The first trial of a special butterbur extract for the prevention of migraine

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A Profile of Butterbur Extract: Pharmacology, Safety, and Clinical

Aspects

Author:Danesch U.Source:

Townsend Letter for Doctors and Patients. April, 2003.

Abstract: Butterbur extract with analgesic,

antiinflammatory and spasmolytic actions. Pharmacological data have

demonstrated an inhibition of the prostaglandin and leukotriene

synthesis by the extract. The spasmolytic activity is by an as yet

uncharacterized non-receptor mediated mechanism. Clinical experience

with Petadolex® demonstrates its efficacy in reducing the frequency

of migraine attacks and increasing the proportion of patients with a

reduction of migraine frequencies more than 50%. In acute treatment

preliminary data have shown a reduction in the duration of migraine

attacks.

Pharmacovigilance as well as safety results from clinical

trials have demonstrated that Butterbur is a safe extract with an

excellent tolerability profile. Merely " burping " seems to be a

significant side effect, being of mild and transient nature.The

first placebo-controlled trial of a special butterbur root

extract for the prevention of migraine: reanalysis of efficacy

criteria.

http://www.enzy.com/abstracts/display.asp?id=4192

 

Author:

Diener HC, Rahlfs VW, Danesch U.

Source:Eur Neurol. 2004;51:89-97.

Abstract:

 

This is an independent reanalysis of a randomised, placebo-

controlled parallel-group study on the efficacy and tolerability of

a special butterbur root extract (Petadolex®) for the prophylaxis of

migraine. The original protocol and analysis had a number of major

shortcomings. In order to follow regulatory requirements, an

independent reanalysis of the original data was performed. Following

a 4-week baseline phase, 33 patients were randomised to treatment

with two capsules 25 mg butterbur twice a day and 27 to placebo.

 

The mean attack frequency per month decreased from 3.4 at baseline

to

1.8 after 3 months (p = 0.0024) in the verum group and from 2.9 to

2.6 in the placebo group (n.s.). The responder rate (improvement of

migraine frequency 650%) was 45% in the verum group and 15% in the

placebo group. Butterbur was well tolerated. This small trial

indicates that butterbur may be effective in the prophylaxis of

migraine.

 

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Treatment of Headache. A Profile of

Butterbur Extract: Pharmacology, Safety, and Clinical Aspects

http://www.enzy.com/abstracts/display.asp?id=4196

 

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