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World Congress Integrative Medicine & Health 2017: part two

Berlin, Germany. 3–5 May 2017
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BMC Complementary and Alternative MedicineBMC series – open, inclusive and trusted201717 (Suppl 1) :317

https://doi.org/10.1186/s12906-017-1783-3

  • Published:

P44 Expectancy did not predict treatment response in a randomised sham-controlled trial of acupuncture for menopausal hot flushes

Carolyn Ee1, Sharmala Thuraisingam2, Marie Pirotta2, Simon French3, Charlie Xue4, Helena Teede5

1 National Institute of Complementary Medicine, Western Sydney University, Sydney, Australia; 2 Department of General Practice, University of Melbourne, Melbourne, Australia; 3 School of Rehabilitation Therapy, Queens University, Ontario, Canada; 4 School of Health and Biomedical Sciences, RMIT University, Melbourne, Australia; 5 School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia

Correspondence: Carolyn Ee

Background

Evidence on the impact of expectancy on acupuncture treatment response is conflicting. We conducted a secondary analysis of a randomised sham-controlled trial on acupuncture for menopausal hot flushes. We aimed to evaluate whether baseline expectancy is correlated with hot flush score at end-of-treatment, and determine factors associated with baseline treatment expectancy.

Methods

Women experiencing moderate-severe hot flushes were randomised to receive real or sham acupuncture for eight weeks. We measured expectancy using the Credibility and Expectancy Questionnaire immediately after the first treatment, and hot flush score using a seven-day hot flush diary. A complete mediation analysis using linear mixed-effects models with random intercepts was performed, adjusted by baseline hot flush score, to identify associations between independent variables, expectancy levels and hot flush score at end-of-treatment. Because there was no difference between real and sham acupuncture for the primary outcome of hot flush score, both arms were combined in the analysis (n = 285).

Results

Treatment credibility, perceived allocation to real acupuncture or uncertainty about treatment allocation, and previous positive response to acupuncture predicted higher baseline expectancy. There was no evidence for an association between expectancy and hot flush score at end-of-treatment. Hot flush scores at end-of-treatment were 8.1 (95%CI, 3.03 to 13.20; P = 0.002) points lower in regular smokers compared to those who had never smoked.

Conclusion

In our study of acupuncture for menopausal hot flushes, we did not find an association between expectancy levels and treatment outcome. The association between smoking and improvement in hot flushes warrants further exploration.

This trial was registered with the Australia New Zealand Clinical Trials

Registry ACTRN12611000393954 on 14/04/2011

P45 Prevalence and associations for use of Complementary and Alternative Medicine (CAM) among people diagnosed with, or with a family risk for Coronary Heart Disease (CHD) in the 6th Tromsø Study

Agnete E Kristoffersen1, Fuschia Sirois2, Trine Stub3

1 NAFKAM, UiT, The arctic university of Norway, Tromsø, 9019, Norway; 2 Department of Psychology, University of Sheffield, Sheffield, S1 1HD, United Kingdom; 3 Department of community medicine, UiT The arctic university of Norway, Tromsø, 9019, Norway

Correspondence: Agnete E Kristoffersen

Aim

The aim of this study was to examine prevalence and associations for use of CAM among People diagnosed with, or with a family risk for CHD in the 6th Tromsø Study.

Methods

A total of 12982 men and women (response rate 65.7%) filled in a self-administrated questionnaire with questions about life style and health issues. Eight hundred and thirty of those had been diagnosed with either heart attack and/or angina pectoris while 4830 had a family risk for such disease due to close family members diagnosed with such disease.

Results

CAM use (CAM provider, OTC CAM products and/or CAM techniques) was found in 30.2% of the participants diagnosed with CHD and 35.8% of the participants with family risk of CHD (p < 0.001). Self-rated health, expectations for future health, preventive health beliefs and health behaviour were significant predictors of CAM use for those at risk of CHD. In the CHD patient group only health behaviour and self-rated health were significantly associated with CAM use.

Conclusion

Risk for CHD disease seems to be a stronger predictor for CAM use than the diagnosis of CHD itself.

P46 Addressing training needs of general practitioners working with cancer patients – trial protocol

Jennifer Engler1, Stefanie Joos2, Corina Güthlin1

1 Institue of General Practice, Goethe University Frankfurt, Frankfurt, 60590, Germany; 2 Department of General Practice, University of Tübingen, Tübingen, Germany

Correspondence: Jennifer Engler

Background

During the years 2012–2015 we collected data on training needs of health care personnel working with cancer patients within the research network KOKON. 70% of general practitioners felt it was important for their work to stay informed about CAM, but only 31% felt safe when talking about CAM options. GPs wished to get more information on a variety of CAM options with homeopathy, mistletoe and mind-body-techniques being of highest interest. In a separate study within KOKON it was shown that not only information on CAM but also the issue of how to communicate CAM options mattered to physicians during their training on CAM. Therefore, we plan to offer blended learning training to GPs (e-learning courses on CAM options, i.e. benefits and potential problems AND communication training). We will show the training and the evaluation concept.

Methods

We will conduct an exploratory pilot study with wait-list controlled design in order to study feasibility of the training concept in GPs, but also effects of the training by analyzing real-life communication using vignettes. Roter Interaction Analysis System (RIAS) will be used to evaluate communication training. 15 GPS will be trained first and 15 GPs will be trained after finishing waitlist-control.

Results

The trial protocol will be presented in detail.

Conclusion

Training on CAM options will not suffice unless not incorporated into communication training. We will show an innovative blended-learning concept and an evaluation design explicitly addressing both aspects adequately.

P47 Treatment of patients with digestive disorders with Gentiana Magen Globuli velati (GMGv) – results from a non-interventional study

Jennifer Felenda1, Christiane Beckmann1, Florian Stintzing2

1 Med.-pharm. Information / Klinische Forschung, WALA Heilmittel GmbH, Bad Boll/ Eckwälden, 73087, Germany; 2 Ressortleitung Wissenschaft, WALA Heilmittel GmbH, Bad Boll/ Eckwälden, 73087, Germany

Correspondence: Florian Stintzing

Background

GMGv is an anthroposophical drug used to harmonize the motility and secretion of the gastrointestinal tract, containing Artemisia absinthium, Gentiana lutea, Taraxacum officinale and potentized Strychnos nux-vomica. In Europe the prevalence of unspecific digestive disorders reaches 14% to 25% [1]. According to physicians” expertise, GMGv is an effective medicine, especially for treatment of dyspepsia with the main symptoms digestive weakness, gastric pressure and anorexia [2].

Methods

A national non-interventional study observed 319 adult patients with digestive disorders treated with GMGv. 29 physicians assessed the individual treatment considering diagnostic findings and patients’ preference.

The main aim was to evaluate the application modalities of GMGv: diagnosis, reason of application, duration of therapy and dosage. Secondly, the course of therapy and the patient’s acceptance were monitored.

Results

The intention-to-treat analysis of 292 out of 319 patients (71% females, mean age 47.3 years) showed patients suffering from functional dyspepsia (34%), psychosomatic disorders (21%), colon irritable (13%) and gastroenteritis (9%). The physicians prescribed GMGv to 53% of the patients as single therapy and to 27% because of insufficient efficacy of other drugs, mainly 3×5-10 globules/day for over 22 days. 68% of the patients were cured after completion of the treatment.

Patients’ status of health, evaluated by development of symptoms, global general condition, severity level of the main diagnosis, improved statistically significant.

151 of 195 patients (78%) were satisfied with the treatment and 143 of 165 (87%) would use GMGv again.

Conclusion

GMGv reduce symptoms and the severity level of the main indication, e.g. digestive disorders and improve the global general condition of the patients.

References

1. Mahadeva S., Goh KL. Epidemiology of functional dyspepsia: a global perspective. World Journal of Gastroenterology, 2006. 12: 2661–2666

2. Felenda J., Beckmann C., Stintzing F., Meyer U. Gentiana Magen Globuli velati in der ärztlichen Praxis- Ergebnisse einer Umfrage. Der Merkurstab, 2012. 65: 465–470

P48 Virtual reality environments for supporting mindfulness based healing of low back pain

Roni Evans1, Gert Bronfort1, Daniel Keefe1, Anna Taberko2, Linda Hanson1, Alex Haley1, Haiwei Ma1, Joseph Jolton2, Lana Yarosh1, Francis Keefe1,3, Jung Nam1

1 University of Minnnesota, Minneapolis, 55455, MN, United States; 2 Minneapolis College of Art and Design, Minneapolis, MN, United States; 3 Duke University, Durham, NC, United States

Correspondence: Roni Evans

Background

Low back pain (LBP) is among the most common and burdensome pain conditions worldwide. Mindfulness based interventions (MBIs) are a promising form of self-management which can help LBP patients develop the skills to self-regulate pain responses. However, similar to other self-management interventions, it can be difficult to motivate participants to engage in MBIs. Virtual Reality (VR) can provide individualized, appealing, and immersive environments that motivate patients to practice mindfulness. Our group is conducting a pilot study. One of the questions it will answer is: Can a multi-sensory VR intervention be designed to facilitate engagement in mindfulness practices in patients with LBP?

Methods

A multidisciplinary group of individuals from the fields of mindfulness, psychology, computer science, clinical research, and art and design is using an adapted intervention mapping approach to develop a prototype VR-MBI intervention. A total of 10 participants with chronic, mechanical LBP will use the VR-MBI for 8 weeks. Self-report outcomes (e.g. pain, disability, fear-avoidance, mindfulness, medication use) will be measured pre- and post- intervention; engagement in VR-MBI will be measured via diary and satisfaction, barriers, and facilitators will be assessed through qualitative interviews.

Results

A series of iterative design prototypes including imagery, narration, 3D models, and user interface techniques has been created to explore options for the VR environment that can best support mindfulness practices around pain. Special attention has been given to color, forms, and visual texture to align with the pain narrative, mindfulness exercises, and target outcomes. Patient enrollment and data collection will be completed by 2017.

Conclusions

As VR becomes increasingly affordable and available, it could become a very practical and engaging home-based self-management intervention for patients with persistent pain and other chronic conditions.

P49 Understanding facilitators and barriers to compassionate technology

Roni Evans1, Liwanag Ojala2, Mary J Kreitzer1, Linda Hanson1

1 University of Minnesota, Minneapolis, 55455, MN, United States; 2 Caring Bridge, Minneapolis, MN, United States

Correspondence: Roni Evans

Background

Established in 1997, CaringBridge is a web-based social network serving over 500,000 people daily and over 43 million people annually in over 230 countries. By using personal, protected websites for communities to share, connect, and rally support for people navigating challenging health journeys, CaringBridge sites offer a space for compassion, the natural emotional response to suffering and authentic desire to help. Our overall objective is to use technology to enhance social connectedness, and bring people together to help overcome the isolation that comes with illness. One of our questions examines What are the key characteristics, facilitators, and barriers of compassionate technology that can inform future optimization of web based social networks?

