Hydrotherapy and acupressure in restless legs syndrome: A randomized, controlled, 3-armed, explorative clinical trial.

BACKGROUND: Restless legs syndrome (RLS) is a common neurological disease that has a significant impact on daily activities and quality of life, for which there is often no satisfactory therapy. Complementary medicine, such as acupressure and hydrotherapy, is used to treat patients with RLS; however, the clinical evidence is unclear. This study aims to investigate the effects and feasibility of self-administered hydrotherapy and acupressure in patients with RLS. METHODS: This is a randomized, controlled, open-label, exploratory, clinical study with 3 parallel arms, comparing both self-applied hydrotherapy (according to the German non-medical naturopath Sebastian Kneipp) and acupressure in addition to routine care in comparison to routine care alone (waiting list control) in patients with RLS. Fifty-one patients with at least moderate restless-legs syndrome will be randomized. Patients in the hydrotherapy group will be trained in the self-application of cold knee/lower leg affusions twice daily for 6 weeks. The acupressure group will be trained in the self-application of 6-point-acupressure therapy once daily for 6 weeks. Both interventions take approximately 20 minutes daily. The 6-week mandatory study intervention phase, which is in addition to the patient preexisting routine care treatment, is followed by a 6-week follow-up phase with optional interventions. The waitlist group will not receive any study intervention in addition to their routine care before the end of week 12. Outcome parameters including RLS-severity, disease and health-related quality of life (RLS-QoL, SF-12), Hospital Anxiety and Depression Score in German version, general self-efficacy scale, and study intervention safety will be measured at baseline and after 6 and 12 weeks. The statistical analyses will be descriptive and exploratory. CONCLUSION: In the case of clinically relevant therapeutic effects, feasibility, and therapeutic safety, the results will be the basis for planning a future confirmatory randomized trial and for helping to develop further RLS self-treatment concepts.

[Utilization of routine data from different statutory health insurance funds: a practical report of experience from the TIM-HF2 study about data acquisition, validation, and processing]. / Nutzung von Routinedaten unterschiedlicher gesetzlicher Krankenkassen: Ein Erfahrungsbericht aus der TIM-HF2-Studie zur Datenerschließung, -validierung und -aufbereitung.

BACKGROUND: The randomized controlled clinical trial "TIM-HF2" investigated the benefit of telemonitoring in chronic heart failure. The health economic evaluation of this intervention was based on routine data from statutory health insurance (SHI) funds. Since participants were recruited independently of their SHI affiliation, there was a large number of potential data-providing SHI funds. This resulted in both organizational and methodological challenges, from participation of the data providers to data preparation. METHOD: The procedures are described from study planning and data acquisition to data review and processing in the TIM-HF2 trial. Based on the identification of potential problems for data completeness and data quality, possible solutions have been derived. RESULTS: In total, participants were insured with 49 different SHI funds, which provided routine data for a total of 1450 participants. About half of all initial data deliveries were correct. The most common problems in data preparation occurred in the machine readability of the data. Success factors for a high level of data completeness were close communication with the SHI funds and a high level of time and personnel commitment to intensive data checking and preparation. DISCUSSION: Based on the experience of the TIM-HF2 trial, a high heterogeneity has been detected in data management and transmission of routine data. Universally applicable data descriptions are desired to improve data access, quality, and usability for research purposes.

Acupuncture in Patients with Diabetic Peripheral Neuropathy-Related Complaints: A Randomized Controlled Clinical Trial.

Background: Diabetic polyneuropathy (DPN) is a common complication of diabetes, which presents with a loss of sensorimotor function or pain. This study assessed the effectiveness and safety of acupuncture as a treatment for DPN-related complaints. Methods: In this randomized controlled trial, patients with type II diabetes and symptoms of neuropathy in the lower limbs were included. A total of 12 acupuncture treatments were administered over 8 weeks. The waitlist control group received the same acupuncture treatment starting at week 16 (after baseline). Results: A total of 62 patients were randomized (acupuncture group n = 31; control group n = 31). The primary outcome was overall complaints, and it was reduced with a significant difference of 24.7 on a VAS (CI 95% 14.8;34.7, p < 0.001) between both groups in favor of acupuncture. Reductions were recorded for the secondary outcomes VAS pain, neuropathic pain symptom inventory (NPSI), emotional dimensions of pain, SF-12, and diabetic peripheral neuropathic pain impact (DPNPI) after the intervention and at the follow-ups in the acupuncture group. Adverse reactions were minor and transient. Conclusions: Acupuncture leads to a significant and lasting reduction in DPN-related complaints when compared to routine care and is well tolerated, with minor side effects.

