Luna's Herbal

Vitex agnus castus for Support of Menstrual symptoms

Brenna Hendrick

American College of Healthcare Sciences RES 503

Dr. Glen Nagel

Abstract

Chaste tree berry, Vitex agnus castus, is approved by the German E Monograph for treatment of PMS. The effectiveness of this herbal remedy as an alternative to conventional medicine is supported by clinical studies. The purpose of this research is to evaluate if Vitex agnus castus can result in improved menstrual symptoms. There is a plethora of primary evidence that chaste tree berry has statistically significant therapeutic properties for PMS symptoms. Premenstrual syndrome is associated with psychological and somatic complaints.

The potential use of the herbal remedy Vitex agnus castus, to improve PMS for patients was evaluated by reading and assessing primary and secondary peer-reviewed scholarly journals. The clinical studies evaluated symptoms using various assessment tools. The evidence suggest Vitex agnus castus supports menstrual symptoms.

Keywords: Vitex agnus castus, Chaste Tree Berry, Phytotherapy, Pre-Menstrual-Syndrome, Menopause, Female Reproductive Health, Herbal Remedies, Natural Medicine, Monks Pepper.

  Introduction

Pre-menstrual syndrome (PMS) is noted to impact 70-90% of women (Ambrosini et al., 2013). The diagnosis is called PMS because the symptoms are isolated to the luteal phase which occurs after ovulation and before menses begins (Ambrosini et al., 2013). PMS can negatively impact daily activities and disturb interpersonal relationships (Zamani et al., 2012). The syndrome can result in anxiety, depression, headaches, bloating, and breast tenderness (Berger, 2000). A common current treatment for PMS is birth control, such as daily oral levonorgestrel plus ethinylestradoil (Kwan & Onwude, 2015). This issues associated with these treatments include some serious side effects such as vaginal hemorrhage, metrorrhagia, flu-like symptoms, deep vein thrombosis, breast cancer ad pulmonary embolism (Kwan & Onwude, 2015). There has been a trend to seek our more synergistic plant based medicines for treatment of diseases and maintaining health (Jiao, 2022).The research presented shows the plant Vitex agnus castus can be an effective treatment for PMS. This plant is a deciduous shrub in the Verbenaceae family native to Mediterranean Europe and Central Asia (Daniele et al., 2005). The research presented explored Vitex agnus castus as a treatment option for PMS. Vitex angus-castus is noted to have an agonistic dopaminergic effect which is hypothesized to decrease prolactin release (Berger et al, 2000). A decrease in prolactin is correlated to a reduction in PMS symptoms (Berger et al, 2000). In addition Vitex angus-castus contains neuroactive flavonoids that have been shown to improve psychological wellbeing (Berger et al, 2000).  The clinical studies evaluated use of Vitex agnus castus to measure PMS symptoms before and after treatment. Peer-reviewed journal articles were primarily accessed through PubMed and American College of Health Care Sciences University's library databases. The clinical studies reviewed were assessed in detail and looked at pre-treatment and post-treatment symptoms before and after administering Vitex agnus castus amongst patients diagnosed with PMS. The clinical evaluations varied in dosage and duration of time. The results show that Vitex agnus castus has the ability to support and alleviate PMS symptoms.

Results

A multicenter trial took place to study if chaste tree berry, Vitex angus-castus, is an effective treatment to alleviate PMS. The study used Ze 440. Ze 440 is a trademarked Vitex angus castus extract standardized for percent casticin, a flavonoid. A total of 50 patients all over the age of 18 participated in a study that lasted for 8 menstrual cycles. All patients signed written consent forms. In addition the study was evaluated and approved by an ethics committee.  The evaluation tools were Moo’s menstrual distress questionnaire (MMQD) and self-assessments.  At the end of the study, 43 patients were evaluated. All the patients evaluated took at least 85% of the medication, a 20 mg extract, once daily. The MMQD score showed a statistically significant reduction of symptoms (p<0.001).  The symptoms returned at the end of treatment, but an improvement lasted for 3 cycles after cessation. In addition, there was an improvement shown in the self-assessment. During this study, 1 of the patients that dropped out expressed it was related to fatigue associated with treatment. The study concluded that patients could be safely treated for PMS with Ze 440. The constituents in Vitex angus-castus work together to cover multiple symptoms and should continue to be evaluated as a holistic treatment for PMS (Berger et al, 2000). No conflicts of interest were found. 