Methods

As part of a larger multi-phase project addressing the range of stakeholders, we conducted an electronic qualitative survey using Qualtrics. This survey was sent to CaringBridge staff and leadership and queried individuals regarding their perceptions of why people use CaringBridge, barriers to engagement, and unique characteristics of the CaringBridge experience and platform. Content analysis of text responses was performed to identify major themes.

Results

A total of 38/62 (62%) individuals affiliated with CaringBridge responded to the survey. Eight individuals each identified themselves as having used CaringBridge themselves as a patient (21%) or a caregiver (21%); 84% also identified as active visitors. Perceived motivators to using CaringBridge included ease of communication and the opportunity to see and feel much needed social support. Potential barriers to using CaringBridge included discomfort with technology, privacy concerns, a lack of awareness or understanding the goals of the site, and not knowing how to participate or what to say. Among the unique features mentioned was the journal component, where patient authors share their thoughts and emotions, and be vulnerable in a safe space, cultivating a powerful sense of community and shared experience.

Conclusions

As expressed by key stakeholders, compassionate technology sites, like CaringBridge, can meet important social needs associated with serious illness. Through identification of facilitators and barriers, implementation and accessibility of this potentially impactful social networking resource can be optimized for greater reach.

P50 Althaea officinalis cough preparations: Data from two independent consumer surveys underlining efficacy and tolerability for the treatment of irritative cough

Careen Fink1, Karin Kraft2

1 Phytomedicines Supply and Development Center, Innovation & Development, Bayer Consumer Health Steigerwald Arzneimittelwerk GmbH, Darmstadt, 68526, Germany; 2 University Medicine of Rostock, Rostock, 18055, Germany

Correspondence: Careen Fink

Background

Cough preparations containing aqueous Marshmallow root extracts (Althaea officinalis) are well established as medicinal products in Germany. Measuring the consumer experience and satisfaction is the key factor to their understanding. Especially for non-prescribed over-the-counter (OTC) medication, the experiences and needs of consumers are the key resource for information

Material and Methods

Two independent prospective, non-interventional pharmacy surveys were performed in German pharmacies on consumers buying either lozenges (winter season 2014/15) or a syrup (winter 2015/2016) of the aqueous Marshmallow root extract STW42. They were requested to complete a questionnaire on the course of cough symptoms, onset of effect, global assessment of efficacy, and tolerability during a 7 days treatment.

Results

These two prospective, non-interventional pharmacy surveys focussed on creating a better understanding of the patient’s impression of the efficacy, tolerability and satisfaction. A total of 822 questionnaires (syrup: n = 516, lozenges n = 306) consumers were evaluated. The median duration for recovery from symptoms was five days. Relief of oral or pharyngeal irritation and associated dry cough started within 10 min after application in >58% of the consumer, efficacy was rated at least as good by >83%.

The studies confirmed a good efficacy for the symptomatic treatment of oral or pharyngeal irritation and associated dry cough with a very quick onset of action: in the majority of cases the effect was stated within 10 minutes or less.

Conclusion

The surveys justify the long-standing use of Marshmallow preparations in cough treatment, and confirm the excellent tolerability of corresponding preparations.

P51 The RUTI trial: a multi-centred, 16 week, randomised, double blind, placebo controlled feasibility study of Chinese herbal medicine (CHM) for women with Recurrent Urinary Tract Infections (RUTIs)

Andrew Flower1, George Lewith1, Kim Harman1, Beth Stuart1, Felicity L Bishop2

1 Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom; 2 Psychology, University of Southampton, Southampton, United Kingdom

Correspondence: Andrew Flower

Background

Recurrent urinary tract infections (RUTIs) are an unpleasant, disabling and expensive condition affecting an estimated 3–4% of adult women. Usual treatment involves long-term antibiotics. The growing threat of antimicrobial resistance has resulted in an interest in herbal alternatives to antibiotics. Chinese herbal medicine (CHM) may be a useful treatment for RUTIs. This trial explores the feasibility of CHM for RUTIs in UK primary care with particular reference to (1) obtaining UK regulatory approval for CHM as a Clinical Trial of an Investigational Medicinal Product (CTIMP); (2) comparing the effect sizes of individualised CHM, standardised CHM and placebo treatments; (3) investigating the feasibility and acceptability of administering CHM in UK GP practices; (4) exploring the impact of different therapeutic environments on contextual treatment effects.

Methods

16 week, multi-site, double blinded, randomized, placebo controlled, mixed methods, pilot/feasibility trial, involving up to 80 women aged between 18–65 designed to compare standardized CHM remedies administered via GP practices, with individualized CHM formulae administered by an experienced TCM practitioner. Feasibility outcomes include the viability of developing, implementing and evaluating a CHM intervention within UK primary care with respect to recruitment, referral patterns, patient compliance, the use of a herbal placebo, and drop out rates. Quantitative outcomes included changes in the duration, severity and recurrence of acute UTI. Qualitative outcomes will explore the experience of patients and practice nurses during the delivery of CHM.

Results

After a protracted process MHRA and NHS regulatory approval was obtained for the first Clinical Trial of an Investigational Medicinal Product (CTIMP) of CHM in the UK. In total so far 41 primary care sites have participated in the identification of recruits in the individualised arm recruiting 21 women; and 18 sites have been set up (with 6 active) in the standardised arm recruiting 15 women.

Conclusion

We have shown it is feasible to conduct a CTIMP trial in the UK and to recruit via NHS primary care sites. Important lessons have already been learned that could inform a more definitive future trial. A full quantitative and qualitative analysis of the final data will be available in March 2017.

P52 Consultations with complementary medicine practitioners and childhood vaccine uptake: is there cause for concern

Jane Frawley

Faculty of Health, University of Technology Sydney, Sydney, 2007, Australia

Background

Is there an association between complementary medicine (CM) use and vaccine uptake in Australian children? Data from the US and Canada demonstrates that parents who use CM are more likely to delay or forgo vaccination, however this association has not been examined in an Australian paediatric population.

Methods

An online survey (n = 149) was carried out to determine parent’s attitudes and decision-making regarding their children’s health care needs, including vaccination.

Results

A total of 73.8% of children had visited a complementary medicine (CM) practitioner (48.3%) or used a CM product (68.5%) in the previous 12 months. Many children had also consulted a general practitioner (89.9%), community health nurse (31.29%), paediatrician (30.3%), and other medical specialist (38.8%). Children had also visited a naturopath/herbalist (30.4%), chiropractor (18.4%), homeopath (11.6%), nutritionist (6.8%) or traditional Chinese medicine practitioner (8.2%) and 52% of parents did not disclose the use of CM to their primary health care physician. A high number of children (35.6%) were not vaccinated with safety concerns being the most common reason (76.6%). Visits to a CM practitioner (OR 0.16; CI 0.07, 0.36; p < 0.001) and the use of CM products (OR 0.25; CI 0.09, 0.64; p = 0.004) were more likely if childhood vaccinations were not up to date.

Conclusions

Poor vaccination uptake is associated with the use of CM in this sample and nationally representative studies are needed to confirm these findings. Research is also needed to determine if these associations are due to CM practitioner attitudes to vaccination or parental health beliefs.

P53 The effects of modulated electro-hyperthermia on hepatocellular carcinoma in vitro and in vivo models

Lilla Füleki, Eva Kiss, Tamas Vancsik, Tibor Krenacs

1st Department of Pathology and Experimental Cancer Research, Semmelweis University, Budapest, 1085, Hungary

Correspondence: Lilla Füleki

Modulated electro-hyperthermia (mEHT) is an integrative approach to chemo- and radiotherapy. Electromagnetic field and the concomitant heat (<42 °C) can target malignancies due to their elevated ion-concentration (Warburg-effect) and electric conductivity. We tested the effects of mEHT on a hepatocellular carcinoma cell line (HepG2) in vitro and in vivo.

HepG2 culture was treated in vitro three times for 60 minutes (42 °C) during two days. Heat-stress was measured by western blot for Hsp70. Cells were counted for viability in Bürker-chamber using resazurin assay. Tumor cell proliferation was assessed using Ki67 immunocytochemistry. Flow cytometry for annexin-V/propidium iodide (PI) was used to determine the apoptotic per necrotic rates. HepG2 xenografts in SCID mice were treated with mEHT for 30 minutes. Formalin-fixed, paraffin.embedded tumors were tested 24 and 96 hours after treatment using hematoxillin-eosin based morphometry and immunhistochemistry to identify proliferating (Ki67) and apoptotic (cleaved caspase-3) cell fractions.

mEHT treatment in vitro resulted in a significant destruction and loss of tumor cells. Elevated release of stress-associated Hsp70 was also observed. Annexin-V/PI measurements confirmed elevated apoptotic cell death rate. Directly after mEHT treatment there was a transitional elevation of resazurin uptake in tumor cells which later decreased to the control level. This phenomenon could be a residual effect on enzyme activity after the thermal impact. The proliferation of the tumor cells was reduced based on the Ki67 assessment. In vivo, mEHT treatment induced caspase-3-mediated tumor-destruction and reduced tumor cell proliferation. Further studies are under way to clarify the mechanism of action of mEHT on HEPG2 cells.

P54 Preliminary findings from an active surveillance reporting system among spinal manipulative therapy providers

Martha Funabashi1, Katherine A Pohlman1,2, Silvano Mior3, Haymo Thiel4, Michael D Hill5, David J Cassidy6, Michael Westaway5, Jerome Yager1, Eric Hurwitz7, Gregory N Kawchuk1, Maeve O’Beirne5, Sunita Vohra1

1 University of Alberta, Edmonton, Canada; 2 Parker University, Dallas, TX, United States; 3 Canadian Memorial Chiropractic College, Toronto, Canada; 4 Anglo-European College of Chiropractic, Bournemouth, United Kingdom; 5 University of Calgary, Calgary, Canada, ; 6 University of Toronto, Toronto, Canada; 7 University of Hawaii at Manoa, Honolulu, Hawai’I, United States

Correspondence: Martha Funabashi (funabash@ualberta.ca)

Background

Patient safety is one of the leading healthcare challenges globally. The aim of this study was to evaluate initial findings from an active surveillance reporting system to identify adverse events (AEs) following spinal manipulative therapy (SMT).

Methods

Chiropractors and physiotherapists were recruited for this study. Chiropractors were asked to collect data from 100 consecutive, unique patients and physiotherapists from 50. Data collected included relevant health history, medication list, treatment provided (including SMT), and symptoms before and immediately after SMT. Patients were also asked to describe symptom changes up to one week after the treatment. Any worsened or new symptom following SMT was considered an AE.

Results

To date, 4 chiropractors and 2 physiotherapists collected data from 500 patients with 299 patients providing post-treatment data 4.4 days after treatment (average, range: 0–29 days). The most common reason for care was low back pain (24.2%) then neck pain (21.2%). On an 11-point scale, patients reported an average decrease of 0.88 points after treatment. For pre-existing symptoms, 48.3% of patients reported symptom improvement, 47.4% no change in symptoms, and 4.3% reported worsened symptoms. Eighteen patients (3.6%) reported a total of 50 new symptoms after SMT of which 37 were rated as mild, 10 moderate and 3 severe.

