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The Open Placebo Study…and why I’m not sure I buy it. December 24, 2010

Posted by mareserinitatis in research.
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I’m really bothered by this, so I have to say something. This is totally outside my field, but it’s something that I’ve learned a lot about through reading and my doctors, so I feel like I should address the huge red flags waving around.

There was a study done recently, showing how IBS patients who took pills clearly labeled as placebos showed improvement. The paper is available here.

Having fought with the IBS monster myself for over six years, there were two things that popped into my head.

The first issue is a pet peeve (and minor in comparison to the other problem). Although the researchers who published the article discussed IBS as a serious illness, how many doctors are going to read this study and think, “Oh, gee! I knew it was all in their head.” Honestly, having had to go through 5 doctors before finding one who didn’t think it was in my head (probably because he was a GI specialist), I can tell you it’s already hard to find doctors who don’t see IBS as an manifestation of mental health issues.

Second, and far more important in my mind, was the fact that they were giving sugar pills to IBS patients. Research on IBS has shown that up to half of IBS patients who have the problem actually have an intolerance to various types of saccharides (things we commonly refer to as sugar). In fact, one thing that sets off IBS in some individuals is an intolerance to fructose (referred to as fructose malabsorption. This results when someone eats too much fructose relative to the amount of glucose in their diet. If they were giving IBS patients sugar pills, these will generally contain starch or dextrose (which is glucose). One of the ways for some people to prevent the onset of IBS, if it is caused by fructose malabsorption, is to make sure that to balance an intake of fructose with an equal or greater amount of glucose. The body absorbs fructose in equal amounts with glucose, but in patients with FODMAPs sensitivities, fructose intake, in excess of glucose, is what often lead to IBS symptoms. (Other sensitivities can result from consuming lactose or galactose, but if I understand correctly, those are saccharides one simply has to avoid rather than balance with glucose for relief of symptoms.)

Patsy Catsos has done a lot to educate people on this issue in the US, but most of the research has been done in Australia. (This is one of the first papers I came across when learning about FODMAPS.)

My concern therefore is that the placebo pill may have actually been doing something to reduce symptoms through a physical mechanism in the digestive system. If the pills are made from glucose, and there was enough there to balance out an excess of fructose, then it’s possible that taking the pill did something other than stimulate the mind to heal: it really could have done something to aid patients with IBS caused by fructose malabsorption. It’s hard to say if this is true or not because I couldn’t find dosages for the sugar pills, don’t know exactly what was in them, and don’t know if the patients were taking these with meals or other factors that can affect the onset of IBS.

I know it seems surprising given the overall quantity of starch is probably fairly small. However, it’s not hard to imagine that if someone is taking a pill made primarily of glucose with a soda (which generally contains high fructose corn syrup, probably in a ratio of 55% fructose to 45% glucose, and would set off symptoms for someone with fructose malabsorption), the glucose in a sugar pill could potentially ease the symptoms.

Anyway, my contention is that the assumption that ‘sugar pills don’t do anything’ is false in the case of IBS patients because of recent work showing that saccharide sensitivity may be a cause. The results they saw in the study could, in fact, have been as a result of the pills and not simply the psychological boost gained from having a doctor who seems concerned about your condition. The real question, if this is a factor, is whether they can replicate the findings on placebos in people who have other types of illnesses which are less likely to be directly affected by sugar pills or whether they can give IBS patients some other type of pill (gelatin, perhaps?) that would be neutral in regard to potential saccharide sensitivity.

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Comments»

1. FrauTech - December 31, 2010

As a fellow sufferer of IBS I was disappointed when I saw this too, though for my own part I’ve discovered most of my triggers and can control it. I wouldn’t say the doctors I saw were doubtful, just that they though it was something they didn’t need to treat and I could just get over somehow. My theory is even though people were told it was a placebo, they might have been suspicious it wasn’t and might have been trying to “outsmart” the doctors. Others have mentioned how the advertising for the study may have attracted people who believe in woo and sugar pills and homeopathy.

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mareserinitatis - December 31, 2010

I ran the whole gamut with doctors, but the worst was one who said I had anxiety that was causing the IBS. She put me on meds for a couple months, but I discovered it just made me dazed and unable to work without helping the IBS at all. Finally, I went to a GI, who was able to suggest fructose malabsorption. (And if I did have anxiety, I’m fairly certain it was the IBS/chronic dehydration/resulting kidney stones and non-stop headaches that were causing it. I still have no idea how I functioned like that for nearly 4 years.)

So yeah, there are doctors who think that IBS is a symptom of a mental health issue. :-/

That makes it even worse if they were choosing people who were frustrated and looking for ‘alternative medicine.’ But I still sort of wonder if adding starch to the diet may have done something beneficial. I also think a lot of people may have figured out some things on their own during the course of the study. Either way, I have issues with it. 🙂

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2. resinlabdog - February 10, 2012

take heart Guys…
Good news:
I think you may be misinterpreting the meaning of the result here:
No one doubts that your condition is anything other than real or debilitating.
The placebo effect is real enough and continues to baffle medical researchers to this day. Read the book ‘Bad Science’ by Ben Goldacre for an accessible treatment of some of the more bizarre aspects of this weirdness!
Its not that those subjects in the ‘open placebo’ arms weren’t suffering, and its not that the condition was ‘all in their head’.
Instead it is simply that ‘open placebo’ was a genuinely effective treatment for some (but not all) of those enrolled in the study.
In other words, they genuinely cured themselves by means of some strange, poorly understood, but very real phsyiological/psychological interaction.
This happens alot… and if medical researchers ever get to the bottom of how (the hell) and why this happens, we’ll understand alot more about the mysteries of the human brain!

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mareserinitatis - February 11, 2012

My problem with this is that there are a number of doctors who do assume it’s strictly a psychological problem. In fact, one doctor I had said anxiety caused my IBS and put me on anti-anxiety meds which did nothing but make me loopy. Therefore, there are a lot of doctors who are treating it as a mental disorder, and while the doctors who performed the study may think there’s a physiological component, I don’t think that’s the general view.

What I found out after suffering through this for nearly a decade is that I have sensitivities to corn, tomatoes, fructose, polyols and large amounts of fructans and galactans. While doctors in the US are trying to figure out how to fix this ‘mental health’ problem by giving people pills, doctors in Australia have found that changing one’s diet is a very effective treatment for over 50% of people who have IBS, and the culprit seems to be, of all things, certain kinds of foods that are prevalent in the modern diet. I simply can’t believe doctors in the US don’t seem to make the connection between food and intestinal issues.

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3. Nino Rekhviashvili - January 30, 2014

It’s not that they’re saying “it’s all in their heads!” They’re saying the cure can be a placebo. It’s estimated that 70-90% of ALL medicine, for cancer, for IBS, for depression, WHATEVER, is a placebo 😉 No one’s trying to “put down” IBS as a mental health issue; mental health issues are very serious things. This study brings into focus the mind-body connection; the way the mind works with the brain and how the brain influences the body. There’s nothing to be disappointed about here.

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mareserinitatis - February 9, 2014

The study was horribly designed. As some of the commenters noted, cellulose fiber is NOT a placebo and has been found to have a positive impact on those with IBS. (In particular, if you read up on resistant starch, they’ve found that has a great impact on those with IBS and diabetes.) The people who designed the study had already decided that IBS was psychosomatic because that’s what they wanted as an outcome. They didn’t take into consideration that if you put *anything* in the GI system, it’s going to impact the environment, particularly for gut biota.

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