            The Journal of Phytomedicine published an article looking at Agnolyt®, a trademarked phytomedicine comprised of chaste tree berry, Vitex angus-castus. The clinical trial compared Agnolyt® to pyridoxine, comprised of the vitamin B6. The participants were females aged 18-45. All participants provided written consent and the trial was approved by an ethics committee. Of the participants, 85 were given Agnolyt® and 90 were given pyridoxine. The women were assessed using a premenstrual tension syndrome scale (PMTS scale), looking at symptoms such as headaches, mood, and breast tenderness. The clinical trial was blind and lasted for a duration of three menstrual cycles. Agnolyt® is a 3.5-4.2 mg dried capsule that was taken daily by participants.  Agnolyt®  is standardized for percent casticin, a flavonoid. In both groups, 80% of participants noted improved results.  For the individuals treated with Agnolyt® 24.5% reported excellent results, and for individuals treated with pyridoxine, 12.1% reported excellent results. The results show potential for Agnolyt® being a benefit for PMS. No serious adverse events were observed, 36.1% treated with Agnolyt® had no complaints, and 21.3% of individuals treated with pyridoxine had no complaints. The authors concluded that Agnolyt® is as effective as pyridoxine for treating PMS (Lauritzen et al., 1997). More data needs to be conducted to see if the results are repeatable.

            Chaste tree berry, Vitex angus castus, extract Ze 440 was used in a randomized placebo controlled study to evaluate the efficacy of the medicinal for premenstrual syndrome. Ze 440 is a trademarked Vitex angus castus extract standardized for percent casticin, a flavonoid. Participants took one 20 mg tablet once daily of Ze 440 or one placebo once daily. A total of 170 women around the age of 35 participated in the clinical trial.  All women signed written consent prior to treatment. In addition the study was approved by an ethics committee. Half of the women took a placebo and the other half was given a dry extract tablet, extract Ze 440. One tablet of placebo or extract was given daily for 3 consecutive menstrual cycles. Women completed a self-assessment relating to mood, bloating, headaches and other menstrual syndromes.  The results showed a statistically significant improvement in the group treated with extract Ze 440, for all variables excluding bloating, in comparison to the placebo group. Adverse events were reported for both the placebo and extract group (3 placebo, 4 extract). None of the adverse events were severe enough for the participant to discontinue participating in the study.  The results are promising and show that Ze 440 could be an effective treatment for women struggling with menstrual symptoms (Schellenberg, 2001).  Zeller funded the clinical study, and Zeller is the manufacturer of Ze 440. Even though the data is statistically significant Zeller funding the clinical study could be considered a conflict of interest.

Loch et al., (2000) conducted an open study control that did not use a placebo. The participants took a capsule containing 20 mg of Vitex agnus castus. The extract was a trademarked phytotherapy, Femicur® capsules by the Schaper & Brümmer GmbH company. Femicur® is a trademarked Vitex angus castus extract standardized for percent casticin, a flavonoid (Niroumand et al., 2018). The capsules contained dried plant material and were administered for 3 menstrual cycles. A questionnaire was taken before and after treatment and evaluated physical and mental complaints for 1,634 patients. There was no indication of approval by an ethics committee. Investigators monitored the compliance of participants and stated a 98% compliance rate. Any patients who became pregnant were not included in the study. After three menses, 93% of participants showed a decrease in premenstrual symptoms (PMS), and 81% reported feeling much better. Adverse events were low and reported at 1.2%. The evidence suggests that Vitex angus castus is an effective treatment for PMS (Loch et al, 2000). To verify results more research should be conducted, and a control should be used to evaluate the placebo effect. No conflicts of interest were declared.

An article published in the Journal of Alternative and Complementary Medicine looked into a blend of chaste tree berry, Vitex agnus-castus, and St. Johnswort, Hypericum perforatrum, and its effect on premenstrual (PMS) symptoms for perimenopausal women. All participants signed written consent and the study was approved by an ethics committee prior to beginning.  The research article was based on a double-blind, randomized, placebo-controlled study.  Fourteen perimenopausal women participated in 16 weeks of treatment. Half the group took a placebo, and the other half was administered a combination tablet of Vitex agnus-castus and Hypericum perforatrum. The tablets were manufactured by Mediherb Australia following good manufacturing practices. The daily dosage of Vitex angus-castus was equivalent to 1000 mg of dried fruit, and 990 ug of Hypericum perforatrum. The Vitex angus-castus tablet administered was not a standardized extract. The Abrahams Menstrual Symptoms Questionnaire measured PMS scores for anxiety, depression, hydration, and cravings. Paired sample t-tests were used, and the results show that the herbal blend significantly improved PMS symptoms compared to the placebo group. For depression, p = 0.006. For anxiety, p = 0.003. For cravings, p = 0.027, and for hydration, p = 0.002. The p values demonstrate that Vitex agnus-castus and Hypericum perforatrum can help PMS in perimenopausal women (van Die et al., 2009). Further research needs to be done to verify these findings. The number of participants is limited, which could result in variability on a larger scale. There were no conflicts of interest presented.

