a definitive diagnosis of COVID-19. The inclusion criteria are aged between 20 and 75 years, confirmation of COVID-19 based on the PCR test, and admitted to the ICU. The exclusion criteria include the present use of parenteral nutrition support, a history of underlying diseases such as congenital disorders, immune diseases, renal and hepatic insufficiency, and pancreatitis, a history of sensitivity to herbal remedies such as turmeric and pepper, and regular use of anticoagulant drugs such as warfarin. This study will be performed in the Al-Zahra hospital, an academic hospital affiliated with Isfahan University of Medical Sciences, Isfahan, Iran. INTERVENTION AND COMPARATOR: Sixty eligible patients will be randomly assigned, in a 1:1 ratio, to receive curcumin-piperine capsules (three capsules/day; each capsules containing 500 mg curcumin plus 5 mg piperine; in total 1500 mg curcumin and 15 mg piperine/daily) for seven days (n=30) or matching placebo capsules (three capsules/day; each capsules containing 505 mg maltodextrin; totally 1515 mg, maltodextrin/ daily) for same duration (n=30). Capsules will be administered after oral or enteral feeding at 9, 15 and 21 o'clock. MAIN OUTCOMES: The primary outcome is the time from initiation of supplementation (curcumin-piperine or placebo) to normalization of fever, respiratory rate, and blood oxygen saturation. The secondary outcomes are the mortality rate, length of stay in ICU, temperature, levels of blood oxygen saturation, ventilator dependency, respiratory rate, levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), levels of liver markers (ALT, AST, LDH), and levels of kidney function markers (BUN, Creatinine). FOLLOW UP: All of the parameters will be assessed at baseline and end of the study (7 days intervention). In addition, the rate of mortality will be collected after 4 weeks (28 days' mortality in the ICU, 4 weeks follow up). RANDOMISATION: Eligible patients will be randomly assigned to either the intervention group (Curcumin-piperine) or the control group (Placebo). Randomization sequences will be generated using an electronic table of random numbers to allocate the included participants into either control or intervention groups (in a 1:1 ratio) using the stratified block randomization method. Stratification was conducted according to sex (male and female), with a block size of four. The allocation sequences will be prepared by an independent statistician and will be kept inside sealed, opaque, and consecutively numbered envelopes. Participants, investigators, nurses, and physicians will be unaware of the trial-group assignment. BLINDING (MASKING): This study is a double-blind clinical trial (participants, investigators, nurses, and physicians). The curcumin-piperine and placebo supplements will be similar in the terms of texture, taste, color, odor, and weight. Both tablets will be provided in containers that are completely identical in weight, shape, labeling, and packaging. All participants, investigators, nurses, and physicians will be unaware of the trial-group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The sample size is estimated at 60 participants, including 30 patients in the intervention group and 30 patients in the placebo group. TRIAL STATUS: The protocol is Version 2, registered on May 13, 2021. Recruitment began May 20, 2021, and is anticipated to be completed by September 20, 2021. TRIAL REGISTRATION: This trial has been registered in Iranian Registry of Clinical Trials (IRCT) with the title of "Evaluation of the effect of curcumin-piperine supplementation in patients with coronavirus admitted to the intensive care unit (ICU): a double-blind clinical trial study". IRCT registration number is IRCT20121216011763N52 . The registration date was May 13, 2021. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (File 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Effects of curcumin-piperine co-supplementation on clinical signs, duration, severity, and inflammatory factors in patients with COVID-19: a structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: This study aims to investigate the efficacy of curcumin-piperine co-supplementation on disease duration, severity and clinical symptoms, and inflammatory mediators in patients with coronavirus (COVID-19). TRIAL DESIGN: This is a randomized, placebo-controlled, double-blind, parallel arm clinical trial. PARTICIPANTS: All patients aged 20-75 years with the diagnosis of Covid-19 based on the PCR test. The exclusion criteria will include an age less than 20 and more than 75 years, current use of warfarin or other anticoagulant drugs, and the presence of sensitivity to herbal products such as turmeric and pepper. This study will be conducted in academic hospitals affiliated to Isfahan University of Medical Sciences, Isfahan, Iran. INTERVENTION AND COMPARATOR: Fifty outpatients will be randomly allocated in a ratio of 1:1 to receive a capsule of curcumin-piperine containing 500 mg curcumin plus 5 mg piperine or matching placebo containing 505 mg maltodextrin twice a daily, after lunch and dinner, over a period of 2 weeks. Similarly, 50 inpatients who are admitted to hospital wards excluding intensive care unit (ICU) will be randomly assigned in a ratio of 1:1 to receive a capsule curcumin-piperine or matching placebo (provided by the Sami Labs company) twice a daily, after lunch and dinner, over a period of 2 weeks. MAIN OUTCOMES: The main outcomes of this study are the efficacy of curcumin-piperine on coronavirus disease's clinical symptoms, duration, severity, and inflammatory mediators after 2 weeks of curcumin-piperine co-supplementation. RANDOMISATION: Randomization sequences will be generated with the use of a random-number table with a permuted block design (block size of 4) and stratification according to the gender variable (male vs. female). These sequences will be prepared by an independent statistician and will be kept in opaque, sealed, numbered envelopes which will be opened only at the time of enrollment. The allocation ratio in intervention and control groups is 1:1. Researchers and all patients will be unaware of the study-group assignment until the completion of data analyses. BLINDING (MASKING): This study is a double-blind clinical trial (participant, researcher). The curcumin-piperine and placebo supplements are packaged in similar numbered drug containers, and the researcher and all patients will be unaware of the study assignment until the end of the study. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The calculated total sample size is 100 patients, with 25 patients in each group. TRIAL STATUS: The protocol is Version 2.0, May 24, 2020. Recruitment began May 4, 2020, and is anticipated to be completed by April 19, 2021. TRIAL REGISTRATION: This trial has been registered by the title of "Effect of curcumin-piperine co-supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study" in the Iranian Registry of Clinical Trials (IRCT) with code "IRCT20121216011763N46", https://www.irct.ir/trial/47529 . The registration date is May 4, 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Effects of vitamin D-fortified low fat yogurt on glycemic status, anthropometric indexes, inflammation, and bone turnover in diabetic postmenopausal women: A randomised controlled clinical trial.