Conclusion

Although a small percentage of patients reported new or aggravated symptoms, most reported symptom improvement after care. Further investigations are recommended, however, to determine if these new/aggravated symptoms are related to care or reflect the natural history of the presenting conditions.

P55 Scientific production on the efficacy of osteopathy: a bibliometric analysis from 1980 to 2015

Isabelle Gaboury, Chantal Morin

Family Medicine, Universite de Sherbrooke, Sherbrooke, J1H 5N4, Canada

Correspondence: Isabelle Gaboury

In the last two decades, osteopathy has gained interest among the general population as well as among the scientific community. To better understanding publishing on this topic, we conducted a bibliometric analysis to describe the scientific production of empirical studies on osteopathic interventions, analyze its trends, and identify research gaps.

Articles published between 1980 and 2015 were retrieved from Medline and CINAHL. Keywords used to identify the articles of interest were a combination of osteopath*, manipulation, and treatment or synonyms as well as a list of manual techniques used by osteopaths and terms referring to empirical study designs. Three rounds of reviews were conducted (reviewing titles, abstracts, and full articles) to determine eligibility for inclusion of articles. Bibliometric indicators, such as scientific productivity, research design, and treated conditions were extracted.

3103 articles were retrieved by the literature search, and 426 were considered in the analysis. Scientific production is following an increasing trend, with the number of publications doubling every 5 years. 111 journals published empirical results of osteopathic interventions, with four of the top five journals (representing almost 2/3 of the articles) dedicated to an osteopathic readership. Most popular research designs are randomized controlled trial (37%), followed by case study (26%). Neck, thoracic and low back pain (20%) and visceral-related issues (18%) were the most often treated conditions.

This study identifies trends and gaps that could contribute to the development of rigorous studies evaluating the efficacy of osteopathic interventions. Dissemination strategies are relatively limited to the community of osteopaths.

P56 Meta-analysis of clinical trials in homeopathy: anything left to learn? – protocol for a new approach

Katharina Gaertner1, Loredana Torchetti1, Martin Frei-Erb1, Michael Kundi2, Michael Frass3

1 Institute for Complementary Medicine, University of Bern, Bern, 3008, Switzerland; 2 Institute of Environmental Health, Medical University of Vienna, Vienna, 1090, Austria; 3 Department of Medicine I, Clinical Division of Oncology, Medical University of Vienna, Vienna, 1090, Austria

Correspondence: Katharina Gaertner

Purpose

A systematic review with meta-analyses of the various homeopathic interventions and their effects in specific pathologies is outstanding.

Method

The study protocol provides a new methodological bottom-up approach, including grey literature and observational studies, the assessment of study quality regarding internal, external and model validity as well as a refinement of the overall analysis by gradual detection of differences by means of subgroup and sensitivity analyses. Available studies are allocated into three meta-analyses that try to identify: Clinical effects of homeopathic medicines (HOM) in randomized controlled trials (RCT), in observational studies (OS) and in preventive use; each compared to placebo or to conventional treatment in 9 pathology-based subgroups. An initial set of 535 Studies has been reviewed and screened for inclusion. 1,216 master theses have been identified as suitable for further evaluation. A second literature search, especially for the years 2013–2015, is ongoing.

Results

380 studies were included for further data-extraction. 72.5% of the included studies use RCT, 27.5% OS techniques. The studies, which apply HOM for preventive purpose (19.6%) will be analyzed separately. In the study-set of therapeutic use, the investigations of individualized and complex homeopathy count around 35%, clinical homeopathy approximately 25%, and isopathy 5%. In one third of studies the comparator is standard therapy, in two thirds placebo.

Conclusion

Investigating clinical studies of HOM with meta-analytical means by subgrouping of homeopathic methods, study designs and pathologies may contribute to a better understanding of the clinical effects of HOM and may open new perspectives for homeopathic research.

P57 SENeCA Study: observational study on the effect of medicinal cannabis on quality of life and nutritional outcomes

Eugenia Gallo1,2,3, Valentina Maggini1,2,3, Mattia Comite2,3, Francesco Sofi1, Sonia Baccetti4, Alfredo Vannacci1, Mariella Di Stefano4, Maria V Monechi4, Luigi Gori2,3, Elio Rossi4, Fabio Firenzuoli2,3,4, Rocco D Mediati5, Giovanna Ballerini5

1 Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; 2 Center for Integrative Medicine, Careggi Universtary Hospital, Florence, Italy; 3 Referring Centre for Phytoterapy, Region Tuscany, Florence, Italy; 4 Tuscan Network of Integrative Medicine, Region of Tuscany, Florence, Italy; 5 Cure Palliative e Terapia Del Dolore, Careggi Universitary Hospital, Florence, Italy

Correspondence: Eugenia Gallo

Background

The Tuscany Health System offers the medicinal use of Cannabis especially for the treatment of oncologic or neuropathic chronic pain, resistant to conventional therapy. Our Centre has promoted this retrospective study to evaluate the efficacy and safety profile of Cannabis. In particular, the effects on pain, quality of life (QoL), anxiety, nausea, fatigue, and nutritional assessment of the patients will be taken into account.

Methods

Hospital Pharmacy has prepared Cannabis flos (19% THC) dispensed for decoction or as an oil extract. A total of 40 patients (32.5% male/ 67.5% females), age mean di 57,10 who had taken cannabis for 250 days was observed. Clinical data, QoL, lifestyle, drugs use and adverse effects were assessed by administering an appropriate questionnaire to the patients treated with cannabis.

Results

All 40 patients (mean age 57,1 ± 13,6 years) have been included in the study. Seventy percent of the oncologic and neurologic patients has received Cannabis for pain relief. Pain symptoms are improved in the 60% of subjects in 10–15 days. QoL is improved in the 50% of patients, in particular for mood and sleep; the abdominal swelling is reduced in the 41% of subjects. Seventy-one percent of patients with nausea is improved, with an increase in weight in 45% of the cases. Adverse effects are reported for the 27% of the patients.

Conclusions

Preliminary results of study suggest that Cannabis treatment in patients with conventional treatment-resistant chronic pain may result in improved pain, QoL and appetite as well as reduced opioids and NSAIDs use.

P58 Lessons learned during the Integrative Medical Group Visits (IMGV): randomized controlled trial for recruiting low-income racial/ ethnic minority research study participants

Paula Gardiner1,2, Anna S Lestoquoy1, Lily Negash1, Sarah Stillman1, Prachi Shah1, Jane Liebschutz1,2, Pamela Adelstein3, Christine Farrell-Riley3, Ivy Brackup4, Brian Penti1, Robert Saper1,2

1 Family Medicine, Boston University Medical Center, Boston, 02118, MA, United States; 2 Boston University School of Medicine, Boston, MA, United States; 3 Codman Square Health Center, Dorchester, MA, United States; 4 Dothouse Health Center, Dorchester, MA, United States

Correspondence: Anna S Lestoquoy

Background

Integrative Medical Group Visits (IMGV) are an innovative program for delivering chronic pain and depression care. This randomized control trial compares the IMGV model to primary care appointments across three inner city clinics in Boston. Our participants largely identify as racial/ ethnic minorities, a historically challenging population for research recruitment. This poster will share our methods and strategies in overcoming barriers related to recruitment of this patient population.

Methods

Participants were recruited through provider referral, warm handoffs (face to face encounters with a research assistant during a clinical session), targeted letters or self-referred after seeing flyers or other study recruitment related materials. Trained research assistants either contacted or were contacted by patients for screening and consenting procedures.

Results

A total of 331 patients were consented and screened for inclusion in the study, and 154 enrolled. Seventeen percent of those screened were male; fifty-nine percent identified as Black; with the site specific demographics similar to each site’s patient population. Over the course of the study, in order to ensure a representative sample we changed our recruitment methods to enroll a greater number of male participants. Different patients responded to different recruitment methods, with older patients responding largely to targeted letters and younger patients responding to self-referral and provider referral (p = 0.0003, α = 0.05). The most common reasons for declining participation was not being interested in groups or having scheduling conflicts with the group schedule.

Conclusion

Different populations of patients respond to different forms of recruitment. Our varied approaches resulted in successfully recruiting our target number of participants.

P59 Acupuncture as a complementary technique in assisted reproduction patients in an integrative way: the results from 6 years’ experience

Isabel Giralt Sampedro1,2, Gilda Carvajal1

1 ENERGIMED, Barcelona, 08007, Spain; 2 Ginecology, Obstetrics and Reproduction, Hospital Universitari Quiron Dexeus, Barcelona, Spain

Correspondence: Isabel Giralt Sampedro

We would like to present our work in the Clinic “Salut de la Dona Dexeus” in Barcelona over more than 6 years using Acupuncture as a complementary treatment during IVF. Our experience is an Integrative Medicine experience as we are working in a cooperation way in the Fertility Department of this Gynecology Clinic.

Treatments such as In vitro Fertilization (IVF) have always been associated with high monetary costs, anxiety and secondary effects. Because of this, there is a demand to increase success rates while lowering the overall costs. Previous studies on the application of acupuncture with IVF have showed positive effects on pregnancy rates. The combination of these techniques in an Integrative form could be a possible solution for increasing benefits and lowering costs.

In our study 135 women were undergoing IVF accepted Acupuncture treatment during the application. Acupuncture was applied twice before oocyte extraction and in an immediately after embryo transfer or at list within a 24 hour time frame. We compared the results of the Acupuncture group with the results of the IVF performances without Acupuncture.

In our Acupuncture treatments we use some standard points and some other individual points related to the energetic woman disease according to an individualized medicine.

We are currently waiting on the complete study results from our clinic. However there are some results from our preliminary study from which some suggestions can be made: Acupuncture is very useful especially when we apply in women who receive a frozen embryo transfer with a 57% positive response while the global clinical rates in our Clinic are39 % . Results in the Acupuncture group for direct IVF ( embryo fresh ) are not presenting so significant differences.

In our speech we will explain points and techniques in our Acupuncture treatments and how it was combined with the conventional treatments in an Integrative way. We will update the results with new cases because we will continuous working in this issue until the Congress.

P60 Identifiability of components of complex interventions

Andreas Gleiss

Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, 1090, Austria

Background

During the last years interventions in complementary and alternative medicine (CAM) were increasingly viewed as complex interventions. The ‘active ingredients’, i.e. the intervention’s multiple components, were classified as specific or non-specific, characteristic or incidental, and their possible interactions were discussed. Various trials were conducted in, e.g., homeopathy or acupuncture to shed some light on the importance of these components.

Methods

Many of these CAMstudies exhibit the structure of factorial designs. In this class of designs all possible combinations of the levels of two or more treatments occur together. In this talk, complex interventions are viewed as factorial combinations of their components.

