This seems to be a nice observational study which analyses already available data, with an interesting and potentially important finding.
They didn’t do “controlling” in the technical sense of the word, they matched cases and controls on 40 baseline variables in the cohort with “demographics, 15 comorbidities, concomitant cardiometabolic drugs, laboratories, vitals, and health-care utilization”
The big caveat here is that these impressive observational findings often disappear, or become much smaller when a randomised controlled trial is done. Observational studies can never prove causation.Usually that is because there is some silent feature about the kind of people that use melatonin to sleep, that couldn’t be matched for or was missed in the matching. A speculative example here could be that some silent, unknown illnesses could have caused people to have poor sleep—which lead to melatonin use. Also what if poor sleep itself led to poor cardiovascular health not the melatonin itself?
This might be enough initial data to trigger a randomised placebo control trial using melatonin. It might be hard to sign enough people up to detect an effect on mortality—although a smaller study could still at least pick up if melatonin caused cardiovascular disease.
I agree with their conclusion which I think is a great takeaway
”These findings challenge the perception of melatonin as a benign chronic therapy and underscore the need for randomized trials to clarify its cardiovascular safety profile.”
This seems to be a nice observational study which analyses already available data, with an interesting and potentially important finding.
They didn’t do “controlling” in the technical sense of the word, they matched cases and controls on 40 baseline variables in the cohort with “demographics, 15 comorbidities, concomitant cardiometabolic drugs, laboratories, vitals, and health-care utilization”
The big caveat here is that these impressive observational findings often disappear, or become much smaller when a randomised controlled trial is done. Observational studies can never prove causation. Usually that is because there is some silent feature about the kind of people that use melatonin to sleep, that couldn’t be matched for or was missed in the matching. A speculative example here could be that some silent, unknown illnesses could have caused people to have poor sleep—which lead to melatonin use. Also what if poor sleep itself led to poor cardiovascular health not the melatonin itself?
This might be enough initial data to trigger a randomised placebo control trial using melatonin. It might be hard to sign enough people up to detect an effect on mortality—although a smaller study could still at least pick up if melatonin caused cardiovascular disease.
I agree with their conclusion which I think is a great takeaway
”These findings challenge the perception of melatonin as a benign chronic therapy and underscore the need for randomized trials to clarify its cardiovascular safety profile.”