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

BACKGROUND: After menopause, 10–20% of all women have nearly intolerable hot flushes. Long term use of hormone replacement therapy involves a health risk, and many women seek alternative strategies to relieve climacteric complaints. Acupuncture is one of the most frequently used complementary therapies in Norway. We designed a study to evaluate whether Traditional Chinese Medicine acupuncture-care together with self-care is more effective than self-care alone to relieve climacteric complaints. METHODS/DESIGN: The study is a multi-centre pragmatic randomised controlled trial with two parallel arms. Participants are postmenopausal women who document ≥7 flushes/24 hours and who are not using hormone replacement therapy or other medication that may influence flushes. According to power calculations 200 women are needed to detect a 50% reduction in flushes, and altogether 286 women will be recruited to allow for a 30% dropout rate. The treatment group receives 10 sessions of Traditional Chinese Medicine acupuncture-care and self-care; the control group will engage in self-care only. A team of experienced Traditional Chinese Medicine acupuncturists give acupuncture treatments. DISCUSSION: The study tests acupuncture as a complete treatment package including the therapeutic relationship and expectation. The intervention period lasts for 12 weeks, with follow up at 6 and 12 months. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life, assessed by the Women's Health Questionnaire. We also collect data on Traditional Chinese Medicine diagnoses, and we examine treatment experiences using a qualitative approach. Finally we measure biological variables, to examine potential mechanisms for the effect of acupuncture. The study is funded by The Research Council of Norway

Any difference? Use of a CAM provider among cancer patients, coronary heart disease (CHD) patients and individuals with no cancer/CHD

<p>Abstract</p> <p>Background</p> <p>Although use of complementary and alternative medicine (CAM) among cancer patients has been described previously, prevalence of use has not commonly been compared to other disease groups in a true population sample where CAM use or cancer is not the main focus. The aims of the present study are to (1) examine how CAM use in cancer patients differs from people with a previous CHD diagnosis and people with no cancer or CHD diagnosis in an unselected general population and (2), investigate the use of a CAM provider among individuals with a previous cancer diagnosis.</p> <p>Methods</p> <p>A total of 8040 men and women aged 29 to 87 in the city of Tromsø, Norway filled in a questionnaire developed specifically for the Tromsø V study with questions on life style and health issues. Visits to a CAM provider within the last 12 months and information on cancer, heart attack and angina pectoris (heart cramp) were among the questions. 1449 respondents were excluded from the analyses.</p> <p>Results</p> <p>Among the 6591 analysed respondents 331 had a prior cancer diagnosis, of whom 7.9% reported to have seen a CAM provider within the last 12 months. This did not differ significantly from neither the CHD group (6.4%, p = 0.402) nor the no cancer/CHD group (9.5%, p = 0.325).</p> <p>Conclusion</p> <p>According to this study, the proportion of cancer patients seeing a CAM provider was not statistically significantly different from patients with CHD or individuals without cancer or CHD.</p

Homeopathic care for the prevention of upper respiratory tract infections in children: a pragmatic, randomised, controlled trial comparing individualised homeopathic care and waiting-list controls

ObjectiveTo investigate whether individualised treatment by homeopaths is effective in preventing childhood upper respiratory tract infection (URTI).MethodsOpen, pragmatic, randomised parallel-group trial with waiting-list group as control. One hundred and sixty-nine children below the age of 10 years, recruited by post from children previously diagnosed with URTI, were randomly assigned to receive either pragmatic homeopathic care from one of five homeopaths for 12 weeks or to a waiting-list control using self-selected, conventional health care.ResultThere was a significant difference in median total symptom score in favour of homeopathic care (24 points) compared to the control group (44 points) (p = 0.026). The difference in the median number of days with URTI symptoms was statistically significant with 8 days in the homeopathic group and 13 days in the control group (p = 0.006). There was no statistical difference in the use of conventional medication or care between the two groups.ConclusionIn this study, there was a clinically relevant effect of individualised homeopathic care in the prevention of URTI in children

The use of simplified constitutional indications for self-prescription of homeopathic medicine

Objectives: To develop simplified constitutional indications for homeopathic medicines so that parents of children with recurrent upper respiratory tract infection (URTI) could choose homeopathic medicines for their children more “accurately”, and to subsequently evaluate if these choices match the prescriptions of trained homeopaths.Design and setting: To initially select the most commonly used homeopathic medicines for URTI, data from a survey of 1097 patients visiting 80 different Norwegian homeopaths were used. A simplified constitutional indication was then developed for the three homeopathic medicines most frequently prescribed for recurrent URTI and otitis media. The constitutional indications were developed by a group of five homeopaths and were then sent to 20 homeopaths for further evaluation. To evaluate the parents’ choice of homeopathic medicines compared to the prescription by trained homeopaths, a group of 11 randomly selected homeopaths were asked to participate. They recruited parents of 70 child patients.Result: By using simplified constitutional indications for the three most commonly prescribed remedies, Calcarea carb, Pulsatilla and Sulphur, parents were able to choose the same homeopathic medicine as homeopaths’ prescribed for 55% (95% CI 43–67) of children with URTI. There was excellent agreement between parents’ choice and homeopaths’ prescription for the three medicines (Kappa of 0.77, p &lt; 0.001).Conclusion: Simplified constitutional indications can be used to improve the quality of the choice of homeopathic medicines purchased over the counter (OTC) for self-treatment. <br/

