Melatonin supplementation improves N-terminal pro-B-type natriuretic peptide levels and quality of life in patients with heart failure with reduced ejection fraction: Results from MeHR trial, a randomized clinical trial.

BACKGROUND: Melatonin, the major secretion of the pineal gland, has beneficial effects on the cardiovascular system and might advantage heart failure with reduced ejection fraction (HFrEF) by attenuating the effects of the renin-angiotensin-aldosterone and sympathetic system on the heart besides its antioxidant and anti-inflammatory effects. HYPOTHESIS: We hypothesized that oral melatonin might improve echocardiographic parameters, serum biomarkers, and a composite clinical outcome (including quality of life, hospitalization, and mortality) in patients with HFrEF. METHODS: A placebo-controlled double-blinded randomized clinical trial was conducted on patients with stable HFrEF. The intervention was 10 mg melatonin or placebo tablets administered every night for 24 weeks. Echocardiography and measurements of N-terminal pro-B-type natriuretic peptide (NT-Pro BNP), high-sensitivity C-reactive protein, lipid profile, and psychological parameters were done at baseline and after 24 weeks. RESULTS: Overall, 92 patients were recruited, and 85 completed the study (melatonin: 42, placebo: 43). Serum NT-Pro BNP decreased significantly in the melatonin compared with the placebo group (estimated marginal means for difference [95% confidence interval]: 111.0 [6.2-215.7], p = .044). Moreover, the melatonin group had a significantly better clinical outcome (0.93 [0.18-1.69], p = .017), quality of life (5.8 [0.9-12.5], p = .037), and New York Heart Association class (odds ratio: 12.9 [1.6-102.4]; p = .015) at the end of the trial. Other studied outcomes were not significantly different between groups. CONCLUSIONS: Oral melatonin decreased NT-Pro BNP and improved the quality of life in patients with HFrEF. Thus it might be a beneficial supplement in HFrEF.

Effect of melatonin supplementation on endothelial function in heart failure with reduced ejection fraction: A randomized, double-blinded clinical trial.

BACKGROUND: This study aimed to investigate the effect of melatonin supplementation on endothelial function in patients with heart failure with reduced ejection fraction (HFrEF). METHODS: This is an analysis of the MeHR trial, a randomized double-blinded placebo-controlled clinical trial with two parallel arms of 1:1. Oral 10 mg melatonin tablets or placebo was administered for 24 weeks. Deference in the percentage of flow-mediated dilatation (FMD) after the intervention was the primary outcome. RESULTS: Ninety-two patients were included in the study (age: 62.7±10.3 years, 87.0% male, ejection fraction (EF): 28.6±8.1). After adjustment for baseline FMD and age, a statistically significant difference in post-treatment FMD in favor of the melatonin group was seen (estimated marginal means [95%CI], melatonin: 7.84% [6.69-8.98], placebo: 5.98% [4.84-7.12], p = .027). There was no significant difference in the mean of post-treatment systolic/diastolic blood pressure, serum total antioxidant capacity, and serum malondialdehyde (MDA) between groups. Subgroup analysis showed significant improvement in FMD and MDA in the melatonin group in nondiabetic patients, while no difference was seen between study groups in diabetic patients. CONCLUSIONS: Melatonin supplementation in HFrEF might improve endothelial function; however, this beneficial effect might not be seen in diabetic patients.

Effect of antioxidant supplementation containing L-carnitine on semen parameters: a prospective interventional study.

OBJECTIVE: One of the remarkable causes of infertility in men is oxidative stress having a reducing effect on their reproductive function. In the present study, we investigated the efficacy of supplementation with antioxidants and L-Carnitine (contained in Androferti) on semen parameters. METHODS: We included 180 infertile male patients diagnosed with idiopathic oligoastenoteratozoospermia (OAT) in this study, and we analyzed the semen sample from 59 patients before and after oral antioxidant treatment, with the commercial name of Androferti (containing 1500 mg of L-Carnitine, 60 mg of vitamin C, 20 mg of coenzyme Q10, 10 mg of vitamin E, 10 mg of zinc, 200 µg of vitamin B9, 50 µg of selenium, 1 µg of vitamin B12). All of the patients received Androferti twice a day for 3 months. RESULTS: There were significant improvements in the sperm concentration (p=0.004) after the antioxidant supplementation. There was also a meaningfully improvement in sperm morphology (p=0.01) after treatment. However, sperm motility was not significantly altered after antioxidant treatment (p=0.2). CONCLUSIONS: Antioxidants supplementation containing 1500 mg L-carnitine can improve the semen quality in infertile men diagnosed with idiopathic OAT. However, further studies are required to determine the antioxidant effects on reproduction function.

Effect of myo-inositol supplementation on ICSI outcomes among poor ovarian responder patients: A randomized controlled trial.

PURPOSE: This study has evaluated the use of myo-inositol supplementation for improving reproductive outcomes in poor responders undergoing intracytoplasmic sperm injection (ICSI). METHODS: One hundred and twelve poor responder patients were included in the study and randomly categorized into two groups using a permuted block randomization method. Group A included 56 patients who received myo-inositol (4 g) and folic acid (400 µg) daily from one month before starting the ICSI cycle continuing until the ovulation triggering day. Group B included 56 patients consuming only folic acid (400 µg) daily for the same period. The outcome measures were the number of retrieved oocytes, embryo quality, Ovarian Sensitivity Index (OSI: number of oocytes retrieved/total Gonadotropins units × 1000), fertilization, implantation, and ongoing pregnancy rates. RESULTS: No significant difference was observed between the two groups regarding the total dose of gonadotropin used, OSI, and the number of total retrieved and mature oocytes. Grad A embryos and fertilization rate were significantly increased in group A. Implantation and pregnancy rates showed statistically insignificant changes. CONCLUSION: Treatment of poor responders with myo-inositol from one month before starting ICSI cycle continuing until ovulation trigger can improve fertilization rate and embryo quality, and may enhance the cumulative pregnancy rate in poor responders.