Prophylactic Acupuncture Treatment during Chemotherapy in Patients with Breast Cancer – Results of a Qualitative Study nested in a Randomized Pragmatic Trial

Background: In a randomized controlled trial, compared with standard care alone in breast cancer, acupuncture as a prophylactic treatment did not show better quality of life or fewer side effects of chemotherapy (NCT01727362 [clinicaltrials.gov]). The aim of the qualitative part of this mixed methods study was to better understand the subjective perspectives of the patients regarding quality of life during chemotherapy and the perceived effects of acupuncture. Methods: In a nested retrospective qualitative study, semi-structured telephone interviews were conducted with 5 responders and 5 non-responders (defined by the outcome of the primary parameter FACT-B) who were randomly selected from both study arms. The interviews were digitally recorded, pseudonymized, transcribed, and then deductively and inductively analyzed according to Qualitative Content Analysis using MAXQDA® software. Results: A total of 20 patients were included in the qualitative part of the study. In both groups, most women stated that their quality of life was surprisingly better than what they had expected before starting the chemotherapy. All patients of the acupuncture group experienced the acupuncture treatments as relaxing and beneficial, mentioning a friendly setting, and empathic attitude of the therapist. Most of these patients stated that the acupuncture treatment reduced chemotherapy-induced side effects. The patients reported that acupuncture was supportive for coping with the disease in a salutogenic way. For all patients, finding strategies to cope with life-threatening cancer and the side effects of chemotherapy was essential, for example, keeping a positive attitude toward life, selecting social contacts, and staying active as much as possible. Conclusions: Patients in the acupuncture group reported positive effects on psychological and physical well-being after receiving the study intervention. For all patients, having coping strategies for cancer seemed to be more important than reducing side effects. Therefore, further studies should focus more on coping strategies and reducing acute side effects

Experiences and Perceived Effects of Rosary Praying: A Qualitative Study

The aim of this study is to explore experiences and perceived effects of the Rosary on issues around health and well-being, as well as on spirituality and religiosity. A qualitative study was conducted interviewing ten Roman Catholic German adults who regularly practiced the Rosary prayer. As a result of using a tangible prayer cord and from the rhythmic repetition of prayers, the participants described experiencing stability, peace and a contemplative connection with the Divine, with Mary as a guide and mediator before God. Praying the Rosary was described as helpful in coping with critical life events and in fostering an attitude of acceptance, humbleness and devotion

Learning to Establish a Therapeutic Doctor-Patient Communication: German and Israeli Medical Students Experiencing Integrative Medicine’s Skills

The doctors’ clinical time collides with the increasing of the use of telecare technologies in our digital era, reducing the actual doctor-patient interaction and the potential to engage with therapeutic doctor-patient communication. In our qualitative study, we followed a collaborative German-Israeli project that trained medical students to use complementary and integrative medicine (CIM) methods in order to improve doctor-patient communication. Interviews with the participants and participatory observation revealed the ways the mentors taught CIM methods, the meaning of therapuitic doctor-patient communication and how the students learned and implemented these skills in different ways. Our findings show that students expand their communication channels and skills, notice their own somatic-sensory states, and engage with somatic knowledge in different interactions. Our findings correspond with, and signify the intercorporeal space of doctor-patient interaction in the way in which doctors’ and patients’ soma-sensual aspects are interact, influence each another, and enable therapeutic communication

Acupuncture randomized trials (ART) in patients with chronic low back pain and osteoarthritis of the knee - Design and protocols

Background: We report on the study design and protocols of two randomized controlled trials (Acupuncture Randomized Trials = ART) that investigate the efficacy of acupuncture in the treatment of chronic low back pain and osteoarthritis of the knee, respectively. Objective: To investigate whether acupuncture is more efficacious than (a) no treatment or (b) minimal acupuncture in the treatment of low back pain and osteoarthritis. Design: Two randomized, controlled, multicenter trials with three treatment arms and a total follow-up time of 52 weeks. Setting: 30 practitioners and outpatient units in Germany specialized in acupuncture treatment. Patients: 300 patients will be included in each study. In the low back pain trial, patients will be included according to clinical diagnosis. In the osteoarthritis pain trial, patients will be included according to the American College of Rheumatology criteria. Interventions: Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) minimal acupuncture at non-acupuncture points (75 patients), or (3) no treatment for two months followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks. Main Outcome Measure: The main outcome measure is the difference between baseline and the end of the 8-week treatment period in the following parameters: pain intensity as measured by a visual analogue scale (VAS; 0-100 mm) in the low back pain trial and by the Western Ontario and McMaster Universities Osteoarthritis Score (WOMAC) in the osteoarthritis trial. Outlook: The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy

Complementary and Integrative Medicine in Nursing Homes: Results of a Cross-Sectional Study in Residents and Caregivers

