Viagra’s Efficacy with Psychiatric Patients – Comprehensive Analysis

depression disorderDepression is one of the causes of erectile dysfunction in men and unfortunately the anti-depressant medications used to treat the condition can themselves trigger erection and libido problems. This research investigates Viagra’s efficacy when it comes to psychiatric patients.

The Study

The efficiency of Viagra has been examined for the purpose of treatment of antidepressant-associated sexual dysfunction or AASD. Investigators studied 90 men in a prospective, randomized, parallel-group, double-blind, placebo-controlled trial, who fit in the criteria of DSM-IV for AASD and whose depression was in remission and whose antidepressant dosage had been stable for a minimum time period of 6 weeks. 88% of the antidepressant treatment constituted of fluoxetine, citalopram, sertraline and paroxetine. Viagra and placebo were randomly given to patients at a flexible dose starting with 50mg and that could be increased to 100mg for a span of 6 weeks.

The results were analyzed using the Clinical Global Impression Scale for Sexual Function( CGI-SF), the IIEF, the Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ), and the Arizona Sexual Experience Scale (ASEX). Baseline sexual complaints of the patients were not mutually confined and they included arousal problems (>87.8%), anorgasmia(21.2%), libido issues (64.4%), erectile dysfunction (86.7%), ejaculatory delay (69.9%) and 5.5% included various other problems related with ejaculation and orgasm. In the final analysis, observations of 89 out of 90 subjects were included and the last observation was carried forward.

Efficacy of Viagra

At least one dose of study medicine was taken by 93% of the subjects and a total of 85% subjects finished the entire 6 week protocol. As per the CGI-SF, 54% of the men who took Viagra showed good or excellent improvement in comparison with improvement being observed in only 4.4% of the men who were part of the placebo group (p<.001). On the total IIEF score, question 3 and 4, and also in the areas of orgasmic function, functions related to erection, intercourse and complete satisfaction, the efficiency of Viagra proved to be much more than that of placebo.  The only aspect which was not different in the two groups, in terms of statistics was the sexual desire.

Based on the total ASEX (self rated) and MGH-SFQ (clinician rated), the efficiency of Viagra was proved much higher in all areas such as arousal, sexual desire, orgasm ability, arousal, erectile function as well as overall complete satisfaction. There was no difference in the number of sexual attempts in interval of every 2 weeks for both the groups. It was 5.3 for the Viagra group and 4.5 for the placebo group. In comparison with placebo, men who were taking Viagra were seen to have more adverse effects (headache (40.5% vs. 9.8%),palpitations (4.8% vs. 0%), flushing (16.7% vs. 2.4%),  insomnia (9.5% vs. 4.9%), visual disturbances (11.9% vs. 4.9%), dyspepsia (7% vs. 0), nasal congestion (11.9% vs. 2.4%) and restlessness/anxiety (0% vs. 19.5%). The conclusion drawn by the investigators was that the men with AASD showed improvement in sexual as well as erectile function when they took Viagra and this betterment is likely to increase the cohesion to antidepressant therapy.

Investigation

In a study meant to analyze if the response to erectile dysfunction treatment is affected due to depression or not and if co-morbid depression and the quality of life symptoms are affected by the treatment of erectile dysfunction, men who were undergoing treatment for erectile dysfunction and who met the DSM-IV criteria for depressive disorder not otherwise mentioned (Depression, NOS), were enrolled by the investigators. All men who were suitable in the inclusion as well as exclusion criteria were taken in this double-blind, flexible dose, placebo-controlled trial of 12 weeks and they were randomized to one of the two medications, Viagra 50 mg or equal quantity of placebo.

All the subjects were required to complete the self report questionnaires and there was a psychiatrist who interviewed them at the beginning and then at weeks 8 as well as 12. Hamilton depressive scale (HAM-D), the Beck Depressive Inventory (BDI), the Clinical Global Impression (CGI) improvement scale, the Life Satisfaction Checklist as well as to global questions, “Did treatment improve your erection?” and  “Did treatment improve your ability to have sexual intercourse?” , were used to analyze the results. All men who took a minimum of one dose of study medicine and who had minimum one evaluation for efficacy, were included in the intent-to-treat analysis.

Analysis and Results

152 men in all were randomized (Viagra=74, placebo=78) and they were given one dose of study medicine , 136 of them had a minimum of one post randomization efficacy evaluation and 125 men or 82.2% of the total group finished the study ( Viagra=65, placebo=60). For 79.2% men, 100 mg was the final dose of Viagra  and it was 50 mg for the 19.4%. Only one man took 25 mg in comparison with the other 97.3% who were taking 100 mg in the placebo group. During the comparison between the initial and the final scores, it was concluded that the improvement was much higher for the Viagra group (in IIEF total score, questions 3 and 4,  sexual desire, intercourse satisfaction, orgasmic function, and overall satisfaction) as compared to the placebo group (p<.001 for all measures). Men who took Viagra showed 90.9% improved erections as compared to 11.4% for the placebo group and the ability  to have sexual intercourse was 89.4% better for Viagra group as compared to 14.3% for the placebo group. Only 14.3% men receiving placebo were regarded as the treatment responders, compared to 73% who received Viagra.

Conclusion

There was an association established between the improvement in the symptoms of depression and the improvement in the erectile function and this was regardless of the treatment assignment. There was a decline in the mean HAM-D and BDI scores of treatment-responsive men, 10.6 and 10.7 respectively. These reductions were definitely higher than the ones in men who were not treatment-responsive, 2.3 and 3.7 respectively (p<.001).There was a deep correlation established between the changes in IIEF questions 3 and 4, and erectile function scores and the changes in the HAM-D scores for all males. A higher percentage of men considering treatment-responders  compared to non-responders were able to meet the response criteria for depression an this percentage was measured by the HAM-D, 75.9% vs. 14.1% (p<.001), as well as CGI, 82.8% vs. 7.7%. Life as a whole is taken into consideration in the improvement of quality of life measures, and it was observed that the treatment-responders showed better sexual life, social contacts, relationship with the partner, leisure situation, financial condition and vocational situation. The percentage of adverse effects in Viagra group was 47.3 and 12.8 in the placebo group. A conclusion was drawn that erectile dysfunction in men along with mild to moderate depressive illness could be more efficiently treated with Viagra. An association between the erectile dysfunction improvement and depression and life quality improvement was also established.


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