Petasitidis rhizoma

Petasitidis rhizoma, also known as butterbur rhizome, is a drug used in herbal medicinal products for the treatment of acute and spasmodic pain in the urinary tract, especially in nephrolithiasis(Commission E); the drug is also used for migraine prophylaxis. In some countries (e.g. Switzerland) the drug is approved for the treatment of allergic rhinitis.

HMPC: - not processed

ESCOP: - not processed

Commission E-monograph: -Root: positive evaluation: Adjuvant for acute spasmodic pain in the urinary tract, especially stones.

negative evaluation for the leaves!

Empirical medicine: Migraine, therapy and prophylaxis, neck and back pain, cramps.

Butterbur contains sesquiterpenes such as petasin, neopetasin and isopetasin, mucilages and pyrrolizdine alkaloids of toxicological concern with 1,2 unsaturated necin skeleton and their N-oxides. However, these are present in finished medicinal products in such small amounts that they are below the detection limit of 0.1 ppm and are negligible.

Petasitidis rhizoma has anti-inflammatory, antispasmodic and analgesic effects. In addition, it inhibits the synthesis of leukotriene and the synthesis of the enzyme COX-2. reduction of the release of histamine and serotonin.

Petasitidis rhizoma is used for the prophylaxis of migraine and for the symptomatic treatment of acute allergic rhinitis (licensed in Switzerland). Other indications are bronchial asthma and acute and cramp-like pain in the urinary tract (especially in nephrolithiasis, ureteral colic).

A clinical, placebo-controlled study on 60 patients proved the effectiveness of the extract (50 mg rhizome extract/day) in migraine prophylaxis.

Petasins, bicyclic sesquiterpene alcohols, as well as the total extract from butterbur leaves have a blocking effect on the release of various inflammatory mediators, such as e.g. the inflammatory mediators of the brain. Inflammatory mediators such as histamine. This effect forms the pharmacological basis for improving the symptoms of allergic rhinitis. There is also evidence of an inhibition of leukotriene synthesis. In a randomized double-blind clinical study on 125 hay fever patients, an extract of butterbur leaves proved to be as effective as the antihistamine cetirizine. Due to the relatively short half-life of the drug, it must be taken 4 times a day. Tesalin® N, an extract of butterbur leaves, is approved in Switzerland for the indication rhinitis allergica, see also under trade names.

Topical formulations of the extract in a lipolotion are being tested for atopic eczema.

Cosmetics: Root extracts of the plant are used for skin care under the name Petasides hybridus extract.

The daily dose of the drug is between 4.5 and 7 g. It should not exceed the value of 1 ug of pyrrolizide alkaloids with 1,2 unsaturated necine skeleton including N-oxides.
The duration of use should not exceed 4 to 6 weeks per year.

In a few individual cases liver damage and liver toxic reactions have been reported. Since the findings are not confirmed and are therefore not considered an official side effect, it is nevertheless advisable to refrain from prophylactic use in the case of pre-existing liver damage.

If you are pregnant or breastfeeding, you should not take it. Children < 12 years of age (no experience is available for this age group).

There are no known interactions with other drugs.

Petadolex capsules (1-1-1/day p.o. or 2-0-2)

Since mid-July 2009, the preparation Petadolex capsules has no longer been available as a medicinal product in Germany, despite the recognized medical standard for migraine prevention and its inclusion in the recommendations of the DGN (German Society of Neurology) guideline for migraine prophylaxis. Still on the market as a dietary supplement.

Due to the adaptation of the extraction agent to the state of the art (from dichloromethane to CO2), a subsequent approval was granted by the BfArM in Germany. The CO2 extract in Petadolex capsules was defined as a new active ingredient and required a completely new approval.

^TESALIN® N approved in Switzerland for rhinitis allergica

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12. https://register.awmf.org/assets/guidelines/030-057l_S1_Therapy-of-migraine-attack-prophylaxis-of-migraine_2024-06.pdf
13. https://www.aerzteblatt.de/archiv/955/Phytotherapie-mit-Pestwurz-Extrakt-Spasmolytischer-Effekt-bewiesen