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Alternative and complementary therapies for the menopause: A homeopathic approach
Maturitas 66 (2010) 350–354
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Review
Alternative and complementary therapies for the menopause: A homeopathic approach Elizabeth A. Thompson Bristol Homeopathic Hospital, Cotham Hill, Bristol BS6 6PD, UK
a r t i c l e
i n f o
Article history: Received 22 January 2010 Accepted 5 February 2010
Keywords: Homeopathy Menopause Hot flushes Fatigue Complementary Integration
a b s t r a c t The menopause is seen as a highly variable adjustment phase where for some women difficult symptoms can significantly impact on quality of life and in breast cancer that adjustment phase can be intensified and prolonged by anti-oestrogen medication. Homeopathy, defined as one of the many complementary and alternative medicines which women use to manage this transition, has been delivered within the National Health Service since its inception and has been used to alleviate menopausal symptoms both in the climacteric and more recently in breast cancer survivors. Individualized treatment by a homeopath, regarded as the gold standard of homeopathic care, is a complex intervention where the homeopathic medicine is matched to a woman presenting with a range of symptoms such as hot flushes, sleep and mood disturbance, joint pains and fatigue. These symptoms are thought to represent a whole system disturbance and the homeopathic medicine chosen reflects this disturbance. This article describes the delivery of homeopathic care within the UK, as part of an integrated approach to difficult symptoms, basic science that might offer a potential model of action, and reviews available data from observational studies and randomised trials in this clinical setting. © 2010 Elsevier Ireland Ltd. All rights reserved.
Contents 1. 2. 3. 4.
5.
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Delivery of homeopathic care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Homeopathy in clinical practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1. Background philosophy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Delivery of care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1. The levels of the individual experience of illness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2. Potential harm of homeopathic medicines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3. Basic science . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.4. Summary of meta-analyses and systematic reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.5. Observational studies of homeopathy and the menopause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.6. Randomised controlled trials for homeopathy and the menopause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.7. Clinical trials of individualized homeopathy in breast cancer survivors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conflict of interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contributor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Provenance and peer review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
E-mail address: [email protected]. 0378-5122/$ – see front matter © 2010 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.maturitas.2010.02.003
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Transition Head for the space where thoughts are let loosed childish dreams exchanged for chroneish reality lines etched hearts broken no longer generating fertility emotions unmoored fired up and washed away in the crucible of change what will survive this treacherous transition when awakening each day to a different you?
1. Introduction The menopause creates a challenging adjustment process for many women where changing hormone levels trigger a number of symptoms in the body which for some are mild and for others significantly impact on quality of life [1]. Thirty to 70% of women experience vasomotor symptoms such as hot flushes and night sweats during the menopause [2] and for 20–25% of women, symptoms can persist for at least 5 years along with fatigue and mood disturbance. Menopausal symptoms due to chemotherapy induced follicle cell death, ovarian ablation or the use of anti-oestrogen medication are associated with low quality of life for breast cancer survivors. Research confirms that hot flushes begin at an earlier age and may occur at a greater frequency and intensity compared with hot flushes associated with the normal menopause [3]. Management of menopausal symptoms is based on symptom control with a range of hormonal, non-hormonal and complementary therapies [4]. As potential problems with long-term HRT emerge the role of non-hormonal and complementary therapies in this clinical arena become of greater significance.
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Hahnemann tested medicines and the first proving (pruefung meaning a trial of a substance) used Chinchona, the Peruvian Yew bark, known for its beneficial action in malaria and from which we eventually derived Quinine. When given to a healthy person Hahnemann found that a pattern of symptoms developed similar to those found in the malaria sufferer. These symptom pictures particular to a medicine, could be matched to the symptoms in the sick person. Having discovered that medicines given in this way could be curative in acute diseases, he restated the law of similars, “let like be treated with like”, a concept already offered by Hippocrates centuries before. Provings are done to this present day as there are infinite substances, plant, mineral and animal whose symptom pictures could be ascertained. The third concept central to homeopathic thinking is the minimum dose which Hahnemann pursued—the smallest amount of a substance that could be given to avoid side effects and yet would still bring about a regulatory response. To his surprise, at some of the lower doses, the curative action of certain preparations seemed to be stronger, particularly when shaken vigorously (a process known as succussion). The preparation of a homoeopathic medicine using serial dilution and succussion, he termed potentisation and the succussion process rather than the dilution may be the key to activating a solution.
Three central tenets of homoeopathic philosophy • Man has a regulating mechanism responsible for growth and repair through which the homoeopathic remedy acts. • Homeo (similar) pathos (suffering) encapsulates the law of similars where the symptom picture guides the practioner to a substance in nature which causes these similar symptoms. Provings, toxicology and clinical cases give information about these homeopathic symptom pictures. • Homeopathic medicines are ultra-dilute and highly succussed and these low doses reflect the body’s innate sensitivity to certain medicines.
2. Delivery of homeopathic care Homeopathy, regarded as a Complementary and Alternative Medicine (CAM), is delivered across Europe via public and private healthcare systems. For example it has been available in the United Kingdom National Health Service (NHS) since 1948 and a survey of one in eight general practices in 2001 reported that homeopathy was one of the two most commonly provided CAM therapies [5]. In a recent retrospective questionnaire based study of a sample of 563 menopausal women in the USA who discontinued HRT nearly half were using CAM and homeopathy was one of the more common choices women made [6]. An integrated approach where a range of conventional and complementary treatment options are offered is popular with women. Given the large number of users, and the availability of homeopathy within the NHS, it is important to establish whether homeopathy is a clinically relevant option for women with menopausal symptoms. 3. Homeopathy in clinical practice 3.1. Background philosophy Samuel Hahnemann (1755–1843), a German physician and scientist, uncovered the central tenets of homoeopathic philosophy and believed in the vital force, thought to direct growth, healing and repair in the body. He postulated that the homoeopathic remedy acted through the vital force stimulating a repair response.
