Butterbur Herbal Extract

A placebo controlled clinical study using Petadolex

Petadolex Butterbur Gelcaps (Standardized Butterbur Extract)
Der Freie Arzt, Nr. 3 May/June 1996

Migraine Prophylaxis with a phytopharmaceutical remedy:

The results of a randomized, placebo-controlled, double-blind clinical study with Petadolex Gelcaps™

Werner Grossman, Professor at the University of Munich, Dpt. of Neurology and Pharmacology, Germany

Migraine is a syndrome generally characterized by a paroxysmal and often unilateral headache. The frequency, intensity and duration of migraine attacks are variable. The headache is usually accompanied by vegetative symptoms such as nausea, vomiting, tachycardia, and hypersensitivity to light and noise, but can also include localized central nervous system disturbances.

Currently, migraine treatment distinguishes between treatment of acute attacks and prophylaxis. For prophylactic treatment a medication is taken regularly over a course of months and the dosage reduced or discontinued when successful.

Should the latter symptoms recur, medication is given again and the treatment regimen is repeated. This therapy scheme is in accordance with clinical observations which show that repeated treatment regimens carried out over a period of several months can offer long-term success.

The substances most commonly applied in migraine prophylaxis include beta-blockers (e.g., Propanolol and Metoprolol which have side effects of bradycardia, drop in blood pressure, muscle weakness, depression, aggressive migrainechart1.gif (3590 bytes)dreams, digestive disturbances, bronchial spasms, etc.); calcium antagonists (e.g., Flunarizin which has side effects of tiredness, weight increase, Parkinson-Syndrome, dyskinesia, depression, etc.); or serotonin antagonists (e.g., Methysergid and Pizotifen which have side effects that include concentration disturbances, tiredness, depression, weight increase, nausea, digestive disturbances, peripheral vasoconstriction, fibrosis of the cardio-valves, pleura or retroperitoneal tissue, etc.). The potential effectiveness of each of these agents is placed at 50 – 70%, whereas individual responsiveness varies considerably from patient to patient.

In most cases, migraine is an annoying condition for patients, but it is not necessarily dangerous. A prophlylactic therapy should therefore not only be effective but, when possible, harmless and free of side effects. Up until now, however, these criteria have not been satisfactorily fulfilled.

Actually, we present here a traditional phytopharmaceutical which has gone through a development and purification process over years. Petadolex Gels is a standardized high potency lipophilic extract of the Petasites hybridis rhizome.dayschart.GIF (3590 bytes) In Pharmacology, this extract is known to have a spasmolytic effect. This means that it reduces spontaneous activity and spasms in the smooth muscular system, including the vascular walls.

Beyond this, it acts on the arachidon acid cycle and reduces leukotriene synthesis, thus providing an anti-inflammatory effect. In these ways the specific mechanisms of action found in Petadolex Butterbur Gelcaps™ are similar to those found in other migraine medications.

A number of phytotherapeutical observational reports attest to the anti-convulsive, pain-alleviating, relaxing and vegetative-regulating effects of the Gelcaps on humans. Gruia (1986) reported for the first time that migraine patients treated with Petadolex Butterbur Gelcaps™ exhibited longer intervals of time between attacks and a reduction in pain intensity.

The study presented here draws upon the clinical experiences to date.

Study Design

The objective of this study was to compare the effectiveness and tolerability of Petadole capsules as a prophylaxis for migraine (with and without aura) to a placebo. A randomized, parallel-group, double-blind study was conducted. The methods applied, objective criteria, inclusion/exclusion criteria, as well as statistical evaluation, were carried out in strict accordance with standards established by the International Headache Society and Good Clinical Practice.

The objective criteria were:

the number of migraine attacks/month,
the average duration of the migraine attacks/month,
the intensity of individual migraine attacks/month.

Additionally investigated were:

the frequency intake of other analgesics,
the patients overall assessment of therapy success.

Subjects: 60 patients of both sexes, mean age 28.7 years.

Medication: 50mg b.i.d. Petadolex Butterbur capsules or placebo.

Duration of treatment: 4 week baseline period free of medication, followed by a treatment period of 3 months.
1.Results
Evaluation of Migraine diaries:

The patients regularly recorded the number of attacks, the day,time of the attacks, duration, and pain intensity in diaries.
Number of migraine attacks/month:

Petadolex Gelcaps group had significantly fewer attacks than PLACEBO
Number of migraine days/month:

Petadolex Gelcaps group had fewer migraine days than PLACEBO
Pain intensity of the migraine attacks:

Petadolex Butterbur Gelcaps™ group had less than PLACEBO, although not statistically significant
Duration of the migraine attacks:

Petadolex group had shorter attack durations than PLACEBO, although not statistically significant (figure 4).
2.Results of Physician Interviews

Patients were asked to assess the overall treatment benefit, as well as the effects on number of migraine attacks, migraine days, duration and pain intensity.

QUESTION: “Did the therapy help you in any way?”
Petadolex Gelcaps™ clearly demonstrated superiority over PLACEBO.

For Number of migraine attacks, migraine days, duration and intensity of pain, physician interviews revealed results similar to patient diaries.

(See results above)

Attack medication: No significant difference between Petadolex group and PLACEBO.

Side effects: None, either in the group treated with Petadolex or in the PLACEBO.

Drop-outs: Two, one due to suspected pregnancy, and the other due to lack of compliance.
3.Evaluation and Conclusion

This study shows Petadolex Butterbur Gelcaps™ significantly reduces the number of migraine attacks by 60% compared to a placebo. Petadolex Butterbur Gelcaps™ therefore performs comparably to other migraine prophylactics.

With regard to duration of migraine attacks, however, results indicate no significant reduction.

The results of patient overall assessment of treatment benefits (Question: “Did you benefit from this treatment?”) are outstanding. In both cases, the results in favor of the treatment with Petadolex were significant.

The results regarding side effects of the medication were also outstanding. Not considering the 2 non-therapy drop-outs, there were no side effects reported during the entire three month treatment phase. These results correspond to the 25-year clinical experience with Petadolex, as well as to other studies on its effects when used to treat other painful conditions. In this respect, Petadolex is superior to all other migraine prophylactics.

Both its effectiveness and safety prove Petadolex Butterbur Gelcaps™ to be first line therapy for prevention of migraine attacks.

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