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Study demonstrates that combination of black cohosh and St. John's wort provides effective relief for two common menopausal complaints

In February 2006, the results from a study published in Obstetrics & Gynecology demonstrated that the combination of black cohosh and St. John’s wort provided effective relief from hot flushes and depression in peri-menopausal women.  Given the increased risk of breast cancer and cardiovascular events associated hormone replacement therapy – historically the standard treatment protocol for women experiencing these symptoms - the study findings were significant.  This is good news for the more than 75 million women expected to transition through this normal life event during the next decade and seeking an alternative to deal with the symptoms associated with declining hormones later in life.

Menopause Treatment Options

For the last 50 years, hormone replacement therapy (HRT) has been the standard treatment of care for women experiencing hot flushes and other vasomotor symptoms associated with peri-menopause.  However, in 2002, a study conducted by the Women’s Health Initiative (WHI) that was investigating the effects of using hormone replacement (Prempro®) in postmenopausal women was halted.  The large study, which involved over 16,000 women, showed that rates of breast cancer and cardiovascular events increased in the treatment group.  A more detailed follow-up analysis of the WHI study findings published last year showed that for women in their 50s, using HRT at the smallest effective dose, for a limited duration, the benefits outweigh the risks.  Despite this new information, many women experiencing menopausal symptoms have been reluctant to start or continue HRT.

As a result of the WHI study findings, many women have turned to natural therapies for relief of menopausal symptoms.   The most popular supplements are made from the extracts of red clover and black cohosh.  These supplements contain phytoestrogens or plant estrogens which bind with estrogen cell receptor sites but do not exert the proliferative (cancer promoting) effect of human estrogens.  Ingesting these botanical compounds can provide some relief from the vasomotor complaints women experience during menopause.

In addition to hot flushes, many women experience psychological disturbances while going through menopause.  A variety of anti-depressants are available including selective serotonin reuptake inhibitors (SSRIs).  However, as with many drugs, these medications have significant side-effects.  In particular, a debate has continued as to whether SSRIs increase the rate of suicide in some patients.  A natural therapy that is widely prescribed in Europe and used in the U.S. for treatment of mild to moderate depression is St. John’s wort. 

Black Cohosh and St. John’s Wort Study Design

The aim of the study was to investigate the effects of combining both black cohosh and St. John’s wort in menopausal women experiencing both vasomotor symptoms and mild depression.  Several well-designed studies involving over 700 women, have demonstrated the effect of black cohosh on reducing the vasomotor symptoms associated with menopause.  A number of well-designed studies as well as meta-analysis have also demonstrated the efficacy of St. John’s wort in alleviating symptoms of mild to moderate depression.  The researchers theorized that the unique combination of the two botanical compounds could provide an additive benefit and effect.

A total of 301 women were included in the study at a median age of 52 years.  At the study’s onset, the women in both the treatment and in the control group experienced an average of 5+ hot flushes and 4 depressive moods per week.  The average age of onset of complaints was 47 years, with the complaints lasting for almost 5 years. 

To assess menopausal symptoms The Menopause Rating Scale was used.  The scale consists of 10 items and to participate in the study, a rating of 0.4 was required in at least 3 items†.  The Hamilton Depression Rating Scale was used to assess depression, with a score of 15 to 23 points required to participate in the study††.  Exclusion criteria included use of HRT or antidepressants and psychological or psychiatric therapy of depression symptoms. 

Half of the women received the treatment which consisted of a combination tablet of black cohosh and St. John’s wort (standardized to 1 mg triterpene glycosides and 0.25 mg of hypericine).  During the 16-week study, women in the treatment group took 2 tablets, twice a day for 8 weeks.  After 8 weeks, the dosing was reduced to 1 tablet, twice a day.  The remaining 150 women received a placebo.  The study was administered in one location with one researcher blinded to the patients and to the medication.  The patients visited the clinical investigator at base line, 8 weeks and 16 weeks.

Botanical Combination is Effective

At the beginning of the study, the mean Menopause Rating total score was 0.46 in both groups.  At 8 weeks, the mean total score was 0.30 in the treatment group and 0.36 in the placebo group.  By the study completion, this number had dropped to 0.23 in the treatment group but increased to 0.37 in the placebo group.  This highly significant finding showed the superiority of treatment compared with placebo on all 10 items of the score.  In addition, the improvement in each of the menopause factors (hot flushes, atrophy, psyche and soma) showed significant improvement by the second visit or 8 weeks and continued improvement by the study’s completion.

At the study start, The Hamilton Depression Rating scale total score of 18.9 points was observed in both groups.  At 8 weeks, the mean score was 13.2 in the treatment group and 16.3 in the placebo group.  By the study completion, this number had dropped to 11.0 in the treatment group but increased to 16.5 in the placebo group.  The mean group difference was considered significant.

By the end of the study, the efficacy of the medication was considered to be “moderate” or “very good” for 78.8% of the treatment group and only 14.9% for the placebo group.  Importantly, the number of adverse events was low in both the first and second phase of the study and was similar in both groups.  Additionally, many of these events were not judged to be related to the treatment.  This is important given that the dosing was higher in the initial 8 week phase of the study.

The study also demonstrated that the majority of women from both groups were very compliant (a patient was considered compliant if she came to the scheduled 8 and 16 week visits and had not taken less than 80% or more than 120% of the study medication).  Of the 301 participating in the study, results were obtained from 294 participants.

Botanical Compounds offer a Solution

Given that an estimated 75 million women will be entering menopause during the next decade, and that three-quarters will experience climacteric symptoms, finding safe yet effective solutions to ease complaints is an important medical challenge.

Unlike medications, herbal preparations are usually low-dosed so that it takes some time to develop their peak efficacy.  At the same time, because they tend to be very safe, they are ideal for long-term therapy.  Based on this most recent study, the combination of black cohosh and St. John’s wort provides a safe yet effective solution, with limited side-effects for women experiencing menopausal symptoms.

†The Menopause Rating Scale was grouped into four factors:  “hot flushes” (items 1, 3); “atrophy” (items 7-9); “psyche” (items 4-6) and “soma” (items 2, 10).

††The Hamilton Depression Rating Scale total score consists of 17 items which can be evaluated after treatment to determine improvement in depression.

Source:

“Black Cohosh and St. John’s Wort for Climacteric Complaints”, R. Uebelhack, et al, Obstetrics & Gynecology, 2006; 107: 247-255.