BACKGROUND & AIMS: Low levels of serum 25-hydroxy vitamin D (25(OH)D) are common in type 2 diabetic patients and cause several complications particularly, in postmenopausal women due to their senile and physiological conditions. This study aimed to assess the effects of vitamin D-fortified low fat yogurt on glycemic status, anthropometric indexes, inflammation, and bone turnover in diabetic postmenopausal women. METHODS: In a randomized, placebo-controlled, double-blind parallel-group clinical trial, 59 postmenopausal women with type 2 diabetes received fortified yogurt (FY; 2000 IU vitamin D in 100 g/day) or plain yogurt (PY) for 12 weeks. Glycemic markers, anthropometric indexes, inflammatory, and bone turnover markers were assessed at baseline and after 12 weeks. RESULTS: After intervention, in FY group (vs PY group), were observed: significant increase in serum 25(OH)D and decrease of PTH (stable values in PY); significant improvement in serum fasting insulin, HOMA-IR, HOMA-B, QUICKI, and no changes in serum fasting glucose and HbA1c (significant worsening of all indexes in PY); significant improvement in WC, WHR, FM, and no change in weight and BMI (stable values in PY); significant increase of omentin (stable in PY) and decrease of sNTX (significant increase in PY). Final values of glycemic markers (except HbA1c), omentin, and bone turnover markers significantly improved in FY group compared to PY group. Regarding final values of serum 25(OH)D in FY group, subjects were classified in insufficient and sufficient categories. Glycemic status improved more significantly in the insufficient rather than sufficient category; whereas the other parameters had more amelioration in the sufficient category. CONCLUSIONS: Daily consumption of 2000 IU vitamin D-fortified yogurt for 12 weeks improved glycemic markers (except HbA1c), anthropometric indexes, inflammation, and bone turnover markers in postmenopausal women with type 2 diabetes. TRIAL REGISTRATION: www.irct.ir (IRCT2013110515294N1).

