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Efficacy and safety of Vitex agnus-castus extract for treatment of premenstrual syndrome in Japanese patients: a prospective, open-label study.

  • 2014-03
  • Advances in therapy 31(3)
    • Mikio Momoeda
    • Hidetaka Sasaki
    • Eiko Tagashira
    • Masayuki Ogishima
    • Yuichi Takano
    • Kazunori Ochiai

Study Design

Type
Clinical Trial
Population
Japanese women with PMS and aged 18-44 years
Methods
Multi-center, prospective, open-label, single-arm, phase 3 study; patients received Prefemin® containing 20 mg of VAC extract once daily for three menstrual cycles
Blinding
Open-label
Duration
three menstrual cycles
Funding
Unclear

Introduction

Herbal medicine containing Vitex agnus-castus (VAC) extract is widely used by women with premenstrual syndrome (PMS) in Europe, however, in Japan, clinical evidence remains to be determined. This study attempted to investigate the efficacy and safety profiles of VAC extract in Japanese patients with PMS.

Methods

A multi-center, prospective, open-label, single-arm, phase 3 study was performed in Japanese women with PMS and aged 18-44 years. The patients received Prefemin® (Max Zeller Söhne AG, Romanshorn, Switzerland), containing 20 mg of VAC extract, once daily for three menstrual cycles. The efficacy profile was examined based on the intensity of ten PMS symptoms-irritability, depressed mood, anger, headache, bloating, breast fullness, skin disorder, fatigue, drowsiness, and sleeplessness-recorded by patients via a visual analog scale (VAS). In addition, the responder rate was calculated based on the total VAS score defined by the sum of the VAS scores of the first six symptoms mentioned above. Furthermore, physician's global assessment (PGA) scores were recorded. Adverse events including vital signs and laboratory test values were monitored as safety evaluation.

Results

Sixty-nine patients received Prefemin®. After the first menstrual cycle, a statistically significant decrease in total VAS score was observed (P<0.001), and the score continued to diminish for the following two cycles. Each of the ten symptom scores decreased significantly in this manner. In addition, the responder rate increased in a time-dependent manner; the rate at the third menstrual cycle was 91.0%, and almost all of the patients were without symptoms or exhibited only mild symptoms based on PGA. Eight patients exhibited non-serious adverse events, one of which was allergic dermatitis whose causal relationship with VAC was not ruled out.

Conclusion

VAC extract improved PMS symptoms in Japanese patients, with no substantial adverse events. This is the first study to report the effect of VAC extract in Japanese patients.

Research Insights

  • Vitex→Improved Physician Global Assessment

    almost all of the patients were without symptoms or exhibited only mild symptoms based on PGA

    Effect
    Beneficial
    Effect size
    Large
    Dose
    20 mg/day
  • Vitex→Improved Responder Rate

    In addition, the responder rate increased in a time-dependent manner; the rate at the third menstrual cycle was 91.0%

    Effect
    Beneficial
    Effect size
    Large
    Dose
    20 mg/day
  • Vitex→Reduced Allergic Dermatitis

    Eight patients exhibited non-serious adverse events, one of which was allergic dermatitis whose causal relationship with VAC was not ruled out.

    Effect
    Harmful
    Effect size
    Small
    Dose
    20 mg/day
  • Vitex→Reduced Anger

    Each of the ten symptom scores decreased significantly in this manner.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    20 mg/day
  • Vitex→Reduced Breast Fullness

    Each of the ten symptom scores decreased significantly in this manner.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    20 mg/day
  • Vitex→Reduced Depressed Mood

    Each of the ten symptom scores decreased significantly in this manner.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    20 mg/day
  • Vitex→Reduced Drowsiness

    Each of the ten symptom scores decreased significantly in this manner.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    20 mg/day
  • Vitex→Reduced Fatigue

    Each of the ten symptom scores decreased significantly in this manner.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    20 mg/day
  • Vitex→Reduced Flatulence

    Each of the ten symptom scores decreased significantly in this manner.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    20 mg/day
  • Vitex→Reduced Headache

    Each of the ten symptom scores decreased significantly in this manner.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    20 mg/day
  • Vitex→Reduced Irritability

    Each of the ten symptom scores decreased significantly in this manner.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    20 mg/day
  • Vitex→Reduced Pain Score

    After the first menstrual cycle, a statistically significant decrease in total VAS score was observed (P<0.001), and the score continued to diminish for the following two cycles.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    20 mg/day
  • Vitex→Reduced Premenstrual Syndrome Symptom Score

    After the first menstrual cycle, a statistically significant decrease in total VAS score was observed (P<0.001), and the score continued to diminish for the following two cycles.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    20 mg once daily
  • Vitex→Reduced Skin Disorder

    Each of the ten symptom scores decreased significantly in this manner.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    20 mg/day
  • Vitex→Reduced Sleeplessness

    Each of the ten symptom scores decreased significantly in this manner.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    20 mg/day
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