4. Delivery of care Homeopathic care varies and researchers have been encouraged to report the nature of the intervention clearly in trials [7]. Individual treatment by a homeopath, regarded as the gold standard of homeopathic care, consists of a series of in-depth interviews with a strong focus on the patient’s subjective experience to match the homeopathic medicine to the totality of symptoms that emerge during a consultation. Formulaic or complex homeopathy contains one or many remedies, put together for a particular clinical indication and are often sold over the counter. The homeopathic community debates, which approach is most effective but most prescribers agree that the closely matched similar using the totality of the symptom picture is the ideal and when accurate leads to the strongest stimulus [8]. The body’s innate sensitivity to a small range of medicines may explain why case studies suggest that one remedy may not produce any response whereas another, which fits the symptom pattern more closely, may be followed by dramatic improvement in key symptoms as well as non-specific improvements in anxiety and psychological adjustment. As the homeopath becomes more experienced they are able to bring coherence to the developing symptom picture and thereby identify remedies more accurately. A conceptual framework, known as “the levels” lets the practioner know where they are in the territory of the individual’s map of experience [9]. It begins with level 1; the name of the disease and then moves to the level of fact; the level of symptoms,
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into the level of emotion then further into the level of delusion or how the individual views their world and finally to a deeper more abstract level of vital sensation. Symptoms at the deeper levels can sometimes define the heart sink patient as they do not sit easily in a conventional framework but are often experienced vividly by the patient. It is the synthesis of symptoms from all levels that brings us to the totality of symptoms and hence to the indicated remedy. 4.1. The levels of the individual experience of illness Level 1 NAME Level 2 FACT/SYMPTOMS
Level 3 EMOTIONS
Level 4 DELUSION Level 5 SENSATION
Diagnosis: some systems of medicine would not move beyond the diagnosis in managing the problem. “You have a lump, it is cancer let’s cut it out.” Symptoms: modern medicine deals with symptoms as a means to confirm the diagnosis and usually surgery or a drug intervention is prescribed whereas homeopathy sees symptoms as a form of communication where the body is requesting a specific intervention. Emotions: holistic approaches in general will begin to take into account how feelings influence any illness and may hold some of the therapeutic effect of the encounter. However, emotions are still regarded as non-specific in terms of guiding the practioner to a remedy Delusion or world view: describes how the person perceives the world and builds up their map of individual experience. This is the level of fears, dreams and passions. Vital sensation: information is often abstract reflecting the “intelligence” of the body, e.g. the buttercup plant family have the experience as if their nerves are raw and unprotected.
Sometimes the choice of a remedy is through knowledge of materia medica as is the case above or through hints we might get through the repertory (see below). Choosing symptoms which most reflect the central themes and then finding the relevant remedies is known as repertorisation and is aided by the use of the Repertory and Materia Medica. Both of these are now available as computerised software. 4.2. Potential harm of homeopathic medicines Clinical trials are used to assess the benefits and harms of interventions in health care. Delay in diagnosis has been cited as a potential harm of homeopathy [10] but in an integrative setting this is not an issue and the majority of side effects of homeopathic treatment are transient and not regarded as adverse [11]. The homeopathic aggravation is defined as a worsening of symptoms that occurs close to the time of taking the remedy and is either followed by the symptoms settling again to their previous state or by an overall improvement of symptoms. This is regarded as evidence that there has been a reaction and the person is sensitive to the remedy and will settle on stopping the homeopathic medicine and should be followed by an overall improvement in baseline symptoms. With a partial similar the body will struggle to self correct and then fall back to those baseline symptoms suggesting a close relative is indicated. As the method of developing symptom pictures is to give the medicine to healthy volunteers and then record the emerging symptom picture some patients can develop new or proving symptoms, particularly if the medicine is repeated. Ideally a few doses only are given every 4–6 weeks.
Case history from clinical practice DG was referred in October 2007 at the age of 54 having been diagnosed in 1989 with DCIS of the right breast when she underwent mastectomy and reconstruction. In 1997 she had a total abdominal hysterectomy and bilateral salpingo oophorectomy and developed severe hot flushes and fatigue. She was prescribed HRT but then a lesion in the left breast was found and she underwent left wide local excision of a grade 1 ductal carcinoma with no lymph node involvement. DG was very reluctant to come off her HRT as described by the breast care nurse who referred her. She was seen November 2007 and had difficult night time sweats leaving her fatigued. She describes the hot flushes “They are not very pleasant, mainly occurring at night, it’s like going to bed with an Aga cooking all night. I get hot, damp, very wet and wretched. I flag easily. In the day I can cope but I want to withdraw from the situation. The flushes come right up, I get crimson, agitated, not comfortable, like semi-drowning. I am aware of others noticing and it affects how confident you are with the flushes. If I am a bit anxious like something where I am not sure; for example it took me a long time to learn how to drive. If I get something wrong everybody is looking at me. It’s that fear of not being confident, of doing it wrong. What is it like when everyone is looking at you?—“It shatters my confidence, I get hot and bothered, it is horrid, I want to withdraw, redder and hotter, they have noticed.” What is the feeling?—“Incomplete, how lucky they are to cope with any situation. It stems from my childhood, I am one of five. I am the second daughter. My oldest sister always did everything right. She was extremely clever. Everything she did was perfect. I didn’t dislike her, I always looked up to her, but I remember my parents discussing how clever she was. My feeling was “I can’t do this” and I failed the Eleven Plus.” My first prescription is Natrum carbonicum 200c, three doses 12 h apart. In review at 6 weeks she says “I am embarrassed but so many things came out. I am not drowning so much at night, not as bad but I am still getting disturbed nights. So with this first medicine there was little change and Red Clover appeared to have helped a little. I therefore change to Calcarea silicata 200c, three doses 12 h apart and asked her to ring me if there was no change. She contacted to say there was no change and I then changed to Calcarea sulphuricum 200c. She rang to say that this remedy had been a success and she was feeling much more comfortable. I then saw her for review June 2008. Flushes were much reduced, much less fatigue and confidence improved and I left her to repeat the Calc sulphuricum, three doses 12 h apart as and when needed. Calcarea Sulphuricum is a mineral remedy and the sulphur element is often used in the climacteric as it is associated with heat in the body particular the feet which have to be thrust out of the bed clothes at night. A guiding symptom of Calcarea sulphuricum at level 4 of the map of individual experience found in the repertory is “delusion she is unappreciated”. At a deeper level sulphur represents the point in ego development where the individual needs to be recognised and acknowledged and confidence is a central issue to developing success. The calcarea element brings shyness an withdrawal and these two facets of someone character create conflict—wanting to be appreciated but too shy to present oneself in public which leads to jealousy of others success. At level 5, the deepest level, the mineral sensation is to feel incomplete as if there is a gap or rift in the system, where one is lacking and failing.
