(1) The randomization wasn’t super good, probably as expected with 500 people per group
(2) 30 people were lost to follow-up in the berberine group compared with placebo. If you exclude a bunch of people that will change the result.
(3) There are barely any adverse events reported in the trial, for the placebo group too, shouldn’t it be much more? (JUPITER had 15% serious adverse events in the placebo group).
They might’ve not reported adverse events properly.
I never expected supplement companies to be able to pay for the studies so there is comparable safety data with drugs… but that does not detract from my point.
It is not GRAS by the FDA and EFSA is doing a review soon, I would at least wait for that.
EFSA is reviewing the case because a member state “FDA” brought it to their attention:
The French Agency for Food, Environmental and Occupational Health & Safety (ANSES) has brought this ingredient to the EC’s attention, claiming the consumption of supplements made with plants containing berberine has led to gastrointestinal disorders, hypoglycemia and hypotension.
Bucchini is fairly certain this substance will be restricted, and points out it will be up to the industry to prove its safety. …
Thanks - Interesting reply. So not “super good” randomization - but good I surmise. I like how you point out about the 30 people lost to follow-up and how that impacts. And adverse events being possibly under-reported in placebo group.
I generally think the research literature, seeing as it is coming from China has been unrepresented in this discussion. Why wouldn’t a country looking out for its citizens welfare not want to take advantage of a cheap and historically valued drug? I think there is sound evidence - but not the kind you require.
It doesn’t matter where a study is from, there are flaws with this study which doesn’t make me believe in it, and there are better drugs than berberine. I see no reason why you would choose berberine over atorvastatin, for example, and a SGLT2i. Both have been studied in massive clinical trials and shown efficacy in hard endpoints. It is being evaluated by EFSA and people seem to believe it will be banned in EU - that is a very strong signal against safety if true.
I think I have a more pragmatic view than you. Berberine, in China, at simplest is used for intestinal distress. It is cheap, over the counter, effective. We are talking about a poor country. I will take your word for it that there are better drugs, but Berberine could simply suffice and have more impact given a drug’s cost.
People have their biases and it’s always a good idea to keep that in mind. @AnUser has a particular bias against supplements and in favor of pharmaceuticals and other people here do as well. That’s fine but should be taken into context. For the comment about Bucchini, you should read this for background. Not unbiased…but what is?
I am biased towards things that work and safely, based on available information.
There is a famous quote from Deng Xiaoping which summarizes my view on supplements vs. drugs: “It doesn’t matter whether a cat is black or white, as long as it catches mice.”
Since you brought up Deng and cats, let me quote his good buddy…
“We did get something, a gift, after the election … You know what it was? It was a little cocker spaniel dog … black and white, spotted, and our little girl Tricia, the six year old, named it Checkers. And you know, the kids, like all kids, loved the dog, and I just want to say this, right now, that regardless of what they say about it, we’re going to keep it.”
Richard Nixon
That’s the way I feel about supplements…“regardless of what they say about (them), (I’m) going to keep (them).”
I personally use Acarbose and Empagliflozin instead of berberine but if someone didn’t have access to those drugs, I could see berberine being beneficial.
