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

Street Health: Cross-sectional study identifying social medicine issues amongst patients of the Health Center for Homeless in Berlin, Germany

Background: An estimated 265,000 people are homeless in Germany, with 10,000 in Berlin alone. Their physical and psychological health is particularly threatened by their living conditions. Access to health services is often difficult, sometimes impossible, for them. New approaches to care of the homeless offer multidisciplinary support, but systematic analysis of these are lacking. The aim of this study is to analyze socio-demographic and health characteristics of patients at the Berlin Health Center for Homeless (Gesundheitszentrum für Obdachlose), founded in 2006. Methods: Retrospective analysis of primary care patient data from September 2006 to March 2008 regarding reasons for seeking care, existing health problems, and socio-demographic characteristics. Results: Among a total of 440 homeless patients, 81% were male, with a mean age of 43.5 years (SD=13), 19% were female, with a mean age of 37.2 years (SD=12.8), 62% were single, 26% were foreigners (particularly from Eastern Europe), 71% had obtained a graduation certificate after at least 10 years of schooling, 16% had higher education, and 53% were without health insurance. 58% had a tobacco addiction and 43% an alcohol addiction. The most frequent health complaints were infectious diseases (16%), trauma (15%), respiratory diseases (14%), and skin diseases (9%). Conclusions: Despite popular perceptions, homelessness in Berlin increasingly affects women, young adults, and better-educated patients. More systematic and longitudinal studies analyzing specific medical care for the homeless are urgently needed

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

Abstract 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)

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 (). 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

Akupunktur bei Patienten mit allergischer Rhinitis - Analyse der Studienintervention und Syndrommuster der randomisierten Multicenter-Studie ACUSAR.

Hintergrund: In der DFG-gef&ouml;rderten &bdquo;ACUpuncture in Seasonal Allergic Rhinitis&ldquo;- (ACUSAR-) Studie bei Patienten mit allergischer Rhinitis war Akupunktur wirksamer im Vergleich zu Sham-Akupunktur und zu einer Kontrollgruppe, die nur Bedarfsmedikation erhielt. In diesem Artikel werden die Studienintervention, die zugrunde liegenden theoretischen &Uuml;berlegungen der chinesischen Medizin und auch die Lehren f&uuml;r weitere Studien und die Praxis dargestellt. Studiendesign: Dreiarmige, randomisierte, kontrollierte Multicenter-Studie mit einem Follow-up von 16 Wochen im ersten Jahr und weiteren 8 Wochen im Folgejahr. Studienzentren: 6 Kliniken bzw. Universit&auml;tsambulanzen und 32 Privatpraxen in Deutschland. Studienintervention: Insgesamt wurden 422 Patienten mit saisonaler allergischer Rhinitis und nachgewiesener Allergie gegen Birken- und Gr&auml;serpollen in 3 Gruppen randomisiert: Die Akupunkturgruppe erhielt 12 semi-standardisierte Behandlungen (4 obligatorische Punkte, mindestens 3 von 8 fakultativen Basis-Punkten und mindestens 3 andere lokale Ohr- oder Fernpunkte) und bei Bedarf eine &bdquo;Rescue&ldquo;-Medikation (RM) (Cetirizin). Die Sham-Akupunktur-Gruppe wurde 12-mal an Nicht-Akupunktur-Punkten genadelt (genau vorgegebene Punkte, streng oberfl&auml;chliche Nadelung, beidseits mindestens 5&minus;7 Punkte) und konnte RM einnehmen, die Wartelisten-Gruppe erhielt 8 Wochen lang nur RM und wurde dann nach dem Akupunktur-Schema behandelt. Die Studienintervention wurde im Rahmen eines Delphi-Prozesses festgelegt, an dem f&uuml;nf Experten von zwei gr&ouml;&szlig;eren Akupunkturgesellschaften und drei Experten in Studienmethodologie teilnahmen. Ergebnisse: Die h&auml;ufigsten Syndrommuster waren &bdquo;Wind-K&auml;lte&ldquo; (algor venti, fenghan) und &bdquo;Wind-Hitze&ldquo; (calor venti, fengre) im Funktionskreis (Fk) &bdquo;Lunge&ldquo; (o. pulmonalis, fei) mit je 37 % der Patienten. Bei der Behandlung der Akupunkturgruppe wurden die vorgegebenen obligatorischen Basispunkte in 97 % der Behandlungen genadelt (Di4/IC4 [&laquo;Vereinte T&auml;ler&raquo;, hegu], Di11/IC11 [&bdquo;Gekr&uuml;mmter Teich&ldquo;, quchi], Di20/IC20 [&bdquo;Empfangen der Wohlger&uuml;che&ldquo;, yingxiang] und Ex-HN 3/Ex1 [&bdquo;Siegelhalle&ldquo;, yintang]). Gb20/F20 (&bdquo;Teich des Windes&ldquo;, fengchi), H3/Le3 (&bdquo;Die m&auml;chtige gro&szlig;e Stra&szlig;e&ldquo;, taichong), S36/Ma36 (&bdquo;Dritter Weiler am Fu&szlig;&ldquo;, zusanli), Lu7/P7 (&bdquo;Reihe von L&uuml;cken&ldquo;, lieque) und L6/Mi6 (&bdquo;Die Verbindung der drei Yin&ldquo;, sanyinjiao) waren die am h&auml;ufigsten gew&auml;hlten optionalen Akupunkturpunkte. Durchschnittlich wurden in einer Akupunkturbehandlung 15,7 (&plusmn; 2,5) Nadeln gesetzt, bei der Behandlung mit Sham-Akupunktur 10,0 (&plusmn; 1,6). Schlussfolgerung: Die Untersuchung der Studienintervention zeigt, dass in der Akupunkturgruppe die Studienintervention der chinesischen Syndromdiagnose entsprechend ausgerichtet war. Insgesamt wurden in der Akupunkturgruppe mehr Akupunkturnadeln als in der Sham-Akupunktur-Gruppe eingesetzt. Beides sind m&ouml;gliche Gr&uuml;nde f&uuml;r die Wirksamkeit der Akupunktur in dieser Studie