Results

The application of well-known concepts from experimental design helps to recognize which components or sums or interactions of components are identifiable within a given study design. The question of identifiability, i.e. unique estimability of the components effects from the observed data, arises particularly if some combinations are not or cannot be observed (e.g. individualized homeopathic prescription without consultation). Furthermore, it will be demonstrated, using study designs from published CAM studies, that the factorial design view enables a clear and correct interpretation of the studied components.

Conclusions

In conclusion, some recommendations are given concerning the design and analysis of complex intervention studies. Multi-component intervention studies should be designed in such a way that the effects of interest are identifiable and can thus be uniquely estimated from empirical data once the study has been conducted.

P61 Spicing up warming compresses – the influence of ginger on the perception of warmth and relaxation through warming compresses

Marie M Gross, Dorothea Brendlin, Jonas Röttger, Wiebke Stritter, Georg Seifert

AG für Integrative Medizin in der Pädiatrischen Onkologie, Charité Universitätsmedizin, Berlin, 13353, Germany

Background

Though external ginger applications such as warming compresses are commonly used in anthroposophical care, practice and clinical application are mainly based on experience. There is little empirical data on their effect. The aim of this study was to separate factors such as quietness, attentiveness and external thermal application from the effectiveness of ginger powder itself.

Methods

In a controlled study design we applied different compresses to healthy adults, adding another factor with every application. Physiological and psychometric data was collected and we conducted phenomenological interviews, which were analyzed according to thematic analysis. Here we focused on reported sensation of warmth and relaxation.

Results

In comparison to the hot-water compress, the ginger compress had less influence on temperature perception, and this influence was more diverse. During the application warmth developed differently. A second thermal peak was described after moments of chillness, especially during the resting period with the ginger compress, giving a sensation of burning sun.

While participants felt more relaxed, balanced and reported a greater peace of mind after the ginger compress, they experienced an impulse to move, wandering thoughts and a feeling of agitation especially in the resting period during the hot-water compress.

Conclusion

The ginger powder seemed to have an impact on the participants perception of temperature, influencing especially the thermal development. Referring to relaxation the ginger powder might have an additional calming influence compared to the hot-water compress.

P62 Relevance and acceptance of naturopathic and complementary medicine in women suffering from endometriosis

Noelle Grzanna1, Rainer Stange2, Peter W Guendling1

1 Complementary Medicine, Hochschule Fresenius, München, 80798, Germany; 2 Naturheilkunde, Immanuel-Krankenhaus, Berlin, 14109, Germany

Correspondence: Noelle Grzanna

Background

Endometriosis describes a gynaecological disease that should be regarded as chronic relapsing. It occurs in women of childbearing age. Characteristic of this disease is the appearance of cell aggregates like the endometrium outside their eutopic localization in the uterine cavity. The current estimated prevalence is about 10–15%. In which about 40% of affected women have endometriosis requiring therapy.

The cardinal symptoms of endometriosis are secondary dysmenorrhea, pelvic pain and dyspareunia, the clinical picture is dominated by the localization of endometriosis lesions.

Objectives

Survey of the relevance and acceptance of naturopathic and complementary procedures (CAM) with women who are affected by endometriosis.

Methods

An anonymous cross-sectional survey with women who have had a secured endometriosis diagnosis. Patients answered a comprehensive questionnaire of 40 questions, either in paper format or as an online version. The questionnaires were distributed in paper format over 14 doctors’ offices and clinics across Germany to potential study participants. The link to the online version of the questionnaire was passed on to women in endometriosis support groups, patients organizations and women’s health centres. The data were subjected to descriptive statistical analysis.

Results

133 patients answered the questions. 86.2% of them had already applied one or more naturopathic and / or complementary procedures for the treatment of endometriosis. Where 77.2% applying subjectively as ‘very important’ rated. Dissatisfaction with the conventional endometriosis treatment moved 61.5% of women to apply naturopathic and / or complementary procedures. Next led the symptoms of endometriosis (53.8%) and infertility (46.9%) for this process selection. TCM (51.1%), acupuncture (60.3%) and SART (40.8%), which contains these therapies were used most frequently. Homeopathy (52.7%) and osteopathy (40.5%) were often used as well. 91.8% of women described an improvement in their symptoms and quality of life through the use of CAM.

Conclusion

Patients of endometriosis seem to benefit significantly from the use of naturopathic and complementary procedures. Randomised controlled studies to further investigate the effectiveness of naturopathic and complementary procedures are highly warranted.

P63 Effects of the Qinlingye extraction on PGC-1a and related inflammatory factors in vitro

Wen Gu1, Yan Lu2, Jie Wang3, Chengcheng Zhang4, Hua Bai5, Yuxi He3, Xiaoxu Zhang3, Zhengju Zhang3, Dali Wang3, Fengxian Meng3

1 Beijing Hospital of Traditional Chinese Medicine , Rheumatism, Beijing, China; 2 Xiyuan Hospital, Emergency Department, Beijing, China; 3 Dongfang Hospital, Beijing University of Chinese Medicine, Rheumatism, Beijing, China; 4 Dongfang Hospital, Beijing University of Chinese Medicine, Nephrology, Beijing, China; 5 Xiluoyuan Community Health Service Centre, Rehabilitation Department, Beijing, China

Correspondence: Fengxian Meng (0614064@163.com)

Objective

To study the effect of Qinlingye extraction (QLYE) on PGC-1a, IL-18 and IL-1β in vitro, and to explore the mechanism of inhibiting immune inflammatory injury from hyperuricemic nephropathy.

Methods

Human renal tubular epithelial cells (HKC) and macrophage cells in mice (RAW264.7) were cultured respectively. HKC cells were induced by uric acid (UA) in the model group. While stimulated by UA, the administered groups were intervened by high-, middle- and low-dose of QLYE. After 24, 36 and 48 hours intervention, the total RNA and protein were extracted, and the mRNA transcription and protein expression of PGC-1a were detected. RAW264.7 cells were induced by lipopolysaccharide (LPS) in the model group. While stimulated by LPS, the administered groups were intervened by high-, middle- and low-dose of QLYE. After 24, 36 and 48 hours intervention, the total RNA and protein were extracted, and the mRNA transcription and protein expression of IL-18 and IL-1β were detected.

Results

(1)HKC cell experiments: In the model groups, the PGC-1a gene expression level was down-regulated at 24th hour, and the significant reduction of PGC-1a protein content were observed at both the 36th and 48th hour. Compared with the model groups, the PGC-1a gene expression level were upregulated in the medium- and high- dosage group at the 36th and 48th hour respectively. At the 36th hour the PGC-1a protein content were elevated in all three herbal groups and at the 48th hour, the PGC-1a protein content were elevated in both medium- and lower- dosage groups respectively. (2)RAW264.7 cell experiments: In the model groups, the IL-1β gene expression level was up-regulated at the 6th hour, the IL-1β and IL-18 gene expression level were up-regulated at the 12th hour. The significant increase of PGC-1a protein content were observed at 6th, 12th and 24th hour. Compared with the model group, the IL-1β gene expression level were down-regulated in the high- dosage group at the 6th hour, the IL-18 gene expression level in high- dosage group and the IL-1β gene expression level in high- and low- dosage groups were all down- regulated at the 12th hour. The IL-18、IL-1β protein content were down-regulated in all three administered groups at the 6th, 12th and 24th hour.

Conclusion

The mechanism how Qinlingye extraction inhibit immune inflammatory injury from hyperuricemic nephropathy may be associated with the upregulation of PGC-1a and the inhibition of its related inflammatory factors——IL-18, IL-1β.

P64 Plasma concentrations of ascorbic acid in a cross section of the German population

Alexander Hagel1, Heinz Albrecht1, Claudia Vollbracht2, Wolfgang Dauth3, Wolfgang Hagel 4, Francesco Vitali1, Ingo Ganzleben1, Hans Schultis5, Peter Konturek6, Jürgen Stein7, Markus Neurath1, Martin Raithel1

1 University of Erlangen, Erlangen, 91054, Germany; 2 Pascoe Naturmedizin, Gießen, 35394, Germany; 3 Institute of Employment Research, Nuremberg, Germany; 4 Martha Maria, Nuremberg, Germany; 5 Synlab, Weiden, Germany; 6 Thuringia Clinic, Saalfeld, Germany; 7 Department of Nutritional Medicine, Sachsenhausen , Germany

Correspondence: Heinz Albrecht; Claudia Vollbracht

In modern industrialized countries, vitamin C deficiency is commonly conceived to be extremely rare. The aim of the present study was to assess vitamin C levels in the German population.

As part of a consultant-patient seminar on nutrition and food intolerances, patients were asked to participate in the study on a voluntary basis. Blood samples were taken for analysis of serum vitamin C and patients were asked to complete a questionnaire. Vitamin C levels were determined by high performance liquid chromatography.

Of approximately 300 patients attending the seminar, 188 (62.6%) consented to blood sample analysis for vitamin C and 178 (59.3%) answered the questionnaire. Mean vitamin C level was 7.98 mg/L (range 0.5–17.4; reference value 5–15 mg/L). Low plasma levels with risk of vitamin C deficiency (<5 mg/L) was found in 31 (17.4%), and a potential scorbutogenic deficiency (<1.5 mg/L) in 6 subjects (3.3%). Body mass index correlated inversely with vitamin C levels.

In accordance with older studies, potential vitamin C deficiency was found to be common. A high BMI was associated with reduced vitamin C levels, particularly in older females. It is therefore possible, even in modern developed populations, that certain individuals may require a higher intake of vitamin C.

P65 Intravenous vitamin C in the treatment of allergies: an interim subgroup analysis of a long-term observational study

Alexander Hagel1, Claudia Vollbracht2, Martin Raithel1, Peter Konturek3, Bianka Krick2

1 University of Erlangen, Erlangen, 91054, Germany; 2 Pascoe Naturmedizin, Gießen, 35394, Germany; 3 Thuringia Clinic, Saalfeld, Germany

Correspondence: Alexander Hagel

Background

Oxidative stress in allergic diseases appears to play not only a key factor in the pathogenesis of the disease but also represents a promising therapeutic target. Allergic diseases have been reported as being associated with reduced plasma ascorbate levels, which is a key physiological antioxidant. Hereby it prevents excessive inflammatory reactions without reducing the defensive function of the immune system.

Method

An interim analysis of a multicentre prospective observational study was conducted to investigate the change in disease-specific and non-specific symptoms (tiredness/fatigue, sleep disorders, depression, lack of concentration) during adjuvant treatment with vitamin C infusions (Pascorbin®) in 71 patients with allergy-related respiratory or cutaneous indications. Symptoms atbaseline/visit 1 vs.end of observation period were compared. Change in sum scores of the 3 most prominent disease-specific symptoms and the 4non-specific symptoms were calculated.

Results

The mean sum score (0–9) of the disease-specific symptoms decreased significantly by 4.71 points between start (5.9) and end (1.2) of treatment (p

Conclusion

Our descriptive statistical data suggests that a treatment with intravenous high-dose vitamin C reduces allergy-related symptoms. This observational study provides information on allergy-related vitamin C deficiency, effective vitamin C dosages and relevant outcomes for conducting a controlled clinical study with more definitive, clinically-relevant endpoints.