4.3. Basic science The starting point for most homeopathic medicines is the Mother Tincture, an alcoholic extract of the original substance which can be plant, mineral or zoological. Insoluble substances are initially triturated (ground up) with lactose before being suspended in the alcoholic diluent. This undergoes a process termed potentisation which consists of serial dilutions alternating with succussion
(a form of vigorous shaking). It is this latter process which causes understandable controversy as there is no clear theory as yet for how these very low doses could be biologically active. The presence of self sustaining aqueous nanostructures have been described at high dilution [12] and scientists presently hypothesise that water, and other polar solvents can, under specific conditions store spe-
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Tools to assist the homeopathy in finding a good match for the individual. The Repertory: This book lists thousands of symptoms arranged in sections according to their anatomical site of origin. Alongside each symptom is recorded all the remedies that include this symptom in their picture. e.g. Chest; CANCER; Mammae; injuries, after [2]: con., hyper. Materia Medica: This complements the repertory by listing remedies along with their characteristic symptoms. Information from toxicology, provings and clinical experience are collected together to create a comprehensive picture for each remedy.
cific information about substances with which they have previously been in contact and subsequently transmit this information to presensitised biosystems [13]. 4.4. Summary of meta-analyses and systematic reviews Although the available systematic reviews reflect the prevailing belief that homeopathy is implausible the majority of reviews do demonstrate more than placebo effects even when confined only to large number of high-quality trials [14–17]. Along with conventional trials of medicines, specific effects can lessen as the quality of trials increases and potential bias decreases. However, at present it appears that the clinical benefits of homeopathy cannot be explained by the hypothesis that homeopathy is ‘just a placebo’. 4.5. Observational studies of homeopathy and the menopause A body of observational data have been collected from the homeopathic hospitals around the UK using an outcome score based on a seven-point scale [18–20]. Outcome is rated in consultation with the doctor and 2 or 3 on these scores are regarded as treatment successes and reflect changes that are large enough to improve well being. An average of 61% of women continuing to attend outpatients for more than one follow-up visit, rated an outcome of 2 or 3 for their menopausal symptoms [18]. This compares with a figure of 70% of attendees to the Royal London Homeopathic Hospital Women’s Clinic who experienced improvement in symptoms, although no mention of the outcome score used to make these assessments is made [21]. An uncontrolled, pilot outcome study, conducted at the Tunbridge Wells Homeopathic Hospital (TWHH) in 1998–1999 examined outpatient consultations [22]. Thirty-one patients with menopausal flushes were assessed for hot flush frequency and severity in three groups (no history of carcinoma of the breast; treatment for breast carcinoma, not receiving tamoxifen; treatment for breast cancer including tamoxifen). Results indicated useful symptomatic benefit for all three groups of patients. Both individualized prescriptions and formulaic prescriptions were used. One study, as part of a coordinated quality improvement programme, within the five Homeopathic Hospitals in the UK collected data from 1797 patients over 4 weeks [23]. Menopause and breast cancer were found to be in the 10 most commonly treated complaints. Patient reported change in presenting complaint and wellbeing using Outcome Related to Impact on Daily Living (ORIDL), a validated tool, showed that 73% of women with menopausal symptoms scored greater than or equal to 2 (defined as a moderate or major improvement enough to affect daily living). One prospective study of breast cancer survivors showed significant improvements in troublesome symptoms including hot flushes and fatigue (p < 0.001) and anxiety (p < 0.013) [24]. An audit of a NHS community menopause clinic demonstrated significant
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improvements in headaches, vasomotor symptoms, emotional and psychological symptoms, tiredness and fatigue [25]. A European study of 99 physicians in eight countries included 438 patients demonstrated significant reduction (p < 0.001) in the frequency of hot flushes day and night. The majority of change took place in the first 15 days of treatment [26]. Greene in an insightful review of observational studies challenges the notion that observational studies and randomised clinical trials are in competition with each other [27]. In fact they reflect a complete process with an initial step of observation followed by experimentation, and that first step is used to uncover patterns and formulate hypotheses regarding cause-andeffect relationships. The problem occurs when what is seen in an observational study is then not experimented upon using a clear hypothesis. From an NHS perspective, the working hypothesis is that a package of care delivering individualized homeopathy can offer a safe intervention which leads to improvements in hot flushes, fatigue, mood disturbance and quality of life for women with menopausal symptoms including breast cancer survivors. 4.6. Randomised controlled trials for homeopathy and the menopause Two randomised studies evaluated the use of homeopathy for menopausal symptoms in the climacteric [28,29]. Five patients participated in a placebo-controlled semicrossover survey in general practice and no statistically significant differences were found. Another study randomised 20 subjects to three groups: clonidine or Lachesis muta or placebo and did not find a difference between groups. However, using a single homeopathic medicine for a whole population is not the gold standard of homeopathic care, and numbers were too small in either trial to obtain meaningful results. Well-designed trials of homeopathy for menopausal symptoms are clearly needed. 4.7. Clinical trials of individualized homeopathy in breast cancer survivors There have been two clinical trials of homeopathy for breast cancer survivors, regarded as high-quality trials and included in a systematic review of homeopathic trials and a Cochrane review in the cancer setting [30,31]. Both trials used the same inclusion criteria of more than three hot flushes daily and similar exclusion criteria [32,33]. Mean age was 52 in the Thompson trial and 55 in the Jacobs trial. The Jacobs trial has a higher dropout rate (28/83) compared with (5/53) perhaps reflecting the differing design of a study period of 12 months versus 16 weeks. In the Jacobs study, women were randomised to receive either an individualized medicine, a formulaic complex remedy containing three medicines known to be useful in the climacteric or placebo. Thompson used MYMOP as the main outcome measure, whereas Jacobs used hot flash severity and frequency score. For the Jacobs trial there was no significant difference in the primary outcome measure although there was a positive trend in the single remedy group in the first 3 months along with a significant improvement in general health score in both homeopathy groups on the SF-36. There was evidence that women taking the complex homeopathic remedy, containing Sanguinaria, Amyl nitrate and Lachesis, experienced increased headaches, which could be due to the development of new symptoms as described in the section on side effects of homeopathic medicines. Despite a treatment effect over baseline of greater than 1, the Thompson trial demonstrated no significant difference for the primary outcome measure between groups, although final numbers recruited may have led to the trial being underpowered to detect a difference.
