Spotlight on McDeavitt's literature review by Beryl Koener
- La Petite Sirène
- Jun 26
- 5 min read
McDeavitt, K., Cohn, J. & Kulatunga-Moruzi, C. Pediatric Gender Affirming Care is Not Evidence-based. Curr Sex Health Rep 17, 12 (2025).
This literature review evaluates both the benefits and the risks associated with the use of puberty blockers (PB) and gender-affirming hormones (GAH) in pediatric populations for the indication of gender dysphoria.
To do so, it reviews:
All available clinical studies (non-randomized studies or observational clinical research studies) to date on the use of puberty blockers (PB) and gender-affirming hormones (GAH) in pediatric populations with a diagnosis of gender dysphoria.
All available systematic reviews to date on the use of PB and GAH in pediatric populations for the indication of gender dysphoria.
→ As a reminder, according to the “evidence pyramid” recognized by the Cochrane Library and OpenMD (“Evidence Pyramid.” https://s4be.cochrane.org/blog/2014/04/29/the-evidence-based-medicine-pyramid/), systematic reviews and meta-analyses are at the top of the hierarchy of evidence quality.
Results: Safety and Effectiveness of PB/GAH – Individual Research Studies (Base of the Pyramid)
Table 1 of the review summarizes clinical studies on safety and risks.
Table 2 of the review summarizes clinical studies on efficacy and benefits.
→ Both tables present statistically relevant data from the reviewed studies.
Findings:
11 longitudinal studies found a decrease in bone mineralization with PB use; two longer-term studies showed that bone mineralization returned to baseline levels after 3 to 11 years of subsequent GAH use in birth-assigned females—but not in birth-assigned males.
Several longitudinal studies on metabolic outcomes after PB and/or GAH use reported increased body mass index (BMI) and atherogenic changes in blood lipid profiles.
About half of these studies reported improvement in at least one mental health outcome; however, the largest study found worsening mental health, as measured by an increase in psychotropic medication use (Hisle-Gorman E et al., J Sex Med. 2021;18(8):1444–54), and two patient suicides were reported in one study (Chen D, N Engl J Med. 2023;388(3):240–50). Seven studies found no change in mental health outcomes, and one cohort study reported that improvements were similar between a group treated with PBs and a group treated with psychotherapy alone (Costa R et al., J Sex Med. 2015;12(11):2206–14).
Note: A small number of studies evaluated sexual function and surgical outcomes as related to prior treatments (age of initiation, type of intervention…):
→ Findings on sexual function are inconsistent.
→ Studies reported a higher number of intestinal vaginoplasties in patients treated with PBs at Tanner stage II or III.
Results: Safety and Effectiveness of PB/GAH – Systematic Reviews and Meta-Analyses (Top of the Evidence Pyramid)
Table 3 of the review summarizes all existing systematic reviews.
Findings:
One review, commissioned by Finnish health authorities in 2019, is not available in English.
Two reviews (Rew L, et al., Child Adolesc Ment Health. 2021;26(1):3–14; Ramos GGF, et al., J Endocrinol Invest. 2021;44(6):1151–8) were less rigorous (they did not assess the quality of the evidence). This lack of rigor was noted in an umbrella review that rated their methodologies as low quality (Brignardello-Petersen R, et al., [link above]).
Rigorous systematic reviews:
a. Emphasized that most studies in the field suffer from methodological weaknesses, such as short follow-up periods, lack of control groups, high attrition rates, and failure to control for confounding factors. No randomized controlled trials exist, and heterogeneity among populations and interventions limits analysis.
b. Systematic reviews using the GRADE method generally found the evidence to be of very low certainty regarding treatment benefits. This means the actual effect of PB/GAH (on outcomes such as mental health, gender dysphoria, depression, suicide risk, etc.) is likely to differ significantly from the reported results.
c. Other rigorous reviews used standardized alternative methods to evaluate the evidence and arrived at similar conclusions: evidence on the use of PB/GAH in this population is weak.
