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Wait. Did you just call the efficacy of an FDA approved product “fake” while heaping praise on a compound that’s never gone through a clinical trial?


Randomized study of the efficacy and safety of oral elderberry extract in the treatment of influenza A and B virus infections.

https://www.ncbi.nlm.nih.gov/pubmed/15080016

Edit: Symptoms were relieved on average 4 days earlier and use of rescue medication was significantly less in those receiving elderberry extract compared with placebo.


All right, so it was tested in a randomized clinical trial. However it was 30 treated patients, so pretty small. And a trial not actually signed off on by the FDA.

Also, I’m surprised symptoms were alleviated 4 days (96 hours) sooner when the Tamiflu trial said total duration of symptoms were 78 hours for the placebo.


> All right, so it was tested in a randomized clinical trial.

Three or four actually.

> Tamiflu trial said total duration of symptoms were 78 hours for the placebo

And again, the Tamiflu data was faked. You can read the background on this here: https://www.bmj.com/content/345/bmj.e7303

When the real data was finally FOIA'd or whatever, it became clear that it no longer had even the minimal efficacy that was originally claimed. The way that FDA trials work is that you need two phase III studies showing a drug is more effective than placebo, but you're allowed to conduct unlimited trials that don't find any advantage over placebo without being required to make the data from these other studies public. That's what happened in this case, there were one or more additional studies that showed it wasn't effective, and when you included the data from the additional studies to calculate the overall effect the advantages disappeared.

There are several books about this, but since every time I link to books people complain that I'm trying to trick them into reading, here's an Internet article about what happened instead: https://articles.mercola.com/sites/articles/archive/2015/10/...

The main caveat on elderberry, other than the lack of FDA monitored clinical trials, is just that the stuff you're likely to find in your local drug store is Sambucol, which isn't the best quality. But you can go and buy this online that's actually good quality and not that expensive:

https://www.amazon.com/Gaia-Herbs-Black-Elderberry-Syrup/dp/...


I don't think the FDA would sign off on this RCT since it isn't a drug trial.


My question was more song the lines - “is this rigorous enough for FDA approval”?


> “is this rigorous enough for FDA approval”

Clearly it wouldn't meet the standards for a phase III clinical trial. But that doesn't necessarily mean it's worse. Pharma studies and plant studies both have their own sets of methodological issues, so it's hard to really compare them on how likely their findings are to be accurate or whatever. E.g. because elderberry isn't patentable, that eliminates most of the incentive to basically make up results like what happened with Tamiflu. But you also don't have the money to run multi-thousand person trials. How do these really compare with one another? It's hard to say.

For me, elderberry seems like the clear winner over Tamiflu because there are no negative side effects. At worst, it just doesn't work, but it only costs ~$0.65 per dose and the evidence that it does work is actually pretty compelling even though it would obviously be better if there were multi-site trials with larger sample sizes.


I'm afraid you _maybe_ just made the same mistake as those that knee-jerk down-voted you -- it would be incredible if there really were no side-effects at all; some people must be allergic? No negative interactions?


> it would be incredible if there really were no side-effects at all; some people must be allergic? No negative interactions?

Fair enough. Perhaps a more appropriate way to phrase that would be that it using it doesn't require any more precaution than trying any other new food for the first time.


How do you know 30 is small? What number is large, and how do you know that, too?


Xofluza’s phase III was almost 1,900 patients.

Generally the size of the trial scales with the potential population and the statistical power you are shooting for.


Just to add, it’s also a question of how many studies you can preform and not publish the results. Doing 100 different 30 person studies is vastly easier than doing the same with 2,000 people studies.


Well the efficacy of Tamiflu is very questionable, but I’ll admit the “elderberry syrup” thing threw me. Maybe a broken clock thing?


Wait. Did you just assume something hasn't gone through a clinical trial because of how it sounds? There have been trials done of the effectiveness of elderberry syrup.


What were the results? For that matter, do you have a reference?


as someone else pointed out above: https://www.ncbi.nlm.nih.gov/pubmed/15080016




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