3 ms·

It's a first step. Preliminary studies like this are important: before investing a huge amount of money into proper studies, it's fiscally prudent to take small

It's a first step. Preliminary studies like this are important: before investing a huge amount of money into proper studies, it's fiscally prudent to take smaller steps. Instead of going straight for the generic criticism, you might ask "what's cool about this study?"

cpncrunch 12y ago
It doesn't really tell us anything, like all open-label studies (except perhaps whether or not the treatment is dangerous and whether it might provide a benefit). Also it doesn't really cost any more to do a small-scale placebo-controlled trial vs an open-label study. Overall open-label studies just give false hope to people who don't understand science and the placebo effect (i.e. most people).
- ZenoArrow 12y ago
  "just give false hope to people who don't understand science and the placebo effect" You understand how the placebo effect works then? You'd be the first person in the world that did. As kevinalexbrown said, this trial can be seen as a first step, nobody who read the article could reasonably expect the FDA to approve this tomorrow.
  - cpncrunch 12y ago
    I didn't say I understood how the placebo effect works (although perhaps I have a better idea than many people, as I've written a book about it). What I meant is that - as I pointed out above - this study will have a siginificant placebo effect, and the results should therefore be treated with extreme caution. We still have no idea whether this treatment actually works, and I'm constantly surprised that studies like this continually make the first page of HN. I think the problem is that most people don't know that the placebo effect actually exists (or at least, they forget about it when they read a study like this, or downplay its significance). Even many researchers underestimate the placebo effect, and then we end up spending billions of dollars a year on a useless treatment until someone actually proves that it is no better than placebo. http://www.nytimes.com/2014/10/07/upshot/the-placebo-effect-doesnt-apply-just-to-pills.html?_r=0&abt=0002&abg=0 http://www.nytimes.com/2014/10/07/upshot/the-placebo-effect-...
    - ZenoArrow 12y ago
      "this study will have a siginificant placebo effect, and the results should therefore be treated with extreme caution" You have no way of proving this. Let's face it, we do not have a good grasp on the factors involved in the placebo effect, for example we don't know whether someone needs to be susceptible to it for it to work, we don't know how to reliably trigger it, we don't know whether there are limits on its effects in the body. As you're an author of a book on the subject, you already know all this. Regarding people's hope, there's no guarantee that people will read more into the study than they should, but we should give people the benefit of the doubt. It's fairly common to read about promising scientific studies that take a long time to develop into something more tangible, if at all (for example, here's a whole website full of such stories... http://phys.org/ http://phys.org/). Anyone with an interest in science is going to be used to these stories by now, but it doesn't mean there isn't something promising that can come of single research studies, once the data can be verified.
      - cpncrunch 12y ago
        The study just looked at number of bowel movements and self-rated health, both of which have been shown to have a significant placebo effect. See for example: http://www.webmd.com/ibs/news/20101221/secrecy-may-be-unnecessary-for-placebo-effect http://www.webmd.com/ibs/news/20101221/secrecy-may-be-unnece... A Nature review looking at fecal transplants for C difficile cautions that a strong placebo effect is common with invasive procedures. (This particular study isn't invasive, but it is highly novel, and that has also been shown to correlate with a large placebo effect). http://tcminfection.com/pdf/5%20(119).pdf http://tcminfection.com/pdf/5%20(119).pdf
        refurb 12y ago
        From your second link: "FMT holds considerable promise as a therapy for recurrent CDI but well-designed, RCTs and long-term follow-up registries are still required. These are needed to identify the right patient, efficacy and safety profi le of FMT before this approach can be widely advocated." I don't disagree with this conclusion at all. The existing data is very encouraging, but more studies are needed before it can be considered for widespread use.
- refurb 12y ago
  I've never seen (although it might be possible) the placebo effect cure a bacterial infection. C. difficle infections are notoriously difficult to treat, even with specific drugs like Dificid. If an open-label, uncontrolled study of fecal transplants cures a ton of people, that's very strong evidence that it works. Closed, double-blinded clinical trials offer different value for different diseases. That's why the FDA will accept an open-label, uncontrolled clinical trial for a drug that treats cancer.
  - cpncrunch 12y ago
    The study didn't show that the treatment cured the infection. It just found that bowel movements decreased, and patient self-rated health increased. The placebo effect has been shown to have a significant effect on diarrhea for IBS: http://www.webmd.com/ibs/news/20101221/secrecy-may-be-unnecessary-for-placebo-effect http://www.webmd.com/ibs/news/20101221/secrecy-may-be-unnece... Also, there are currently no RCTs showing the effectiveness of fecal transplant for C difficile, and a Nature review cautions that there will be a strong placebo effect for invasive procedures: http://tcminfection.com/pdf/5%20(119).pdf http://tcminfection.com/pdf/5%20(119).pdf (This particular study isn't invasive, but it is highly novel, and that has also been shown to correlate with a large placebo effect).
    - refurb 12y ago
      I didn't look into the details of this particular trial, so if in fact it did just look at patient self-rated health then yes, placebo effect could be a big factor. I have seen other open-label uncontrolled studies for fecal transplant that had some pretty spectacular outcomes. Is such a trial as rigorous as a RCT? No, but it's a pretty positive signal.
    - cpncrunch 12y ago
      Also, here is the full-text of this study: http://jama.jamanetwork.com/article.aspx?articleid=1916296 http://jama.jamanetwork.com/article.aspx?articleid=1916296
cpncrunch 12y ago
Also, it's worrying that the author says that they elected not to do a placebo-controlled trial due to the "efficacy" of fecal transplant. However there are no RCTs for fecal transplant, and Nature cautions that there is likely to be a large placebo effect.

cpncrunch 12y ago

It doesn't really tell us anything, like all open-label studies (except perhaps whether or not the treatment is dangerous and whether it might provide a benefit). Also it doesn't really cost any more to do a small-scale placebo-controlled trial vs an open-label study. Overall open-label studies just give false hope to people who don't understand science and the placebo effect (i.e. most people).

