Italy's National Bioethics Committee (CNB) has issued updated guidance recommending significant restrictions on the use of puberty blockers for treating gender dysphoria, advocating for psychotherapy as the first line of treatment. The CNB's November 2024 guidance stipulates that puberty blockers should only be considered after mental health interventions have proven ineffective and exclusively within the context of well-designed research trials.
The CNB's recommendations are rooted in concerns about the limited scientific evidence supporting the use of puberty blockers for gender dysphoria. The committee highlighted the "insufficiency of scientific data" and the need for more robust studies to evaluate the efficacy and risks associated with these drugs. They emphasized that existing research is "inadequate to the objective" of determining the long-term effects of puberty blockers on adolescents.
Call for Rigorous Clinical Trials
The CNB strongly recommends that Italy fund independent clinical studies to obtain decisive data on the efficacy and risks of puberty blocker administration. These trials should adhere to the gold standard of double-blind, randomized controlled designs. While acknowledging the challenges of blinding in this context, the CNB believes that feasible designs can address this concern. They also call for a systematic review of existing evidence and relevant observational data within Italy, with analysis of outcomes by sex.
Ethical Considerations and Multidisciplinary Assessment
From an ethical standpoint, the CNB emphasizes the importance of multidisciplinary clinical evaluations. The prescription of tryptorelin, a common puberty blocker, should only occur after a finding of ineffectiveness of psychotherapeutic, psychological, and possibly psychiatric interventions. The decision-making process must be thoroughly documented at every step.
International Context and Diverging Practices
The CNB's report acknowledges the ongoing international debate surrounding the use of puberty blockers. It notes that while some countries, such as the United Kingdom, Sweden, Finland, and Norway, have discontinued or limited their use, others like Canada, the Netherlands, Belgium, and Switzerland continue to use them, albeit with heterogeneous practices. This divergence underscores the need for more definitive research to guide clinical practice.
Data Collection and Registry
Recognizing the uncertainty surrounding the risk-benefit ratio of tryptorelin, the CNB advocates for prescriptions to occur primarily within trials sponsored by the Ministry of Health. Even when administrations occur outside of trials, the CNB recommends adhering to the same rigorous criteria and submitting all data to a dedicated national registry. This is particularly important given the current lack of comprehensive data on tryptorelin use across Italian regions from 2019 to 2023.
