Effect of coenzyme Q10 in Europeans with chronic heart failure: A sub-group analysis of the Q-SYMBIO randomized double-blind trial

Background: Geographical differences in patient characteristics, management and outcomes in heart failure (HF) trials are well recognized. The aim of this study was to assess the consistency of the treat- ment effect of coenzyme Q10 (CoQ10) in the European sub-population of Q-SYMBIO, a randomized double-blind multinational trial of treatment with CoQ10, in addition to standard therapy in chronic HF.  Methods: Patients with moderate to severe HF were randomized to CoQ10 300 mg daily or placebo in addition to standard therapy. At 3 months the primary short-term endpoints were changes in New York Heart Association (NYHA) functional classification, 6-min walk test, and levels of N-terminal pro–B type natriuretic peptide. At 2 years the primary long-term endpoint was major adverse cardiovascular events (MACE). Results: There were no significant changes in short-term endpoints. The primary long-term endpoint of MACE was reached by significantly fewer patients in the CoQ10 group (n = 10, 9%) compared to the placebo group (n = 33, 27%, p = 0.001). The following secondary endpoints were significantly improved in the CoQ10 group compared with the placebo group: all-cause and cardiovascular mortality, NYHA classification and left ventricular ejection fraction (LVEF). In the European sub-population, when compared to the whole group, there was greater adherence to guideline directed therapy and similar results for short- and long-term endpoints. A new finding revealed a significant improvement in LVEF. Conclusions: The therapeutic efficacy of CoQ10 demonstrated in the Q-SYMBIO study was confirmed in the European sub-population in terms of safely reducing MACE, all-cause mortality, cardiovascular mortality, hospitalization and improvement of symptoms

Massage therapy for cardiac surgery patients—a randomized trial

ObjectivesTo determine whether massage significantly reduces anxiety, pain, and muscular tension and enhances relaxation compared with an equivalent period of rest time after cardiac surgery. The feasibility of delivering the treatment, effects on heart rate, blood pressure, and respiratory rate, and patient satisfaction were also assessed.MethodsElective cardiac surgery patients were randomized to receive massage or rest time at 2 points after surgery. Visual analog scales were used to measure pain, anxiety, relaxation, muscular tension, and satisfaction. Heart rate, respiratory rate, and blood pressure were measured before and after treatment. Focus groups and feedback were used to collect qualitative data about clinical significance and feasibility.ResultsA total of 152 patients (99% response rate) participated. Massage therapy produced a significantly greater reduction in pain (P = .001), anxiety (P < .0001), and muscular tension (P = .002) and increases in relaxation (P < .0001) and satisfaction (P = .016) compared to the rest time. No significant differences were seen for heart rate, respiratory rate, and blood pressure. Pain was significantly reduced after massage on day 3 or 4 (P < .0001) and day 5 or 6 (P = .003). The control group experienced no significant change at either time. Anxiety (P < .0001) and muscular tension (P < .0001) were also significantly reduced in the massage group at both points. Relaxation was significantly improved on day 3 or 4 for both groups (massage, P < .0001; rest time, P = .006), but only massage was effective on day 5 or 6 (P < .0001). Nurses and physiotherapists observed patient improvements and helped facilitate delivery of the treatment by the massage therapists on the ward.ConclusionsMassage therapy significantly reduced the pain, anxiety, and muscular tension and improves relaxation and satisfaction after cardiac surgery

Skeletonized internal thoracic artery harvesting reduces chest wall dysesthesia after coronary bypass surgery

ObjectiveA pain syndrome related to intercostal nerve injury during internal thoracic artery harvesting causes significant morbidity after coronary bypass surgery. We hypothesized that its incidence and severity might be reduced by using skeletonized internal thoracic artery harvesting rather than pedicled harvesting.MethodsIn a prospective double-blind clinical trial, 41 patients undergoing coronary bypass were randomized to receive either unilateral pedicled or skeletonized internal thoracic artery harvesting. Patients were assessed 7 (early) and 21 (late) weeks postoperatively with reproducible sensory stimuli used to detect chest wall sensory deficits (dysesthesia) and with a pain questionnaire used to assess neuropathic pain.ResultsAt 7 weeks postoperatively, the area of harvest dysesthesia (percentage of the chest) in the skeletonized group (n = 21) was less (median, 0%; interquartile range, 0–0) than in the pedicled group (n = 20) (2.8% [0–13], P = .005). The incidence of harvest dysesthesia at 7 weeks was 14% in the skeletonized group versus 50% in the pedicled group (P = .02). These differences were not sustained at 21 weeks, as the median area of harvest dysesthesia in both groups was 0% (P = .89) and the incidence was 24% and 25% in the skeletonized and pedicled groups, respectively (P = 1.0). The incidence of neuropathic pain in the skeletonized group compared with the pedicled group was 5% versus 10% (P = .6) at 7 weeks and 0% versus 0% (P = 1.0) at 21 weeks.ConclusionsCompared with pedicled harvesting, skeletonized harvesting of the internal thoracic artery provides a short-term reduction in the extent and incidence of chest wall dysesthesia after coronary bypass, consistent with reduced intercostal nerve injury and therefore the reduced potential for neuropathic chest pain

Coenzyme Q10 therapy before cardiac surgery improves mitochondrial function and in vitro contractility of myocardial tissue

