Carolyn Ee

Acupuncture for pelvic and back pain in pregnancy : a systematic review

The objective of our study was to review the effectiveness of needle acupuncture in treating the common and disabling problem of pelvic and back pain in pregnancy. Two small trials on mixed pelvic/back pain and 1 large high-quality trial on pelvic pain met the inclusion criteria. Acupuncture, as an adjunct to standard treatment, was superior to standard treatment alone and physiotherapy in relieving mixed pelvic/back pain. Women with well-defined pelvic pain had greater relief of pain with a combination of acupuncture and standard treatment, compared to standard treatment alone or stabilizing exercises and standard treatment. We used a narrative synthesis due to significant clinical heterogeneity between trials. Few and minor adverse events were reported. We conclude that limited evidence supports acupuncture use in treating pregnancy-related pelvic and back pain. Additional high-quality trials are needed to test the existing promising evidence for this relatively safe and popular complementary therapy.

Acupuncture for Menopausal Hot Flashes: A Randomized Trial.

Context Up to 75% of menopausal women experience hot flashes (HFs). Although acupuncture is effective for treating these symptoms compared with self-care, data conflict about its efficacy compared with sham acupuncture. Contribution In this randomized, controlled trial, standardized Chinese medicine acupuncture resulted in a reduction in HFs similar to noninsertive sham acupuncture among women who were postmenopausal or in late menopausal transition. Caution Study participants were predominantly Caucasian. Implication Standardized Chinese medicine acupuncture offers no additional benefit over noninsertive sham acupuncture for menopausal HFs. Vasomotor symptoms (VMSs), or hot flashes (HFs) and night sweats, affect up to 75% of women, last an average of 5 years, and cause a considerable loss of quality of life (1) and financial burden (2). Some women are reluctant to use hormone replacement therapy (HRT), a highly effective treatment, because of such adverse events as cardiovascular disease and breast cancer (1). Other conventional treatments, such as selective serotonin reuptake inhibitors, also cause adverse events and are less effective than HRT (3). Complementary therapies account for

Acupuncture for menopausal vasomotor symptoms: study protocol for a randomised controlled trial

