March 2007 Archives

Zelnorm, the drug for constipation-predominant IBS, has been withdrawn in the US. It has never been available in the UK, but I know it has helped a great deal of people in America and other countries as well, and IBS drugs are so thin on the ground anyway that this is really not good news.

It's also eerily reminiscent of the bizarre situation which surrounded the IBS-D drug Lotronex, which was approved and then withdrawn and then approved again after a campaign by IBS sufferers. Looks like we might have to start fighting again...

The reason given for the withdrawal is that the drug was linked in a retrospective review of the entire clinical database of Zelnorm patients to a higher risk of heart attacks, strokes and chest pain. The review compared the incidences of heart problems in patients taking Zelnorm to the number of incidences in patients taking the placebo. This is the first time I had heard of any major concerns over cardiovascular side effects from Zelnorm, although there had been concerns over ischemic colitis.

In a statement on their homepage, the manufacturers Novartis say this:

"The data, which were reviewed by independent experts, showed that events occurred in 13 out of 11,614 patients treated with Zelnorm/Zelmac (0.11%), compared to one case in 7,031 placebo-treated patients (0.01%). All patients affected had pre-existing cardiovascular disease and/or CV risk factors."

Now, 13 out of 11,614 patients seems to me to be a fantastically tiny number, but apparently it is high enough to make the link statistically significant, and therefore the FDA asked for the drug's withdrawal.

I'll update this entry as I get more info.

Update: The FDA have issued a statement which includes advice to anyone currently taking Zelnorm...

"FDA is currently advising patients who are using Zelnorm to contact their health care providers to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke."

Now that sounds like a very alarming statement, and obviously anyone who is worried should contact their doctor, but the fact remains that only 13 out of 11,614 patients reported heart issues, so this is not a reason to panic.

The FDA also say the following:

"FDA will work with Novartis to allow access to Zelnorm as an investigational drug for patients with no other treatment options where the benefits may outweigh the risks. FDA has also indicated to Novartis the possibility of considering limited re-introduction of Zelnorm at a later date if a population of patients can be identified in which the benefits of the drug outweigh the risks."

The "benefits outweighing the risks" argument is the main source of contention in this kind of situation. Almost all drugs have side effects, and when we are talking about non-fatal conditions such as IBS, the severity of those side effects is weighed against the perceived severity of the medical condition itself. I think it would be fair to say that the impact of IBS is often under-rated, which may mean that the FDA are too quick to pull drugs for IBS because they believe that we can live pretty well without them...

For more info see the Novartis website or the FDA website.

I started a big old debate when I criticised a supplement called Digestrol a while back, and some people strongly disagreed with my view of the product, saying that it had worked for them so I shouldn't criticise it.

Now, I'm quite happy to hear opposing opinions, and if any treatment works for you then that's grand. What I have been a bit dismayed about is the number of people who seem to believe wholeheartedly in the power of anecdotal evidence, and the flimsiest of anecdotal evidence at that.

Anecdotal evidence is just what it sounds like - evidence which is based on anecdotes, or word-of-mouth information. So, my friend Bob might tell me that a particular garage is fantastic at fixing cars, because they fixed his car last week, and now it works. That's all there is to it.

The argument is that if Bowlex works for you, or it works for a handful of other sufferers, then this is proof that Bowlex works at least some of the time, and therefore it is beyond criticism. Now, as the owner of an IBS website I hear masses of anecdotal evidence, and I therefore have proof that every kind of treatment from crystal dowsing to the wearing of magnetic bracelets works for IBS. People have told me so; it must be true.

A sister argument says that I cannot have an opinion on any IBS supplement that I have not tried myself, because if I haven't personally tried it there's no way for me to give a personal opinion (or no way for me to tell an "anecdote"). I must personally quoff every last pill and potion available, observe my own symptoms, and then report. There is no other righteous way.

We often use anecdotal evidence to make decisions. But if we rely on anecdotal evidence alone we're opening ourselves up to all kinds of problems, and this is especially true if we rely on anecdotal evidence when we're choosing a new IBS treatment. Here's why...

Bob tells you that the garage he went to is fantastic. His car was broken, and now it isn't. So that's great. This is proof that the garage have some kind of skill at fixing cars, and it is proof that on this occasion they managed to fix Bob's car.

But what about if you did a survey of the last 1,000 customers who used the garage? If you got 1,000 replies strongly agreeing with Bob, then that's all the evidence I would need as a consumer to tell me that that's a great garage.

