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    3 Comments for this article
    EXPAND ALL
    Reliable Efficacy
    Paul Nelson, M.S., M.D. | Family Health Care, P.C. retired
    Now retired as of 2016, my professional career spanned 41 years as a Med-Ped Primary Physician. Amidst the human expression of each person's sentient Reflective-Cognition capabilities, it is seemingly impossible to understand the phenomenon of pedophilia. The tragic effect on its victims and their parents is profound, as must be the unrelenting isolation and obsessive loss of thought control that is experienced by the perpetrator. During a Primary Physician's career, my own estimate is that the occurrence rate is somewhere around 5 of their patients during a lifetime career will be so affected. These relationships are never to be forgotten.

    For this study, a 10-week trial may be a good beginning, trailhead if you will, but it should never be viewed as a potential treatment paradigm. The risks to a community's neighborhoods are just too high given that a fundamental explanation for this isolated, deeply entrenched anomaly of life just doesn't exist.
    CONFLICT OF INTEREST: None Reported
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    Editorial comments: Landgren et al (2020)
    Renee Sorrentino, Clinical Assist Prof | Harvard Medical School; Institute for Sexual Wellness
    Landgren et al (2020) wrote an important article about preventing child sexual abuse by treating pedophilic disorder. It gives us who treat paraphilias another weapon in our scant armamentarium. I would like to offer three comments. First I think if you carried out a “crossover study” by giving the placebo group Degarelix and vice versa you would have increased the statistical power of your study of small numbers. Secondly, if you added an objective measure of sexual arousal such as the penile plethsmograph, you could establish an objective measure of efficacy. Lastly I find it interesting that you would not separately refer to my article published in 2012, which was specifically written for the use of Degarelix in paraphilias and chose to bundle my 2012 article with other articles that do not mention Degarelix but other drugs with antagonistic properties to treat paraphilias. As far as I know I was the first to postulate and publish that Degarelix could be used to treat paraphilias. I welcome your response.
    CONFLICT OF INTEREST: None Reported
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    Answer to Dr. Sorrentino
    Christoffer Rahm, MD PhD | Karolinska Institutet
    Dear Dr. Sorrentino,
     
    Thank you for your comment.
     
    When planning for the study back in 2013, we analysed the neurobiology involved in dynamic risk factors for committing repeated sexual offences (not only related to paraphilia, but in general), and found them to partly converge on testosterone, probably both its genomic and non-genomic effects. We thought that if a GnRH antagonist was used it would most likely have a beneficial effect on total risk. Based on clinical experience, our use of degarelix in research for other clinical groups, and experience from the helpline Preventell calling for a quick-acting medicine with
    a tolerable side effect profile and few drop outs, without need for multipharmacy, we thought degarelix would be the most optimal choice and an hypothesis worth exploring in a clinical trial. It was encouraging to discover your article a couple of years later, where you with a slightly different line of reasoning had suggested degarelix should be explored as a treatment for paraphilia. It felt natural to cite you in the resulting article, but we didn’t want to neglect the importance of some other papers in the long history of using antiandrogens as paraphilia treatment.
     
    There are pros and cons with different trial designs, and the choice needs to be balanced against several factors. While we agree that a cross-over design would yield increased statistical power, blinding of participants most probably would be compromised; participants would understand whether the new injection is placebo or castration. The cross over design also includes the risk for carry-over effects that are unknown in this type of intervention therapy where we do not know what washout time would be needed and how slow/fast recovery might be.

    Our design and outcome measures were chosen for reasons we describe in the paper. We encourage anyone with an interest for paraphilic disorder treatment to go from theory to practice and initiate clinical trials, and the design you suggest might be a good alternative depending on the purpose of the trial. 
     
    Kind regards
    Christoffer, Valdemar & Stefan
    CONFLICT OF INTEREST: None Reported
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    Original Investigation
    April 29, 2020

    Effect of Gonadotropin-Releasing Hormone Antagonist on Risk of Committing Child Sexual Abuse in Men With Pedophilic Disorder: A Randomized Clinical Trial

    Author Affiliations
    • 1Institute of Neuroscience and Physiology, Gothenburg University, Gothenburg, Sweden
    • 2Karolinska University Hospital, Stockholm, Sweden
    • 3Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
    • 4Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden
    • 5Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
    • 6Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden
    JAMA Psychiatry. Published online April 29, 2020. doi:10.1001/jamapsychiatry.2020.0440
    Key Points

    Question  Can a gonadotropin-releasing hormone antagonist rapidly reduce the risk for committing child sexual abuse in men with pedophilic disorder who are seeking help?

