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        New Message Board Archives >> Medications, Treatments, Therapies 2003 >> Placebo response in cluster headache trials 
        
(Message started by: dougW on Sep 4^th, 2003, 7:28pm)

Title: Placebo response in cluster headache trials
Post by dougW on Sep 4^th, 2003, 7:28pm

Interesting report. overall a 7 to 43% response to a placebo. Pass the sugar pills, it's all in my head!

Cephalalgia
Volume 23 Issue 7 Page 504 - September 2003
doi:10.1046/j.1468-2982.2003.00531.x

Placebo response in cluster headache trials: a review
AIM Nilsson Remahl1, E Laudon Meyer1, C Cordonnier2 & PJ Goadsby3

Probably because of its relative rarity as primary headache, there are few well-controlled clinical trials on cluster headache (CH) patients. Due to the severity of the pain, the placebo response in CH has been considered to be small. During the eighties the first double-blind, placebo-controlled trials were reported, and placebo responses demonstrated. Here we review the placebo response in CH trials in order to assess its magnitude and consider how future studies can be optimized. Six trials were identified with a double-blind, placebo-controlled, cross-over design testing treatments of acute CH. For those with a primary endpoint set to no or mild headache the placebo responses varied from 7 to 42%. In five of seven prophylactic trials, using a double-blind, placebo-controlled, parallel-group design, the placebo was merely used to set a baseline for comparison. The placebo responses were reported in only two trials. Here the response varies from 14 to 43%, the lowest value was reported using the strict endpoint; cessation of headache attacks. We conclude that a placebo response exists in trials of drugs on CH patients. Furthermore, this placebo response is of the same magnitude as that seen in migraine studies. We recommend the use of IHS guidelines when designing new trials. The possibility of a genuine biological mechanism responsible for the placebo response is discussed.

Title: Re: Placebo response in cluster headache trials
Post by ave on Sep 5^th, 2003, 3:14am

Let's not be too hasty saying it's all in our heads.
What was in the placebo, f'r instance?

Can't help thinking of the treatment for mastitis in cows. First they squirted distilled water into the teat.
Then at one time plain water, 'cause the distilled wasn't on hand.
Finally they squirted in air.
And it all worked.

Tirned out it was the distention of the teat, and not the medium used that helped cure mastitis...

Title: Re: Placebo response in cluster headache trials
Post by floridian on Sep 5^th, 2003, 7:45am

There are two types of placebo effect. The active placebo effect is caused when changing an attitude changes the body - people believe in the sugar pill, and these beliefs lead to improved well being. Confidence lets the patient start moving, and sucess in dealing with the disease amplifies the confidence. Biologically, an active placebo may involve changes in endorphins, or reduced cortisol and adrenaline, etc.

The second type of placebo (passive) - doesn't require the patient to believe. It is based on the fact that diseases tend to clear up even when nothing is done. Take a pill, even a sugar pill, and if the disease improves, many will link the improvement with the placebo. This is very different from an active placebo - passive placebos don't help at all, but through faulty reasoning, patients and doctors may believe that they do. Maybe it should be called a "pseudoplacebo" instead.

With cluster headaches, people are switching strategies all the time, and eventually a cluster ends. It is a natural tendency to think that the last strategy employed was responsible for the "cure". Unfortunately, the next cycle swings around, and the cure doesn't work because it never had any effect.

The article is good because it shows that double-blind controlled research is needed to overcome this placebo effect. But the nature of the placebo effect in CH is not yet understood. More Research! More Research!!

Title: Re: Placebo response in cluster headache trials
Post by Artie on Sep 7^th, 2003, 7:03pm

I agree that properly controled studies are a critical component to finding out what works and why. However, placebo or not, relief is relief.....

Title: Re: Placebo response in cluster headache trials
Post by Lori on Sep 9^th, 2003, 8:15am

How do they know it wasn't just the headache actually ending, not the placebo working? I just didn't see anything about how long the HA's were and when they stopped once taking the placebo. Any info on that? I may have missed it.

Title: Re: Placebo response in cluster headache trials
Post by vig on Sep 16^th, 2003, 4:19pm

I agree with Lori,
ANY assumptions made during these tests are suspect.
I can see they are making great efforts to design controlled experiments, but they're not even close.

They're not really learning anything useful.

Title: Re: Placebo response in cluster headache trials
Post by Prense on Sep 16^th, 2003, 6:46pm

Trial or no trial...maxalt did not a damn thing for me and imitrex is a miracle! Trust me, the attitude was the same...I wanted in the worst possible way for the HA to GO AWAY! Attitude my ass! If a HA lasts 1+ hours, then whatever I took didn't do JACK...if it lasts 15 minutes or so, then it worked. Simple enough. ;D