The effect of TCM acupuncture on hot flushes among menopausal women (ACUFLASH) study: A study protocol of an ongoing multi-centre randomised controlled clinical trial

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The effect of TCM acupuncture on hot flushes among menopausal women (ACUFLASH) study: A study protocol of an ongoing multi-centre randomised controlled clinical trial
Received: 21 November 2006
Accepted: 26 February 2007
Published: 26 February 2007
Einar K Borud1 , Terje Alraek1 , Adrian White3 , Vinjar Fonnebo1 and Sameline Grimsgaard2
BMC Complementary and Alternative Medicine 2007

1National Research Center in Complementary and Alternative Medicine, University of Tromsoe, N-9037 Tromsoe, Norway
2Clinical Research Centre, University Hospital of North-Norway, N-9038 Tromsoe, Norway
3Department of General Practice and Primary Care, Peninsula Medical School, Plymouth, PL6 8BU, UK

Abstract

Background
After menopause, 10Ò20% of all women have nearly intolerable hot flushes. Long term use of hormone replacement therapy involves a health risk, and many women seek alternative strategies to relieve climacteric complaints. Acupuncture is one of the most frequently used complementary therapies in Norway. We designed a study to evaluate whether Traditional Chinese Medicine acupuncture-care together with self-care is more effective than self-care alone to relieve climacteric complaints.

Methods/Design
The study is a multi-centre pragmatic randomised controlled trial with two parallel arms. Participants are postmenopausal women who document ≥7 flushes/24 hours and who are not using hormone replacement therapy or other medication that may influence flushes. According to power calculations 200 women are needed to detect a 50% reduction in flushes, and altogether 286 women will be recruited to allow for a 30% dropout rate.

The treatment group receives 10 sessions of Traditional Chinese Medicine acupuncture-care and self-care; the control group will engage in self-care only. A team of experienced Traditional Chinese Medicine acupuncturists give acupuncture treatments.

Discussion
The study tests acupuncture as a complete treatment package including the therapeutic relationship and expectation. The intervention period lasts for 12 weeks, with follow up at 6 and 12 months. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life, assessed by the Women's Health Questionnaire. We also collect data on Traditional Chinese Medicine diagnoses, and we examine treatment experiences using a qualitative approach. Finally we measure biological variables, to examine potential mechanisms for the effect of acupuncture. The study is funded by The Research Council of Norway.

Background
After menopause, almost two thirds of women experience hot flushes. One third have symptoms persisting up to five years after natural menopause, and 10Ò20% find symptoms very distressing [1]. Hormone replacement therapy (HRT) is considered the most effective treatment for hot flushes [2]. However, HRT has other biological effects: it prevents fractures and cancer of the colon [3], but increases the risk of breast cancer [4] and thrombo-embolic disease [5]. Based on these data, the Norwegian Medicines Agency revised the guidelines for prescribing HRT in 2003 [6]. Indications are now only hot flushes and urogenital symptoms. HRT should be used for a short time period, in the lowest possible dose, and other strategies should be considered. The reports of adverse events generated considerable public interest in Norway, and sales figures for systemic HRT have decreased by 45 % since 2001 [7]. Moreover, a Scandinavian study conducted among women treated for breast cancer was terminated when the interim analysis showed that HRT was associated with an increased risk for relapse of the disease [8]. A Norwegian cohort study showed that HRT formulations used in Norway are also associated with an increased risk of breast cancer [9]. The data received considerable public attention and we suppose that they enhanced Norwegian women's interest in low risk strategies to relieve their climacteric complaints.

A large body of data already shows that HRT effectively relieves hot flush activity (frequency and severity) by approximately 80% [2]. Estrogen placebo interventions reduce hot flush activity by 20Ò30% [10]. Selective serotonin reuptake inhibitors (SSRIs) and selective noradrenaline reuptake inhibitors (SNRIs) reduce the number of hot flushes by 50Ò60% in the short term in some studies [11]. On this basis it has been advocated that clinically relevant interventions must have the ability to reduce hot flush activity by 50% or more [10].

Women may explore other approaches to manage their menopausal symptoms. These include phyto-estrogens such as soy, herbal remedies such as black cohosh and red clover, or vitamin E. There is a lack of good evidence of their effectiveness, and lack of knowledge of drug interactions and of long-term safety [1]. Commonly recommended lifestyle changes include stress reduction, increased fruit and vegetable intake, reduced caffeine and alcohol intake, smoking cessation, and increased physical exercise. The evidence for these is anecdotal, supported in some cases by epidemiological studies but not by intervention trials [12].

Acupuncture is one of the most frequently used complementary therapies in Norway [13], and is considered safe in the hands of competent practitioners [14]. One small randomised trial (n = 24) conducted in a Swedish university clinic showed that hot flushes decreased by 50% among women who received standardized electroacupuncture [15]. A further study (n = 30) by the same group found a trend in favour of acupuncture compared with sham acupuncture for climacteric symptoms [16]. In a small crossover study (n = 10) in hypertensive postmenopausal women, acupuncture was associated with a significant reduction in 'complaints' though not in blood pressure [17]. An uncontrolled study in 11 participants found a mean reduction in flush score from 4.2 to 1.9 [18]. A small RCT (n = 16) found genuine acupuncture more effective than sham-acupuncture, with a 76% reduction in flushes [19]. An unpublished Norwegian case series (n = 18) suggests that individualized Traditional Chinese Medicine (TCM) acupuncture can reduce hot flushes by 77%. The current data are insufficient to make recommendations regarding acupuncture treatment for hot flushes, but sufficient to justify further research.

Two studies of acupuncture for hot flushes published since the development of this protocol yielded conflicting results: one study of 103 participants found no effect on daily flush frequency [20], whereas a second study of 29 participants found a reduction in severity but not frequency of nocturnal flushes [21].

There is common agreement among acupuncturists that a minimum of six treatment sessions are necessary to evaluate treatment effect, and as many as eight to ten sessions are necessary to establish a maximum effect [22]. Continuation of the effect may require repeated, but less frequent, treatments. If symptoms relapse, as little as two to three treatments can be sufficient to trigger the treatment effect again. An acupuncture session usually costs NOK 300, and accordingly a typical series of treatments costs NOK 3000.

In Norway, most acupuncture practitioners use the TCM approach, and about 500 practitioners belong to the professional organisation, NAFO. A woman who seeks a TCM acupuncture practitioner for hot flushes chooses a treatment strategy rather than a single intervention. The practitioner will most likely focus on climacteric complaints and general well being rather than hot flush activity alone. Treatment involves a comprehensive TCM diagnostic procedure and general life-style advice in addition to individualized acupuncture treatment. Acupuncturists generally consider that these elements interact intentionally with each other during treatment and constitute a treatment package, i.e. "acupuncture-care". If the elements are separated, the treatment will not reflect what TCM acupuncturists consider relevant and good quality acupuncture for a given condition.

© 2007 Borud et al; licensee BioMed Central Ltd.
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