    Findings  In this randomized clinical trial of 52 men with pedophilic disorder, treatment with degarelix statistically significantly reduced the risk for committing child sexual abuse 2 weeks after the initial injection.

    Meaning  This finding suggests that degarelix may serve as a rapid-onset, risk-reducing medication for men with pedophilic disorder.

    Abstract

    Importance  Evidence-based treatments from randomized clinical trials for pedophilic disorder are lacking.

    Objective  To determine whether a gonadotropin-releasing hormone antagonist reduces dynamic risk factors for committing child sexual abuse.

    Design, Setting, and Participants  This academically initiated, double-blind, placebo-controlled, parallel-group, phase 2 randomized clinical trial was conducted at the ANOVA center in Stockholm, Sweden, from March 1, 2016, to April 30, 2019. Individuals who contacted PrevenTell, the national telephone helpline for unwanted sexuality, were recruited. Eligible participants were men seeking help aged 18 to 66 years with a pedophilic disorder diagnosis and no contraindications to the intervention. The primary end point was assessed by intent-to-treat analysis.

    Interventions  Randomization to receive either 2 subcutaneous injections of 120 mg of degarelix acetate or equal volume of placebo.

    Main Outcomes and Measures  The primary end point was the mean change between baseline and 2 weeks in the composite risk score of 5 domains of child sexual abuse ranging from 0 to 15 points; each domain could be rated from 0 to 3 points. Secondary end points included efficacy at 2 and 10 weeks as measured by the composite score, each risk domain, quality of life, self-reported effects, and adverse events.

    Results  A total of 52 male participants (mean [SD] age, 36 [12] years) were randomized to receive either degarelix (n = 25; with 1 withdrawal) or placebo (n = 26). At 2 weeks, the composite risk score decreased from 7.4 to 4.4 for participants in the degarelix group and from 7.8 to 6.6 for the placebo group, a mean between-group difference of –1.8 (95% CI, –3.2 to –0.5; P = .01). A decrease was seen in the composite score at 10 weeks (−2.2 [95% CI, −3.6 to −0.7]) as well as in the domains of pedophilic disorder (2 weeks: −0.7 [95% CI, −1.4 to 0.0]; 10 weeks: −1.1 [95% CI, −1.8 to −0.4]) and sexual preoccupation (2 weeks: −0.7 [95% CI, −1.2 to −0.3]; 10 weeks: −0.8 [95% CI, −1.3 to −0.3]) in the degarelix group compared with the placebo group. No difference was seen for the domains of self-rated risk (2 weeks: −0.4 [95% CI, −0.9 to 0.1]; 10 weeks: −0.5 [95% CI, −1 to 0.0]), low empathy (2 weeks: 0.2 [95% CI, −0.3 to 0.6]; 10 weeks: 0.2 [95% CI, −0.2 to 0.6]), and impaired self-regulation (2 weeks: −0.0 [95% CI, −0.7 to 0.6]; 10 weeks: 0.1 [95% CI, −0.5 to 0.8]), or quality of life (EuroQol 5 Dimensions questionnaire index score, 2 weeks: 0.06 [95% CI, −0.00 to 0.12], and 10 weeks: 0.04; 95% CI, −0.02 to 0.10; EuroQol visual analog scale, 2 weeks: 0.6 [95% CI, −9.7 to 10.9], and 10 weeks: 4.2 [95% CI, −6.0 to 14.4]). Two hospitalizations occurred from increased suicidal ideation, and more injection site reactions (degarelix: 22 of 25 [88%]; placebo: 1 of 26 [4%]) and hepatobiliary enzyme level elevations were reported by participants who received degarelix (degarelix: 11 of 25 [44%]; placebo: 2 of 26 [8%]). Among the 26 participants randomized to receive degarelix, 20 (77%) experienced positive effects (eg, improved attitude or behavior) on sexuality and 23 (89%) reported adverse effects on the body.

    Conclusion and Relevance  This trial found that degarelix reduced the risk score for committing child sexual abuse in men with pedophilic disorder 2 weeks after initial injection, suggesting use of the drug as a rapid-onset treatment option. Further studies are warranted into the effects and long-term adverse effects of hormone deficiency.

    Trial Registration  EU Clinical Trials Register Identifier: 2014-000647-32

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