Homeopathy for seasonal allergic rhinitis: rationale, design and methods of the three-armed randomized controlled HOMEOSAR trial.

BACKGROUND: Patients with seasonal allergic rhinitis (SAR) frequently use homeopathic therapy. Although there is some evidence that homeopathy may be effective in treating symptoms of SAR, there is a lack of high-quality clinical trials. Therefore, the aim of the homeopathy for SAR (HOMEOSAR) trial is to determine the efficacy of individualized or standardized homeopathic drug treatment compared to placebo regarding rhinitis-related quality of life in patients with SAR. METHODS: This randomized, placebo-controlled, double-blind, three-armed intervention study will be conducted at two university hospital outpatient clinics for complementary and integrative medicine in Berlin and in 12 office-based practices specializing in homeopathic treatment in Germany. A total of 270 patients with clinical symptoms of SAR and positive allergy test to birch and grass pollen will receive homeopathic anamnesis and subsequently be randomized into (a) standardized homeopathic drug treatment with Galphimia Glauca (potency D6), (b) individualized homeopathic drug treatment (D6), or (c) placebo. All three groups can receive on-demand rescue medication as needed. Treatment will consist of two consultations and daily intake of the study medication for 4 weeks during the pollen season. The primary outcome is the mean overall score of the Rhinitis Quality of Life Questionnaire (RQLQ) in weeks 3 and 4, analyzed using analysis of covariance (adjusted for baseline RQLQ overall score and study center). A closed testing procedure will be used to control the overall type I error comparing the 3 treatment groups. Secondary outcomes include the overall RQLQ and its seven domain scores, responder status (decrease in RQLQ overall score of at least 0.5 points compared to the baseline value), use of rescue medication, intensity of total and individual SAR symptoms based on visual analog scale, generic health-related quality of life, safety, utilization of health care resources and associated costs. In addition, a qualitative data analysis is planned. CONCLUSION: The results of our study will contribute to clarifying the possible therapeutic effects of homeopathic drug treatment for patients with SAR. TRIAL REGISTRATION: This study has been registered in the German Clinical Trial Registry with trial ID DRKS00018081 on June 09, 2020.

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.

Thoughts, beliefs and concepts concerning infectious childhood diseases of physicians practicing homeopathic, anthroposophic and conventional medicine - a qualitative study.

BACKGROUND: Physicians who include complementary medicine in their practice are thought to have an understanding of health and disease different from that of colleagues practicing conventional medicine. The aim of this study was to identify and compare the thoughts and concepts concerning infectious childhood diseases (measles, mumps, rubella, chickenpox, pertussis and scarlet fever) of physicians practicing homeopathic, anthroposophic and conventional medicine. METHODS: This qualitative study used semistructured interviews. Participating physicians were either general practitioners or pediatricians. Data collection and analysis were guided by a grounded theory approach. RESULTS: Eighteen physicians were interviewed (6 homeopathic, 6 anthroposophic and 6 conventional). All physicians agreed that while many classic infectious childhood diseases such as measles, mumps and rubella are rarely observed today, other diseases, such as chickenpox and scarlet fever, are still commonly diagnosed. All interviewed physicians vaccinated against childhood diseases. A core concern for physicians practicing conventional medicine was the risk of complications of the diseases. Therefore, it was considered essential for them to advise their patients to strictly follow the vaccination schedule. Homeopathic-oriented physicians viewed acute disease as a biological process necessary to strengthen health, fortify the immune system and increase resistance to chronic disease. They tended to treat infectious childhood diseases with homeopathic remedies and administered available vaccines as part of individual decision-making approaches with parents. For anthroposophic-oriented physicians, infectious childhood diseases were considered a crucial factor in the psychosocial growth of children. They tended to treat these diseases with anthroposophic medicine and underlined the importance of the family's resources. Informing parents about the potential benefits and risks of vaccination was considered important. All physicians agreed that parent-delivered loving care of a sick child could benefit the parent-child relationship. Additionally, all recognized that existing working conditions hindered parents from providing such care for longer durations of time. CONCLUSIONS: The interviewed physicians agreed that vaccines are an important aspect of modern pediatrics. They differed in their approach regarding when and what to vaccinate against. The different conceptual understandings of infectious childhood diseases influenced this decision-making. A survey with a larger sample would be needed to verify these observations.

Can complementary medicine enhance doctor-patient communication skills? Insights from an international medical student project.