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5. Conclusions For women who suffer menopausal symptoms who do not want to or cannot take HRT (e.g. breast cancer survivors) there is a need for safe and clinically effective treatment options. Homeopathy appears to do little harm but clinical benefits remain unclear. Observational evidence demonstrates an association between treatment by a homeopath and improvement in hot flushes, fatigue, anxiety, depression and quality of life for menopausal women and breast cancer survivors. Whether these improvements are due to the whole package of care or whether the homeopathic medicine itself confers specific effects remains unproven. It has been argued that separating consultation from remedy does not offer a meaningful design, creating confusion in follow-up and therefore altering how care is delivered in practice [34,35]. Putting aside the question of whether homeopathy’s clinical effects are mediated via placebo or context effects and acknowledging the effectiveness gap that remains for women with menopausal symptoms, pragmatic trials may assist clinicians, patients and commissioners to chose between options of care [36]. More homeopathic research is needed particularly in the menopause where no well-designed randomised trial has as yet been performed to test the effectiveness of homeopathy for symptoms of the climacteric. A variety of trial designs may help capture the value of homeopathic care in this important clinical setting providing a safe and relatively low cost option as part of an integrated approach to managing symptoms of the menopause. Conflict of interest None. Contributor Elizabeth A Thompson is the sole contributor. Provenance and peer review Commissioned and externally peer reviewed. References [1] Daly E, Gray A, Barlow D, McPherson K, Roche M, Vessey M. Measuring the impact of menopausal symptoms on quality of life. BMJ 1993;307(October (6908)):836–40. [2] Management of the Menopause. The handbook of the British menopause society. BMS Publications Ltd.; 2008. [3] Canney PA, Hatton MQ. The prevalence of menopausal symptoms in patients treated for breast cancer. Clin Oncol (R Coll Radiol) 1994;6(5):297–9. [4] Roberts H. Managing the menopause. BMJ 2007;334(April (7596)):736–41. [5] Thomas KJ, Coleman P, Nicholl JP. Trends in access to complementary or alternative medicines via primary care in England: 1995–2001 results from a follow-up national survey. Fam Pract 2003;20(October (5)):575–7. [6] Kupferer EM, Dormire SL, Becker H. Complementary and alternative medicine use for vasomotor symptoms among women who have discontinued hormone therapy. J Obstet Gynecol Neonatal Nurs 2009;38(January (1)):50–9. [7] Relton C, O’Cathain A, Thomas KJ. ‘Homeopathy’: untangling the debate. Homeopathy 2008;97(July (3)):152–5. [8] Blackstone V. Single or multiple prescribing—a debate. Br Homeopath J; 1993(January):37–52. [9] Sankaran DR. The sensation in homeopathy. 2nd ed. Homeopathic Medical Publishers; 2005.
[10] Ernst E. Intangible risks of complementary and alternative medicine. J Clin Oncol 2001;19(April (8)):2365–6. [11] Thompson E, Barron S, Spence D. A preliminary audit investigating remedy reactions including adverse events in routine homeopathic practice. Homeopathy 2004;93(October (4)):203–9. [12] Luc Montagnier JASFJ-LMaC.L. Electromagnetic signals are produced by aqueous nanostructures derived from bacterial DNA sequences. Interdiscip Sci: Comput Life Sci 2009;1(2):81–90. [13] Fisher P. In: Schulte J, Endler PC, editors. The information medicine hypothesis. Kluwer Dordrecht; 1998. p. xi–iv. [14] Kleijnen J, Knipschild P, ter RG. Clinical trials of homoeopathy. BMJ 1991;302(February (6772)):316–23. [15] Linde K, Scholz M, Ramirez G, Clausius N, Melchart D, Jonas WB. Impact of study quality on outcome in placebo-controlled trials of homeopathy. J Clin Epidemiol 1999;52(July (7)):631–6. [16] Shang A, Huwiler-Muntener K, Nartey L, et al. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet 2005;366(August (9487)):726–32. [17] Ludtke R, Rutten AL. The conclusions on the effectiveness of homeopathy highly depend on the set of analyzed trials. J Clin Epidemiol 2008;61(December (12)):1197–204. [18] Richardson WR. Patient benefit survey: Liverpool Regional Department of Homoeopathic Medicine. Br Homeopath J 2001;90(July (3)):158–62. [19] Clover A. Patient benefit survey: Tunbridge Wells Homoeopathic Hospital. Br Homeopath J 2000;89(April (2)):68–72. [20] Spence DS, Thompson EA, Barron SJ. Homeopathic treatment for chronic disease: a 6-year, university-hospital outpatient observational study. J Altern Complement Med 2005;11(October (5)):793–8. [21] Katz T. Homoeopathic treatment during the menopause. Complement Ther Nurs Midwifery 1997;3(April (2)):46–50. [22] Clover A, Ratsey D. Homeopathic treatment of hot flushes: a pilot study. Homeopathy 2002;91(April (2)):75–9. [23] Thompson EA, Mathie RT, Baitson ES, et al. Towards standard setting for patient-reported outcomes in the NHS homeopathic hospitals. Homeopathy 2008;97(July (3)):114–21. [24] Thompson EA, Reilly D. The homeopathic approach to the treatment of symptoms of oestrogen withdrawal in breast cancer patients. A prospective observational study. Homeopathy 2003;92(July (3)):131–4. [25] Relton C, Weatherley-Jones E. Homeopathy service in a National Health Service community menopause clinic: audit of clinical outcomes. J Br Menopause Soc 2005;11(June (2)):72–3. [26] Bordet MF, Colas A, Marijnen P, Masson J, Trichard M. Treating hot flushes in menopausal women with homeopathic treatment—results of an observational study. Homeopathy 2008;97(January (1)):10–5. [27] Greene. Are observational studies just as effective as randomized clinical trials. Blood Purif 2000;18:317–22. [28] Bekkering G, van den Bosch WJ, van den Hoogen HJ. Bedriegt Schone Schijn? Een Onderzoek Om De Gerapporteerde Werking Van Een Homeopathisch Middel Te Objectiveren. Huisarts en Wetenschap 1993;36:414–5. [29] Gautier J. Essai Therapeutique Comparitif De L’action De La Clonidine et Du Lachesis Mutans Dans Le Traitement des Bouffes