Table 4. Gender affirming hormone therapy versus no gender affirming hormone therapy: evidence from case series.
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Certainty of evidence (GRADE) | Comments | |
|---|---|---|---|---|---|---|
| Risk with no GAHT | Risk with GAHT | |||||
| Death by suicide, long term follow-up assessed with: medical records, follow-up mean 24 months† | No comparison group available | 6 per 1000 (1 to 18) | Proportion 0.006 (0.001 to 0.018) | 315 (1 non-randomised study)20 | ⨁◯◯◯ Very low‡ | The evidence is very uncertain about the effect of GAHT on death by suicide at long term follow-up in natal males and females |
| Cardiovascular events, long term follow-up assessed with: medical records, number of events, follow-up 7–109 months†§ | No comparison group available | 40 per 1000 (30 to 50) | Proportion 0.04 (0.03 to 0.05) | 3875 (1 non-randomised study)31 | ⨁⨁⨁ ⨁ High¶ | The proportion of natal females experiencing cardiovascular events at long term follow-up is 40 per 1000 |
| Cardiovascular events, long term follow-up assessed with: medical records, number of participants with an event, follow-up mean 26 months†** | No comparison group available | 0 per 1000 (0 to 10) | Proportion 0.00 (0.00 to 0.01) | 1893 (1 non-randomised study)32 | ⨁⨁⨁◯ Moderate††¶ | The proportion of natal females experiencing cardiovascular events at long term follow-up is 1 per 1000 |
| Other outcomes, not measured‡‡ | – | – | – | – | – | – |
Grading of recommendations assessment, development and evaluation (GRADE) Working Group grades of evidence. High certainty=we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty=we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty=our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty=we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
The risk in the intervention group (with 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (with 95% CI).
Long term follow-up: outcome measured at ≥12 months of follow-up.
Rated down three levels for risk of bias due to lack of a comparison group.
Cardiovascular events included stroke, myocardial infarction and venous thromboembolism.
We did not rate down for risk of bias because this outcome does not need a comparison group, as the study participants can only experience this outcome if they have received the intervention.
Cardiovascular events included thromboembolism.
Rated down one level for indirectness because this study included natal males only.
Other outcomes not measured: gender dysphoria, global function, depression, sexual dysfunction from physiological perspective (ie, lack of erection, dyspareunia, problems related to dry and degenerated mucosal tissue, and anorgasmia) and bone mineral density.
GAHT, gender affirming hormone therapy.