The association between serum selenium and gestational diabetes mellitus: a systematic review and meta-analysis.

BACKGROUND: Results of the studies about association between serum selenium concentration and gestational hyperglycemia are inconsistent. Some studies have demonstrated that women with gestational diabetes mellitus (GDM) have lower Se concentrations while contrary results are reported in other studies. AIM: The aim of this study is to compare the serum Se concentration in women with GDM and normoglycemic pregnant women via a systematic review and meta-analysis. METHODS: A computerized literature search on four databases (PubMed, Cochrane register of control trials, Scopus and Google scholar) was performed from inception through August 2013. Necessary data were extracted and random effects model was used to conduct the meta-analysis. RESULTS: Six observational studies (containing 147 women with GDM and 360 normoglycemic pregnant women) were found, which had compared serum Se concentration in women suffering from GDM with normal pregnant ones. Our meta-analysis revealed that serum Se concentration was lower in women with GDM compared to normoglycemic pregnant women (Hedges=-1.34; 95% CI: -2.33 to -0.36; P<0.01). Stratified meta-analysis demonstrated that concentration of Se in the sera of women with GDM was lower than normal pregnant women both in second and third trimesters, but the result was not significant in second trimester (second trimester: Hedges=-0.68; 95% CI: -1.60-0.25; P=0.15, third trimester: Hedges=-2.81; 95% CI: -5.21 to -0.42; P<0.05). It was also demonstrated that serum Se status was lower in pregnant women with impaired glucose tolerance (IGT) compared to normoglycemic pregnant women (Hedges=-0.85; 95% CI: -1.18 to -0.52). CONCLUSION: The available evidences suggest that serum Se concentration is significantly lower in pregnant women with gestational hyperglycemia compared to normal pregnant women.

Does omega-3 fatty acids supplementation affect circulating leptin levels? A systematic review and meta-analysis on randomized controlled clinical trials.

BACKGROUND: Omega-3 fatty acids have attracted researchers for their effect on circulatory hormone-like peptides affecting weight control. OBJECTIVE: Our objective was to conduct a systematic review and meta-analysis on randomized controlled trials (RCTs) assessed the effects of omega-3 supplementation on serum leptin concentration and to find the possible sources of heterogeneity in their results. METHODS: We searched PubMed/Medline, Google Scholar, Ovid, SCOPUS and ISI web of science up to April 2014. RCTs conducted among human adults, examined the effect of omega-3 fatty acid supplements on serum leptin concentrations as an outcome variable were included. The mean difference and standard deviation (SD) of changes in serum leptin levels were used as effect size for the meta-analysis. Summary mean estimates with their corresponding SDs were derived using random effects model. RESULTS: Totally 14 RCTs were eligible to be included in the systematic review, and the meta-analysis was performed on 13 articles. Our analysis showed that omega-3 supplementation significantly reduces leptin levels (mean difference (MD) = -1·71 ng/ml 95% confidence interval (CI): -3·17 to -0·24, P = 0·022). Subgroup analysis based on BMI status showed that the omega-3 supplementation reduces leptin when used for nonobese subjects (MD = -3·60 ng/ml; 95% CI -6·23 to -0·90; P = 0·011); however, this was not true for obese participants (MD = -0·86 ng/ml; 95% CI: -2·63 to -0·90; P = 0·296). Subgroup analysis based on omega-3 source also showed that omega-3 from marine sources may significantly reduce leptin levels (MD = -1·73 ng/ml; 95% CI -3·25 to -0·2; P = 0·026), but plant sources do not significantly affect serum leptin levels (MD = -1·48 ng/ml; 95% CI -6·78 to 3·23; P = 0·585). Our results were highly sensitive to one study. CONCLUSIONS: Omega-3 supplementation might moderately decrease circulatory leptin levels only among nonobese adults. RCTs with longer follow-up period, using higher doses for obese adults and exploring the effect in different genders, are needed to replicate our results.