Vitex agnus-castus safety studies
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Safety Profile of Vitex agnus-castus in Clinical Use
Multiple clinical trials and systematic reviews have found that Vitex agnus-castus (VAC) is generally safe for use in women, especially for conditions like premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), and mild hyperprolactinaemia. Across several randomized controlled trials, adverse events reported with VAC were mild and infrequent, with no serious side effects documented. These findings are consistent across different preparations and studies, supporting the herb’s good tolerability in clinical settings 1258.
Adverse Effects and Tolerability
The most commonly reported side effects of VAC are mild and reversible, such as gastrointestinal discomfort, headache, or skin reactions. No significant drug interactions have been recognized in systematic reviews, although theoretical concerns exist regarding potential interactions with dopaminergic antagonists due to the plant’s dopaminergic activity 125. Overall, the safety profile is favorable, and VAC is considered well tolerated by most users 125.
Safety in Pregnancy and Fertility Concerns
Animal studies indicate that VAC may affect pregnancy outcomes, including pregnancy rate, live birth rate, abortion, and stillbirth rates, depending on the timing and duration of administration. These effects were observed in rats, with some groups showing decreased fetal weight and altered pregnancy outcomes. Therefore, caution is advised when considering VAC for women who are pregnant or planning pregnancy, and its use is generally contraindicated during pregnancy due to potential hormonal effects 35.
Acute Toxicity and Preclinical Safety
Preclinical studies in rats have shown that VAC fruit decoctions did not cause toxicity or mortality at doses above 200 mg/kg, supporting its safety in acute settings. These studies also highlight the absence of significant toxic effects at commonly used doses, further validating its traditional use 4.
Recommendations and Research Gaps
While current evidence supports the safety of VAC for most women, especially for short-term use in reproductive health conditions, more high-quality, large-scale studies are needed to fully assess its long-term safety and effects in special populations, such as pregnant women or those with complex medical conditions 1258.
Conclusion
Vitex agnus-castus is generally safe and well tolerated for most users, with only mild and reversible side effects reported in clinical trials. However, its use during pregnancy should be avoided due to potential risks observed in animal studies. Continued research is recommended to further clarify its safety profile, especially for long-term use and in sensitive populations.
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