et De Lia Chaleur De La Menopause; 1983. [30] Milazzo S, Russell N, Ernst E. Efficacy of homeopathic therapy in cancer treatment. Eur J Cancer 2006;42(February (3)):282–9. [31] Kassab S, Cummings M, Berkovitz S, van HR, Fisher P. Homeopathic medicines for adverse effects of cancer treatments. Cochrane Database Syst Rev 2009;(April (2)). CD004845. [32] Thompson EA, Montgomery A, Douglas D, Reilly D. A pilot, randomized, doubleblinded, placebo-controlled trial of individualized homeopathy for symptoms of estrogen withdrawal in breast-cancer survivors. J Altern Complement Med 2005;11(February (1)):13–20. [33] Jacobs J, Herman P, Heron K, Olsen S, Vaughters L. Homeopathy for menopausal symptoms in breast cancer survivors: a preliminary randomized controlled trial. J Altern Complement Med 2005;11(February (1)):21–7. [34] Linde K, Melchart D. Randomized controlled trials of individualized homeopathy: a state-of-the-art review. J Altern Complement Med 1998;4(4): 371–88. [35] Weatherley-Jones E, Thompson EA, Thomas KJ. The placebo-controlled trial as a test of complementary and alternative medicine: observations from research experience of individualised homeopathic treatment. Homeopathy 2004;93(October (4)):186–9. [36] Schwartz D, Lellouch J. Explanatory pragmatic attitudes in therapeutical trials. J Chronic Dis 1967;20(August (8)):637–48.
Contents lists available at ScienceDirect
Maturitas journal homepage: www.elsevier.com/locate/maturitas
Review
Alternative and complementary therapies for the menopause: A homeopathic approach Elizabeth A. Thompson Bristol Homeopathic Hospital, Cotham Hill, Bristol BS6 6PD, UK
a r t i c l e
i n f o
Article history: Received 22 January 2010 Accepted 5 February 2010
Keywords: Homeopathy Menopause Hot flushes Fatigue Complementary Integration
a b s t r a c t The menopause is seen as a highly variable adjustment phase where for some women difficult symptoms can significantly impact on quality of life and in breast cancer that adjustment phase can be intensified and prolonged by anti-oestrogen medication. Homeopathy, defined as one of the many complementary and alternative medicines which women use to manage this transition, has been delivered within the National Health Service since its inception and has been used to alleviate menopausal symptoms both in the climacteric and more recently in breast cancer survivors. Individualized treatment by a homeopath, regarded as the gold standard of homeopathic care, is a complex intervention where the homeopathic medicine is matched to a woman presenting with a range of symptoms such as hot flushes, sleep and mood disturbance, joint pains and fatigue. These symptoms are thought to represent a whole system disturbance and the homeopathic medicine chosen reflects this disturbance. This article describes the delivery of homeopathic care within the UK, as part of an integrated approach to difficult symptoms, basic science that might offer a potential model of action, and reviews available data from observational studies and randomised trials in this clinical setting. © 2010 Elsevier Ireland Ltd. All rights reserved.
Contents 1. 2. 3. 4.
5.
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Delivery of homeopathic care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Homeopathy in clinical practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1. Background philosophy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Delivery of care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1. The levels of the individual experience of illness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2. Potential harm of homeopathic medicines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3. Basic science . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.4. Summary of meta-analyses and systematic reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.5. Observational studies of homeopathy and the menopause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.6. Randomised controlled trials for homeopathy and the menopause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.7. Clinical trials of individualized homeopathy in breast cancer survivors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conflict of interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contributor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Provenance and peer review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
E-mail address: [email protected]. 0378-5122/$ – see front matter © 2010 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.maturitas.2010.02.003
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Transition Head for the space where thoughts are let loosed childish dreams exchanged for chroneish reality lines etched hearts broken no longer generating fertility emotions unmoored fired up and washed away in the crucible of change what will survive this treacherous transition when awakening each day to a different you?
1. Introduction The menopause creates a challenging adjustment process for many women where changing hormone levels trigger a number of symptoms in the body which for some are mild and for others significantly impact on quality of life [1]. Thirty to 70% of women experience vasomotor symptoms such as hot flushes and night sweats during the menopause [2] and for 20–25% of women, symptoms can persist for at least 5 years along with fatigue and mood disturbance. Menopausal symptoms due to chemotherapy induced follicle cell death, ovarian ablation or the use of anti-oestrogen medication are associated with low quality of life for breast cancer survivors. Research confirms that hot flushes begin at an earlier age and may occur at a greater frequency and intensity compared with hot flushes associated with the normal menopause [3]. Management of menopausal symptoms is based on symptom control with a range of hormonal, non-hormonal and complementary therapies [4]. As potential problems with long-term HRT emerge the role of non-hormonal and complementary therapies in this clinical arena become of greater significance.
