Family Practice Advance Access originally published online on August 14, 2007
Family Practice 2007 24(5):468-474; doi:10.1093/fampra/cmm048
Treatment of menopausal symptoms by qualified herbal practitioners: a prospective, randomized controlled trial
a Faculty of Service and Leisure, City of Bristol College, Bristol
b Department of Nursing, University of Central Lancashire, Preston
c Bristol Research and Development Support Unit, United Bristol Healthcare Trust, Bristol
d School of Health and Bioscience, University of East London, London, UK
Correspondence to Julia Green, City of Bristol College, 286 Ashley Down Road, Bristol BS7 9BQ, UK; Email: julia.green{at}ukonline.co.uk
Received 10 July 2006; Revised 3 July 2007; Accepted 12 July 2007.
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Abstract |
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Objectives. To assess the effectiveness of professional herbal practice in the treatment of menopausal symptoms. To generate pilot data for future sample size calculations.
Methods. A pilot prospective, randomized, waiting list controlled trial was conducted in primary care at one urban UK GP practice. Participants were 45 women aged 46–59, experiencing self-defined menopausal symptoms and no menstrual bleeding for 3 months. Exclusion criteria included use of hormone replacement therapy. Participants were block randomized into a treatment group (n = 15) who received a course of individualized treatment from one of three herbal practitioners, and control group (n = 30) offered treatment after waiting 4 months. Treatment was six consultations over 5 months including discussion of nutrition, lifestyle and individualized herbal prescription. Change in menopausal symptoms was measured in both groups using the validated Greene Climacteric Scale. Measure Yourself Medical Outcome Profile recorded changes in self-defined most troublesome symptoms.
Results. Forty-four participants completed the study. The treatment group demonstrated a statistically and clinically significant reduction in menopausal symptoms compared to the control group. Total scores for menopausal symptoms reduced for both groups. Reduction for the treated group was 9.05 points greater than that for the control group, CI 5.08–13.03, as were changes in vasomotor scores (mean 1.81, CI 1.00–2.62). Libido increased (mean 0.69, CI 0.38–0.99) in the group receiving herbal treatment.
Conclusion. The treatment package from herbal practitioners improved menopausal symptoms, particularly hot flushes and low libido. This offers evidence to support herbal medicine as a treatment choice during the menopause.
Keywords. Complementary therapies, herbal medicine, hot flushes, libido, menopause.
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Introduction |
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Symptoms associated with the menopausal transition1 include hot flushes, night sweats, palpitations, insomnia, depression and vaginal dryness. In a UK survey of 8000 women aged 45–54, 57% of respondents experienced one or more of 15 menopausal symptoms and 22% found them a problem.2 Another UK survey of 1206 women aged 46–55 found that 47% had menopausal symptoms and these 563 women used a range of methods for symptom control such as diet/nutrition (44%) and exercise/yoga (41%).3 Studies in the UK have shown an association between reduced quality of life and incidence of menopausal symptoms.4 Members of the National Institute of Medical Herbalists (NIMH) reported menopausal symptoms as a frequent reason for consultation.5 There have been clinical trials on single herbs used in treating menopausal symptoms,6 but the trial quality is variable and the evidence contradictory. Herbal practice is well established in the UK7 and statutory regulation is in progress, but the effectiveness of holistic herbal practice by qualified practitioners has not been explored.
Fewer women are now advised by their GP to use hormone replacement therapy (HRT)8 because of the associated increased risk of breast cancer and cardiovascular disease. Decreased confidence in HRT among menopausal women has highlighted the need for alternative treatment options.9 Health care professionals would like a clear evidence base from which to advise women.10
The main aim of this pilot study was to find out whether it was possible to evaluate the effectiveness of treatment of women with menopausal symptoms by qualified herbal practitioners. A secondary aim was to estimate recruitment rates and to gather data to inform the sample size calculation for a future clinical trial in primary care using the Greene Climacteric Scale. The study was pragmatic and investigated the outcome of the whole package of care, which includes an in-depth consultation, nutritional and lifestyle advice and a personal herbal prescription. This pilot prospective, randomized, waiting list controlled trial of the treatment of menopausal symptoms brings rigorous examination to the use of a complex intervention in complementary medicine. The main hypothesis was that the total Greene Climacteric score would reduce for women who received herbal treatment compared to a waiting list control group, using the 5% level of statistical significance.