INTRODUCTION: Communication is an essential component of patient care, and although medical schools provide training on this topic, patients and physicians alike express the need to improve their communication skills. An international medical student collaboration explored whether complementary medicine (CM) has the ability to further enhance patient-doctor communication. METHODS: Twenty-two medical students, nine mentors and two public representatives from Israel and Germany participated in this 18-month international group project. The goal was to explore CM methods that could enrich doctor-patient communication in several aspects. The group eventually chose to focus on four CM modalities, which included Chinese medicine; Mind-Body medicine; Touch therapies; Mindfulness and Herbal medicine. One workshop took place in Haifa and two workshops in Berlin, with continued inter-group work in-between. The workshops included interactive group formats such as "World Café", self-experience sessions in CM, working in small groups and delivering presentations to the entire group. RESULTS: Besides benefitting from cultural exchange and networking, students learned various aspects of CM, with a particular focus on their relevance for enriching their communication skills. The main CM aspects that were highlighted included patient characterization in the context of Chinese medicine diagnosis, mindfulness, anamnesis regarding herbal use, and a physical exam based on concepts from touch therapies. Students summarized and condensed their observations into five educational modules, which are available online: http://www.b-zion.org.il/pages_e/6683.aspx. CONCLUSION: The cultural exchange and explorative process in this international medical student collaboration led to insights regarding the potential contribution of CM to patient-doctor communication. The outcomes of this international collaboration, specifically the educational modules it produced, should be further explored by medical schools, and assessed in clinical trials.

Pulsatile dry cupping in chronic low back pain - a randomized three-armed controlled clinical trial.

BACKGROUND: We aimed to investigate the effectiveness of two different forms of dry pulsatile cupping in patients with chronic low back pain (cLBP) compared to medication on demand only in a three-armed randomized trial. METHODS: 110 cLBP patients were randomized to regular pulsatile cupping with 8 treatments plus paracetamol on demand (n = 37), minimal cupping with 8 treatments plus paracetamol on demand (n = 36) or the control group with paracetamol on demand only (n = 37). Primary outcome was the pain intensity on a visual analogue scale (VAS, 0-100 mm) after 4 weeks, secondary outcome parameter included VAS pain intensity after 12 weeks, back function as measured with the 'Funktionsfragebogen Hannover Rücken' (FFbH-R) and health related quality of life questionnaire Short form 36 (SF-36) after 4 and 12 weeks. RESULTS: The mean baseline-adjusted VAS after 4 weeks was 34.9 mm (95% CI: 28.7; 41.2) for pulsatile cupping, 40.4 (34.2; 46.7) for minimal cupping and 56.1 (49.8; 62.4) for control group, resulting in statistically significant differences between pulsatile cupping vs. control (21.2 (12.2; 30.1); p < 0.001) and minimal cupping vs. control (15.7 (6.9; 24.4); p = 0.001). After 12 weeks, mean adjusted VAS difference between pulsatile cupping vs. control was 15.1 ((3.1; 27.1); p = 0.014), and between minimal cupping vs. control 11.5 ((- 0.44; 23.4); p = 0.059). Differences of VAS between pulsatile cupping and minimal cupping showed no significant differences after 4 or 12 weeks. Pulsatile cupping was also better (- 5.8 (- 11.5;-0.1); p = 0.045) compared to control for back function after 4 weeks, but not after 12 weeks (- 5.4 (- 11.7;0.8); p = 0.088), pulsatile cupping also showed better improvements on SF-36 physical component scale compared to control at 4 and 12 weeks (- 5.6 (- 9.3;-2.0); p = 0.003; - 6.1 (- 9.9;-2.4); p = 0.002). For back function and quality of life minimal cupping group was not statistically different to control after 4 and 12 weeks. Paracetamol intake did not differ between the groups (cupping vs. control (7.3 (- 0.4;15.0); p = 0.063); minimal cupping vs. control (6.3 (- 2.0;14.5); p = 0.133). CONCLUSIONS: Both forms of cupping were effective in cLBP without showing significant differences in direct comparison after four weeks, only pulsatile cupping showed effects compared to control after 12 weeks. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (identifier: NCT02090686 ).

Hypnosis in patients with perceived stress - a systematic review.

