Treatment for the premenstrual syndrome with agnus castus fruit extract: prospective, randomised, placebo controlled study.

Institute for Health Care and Science, 35625 Hüttenberg, Germany.
BMJ Clinical Research (Impact Factor: 14.09). 01/2001; 322(7279):134-7. DOI: 10.1136/bmj.322.7279.134
Source: PubMed

ABSTRACT To compare the efficacy and tolerability of agnus castus fruit (Vitex agnus castus L extract Ze 440) with placebo for women with the premenstrual syndrome.
Randomised, double blind, placebo controlled, parallel group comparison over three menstrual cycles.
General medicine community clinics. Participants: 178 women were screened and 170 were evaluated (active 86; placebo 84). Mean age was 36 years, mean cycle length was 28 days, mean duration of menses was 4.5 days.
Agnus castus (dry extract tablets) one tablet daily or matching placebo, given for three consecutive cycles.
Main efficacy variable: change from baseline to end point (end of third cycle) in women's self assessment of irritability, mood alteration, anger, headache, breast fullness, and other menstrual symptoms including bloating. Secondary efficacy variables: changes in clinical global impression (severity of condition, global improvement, and risk or benefit) and responder rate (50% reduction in symptoms).
Improvement in the main variable was greater in the active group compared with placebo group (P<0.001). Analysis of the secondary variables showed significant (P<0.001) superiority of active treatment in each of the three global impression items. Responder rates were 52% and 24% for active and placebo, respectively. Seven women reported mild adverse events (four active; three placebo), none of which caused discontinuation of treatment.
Dry extract of agnus castus fruit is an effective and well tolerated treatment for the relief of symptoms of the premenstrual syndrome.

  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: With a prevalence of 3 to 8% among women of reproductive age, severe premenstrual symptoms are very common. Symptoms range from emotional and cognitive to physical changes. Severe symptoms (that is, premenstrual syndrome) can have a strong impact on everyday functioning and quality of life. Impairment can be as serious as that of dysthymic disorders. Many affected women receive either no treatment at all or are unsatisfied with their treatment. Although there is some evidence for the reduction of distress through cognitive behavioural therapy, there are only a small number of randomised controlled trials carefully investigating the efficacy of this psychotherapeutic approach. Thus, this study aims to evaluate the efficacy of a cognitive behavioural self-help treatment for women suffering from premenstrual syndrome.Methods/design: The study is conducted as a randomised controlled trial. The complex diagnostic assessment includes the completion of a symptom diary over two consecutive cycles and a telephone interview. Eligible women are randomly assigned to either a treatment or a wait-list control group. The intervention is based on cognitive behavioural therapy principles and is provided via the internet. It consists of 14 different modules on which participants work over 8 consecutive weeks. In addition to written information, participants receive email feedback from a clinical psychologist on a weekly basis. Participants assigned to the wait-list receive the treatment after the end of the waiting period (8 weeks). The primary outcome measure is the Premenstrual Syndrome Impairment Measure. Secondary outcomes include the Premenstrual Syndrome Coping Measure, the Short-Form Social Support Questionnaire, the Questionnaire for the Assessment of Relationship Quality, and the Perceived Stress Scale. Data is collected during the premenstrual (luteal) phase at pre-treatment, post-treatment, and 6-month follow-up. So far, there is no study investigating internet-based cognitive behavioural therapy for premenstrual syndrome. The programme approaches the problem of high prevalence in combination with severe impairment and insufficient treatment options.Trial registration: NCT01961479, 9 October 2013.
    Trials 12/2014; 15(1):472. · 2.12 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background: Plants have been used therapeutically for thousands of years and continue to be the main treatment modality for a large percentage of the world’s population. Furthermore, herbal medicine usage is increasing in Western countries as complementary (and sometimes alternative) treatments in conjunction with allopathic medicine. At the same time, the usage of allopathic medicines is being increasingly incorporated into the medicinal systems of developing countries, often resulting in the concurrent usage of both systems. Importance of the Study: Despite the widespread usage in developing countries and the trend of increasing medicinal plant usage in Western countries, herbal medicines remain understudied and there are misunderstandings amongst users and practitioners about the safe usage of these medications, particularly when used in conjunction with other medicines. Herbal medicines are generally not held to the same rigorous standards as allopathic medicines. There is usually a lack of industry regulation and manufacturing standards and guidelines, resulting in inferior (or unsafe) medicines being sold to consumers. Similarly, there is a lack of understanding amongst many medical practitioners of both traditional and allopathic medicine systems of how drugs from the two systems can be safely used together. Aim: The aim of this review is to summarise the current knowledge about herbal medicines and how they can be used safely, with the aim of not only highlighting some of the unsafe uses, but also to stimulate further research. I have also aimed to highlight the need for greater regulation and standardisation of herbal medicines.
    Pharmacognosy Communications. 01/2015; 5(1):2-50.
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Objective: Vitex agnus-castus (VAC) and its essential oil traditionally used to treat many conditions and symptoms such as premenstrual problems, mastalgia, inflammation, sexual dysfunction and pain. This study was conducted to investigate the analgesic effect of essential oil extracted from VAC (EOVAC) leaves in acute trigeminal model of nociception in adult male Wistar rats. Furthermore, possible involvements of opioidergic, cholinergic and L-arginine/NO/cyclic GMP pathway in analgesic activity of EOVAC were investigated. Methods: The EOVAC was extracted from powdered plant material by hydro-distillation in a Clevenger type apparatus. Acute trigeminal pain was induced by putting a drop of NaCl 5 M solution (40 μl) on the corneal surface of the eye and the numbers of eye wipes counted during the first 30 seconds. Results: EOVAC at doses of 100 and 200 mg/kg subcutaneous and morphine 2.5 and 5 mg/kg i.p. produced a significant anti-nociceptive effect in this model of corneal pain. Naloxone (1 mg/kg i.p.) and atropine (1 mg/kg i.p.), L-arginine (100 and 200 mg/kg i.p.) and methylene blue (5 and 10 mg/kg i.p.) alone had no any effect in the acute corneal pain. Pretreatment with naloxone or atropine significantly reversed the EOVAC‑induced analgesia, but L-arginine (300 mg/kg) and methylene blue (5 mg/kg) did not change the suppressive effect of EOVAC on pain response. Conclusion: The present results suggest that the EOVAC produced anti-nociception in the acute corneal pain through mechanisms that involved both opioidergic system and/or the cholinergic system, but not via L-arginine/NO/cyclic GMP pathway, supporting the folkloric usage of the plant to treat various painful processes.
    Asian Journal of Pharmaceutical and Clinical Research 01/2015; 8(1):283-286. · 0.51 Impact Factor

Full-text (2 Sources)

Available from
Jun 1, 2014