Tavi finally publish their study...

[rogdmum]

“ Overall patient experience of changes on GnRHa treatment was positive. We identified no changes in psychological function. Changes in BMD were consistent with suppression of growth. Larger and longer-term prospective studies using a range of designs are needed to more fully quantify the benefits and harms of pubertal suppression in GD”

Looking forward to the experts going through it...

journals.plos.org/plosone/article?id=10.1371/journal.pone.0243894

The kids were 12-15 & apparently able to give informed consent. So precisely the age range the court considered would be unlikely to be able to give informed consent.

So not better psychologically then? And why would you want to suppress growth in teenagers exactly?

This is what Mermaids have tweeted about the study

This peer-reviewed paper highlighted that the majority of young people felt 'happier' and developed 'better relationships with family and peers once treatment had begun'.

Which isn't quite true. I think they need to look more carefully at the graphs and the study then go on to read the full report including this important sentence

"We found no evidence of change in psychological function with GnRHa treatment as indicated by parent report (CBCL) or self-report (YSR) of overall problems, internalising or externalising problems or self-harm."

@Langrycleg

So not better psychologically then? And why would you want to suppress growth in teenagers exactly?

Growth in teenage boys perhaps, but not girls.

And doesn't bone mass usually increase greatly during adolescence, which is a good thing.

What does "no changes in psychological function mean"?

What does "no changes in psychological function mean"?

It means they didn't feel any happier despite being closer to their true authentic self.

So the report says they didn't feel any better and that long term studies on the physical implications are needed. And this is a victory?

All the stuff about bone density loss, developmental delay and other adverse outcomes is already known. There is only one relevant new piece of data in there.

Young people experienced little change in psychological functioning across the study. We found no differences between baseline and later outcomes for overall psychological distress as rated by parents and young people, nor for self-harm.

In other words PBs have no positive effect on Gender Dysphoria. All those costs for no benefit.

This was actually released the very day after the Bell case concluded. It's the data they told the court wasn't ready.

And why would you want to suppress growth in teenagers exactly?

Yes, all these teen girls who are being 'helped not to grow boobs and have periods get the joy of living as a really tiny bloke.

If they'd been brought up in masculine culture they think twice about that grass being greener.

'44 patients had data at 12 months follow-up, 24 at 24 months and 14 at 36 months'

Its a pretty small sample, no?

Its a pretty small sample, no?

Yep, and yet it's the most long term follow up they've ever done.

I can't actually think of another study explicitly on PBs in children which has better data. The more relevant ones are linked in the discussion at the end of this study and some of their limitations are highlighted.

Would be interested if anyone has a longitudinal study with bigger samples.

A very quick look at this makes me wonder about a number of areas. No data sharing, of course, which is a shame.

What did that letter by Biggs say? They're talking about sample size and type 1 errors a lot, but/so why are they not reporting effect sizes as well as statistical significance, to back up their arguments (if the effect sizes do indeed back up their arguments)?

This is an interesting sentence:
The differences between our findings and the previous GIDS study re change in psychological function may relate simply to sample size

From what I can see, the previous study (which presumably showed improvements in psychological functioning) used a clinician-reported measure (i.e., clinicians giving ratings based on their judgments). The measures in the current study are based on parent- and self-report.

The follow-up rate at 24 months isn't great, is it? Less than a third for most measures?

Also, if it is down to small sample size that they're not seeing improvements, you'd expect the trends to be in positive directions, which doesn't seem to be consistently the case. Again - what are the effect sizes? This is a lazy report, at best.

Mermaids reporting of this study is deeply irresponsible (cherry picking qualitative data and missing the overall messages). What a surprise....

The numbers are tiny and they have a very high drop out rate- almost 50% over 3 years, with no comment made on this. They've conflated the male and female data in the tables so unpicking what happened to bone mass density and height in the different sexes is impossible. The overall result seems to be no change in psychological
functioning (including self-harming) so no happier and no less risk of self-harm, shorter, fatter and lower bone mass density. Seems like a pretty useless 'treatment'. Median time to starting puberty blockers after first consult was less than 4 months.

Apologies I got the drop out rate wrong- only 14/44 followed up to 36 months. That's pretty terrible & the reviewers really should have questioned why that was. They also should have summarised their data by sex, as height & bone mass density develop differently in males & females. The tables are poorly done.

