1. Men with pedophilic disorder treated with gonadotropin-releasing hormone antagonist degarelix were at significantly lower risk of committing sexual abuse 2 weeks following initial injection, as measured by a composite risk score.
Evidence Rating: 1 (Excellent)
It is estimated that roughly half of child sexual offenders have pedophilic disorder, defined as recurrent sexual attraction to prepubescent children associated with distress or negative consequences. Prior literature have found that offenders often report long periods of struggle with sexual urges prior to first offence, suggesting a possible window for intervention before a crime is committed. Currently, treatment options are limited, with psychotherapy, testosterone-suppressing medications, and antidepressants being some of the few recommended intervention options. In this randomized clinical trial, researchers recruited 52 men with pedophilic disorder to investigate the possible efficacy of degarelix, a gonadotropin-releasing hormone antagonist to rapidly reduce the risk of committing child sexual abuse. Prior literature have found the drug to be effective in decreasing testosterone levels to castration levels within 3 days without causing a testosterone flare, which is associated with significant side effects, and as such, the drug was hypothesized as a potentially effective rapid-onset treatment option that would be relatively well tolerated. A composite risk score (range, 0-15 points) consisting of 5 domains (pedophilic disorder, sexual preoccupation, impaired self-regulation, low empathy, and self-rated risk) was derived to operationally define sexual abuse risk and used as the primary end point. The composite risk score decreased from 7.4 to 4.4 for the 25 participants assigned to receive 240mg of degarelix subcutaneously, and from 7.8 to 6.6 for the 26 participants in the placebo group, a significant mean between-group difference of –1.8 (95% CI, –3.2 to –0.5; P = .01) – a result that was still present at 10 weeks post injection. The drug was also found to be effective in the high risk group (defined as composite risk score >10), which achieved a composite score reduction of 3.3 points by week 2, compared to no change in the placebo group. The drug was well tolerated, with no major adverse events being recorded and the majority of adverse events being confined to the injection site. Although findings concerning the primary end point appear promising, it was noted that there was no significant difference in quality of life between the treatment and placebo groups at 2 and 10 weeks, indicating that quality of life in affected individuals are governed by more than the core symptoms of the disorder alone. Nevertheless, study findings are promising and suggest that degarelix, or other gonadotropin-releasing hormone antagonists may emerge as a novel treatment option for rapid risk reduction in individuals with pedophilic disorder.
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