Trial registration: Clinical Trials NCT02422901

P66 Mindfulness-based stress reduction for women with breast cancer: an updated systematic review and meta-analysis

Heidemarie Haller1, Petra Klose1, Gustav Dobos1, Sherko Kümmel2, Holger Cramer1

1 Department of Internal and Integrative Medicine, Faculty of Medicine, University of Duisburg-Essen, Essen, 45276, Germany; 2 Breast Unit, Kliniken Essen-Mitte, Essen, Germany

Correspondence: Heidemarie Haller

Aim

The aim of this meta-analysis was to systematically update the effectiveness of mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) in women with breast cancer.

Methods

Medline/PubMed, Scopus and Central were searched through October 2016 for randomized controlled trials (RCTs) assessing the effects of MBSR/MBCT in adult women with breast cancer. Primary outcomes were quality of life, fatigue and sleep. Stress, depression, anxiety and safety were secondary outcomes. For each outcome, standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated. Risk of bias was assessed using the Cochrane risk of bias tool.

Results

Literature search revealed 15 articles on 11 studies including 1772 participants. Overall risk of bias was at least unclear, except for low attrition and low other bias. Compared to usual care, significant short-term effects of MBSR / MBCT were found for quality of life (SMD = 0.21; 95%CI = [0.04│0.39]), fatigue (SMD = -0.28; 95%CI = [−0.43│−0.14]), sleep (SMD = −0.23; 95%CI = [−0.40│−0.05]), stress (SMD = −0.33; 95%CI = [−0.61│−0.05]), anxiety (SMD = −0.28; 95%CI = [−0.39│−0.16]), and depression (SMD = −0.34; 95%CI = [−0.46│−0.21]). Medium-term effects were significant for anxiety (SMD = −0.28; 95%CI = [−0.47│−0.09]) and depression (SMD = −0.26; 95%CI = [−0.47│−0.04]); long term-effects for anxiety (SMD = −0.21; 95%CI = [−0.40│−0.03]). Compared to other active interventions, significant effects were only found for short-term and only for anxiety (SMD = −0.45; 95%CI = [−0.71│−0.18]) and depression (SMD = −0.39; 95%CI = [−0.65│−0.14]). Subgroup analysis revealed no differences between MBSR and MBCT, cancer stages, or women during versus finishing adjuvant treatment. Effects were robust against potential methodological bias. Adverse events were reported insufficiently.

Conclusions

There is promising evidence for short-term effectiveness and safety of MBSR/MBCT in women with breast cancer. However, concerning the small number of available RCTs for medium- and long-term comparisons, more research is needed to draw further conclusions.

P67 Physical and emotional release effects of Neural Therapy: a qualitative analysis of therapeutic mechanisms and health outcomes

Heidemarie Haller1, Felix J. Saha1, Anna Kowoll1, Barbara Ebner1, Bettina Berger2, Gustav Dobos1, Kyung-Eun Choi1

1 Department of Internal and Integrative Medicine, Faculty of Medicine, University of Duisburg-Essen, Essen, 45276, Germany; 2 Department of Health, Institute for Integrative Medicine, Witten/Herdecke University, Herdecke, Germany

Correspondence: Heidemarie Haller

Background

Research on neural therapy is limited and mainly focused on physical outcomes. This study aimed at describing heterogeneous experiences of patients treated with procaine injections.

Methods

Maximum variation sampling was used to collect 22 inpatients aged 59.6 ± 14.9 years (81.8% female) undergoing integrative treatment including neural therapy. With 9.4 ± 6.9 diagnoses patients were mostly multi-morbid. Semi-structured interviews were analyzed in MAXQDA using qualitative content analysis.

Results

With injection, patients described anesthetic effects and increased local warmth; sometimes followed by vagotonic responses of weakness or dizziness as well as temporary aggravation of existing symptoms or appearance of new, concealed or phantom symptoms. Thereupon, pain and associated symptoms decreased. Treated areas were perceived as more vivid and reintegrated within the body image. In several cases, injections triggered memories with suppressed emotions. Emotional release was often accompanied by weeping and experienced as initially overwhelming. However, recalled images could be perceived from a distant observer perspective helping patients to reevaluate and reintegrate them into a new emotional context. This led to emotional relief, increased pain acceptance and empowerment. Other patients did not report distinct emotional events, but were surprised at the feelings of happiness, confidence and regained enjoyment of life after treatment. Adverse events included pain due to injection, vegetative complaints and emotional turmoil lasting minutes or hours with a maximum of two days.

Conclusions

Neural therapy suggested promising effects on various chronic symptoms, improved daily functioning and mental quality of life. Further studies on its specific efficacy and safety are needed.

P68 Blinding, easier said than done: experiences from trials of Chinese Herbal Medicine

Lisha He, Han Wang, X. He, C. Gu, Y. Zhang, Linhua Zhao, Xiaolin Tong

Guang’anmen Hospital, China Acadamy of Chinese Medicine Sciences, Beijing, China

Correspondence: Linhua Zhao (melonzhao@163.com)

Background

With the development of evidence-based medicine, a number of RCTs had been carried out to confirm the efficacy of Chinese Herbal Medicine (CHM). Blinding is a strategy to control measurement bias in clinical trials. But it has certain challenges in the implementation of blinding in placebo-controlled trial of CHM, especially the placebo presentation, so we had made some efforts on it in several studies.

Methods

Staffs who had been involved in the procedure of randomization code generation and concealment or drug blinding will work independent of the data collection and analysis. Both participants and investigators were kept in blinding status to the allocations until the trial was completed. For placebo preparation of CHM decoction, the placebo was prepared by 0.9% of the high-dose group in the trial of GQD treatment of diabetes. For placebo preparation of CHM granules, the placebo was prepared by adding bitters, caramel pigment and additives to ensure the same color, appearance and taste as the treatment drug in another trial of GQD. When the control group was treated with Western Medicine, we applied the double-blind double-dummy method. We prepared both simulation agents for CHM granules and western medicine in a trial of Shenzhuo formula (SZF) treatment of DN.

Results

Blinding had been strictly implemented and followed in several trials of CHM formula. Some strategies and standard operations were proposed.

Conclusions

There are many similarities between trials of CHM and other complementary and alternative medicines. The practical strategies could be shared and inspired by each other.

This study was funded by the Key Project of the National Natural Foundation of China (Grant No: 81430097), and The Innovation Funding for PhD Students at China Academy of Chinese Medical Sciences.

P69 How to administrate placebo to patients with diabetes in RCTs of Chinese Herbal Medicine? Practicable and ethical issues

Lisha He, Han Wang, Xinhui He, Chengjuan Gu, Ying Zhang, Linhua Zhao, Xiaolin Tong

Guang’anmen Hospital, China Acadamy of Chinese Medicine Sciences, Beijing, China

Correspondence: Lisha He

Background

Placebo-controlled design is necessary for evaluation efficacy of interventions. However, it will meet many challenges to administrate placebo in chronic diseases such as diabetes considering routine treatments. Challenges may be more serious in Chinese Herbal Medicine (CHM) researches because of placebo preparation for CHM is quiet difficult, which leads to the deficiency of the implementation of blinding. Maintain patients compliance and relative ethical issues also need to be carefully considered. In our ongoing trial, we made several efforts to make it practicable and ethical.

Methods

This study is a randomized, double-blinded, and placebo-controlled clinical trial. 120 diabetes patients were randomly allocated to receive either Gegen Qinlian Decoction (GQD) or placebo for 12 weeks. The HbA1c, FPG, 2hPG, blood lipids, HOMA-IR and HOMA-β were evaluated. The placebo was prepared by adding bitters, caramel pigment and additives to ensure the same color, appearance and taste as the treatment drug. In order to ensure patients compliance, they all received face-to-face lifestyle education, including dietary and exercise education every 4 weeks. A safety assessment will be performed at every 4 weeks to monitor patients’ safety.

Results

This study had been approved by the ethics committee of Guang’anmen hospital (Beijing) before initiation. According to the monitoring data, the overall dropout rate is less than 20%. Most of the adverse reactions are mild, including nausea, flatulence and diarrhea etc.

Conclusions

In order to evaluate efficacy and safety of GQD, good management strategies to patients often plays an important role in the placebo-controlled CHM clinical trials.

This study was funded by the Key Project of the National Natural Foundation of China (Grant No: 81430097), and The Innovation Funding for PhD Students at China Academy of Chinese Medical Sciences.

P70 Sample size calculations: perspectives from investigators of Chinese Herbal Medicine

Lisha He, Han Wang, Xinhui He, Chengjuan Gu, Ying Zhang, Linhua Zhao, Xiaolin Tong

Guang’anmen Hospital, China Acadamy of Chinese Medicine Sciences, Beijing, China

Correspondence: Lisha He

Background

The sample size calculation is to determine the minimum number of observed cases, which ensure the reliability of research conclusions with enough statistical power. The sample size is determined by several aspects including types of study design, central and dispersion tendency of main outcomes, group allocation ratio, dropout and other attrition rate etc. The clinical research of Chinese Herbal Medicine (CHM) has its own characteristics, we made several efforts in our clinical trial.

Methods

We conducted a randomized, double-blinded, and placebo-controlled clinical trial to determine the efficiency of Gegen Qinlian Decoction (GQD) on the treatment of diabetes. The sample size was estimated based on results from our preliminary trial. HbA1c was selected as the primary main point which was also the basis of null and alternative hypothesis for statistics. Preliminary study results showed that the mean difference of HbA1c between the GQD group and the placebo group was between 0.6% and 0.8%. According to the previous results, the standard deviation (SD) of the placebo group was calculated to be 1.02%.

Results

Finally, the sample size was estimated to be 50 in each group, with 90% power to detect the 0.66% difference of HbA1c between two groups at the 2-sided significance level of 0.05. Assuming the total attrition rate of 20%, sample size was planned to be 120 totally.

Conclusions

To achieve a well-designed trial, investigators should give more attention to sample size estimation. It may involve many efforts from different roles, including investigators, statisticians, monitors, staffs of data management etc.

This study was funded by the Key Project of the National Natural Foundation of China (Grant No: 81430097), and The Innovation Funding for PhD Students at China Academy of Chinese Medical Sciences.

P71 Acupuncture and related therapies used as add-on or alternative to prokinetics for functional dyspepsia: overview of systematic reviews and network meta-analysis

Robin ST Ho1, Vincent CH Chung1,2, Xinyin Wu2, Charlene HL Wong2, Justin CY Wu2, Samuel YS Wong1, Alexander YL Lau2, Regina WS Sit1,2, Wendy Wong2

1 Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong, 852, Hong Kong; 2 Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Hong Kong, 852, Hong Kong

Correspondence: Robin ST Ho

Background

Prokinetics for functional dyspepsia (FD) have relatively higher number needed to treat values. Acupuncture and related therapies could be used as an add-on or alternative. An overview of systematic reviews (SRs) and network meta-analyses (NMA) were performed to evaluate the comparative effectiveness of different acupuncture and related therapies.

