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Vitex agnus castus

A Systematic Review of Adverse Events

Drug Safety volume 28, pages 319–332 (2005)Cite this article

Abstract

Vitex agnus castus L. (VAC) [Verbenaceae] is a deciduous shrub that is native to Mediterranean Europe and Central Asia. Traditionally, VAC fruit extract has been used in the treatment of many female conditions, including menstrual disorders (amenorrhoea, dysmenorrhoea), premenstrual syndrome (PMS), corpus luteum insufficiency, hyperprolactinaemia, infertility, acne, menopause and disrupted lactation. The German Commission E has approved the use of VAC for irregularities of the menstrual cycle, premenstrual disturbances and mastodynia. Clinical reviews are available for the efficacy of VAC in PMS, cycle disorders, hyperprolactinaemia and mastalgia, but so far no systematic review has been published on adverse events or drug interactions associated with VAC. Therefore, this review was conducted to evaluate all the available human safety data of VAC monopreparations.

Literature searches were conducted in six electronic databases, in references lists of all identified papers and in departmental files. Data from spontaneous reporting schemes of the WHO and national drug safety bodies were also included. Twelve manufacturers of VAC-containing preparations and five herbalist organisations were contacted for additional information. No language restrictions were imposed. Combination preparations including VAC or homeopathic preparations of VAC were excluded. Data extraction of key data from all articles reporting adverse events or interactions was performed independently by at least two reviewers, regardless of study design.

Data from clinical trials, postmarketing surveillance studies, surveys, spontaneous reporting schemes, manufacturers and herbalist organisations indicate that the adverse events following VAC treatment are mild and reversible. The most frequent adverse events are nausea, headache, gastrointestinal disturbances, menstrual disorders, acne, pruritus and erythematous rash. No drug interactions were reported. Use of VAC should be avoided during pregnancy or lactation. Theoretically, VAC might also interfere with dopaminergic antagonists.

Although further rigorous studies are needed to assess the safety of VAC, the data available seem to indicate that VAC is a safe herbal medicine.

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Notes

  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgements

The authors wish to thank Barbara Wider and Katja Schmidt, Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, for the translation of studies from German and Professor Gabriela Mazzanti, Department of Pharmacology of Natural Substances and General Physiology, University of Rome ‘La Sapienza’, for her support.

No sources of funding were used to assist in the preparation of this review. The authors have no conflicts of interest that are directly relevant to the content of this review.

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  1. Department of Pharmacology of Natural Substances and General Physiology, University of Rome ‘La Sapienza’, Rome, Italy

    Claudia Daniele

  2. Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, 25 Victoria Park Road, Exeter, EX2 4NT, UK

    Joanna Thompson Coon, Max H. Pittler &  Edzard Ernst

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  1. Claudia Daniele
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Correspondence to Edzard Ernst.

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Daniele, C., Coon, J.T., Pittler, M.H. et al. Vitex agnus castus. Drug-Safety 28, 319–332 (2005). https://doi.org/10.2165/00002018-200528040-00004

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Keywords

  • Acne
  • Ambroxol
  • Menstrual Disorder
  • Aucubin
  • Adverse Drug Reaction Advisory Committee