Nguyen-Khac E, Thevenot T, Piquet M-A, Benferhat S, Goria O, Chatelain D, Tramier B, Dewaele F, Ghrib S, Rudler M, Carbonell N, Tossou H, Bental A, Bernard-Chabert B, Dupas J-L, AAH-NAC Study Group. Glucocorticoids plus N-acetylcysteine in severe alcoholic hepatitis. N Engl J Med 2011 Nov.;365(19):1781–1789. PMID 22070475
NAC seems to be the drug of choice for all things liver related, and now people have tried it for alcoholic hepatitis
I remember finding out that you could use steroids for alcoholic heaptitis a few years ago and have used it a couple of times since – with occasional surprise from the med reg on call. There’s a Cochrane review under way at present
- In this trial in France, a group of unconflcited, non-pharma funded authors gave standard reigime of NAC (the paracetamol OD protocol) to people with alcoholic hepatitis.
- everyone got a month of 40mg pred ± NAC
- primary outcome was 6 month mortality
- n = 174
- mortality at 1 month 8% v 24% favouring NAC
- mortality at 6 months 27% v 38% favouring NAC
There were no real AEs of note from the NAC.
The interesting thing is that the authors just flat out call it a -ve trial, which strictly speaking it is. There statistical analysis required a p<0.05 and the 6 month mortality p was only 0.07
And that really doesn’t bother me too much I must say. For a drug that’s cheap and has minimal SEs (I know about the rash and the very rare anaphylaxis but it’s hardly a big deal) and seems to provide an actual mortality benefit then I think it’s something worth doing.
Be careful with p values as they do have a role, but remember they only tell us about the odds of a result being down to chance and say nothing about clinical significance. This is a small trial and a simple look back at the history of research will tell us that lot’s of things that initially look promising end up being wrong when we re-study them.
Even having said that I think I’d be happy enough to try this at this point. Anyone else?