Objective: Some nursing homes for the elderly in Germany integrate complex complementary and integrative medicine interventions in the form of hydrotherapy, herbal and mind-body therapies, physical activities, and healthy eating, known as Kneipp therapy (KT), in care. This pilot study explored health- and work-related characteristics and acceptance of KT amongst residents and caregivers. Methods: Within a mixed-methods cross-sectional study in nursing homes who had integrated KT, we assessed work ability, psychosocial burden at work and health-related quality of life of caregivers, as well as a broad selection of health-related data of residents by questionnaires and assessments. Data were analyzed descriptively. Results: The data from 29 female caregivers (42.0 ± 11.7 years) and 64 residents (83.2 ± 8.1 years) were analyzed. Both caregivers (96%) and residents (89%) considered KT to be beneficial for health and well-being. Ninety percent of the caregivers indicated an improved relationship to residents since implementing KT. Caregivers showed a good work ability and quality of life. Residents attained remarkable ratings in social relation and affect-related aspects of quality of life. Conclusion: The results of this cross-sectional study indicate a high acceptance of integrating KT by residents and caregivers. The effectiveness and safety of KT should be explored in further comparative studies.Hintergrund: Einige Senioreneinrichtungen in Deutschland integrieren die Kombination aus Hydrotherapie, Phytotherapie, Ordnungstherapie, Bewegung und gesunder Ernährung als Kneipp-Therapie (KT) in die Pflege und Betreuung von Bewohnern. Diese Pilotstudie zielte darauf ab, gesundheits- und arbeitsbezogene Charakte­ristika und die Akzeptanz von KT bei Bewohnern und ­Mitarbeitern dieser Pflegeeinrichtungen zu untersuchen. Methoden: Im Rahmen einer Mixed-Methods-Querschnittsstudie in vier Senioreneinrichtungen, die KT integrierten, wurden unter anderem die Arbeitsfähigkeit, die psychosoziale Belastung am Arbeitsplatz und die gesundheitsbezogene Lebensqualität der Pflegekräfte sowie eine breite Auswahl an gesundheitsbezogenen Daten und die Lebensqualität der Bewohner durch Fragebögen erhoben. Alle Daten wurden deskriptiv analysiert. Ergebnisse: Es wurden die Daten von 29 Mitarbeiterinnen (42,0 ± 11,7 Jahre) und 64 Bewohnern (83,2 ± 8,1 Jahre) analysiert. Sowohl die Pflegekräfte (96%) als auch die Bewohner (89%) betrachteten KT als vorteilhaft für die Gesundheit und das Wohlbefinden. Ausserdem gaben 90% der Mitarbeiterinnen eine verbesserte Beziehung zu den Bewohnern seit der Einführung von KT an. Die Mitarbeiterinnen zeigten eine gute Arbeitsfähigkeit und Lebensqua­lität. Die Bewohner zeigten gute Bewertungen von Aspekten der Lebensqualität, die mit sozialer Beziehung und Affekt zusammenhängen. Fazit: Die Ergebnisse zeigen, dass KT in den untersuchten Senioreneinrichtungen von den Bewohnern und Betreuern gut angenommen wurde. Die spezifische Wirksamkeit und Sicherheit von KT sollten in weiteren vergleichenden Studien untersucht werden

Efficacy of Injections with Disci/Rhus Toxicodendron Compositum for Chronic Low Back Pain – A Randomized Placebo-Controlled Trial

The effectiveness of injection therapy for low-back pain is still debatable. We compared the efficacy of local injections of the homeopathic preparation Disci/Rhus toxicodendron compositum (verum) with placebo injections and with no treatment in patients with chronic low back pain.In a randomized controlled partly double blind multicenter trial patients with chronic low back pain from 9 German outpatient clinics were enrolled and randomly allocated in a 1∶1∶1 ratio to receive subcutaneous injections (verum or placebo) into painful sites on the lower back over 12 treatment sessions within eight weeks, or no treatment (rescue pain medication with paracetamol or NSAIDs). All trial personnel and participants were masked to treatment allocation. The primary outcome measure was the average pain intensity over the last seven days on a visual analogue scale (0-100 mm, 0 = no pain, 100 = worst imaginable pain) after eight weeks. Follow-up was 26 weeks. Primary analysis was by intention to treat. Between August 2007 and June 2008, 150 patients were randomly allocated to three groups (51 verum, 48 placebo and 51 no treatment). The mean baseline-adjusted low back pain intensity at week eight was: verum group 37.0 mm (97.5% CI 25.3;48.8), no treatment group 53.0 (41.8;64.2), and placebo group 41.8 (30.1;53.6). The verum was significantly superior to no treatment (P = 0.001), but not to placebo (P = 0.350). No significant side effects were reported.The homeopathic preparation was not superior to placebo. Compared to no treatment injections resulted in significant and clinical relevant chronic back pain relief.ClinicalTrials.gov NCT00567736

Acupuncture in Seasonal Allergic Rhinitis (ACUSAR) - Design and Protocol of a Randomised Controlled Multi-Centre Trial