It’s not a drop out rate. It’s due to the varying ages the children were when they started in the study and so how long they were on PBs before moving onto CSH.

Am I overlooking it, or is there no breakdown of the "psychological functioning"/distress data for males and females? It's noted in the discussion that a previous study found a benefit for males and not females(? - am I remembering this right?). If so, there may also be some obfuscation here.
While there's an argument for not doing too many significance tests on the data, why are they not publishing the effect sizes and confidence intervals for the males and females separately? I hope there's supplementary info available somewhere....

rogdmum - is the average age to go onto CSH 16/17? So there were 14 children who started PBs at 13 and the other children in the study were older?

There is a real possibility that people declined to complete the study because of worsening mental health, or because they detransitioned or other wise stopped medical treatment. This is not discussed in the article. No way can this be used as an evidence base for puberty blockers.

Clymene Yes, 16 as the starting age for CSH (assuming all more or less went straight onto them- haven’t read it fully to see if there were any long delays in the 43) so yes re ages.

Raiders No, no one dropped out. 43 out of the 44 went onto CSH. Only one didn’t (but did stop PBs)

No change is pretty bad. You would have thought placebo effect and regression to the mean should have shown some positive impact so no change would suggest a possible negative impact?

Also, didn't Biggs find an increase in self harming in girls in earlier data? Now hidden by mixing sexes.

Without looking but from memory, only 3 of the boys tried to freeze sperm and failed.

Maybe Mermaids could comment on that.

Changes in BMD were consistent with suppression of growth.

I view this as unethical. BMD is supposed to increase to peak level during puberty.

Think of dwelling in the foothills until puberty, then rapidly climbing a very high mountain, then coming off post-puberty on a gentle slope that then declines much more noticeably in postmenopausal women (whose levels remained above the foothills of their childhood though). BMD levels in these kids on PBs never leave the foothills. They remain below the levels of a postmenopausal woman.

Not to specifically point this out is to deliberately minimise a severely harmful side effect of PBs.

There is an obvious explanation as to why psychological functioning and distress data show no improvement.

These children are frozen. Their peers continue to develop. That's why earlier analysis showed that they showed an initial improvement, but within a year were either as bad as or worse than before.

Because their peers are moving on. They're standing still. They're old enough not just to notice but understand that this is not good for them.

Physical development arrested.
Brain development arrested.
Emotional development arrested.

Their peers are falling in love, taking first tentative steps exploring sexuality. They're maturing emotionally. Their decision making and reasoning improves. Their ability to handle challenging situations improves. And so on.

But these kids are on PBs and have to wait until they're 16 before they can move on. They cannot ever catch up, because their peers continue to develop.

So, if this is the preferred answer to the criticism of puberty blockers, then puberty blockers cannot be said to offer a pause that alleviates distress and allows time to consider the options in an atmosphere free from stress and pressure.

So what are they then? Logically, the stepping stone to the whole package of life-altering medical transition.

Times reports it also:

www.thetimes.co.uk/article/01718952-6591-11eb-908c-00b0fcb974f6?shareToken=5d13efa8babcf054d5272568ada1b731

Changes in BMD were consistent with suppression of growth.

This is unusually honest. They usually gloss this more and say "there was no loss/change in bone density". Hoping readers don't register the fact that bone density should be increasing rapidly in normal development at this point.

I think they may have changed this in review, because there was some reporting on the first draft around this point, eg this by Michael Laidlaw. (Where did his Twitter go?)

What would need to be established is whether it's possible to catch up with the missed bone density gain later.

And I assume the Tavistock aren't doing any such studies because by that point they've passed their puberty-blocked children onto adult services? Is anyone?

Here's another thread by Will Malone about a previous study.

That study was pretty blasé:

We have shown that there is no actual change in BMAD or tBMD in young transgender adolescents on long term GnRHa therapy, and certainly no true fall as initially suspected. We suggest that yearly DEXA scans may not be necessary. We also suggest that reference ranges may need to be re-defined for this patient cohort.

In both cases they're effectively asserting "it's okay, because we've stopped growth". They're (possibly more accurately) viewing "puberty blockers" as "growth blockers" or "maturity blockers", in which case, yes, maybe you wouldn't expect to see gain while receiving them.

But will you get it back later? Studies?