Acupuncture for cancer-related fatigue in patients with breast cancer: a pragmatic randomized controlled trial.

PURPOSE: We aimed to assess the effectiveness of acupuncture for cancer-related fatigue (CRF) in patients with breast cancer. PATIENTS AND METHODS: We conducted a pragmatic, randomized controlled trial comparing acupuncture with enhanced usual care. Three hundred two outpatients with breast cancer participated. We randomly assigned 75 patients to usual care and 227 patients to acupuncture plus usual care (random assignment of 1:3 respectively) with minimization controlling for baseline general fatigue and maintenance treatment. Treatment was delivered by acupuncturists once a week for 6 weeks through needling three pairs of acupoints. The usual care group received a booklet with information about fatigue and its management. Primary outcome was general fatigue at 6 weeks, measured with the Multidimensional Fatigue Inventory (MFI). Other measurements included the Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Therapy-General quality-of-life scale, and expectation of acupuncture effect. Analyses were by intention to treat. RESULTS: Two hundred forty-six of 302 patients randomly assigned provided complete data at 6 weeks. The difference in the mean General Fatigue score, between those who received the intervention and those who did not, was -3.11 (95% CI, -3.97 to -2.25; P < .001). The intervention also improved all other fatigue aspects measured by MFI, including Physical Fatigue and Mental Fatigue (acupuncture effect, -2.36 and -1.94, respectively; both at P < .001), anxiety and depression (acupuncture effect, -1.83 and -2.13, respectively; both at P < .001), and quality of life (Physical Well-Being effect, 3.30; Functional Well-Being effect, 3.57; both at P < .001; Emotional Well-Being effect, 1.93; P = .001; and Social Functioning Well-Being effect, 1.05; P < .05). CONCLUSION: Acupuncture is an effective intervention for managing the symptom of CRF and improving patients' quality of life.

Defining an adequate dose of acupuncture using a neurophysiological approach--a narrative review of the literature.

Many different styles of acupuncture practice exist, and lack of agreement on the optimal acupuncture treatment for any particular condition may mean that some patients do not receive the best treatment. This uncertainty also makes the negative results of sham controlled trials difficult to interpret. Unless we can be sure that both adequate acupuncture and an inactive sham were used in a particular trial, then that trial should not be interpreted as dismissing acupuncture for that condition. Acupuncture practice clearly involves much more than needling procedures, but there is a strong argument for elucidating the role of those needling procedures first. The components of acupuncture needling procedures have been described in the STRICTA document, but it is also clear that the patient's perception of needling is relevant for the outcome of treatment. We therefore recommend the concept of 'dose' of acupuncture needling, which should include both the stimulus given to the patient, and certain aspects of the patient's perceptions and response that are known to be linked to the subsequent therapeutic response. We propose the following definition of dose: the physical procedures applied in each session, using one or more needles, taking account of the patient's resulting perception (sensory, affective and cognitive) and other responses (including motor). The dose may be affected by the state of the patient (eg nervous, immune and endocrine systems); different doses may be required for different conditions. The constituents of an adequate dose can be established initially by clinical opinion and subsequently by empirical evidence from experimental studies, which may be either clinical or basic research studies. Systematic reviews which do not consider the adequacy of the acupuncture treatment may have unreliable conclusions. Out of 47 recent systematic reviews, only six have applied some criteria for adequacy. Five used a rating system or conducted a subgroup analysis, and one excluded studies from the analysis altogether if they did not meet criteria for adequacy. Research into what constitutes an adequate dose of acupuncture has long been neglected and is now urgent. Clinical studies that compare the effects of different treatment protocols are probably the most reliable source of evidence, and may also demonstrate a dose-response relationship.

The role of complementary and alternative medicine in the management of early breast cancer: recommendations of the European Society of Mastology (EUSOMA).

Patients diagnosed with breast cancer have many needs that for a start include the expectation of cure. Where cure is unlikely there is always a place for hope and spiritual support. Furthermore whether dealing with the early stages or with the advanced disease patients require symptomatic control that encompasses pain relief, control of nausea and vomiting and psychological distress. To achieve all of these goals there is a need that goes beyond the role of scientific medicine. This position papers describes the guidelines for the use of complimentary and alternative medicine (CAM) developed by a workshop on behalf of the European Society of Mastology (EUSOMA).

Complementary and alternative medicine.

Thirty years ago, the integration of complementary medicine into cancer care almost was dismissed as quackery. Today, a whole range of complementary and alternative medicine (CAM) techniques have been integrated into the management of cancer, which are often of benefit to patients, when conventional treatment is deemed to have failed or caused intolerable side effects. Health care workers need to inquire about the use of CAM in their patients routinely in a sensitive and nonjudgmental way, and may need to advise patients to stop certain therapies. Yet in advanced cancer, a sensible balance needs to be struck between fear about adverse effects and interactions and the importance of making the remaining weeks/days/months as comfortable and enjoyable as possible.

Guidelines for providing acupuncture treatment for cancer patients--a peer-reviewed sample policy document.