Results: Surgical Interventions in Minors
The review does not discuss outcomes of surgical interventions in minors in detail, but includes three clinical studies to date on surgeries for minors (see Tables 1 and 2), and refers to a recent systematic review and meta-analysis on mastectomy:
Findings:
Evidence on the outcomes of gender-affirming surgeries in children and adolescents is also limited.
A recent systematic review on mastectomy in youth with gender dysphoria (Miroshnychenko A et al.) found low or very low-certainty evidence on mental health outcomes and high-certainty evidence of at least one elevated risk of harm (including necrosis and excessive scarring).
The umbrella review (Brignardello-Petersen R, et al.) likewise found low or very low-certainty evidence regarding surgical outcomes in adolescents—confirming findings from another recent systematic review (Dopp AR, et al.).
Discussion and Conclusion (translated excerpts from the article):
“Based on the current state of evidence, it is impossible to determine what kind of impact—positive, neutral, or negative—gender-affirming care in the form of PB/GAH might have on mental health outcomes, including gender dysphoria or suicidality. Evidence regarding risks such as reduced bone mineralization or metabolic issues is also of low or very low certainty. However, this does not contradict the fact that infertility is an expected side effect of treatment for some patients, as is the possibility of long-term sexual dysfunction.”
“If PB/GAH are administered with the aim of improving mental health outcomes (e.g., gender dysphoria, suicidality) or related measures (e.g., quality of life, psychosocial functioning), clinicians must be aware that the evidence supporting such use is remarkably weak. Based on existing studies, it is not possible to determine what effects PB/GAH may have on the health and well-being of minors experiencing gender-related distress. Therefore, it is inaccurate to describe current pediatric gender-affirming care as “evidence-based” (EBM).”
[1] - van de Grift TC, van Gelder ZJ, Mullender MG, Steensma TD, de Vries ALC, Bouman MB. Timing of puberty suppres- sion and surgical options for transgender youth. Pediatrics. 2020;146(5):e20193653.
- Bungener SL, de Vries ALC, Popma A, Steensma TD. Sexual experiences of young transgender persons during and after gen- der-affirmative treatment. Pediatrics. 2020;146(6):e20191411.
- Van Der Meulen IS, Bungener SL, Van Der Miesen AIR, Hannema SE, Kreukels BPC, Steensma TD, et al. Timing of puberty suppression in transgender adolescents and sexual func- tioning after vaginoplasty. J Sex Med. 2024;22(1):196–204.
[2] - Ascha M, Sasson DC, Sood R, Cornelius JW, Schauer JM, Runge A, Muldoon AL, Gangopadhyay N, Simons L, Chen D, Corco- ran JF. Top surgery and chest dysphoria among transmasculine and nonbinary adolescents and young adults. JAMA Pediatr. 2022;176(11):1115–22. Available from: https://jamanetwork. com/journals/jamapediatrics/fullarticle/2796426.
- Milrod C, Karasic DH. Age is just a number: WPATH-affili- ated surgeons’ experiences and attitudes toward vaginoplasty in transgender females under 18 years of age in the United States. J Sex Med. 2017;14(4):624–34.
- Olson-Kennedy J, Warus J, Okonta V, Belzer M, Clark LF. Chest reconstruction and chest dysphoria in transmasculine minors and young adults. JAMA Pediatr. 2018;172(5):431–6.
[3] Miroshnychenko A, Roldan YM, Ibrahim S, Kulatunga-Moruzi C, Dahlin K, Montante S, Couban R, Guyatt G, Brignardello- Petersen R. Mastectomy for individuals with gender dysphoria below 26 years of age: a systematic review and meta-analy- sis. Plast Reconstr Surg. 2021:10–97.
[4] Dopp AR. Interventions for gender dysphoria and related health problems in transgender and gender-expansive youth: A system- atic review of benefits and risks to inform practice, policy, and research. Rand Health Q. 2024;12(2):2.
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