BACKGROUND: Although hypnosis and hypnotherapy have become more popular in recent years, the evidence for hypnosis to influence perceived stress is unclear. In this systematic review we searched and evaluated randomized clinical studies investigating the effect of hypnosis on perceived stress reduction and coping. METHODS: The Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, the Database of Abstracts of Review of Effects, EMBASE, Medline, PsycINFO, PSYNDEX and PubMed were systematically screened from their inception until December 2015 for randomized controlled trials (RCTs) reporting about hypnosis or hypnotherapy for stress reduction in healthy participants. Risk of Bias was assessed according the Cochrane Collaboration recommendations. RESULTS: Nine RCTs with a total of 365 participants met the inclusion criteria and were included in this review. Most included participants were medical students, predominantly female (n = 211). Mean age of participants ranged in most studies between 20 and 25 years, in three studies the mean ages were between 30 and 42 years. Perceived stress was measured by a wide range of psychological questionnaires including Face Valid Stress Test, Stress Thermometer, and immunological data was collected. All nine included studies used explorative designs and showed a high risk of bias. Six out of nine studies reported significant positive effects of hypnosis for stress reduction in the main outcome parameter compared to control groups (3 active controls, 3 no therapy controls). Immunological outcomes were assessed in six studies, the results were inconclusive. CONCLUSIONS: Due to exploratory designs and high risk of bias, the effectiveness of hypnosis or hypnotherapy in stress reduction remains still unclear. More high quality clinical research is urgently needed.

Healing Relationships: A Qualitative Study of Healers and Their Clients in Germany.

Background. The aim of this study was to investigate the nature of the relationships between healers and their clients in Germany. Methods. An interdisciplinary research team performed semistructured interviews with healers and clients and participatory observation of healing sessions. All interviews were digitally recorded, transcribed, and analyzed using content analysis. Results. Fifteen healers and sixteen clients were included. The healer-client relationship was described as a profound and unique experience, which brought forth interpersonal and spiritual connections. The healers were seen as role models for healing to occur and support for being connected spiritually. The clients had to be open-minded and responsible. The importance of the healers' empathy was emphasized. Discussion. The relationship between healer and client can be seen as a triangular connection between client, healer, and a transcendent source which is not the case in typical patient-doctor relationships. The spiritual connection is also said to enhance the empathetic understanding of the healer. The personality and a partner-like attitude of the healer supported the client in giving a more positive meaning to his life, in reconnecting to his spirituality, and in taking responsibility. Future studies should address the role of spirituality in health care and the development of enduring healer-client relationships.

Treating Palliative Care Patients with Pain with the Body Tambura: A Prospective Case Study at St. Joseph's Hospice for Dying destitute in Dindigul South India.

BACKGROUND: The Body Tambura is a recently invented stringed instrument that is used for receptive music therapy designed to be placed and attached on the human body. The aim of this study was to record perceived effects of a treatment with the Body Tambura on palliative care patients with special reference to pain. MATERIALS AND METHODS: A prospective case study was carried out with patients of St. Joseph's Hospice for Dying Destitute in Dindigul/South India. Patients were treated with a treatment after baseline assessment and also on the next day. Outcomes were measured quantitatively by using a numeric rating scale (0-10, 10 maximum intensity of pain felt) at baseline, directly after treatment, and the day after the treatment to determine the intensity of the pain. RESULTS: Ten patients (five women and five men) participated in the study. The majority described the therapy as a pleasant experience. The pain intensity at baseline was reduced from 8.3 ± standard deviation (SD) 1.16 to 4.6 ± 1.52 at day 1 and from 4.6 ± 2.07 to 2.4 ± 1.58 at day 2. CONCLUSION: A clinically relevant pain reduction was described as short time outcome; the therapy was received and perceived well. Forthcoming research should include a control group, randomization, a larger number of participants, and a longer period of treatment.

CAM Use and Suggestions for Medical Care of Senior Citizens: A Qualitative Study Using the World Café Method.

Background. Little data exists concerning the reasons for using complementary and alternative (CAM) therapies by seniors. Therefore, the aim of this study is to learn about motives of German seniors for using CAM therapies and their wishes for health care in general. Methods. One focus group and one "World Café" following a semistructured interview guide were conducted. All discussions were recorded digitally, transcribed, and analyzed according to Qualitative Content Analysis using the software MAXQDA. Results. In total 21 seniors participated (eighteen female, three male, mean age 72.5 ± 4.3 years). Most of the participants had lifelong experiences with medicinal herbs and home remedies due to unavailable conventional care during childhood. Also important for them were nutrition and exercise. These methods were often used as self-care to enhance wellbeing, to prevent and to cure illnesses. The participants would welcome an integration of CAM in health care services. They asked especially for more empathic physicians who are better trained in CAM and respect their experiences. Conclusion. The importance of life experience in regard to health care by senior can be seen as a resource. Qualitative studies investigating physician-patient relationships and intergenerational aspects in CAM use could be of interest for further studies.

