I reported about a study on Rifaximin a few months ago. I was not that impressed by the results at that time. Well there has been a new study released on Rifaxmin showing pretty much the same unimpressive results. The facts are still that only about 11% saw benefit over placebo. That difference seems even more dubious what with the recent placebo study showing a similar level of efficacy. Who knows if the Rifaximin is really doing anything at all? Additionally patients are only tracked for 10-weeks, there is no information for what happens after that. It appears I am not alone in my concerns regarding the study. If you check out the comments on the study you’ll find there are a few doctors chiming in with their concerns:
“Here we go on another journey into a poorly supported area of new treatment…….this article barely shows a statistically signifincant difference, and certainly not a convincing one.” – MICHAEL ELIASTAM, MD
“This study is problematic in several ways, not least of which is the long list of companies involved, and somehow attached to the trial’s outcome.” – DAVID GLUCK, MD
“As a practicing gastroenterologist for 12 years as well as an IBS sufferer for almost 40, I realized long ago that we cannot treat IBS with a pill and that IBS is for life, and not for 10 weeks. I have been following Dr. Pimental’s studies for years, and I have yet to see anything last as long as the stress and psychological manipulation techniques that I and many others have been advocating for years.” – KIMBERLY CUSATO, MD
So buyer beware, Rifaximin may not be all it’s cracked up to be or what the hype my have you believe.
You clearly have not modeled the actual and pro forma #s for Zelnorm and Lotronex. The etiology and MOA of rifa is undisputedly lost on you. If I gave you an A, B, C, D list of options for the # of rifa studies you would never pick the correct letter corresponding to… >500. And your survey of 3 again suggests you have no problem writing an article without having any shrapnel of facts to support your conclusion.
Consider trial design (12 weeks is FDA endpoint, required to gain passage to the market); no IBS-D approved drug; #s of symptomatic (I won’t bother to explain why that’s important to you, you won’t ever get the depth of why that’s important) IBS sufferers; the lack of AE’s or how there could be; and finally, why the failure of Xifax at FDA bodes well for the # of years Xifax will be on the market is truly complicated…. suffice it to say that you’ll have time to ponder why you got it wrong.
The 500 studies you cite regarding Rifaxmin have they all been IBS related studies?
The numbers I see for Zelnorm & Lotronex were similar, though they operate differently than Rifaximin. The fact that both Zelnorm & Letronex were recalled after “successful” studies just shows that a positive study doesn’t mean your drug works that well or is safe. The fact that Rifaximin is a short-term antibiotic treatment might mean it’s less dangerous than the other drugs that have been on the market for IBS. I am not completely down on Rifaxmin but when others in the medical community have concerns & the numbers I see aren’t much more impressive than what other drugs or even placebo has been able to accomplish, I think it’s worth pausing and taking a look at. I don’t feel like parroting out a press release about a “successful new cure for IBS”.
Also keep in mind that many people who read this blog do not have a medical background. If you want to warn people of my ignorance then please ensure you are communicating it clearly and in a way that people will understand.
If you would like to go into more detail about why I am wrong and do so in a concise, easy to understand manner, I’d be happy to post your article on the front page.
@KIMBERLY CUSATO, MD,
I do not think you are doing any of your patients a favor by spreading the false and unproven notion that IBS is all in the patient’s head, and can be treated with biofeedback, or other forms of positive thinking.
Had you bothered to read the comments of IBS sufferers that are posted on the various IBS sites you would see, many people report unexpected improvements for short durations when using antibiotics for other health issues.
This should tell a keen observer something.
IBS is nothing more than an umbrella term used to describe similar sets of symptoms that may indeed have slightly different root causes, and a universal condemnation of a promising study is completely out of order.
The study cited in the NJM, targeted a specific kind of IBS, IBS that had diarrhea and NOT constipation as the main symptoms.
This type of IBS does indeed respond to antimicrobial treatment.
The study cited relief for up to 10 weeks.
Well I would say if Rifaxamin can provide relief for up to 10 weeks, they you should be asking yourself WHY?
But why only 10 weeks?
In understanding the root cause of this type of IBS, you would understand it is caused by not only an overgrowth of gut bacteria, but by unhealthy rations of bad/disruptive bacteria and yeasts vs healthy bacteria.
While Rifaximin is beneficial for knocking down bacterial overgrowth, I ask, after treatment with Rifaximin was discontinued were the patients who participated in the study given the second part of their treatment?
The second part of their treatment is even more important than taking Rifaximin. The second part involves repopulating the gut with healthy flora in order to change the ratio of good vs bad/disruptive bacteria.
Its the ratio of good vs bad/disruptive bacteria that is the key to curing this type of IBS.
We study participants given S. Boulardii to inhibit Candida while taking Rifaximin?
The study is a first step in exploring a new direction of treatment for a specific type of IBS.
A universal condemnation, and a mistaken belief that IBS must be something the patient wants to have, and therefore can be controlled with relaxation techniques/biofeedback or some kind of New Age Positive Thinking quackery, is straight out of the Dark Ages, where medical doctors used to bleed people in order to cure disease.
Medicine is science, not voodoo.
And it does not surprise me in the least, that after suffering with IBS for nearly 40 years, you continue to suffer.
And the fact that you have resigned yourself to the mistaken idea that IBS is for life also tells me, you are not really looking for the solution to this problem. The belief that IBS is for life, indicates to me that you have given up.
Every malfunction in the human body has a reason behind it.
Medical researchers who are trying to find the solutions to those problems should not be condemned.
And it would help, if doctors like you, actually took the time to listen to what patients are telling you.
Patients have been telling doctors for years, that there is a connection between certain types of foods and a worsening of their symptoms.
Of course there is, certain foods feed the bad/disruptive bacteria, and cause rapid growth leading to worsening symptoms. Just like sugar feeds yeast. Dietary management, only serves to control symptoms and not fix the underlying problem.
But doctors like you do not bother to listen to what your patients are telling you. You waste their time, and you waste vast amounts to medical resources while doing nothing to address the problem.
And yes, I was also an IBS sufferer for 30 years.
So I know what I am talking about.
If what you have been saying here, and in other posts of yours I have been reading, is true, then you, and YOU ALONE, have the answer and therefore all research into IBS should be halted because….there is no solution.
Science is not voodoo, or New Age crap. Science is the careful observation of cause and effect in a controlled environment. Statistical data is compiled, and analyzed, and trends observed. Creative thinking in the approach to problem solving is part of the discovery process. The study involving Rifaximin is on the right track although does not detail a complete treatment protocol.
You keep meditating.
Happy suffering.