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Hahnemann tested medicines and the first proving (pruefung meaning a trial of a substance) used Chinchona, the Peruvian Yew bark, known for its beneficial action in malaria and from which we eventually derived Quinine. When given to a healthy person Hahnemann found that a pattern of symptoms developed similar to those found in the malaria sufferer. These symptom pictures particular to a medicine, could be matched to the symptoms in the sick person. Having discovered that medicines given in this way could be curative in acute diseases, he restated the law of similars, “let like be treated with like”, a concept already offered by Hippocrates centuries before. Provings are done to this present day as there are infinite substances, plant, mineral and animal whose symptom pictures could be ascertained. The third concept central to homeopathic thinking is the minimum dose which Hahnemann pursued—the smallest amount of a substance that could be given to avoid side effects and yet would still bring about a regulatory response. To his surprise, at some of the lower doses, the curative action of certain preparations seemed to be stronger, particularly when shaken vigorously (a process known as succussion). The preparation of a homoeopathic medicine using serial dilution and succussion, he termed potentisation and the succussion process rather than the dilution may be the key to activating a solution.
Three central tenets of homoeopathic philosophy • Man has a regulating mechanism responsible for growth and repair through which the homoeopathic remedy acts. • Homeo (similar) pathos (suffering) encapsulates the law of similars where the symptom picture guides the practioner to a substance in nature which causes these similar symptoms. Provings, toxicology and clinical cases give information about these homeopathic symptom pictures. • Homeopathic medicines are ultra-dilute and highly succussed and these low doses reflect the body’s innate sensitivity to certain medicines.
2. Delivery of homeopathic care Homeopathy, regarded as a Complementary and Alternative Medicine (CAM), is delivered across Europe via public and private healthcare systems. For example it has been available in the United Kingdom National Health Service (NHS) since 1948 and a survey of one in eight general practices in 2001 reported that homeopathy was one of the two most commonly provided CAM therapies [5]. In a recent retrospective questionnaire based study of a sample of 563 menopausal women in the USA who discontinued HRT nearly half were using CAM and homeopathy was one of the more common choices women made [6]. An integrated approach where a range of conventional and complementary treatment options are offered is popular with women. Given the large number of users, and the availability of homeopathy within the NHS, it is important to establish whether homeopathy is a clinically relevant option for women with menopausal symptoms. 3. Homeopathy in clinical practice 3.1. Background philosophy Samuel Hahnemann (1755–1843), a German physician and scientist, uncovered the central tenets of homoeopathic philosophy and believed in the vital force, thought to direct growth, healing and repair in the body. He postulated that the homoeopathic remedy acted through the vital force stimulating a repair response.
4. Delivery of care Homeopathic care varies and researchers have been encouraged to report the nature of the intervention clearly in trials [7]. Individual treatment by a homeopath, regarded as the gold standard of homeopathic care, consists of a series of in-depth interviews with a strong focus on the patient’s subjective experience to match the homeopathic medicine to the totality of symptoms that emerge during a consultation. Formulaic or complex homeopathy contains one or many remedies, put together for a particular clinical indication and are often sold over the counter. The homeopathic community debates, which approach is most effective but most prescribers agree that the closely matched similar using the totality of the symptom picture is the ideal and when accurate leads to the strongest stimulus [8]. The body’s innate sensitivity to a small range of medicines may explain why case studies suggest that one remedy may not produce any response whereas another, which fits the symptom pattern more closely, may be followed by dramatic improvement in key symptoms as well as non-specific improvements in anxiety and psychological adjustment. As the homeopath becomes more experienced they are able to bring coherence to the developing symptom picture and thereby identify remedies more accurately. A conceptual framework, known as “the levels” lets the practioner know where they are in the territory of the individual’s map of experience [9]. It begins with level 1; the name of the disease and then moves to the level of fact; the level of symptoms,
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into the level of emotion then further into the level of delusion or how the individual views their world and finally to a deeper more abstract level of vital sensation. Symptoms at the deeper levels can sometimes define the heart sink patient as they do not sit easily in a conventional framework but are often experienced vividly by the patient. It is the synthesis of symptoms from all levels that brings us to the totality of symptoms and hence to the indicated remedy. 4.1. The levels of the individual experience of illness Level 1 NAME Level 2 FACT/SYMPTOMS
Level 3 EMOTIONS
Level 4 DELUSION Level 5 SENSATION
Diagnosis: some systems of medicine would not move beyond the diagnosis in managing the problem. “You have a lump, it is cancer let’s cut it out.” Symptoms: modern medicine deals with symptoms as a means to confirm the diagnosis and usually surgery or a drug intervention is prescribed whereas homeopathy sees symptoms as a form of communication where the body is requesting a specific intervention. Emotions: holistic approaches in general will begin to take into account how feelings influence any illness and may hold some of the therapeutic effect of the encounter. However, emotions are still regarded as non-specific in terms of guiding the practioner to a remedy Delusion or world view: describes how the person perceives the world and builds up their map of individual experience. This is the level of fears, dreams and passions. Vital sensation: information is often abstract reflecting the “intelligence” of the body, e.g. the buttercup plant family have the experience as if their nerves are raw and unprotected.
Sometimes the choice of a remedy is through knowledge of materia medica as is the case above or through hints we might get through the repertory (see below). Choosing symptoms which most reflect the central themes and then finding the relevant remedies is known as repertorisation and is aided by the use of the Repertory and Materia Medica. Both of these are now available as computerised software. 4.2. Potential harm of homeopathic medicines Clinical trials are used to assess the benefits and harms of interventions in health care. Delay in diagnosis has been cited as a potential harm of homeopathy [10] but in an integrative setting this is not an issue and the majority of side effects of homeopathic treatment are transient and not regarded as adverse [11]. The homeopathic aggravation is defined as a worsening of symptoms that occurs close to the time of taking the remedy and is either followed by the symptoms settling again to their previous state or by an overall improvement of symptoms. This is regarded as evidence that there has been a reaction and the person is sensitive to the remedy and will settle on stopping the homeopathic medicine and should be followed by an overall improvement in baseline symptoms. With a partial similar the body will struggle to self correct and then fall back to those baseline symptoms suggesting a close relative is indicated. As the method of developing symptom pictures is to give the medicine to healthy volunteers and then record the emerging symptom picture some patients can develop new or proving symptoms, particularly if the medicine is repeated. Ideally a few doses only are given every 4–6 weeks.