AbstractObjectivesPrevious clinical trials suggest that coenzyme Q10 might afford myocardial protection during cardiac surgery. We sought to measure the effect of coenzyme Q10 therapy on coenzyme Q10 levels in serum, atrial trabeculae, and mitochondria; to assess the effect of coenzyme Q10 on mitochondrial function; to test the effect of coenzyme Q10 in protecting cardiac myocardium against a standard hypoxia-reoxygentation stress in vitro; and to determine whether coenzyme Q10 therapy improves recovery of the heart after cardiac surgery.MethodsPatients undergoing elective cardiac surgery were randomized to receive oral coenzyme Q10 (300 mg/d) or placebo for 2 weeks preoperatively. Pectinate trabeculae from right atrial appendages were excised, and mitochondria were isolated and studied. Trabeculae were subjected to 30 minutes of hypoxia, and contractile recovery was measured. Postoperative cardiac function and troponin I release were assessed.ResultsPatients receiving coenzyme Q10 (n = 62) had increased coenzyme Q10 levels in serum (P = .001), atrial trabeculae (P = .0001), and isolated mitochondria (P = .0002) compared with levels seen in patients receiving placebo (n = 59). Mitochondrial respiration (adenosine diphosphate/oxygen ratio) was more efficient (P = .012), and mitochondrial malondialdehyde content was lower (P = .002) with coenzyme Q10 than with placebo. After 30 minutes of hypoxia in vitro, pectinate trabeculae isolated from patients receiving coenzyme Q10 exhibited a greater recovery of developed force compared with those in patients receiving placebo (46.3% ± 4.3% vs 64.0% ± 2.9%, P = .001). There was no between-treatment difference in preoperative or postoperative hemodynamics or in release of troponin I.ConclusionsPreoperative oral coenzyme Q10 therapy in patients undergoing cardiac surgery increases myocardial and cardiac mitochondrial coenzyme Q10 levels, improves mitochondrial efficiency, and increases myocardial tolerance to in vitro hypoxia-reoxygenation stress

CoQ10 and Cognition a Review and Study Protocol for a 90-Day Randomized Controlled Trial Investigating the Cognitive Effects of Ubiquinol in the Healthy Elderly

Introduction: With an aging population there is an important need for the development of effective treatments for the amelioration of cognitive decline. Multiple mechanisms underlie age-related cognitive decline including cerebrovascular disease, oxidative stress, reduced antioxidant capacity and mitochondrial dysfunction. CoQ10 is a novel treatment which has the potential to improve brain function in healthy elderly populations due to established beneficial effects on mitochondrial function, vascular function and oxidative stress.Methods and Analysis: We describe the protocol for a 90-day randomized controlled trial which examines the efficacy of Ubiquinol (200 mg/day) vs. placebo for the amelioration of cognitive decline in a healthy (non-demented) elderly sample, aged 60 years and over. The primary outcome is the effect of Ubiquinol at 90 days compared to baseline on CogTrack composite measures of cognition. Additional cognitive measures, as well as measures of cardiovascular function, oxidative stress, liver function and mood will also be monitored across 30-, 60- and 90- day time points. Data analyses will involve repeated measures analysis of variance (ANOVA).Discussion: This study will be the first of its kind to provide important clinical and mechanistic data regarding the efficacy of Ubiquinol as a treatment for age-related cognitive decline in the healthy elderly with important implications for productivity and quality of life within this age group.Clinical Trial Registration: The trial has been registered with the Australian and New Zealand Clinical Trials Registry (ANZCTRN12618001841268)

Physical conditioning and mental stress reduction - a randomised trial in patients undergoing cardiac surgery

<p>Abstract</p> <p>Background</p> <p>Preoperative anxiety and physical unfitness have been shown to have adverse effects on recovery from cardiac surgery. This study involving cardiac surgery patients was primarily aimed at assessing the feasibility of delivering physical conditioning and stress reduction programs within the public hospital setting. Secondary aims were to evaluate the effect of these programs on quality of life (QOL), rates of postoperative atrial fibrillation (AF) and length of stay (LOS) in hospital.</p> <p>Methods</p> <p>Elective patients scheduled for coronary artery bypass graft and/or valve surgery at a public hospital in Melbourne, Australia were enrolled. Patients were randomized to receive either holistic therapy (HT) or usual care (UC). HT consisted of a series of light physical exercise sessions together with a mental stress reduction program administered in an outpatient setting for the first two weeks after placement on the waiting list for surgery. A self-administered SF-36 questionnaire was used to measure QOL and hospital records to collect data on LOS and rate of postoperative AF.</p> <p>Results</p> <p>The study population comprised 117 patients of whom 60 received HT and 57 received UC. Both programs were able to be delivered within the hospital setting but ongoing therapy beyond the two week duration of the program was not carried out due to long waiting periods and insufficient resources. HT, as delivered in this study, compared to UC did not result in significant changes in QOL, LOS or AF incidence.</p> <p>Conclusions</p> <p>Preoperative holistic therapy can be delivered in the hospital setting, although two weeks is insufficient to provide benefits beyond usual care on QOL, LOS or postoperative AF. Further research is now required to determine whether a similar program of longer duration, or targeted to high risk patients can provide measurable benefits.</p> <p>Trial registration</p> <p>This trial was conducted as part of a larger study and according to the principles contained in the CONSORT statement 2001.</p