RE: Overall responder/p-values7 Oct 2020 10:49
Hi harlequinrasbora you have a sensible post on the data in the RNS, from the clinical trial I note
Primary outcome measure
The number of patients who demonstrate more or equal to 50% improvement in their cohort specific symptoms as measured by responses to Abdominal Pain Intensity Scale, Stool Frequency and Stool Consistency questionnaires [ Time Frame: Baseline to EOT up to a maximum of 8 weeks, two treatment cycles (one cycle = 28 days) ]
Whats interesting is many of the placebo arm also reported big improvements on their questionnaire which is obviously an issue when it comes to the results. The difference between the placebo and drug is reported as follows
In IBS-C patients (n=76) a numerically superior but statistically non-significant overall response rates of 25% compared to 17.1% for placebo (n=82) (p=0.152), representing an RR of 1.46 (95% confidence interval: 0.791, 2.711); and
· In IBS-D patients (n=94) a numerically superior but statistically non-significant overall response rate of 23.4% compared to 17.8% for placebo (n=101) (p=0.216), representing an RR of 1.31 (95% confidence interval: 0.753, 2.290).
This is why myself and others are not singing from the rooftops. Maybe I misinterpret the results as im not a scientist but as a trader it made me worry.