Case history from clinical practice DG was referred in October 2007 at the age of 54 having been diagnosed in 1989 with DCIS of the right breast when she underwent mastectomy and reconstruction. In 1997 she had a total abdominal hysterectomy and bilateral salpingo oophorectomy and developed severe hot flushes and fatigue. She was prescribed HRT but then a lesion in the left breast was found and she underwent left wide local excision of a grade 1 ductal carcinoma with no lymph node involvement. DG was very reluctant to come off her HRT as described by the breast care nurse who referred her. She was seen November 2007 and had difficult night time sweats leaving her fatigued. She describes the hot flushes “They are not very pleasant, mainly occurring at night, it’s like going to bed with an Aga cooking all night. I get hot, damp, very wet and wretched. I flag easily. In the day I can cope but I want to withdraw from the situation. The flushes come right up, I get crimson, agitated, not comfortable, like semi-drowning. I am aware of others noticing and it affects how confident you are with the flushes. If I am a bit anxious like something where I am not sure; for example it took me a long time to learn how to drive. If I get something wrong everybody is looking at me. It’s that fear of not being confident, of doing it wrong. What is it like when everyone is looking at you?—“It shatters my confidence, I get hot and bothered, it is horrid, I want to withdraw, redder and hotter, they have noticed.” What is the feeling?—“Incomplete, how lucky they are to cope with any situation. It stems from my childhood, I am one of five. I am the second daughter. My oldest sister always did everything right. She was extremely clever. Everything she did was perfect. I didn’t dislike her, I always looked up to her, but I remember my parents discussing how clever she was. My feeling was “I can’t do this” and I failed the Eleven Plus.” My first prescription is Natrum carbonicum 200c, three doses 12 h apart. In review at 6 weeks she says “I am embarrassed but so many things came out. I am not drowning so much at night, not as bad but I am still getting disturbed nights. So with this first medicine there was little change and Red Clover appeared to have helped a little. I therefore change to Calcarea silicata 200c, three doses 12 h apart and asked her to ring me if there was no change. She contacted to say there was no change and I then changed to Calcarea sulphuricum 200c. She rang to say that this remedy had been a success and she was feeling much more comfortable. I then saw her for review June 2008. Flushes were much reduced, much less fatigue and confidence improved and I left her to repeat the Calc sulphuricum, three doses 12 h apart as and when needed. Calcarea Sulphuricum is a mineral remedy and the sulphur element is often used in the climacteric as it is associated with heat in the body particular the feet which have to be thrust out of the bed clothes at night. A guiding symptom of Calcarea sulphuricum at level 4 of the map of individual experience found in the repertory is “delusion she is unappreciated”. At a deeper level sulphur represents the point in ego development where the individual needs to be recognised and acknowledged and confidence is a central issue to developing success. The calcarea element brings shyness an withdrawal and these two facets of someone character create conflict—wanting to be appreciated but too shy to present oneself in public which leads to jealousy of others success. At level 5, the deepest level, the mineral sensation is to feel incomplete as if there is a gap or rift in the system, where one is lacking and failing.
4.3. Basic science The starting point for most homeopathic medicines is the Mother Tincture, an alcoholic extract of the original substance which can be plant, mineral or zoological. Insoluble substances are initially triturated (ground up) with lactose before being suspended in the alcoholic diluent. This undergoes a process termed potentisation which consists of serial dilutions alternating with succussion
(a form of vigorous shaking). It is this latter process which causes understandable controversy as there is no clear theory as yet for how these very low doses could be biologically active. The presence of self sustaining aqueous nanostructures have been described at high dilution [12] and scientists presently hypothesise that water, and other polar solvents can, under specific conditions store spe-
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Tools to assist the homeopathy in finding a good match for the individual. The Repertory: This book lists thousands of symptoms arranged in sections according to their anatomical site of origin. Alongside each symptom is recorded all the remedies that include this symptom in their picture. e.g. Chest; CANCER; Mammae; injuries, after [2]: con., hyper. Materia Medica: This complements the repertory by listing remedies along with their characteristic symptoms. Information from toxicology, provings and clinical experience are collected together to create a comprehensive picture for each remedy.
cific information about substances with which they have previously been in contact and subsequently transmit this information to presensitised biosystems [13]. 4.4. Summary of meta-analyses and systematic reviews Although the available systematic reviews reflect the prevailing belief that homeopathy is implausible the majority of reviews do demonstrate more than placebo effects even when confined only to large number of high-quality trials [14–17]. Along with conventional trials of medicines, specific effects can lessen as the quality of trials increases and potential bias decreases. However, at present it appears that the clinical benefits of homeopathy cannot be explained by the hypothesis that homeopathy is ‘just a placebo’. 4.5. Observational studies of homeopathy and the menopause A body of observational data have been collected from the homeopathic hospitals around the UK using an outcome score based on a seven-point scale [18–20]. Outcome is rated in consultation with the doctor and 2 or 3 on these scores are regarded as treatment successes and reflect changes that are large enough to improve well being. An average of 61% of women continuing to attend outpatients for more than one follow-up visit, rated an outcome of 2 or 3 for their menopausal symptoms [18]. This compares with a figure of 70% of attendees to the Royal London Homeopathic Hospital Women’s Clinic who experienced improvement in symptoms, although no mention of the outcome score used to make these assessments is made [21]. An uncontrolled, pilot outcome study, conducted at the Tunbridge Wells Homeopathic Hospital (TWHH) in 1998–1999 examined outpatient consultations [22]. Thirty-one patients with menopausal flushes were assessed for hot flush frequency and severity in three groups (no history of carcinoma of the breast; treatment for breast carcinoma, not receiving tamoxifen; treatment for breast cancer including tamoxifen). Results indicated useful symptomatic benefit for all three groups of patients. Both individualized prescriptions and formulaic prescriptions were used. One study, as part of a coordinated quality improvement programme, within the five Homeopathic Hospitals in the UK collected data from 1797 patients over 4 weeks [23]. Menopause and breast cancer were found to be in the 10 most commonly treated complaints. Patient reported change in presenting complaint and wellbeing using Outcome Related to Impact on Daily Living (ORIDL), a validated tool, showed that 73% of women with menopausal symptoms scored greater than or equal to 2 (defined as a moderate or major improvement enough to affect daily living). One prospective study of breast cancer survivors showed significant improvements in troublesome symptoms including hot flushes and fatigue (p < 0.001) and anxiety (p < 0.013) [24]. An audit of a NHS community menopause clinic demonstrated significant
