Remember when Kintor announced Pyrilutamide’s Phase 3 trial results in 2023?
People immediately started coping and claiming this wasn’t that bad because based on the trail results “we know that the hair counts did increase, and the increase was due to the drug and not due to chance” - Haircafe [2].
Except you don’t “know” that. You could you knew that if the Pyrilutamide group performed statistically significantly better than the placebo group, but it didn’t, which implies the hair count increase could have been due to chance (or another factor) and NOT due to the drug. That’s the whole point of the placebo group.
“But who cares if the placebo group did similarly well?" one might say. "The end result is all that matters. If I grow more hair, why would I care if it’s mainly due to the placebo effect and not the actual drug?”
The problem with this train of logic is you don’t know if the improvement in hair counts in any of the groups was actually due to the placebo effect. Just because the control group got a placebo treatment doesn't mean the hair growth was caused by the placebo effect. The increase could have been caused by concomitant therapies, researcher bias, or the care effect; or it could have just been a statistical artifact created by regression to the mean [3, 4]. If this is the case, you would not get the benefit of the placebo effect by taking Pyrilutamide, because the placebo effect didn’t do anything. Really, the placebo effect is largely overhyped because people keep misattributing the effects of these other factors to “I think drug will do thing so thing happens durr”.
The Pyrilutamide group grew hair compared to baseline with statistical significance (P<0.0001). However, there was NO statistical significance compared to placebo (though a “trend in efficacy” was observed) [1].
https://portalvhds1fxb0jchzgjph.blo...ents/1591631/HKEX-EPS_20231127_10979479_0.PDF
https://portalvhds1fxb0jchzgjph.blo...ents/1591631/HKEX-EPS_20231127_10979479_0.PDF
Except you don’t “know” that. You could you knew that if the Pyrilutamide group performed statistically significantly better than the placebo group, but it didn’t, which implies the hair count increase could have been due to chance (or another factor) and NOT due to the drug. That’s the whole point of the placebo group.
“But who cares if the placebo group did similarly well?" one might say. "The end result is all that matters. If I grow more hair, why would I care if it’s mainly due to the placebo effect and not the actual drug?”
The problem with this train of logic is you don’t know if the improvement in hair counts in any of the groups was actually due to the placebo effect. Just because the control group got a placebo treatment doesn't mean the hair growth was caused by the placebo effect. The increase could have been caused by concomitant therapies, researcher bias, or the care effect; or it could have just been a statistical artifact created by regression to the mean [3, 4]. If this is the case, you would not get the benefit of the placebo effect by taking Pyrilutamide, because the placebo effect didn’t do anything. Really, the placebo effect is largely overhyped because people keep misattributing the effects of these other factors to “I think drug will do thing so thing happens durr”.
- Kintor Pharmaceutical Limited. (2023, November 27). KX-826 treatment for male pattern hair loss: China phase III clinical trial results [Press release]. Hong Kong Exchanges and Clearing Limited. https://ea-cdn.eurolandir.com/press-releases-attachments/1591632/HKEX-EPS_20231127_10979480_0.PDF
- Haircafe. (2023, Nov 28). Pyrilutamide phase III results: Kintor has betrayed us! [Video]. YouTube.
- Ernst, E., & Resch, K. L. (1995). Concept of true and perceived placebo effects. Bmj, 311(7004), 551-553.
- Wang, N., Atkins, E. R., Salam, A., Moore, M. N., Sharman, J. E., & Rodgers, A. (2020). Regression to the mean in home blood pressure: analyses of the BP GUIDE study. The Journal of Clinical Hypertension, 22(7), 1184-1191.