You probably wouldn't get that though - you'd probably get some people who agreed with Bob, some who disagreed, and some in the middle. The number of people in each category would tell you how good the garage actually was. You might get 999 people who say the garage painted their cars bright pink and they're really not that happy about it, and one person (Bob) who was completely happy in every way.

So - the evidence of one person is not really evidence at all. And if you apply this to medicine, this means that if one person tells me that wearing sofa covers on their heads has cured their diarrhea, this doesn't in fact mean that sofa-cover-(on-the-head)-wearing is a legitimate IBS treatment.

And, in the case of IBS, and indeed other medical conditions, there are many other reasons why I shouldn't be convinced by the evidence of one person. First, IBS symptoms come and go, so we sometimes assume our new Bowlex pills are working when really we'd feel just the same without them.

Next, the placebo effect applies to all kinds of medical treatments, and we all know how powerful sugar pills and even fake surgeries can be - when we think we're going to feel better, we often do.

Next, IBS symptoms vary a great deal between sufferers. For example, I have IBS-C with a bit of diarrhea thrown in sometimes. I tried hypnotherapy twice, and it didn't do anything for me. Proof that hypno doesn't work for IBS? Or proof that hypno doesn't work for me? Conversely, I find a gluten-free diet very helpful. Is that proof that gluten-free diets work for IBS?

Now, I do have to say that there are times when anecdotal evidence is very useful. Indeed, my whole IBS Treatment site is based on the idea that anecdotal evidence can be helpful (although I try to post as many reviews of each product as possible, and I also include clinical trial data whenever it is available).

But it is important to recognise the limits of this kind of evidence. Anecdotes are great for getting new ideas for treatments and for comparing notes. Some forms of anecdotal evidence are backed up by science or commonsense which makes them stronger - for example, there are a lot of good reviews of calcium supplements for diarrhea on my site, and that seems logical as calcium is naturally constipating.

But do these reviews alone prove that calcium is a good treatment for IBS? Nope.

The gold standard of evidence is, of course, the good old randomised double-blind placebo-controlled trial, which was developed specifically to reduce or eliminate the influence of things like the placebo effect and the fact that the human body varies from day to day.

Without these trials, without this objective way to evaluate treatments, every time you went to the doctor he would just have to start at the top of a list of IBS treatments and work downwards until something randomly worked. (And OK, yes, that does feel like what some doctors do anyway - except that without the controlled trials, the list wouldn't read "Anti-spasmodics, fiber supplements, hypnotherapy", it would read "Aardvark juice, artichoke puree, bear fur souffle, dog biscuits".)

To be honest, I really don't see why anyone would be happy to rely on anecdotal evidence alone as proof of any treatment's efficacy. Perhaps this is especially true for me because I receive so many anecdotes.

If I were to rely on anecdotal evidence, and I subscribed to the view that there was no objective way to evaluate treatments, you just had to swallow them and see what happened, I would spend my entire time and all my life savings buying pill after pill after magnetic bracelet. And I bet I'd still feel crappy in the end.

Romances, Riches and Restrooms is a new book which chronicles one man's battle with IBS over a period of 17 years. Tim Phelan was fresh out of college and starting his first full-time job when he drunk a cup of coffee, had to rush to the bathroom, and was never quite the same again. Although he couldn't put a name to the illness until years later, he had begun to suffer from diarrhea-predominant IBS.

Tim vividly recounts stories of desperate diarrhea attacks in all kinds of situations, as well as the unusual solutions he has to come up with to avoid the ultimate humiliation of soiling himself in public. These solutions include using an industrial car park as an impromptu toilet, and relieving himself in a public park while getting filmed by a tourist with a camcorder...

Not surprisingly, Tim quickly develops a real fear of being trapped in situations where he can't use the loo, and this makes him more anxious - which of course makes his IBS worse, which makes him more anxious, and so the vicious circle of IBS is in place.

While Tim is dealing with the nightmare of IBS, he is also trying to establish a career and a personal life. Like many people, he is reluctant to talk about his illness, and his little white lies and avoidance of non-toileted situations quickly lead to problems. Bosses are unimpressed when he skips meetings and refuses to take public transport, and girlfriends are equally dismayed when he won't offer them a lift or alter his plans to accommodate them.

The problem of trying to cope with IBS while at the same time keeping it secret - and so often appearing rude or bizarre to the people around you - was one I particularly identified with. I am sure there are at least a dozen people I have met over the years who would tell you I am arrogant, obnoxious or have an uncontrollable eating disorder, when my behaviour was in fact just down to the demands of IBS.