Methods

We conducted a comprehensive literature search for SRs of randomized controlled trials (RCTs) in eight international and Chinese databases from their inception till November 2015. Methodological quality of included SRs was assessed with the validated AMSTAR (Assessing the Methodological Quality of Systematic Reviews) Instrument. Data from eligible RCTs were extracted for random effect pairwise meta-analyses. NMA was used to explore the most effective form of treatment among acupuncture and related therapies used alone or as an add-on to prokinetics, compared to prokinetics alone.

Results

From five SRs, 22 RCTs (n = 1727) assessing various acupuncture and related therapies were included. Methodological quality of included SRs were mediocre. No serious adverse events were reported. Five pairwise meta-analyses showed that manual acupuncture has marginally stronger effect in alleviating global FD symptoms, as compared to domperidone (6 RCTs) or itopride (3 RCTs). There were no significant differences in the following comparisons: moxibustion versus domperidone (3 RCTs); manual acupuncture plus moxibustion versus domperidone (2 RCTs); and electroacupuncture versus itopride (2 RCTs). Results from NMA showed that the combination of manual acupuncture, moxibustion and clebopride has the highest probability (95.0%) of being the best option for alleviating patient reported global FD symptom. This is followed by the combination of manual acupuncture, moxibustion and domperidone (76.1%), clebopride alone (74.5%), manual acupuncture alone (62.6%) and moxibustion alone (62.3%).

Conclusions

Combination of manual acupuncture, moxibustion and clebopride might be the most effective treatment for FD symptoms. Patients who are contraindicated for prokinetics may use manual acupuncture and moxibustion as an alternative. Future confirmatory comparative effectiveness trials should compare clebopride with domperidone, when used as an add-on to manual acupuncture and moxibustion. The potential synergistic effect of proton pump inhibitor and acupuncture should also be explored.

P72 Exploring breast cancer survivors’ use of the internet to find information on complementary medicine

Michelle Holmes1, Felicity Bishop1, Lynn Calman2

1 Psychology, University of Southampton, Southampton, SO17 1BJ, United Kingdom; 2 Faculty of Health Sciences, University of Southampton, Southampton, SO17 1BJ, United Kingdom

Correspondence: Michelle Holmes

Question

Breast cancer survivors often turn to the internet as an information resource as part of the decision-making process to use complementary and alternative medicine (CAM). The objective was to explore breast cancer survivors’ use of the internet when making decisions about CAM use.

Methods

A purposive sample of 11 breast cancer survivors (mean age = 56) who had used the internet to find information on CAM completed a quantitative questionnaire and a qualitative telephone interview. The theory of planned behaviour (TPB) was used to guide interview questions. Framework analysis and descriptive statistics were used.

Results

All participants had used some form of CAM after their diagnosis. Themes from the interviews went beyond the standard definitions of the TPB areas. Participants’ cancer diagnosis transformed how they experienced the internet with their perceptions of internet use changing due to their needs as cancer survivors. Despite the lack of approval from their social network and healthcare team surrounding both CAM and internet use, participants used the internet to find information on CAM.

Conclusions

Participants’ use of the internet was more complex than can easily be explained by the TPB and was inherently connected to the experience of self-management for the consequences of cancer and its treatment. Healthcare professionals need to be aware that the information available on the internet plays a role in the decision-making process to use CAM, as breast cancer survivors may not disclose their use of the internet to their healthcare team.

P73 The feasibility of conducting a cluster-randomised trial on patient-reported outcome measures in chiropractic care

Michelle Holmes1, Felicity Bishop1, George Lewith2, Dave Newell3, Jonathan Field4

1 Psychology, University of Southampton, Southampton, SO17 1BJ, United Kingdom; 2 Primary Medical Care, University of Southampton, Southampton, SO16 5ST, United Kingdom; 3 Anglo-European College of Chiropractic, Bournemouth, BH5 2DF, United Kingdom; 4 Back2Health, Southsea, PO4 0DW, United Kingdom

Correspondence: Michelle Holmes

Background

Patient-reported outcome measures (PROMs) are being increasingly utilised in routine clinical practice. The literature indicates PROMs may impact clinically and psychologically on patients, however there is limited evidence to currently support this. The purpose of this study was to explore the feasibility of conducting a cluster-randomised controlled trial on PROMs in chiropractic clinics for low back pain.

Methods

This feasibility study used a mixed methods approach, combining a cluster-randomised controlled trial (n = 8 patients, n = 3 chiropractors), audio recordings of treatment sessions, and qualitative interviews with stakeholders who are involved with PROMs – patients, chiropractors and reception staff (n = 18). Thematic analysis and descriptive statistics were used.

Results

55 eligible patients were invited to take part; 46 declined to participate. Of the nine patients registered to take part in the trial, five were lost to follow up. Despite PROMs being routinely used in chiropractic settings, no participants completed the intervention. The qualitative interviews identified improvements for the development of PROMs as an intervention. This included: selecting relevant PROMs, improving patient engagement with PROMs, and educating clinicians over their use.

Conclusions

Patients’ and chiropractors’ views on participating in a trial identified several recommendations on the evaluation of PROMs. The study identified that patients and clinicians need to understand the value of PROMs within the process of patient care. Further development of PROMs as an intervention is also necessary, in the choice, application and timing of PROMs, to ensure PROMs are meaningful to patients and chiropractors and improve engagement.

P74 Use of traditional, complementary and alternative medicine (TCAM) among stroke patients in Yangon, Myanmar

Win L Htut, Dongwoon Han, Da I Choi, Soo J Choi, Ha Y Kim, Jung H Hwang

Global Health and Development, Hanyang University, College of Medicine, Seoul, 133-791, South Korea

Correspondence: Dongwoon Han

Background

Stroke is major public health concern worldwide due to its significant motility and morbidity. Lack of comprehensive rehabilitation care and chronic consequences of stroke, long-term care by using Traditional, Complementary and Alternative Medicine (TCAM), is very common in stroke patients. Stroke patients own sense of severity and functional limitation has been proven to be essential in effective rehabilitation care. However, association between patients self-reported severity and choice of TCAM has not been still documented.

Methods

A cross-sectional study was conducted among 310 stroke rehabilitation patients attending outpatient clinics of National Rehabilitation Hospital, Yangon, Myanmar. Data was collected by face-to-face interview with structured questionnaires, containing 35items. Descriptive analysis was done and both univariate and multivariable analysis were used to determine the TCAM use among stroke patients according to their different characteristics.

Results

70.3% of the patients used TCAM for their symptom management (55.96%). The main reason for using these treatments was their belief on integrated treatment (42.66%). Stroke patients self-reported severity as less severe used high TCAM (p < 0.01). Moreover, presence of high blood pressure (p < 0.01), having some problem in walking (p < 0.01), self-care (p < 0.05) and usual activities (p < 0.01), feeling moderate anxiety (p < 0.01) were significantly associated with higher TCAM usage. But patients without self-reported pain used more TCAM (p < 0.01).

Conclusion

Significant proportion of stroke patients is using TCAM because of their belief in the effectiveness of combined treatments. Hence, physicians should be aware of using TCAM and have to understand its potential risk. Furthermore, provide education among their patients.

Keywords: Traditional, complementary and alternative medicines (TCAM), stroke, Myanmar

P75 Differences in the use of traditional medicine between South Korea and Taiwan: a preliminary study

Ching W Huang1,2, Bo H Jang1,2, Fang P Chen3, Seong G Ko1,2

1 Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul, 02447, South Korea; 2 Institute of Safety, Efficacy and Effectiveness Evaluation for Korean Medicine, Kyung Hee University, Seoul, South Korea; 3 Taipei Veterans General Hospital, Taipei, Taiwan

Correspondence: Ching W Huang (sunnierlove@gmail.com)

Background

As more people realize the important of the traditional medicine, many people are turning to choose traditional medicine (TM) as a primary healthcare treatment. Herein, this study is the first nationwide study which is comparing two countries—South Korea and Taiwan—in terms of the using pattern of traditional medicine.

Methods

To compare the TM utilization patterns between South Korea and Taiwan, we used the million sampling data from national health insurance data of each country.

Results

There were 138,119 people in South Korea, and 259,897 in Taiwan were recorded to use traditional medicine service more than one time in 2011. In Korea, women, 40y-60y generation and high income level individuals with the highest frequency to use TM service. In Taiwan, women, 20y-40y generation and middle-high income level is the biggest group to use TM service. The two countries did not have significantly different in terms of either number or season of using TM service. But in South Korea, acupuncture is the most common TM treatment while in Taiwan powdered herbal preparations are most often used treatment in TM system.

Conclusion

Under the different health insurance system, there were some different patterns of TM use between South Korea and Taiwan. We surmise one of the important influences was the different coverage between the national health insurance systems of each country.

P76 Investigation and Analysis on the intention of using traditional Chinese medicine in patients with diabetes

Wenjing Huang, De Jin, Fengmei Lian

Department of Endocrinology, Guang’anmen hospital China Academy of Chinese Medical Sciences, Beijing, 100053, China

Correspondence: Fengmei Lian

Purpose

Investigate the treatment intention of diabetics, to learn the development of TCM therapy in the field of diabetes, to provide a basis for clinical medical decision-making.

Method

Juneto August 2016,600 questionnaires were sendedto diabetics in Beijing Chao-Yang Hospital (BCYH) and Guang’anmen Hospital of China Academy of Chinese Medical Sciences (CAMH),592 questionnaires were recovery (296 questionnaires each), investigate the intentions and reasons for the choose TCM.

Results

In the questionnaires, there were 279 (47.1%) patients had used TCM treatment, 255 (91.4%) patients of them will continue using, while 72.2% of 255 patients who thought TCM treatment have curative effect (including improving blood glucose and symptoms), 68.6% patients thought good safety (including no side effects and can reduce the side effects of Western medicine); there were 24 (8.6%) patients did not intend to continue using TCM treatment, while 29.2% patients of them thought that inconvenient to take TCM,12.5% patients did not like to drinking. 313 (52.9%) patients never had used TCM treatment, but there were 149 (47.6%) of 313 patients would use TCM treatment in the future, they believed that security of TCM is good and TCM could make them better, 164 (52.4%) of 313 patients stilled did not choose TCM treatment, they thought TCM is not curative effect and safety, they felt inconvenient to take TCM and did not like to drink . In CAMH, there were 213 (76.3%) of 279 patients of had used TCM treatment, while 203 (97.7%) of 213 patients prefered to continue using TCM. There were 172 (91.48%) patients of BCYH in 188 patients who did not intend to use TCM treatment.

Conclusion

Patients’ intention in hospital of TCM and western medicine hospital maybe related to physician’s medical decision-making and treatment-oriented. Through popularize TCM formula granule and improve the taste, to make more diabetics receive TCM treatment.