Clinical guidelines are statements that have been systematically developed and which aim to assist clinicians in making decisions about treatment for specific conditions, and promote best practice. They are linked to evidence and are meant to facilitate good medical practice. We are not aware of any guidelines for the safe practice of acupuncture in a conventional healthcare setting, yet they are necessary as acupuncture may be performed in a variety of settings and by a variety of healthcare professionals: doctors, nurses, physiotherapists, midwives, and non medically trained practitioners. These guidelines were developed for use in cancer patients, mainly for pain but also for some non-pain indications such as hot flushes. They are presented here as a template for other acupuncturists who are requested to provide policies for acupuncture treatment for cancer patients. This article includes a general review of the evidence on mechanisms, effectiveness and safety of acupuncture that is intended to be used in conjunction with the guidelines; and the guidelines themselves. An appendix includes instructions for self acupuncture. The guidelines contain sections on roles and responsibilities, criteria for acupuncture practice, indications for acupuncture, contraindications and cautions, acupuncture treatment, and review and audit. These guidelines set basic, minimum standards of care, and need re-assessment and ongoing validation as further data and evidence accumulate.

Acupuncture and self acupuncture for long-term treatment of vasomotor symptoms in cancer patients--audit and treatment algorithm.

INTRODUCTION: Since hormone replacement therapy given for long periods is now recognised to produce serious side effects, patients with troublesome vasomotor symptoms are increasingly using non-hormonal treatment including acupuncture. Several randomised controlled trials have shown that acupuncture reduces menopausal symptoms in patients experiencing the normal climacteric. It may have this effect by raising serotonin levels which alter the temperature set point in the hypothalamus. Vasomotor symptoms can be extreme in breast cancer patients and patients with prostate cancer who are undergoing anticancer therapy. The safety of some herbal medicines and phytoestrogens has been questioned, as they could potentially interfere adversely with the bioavailability of tumouricidal drugs. A previous study reports short term benefit from acupuncture, and the aim of this report is to describe our approach to long term treatment. ACUPUNCTURE APPROACH: After piloting several approaches, six weekly treatments were given initially at LI4, TE5, LR3 and SP6 and two upper sternal points, but avoiding any limb with existing lymphoedema or prone to developing it. If there were no contraindications, patients were given clear instructions on how to perform self acupuncture using either semi-permanent needles or conventional needling at SP6, weekly for up to six years, for long term maintenance. AUDIT METHODS AND RESULTS: A retrospective audit of electronic records was carried out by a doctor not involved in treatment. A total of 194 patients were treated, predominantly with breast and prostate cancer. One hundred and eighty two patients were female. The number of pre-treatment hot flushes per day was estimated by the patient: in the 159 cases providing adequate records, the mean was 16 flushes per day. Following treatment, 114 (79%) gained a 50% or greater reduction in hot flushes and 30 (21%) a less than 50% reduction. Treatment was abandoned in those who responded poorly or not at all. The duration of treatment varied from one month to over six years with a mean duration of nine months. Seventeen patients (9%) experienced minor side effects over the six year period, mostly minor rashes; one patient described leg swelling but this was likely to be due to a concurrent fracture. CONCLUSION: Acupuncture including self acupuncture is associated with long-term relief of vasomotor symptoms in cancer patients. Treatment is safe and costs appear to be low. An algorithm is presented to guide clinical use. We recommend the use of self acupuncture with needles at SP6 in preference to semi-permanent needles in the first instance, but poor responders use indwelling studs if they fail to respond adequately to self acupuncture with regular needles. Point location may be of less importance than the overall 'dose', and an appropriate minimum dose may be required to initiate the effect.

Complementary medicine: evidence base, competence to practice and regulation.

This paper describes the current status and evidence base for acupuncture, homeopathy, herbal and manipulative medicine, as well as the regulatory framework within which these therapies are provided. It also explores the present role of the Royal College of Physicians' Subcommittee on Complementary and Alternative Medicine (CAM) in relation to these developments. A number of CAM professions have encouraged the Royal College of Physicians Subcommittee to act as a reference point for their discussions with the conventional medical profession and the subcomittee believes that they are able to fulfil this function.

Galactorrhoea following acupuncture.

A 41-year-old woman with breast cancer was referred to the pain management clinic for a course of acupuncture for intense pain following a subcutaneous mastectomy and a latissimus dorsi flap reconstruction. She was treated with a standard course of acupuncture for breast pain, using paravertebral segmental points, trigger points, plus contralateral L14 on the non-lymphoedematous arm. She experienced an episode of galactorrhoea six days following the first treatment and during the second treatment. She had not previously lactated for four years. CT and MRI of the brain revealed no focal abnormality. Acupuncture has been used in to promote lactation in the Traditional Chinese literature using the 'Tianzong' acupoint SI11. This acupoint coincided with a trigger point over infraspinatus that was included in the neurophysiologically based acupuncture treatment. Quantitative analysis has shown an increase in the production of prolactin and oxytocin following acupuncture. These hormones are involved in the synthesis and release of milk from mammary glands respectively. This is the first report of galactorrhoea, in the contralateral normal breast, following acupuncture in a patient with breast cancer.