Background: We report on the study design and protocol of a randomised controlled trial (Acupuncture in Seasonal Allergic Rhinitis, ACUSAR) that investigates the efficacy of acupuncture in the treatment of seasonal allergic rhinitis (SAR). Objective: To investigate whether acupuncture is non-inferior or superior to (a) penetrating sham acupuncture and (b) rescue medication in the treatment of SAR. Design: 3-armed, randomised controlled multi-centre trial with a total follow-up time of 16 weeks in the 1st year and 8 weeks in the 2nd year. Setting: 41 physicians in 37 out-patient units in Germany specialised in acupuncture treatment. Patients: 400 seasonal allergic rhinitis patients with clinical symptoms and test-positive (skin-prick test and/or specific IgE) to both birch and grass pollen. Interventions: Patients will be randomised in a 2:1:1 ratio to one of three groups: (a) semi-standardised acupuncture plus rescue medication (cetirizine); (b) penetrating sham acupuncture at non-acupuncture points plus rescue medication; or (c) rescue medication alone for 8 weeks (standard treatment group). Acupuncture and sham acupuncture will consist of 12 treatments per patient over 8 weeks. Main Outcome Measures: Average means of the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the Rescue Medication Score (RMS) between weeks 6 and 8 in the first year, adjusted for baseline values. Outlook: The results of this trial available in 2011 will have a major impact on the decision of whether acupuncture should be considered as a therapeutic option in the treatment of SAR

Group hypnosis for stress reduction and improved stress coping: a multicenter randomized controlled trial

Background: The aim of the trial was to investigate the effect of a hypnotherapeutic group program in healthy persons with increased levels of perceived stress. Methods: In a randomized controlled multicenter trial participants with a self-assessed subjective stress level ≥ 40 mm on a visual analogue scale (0–100 mm; VAS) for the previous week and a stable state of health were randomized to either 5 weekly sessions of 120-min duration of a hypnotherapeutic group program for stress reduction and improved stress coping plus 5 hypnosis audiorecords for individual practice at home plus an educational booklet for stress coping (hypnosis group) versus an educational booklet only (control group). The primary outcome parameter was the VAS stress level for the previous week after 5 weeks. Secondary outcome parameters included the VAS stress level after 12 weeks, perceived stress (CPSS), depression (ADS-K), self efficacy (SWE) and quality of life (SF 36) after 5 weeks and 12 weeks. Analysis of covariance with a significance level of 5% using the full analysis set was used for analysis; the model included treatment (fixed effect), VAS baseline value (fixed covariate), and center (random effect). Results: A total of 95 participants were randomized; 47 (40 female, 45 ± 13.4 years of age) were allocated to the hypnosis group, and 48 (41 female, 46.9 ± 14.3 years) were allocated to the control group. Regarding VAS stress level after 5 weeks, the adjusted VAS mean in the hypnosis group was 41.8 mm [95% confidence interval (CI): 35.2; 48.4] compared to 62.9 mm [56.2; 69.7] in the control group, and the group difference was − 21.2 mm [− 30.1; − 12.2] (P < 0.001). After 12 weeks, the stress intensity on the VAS showed a between-group difference of − 14.7 mm [− 25.1; − 4.4] (P = 0.006), and the adjusted means were 41.1 mm [33.4; 48.8] in the hypnosis group and 55.9 mm [48.4; 63.5] in the control group. Improvements were also reported for CPSS, SF-36, SWE and ADS-K after 5 and 12 weeks. Conclusion: Compared to the control group, the hypnosis group showed reduced perceived stress after 5 and 12 weeks. Trial registration: ClinicalTrials.gov NCT03525093; date of registration: May 15, 2018

Self-care strategies for medical students: an uncontrolled mixed-methods evaluation of a mind-body-medicine group course

Background High stress during medical education and its detrimental effects on student health is well documented. This exploratory evaluation study assesses a 10-week Mind-Body-Medicine student course, created to promote student self-care at Charité Universitätsmedizin Berlin, Germany. Methods During 2012–2019, uncontrolled quantitative and qualitative data were gathered from 112 student participants. Outcomes including changes in perceived stress (PSS), mindfulness (FMI/MAAS), self-reflection (GRAS), self-efficacy (GSE), empathy (SPF), and health-related quality of life (SF-12) were measured between the first (T0) and last sessions (T1). Qualitative data were obtained in focus groups at course completion and triangulated with quantitative data. Results Quantitative outcomes showed decreases in perceived stress and increased self-efficacy, mindfulness, self-reflection, and empathy. In focus groups, students reported greater abilities to self-regulate stressful experiences, personal growth and new insights into integrative medicine. Triangulation grounded these effects of MBM practice in its social context, creating an interdependent dynamic between experiences of self and others. Conclusion After completing an MBM course, students reported reduced perceived stress, increased self-efficacy, mindfulness, empathy and positive engagement with integrative concepts of doctor–patient relationships. Further research with larger randomized confirmatory studies is needed to validate these benefits