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Methods |
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Research design
This was a prospective, pragmatic, randomized, waiting list controlled pilot study.
Setting and recruitment of participants
Participants were recruited from one urban GP practice (5000 patients) in the UK, between November 2002 and February 2004. The practice patients have high levels of employment, income and education, and mostly live in owner-occupied houses (Townsend score of –0.06). The database was searched for women aged 46–59 receiving neither a prescription for HRT nor the contraceptive pill. Eligible women were invited by letter to participate in the study and to contact the trial coordinator. Respondents were then sent a patient information sheet and the coordinator telephoned respondents to explain the study. Those willing to take part were invited to an interview. Participants were entered into the trial at interview after review of inclusion and exclusion criteria, baseline data collection, completion of baseline outcome measures and informed consent was given.
Women were included who were experiencing self-defined menopausal problems of at least 3 months duration and whose last menstrual period was at least 3 months ago. Women were excluded who were taking HRT, oral contraception, tamoxifen or using ‘natural progesterone cream’. Also excluded were those women currently receiving complementary treatment for the menopause or psychiatric treatment, those who had received general anaesthesia within 3 months and those who had been advised to take HRT because of osteoporosis or high risk of developing osteoporosis.
Participants were then randomized into the treatment group (n = 15) and a control group (n = 30). The block randomization was prepared by JI at the Bristol Research and Development Support Unit, with a block size of 9, and sealed opaque numbered envelopes delivered to the trial coordinator (JG). Participants were allocated to treatment or control groups by JG at interview and all completed outcome measures. Subsequent outcome measures were posted to participants at weeks 2, 8, 16 and 24. Reminders were made by telephone after 1 week.
The treatment group received a care package from a qualified herbal practitioner over 5 months. The waiting list control group was offered similar treatment after 4 months.
Herbal intervention
The three herbal practitioners had all undertaken a 4-year part-time course in western herbal medicine at the School of Phytotherapy, accredited by the NIMH.11 They had been in practice between 10 and 14 years. Treatment by herbalists is a complex intervention, and the practitioners had, through discussion, established that their clinical methods were comparable. The format of the treatment process was agreed between the practitioners to reflect their normal practice.
The treatment group received a series of six consultations over 18 weeks, at the private clinic of the herbal practitioner, and their herbal medicines were taken for 24 weeks. The clinics were local to the GP practice. At the first consultation of 1 hour, a full clinical history was taken including medications, blood pressure and discussion of diet and lifestyle. A care plan was prepared for each patient according to the presenting symptoms, constitution and other health problems. An individualized herbal prescription was dispensed at the end of the consultation and adjusted as required at subsequent consultations reflecting any reported changes.
Compliance and adverse events were recorded at each consultation; adverse events were tabulated and reviewed by AD.
Outcome measures
The primary outcome measure was the Greene Climacteric Scale12 and the secondary measure was Measure Yourself Medical Outcome Profile (MYMOP2).13
The Greene Climacteric Scale is validated in the UK.14 There are 21 questions, with responses scored on a 0–3 Likert scale. Scores are expressed as a total of all the questions (range 0–63) or as four separate subscales: vasomotor (hot flushes and night sweats) (range 0–6), psychological (anxiety + depression) (range 0–33), somatic (physical) (range 0–21) and loss of interest in sex (libido) (range 0–3).
MYMOP2 is a six-point Likert Scale which has been developed for use in complementary medicine and allows patients to identify their two most troublesome symptoms. It includes a well-being score and records confounding factors such as co-medication and life events.
Design and statistical analysis
The main hypothesis was that the total Greene score would reduce and this was assessed for statistical significance using the 5% level. There were four secondary hypotheses based on the four subscales, and these were assessed at the 1.25% level using a Bonferroni correction (0.05/4) to control for a type I error rate.
The Greene Climacteric Scale data were analysed using Stata v6. A repeated measures analysis of variance (ANOVA) was carried out using the first five data collection points (up to 24 weeks), comparing those offered herbal treatment against those who were not, across time. Last observation carried forward was used to ensure a complete data set and Greenhouse-Geisser estimates were used throughout to control for any sphericity. The statistical significance of the interaction between time and treatment was used to demonstrate a treatment effect.
MYMOP2 scores for those who reported a vasomotor symptom were analysed at the 24-week data collection point using an analysis of covariance (ANCOVA) controlling for baseline values. Inspection of histograms showed that they appeared to have a roughly normal distribution with no obvious floor or ceiling effects.
