Abstract: We included three trials with 381 participants. We were unable to pool the data from the included studies due to the differences in interventions used; therefore we synthesised the trial findings narratively. Two trials were conducted in the USA and one was undertaken in Israel. All trials included participants who were admitted to hospital with myocardial infarction (MI), and one trial also included participants who had undergone coronary artery bypass grafting. All trials followed up participants for a minimum of three months post-intervention; the longest follow-up timepoint was five months. One trial (N = 92) tested an intensive (total five hours) psychotherapeutic sexual counselling intervention delivered by a sexual therapist. One trial (N = 115) used a 15-minute educational video plus written material on resuming sexual activity following a MI. One trial (N = 174) tested the addition of a component that focused on resumption of sexual activity following a MI within a hospital cardiac rehabilitation programme. The quality of the evidence for all outcomes was very low. None of the included studies reported any outcomes from partners. Two trials reported sexual function. One trial compared intervention and control groups on 12 separate sexual function subscales and used a repeated measures analysis of variance (ANOVA) test. They reported statistically significant differences in favour of the intervention. One trial compared intervention and control groups using a repeated measures analysis of covariance (ANCOVA), and concluded: "There were no significant differences between the two groups [for sexual function] at any of the time points". Two trials reported sexual satisfaction. In one trial, the authors compared sexual satisfaction between intervention and control and used a repeated measured ANOVA; they reported "differences were reported in favour of the intervention". One trial compared intervention and control with a repeated measures ANCOVA and reported: "There were no significant differences between the two groups [for sexual satisfaction] at any of the timepoints". All three included trials reported the number of patients returning to sexual activity following MI. One trial found some evidence of an effect of sexual counselling on reported rate of return to sexual activity (yes/no) at four months after completion of the intervention (relative risk (RR) 1.71, 95% confidence interval (CI) 1.26 to 2.32; one trial, 92 participants, very low quality of evidence). Two trials found no evidence of an effect of sexual counselling on rate of return to sexual activity at 12 week (RR 1.01, 95% CI 0.94 to 1.09; one trial, 127 participants, very low quality of evidence) and three month follow-up (RR 0.98, 95% CI 0.88 to 1.10; one trial, 115 participants, very low quality of evidence). Two trials reported psychological well-being. In one trial, no scores were reported, but the trial authors stated: "No treatment effects were observed on state anxiety as measured in three points in time". In the other trial no scores were reported but, based on results of a repeated measures ANCOVA to compare intervention and control groups, the trial authors stated: "The experimental group had significantly greater anxiety at one month post MI". They also reported: "There were no significant differences between the two groups [for anxiety] at any other time points". One trial reporting relationship satisfaction and one trial reporting quality of life found no differences between intervention and control. No trial reported on satisfaction in how sexual issues were addressed in cardiac rehabilitation services. We found no high quality evidence to support the effectiveness of sexual counselling for sexual problems in patients with cardiovascular disease. There is a clear need for robust, methodologically rigorous, adequately powered RCTs to test the effectiveness of sexual counselling interventions for people with cardiovascular disease and their partners.

Plain-language summary: We searched the international literature up to March 2015 for studies that compared any intervention designed to address and counsel people with heart disease in relation to sexual problems with usual care. Three randomised controlled trials (clinical trials where people are allocated at random to one of two or more treatments) that included 381 participants in total met our inclusion criteria. The interventions tested in these studies were quite different from each other. All studies included people who had been admitted to hospital with a heart attack. These studies do not provide strong evidence that sexual counselling can improve sexual outcomes for people with heart disease or their partners. One study, which reported the effects of an intensive intervention, involved five hours of sexual counselling provided by a psychotherapist. It reported improved sexual functioning and satisfaction, and reduced length of time taken for people to return to sexual activity following a cardiac event, in people that received the intervention compared to usual care. The other two studies reported no differences between people that received the intervention and usual care on these outcomes (both studies measured rate of return to sexual activity following a cardiac event; one of these two studies measured sexual functioning and satisfaction). There was no evidence that sexual counselling has an effect on quality of life (measured in one study) or marital satisfaction (measured in one study). One study found that patients who received a 15-minute sexual counselling educational video plus written material had higher levels of anxiety than usual care, as well as better knowledge about sex after a heart attack, one month after their cardiac event, but not at any other timepoints. The evidence was of very low quality. We judged the included studies to be at high risk of bias and study results were poorly reported. Bearing this in mind, the results of this review should be interpreted with caution.