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this turned up in an article on Medscape about IBS....

 

 

 

Trial Design Issues in IBS

 

It is well known that placebo is an excellent treatment for IBS. Indeed, there

have been

reports that the placebo response can be maintained for at least 12 months, a

finding that

remains both surprising and perplexing.[9] Patel and coworkers[13] conducted a

very

interesting meta-analysis of the placebo effect in IBS. They found that the

placebo

response varied anywhere from 16% to 71%, with the mean being 44%. This finding

reflects

how important it is to have a placebo arm included in all randomized controlled

trials that

test new therapies for IBS, because the placebo response remains unpredictable

and can

be high or low, making any conclusion without a placebo virtually meaningless.

It is

interesting to note that variables such as the year in which the study was

conducted, the

number of study arms, entry criteria, crossover or parallel design, study

duration, use of a

run-in period, and exclusion of responders all failed to predict the placebo

response. The

only predictor of the variability of the placebo response that these

investigators observed,

and that seemed to be important, was number of office visits, which was

associated with a

reduced placebo response. Perhaps this fact reflects an exaggerated centrally

mediated

stress response in IBS in those who seek care. Of course, the placebo response

is still a

contentious entity in medicine, and its further elucidation remains a priority.

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Really, if you think about it, isn't this a validation of the TCM pattern

discriminations: Liver overacting on spleen or stomach, relative to IBS?

--See also the chapter on IBS in Flaws & Sionneau's " treatment of Modern

western diseases "

 

On Wed, 23 Jun 2004 06:44:52 -0000 " "

writes:

>

> this turned up in an article on Medscape about IBS....

>

>

>

> Trial Design Issues in IBS

>

> It is well known that placebo is an excellent treatment for IBS.

> Indeed, there have been

> reports that the placebo response can be maintained for at least 12

> months, a finding that

> remains both surprising and perplexing.[9] Patel and coworkers[13]

> conducted a very

> interesting meta-analysis of the placebo effect in IBS. They found

> that the placebo

> response varied anywhere from 16% to 71%, with the mean being 44%.

> This finding reflects

> how important it is to have a placebo arm included in all randomized

> controlled trials that

> test new therapies for IBS, because the placebo response remains

> unpredictable and can

> be high or low, making any conclusion without a placebo virtually

> meaningless. It is

> interesting to note that variables such as the year in which the

> study was conducted, the

> number of study arms, entry criteria, crossover or parallel design,

> study duration, use of a

> run-in period, and exclusion of responders all failed to predict the

> placebo response. The

> only predictor of the variability of the placebo response that these

> investigators observed,

> and that seemed to be important, was number of office visits, which

> was associated with a

> reduced placebo response. Perhaps this fact reflects an exaggerated

> centrally mediated

> stress response in IBS in those who seek care. Of course, the

> placebo response is still a

> contentious entity in medicine, and its further elucidation remains

> a priority.

>

>

>

>

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