Kintor has started Phase 3 trial in China for Pyrilutamide

5minutesbeforemiracle

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Pigeon is right in the essence of what he is trying to say. It's not about the trial being invalid, it's about the fact that the patients who were recruited for the phase 3 trial weren't screened properly. You can't be in the research field and want to be considered a reputable company and be making "mistakes" like that. It could be interpreted that they tried to con their way through the trial by selecting patients who had a better chance of recovery. The 80% share price drop speaks for itself and big money surely knows that too.

I want Kintors treatments to work as much as every optimistic person here, but I believe we should all exercise caution too.
I agree with what you're saying - it's really quite an amateurish error and is not a good look for Kintor. But to me it seemed like Pigeon was implying that they produced an ineffective drug, which is simply impossible to tell from their (lack of) results.
 

pegasus2

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Hmm... shouldn't the subjects not know how well the other participants in the trial are doing? If you hear ppl are regrowing hair, it can contribute to creating a placebo effect whether you're getting the placebo or the real deal.
Unless the primary outcome is patient self-assessment that doesn't matter. The trichoscope will tell how much hair they grew. The problem with that is if they aren't getting results they'll assume they are in the placebo group and start taking minoxidil.
 

Adri23

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Unless the primary outcome is patient self-assessment that doesn't matter. The trichoscope will tell how much hair they grew. The problem with that is if they aren't getting results they'll assume they are in the placebo group and start taking minoxidil.
Don't they sign a contract or something to only take that medication during the time the study is ongoing?
 

pegasus2

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Don't they sign a contract or something to only take that medication during the time the study is ongoing?
People would never lie. Ever wonder why some of these placebo groups have hair count increases? It's because a few of them are lying. Sometimes it's seasonal, but humans don't have a great deal of seasonal hair growth
 

champpy

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If all goes well with the Chinese approval, how much longer would it take before it was approved in the US? Anyone have any ideas?
 

Dimitri001

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Unless the primary outcome is patient self-assessment that doesn't matter. The trichoscope will tell how much hair they grew. The problem with that is if they aren't getting results they'll assume they are in the placebo group and start taking minoxidil.
I'm not saying they'd be fooled into thinking they regrew hair when they didn't, I'm saying hearing it works would induce or amplify a placebo effect, meaning an actual, real effect.
 

hmmmmmmmm

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I'm not saying they'd be fooled into thinking they regrew hair when they didn't, I'm saying hearing it works would induce or amplify a placebo effect, meaning an actual, real effect.
The risks are that people get unblinded, that they influence each other's behaviour or reporting of adverse effects, and that it implies poor study design or management. Placebo effect is just one downstream issue of unblinding

If you talk to another subject and figure out that you're in the placebo group, you may stop complying or even start another treatment without telling researchers.

One person might report that KX gave them weird dreams, and suddenly you have a dozen subjects reporting weird dreams.

Basically all the dumb stuff that happens in the discord groups now becomes possible in a clinical trial, with no upside
 

hmmmmmmmm

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to clarify - data bias won't matter much in this case, since it's a pretty vanilla chemical with a well understood mechanism, good dosing and safety data, and they've already decided to proceed to a multicenter phase III trial on top of a US phase II one

mostly it would be bad in terms of the confidence you could have in a new company being able to run a high quality trial
 

pegasus2

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I'm not saying they'd be fooled into thinking they regrew hair when they didn't, I'm saying hearing it works would induce or amplify a placebo effect, meaning an actual, real effect.
I'm not sure how you could placebo yourself into hair growth. I think this is impossible. Positive thinking won't grow hair. Of course it's amatuerish to allow trial subjects to talk to each other, but in the case of a hair loss trial I don't think it's such a big deal aside from side effects.
 

Dimitri001

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I'm not sure how you could placebo yourself into hair growth. I think this is impossible. Positive thinking won't grow hair. Of course it's amatuerish to allow trial subjects to talk to each other, but in the case of a hair loss trial I don't think it's such a big deal aside from side effects.
The placebo effect doesn't just make people think they're experiencing something when they're not, it's not merely a mental phenomenon, it can have actual physical effects and remarkable ones, ones you wouldn't imagine could be the result of placebo. There ARE thing it can't do, IDK whether hair regrowth is on the list, but I highly doubt it, because there's just so many amazing effects it can have, regrowing balding hair seems like a minor feat in comparison.
 