P77 Attitudes and knowledge on herbal medicine among the Koreans: a cross-sectional survey

Soobin Jang1, Kyeong H Kim1, Eun K Lee1, Seung H Sun2, Ho Y Go3, Youme Ko1, Sunju Park4, Bo H Jang1, Yong C Shin1, Seong G Ko1

1 Kyung Hee University, Seoul, 02447, South Korea; 2 Sangji University Korean Medicine Hospital, Wonju, South Korea; 3 Semyung University, Jecheon, South Korea; 4 Daejeon University, Daejeon, South Korea

Correspondence: Soobin Jang

Background

The global herbal medicines market is growing by 5–15% in every year. However, regulations on herbal medicines of safety are still insufficient and there are many cases that perceptions of general population about herbal medicines are wrong. This study aimed to investigate the opinions about herbal medicines.

Methods

The survey was conducted via Macromill Embrain (http://www.embrain.com), which is the online research company. The questionnaire was developed by five traditional Korean medicine experts, and the questions consisted of attitude toward herbal medicine, and knowledge status about herbal medicines. Statistical analyses were performed by IBM SPSS statistics program ver.18.0. The entire process of this survey was approved by Institutional Review Board of Kyung Hee University (IRB No. KHSIRB1-15-039).

Results

Among the total 1,134 participants, 726 (64.0%) responded that they thought herbal medicines is safe and the remaining 408 (36.0%) responded herbal medicines is not safe. The main reasons of their thoughts were uncertainty of origins (342, 82.8% of 408 those who thought that herbal medicines is not safe), anxiety for harmful substances (289, 70.8%), management insufficiency of herbs (235, 57.6%), and adverse events (190, 46.6%). Of the total respondents, only 308 (27.2%) correctly knew that the difference of herbs for medicine and herbs for food.

Conclusions

This survey suggests that proper education to correct misunderstanding on herbal medicines is needed. Also, the results of survey will be basis of establishing national policies on herbal medicines.

Keywords: herbal medicines, survey, safety, attitude, knowledge

P78 Correlations between pulse wave velocity, age, anxiety and depression of cardiologic patients

Hubert Janik1, Natalie Greiffenhagen1, Jürgen Bolte2, Karin Kraft1

1 Complementary Medicine, University of Medicine Rostock, Rostock, 18057, Germany; 2 Strandklinik Boltenhagen, Boltenhagen, Germany

Correspondence: Hubert Janik

Background

It’s known that cardiovascular events and mortality follow to advanced aortic stiffness. High pulse wave velocity (PWV) may provide evidence to aortic stiffness. The aim of this study was to examine correlations between PWV, age and psychometric scores.

Methods

PWV of N = 25 male patients (age: 59.2 ± 6.9 years, BMI: 28.2 ± 3.9 kg/m2; mean ± SD) was investigated in addition to the standard procedure in a cardiologic rehabilitation clinic. Absolute arrhythmia, pacemaker, treatment with insulin and acute inflammation are some exclusion criteria. The Mobil-O-Graph (IEM, Stolberg, Germany) is a portable 24 h blood pressure recorder with the ability to calculate PWV by use of curve analysis. The Hospital Anxiety and Depression Scale (HADS-D) comprises the dimensions anxiety (A) and depression (D) with a range from 0 to 21 for each dimension.

Results

Mean PWV was 8.1 ± 1.2 m/s. Mean outputs of the HADS-D were 7.2 ± 3.5 for A and 5.0 ± 3.4 for D. Spearman’s rank correlation coefficients were (A & D) = 0.76, (A & age) = 0.62, (A & PWV) = 0.58, (D & age) = 0.54, (D & PWV) = 0.55 and (age & PWV) = 0.90, p < 0.01 for all specified correlations.

Conclusions

High correlations between age, A, D and PWV indicate that these parameters are important for detection of patients with cardiovascular risk and are relevant for prevention and treatment of cardiovascular diseases.

Informed consent was signed.

P79 Sense of responsibility for the health and anxiety in patients with Irritable Bowel Syndrome in context of selected dietary restrictions

Mariusz Jaworski, Miroslawa Adamus, Aleksandra Dobrzynska

Department of Medical Psychology, Medical University of Warsaw, Warsaw, 02-091, Poland

Correspondence: Mariusz Jaworski

Purpose

Currently, there is a small percentage of studies which analyse the relationship between sense of responsibility for health, and healthy behaviour. Therefore, purpose of this study was to analyse the correlation between the level of sense of responsibility for the health and level of anxiety on the one hand, and selected dietary restrictions on the other hand, in patients with Irritable Bowel Syndrome (IBS). Currently, in the literature review, there is no study about this problem.

Methods

Cross-sectional study involving 60 patients with Irritable Bowel Syndrome was carried out. In this study, Information about sociodemographic variables, and standardised measure of psychological variables were collected. The level of sense of responsibility for the health was measured using The Sense of Responsibility for Health Scale (HSRS), but level of anxiety by using The State-Trait Anxiety Inventory (STAI). For calculations there was used the statistical package SPSS version 21.

Results

The level of anxiety has a negative correlation with the global level of Sense of Responsibility for Health (HSR), and its two dimensions: Active Involvement (HSR-AI), and Adequate Behaviour (HSR-AB). Moreover, Sense of Responsibility for Health has positive relationship with reduced consumption of vegetables, meat, fried foods and foods that may cause flatulence (e.g. bean, peas).

Conclusions

The level of anxiety, and sense of responsibility for health play a key role in human food behaviour in patients with IBS. This has important practical and clinical implications.

P80 Mind-Body Medicine and Lifestyle modification in Supportive Cancer Care: a cohort study on a day care clinic program for cancer patients

Michael Jeitler1, Jessica Jaspers2, Christel von Scheidt1, Barbara Koch1, Andreas Michalsen1,2, Nico Steckhan2, Christian Kessler1,2

1 Department of Internal and Complementary Medicine, Immanuel Hospital Berlin, Berlin, 14109, Germany; 2 Charité - University Medical Center, Berlin, 10117, Germany

Correspondence: Michael Jeitler

Question

We developed an integrative day care clinic program for cancer patients focusing on Mind-Body Medicine techniques (meditation, yoga, mindfulness), health-promoting lifestyle modification and self empowerment. The intervention program consisted of 7 h once-per-week group sessions over 12 weeks (84 h intervention time in total).

Methods

A cohort study design with a waiting group was implemented. Outcome parameters were assessed at the beginning (baseline), at the end of the active program (12 weeks), and at a 6 month follow-up. Patients waiting >4 and <12 weeks before treatment start were allocated to the waiting group and additionally assessed at the start of their day care program. Outcome measures included quality of life (FACT-G, FACT-B/C, WHO-5), fatigue (FACIT-F), depression and anxiety (HADS) and mood states (ASTS). A per protocol analysis using mixed linear models was performed.

Results

100 patients were screened on-site for eligibility, of which 86 patients were included into the study. 86 cancer survivors (83% female; mean age 53.7 ± 9.7 years; 49% breast cancer; 7% colon cancer; mean time since first diagnosis 55.06 ± 28.75 months) participated in the program. 62 patients were allocated to the intervention group, 24 patients were allocated to the waiting group (mean waiting time 5 ± 1 weeks). 14 patients in the intervention group discontinued the intervention. 6 data sets were not complete. 66 data sets were included in the final per protocol analysis.

Significant improvements were observed in favour of the intervention group after 12 weeks compared to the waiting group at the end of the waiting list period for quality of life (WHO-5: 3.94 (1.7, 6.1), p = .001; FACT-G: 6.4 (2.3, 10.5), p = .02, FACT-B: 13 (4.5, 21.5), p = .0004), decreased anxiety/depression (HADS -2.8 (−5.3, −0.4, p = .01) and decreased fatigue symptoms (FACIT-F: 6 (1.3, 10.8), p = .02). Results from the 6 month follow-up for the whole study population showed lasting improvement of quality of life. Most practiced Mind-Body techniques were yoga and meditation. The overall effect of the day care clinic program was rated positive from >90% of all participants.

Conclusions

This integrative day care clinic program can be considered as an effective means to improve quality of life, fatigue and mental health of cancer patients. Moreover, it appears to have a sustainable effect, which has to be proved in randomized trials.

Trial registration: DRKS00011027

P81 Research on key techniques of clinical evaluation of qi deficiency and blood stasis syndrome based on literature research and expert questionnaire

De Jin, Wen-jing Huang, Bing Pang, Feng-Mei Lian

Guang An Men Hospital of China Academy of Chinese Medical Sciences, Beijing, 100053, China

Correspondence: Feng-Mei Lian

Objective

To explore the essential factors of clinical evaluation in treating qi deficiency blood stasis syndrome (QDBSS) and find out the reasonable way and scientific method of diagnosis and effect appraisal of QDBSS through literature retrieval and expert questionnaire.

Methods

A search strategy was designed to select published literature focusing on QDBSS from CNKI database and Wanfang database according to certain. The frequency of key information in these search strategies were calculated, summarized and analyzed by SPSS 19.0. And related apartments physicians mentioned in the literature research results were incorporated into the questionnaire investigation, which physicians in Guang’anmen Hospital, Xiyuan Hospital, and Beijing traditional Chinese medicine hospital were selected to be investigated.

Results

The physicians were investigated in these three hospitals from January to March 2015. A total of 440 questionnaires were conducted to face-to-face interviews, and 439 questionnaires were returned (response rate 99.77%). Main representative diseases of QDBSS were coronary heart disease, stroke, lung cancer, and diabetic nephropathy etc. The characteristic signs and symptoms of QDBSS include tingling, fatigue, tongue with teeth marks, etc. The focus of symptoms were switched from qi deficiency syndrome to blood stasis syndrome, with the improvement of physician level. Average duration of QDBSS is 2.82 months. The multiple symptoms improved with four classification methods (42.79%) and all symptoms of the whole syndrome improved with four classification method (24.59%) were mainly selected as a curative effect valuation.

Conclusion

Combination with disease, symptom and syndrome is the precondition of curative effect evaluation of QDBSS, and the treatment course is the key to the clinical evaluation process of QDBBS. Meanwhile, symptom index makes up the fundamental elements of curative effect evaluation. The preliminary results reveal the evaluation factors of the key technology of QDBSS, to provide a new idea for the clinical syndrome efficacy evaluation of traditional Chinese medicine.

P82 Development of monographs for anthroposophic medicinal products, the example of citrus/cydonia

Miek Jong1, Erik Baars1, Anja Glockmann2, Harald Hamre2

1 Louis Bolk Institute, Driebergen, 3972LA, Netherlands; 2 IFAEMM at the Witten/Herdecke University, Freiburg, Germany

Correspondence: Miek Jong

Background

Monographs are condensed reviews of medicinal products that provide information on their pharmaceutical quality, safety and effectiveness. Monographs give guidance to regulators and healthcare professionals. Existing monographs for Anthroposophic Medicinal Products (AMPs) are not adequate according to current standards. The objective of this study is to develop monographs for AMPs, in order to support their scientific and regulatory assessment.

Methods

Standards for scientific assessment of safety and effectiveness of AMPs in monographs were developed and implemented, starting with the AMP Citrus/Cydonia. A systematic literature review of existing data on quality, prescription/use, safety and effectiveness were carried out.