34 billion in out-of-pocket spending in the United States annually (4). More than 50% of women use these therapies for menopausal symptoms, despite little evidence of safety and effectiveness (5). Acupuncturists are the second most consulted therapists by menopausal women (6). Acupuncture is safe (7) and may act on monoamines (8), which are implicated in VMS pathophysiology (1). Although acupuncture for VMSs is more effective than self-care or no treatment (9), results from sham-controlled trials conflict (1012). A recent meta-analysis concluded that acupuncture may be superior to sham procedures for HFs, but methodological flaws and small sample sizes may overestimate this effect (13). At the time of study design, the only trial reporting superiority of acupuncture over sham was a pilot study using noninsertive sham (14). Our objective was to compare the efficacy of Chinese medicine needle acupuncture with noninsertive sham acupuncture in a broader sample of women with menopausal HFs. Methods Design Overview Our study protocol has been published (15). This was a stratified, blinded (except therapists), parallel, randomized, sham-controlled trial with equal allocation conducted between September 2011 and October 2014. All participants provided written informed consent at enrollment. No financial compensation was offered. The Human Research Ethics Committee at the University of Melbourne provided ethics approval. Methods were informed by an unpublished feasibility study (n=27) conducted by Drs. Ee, Pirotta, and Xue. Protocol changes and deviations are described in the Appendix. Setting and Participants Interventions were delivered in 15 acupuncture clinics in Melbourne, Australia, and in areas of Victoria, New South Wales, and Queensland, Australia. We recruited from the community using social media; university student and staff newsletters; newspaper advertisements; media exposure; and strategies through Jean Hailes for Womens Health (www.jeanhailes.org.au), a womens health education and research organization. Women were included if they were postmenopausal (>12 months since their final menstrual period) or in the late menopausal transition (follicular-stimulating hormone level 25 IU, amenorrhea 60 days, and VMSs), had a mean HF score of at least 14 (equal to 7 moderate VMSs daily) (16), or had kidney yin deficiency diagnosed using a structured Chinese medicine history as well as a tongue and pulse examination performed by experienced acupuncturists (Appendix Figures 1 and 2). Kidney yin deficiency, of which night sweats is a cardinal symptom, is a Chinese medicine clinical syndrome diagnosed in 76% to 81% of symptomatic postmenopausal women (17, 18). Women who had had a hysterectomy were included if they were older than 51 years with a follicular-stimulating hormone level of 25 IU or greater. Appendix Figure 1. Chinese medicine questionnaire used to assess kidney yin deficiency. The final scores for kidney yin and yang deficiency were compared, and women who scored higher for kidney yin deficiency were eligible at this point. Scores were filled in only the unshaded areas of the questionnaire. * Scores for this symptom were multiplied by 2 because it is considered a cardinal symptom. Appendix Figure 2. Chinese medicine questionnaire used to assess kidney yang deficiency. The final scores for kidney yin and yang deficiency were compared, and women who scored higher for kidney yin deficiency were eligible at this point. Scores were filled in only the unshaded areas of the questionnaire. * Scores for this symptom were multiplied by 2 because it is considered a cardinal symptom. Exclusion criteria were needle acupuncture in the preceding 2 years, age younger than 40 years, previous diagnosis of premature ovarian failure and age younger than 50 years, bilateral salpingo-oophorectomy, medical reasons for amenorrhea, poorly controlled thyroid disease, VMSs associated with breast cancer, current HRT use, vaginal estrogen therapy in the previous 12 weeks, treatment of VMSs for the previous 12 weeks, relative contraindications to acupuncture (anticoagulation, heart valve disease, or poorly controlled diabetes mellitus), and unwillingness or inability to adhere to trial requirements or to give informed consent. Randomization We randomly allocated participants to receive acupuncture or sham acupuncture. A researcher with no other role in the study generated the computer randomization schedule (Excel 2004 [Microsoft]) with equal allocation and random block sizes of 8 and 12, stratified by acupuncturist. He then created a password-protected electronic Excel spreadsheet containing the concealed allocation schedule. When a participant enrolled, a research assistant (K.N.) activated a randomization function built into the spreadsheet to reveal the next allocation. She informed the acupuncturist of treatment allocation by disclosing the list of points to be used via mobile text, e-mail, or fax. Acupuncturists identified group allocation from differences in treatment protocols between acupuncture and sham groups. Interventions Acupuncture Two practicing Chinese medical acupuncturists and researchers (C.X. and C.E.) developed a standardized protocol to treat kidney yin deficiency according to Chinese medicine principles, using textbook (19) and literature reviews (14, 20, 21), treatment regimens and point selection from trials that reported acupuncture to be superior to sham acupuncture or self-care (9, 14), and comments from 3 leading researchers in womens health acupuncture. Appendix Tables 1 and 2 have further details about interventions. In brief, 6 acupuncture points were needled until de qi (defined as numbness, heaviness, pressure, soreness, or tingling) was obtained. De qi, a specific sensation generated by stimulating acupuncture needles, is considered an important component of acupuncture needling (22). Needles were retained for 20 minutes with manual manipulation (twirling and rotating) after 10 minutes. We used 0.3240mm sterile, disposable, stainless steel needles (DongBang Acupuncture). Ten treatments were provided at no charge over 8 weeks (twice weekly for 2 weeks and weekly thereafter). Appendix Table 1. Location of Points Used in the Acupuncture Group Appendix Table 2. Location of Points Used in the Sham Group* Sham Acupuncture We used the validated Park sham device, a 0.3540mm blunt needle supported by a plastic ring and guide tube (base unit) (23) attached to the skin by using a double-sided adhesive ring. The needle telescopes into itself and shortens on manipulation, giving the visual and physical impression of insertion into the skin. The base unit was used for all treatments, including real acupuncture. Although the sensation from the blunt needle tip can result in weak physiologic effects (24, 25), differences in brain activation have been noted between real and blunt needling (26). Needles were bilaterally inserted into 3 sites that were not acupuncture points and were away from points used in the real acupuncture group. Acupuncturists asked about sensation and pretended to manipulate the needle after 10 minutes, but de qi was not sought. The treatment regimen was the same as in the acupuncture group. Other Concurrent Treatments We discouraged women from starting new co-interventions for HFs during the intervention period. However, participants already receiving non-HRT VMS treatments continued these for the intervention period. We told participants that they had a 50% chance of receiving real or placebo acupuncture and that placebo needles did not stimulate the same nerves as real needles. Participants could withdraw at any time. Acupuncturists were trained to treat participants professionally but to minimize interactions to brief social conversation and asking about adverse events. Standardization of the Intervention The acupuncturists had bachelors degrees in Chinese medicine, at least 5 years of clinical experience, and current registration with the Australian Health Practitioner Regulation Agency. Appendix Table 3 explains details of training and quality assurance visits done to ensure intervention fidelity. Supplement. Frequently asked questions and suggested answers. Appendix Table 3. Checklist Used During Quality Assurance Visits Blinding Participants, outcome assessors, and investigators were blinded to treatment allocation; the acupuncturists and the research assistant who randomly assigned participants were not. The self-reported outcome assessments were blinded. Outcomes and Follow-up The primary outcome was HF score at the end of treatment (EOT) (8 weeks) (16). Participants recorded the number of daily mild, moderate, severe, and very severe HFs for 7 days using a validated HF diary (16). We calculated t

Expectancy after the first treatment and response to acupuncture for menopausal hot flashes.

