Effects of N-acetyl cysteine and melatonin on early reperfusion injury in patients undergoing coronary artery bypass grafting: A randomized, open-labeled, placebo-controlled trial.

OBJECTIVES: This study assessed the efficacy of oral consumption of N-acetyl cysteine (NAC) and melatonin (ML) in reducing early reperfusion injury and acute oxidative stress in patients undergoing coronary artery bypass grafting (CABG) with respect to the measurements of cardiac troponin I, lactate, malondealdehyde (MDA), and tumor necrosis factor-α (TNF-α) levels in the blood. METHODS: This study was a randomized, open-label, placebo-controlled trial. Eighty eight patients, aged between 39 to 76 years and eligible for CABG, were recruited and randomly assigned into 3 intervention groups through a simple randomization method and underwent CABG surgery. Blood samples were withdrawn from arterial line, before the induction of anesthesia (before the start of surgery), after incision (before aortic cross-clamping), during global ischemia (during aortic cross-clamping), after aortic cross-clamping (on set of reperfusion), 15 minutes after reperfusion, and after recovery at the intense care unit. The blood samples were analyzed for troponin I, lactate, MDA and TNF-α levels. RESULTS: There was no significant difference in influencing variables among the groups at the baseline. Overall mean troponin I, lactate, and TNF- α levels were significantly different between the intervention groups (all P < .001) at the recovery phase. Post-hoc pairwise comparisons showed that the differences of mean serum levels between ML and control groups were statistically significant for MDA, TNF- α, lactate, and troponin I (P < .001, P = .001, and P = .001, respectively). The differences between NAC and control groups and between ML and NAC groups were only significant for mean lactate level (P < .001). CONCLUSION: The current study revealed that ML and NAC are potent antioxidants with similar efficacy in terms of reducing CABG related cardiac injury and oxidative stress with the dosage employed for the intervention.

The efficacy of resveratrol in controlling hypertension: study protocol for a randomized, crossover, double-blinded, placebo-controlled trial.

BACKGROUND: Hypertension is a global health concern for which novel treatment strategies are necessary. The aim of this study is to evaluate the efficacy of resveratrol (trans-3, 5, 4'-trihydroxystilbene, a polyphenol present in grapes) in controlling blood pressure in participants diagnosed with prehypertension and stage 1 hypertension. METHODS/DESIGN: In a randomized, crossover, double-blinded, placebo-controlled study, 50 participants with prehypertension (diastolic blood pressure and systolic blood pressure, 80-89 mmHg and 120-139 mmHg, respectively) and 50 participants with stage 1 hypertension (diastolic and systolic, 90-99 mmHg and 140-159 mmHg, respectively) will be assigned to receive resveratrol (99 % pure, from Biotivia Longevity Bioceuticals LLC Company, USA, in 500 mg capsules, twice daily for 4 weeks, orally) or placebo (500 mg neutral microcellulose capsules, twice daily for 4 weeks) in a 2 × 2 crossover design (4 weeks treatment-4 weeks washout-4 weeks treatment). The blood pressure of each participant will be recorded (a mean of two times within a 15-minute interval) every week during the study. The participants in the prehypertensive group will not receive any medication, while those in the stage 1 hypertensive group will continue to receive their routine medications during the study. Blood samples will be taken from all groups and examined for various biochemical parameters. DISCUSSION: This trial will help to establish whether resveratrol is an effective antihypertensive agent in prehypertensive and stage 1-hypertensive patients. The trial outcome will provide novel insight into the clinical efficacy of resveratrol and provide valuable information for conducting future clinical studies with resveratrol. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT201407078129N7. Registered on 15 August 2014.