Results

Searches in EMbase, Pubmed, CAMbase and Anthromedlit demonstrated that Citrus/Cydonia is manufactured and prescribed according to Anthroposophic Medicine (AM) principles, predominantly for the treatment or prophylaxis of hay fever. Citrus Cydonia is used in children (<18 years, n = 417 patients documented), adults (≥18 years, n = 461) and elderly (≥65 years, n = 25). The effectiveness of Citrus/Cydonia for hay fever was supported by three clinical studies and four immunological studies in cell systems. The overall frequency of Adverse Drug Reactions (ADRs) to Citrus/Cydonia in all studies was 1.4% of users (n = 12/879). No serious ADRs were reported.

Conclusions

It is possible to develop AMP monographs that reflect the specific characteristics of AM and adhere to contemporary scientific standards for quality, safety and effectiveness documentation. Standards presented are of interest to other whole medical systems such as Homeopathy and Traditional Chinese Medicine.

P83 Heart rate variability as a predictor of the effectiveness of the Bupleuri Radix (saiko) contained in Kampo Medicines

Mosaburo Kainuma1, Aya Murakami1, Toshio Kubota1, Daisuke Kobayashi1, Yasuhiro Sumoto1, Norihiro Furusyo2, Shin-Ichi Ando3, Takao Shimazoe1

1 Community Medicine Education Unit, Graduate School Of Medical Science, Kyushu University, Fukuoka, 812-8582, Japan / Department of Clinical Pharmacy and Pharmaceutical Care, Graduate School of Pharmaceutical Sciences,kyushu University, , Fukuoka, Japan; 2 Department of General Internal Medicine, Kyushu University, , Fukuoka, Japan; 3 Sleep Apnea Center, Kyushu University Hospital, , Fukuoka, Japan

Background

Kampo prescriptions that include Bupleuri Radix (saiko) are used for neurosis, insomnia, and symptoms that have a strong association with autonomic nervous system disorders, especially for female patients. However, little is known about the objective efficacy of saiko on the autonomic nervous system.

Methods and Results

We retrospectively analyzed the heart rate variability (HRV) data of 54 new female patients (≥20 years) who visited our Kampo Medicine Clinic from 2008 to 2013 to determine if the index of HRV as a surrogate marker of autonomic nervous system is related to the efficacy of saiko and thus can be used to determine for which patients saiko is most effective. The HRV data of patients prescribed medicines that included saiko at their initial visit were divided into effective and ineffective groups (27 patients each) based on the recorded changes of symptoms after two weeks. We found that Very Low Frequency (VLF) (0.003–0.04Hz)/Total Frequency (TF) was significantly higher (p = 0.009) and Ultra Low Frequency (ULF)-1 (0.0001–0.0003Hz)/TF was significantly lower (p = 0.006) in the effective group. The cut-off values for VLF/TF and for ULF-1/TF were 0.35 (Sensitivity, 63%; Specificity, 78%; AUC, 0.71) and 0.24 (Sensitivity, 78%; Specificity, 56%: AUC, 0.71).

Conclusions

Our data suggest that ULF-1/TF and VLF/TF have potential as predictors of the effectiveness of medicines containing saiko.

P84 Ethanol exposure in children: food more relevant than phytomedicines

Olaf Kelber1, S Verjee2, Eva Gorgus2, Dieter Schrenk2

1 Innovation & Development, Phytomedicines Supply and development Center, Steigerwald Arzneimittelwerk GmbH, Bayer Consumer Health, Darmstadt, 64295, Germany; 2 Food Chemistry and Toxicology, University of Kaiserslautern, Kaiserslautern, 67663, Germany

Correspondence: Olaf Kelber (olaf.kelber@bayer.com)

Background

Liquid dosage forms of medicinal products are well suitable for children, as they allow to adapt the dose to the age group. But as in many cases they contain ethanol, they have been repeatedly triggering critical questions.

Aims

The aim was therefore to assess to which extent medicinal products contribute to the ethanol exposition in this age group, in comparison to the normal uptake with usual food items.

Methods

By evaluation of data from the use of herbal medicinal products in liquid form and by generation of a scenario for the exposure by food items based on new analytical data, exposition values for a 6 years old child were estimated.

Results

When using herbal medicinal products, in a 6 years old child amounts of ethanol between 70 and 180 mg are applied with a single dose. With 3 times daily dosing this is 210–540 mg. Related to a body weight [b.w.] of 20 kg, this is 10.1 – 27.0 mg/kg b.w. [1].

An evaluation of side effects of these medicinal products, collected in non interventional studies in more than 50.000 children, and of the spontaneous reports from their use in about 3 Mio. children, did not reveal ethanol related side effects.

For evaluation of the uptake of ethanol with food items commonly used in children, the ethanol content of these items was determined by gas chromatography. E.g. in fruit juices, up to 770 mg/L were found, in bakery products up to 1200 mg/100 g [3]. Based on these data a scenario for the mean ethanol exposure was developed, using data on nutritional habits from USA and Germany.

The resulting mean ethanol exposure was 10.3 mg/kg b.w.. Assuming an ethanol exposure in the upper range of this scenario, it was 12.5 – 23.3 mg/kg b.w..

Conclusion

According to these data, the ethanol uptake with herbal medicinal products in children is in an order of magnitude comparable to everydays exposure with usual food items.

From this point of view, it is conclusive that no ethanol related side effects due to an exposure exceeding the average daily intake via food can be expected after the use of these medicinal products. The exposure to ethanol resulting from the use of these products therefore is no cause for toxicological concerns.

References

1. Kelber O et al. 2008, PharmInd; 70, 1124–1127

2. Kelber O et al. 2016, Wien Med Wochenschr, in press;

3. Gorgus E et al. 2016, J Analyt Toxicol, doi:10.1093/jat/bkw046

P85 Training in integrative therapies increases self-efficacy in providing non-drug therapies and self-confidence in offering compassionate care

Kathi Kemper, Ellie Hill

OSU, Blacklick, 43004, OH, United States

Correspondence: Kathi Kemper

Purpose

This proof of concept project evaluated the feasibility and preliminary impact of training nurses and other health professionals in introductory workshops about complementary therapies.

Methods

We conducted a prospective cohort study of training in acupressure, guided imagery, massage, and Reiki on clinicians sense of self-efficacy in providing non-drug therapies, self-confidence in providing compassionate care, and engagement with work. The training was voluntary as was completion of anonymous online pre- and post-trainng surveys.

Results

All topics except massage met minimum enrollment numbers; 22 of 24 participants completed follow-up as well as pre-training surveys. All would recommend the training to others and planned changes in personal and professional care. There were significant improvements in self-efficacy in using non-drug therapies, confidence in providing compassionate care, and unplanned absenteeism (P < 0.05 for each).

Conclusion

Training in integrative therapies is feasible and associated with significant improvements in clinicians sense of self-efficacy, confidence in providing compassionate care, and engagement with work. Additional studies are needed to determine the impact on quality of care and long-term workforce engagement.

P86 Engaging in online training in Mind-Body practices has long-term benefits

Kathi Kemper1, Nisha Rao2, Gregg Gascon1, John Mahan1

1 OSU, Blacklick, 43004, OH, United States; 2 College of Medicine, OSU, Columbus, 43210, OH, United States

Purpose

Assess the dose-response relationship between the number of hours of online mind-body skills training for health professionals and outcomes one year later.

Methods

Among 1438 registrants for online training (including up to 12 hours of training on mind-body practices) between December, 2013 and December, 2015, we analyzed responses from the first 10% who responded to an anonymous online survey by February 1, 2016. Questions included the type and frequency of mind-body practice in the past 30 days and whether the online training had any impact on personal life or professional practice. Standardized measures were used to assess stress, mindfulness, confidence in providing compassionate care, and burnout.

Results

The 149 respondents represented a variety of ages and health professions; 55% completed one or more mind-body training modules an average of 14 months previously. Most (78%) engaged in one or more mind-body practices in the 30 days before the survey; 79% reported changes in self-care and 71% reported changes in the care of others as a result of participating. Increasing doses of training were significantly associated with practicing mind-body skills more frequently; increasing practice frequency was associated with less stress and burnout, which were in turn associated with missing less work. Greater practice frequency was also associated with improvements in stress, mindfulness, and resilience, which in turn were associated with increased confidence in providing compassionate care.

Conclusions

Online training in mind-body therapies is associated with changes in self-reported behavior; increasing doses of training are associated with more frequent practice which is associated with less stress, burnout, and missing work, and higher levels of mindfulness, resilience and confidence in providing compassionate care. Additional studies are needed to compare mind-body skills training with other interventions designed to improve resilience and compassion while decreasing burnout in health professionals.

P87 Phase II clinical trial on efficacy and safety of additive mistletoe extract therapy in combination with standard radiotherapy and chemotherapy in patients with newly diagnosed glioblastoma after surgical resection (GLIOMIS-trial) – a trial protocol

Gunver Kienle1, Jörg Dietrich2, Claudia Schmoor3 , Roman Huber1

1 Center for Complementary Medicine, Institute for Environmental Health Sciences and Hospital Infection Control, Medical Center – University of Freiburg, Freiburg, 79106, Germany; 2 Massachusetts General Hospital, Boston, MA, United States; 3 Clinical Trials Unit Freiburg, Medical Center – University of Freiburg, Freiburg, Germany

Correspondence: Gunver Kienle

Background

Glioblastoma multiforme (GBM) is the most common primary malignant intracranial neoplasm. Despite surgery, radiotherapy and Temozolomide intervention, GBM cannot be cured and the median survival is 16 months. Treatments are desperately needed that improve the results of standard treatments without further impairing the quality of life. Mistletoe extracts (ME) are widely used in integrative cancer care and show promising preclinical effects in GBM cells but have hardly been investigated in GBM patients.

Objective

Do ME improve progression-free survival, quality of life, cognitive functioning and influence local immune response in GBM patients?

Method

Prospective randomised, double-blind, placebo-controlled, parallel-group, multicentre trial; stratified for center, 1:1 randomization. 150 patients with newly diagnosed, supratentorial glioblastoma, after surgical resection, starting radiotherapy and Temozolomid will be included in 5 US American and German centers. They will be randomized to receive either ME (Iscador Qu®, 0.01–10 mg, sc, 3/week in an individually adapted, dose-escalating scheme), or isotonic saline solution (identical scheme, sc, 3/week), until tumor progression. Primary outcome is progression-free survival, assessed by magnetic resonance imaging as per standard of care (every three months in Germany, every two months in the US) or earlier when clinically indicated, allowing for a one month surveillance period, to account for possible pseudo-progressions. Key secondary endpoints are health-related quality of life (EORTC QLQ-C30, EORTC QLQ BN20), neurocognitive assessment (IPCG battery, MMSE), overall survival, neutropenia due to chemotherapy, safety, immune parameters gene expression profiles in the tumor microenvironment before and after treatment (subgroup of patients).

Funding

Public and