RE:RE:RE:RE:RE:RE:RE:RE:NASH and fructose What you're suggesting is basically unethical and is not what any NASH trial has done in practise. You can't withhold Standard of Care from a patient on a trial. In the case of NASH Standard of Care is advise on diet and exercise (D&E). Every NASH trial has a D&E component. Companies rarely talk about it, probably because it complicates the story as you say. KOLs interested in taking the whole NASH field forward talk about it a lot especially in connection to the problematic placebo signal, you should go find instances were KOLs are talking about the subject to understand it better.
Generally speaking humans are not guinea pigs or robots, you just don't get to completely impose your will on them for the good of the trial. You recognize that some aspects of a trial are suboptimal for the data and you work to minimize the impact.
Jfm the problem you are identifying is real and recognized by the whole field, it's just your solution is way off the Mark. It's not what companies actually do, are allowed to do and I hope want to do. You have to think just a little beyond the desire for 'clean' data to understand why you are wrong.
jfm1330 wrote: I think you don't get my point. I don't care what patients in the trial will eat. The key is for them to continue eating the same stuff that lead them whith NASH in the same way. Same for exercicise. If some patients, not all of them, either in the drug group or placebo group start changing their way of eating and execising, for the worst or the better, it will mess up the results. So this is the key, and it is what will be a challenge for the scientists running that trial.
scarlet1967 wrote: I have no doubt improving eating habits and exercise routines can help the trial in fact that's mostly the only remedy for NASH at the moment but addiction regardless if it's to food,alcohol or drugs etc is a serious disease! Most medical professionals including physicians, psychologists, psychiatrists to this date are struggling with this vicious disease so I don't agree with the notion food addiction is something different to other addictions. My point is you can try to change these habits but you are mostly wasting your time by only giving the patients some printed information and expect it to work and yes it's a challenge even with trial participants regardless whether they are injected routinely for 18 months or not as you can't police them 24/7 and quite frankly I don't blame folks who don't get it cause one has to have been on the receiving end to fully understand the problem.
jfm1330 wrote: Addiction like alcoholism is something else. But again, read the article I referenced. Standardisation of eating and exercise is key to the success of a NASH trial. It is a real challenge. It will not occur for every patients, but some, knowing that they will be closely followed, could change their habits to a certain extent, even more considering that they are motivated enough to enter in a trial where they will need to inject themselves every day.
scarlet1967 wrote: Obviously you are motivated and not compromised mentally so you managed to make changes in your life style which is great. There is a mental aspect to people's habits. A very close person to me is a recovering alcoholic, naively my only advice to her was well stop drinking but that didn't happen so we tried physiotherapists, medication,multiple rehabs for years with no luck until she started to realize she needs to get all the help available otherwise she would die she was ready to change all the above plus AA meetings, AA sponsorship eventually put her on the right track.
That's the reason I say if people could change their habits they would and sometimes it's not as easily done.
Binge eating disorder is the most common eating disorder in the US and Europe and just giving dietary advice will not work unless the underlying mental disorder is addressed.
jfm1330 wrote: Hey! I was not off the marks in my thinking. Here is a link to a recent full article on the subject of the necessity of standardisation of diet and exercise in the context of NASH trials. They say it is a major point in achieving misleading results and hard to compare results with other NASH trials.
https://www.journal-of-hepatology.eu/article/S0168-8278(20)30274-9/pdf
I remember my father was changing his diet two weeks before going to the hospital for his annual blood test. He told me he wanted to please his doctor...
Personnaly, as I said here before, I have a fairly serious chronic illness, and in the last 12 years, I dropped gluten from my diet, and more recently, meat, fish, seafoods, alcohol and I avoid as much as possible refined sugars. No restaurant meal, and no transformed food. I cook everything myself from raw ingredients. Maybe I am different from the average patient, but it's what I had to do to maintain a relatively good quality of life and life expentancy.