ZenoArrow 12y ago
"just give false hope to people who don't understand science and the placebo effect" You understand how the placebo effect works then? You'd be the first person in the world that did. As kevinalexbrown said, this trial can be seen as a first step, nobody who read the article could reasonably expect the FDA to approve this tomorrow.
- cpncrunch 12y ago
  I didn't say I understood how the placebo effect works (although perhaps I have a better idea than many people, as I've written a book about it). What I meant is that - as I pointed out above - this study will have a siginificant placebo effect, and the results should therefore be treated with extreme caution. We still have no idea whether this treatment actually works, and I'm constantly surprised that studies like this continually make the first page of HN. I think the problem is that most people don't know that the placebo effect actually exists (or at least, they forget about it when they read a study like this, or downplay its significance). Even many researchers underestimate the placebo effect, and then we end up spending billions of dollars a year on a useless treatment until someone actually proves that it is no better than placebo. http://www.nytimes.com/2014/10/07/upshot/the-placebo-effect-doesnt-apply-just-to-pills.html?_r=0&abt=0002&abg=0 http://www.nytimes.com/2014/10/07/upshot/the-placebo-effect-...
  - ZenoArrow 12y ago
    "this study will have a siginificant placebo effect, and the results should therefore be treated with extreme caution" You have no way of proving this. Let's face it, we do not have a good grasp on the factors involved in the placebo effect, for example we don't know whether someone needs to be susceptible to it for it to work, we don't know how to reliably trigger it, we don't know whether there are limits on its effects in the body. As you're an author of a book on the subject, you already know all this. Regarding people's hope, there's no guarantee that people will read more into the study than they should, but we should give people the benefit of the doubt. It's fairly common to read about promising scientific studies that take a long time to develop into something more tangible, if at all (for example, here's a whole website full of such stories... http://phys.org/ http://phys.org/). Anyone with an interest in science is going to be used to these stories by now, but it doesn't mean there isn't something promising that can come of single research studies, once the data can be verified.
    - cpncrunch 12y ago
      The study just looked at number of bowel movements and self-rated health, both of which have been shown to have a significant placebo effect. See for example: http://www.webmd.com/ibs/news/20101221/secrecy-may-be-unnecessary-for-placebo-effect http://www.webmd.com/ibs/news/20101221/secrecy-may-be-unnece... A Nature review looking at fecal transplants for C difficile cautions that a strong placebo effect is common with invasive procedures. (This particular study isn't invasive, but it is highly novel, and that has also been shown to correlate with a large placebo effect). http://tcminfection.com/pdf/5%20(119).pdf http://tcminfection.com/pdf/5%20(119).pdf
      - refurb 12y ago
        From your second link: "FMT holds considerable promise as a therapy for recurrent CDI but well-designed, RCTs and long-term follow-up registries are still required. These are needed to identify the right patient, efficacy and safety profi le of FMT before this approach can be widely advocated." I don't disagree with this conclusion at all. The existing data is very encouraging, but more studies are needed before it can be considered for widespread use.
refurb 12y ago
I've never seen (although it might be possible) the placebo effect cure a bacterial infection. C. difficle infections are notoriously difficult to treat, even with specific drugs like Dificid. If an open-label, uncontrolled study of fecal transplants cures a ton of people, that's very strong evidence that it works. Closed, double-blinded clinical trials offer different value for different diseases. That's why the FDA will accept an open-label, uncontrolled clinical trial for a drug that treats cancer.
- cpncrunch 12y ago
  The study didn't show that the treatment cured the infection. It just found that bowel movements decreased, and patient self-rated health increased. The placebo effect has been shown to have a significant effect on diarrhea for IBS: http://www.webmd.com/ibs/news/20101221/secrecy-may-be-unnecessary-for-placebo-effect http://www.webmd.com/ibs/news/20101221/secrecy-may-be-unnece... Also, there are currently no RCTs showing the effectiveness of fecal transplant for C difficile, and a Nature review cautions that there will be a strong placebo effect for invasive procedures: http://tcminfection.com/pdf/5%20(119).pdf http://tcminfection.com/pdf/5%20(119).pdf (This particular study isn't invasive, but it is highly novel, and that has also been shown to correlate with a large placebo effect).
  - refurb 12y ago
    I didn't look into the details of this particular trial, so if in fact it did just look at patient self-rated health then yes, placebo effect could be a big factor. I have seen other open-label uncontrolled studies for fecal transplant that had some pretty spectacular outcomes. Is such a trial as rigorous as a RCT? No, but it's a pretty positive signal.
  - cpncrunch 12y ago
    Also, here is the full-text of this study: http://jama.jamanetwork.com/article.aspx?articleid=1916296 http://jama.jamanetwork.com/article.aspx?articleid=1916296

cpncrunch 12y ago

Also, it's worrying that the author says that they elected not to do a placebo-controlled trial due to the "efficacy" of fecal transplant. However there are no RCTs for fecal transplant, and Nature cautions that there is likely to be a large placebo effect.