Traditionally trained acupuncturists’ views on the World Health Organization traditional medicine ICD-11 codes: A Europe wide mixed methods study

Introduction: The diagnostic categories used in Traditional Medicine (TM) that originated in China and are now used around the world have been classified for inclusion as a chapter within the World Health Organization's International Classification of Diseases (ICD). As a new chapter in ICD, the TM ICD codes were subject to international field testing. A pilot field test of the TM ICD codes was conducted to investigate their clinical utility in the European context. Design: A mixed methods approach, including a Europe wide survey of practitioner views on TM ICD codes; and investigating the coding process of case study vignettes to explore coders’ experiences of using TM ICD codes. Results: Survey: The majority of participants felt TM ICD codes provide a meaningful way to classify TM disorders and patterns; felt their patients’ diagnoses could be represented within the codes; and felt the codes would be important in their clinical practice. Coding of vignettes: In 60.7% of cases the specificity of the assigned code was perceived as ‘just right’. Participants experienced difficulties assigning a single TM ICD disorder and pattern code, due to multiple codes being viewed as appropriate for the case. Conclusions: The European TM practitioners who participated in this study largely perceive the TM ICD codes as valuable, conceptually accurate, and incorporating the range of TM diagnoses utilized within clinical practice. The TM ICD codes could be improved for European TM practitioners by expanding the scope of TM ICD codes, and adopting a multidimensional approach whereby more than one disorder and/or pattern code can be applied to single patients.</p

EU FP7 project 'CAMbrella' to build European research network for complementary and alternative medicine

Background: The status of complementary and alternative medicine (CAM) within the EU needs clarification. The definition and terminology of CAM is heterogeneous. The therapies, legal status, regulations and approaches used vary from country to country but there is widespread use by EU citizens. A coordination project funded by the EU has been launched to improve the knowledge about CAM in Europe. Objectives and Methods: The project aims to evaluate the conditions surrounding CAM use and provision in Europe and to develop a roadmap for European CAM research. Specific objectives are to establish an EU network involving centres of research excellence for collaborative projects, to develop consensus-based terminology to describe CAM interventions, to create a knowledge base that facilitates the understanding of patient demand for CAM and its prevalence, to review the current legal status and policies governing CAM provision, and to explore the needs and attitudes of EU citizens with respect to CAM. Based on this information a roadmap will be created that will enable sustainable and prioritised future European research in CAM. CAMbrella encompasses 16 academic research groups from 12 European countries and will run for 36 months starting from January 2010. The project will be delivered in 9 work packages coordinated by a Management Board and directed by a Scientific Steering Committee with support of an Advisory Board. Output: The outcomes generated will be disseminated through the project’s website, peer review open access publications and a final conference, with emphasis on current and future EU policies, addressing different target audiences

Complementary and alternative medicine for treatment of atopic eczema in children under 14 years old: a systematic review and meta-analysis of randomized controlled trials

Abstract Background Due to limitations of conventional medicine for atopic eczema (AE), complementary and alternative medicine (CAM) is widely used as an alternative, maintaining, or simultaneous treatment for AE. We aimed to evaluate the beneficial and harmful effects of CAM for children with AE under 14 years old. Methods We searched for randomized trials on CAM in 12 Chinese and English databases from their inception to May 2018. We included children (< 14 years) diagnosed with AE, who received CAM therapy alone or combined with conventional medicine. We extracted data, and used the Cochrane “Risk of bias” tool to assess methodological quality. Effect was presented as relative risk (RR) or mean difference (MD) with 95% confidence interval (CI) using RevMan 5.3. Results Twenty-four randomized controlled trials involving 2233 children with AE were included. Methodological quality was of unclear or high risk of bias in general. The trials tested 5 different types of CAM therapies, including probiotics, diet, biofilm, borage oil, and swimming. Compared to placebo, probiotics showed improved effect for the SCORAD index (MD 9.01, 95% CI 7.12–10.90; n = 5). For symptoms and signs such as itching, skin lesions, CAM combined with usual care was more effective for symptom relief ≥95% (RR 1.47, 95% CI 1.30–1.68; n = 8), and for ≥50% symptoms improvement (RR 1.34, 1.25–1.45; n = 9) compared to usual care. There was no statistic significant difference between CAM and usual care on ≥95% improvement or ≥ 50% improvement of symptoms. However, swimming, diet and biofilm showed improvement of clinical symptoms compared with usual care. At follow-up of 8 weeks to 3 years, CAM alone or combined with usual care showed lower relapse rate (RR 0.38, 0.28–0.51, n = 2; RR 0.31, 0.24–0.40, n = 7; respectively) compared to usual care. Twelve out of 24 trials reported no occurrence of severe adverse events. Conclusions Low evidence demonstrates that some CAM modalities may improve symptoms of childhood AE and reduce relapse rate. Safety remains unclear due to insufficient reporting. Further well-designed randomized trials are needed to confirm the potential beneficial effect and to establish safety use