The people in Tim's life range from the bosses who fire him for his lack of commitment, to the girlfriends who are kind and helpful (at least at first). Some of the reactions he recieves were understandable, and some of them just made me fume. One girlfriend tells Tim that he just needs to face his fears about public transport because "It would be nice if you started to act like a man". Another girl genuinely seems to think that a man who drinks peppermint tea is less worthy of her time than a man who drinks espresso. Yeah, that's a good way to choose a life partner.

On top of the bizarre idea that real men can control their own bowels, no matter how sick they might be, the author also has to put up with amateur doctors ("your symptoms are all in your head", "your symptoms are caused by bacteria"), and perhaps even worse, the people who are so ridiculously uptight about a medical condition involving digestion that they want nothing to do with him because of it. (And I want nothing to do with them.)

To try to escape from the IBS trap Tim starts to try various treatments, using everything from Pepto-bismol and Imodium to enemas and colonics to hypnotherapy and cognitive behavioural therapy. There is, thankfully, a happy ending to his story.

Romance, Riches and Restrooms is a very well-written, funny and intelligent book that anyone with IBS will identify with. I would highly recommend it to all IBS sufferers. And if I had the power I would make all the loved ones of IBSers read it as well, as it is a fantastic explanation of how IBS can slowly take control of almost all aspects of your life, however successful or intelligent or confident you are when you first start getting symptoms.

Buy Romance, Riches and Restrooms from Amazon.com

Buy Romance, Riches and Restrooms from Amazon.co.uk

Extra note: I forgot to mention that Tim has his own website.

I've finally got round to doing a few more chapters of my IBS story in podcast format. Sorry for the delay, I have been winning the Nobel Peace Prize/teaching underprivileged kids how to dream/lying around in my underwear (delete as applicable).

So, these podcasts are the second and third chapters of my story. The second chapter covers my years at university dealing with lovely situations like bathrooms shared between 12 people, travelling whilst trying not to crap oneself, and making sure that no-one found out that I had an illness with the word bowel in the title.

The third chapter covers my first full-time job, how I collapsed in a heap after only four months in said job, and how I was officially diagnosed by a specialist who was as much help as a marshmallow trampoline.

Usual deal for listening - either click directly on the link and listen within your browser, or right-click, choose "save as" and download to listen on your computer or transfer to an MP3 player.

IBS and Me: Chapter Two

IBS and Me: Chapter Three

Complete list of my IBS podcasts

Oh dear. A fellow blogger called Shinga has pointed me in the direction of two posts she has made about IGg food intolerance tests, and in particular about the rather inflated claims that some people have for these tests. And this is bad because I really do want to believe in the IGg test, mainly because all the other food intolerance tests I have ever come across are such bunkum, and surely we deserve one easy route to wellness?

But if the thing needs criticising then it needs criticising, and Shinga suggests a number of reasons why the IGg test might not be all that flash. She makes the following points, among others:

1) The one published, peer-reviewed study of IGg testing, which appeared in the journal called Gut, was criticised by a leading IBS expert called Dr Hunter because it produced pretty poor results compared to an old-fashioned elimination diet, where foods are cut out for a week or two at a time. Dr Hunter also said that the mere presence of high IGg levels may not correlate with a bad reaction to that food.

2) The authors of the Gut study responded to Dr Hunter by saying: "It is likely that only a subset of patients are likely to have an immuno-inflammatory basis to their condition and these might be the very individuals who respond to dietary exclusion based on IgG antibodies. This would fit with our results where only a proportion of patients responded despite all having antibodies. This, of course, limits the specificity and usefulness of the test unless such subgroups can be identified beforehand."

So the study authors have agreed that their results were perhaps a little underwhelming. Shinga also quotes a number of health organisations who have made pretty clear statements that they don't recommend the IGg testing (which are, as you would expect, in pretty direct contrast to some of the lovely alternative practitioners who like to support these kind of things 100% and not to really bother about boring stuff like evidence).

There's still hope for the IGg test, and the Gut authors suggest that it might be useful in a subgroup of patients if nothing else. But I have to say that the more I read about it the more sceptical I get, and that's not usually a good sign, because I tend to start off pretty damn sceptical anyway.

I do often wish that I could do a massive clinical trial which would be me versus the IGg - everyone in the IGg test group would take the York test and follow that diet and see how much better they got, and everyone in my group would give up gluten, dairy, alcohol, caffeine, spicy foods and artificial sweeteners, and we'd see who did the best...