Characteristics of Patients Presenting at a University Outpatient Department for Complementary and Integrative Medicine.

BACKGROUND: Complementary and integrative medicine (CIM) is increasingly provided at university outpatient departments (OPDs) in Germany, but its scientific evaluation is sparse. Therefore, we aimed to investigate and evaluate feasibility, patients' characteristics and complaints at a university's CIM-OPD. METHODS: A prospective evaluation included new patients without age restriction. At baseline, and after 6 and 12 months, patients filled out paper questionnaires. Patients rated their mean subjectively perceived severity of the main complaint within the last 7 days on a numerical rating scale (NRS) from 0 = no complaints to 10 = maximum complaints, their perceived resilience capacity in everyday life within the last 7 days (0 = not resilient to 10 = very resilient), and their contentment with the treatment (0 = not content to 10 = very content). Diagnoses were provided by physicians and coded according to the International Statistical Classification of Diseases and Related Health Problems, 10th revision. All data were analyzed descriptively. RESULTS: During two years, 536 new patients {72.6% response, age (mean ± standard deviation [SD] and range) 49.6 ± 15.8 and 1-86 years, 75.7% female} chose to participate. The most frequent diagnosis groups were neoplasms (C00-C97, n = 143, 18.6%) and musculoskeletal diseases (M00-M99, n = 137, 17.9%). In n = 165 patients (30.8%), more than one diagnosis was provided. In a subgroup of 187 patients, who returned the questionnaire after 6 months, we compared baseline to 6-month values: severity of main complaint (mean ± SD) 5.2 ± 2.6 changed to 3.9 ± 2.6; resilience capacity 5.1 ± 2.6 to 5.6 ± 2.4. After 6 months, respondents rated their contentment with the treatment with (mean ± SD) 7.7 ± 2.6. Data after 12 months (n = 113) are comparable to data after 6 months. CONCLUSION: Patients of our CIM-OPD had a broad age range, were predominantly female, and suffered mostly from oncologic-related complaints and musculoskeletal diseases. In the responding subgroup after 6 months, patients were content with the treatment. These results should be verified by further prospective evaluations.Komplementäre und integrative Medizin (CIM) wird in Deutschland zunehmend in Hochschulambulanzen (OPDs) angeboten, deren wissenschaftliche Evaluation ist jedoch unzureichend. Deshalb war es unser Ziel, die Durchführbarkeit einer Evaluation, die Charakteristika und die Beschwerden der Patienten und Patientinnen an einer CIM-ODP zu untersuchen.Eine prospektive Evaluation schloss neue Patienten und Patientinnen ohne Altersbeschränkung ein. Zu Baseline sowie nach sechs und 12 Monaten füllten die Patienten und Patientinnen Papierfragebögen aus. Die Patienten und Patientinnen bewerteten ihre mittlere subjektiv empfundene Schwere der Hauptbeschwerden in den letzten sieben Tagen auf einer numerischen Ratingskala (NRS) von 0 = keine Beschwerden bis 10 = maximale Beschwerden, ihre mittlere subjektiv empfundene Belastbarkeit im Alltag in den letzten sieben Tagen (0 = nicht belastbar bis 10 = sehr belastbar) und ihre Zufriedenheit mit der Behandlung (0 = nicht zufrieden bis 10 = sehr zufrieden). Die Diagnosen wurden von den Ärzten und Ärztinnen gestellt und nach der International Statistical Classification of Diseases and Related Health Problems, 10. Revision, kodiert. Die Daten wurden deskriptiv ausgewertet.Im Laufe von zwei Jahren nahmen 536 neue Patienten und Patientinnen (72.6% Rücklauf, Alter (Mittelwert ± SD und Range) 49.6 ± 15.8 und 1­86 Jahre, 75.7% weiblich) teil. Die häufigsten Diagnosen waren Neoplasmen (C00-C97, n = 143, 18.6%) und Erkrankungen des Bewegungsapparates (M00-M99, n = 137, 17.9%). Bei n = 165 (30.8%) Patienten und Patientinnen wurde mehr als eine Diagnose vergeben. In einer Subgruppe von 187 Patienten und Patientinnen, die den Fragebogen nach 6 Monaten zurücksendeten, verglichen wir die Ausgangs-und 6-Monats-Werte: Schweregrad der Hauptbeschwerden (Mittelwert±SD) 5.2 ± 2.6 veränderte sich zu 3.9 ± 2.6; Belastbarkeit 5.1 ± 2.6 zu 5.6 ± 2.4. Nach sechs Monaten bewerteten die Befragten ihre Zufriedenheit mit der Behandlung mit (Mittelwert±SD) 7.7 ± 2.6. Die Daten nach 12 Monaten (n = 113) sind mit den Daten nach 6 Monaten vergleichbar.Die Patienten und Patientinnen unserer CIM-OPD hatten eine breite Altersspanne, überwiegend weiblich und litten zumeist unter onkologisch bedingten Beschwerden und Erkrankungen des Bewegungsapparates. Patienten und Patientinnen der nach sechs Monaten antwortenden Subgruppe waren mit der Behandlung zufrieden. Die Ergebnisse sollten durch weitere prospektive Evaluationen verifiziert werden.