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pegasus2

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The placebo effect doesn't just make people think they're experiencing something when they're not, it's not merely a mental phenomenon, it can have actual physical effects and remarkable ones, ones you wouldn't imagine could be the result of placebo. There ARE thing it can't do, IDK whether hair regrowth is on the list, but I highly doubt it, because there's just so many amazing effects it can have, regrowing balding hair seems like a minor feat in comparison.
Source? It can only induce things that can be psychological. If stress is a factor then placebo can help. Stress does not cause Androgenetic Alopecia. No placebo can reverse a genetic disease.
 

hmmmmmmmm

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The placebo effect doesn't just make people think they're experiencing something when they're not, it's not merely a mental phenomenon, it can have actual physical effects and remarkable ones, ones you wouldn't imagine could be the result of placebo. There ARE thing it can't do, IDK whether hair regrowth is on the list, but I highly doubt it, because there's just so many amazing effects it can have, regrowing balding hair seems like a minor feat in comparison.
Good summary, people without any scientific or medical background would be very surprised at how much the brain can control our physiology

https://en.wikipedia.org/wiki/Neural_top–down_control_of_physiology

Still don't think that's the main concern here, it's that it would be another possible black mark against a Kintor's ability to run a trial
 

fashy

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Placebo effects mostly extend to psychological effects/perceptions in the user, they can't actually treat the disease itself. A participant in a pain-reliver study might report less pain even though he's effectively taking sugar pills, because the belief of taking the *right* medication can alter his perception of his pain levels, but in something such as a hair loss study you absolutely cannot fool yourself into growing hair as the disease itself is not concerned with the user's psychological state but with processes inside his body that he cannot control. You can't will your body in producing less DHT.
 

hmmmmmmmm

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Placebo effects mostly extend to psychological effects/perceptions in the user, they can't actually treat the disease itself.
You're not wrong that there are limits to this effect, but placebo groups in almost all hair loss studies experience some growth.

And it's a bit nuanced, but the main issue is the impact it would have on the behaviour of the placebo group, which is then falsely attributed to the effect.

Because the placebo effect in research is a latent variable that can only be measured indirectly, and unblinding compromises that measurement.

e.g. somebody figuring out they're not getting the real treatment and dropping out of the trial would be attributed as part of the background dropout rate, making KX look like it has a better dropout rate relative to placebo
 

pegasus2

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People without a medical background greatly exaggerate the ability of perception to alter bological function. These are the people who think prayer can cure their cancer so they forego chemotherapy. There are much more plausible explanations for placebo growth, as I previously mentioned. I was very happy when I started losing my hair. It came out of nowhere and was never expected. If changing my frame of mind, through reducing cortisol or whatever would have cured it then it never would've happened in the first place. This is pointless. When a hair loss drug actually works you will know. You won't have to debate endlessly about placebo effects and whether or not you see an improvement
 

Micky_007

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People without a medical background greatly exaggerate the ability of perception to alter bological function. These are the people who think prayer can cure their cancer so they forego chemotherapy. There are much more plausible explanations for placebo growth, as I previously mentioned. I was very happy when I started losing my hair. It came out of nowhere and was never expected. If changing my frame of mind, through reducing cortisol or whatever would have cured it then it never would've happened in the first place. This is pointless. When a hair loss drug actually works you will know. You won't have to debate endlessly about placebo effects and whether or not you see an improvement

And the same concept can actually be applied to the negative side effects of drugs, whereby people love to say ones sexual sides are "placebo bro" but if the only factor thats changed once someone started using a drug, was the use of the drug itself, and one of the side effects are sexual side effects, then its the drug that's the cause. I'm not mentioning any specific drug because there's a few we all know.
 

badnewsbearer

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People without a medical background greatly exaggerate the ability of perception to alter bological function. These are the people who think prayer can cure their cancer so they forego chemotherapy. There are much more plausible explanations for placebo growth, as I previously mentioned. I was very happy when I started losing my hair. It came out of nowhere and was never expected. If changing my frame of mind, through reducing cortisol or whatever would have cured it then it never would've happened in the first place. This is pointless. When a hair loss drug actually works you will know. You won't have to debate endlessly about placebo effects and whether or not you see an improvement
this right there. for me i can tell within a week if it works, reduction in shedding, reduction of itch, after a few weeks i can feel the difference in hair quality, not necesaarily bx look but by touching it, its heavier at some point, more colorful after a few months. i suppose it could be placebo if someone has verx slow hair loss and gets different cuts for example when i cut short my hair it looks much better because the thinning is then less obvious and shorter hairs feel stronger and more rigid. but other than that hard to believe someone would subjectively falsely think this
 

pegasus2

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And the same concept can actually be applied to the negative side effects of drugs, whereby people love to say ones sexual sides are "placebo bro" but if the only factor thats changed once someone started using a drug, was the use of the drug itself, and one of the side effects are sexual side effects, then its the drug that's the cause. I'm not mentioning any specific drug because there's a few we all know.
Sexual side effects are very easy to induce psychologically. In fact, up to a quarter of clinical ED is psychologically induced, and has no physiological cause. If you think you'll get ED you will. Hair growth isn't so easy unfortunately
 

Micky_007

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Sexual side effects are very easy to induce psychologically. In fact, up to a quarter of clinical ED is psychologically induced, and has no physiological cause. If you think you'll get ED you will. Hair growth isn't so easy unfortunately

I wouldn't agree with this. Its not so easy to just think something and it turn into reality. If such a thing was possible then why is it that the people who still suffer with sexual sides can't just think about having no sexual sides and they get healed? Doesn't work that way.

I know most people who started on anti-androgens were positive minded and ended up with being completely caught blindsided with sexual sides.
 
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