Selective serotonin reuptake inhibitors are an effective treatment for depression, but they can be associated with sexual dysfunction. To improve compliance and overall patient care, added David Michelson, M.D., department of neuroscience at Eli Lilly and Company, and Christina M. Dording, M.D., department of psychiatry at Massachusetts General Hospital, clinicians must understand the changes in sexual functioning associated with SSRIs.
Since depression itself is often associated with sexual dysfunction, it can be difficult to ascertain how much of the dysfunction following treatment is related to the pharmaceutical and how much is related to the illness. Michelson and Dording indicated that data on this subject remain inadequate and that more research needs to be completed on such factors as onset, treatment, mechanisms and interventions.
Michelson discussed a recent placebo-controlled study of fluoxetine (Prozac) in men and women aged 18 to 80 years old (n=501). The study included 13 weeks of acute treatment (patients received 20 mg fluoxetine/day), followed by 25 weeks of continuation therapy. Patients with a Hamilton Rating Scale for Depression (HAM-D) score і18 were eligible to enter the study; after the acute phase, responders were eligible for the continuation phase if they had a HAM-D score Ј9 and a Cognitive Global Impression score Ј2. In a double-blind fashion, these patients were randomized into a treatment group of 20 mg fluoxetine/day (n=189), 90 mg fluoxetine/week (n=190) or placebo (n=122). A four-question self-assessment scale on sexual dysfunction was administered to patients at baseline, after completion of the acute phase and then on a monthly basis.
Approximately 50% of patients at baseline reported difficulties in the interest and lubrication aspects of the self-assessment scale. After treatment, however, 70% reported no or minimal disruption. In fact, a majority of patients reported improvement or no change in every aspect of sexuality addressed by the self-assessments. Overall, men had lower reporting rates of dysfunction as compared to women. About 50% of the women studied and 40% of the men said they experienced an increase in overall sexual satisfaction, and approximately 40% of both gender groups reported no change in sexual functioning following treatment. About 18% of men and 13% of women in the study reported a worsening of sexual dysfunction.
The researchers found no statistical difference across the three treatment groups; data indicated a normal distribution over improved, no change and worsening status. There were several limitations of the research protocol, the most obvious being that sexual dysfunction was self-reported. Researchers also noted that 32% of patients did not report any sexual dysfunction at onset; since almost 70% of patients had self-reported sexual dysfunction upon entering the study, meeting participants said they were not surprised to see improvement or no change in self-reported sexual dysfunction. There was also a small dropout rate due to sexual dysfunction, but the researchers did not address this issue because they felt it was “not really a concern,” according to Michelson.
The researchers noted that both doses of fluoxetine (Prozac) were statistically significantly better than placebo in treating depression, with few adverse events reported. Moreover, they found no correlation between fluoxetine plasma levels and sexual dysfunction.
Dording also discussed the wide estimates, nature and course of sexual dysfunction incidence during continuation therapy. Interestingly, she noted that more detailed questionnaires resulted in reports of greater dysfunction. In addition, she cautioned the meeting attendees about confounders, including other illnesses (medical and psychiatric) and medications. For instance, depression, alcohol and substance abuse, psychoses and other psychiatric disorders, as well as the quality of the patient’s relationship (i.e., if they have a regular partner, if the relationship is stable or abusive), also affect sexual functioning.
Dording and colleagues conducted a trial with fluoxetine alone versus fluoxetine (Prozac) with cognitive-behavioral therapy (CBT). Patients diagnosed with major depressive disorder (using the Structured Clinical Interview for the DSM-IV-P and having HAM-D-17 scores і16) were admitted to the study and received fluoxetine 20 mg/day for eight weeks. Those who responded (n=127) to treatment were randomized to fluoxetine 40 mg/day and CBT or medication management. During each visit, patients were asked if they were experiencing any adverse events. Dording and colleagues used spontaneous reporting to eliminate the power of suggestion and, therefore, false positives.
Over the course of treatment, 19% of patients (24 of 127) who completed the study reported sexual dysfunction at some point. Fifteen patients reported dysfunction during the acute phase; 14 first reported problems during the continuation phase (after eight weeks and doubling of fluoxetine (Prozac) dose). Eighteen of these patients were male. The two top self-reported problems included anorgasmia (54%) and decreased libido (50%). The mean time to onset of dysfunction was 13±10 weeks; the mean duration of the problem was 16±10 weeks. Six patients experienced spontaneous resolution to their sexual dysfunction. None of the patients who withdrew from the study did so because of sexual dysfunction, but instead due to other variables and/or adverse events.
Both researchers agreed that clinicians should address sexual dysfunction issues, when necessary, to ensure compliance. They reminded the attendees that each patient is an individual and that sexual function, especially in relation to their depressed state, will have different importance to each patient.
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