Mindful walking in psychologically distressed individuals: a randomized controlled trial.

Background. The aim of this randomized, controlled study was to investigate the effectiveness of a mindful walking program in patients with high levels of perceived psychological distress. Methods. Participants aged between 18 and 65 years with moderate to high levels of perceived psychological distress were randomized to 8 sessions of mindful walking in 4 weeks (each 40 minutes walking, 10 minutes mindful walking, 10 minutes discussion) or to no study intervention (waiting group). Primary outcome parameter was the difference to baseline on Cohen's Perceived Stress Scale (CPSS) after 4 weeks between intervention and control. Results. Seventy-four participants were randomized in the study; 36 (32 female, 52.3 ± 8.6 years) were allocated to the intervention and 38 (35 female, 49.5 ± 8.8 years) to the control group. Adjusted CPSS differences after 4 weeks were -8.8 [95% CI: -10.8; -6.8] (mean 24.2 [22.2; 26.2]) in the intervention group and -1.0 [-2.9; 0.9] (mean 32.0 [30.1; 33.9]) in the control group, resulting in a highly significant group difference (P < 0.001). Conclusion. Patients participating in a mindful walking program showed reduced psychological stress symptoms and improved quality of life compared to no study intervention. Further studies should include an active treatment group and a long-term follow-up.

Paediatric and adult multiple sclerosis: age-related differences and time course of the neuroimmunological response in cerebrospinal fluid.

We investigate common pathophysiology in paediatric and adult multiple sclerosis (MS) by comparison of cerebrospinal fluid (CSF) data. We compared cerebrospinal fluid (CSF) data from eight patient groups with onset of MS at 7 to 29 years (n = 184). A new statistics program allows sensitive detection, quantifies the mean amount of intrathecal Ig synthesis in groups based on the 96% reference range of 4100 non-inflammatory controls, corrects for age-related increase of blood-derived albumin and immunoglobulins in CSF, and presents graphical data interpretation in Reibergrams. Already at onset of MS before puberty (< or =10 years) the frequency of intrathecal IgG synthesis (oligoclonal IgG) was 100% like in adults with 98%, but the amount of intrathecal IgG increases twofold during puberty. Intrathecal IgM synthesis is most frequent before and during puberty (in 57-67% of patients) compared with 41% in adults. The amount of intrathecal IgM synthesis before puberty is only 30% of that in adults. IgG and IgM Index are biased evaluations not suitable for characterizing age-related dynamics. A twofold age-related increase of the albumin quotient, Q(Alb), as a measure of the blood-CSF barrier function, represents normal physiological growth. Cell counts in CSF are low. The pre-puberty gender ratio is about 1:1. Intrathecal antibodies against measles, rubella and/or varicella zoster virus are detected in 73% of patients before puberty compared with 89% of adults. Individual paediatric patients (n = 17), with sequential punctures over 2-5 years, show constant quantities of intrathecal IgM and specific antibodies. In conclusion, paediatric MS already at first clinical manifestation shows the complete, neuroimmunological data pattern in CSF, i.e. inflammatory signs are not gradually evolving. Paediatric and adult MS differ quantitatively but not qualitatively in neuroimmunological patterns which does not allow for discrimination between 'early' and 'late' onset MS. CSF analysis may help to discriminate between acute and mono-symptomatic chronic inflammatory disease already at earliest clinical manifestation.

[Homeopathy between vital force and self-organization]. / Homöopathie zwischen Lebenskraft und Selbstorganisation.

The idea of the vital force served European 18th-century scientists as theoretical background and as an integration model for many popular theories. The vital force was used to explain why physiological processes occur in a practical, useful and functional way and to answer the questions about the nature of biotic organization. At the end of 18th century, Samuel Hahnemann, the founder of homeopathy, used the theory of the vital force as a theoretical basis to explain the effects of homeopathic treatment and to justify his medical system. Vitalists represented a holistic tradition, they were not willing to accept purely mechanical interpretations of biological phenomena. The discussion between holistic and mechanistic scientists resulted in the development of modern self-organization theories, such as system, network, and chaos theory.The article gives an overview about the historical development from vital force to modern self-organization theories and discusses the relevance of the modern theories for homeopathic research.