The study design of 1:2 randomization was carried out to maximize the study power within budget constraints15 and to allow for the risk of high dropout in the control group, as there was concern at the planning stage that low compliance in the control group might make it impossible to perform a power calculation for a future study. A study with 15 subjects in two equally sized groups would have 75% power to investigate an effect size of 1 SD with an unpaired t-test for differences in mean improvement, whereas a study with 30 subjects in the control arm has 87% power to investigate the same effect size. The sample of 15 treated subjects was selected to allow each of three herbalists to treat a similar number of subjects.
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Results |
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Recruitment
The search of the practice database produced 252 women aged 46–59 who were not on HRT or contraceptives. Of these, 161 replied and over 50% were excluded because they were still menstruating. Of the 252 women contacted, 45 of 161 who replied met the criteria and were enrolled at the interview with the trial coordinator.
Table 1 shows the baseline characteristics of the two groups. Figure 1 shows the trial flow diagram.
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One treated subject was excluded early in the trial as post-operative complications of a previous knee operation meant that she was unable to attend for treatment (reducing treated arm to 14). One control subject moved without leaving a forwarding address after outcome measure 3 (8 weeks), but her data before then are included.
Primary outcome
The Greene Climacteric Scale comprises four subscales in addition to the total.
Changes in scores from baseline to end of treatment in both groups (24 weeks) are shown in Table 2 and displayed in Figure 2. Table 3 shows the mean difference from baseline to 24 weeks, confidence intervals for the mean difference, the effect size and the observed power for the total and subscales, calculated using a repeated measures ANOVA.
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Figure 2 shows the total Greene scores over time for the treated and untreated women. There was a noticeable reduction in scores for the treatment group by 8 weeks after entry into the trial. Table 2 shows that there was a significant effect of the herbal treatment for the total Greene score and also for the vasomotor and libido subscales when compared between baseline and 24 weeks. All the scales demonstrated reductions in scores with the treated group having the greatest reduction.
This pilot trial was designed to provide data to inform a sample size calculation for a larger trial (Table 2). Exact calculations will depend on future study design. Table 3 shows that even the small numbers used had sufficient power to detect significant changes over time for the total Greene scale and all but two of the subscales.
Secondary outcomes
In the MYMOP2 questionnaire, 26 of the 44 women chose vasomotor symptoms as their most troublesome menopausal symptoms (23 named hot flushes and six night sweats). Results are shown in Table 2. The ANCOVA analysis showed a statistically significant (P = 0.011) reduction in scores for the treatment group (9) compared to the controls (17).
Herbal prescriptions and other advice
For the 14 women, the three practitioners used 58 herbs. The mean number of herbs per prescription was 6 and the mean number of prescriptions per participant was 4.
Lifestyle and dietary advice was noted at 61/84 of consultations (72%).
Women's expectations
The baseline figures show that 36% of the treatment group and 20% of the control group had no expectations of herbal treatment and 45% of the treatment group and 70% of the control group had some expectations about what might be achieved.
Adverse events
In the treatment group, 68 of 70 adverse event report forms were completed. Four women reported adverse events including an unusual headache at the second visit, worsening of pre-existing insomnia and headache at the second visit, sinus and nasal catarrh at the second visit and headache and loose bowels in the first 2 days of treatment. These symptoms resolved before the next consultation. Adverse events were not recorded for the control group.
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Discussion |
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Summary of main findings
This study indicates that treatment by qualified herbal practitioners reduces the total Greene score by 9.05 points above that of the controls in a group of menopausal women and that this was statistically significant (P < 0.001). All subscales showed greater improvement in the treated group compared to the control group, with the vasomotor symptoms (hot flushes and night sweats) and libido scores retaining statistical significance even after applying a Bonferroni correction (P < 0.01). Symptoms for the control group also decreased slightly but the changes were not statistically significant over the period of waiting for treatment.
When this trial was in the planning stage, there was no information on the sensitivity to change of the Greene Scale12 but our findings correspond with recent trials, which have defined a difference of 7–13 points as clinically significant.16,17
Strengths and limitations of the study
The strengths of the study include that it is a randomized controlled study of a complex treatment intervention by qualified complementary practitioners in primary care and the first trial of treatment by qualified herbal practitioners. The length of trial was adequate to measure change and although symptoms may fluctuate during the menopause, the treatment was particularly effective for the troublesome symptoms (hot flushes and night sweats).
