ESCOP monographs The Scientific Foundation for Herbal Medicinal Products. Online series. Primulae radix (Primula root). Exeter: ESCOP; 2021.

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SUMMARY

The herbal monograph selects and summarizes scientific studies and textbooks regarding efficacy, dosage and safety, to support the therapeutic uses of primula root.

This herbal drug by definition consists of the whole or cut, dried rhizome and root of Primula veris L. or P. elatior Hil.

Studies with its main characteristic constituents, triterpene saponins of the oleanane-type and the phenolic glycosides primverin and primulaverin, are included.

The therapeutic indication is cough associated with common cold.

Administration of primula root addresses posology; its duration of use; contra-indications; special warnings; special precautions for use; undesirable effects; overdose.

In vitro experiments with primula root saponins demonstrated anti-bacterial, anti-fungal, and anti-viral activity. Extracts inhibited COX-1, COX-2 and LPS-induced release of IL-8 in human monocytes. In vivo experiments with primula root saponins increased the ciliary activity of the throat epithelium of curarized frog and inhibited pain provoked by compression of inflamed paws of rats in a dose-dependent fashion.

A non-controlled clinical study, in patients with antibiotic-resistant stomatitis caused by Candida albicans, topical treatment with saponins from primula root, led to the disappearance of local symptoms within 2-3 days.

Pharmacokinetics for orally administered primula root saponins are not available, but saponins, in general, are poorly absorbed from the gastrointestinal tract.

Preclinical safety data were assessed in toxicity studies.

Safety data were assessed in several observational and two randomized, double-blind, placebo-controlled studies, in children, women, and men, treated with combination products containing primula root. Rare cases of pruritus, itching, exanthema, and slight gastrointestinal complaints occurred. The tolerability of the two combination products was rated by the patients and physicians as “good” or “very good”.

The selection of literature cited in the monograph is aimed at bringing together relevant information about the possible physiological roles of primula root and its major constituents.

KEYWORDS

• Primulae radix
• Primula root
• Primula veris L.
• Primula elatior Hil.
• Respiratory disorders
• Mouth and throat disorders
• Cough associated with common cold

Reference: European Scientific Cooperative on Phytotherapy. ESCOP monographs The Scientific Foundation for Herbal Medicinal Products. Online series. Primulae radix (Primula root). Exeter: ESCOP; 2021.