BackgroundHot flushes and night sweats (vasomotor symptoms) are common menopausal symptoms, often causing distress, sleep deprivation and reduced quality of life. Although hormone replacement therapy is an effective treatment, there are concerns about serious adverse events. Non-hormonal pharmacological therapies are less effective and can also cause adverse effects. Complementary therapies, including acupuncture, are commonly used for menopausal vasomotor symptoms. While the evidence for the effectiveness of acupuncture in treating vasomotor symptoms is inconclusive, acupuncture has a low risk of adverse effects, and two small studies suggest it may be more effective than non-insertive sham acupuncture. Our objective is to assess the efficacy of needle acupuncture in improving hot flush severity and frequency in menopausal women. Our current study design is informed by methods tested in a pilot study.Methods/designThis is a stratified, parallel, randomised sham-controlled trial with equal allocation of participants to two trial groups. We are recruiting 360 menopausal women experiencing a minimum average of seven moderate hot flushes a day over a seven-day period and who meet diagnostic criteria for the Traditional Chinese Medicine diagnosis of Kidney Yin deficiency. Exclusion criteria include breast cancer, surgical menopause, and current hormone replacement therapy use. Eligible women are randomised to receive either true needle acupuncture or sham acupuncture with non-insertive (blunt) needles for ten treatments over eight weeks. Participants are blinded to treatment allocation. Interventions are provided by Chinese medicine acupuncturists who have received specific training on trial procedures. The primary outcome measure is hot flush score, assessed using the validated Hot Flush Diary. Secondary outcome measures include health-related quality of life, anxiety and depression symptoms, credibility of the sham treatment, expectancy and beliefs about acupuncture, and adverse events. Participants will be analysed in the groups in which they were randomised using an intention-to-treat analysis strategy.DiscussionResults from this trial will significantly add to the current body of evidence on the role of acupuncture for vasomotor symptoms. If found to be effective and safe, acupuncture will be a valuable additional treatment option for women who experience menopausal vasomotor symptoms.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12611000393954 11/02/2009.

Acupuncture for menopausal hot flashes : clinical evidence update and its relevance to decision making

Background Evidence on the impact of expectancy on acupuncture treatment response is conflicting. Objectives This secondary analysis of a randomized sham-controlled trial on acupuncture for menopausal hot flashes investigated whether treatment expectancy score was associated with hot flash score at end-of-treatment. Secondary analyses investigated whether there were associations between other pre-specified factors and hot flash score. Study design Women experiencing moderately-severe hot flashes were randomized to receive 10 sessions of real or sham acupuncture over eight weeks. Hot flash score was collected using a seven-day hot flash diary, and expectancy using the modified Credibility and Expectancy Questionnaire immediately after the first treatment. Linear mixed-effects models with random intercepts were used to identify associations between expectancy score and hot flash score at end-of-treatment. Regression was also used to identify associations between pre-specified factors of interest and hot flash score. Because there was no difference between real and sham acupuncture for the primary outcome of hot flash score, both arms were combined in the analysis. Results 285 women returned the Credibility and Expectancy Questionnaire, and 283 women completed both expectancy measures. We found no evidence for an association between expectancy and hot flash score at end-of-treatment for individual cases in either acupuncture or sham group. Hot flash scores at end-of-treatment were 8.1 (95%CI, 3.0 to 13.2; P = 0.002) points lower in regular smokers compared to those who had never smoked, equivalent to four fewer moderate hot flashes a day. Conclusion In our study of acupuncture for menopausal hot flashes, higher expectancy after the first treatment did not predict better treatment outcomes. Future research may focus on other determinants of outcomes in acupuncture such as therapist attention. The relationship between smoking and hot flashes is poorly understood and needs further exploration.