A limitation of the study is its small size in one geographical area. However, the study could be generalized to a wider population, since the most troubling symptoms of hot flushes and night sweats indicated on MYMOP2 are similar in incidence to those reported in larger demographic studies.18
The external validity of the study may be affected by the expectations of the participants. As 36% of the treatment group and 30% of the control group had consulted a herbalist in the past, this could be associated with raised expectations, but the numbers are too small to form any conclusions. However, a recent survey in the UK found that of 563 women aged 46–55 with menopausal symptoms, 25% used natural remedies and the authors comment on the relatively higher level of usage of such products compared to earlier surveys.3 The study also showed that the women found a wide range of self-help and practitioner-based interventions useful in helping with menopausal symptoms. The only UK estimate of consultation with herbal practitioners is from a recent study which estimated that of a random stratified sample of 1794 adults, 0.8% of the sample had consulted a herbal practitioner.19
A further limitation of the study may be the degree to which the use of a waiting list methodology controlled for the bias of contact with the practitioner. The methodology controlled for the natural progression of the condition and investigated normal practice, since monitoring of women during the menopause is not the norm in primary care. The waiting list methodology enabled the investigation of a complex holistic intervention, which was not appropriate to use placebo or blinding as control.20 The aim was to evaluate the treatment effect of herbal practice not to separate out any one component. In order to develop future herbal research methodology, we sought to reproduce normal clinical practice as closely as possible. Other clinical trials have been published recently, which have used a waiting list control group, for example of cognitive behaviour therapy in chronic fatigue.21 The low dropout and acceptability to patients of a waiting list methodology confirms recent findings in a randomized controlled trial of group-delivered courses in self-management of long-term disease.22 The high level of compliance with outcome measures completion in both the treatment and the control group suggests that this methodology may be useful in primary care and complementary medicine.
Relationship of study with existing literature
It has been argued that incidence and perceived severity of menopausal symptoms can be related to mood and so any therapeutic attention may be useful.23 Our trial did not attempt to distinguish between the value of the herbal medicine and attention. Some randomized controlled clinical trials of single herbs, including Black cohosh (Cimicifuga racemosa syn. Actaea racemosa) and Red clover (Trifolium pratense), have shown significant results in treatment of menopausal symptoms but effectiveness has not been clearly demonstrated.24 Results are not directly comparable as herbal practitioners use a variety of herbs considered appropriate for individual patients.
Implications for clinical practice
The herbal prescriptions and lifestyle advice were recorded and an analysis of these data will be of relevance to herbal practitioners. The implications for primary care of our study depend in part on changes in the regulation of herbal practitioners and the potential for increased availability of herbal medicine with the NHS.25 Our study has shown that there is a herbal option which GPs could consider when advising women suffering from menopausal symptoms for whom HRT is contraindicated for clinical reasons or by choice.
Implications for future research
Future research could repeat the trial with larger numbers to explore and document any adverse events that may not have been apparent from a small study. Recruiting women in different primary care settings and from a wider range of socio-economic groups would make the results more generalizable. Comparing treatment by herbal practitioners with usual care would provide more evidence to support care choices, and including women from a perimenopausal population (rather than just those no longer menstruating) might also have greater external validity and be more relevant to normal clinical practice.
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Declaration |
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Funding: National Institute of Medical Herbalists Education Fund (charity no: 262584); National Institute of Medical Herbalists, administered via the University of Central Lancashire, as research sponsor (grant no. NUX018). All researchers are independent of the funders.
Ethical approval: Obtained June 28, 2002 from the Southmead Research Ethics Committee, Bristol (Reference No. 002/02).
Trial registration: ISRCTN42406364 [controlled-trials.com] .
Conflicts of interest: None.
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Acknowledgments |
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We thank the Spence Group Practice, the herbalists and the women involved in this study and the Bristol complementary and alternative medicine research group for their support. Contributors: JG, AD, SH and JI designed the study; JG was the trial coordinator; SH entered the data and RG and JI performed statistical analysis. AD evaluated adverse events. All authors contributed to the drafts of the paper. JG acts as guarantor.
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Notes |
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Green J, Denham A, Ingram J, Hawkey S and Greenwood R. Treatment of menopausal symptoms by qualified herbal practitioners: a prospective randomized controlled trial. Family Practice 2007; 24: 468–474.
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References |
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