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improvements in headaches, vasomotor symptoms, emotional and psychological symptoms, tiredness and fatigue [25]. A European study of 99 physicians in eight countries included 438 patients demonstrated significant reduction (p < 0.001) in the frequency of hot flushes day and night. The majority of change took place in the first 15 days of treatment [26]. Greene in an insightful review of observational studies challenges the notion that observational studies and randomised clinical trials are in competition with each other [27]. In fact they reflect a complete process with an initial step of observation followed by experimentation, and that first step is used to uncover patterns and formulate hypotheses regarding cause-andeffect relationships. The problem occurs when what is seen in an observational study is then not experimented upon using a clear hypothesis. From an NHS perspective, the working hypothesis is that a package of care delivering individualized homeopathy can offer a safe intervention which leads to improvements in hot flushes, fatigue, mood disturbance and quality of life for women with menopausal symptoms including breast cancer survivors. 4.6. Randomised controlled trials for homeopathy and the menopause Two randomised studies evaluated the use of homeopathy for menopausal symptoms in the climacteric [28,29]. Five patients participated in a placebo-controlled semicrossover survey in general practice and no statistically significant differences were found. Another study randomised 20 subjects to three groups: clonidine or Lachesis muta or placebo and did not find a difference between groups. However, using a single homeopathic medicine for a whole population is not the gold standard of homeopathic care, and numbers were too small in either trial to obtain meaningful results. Well-designed trials of homeopathy for menopausal symptoms are clearly needed. 4.7. Clinical trials of individualized homeopathy in breast cancer survivors There have been two clinical trials of homeopathy for breast cancer survivors, regarded as high-quality trials and included in a systematic review of homeopathic trials and a Cochrane review in the cancer setting [30,31]. Both trials used the same inclusion criteria of more than three hot flushes daily and similar exclusion criteria [32,33]. Mean age was 52 in the Thompson trial and 55 in the Jacobs trial. The Jacobs trial has a higher dropout rate (28/83) compared with (5/53) perhaps reflecting the differing design of a study period of 12 months versus 16 weeks. In the Jacobs study, women were randomised to receive either an individualized medicine, a formulaic complex remedy containing three medicines known to be useful in the climacteric or placebo. Thompson used MYMOP as the main outcome measure, whereas Jacobs used hot flash severity and frequency score. For the Jacobs trial there was no significant difference in the primary outcome measure although there was a positive trend in the single remedy group in the first 3 months along with a significant improvement in general health score in both homeopathy groups on the SF-36. There was evidence that women taking the complex homeopathic remedy, containing Sanguinaria, Amyl nitrate and Lachesis, experienced increased headaches, which could be due to the development of new symptoms as described in the section on side effects of homeopathic medicines. Despite a treatment effect over baseline of greater than 1, the Thompson trial demonstrated no significant difference for the primary outcome measure between groups, although final numbers recruited may have led to the trial being underpowered to detect a difference.
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5. Conclusions For women who suffer menopausal symptoms who do not want to or cannot take HRT (e.g. breast cancer survivors) there is a need for safe and clinically effective treatment options. Homeopathy appears to do little harm but clinical benefits remain unclear. Observational evidence demonstrates an association between treatment by a homeopath and improvement in hot flushes, fatigue, anxiety, depression and quality of life for menopausal women and breast cancer survivors. Whether these improvements are due to the whole package of care or whether the homeopathic medicine itself confers specific effects remains unproven. It has been argued that separating consultation from remedy does not offer a meaningful design, creating confusion in follow-up and therefore altering how care is delivered in practice [34,35]. Putting aside the question of whether homeopathy’s clinical effects are mediated via placebo or context effects and acknowledging the effectiveness gap that remains for women with menopausal symptoms, pragmatic trials may assist clinicians, patients and commissioners to chose between options of care [36]. More homeopathic research is needed particularly in the menopause where no well-designed randomised trial has as yet been performed to test the effectiveness of homeopathy for symptoms of the climacteric. A variety of trial designs may help capture the value of homeopathic care in this important clinical setting providing a safe and relatively low cost option as part of an integrated approach to managing symptoms of the menopause. Conflict of interest None. Contributor Elizabeth A Thompson is the sole contributor. Provenance and peer review Commissioned and externally peer reviewed. References [1] Daly E, Gray A, Barlow D, McPherson K, Roche M, Vessey M. Measuring the impact of menopausal symptoms on quality of life. BMJ 1993;307(October (6908)):836–40. [2] Management of the Menopause. The handbook of the British menopause society. BMS Publications Ltd.; 2008. [3] Canney PA, Hatton MQ. The prevalence of menopausal symptoms in patients treated for breast cancer. Clin Oncol (R Coll Radiol) 1994;6(5):297–9. [4] Roberts H. Managing the menopause. BMJ 2007;334(April (7596)):736–41. [5] Thomas KJ, Coleman P, Nicholl JP. Trends in access to complementary or alternative medicines via primary care in England: 1995–2001 results from a follow-up national survey. Fam Pract 2003;20(October (5)):575–7. [6] Kupferer EM, Dormire SL, Becker H. Complementary and alternative medicine use for vasomotor symptoms among women who have discontinued hormone therapy. J Obstet Gynecol Neonatal Nurs 2009;38(January (1)):50–9. [7] Relton C, O’Cathain A, Thomas KJ. ‘Homeopathy’: untangling the debate. Homeopathy 2008;97(July (3)):152–5. [8] Blackstone V. Single or multiple prescribing—a debate. Br Homeopath J; 1993(January):37–52. [9] Sankaran DR. The sensation in homeopathy. 2nd ed. Homeopathic Medical Publishers; 2005.
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