Complementary Therapies and Medicines and Reproductive Medicine

Objective: There is conflicting evidence on the efficacy and effectiveness of acupuncture for menopausal hot flashes. This article synthesizes the best available evidence for when women are considering whether acupuncture might be useful for menopausal hot flashes. Methods: We searched electronic databases to identify randomized controlled trials and systematic reviews of acupuncture for menopausal hot flushes. Results: The overall evidence demonstrates that acupuncture is effective when compared with no treatment, but not efficacious compared with sham. Methodological challenges such as the complex nature of acupuncture treatment, the physiological effects from sham, and the significant efficacy of placebo therapy generally in treating hot flashes all impact on these considerations. Conclusions: Acupuncture improves menopausal hot flashes compared with no treatment; however, not compared with sham acupuncture. This is also consistent with the evidence that a range of placebo interventions improve menopausal symptoms. As clinicians play a vital role in assisting evidence-informed decisions, we need to ensure women understand the evidence and can integrate it with personal preferences. Some women may choose acupuncture for hot flashes, a potentially disabling condition without long-term adverse health consequences. Yet, women should do so understanding the evidence, and its strengths and weaknesses, around both effective medical therapies and acupuncture. Likewise, cost to the individual and the health system needs to be considered in the context of value-based health care.

Accreditation Standard Guideline Initiative for Tai Chi and Qigong Instructors and Training Institutions

Complementary therapies and medicines are a broad and diverse range of treatments, and are frequently used by women and their partners during the preconception period to assist with infertility, and to address pregnancy-related conditions. Despite frequent use, the evidence examining the efficacy, effectiveness, and safety for many modalities is lacking, with variable study quality. In this article, we provide an overview of research evidence with the aim of examining the evidence to inform clinical practice. During the preconception period, there is mixed evidence for acupuncture to improve ovulation, or increase pregnancy rates. Acupuncture may improve sperm quality, but there is insufficient evidence to determine whether this results in improved pregnancy and live birth rates. Acupuncture can be described as a low-risk intervention. Chinese and Western herbal medicines may increase pregnancy rates; however, study quality is low. The evaluation of efficacy, effectiveness, and safety during the first trimester of pregnancy has most commonly reported on herbs, supplements, and practices such as acupuncture. There is high-quality evidence reporting the benefits of herbal medicines and acupuncture to treat nausea in pregnancy. The benefit from ginger to manage symptoms of nausea in early pregnancy is incorporated in national clinical guidelines, and vitamin B6 is recommended as a first-line treatment for nausea and vomiting in pregnancy. The safety of ginger and vitamin B6 is considered to be well established, and is based on epidemiological studies. Acupuncture has been shown to reduce back pain and improve function for women in early pregnancy. There is little evidence to support the use of cranberries in pregnancy for prevention of urinary tract infections, and chiropractic treatment for back pain. Overall the numbers of studies are small and of low quality, although the modalities appear to be low risk of harm.

Erratum to: Acupuncture for menopausal vasomotor symptoms: study protocol for a randomised controlled trial

Evidence of the health and wellbeing benefits of Tai Chi and Qigong (TQ) have emerged in the past two decades, but TQ is underutilized in modern health care in Western countries due to lack of promotion and the availability of professionally qualified TQ instructors. To date, there are no government regulations for TQ instructors or for training institutions in China and Western countries, even though TQ is considered to be a part of Traditional Chinese medicine that has the potential to manage many chronic diseases. Based on an integrative health care approach, the accreditation standard guideline initiative for TQ instructors and training institutions was developed in collaboration with health professionals, integrative medicine academics, Tai Chi and Qigong master instructors and consumers including public safety officers from several countries, such as Australia, Canada, China, Germany, Italy, Korea, Sweden and USA. In this paper, the rationale for organizing the Medical Tai Chi and Qigong Association (MTQA) is discussed and the accreditation standard guideline for TQ instructors and training institutions developed by the committee members of MTQA is presented. The MTQA acknowledges that the proposed guidelines are broad, so that the diversity of TQ instructors and training institutions can be integrated with recognition that these guidelines can be developed with further refinement. Additionally, these guidelines face challenges in understanding the complexity of TQ associated with different principles, philosophies and schools of thought. Nonetheless, these guidelines represent a necessary first step as primary resource to serve and guide health care professionals and consumers, as well as the TQ community.

Randomized controlled trials

Author details Department of General Practice, University of Melbourne, 200 Berkeley St, Carlton 3053, Victoria, Australia. Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia. Diabetes and Vascular Medicine Unit, Monash Health, Melbourne, Australia. School of Rehabilitation Therapy, Queen’s University, Ontario, Canada. Faculty of Health Sciences, Ontario, Canada. Division of Research, NatMed-Research Unit, Southern Cross University, Lismore, Australia. School of Health Sciences, RMIT University, Melbourne, Australia.