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New CH.com Forum › Cluster Headache Help and Support › Medications, Treatments, Therapies › ALD403 - New Migraine Treatment - Goadsby Trial

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ALD403 - New Migraine Treatment - Goadsby Trial (Read 2193 times)

neuropath CH.com Veteran Offline Same Hit, Different Day Posts: 218	ALD403 - New Migraine Treatment - Goadsby Trial Apr 23^rd, 2014 at 10:50pm For migraine but since Goadsby is involved we will likely hear if this could be relevant to CH too.
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Mike NZ

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Re: ALD403 - New Migraine Treatment - Goadsby Trial
Reply #1 - Apr 24^th, 2014 at 2:42am

What is amazing from this report is how well the placebo effect works.

Drug 1 resulted in a 66% fall compared to 52% from the placebo
Drug 2 resulted in a 63% fall compared to 42% from the placebo

This suggests that each drug only had an improvement of about 14% and 21% respectively with the rest, 52% and 42%, due to the placebo effect.

What wasn't reported but would be interesting to see is what side effects were reported for the placebo.

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AussieBrian CH.com Hall of Famer Offline CH - It's all in your head! Posts: 3851 Cairns, Qld, Australia Gender:	Re: ALD403 - New Migraine Treatment - Goadsby Trial Reply #2 - Apr 24^th, 2014 at 3:51am Mike NZ wrote on Apr 24^th, 2014 at 2:42am: What wasn't reported but would be interesting to see is what side effects were reported for the placebo. What an interesting concept. The side effects of a placebo. A googling I shall go...
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Mike NZ

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Re: ALD403 - New Migraine Treatment - Goadsby Trial
Reply #3 - Apr 24^th, 2014 at 6:10am

There are some interesting reports to be found via Multimedia File Viewing and Clickable Links are available for Registered Members only!! You need to

".

Multimedia File Viewing and Clickable Links are available for Registered Members only!! You need to

This one had side effects for the placebo as irritability (18%), anxiety (12%), being prone to cry (10%) and insomania (7%).

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Quote:

the incidence of drowsiness (9 percent) did not differ significantly from that (10 percent) reported in 334 patients who received placebo.

And just to show how complex the placebo effect is - Multimedia File Viewing and Clickable Links are available for Registered Members only!! You need to

.

The Lancet - Volume 375, Issue 9715, 20–26 February 2010, Pages 686–695
Biological, clinical, and ethical advances of placebo effects

Dr Damien G Finniss, MSc [Med]a, Corresponding author contact information, E-mail the corresponding author,
Ted J Kaptchukb,
Franklin Miller, PhDc,
Prof Fabrizio Benedetti, MDd

Quote:

For many years, placebos have been defined by their inert content and their use as controls in clinical trials and treatments in clinical practice. Recent research shows that placebo effects are genuine psychobiological events attributable to the overall therapeutic context, and that these effects can be robust in both laboratory and clinical settings. There is also evidence that placebo effects can exist in clinical practice, even if no placebo is given. Further promotion and integration of laboratory and clinical research will allow advances in the ethical use of placebo mechanisms that are inherent in routine clinical care, and encourage the use of treatments that stimulate placebo effects.

So even with no placebo there can be a placebo effect! No wonder it is non-trivial to work out how effective medication is. It really shows the value of properly conducted medical trials so we really do know what works and what doesn't.

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Batch

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Re: ALD403 - New Migraine Treatment - Goadsby Trial
Reply #4 - Apr 24^th, 2014 at 11:03am

A very interesting thread...

I've been sensitive to a possible placebo effect associated with the efficacy of the anti-inflammatory regimen from the get-go when I started posting about this regimen in December of 2010.

I ran the trap line of placebo effects across different medical conditions and it appears cluster headache, by its very nature, has one of the lowest placebo effects associated with therapeutic intervention.

In other words, it's difficult at best for a genuine psychobiological event to be attributable to the overall therapeutic results... a complete cessation of CH pain.

The latest harvest of data from the online survey of CH'ers using the anti-inflammatory regimen indicates 106 out of the 127 who completed this survey experienced a significant reduction in the frequency, severity and duration of their CH for a raw efficacy of 83%. 75% experienced pain free days several times a week and 57% remained pain free.

Regarding the role of a possible placebo effect... the raw efficacy of 57% for a sustained pain free end point response to the anti-inflammatory regimen in preventing CH is well beyond the highest possible placebo response in CH of 14% to 43%. The lowest value was reported using the strict endpoint; cessation of headache attacks. Nilsson Remahl AI, Laudon Meyer E, Cordonnier C, Goadsby PJ. Placebo response in cluster headache trials: a review. Cephalalgia. 2003 Sep;23(7):504-10.

The bottom line is simple... Even if there is a placebo effect increasing the overall efficacy of the anti-inflammatory regimen... this is clearly the case where more is better.

Take care,

V/R, Batch

You love lots of things if you live around them. But there isn't any woman and there isn't any horse, that’s as lovely as a great airplane. If it's a beautiful fighter, your heart will be ever there

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