Discussion

Evidence suggests Vitex agnus-castus can improve PMS symptoms as the clinical evidence presented supports this thesis. A sum of 5 clinical studies were evaluated, and 5 out of the 5 clinical evaluations reviewed demonstrated significant improvement in PMS symptoms when taking an extract of chaste-tree berry. Berger et al (2000) and Schellenberg (2001) showed a statistically significant result with the trademark extract Ze 440, an extract standardized for percent casticin. Both Berger et al (2000) and Schellenberg (2001) used a chaste tree berry extract at a dosage equivalent to 20 mg daily. Despite being standardized for casticin it’s likely the blend of constituents have a synergist effect on PMS and that the isolated constituent on its own may not have the same effect (Berger et al, 2000). 

Loch et al (2000) also showed a statistically significant result with a 20 mg extract using the trademarked extract Femicur®. Femicur® is also an extract standardized for percent casticin (Niroumand et al., 2018). Lauritzen et al (1997) used the trademarked drug Agnolyt® at a dose of 3.5-4.2 mg/daily. Agnolyt® is another extract standardized for percent casticin (Niroumand et al., 2018).  Lastly van Die et al (2009) used a non-standardized extract of chaste tree berry at a dose of 1000 mg daily manufactured by Mediherb Australia. All 5 of these studies demonstrated significant improvements and were at least 3 months duration.

All extracts were standardized for percent casticin, this is a based on the Germen Commission E recommendation of an extract of dried fruit standardized to 0.6% casticin (Niroumand et al., 2018).  The German Commission E recommended 30-40 mg/day of extract of dried fruit which is a greater quantity than the amount taken in 4 of the 5 clinical studies evaluated (Niroumand et al., 2018).  This shows there is more research needed to determine appropriate dosing for effectiveness. 

The data presented used varies different tools to assess how to rate symptom severity for PMS, so even though all the results demonstrated significant improvements there is variability in assessments. To evaluate the different trademarked chaste tree berry extracts studied (Ze 440, Agnolyt®, Femicur®) a standardized assessment tool would be required. The current data could have varying results for treatment efficacy if the symptoms assessment tools were different (Kwan & Onwude, 2015).

The data suggest that the chaste tree berry decreases PMS associated depression, anxiety, overall mood, breast tenderness, and headaches (van Die et al., 2009) (Schellenberg, 2001). Berger et al (2000) note Vitex angus-castus has an agonistic dopaminergic effect which is hypothesized to decrease prolactin release (Berger et al, 2000). A decrease in prolactin is correlated to a reduction in PMS symptoms (Berger et al, 2000). In addition Vitex angus-castus contains neuroactive flavonoids that have been shown to improve psychological wellbeing (Berger et al, 2000).  The combination of decreased prolactin and neuroactive flavonoids is likely the reason chaste tree berry shows evidence of being an effective treatment for PMS.

The results from the studies demonstrate that Vitex angus-castus can improve PMS through the constituents and actions of the plant. Vitex agnus castus, is approved by the German E monograph for treatment of PMS (Loch et al., 2000). More data needs to be collected on the minimum acceptable dose, length of time, and active constituent content to truly understand Vitex angus-castus benefits to patients psychological and somatic complaints. Vitex angus-castus  could also be studied more to see if benefits are also present for menopausal women.

Conclusion

Evidence suggests Vitex angus-castus can improve PMS symptoms such as psychological wellbeing, and decreasing symptoms such as headaches and breast tenderness (Berger et al, 2000).   All the clinical studies presented in the report produced statistically significant results (Berger et al, 2000; see also Lauritzen et al., 1997;  Schellenberg, 2001; Loch et al., 2000; van Die et al., 2009) . The purpose of this study is to assess whether Vitex angus-castus supports pre-menstrual syndrome health. The primary sources show that Vitex angus-castus can be therapeutic for people experiencing PMS. More research is needed to understand how long the plant needs to be taken to produce consistent therapeutic actions.

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