Acupuncture in diabetic peripheral neuropathy-neurological outcomes of the randomized acupuncture in diabetic peripheral neuropathy trial.

BACKGROUND: Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and can lead to serious complications. Therapeutic strategies for pain control are available but there are few approaches that influence neurological deficits such as numbness. AIM: To investigate the effectiveness of acupuncture on improving neurological deficits in patients suffering from type 2 DPN. METHODS: The acupuncture in DPN (ACUDPN) study was a two-armed, randomized, controlled, parallel group, open, multicenter clinical trial. Patients were randomized in a 1:1 ratio into two groups: The acupuncture group received 12 acupuncture treatments over 8 wk, and the control group was on a waiting list during the first 16 wk, before it received the same treatment as the other group. Both groups received routine care. Outcome parameters were evaluated after 8, 16 and 24 wk and included neurological scores, such as an 11-point numeric rating scale (NRS) 11 for hypesthesia, neuropathic pain symptom inventory (NPSI), neuropathy deficit score (NDS), neuropathy symptom score (NSS); nerve conduction studies (NCS) were assessed with a handheld point-of-care device. RESULTS: Sixty-two participants were included. The NRS for numbness showed a difference of 2.3 (P < 0.001) in favor of the acupuncture group, the effect persisted until week 16 with a difference of 2.2 (P < 0.001) between groups and 1.8 points at week 24 compared to baseline. The NPSI was improved in the acupuncture group by 12.6 points (P < 0.001) at week 8, the NSS score at week 8 with a difference of 1.3 (P < 0.001); the NDS and the TNSc score improved for the acupuncture group in week 8, with a difference of 2.0 points (P < 0.001) compared to the control group. Effects were persistent in week 16 with a difference of 1.8 points (P < 0.05). The NCS showed no meaningful changes. In both groups only minor side effects were reported. CONCLUSION: Study results suggest that acupuncture may be beneficial in type 2 diabetic DPN and seems to lead to a reduction in neurological deficits. No serious adverse events were recorded and the adherence to treatment was high. Confirmatory randomized sham-controlled clinical studies with adequate patient numbers are needed to confirm the results.

Acupuncture and osteopathic medicine for atopic dermatitis: a three-armed, randomized controlled explorative clinical trial.

BACKGROUND: Patients with atopic dermatitis (AD) frequently use acupuncture (ACU) and osteopathic medicine (OM), although their therapeutic benefits are unclear. AIM: To investigate the effectiveness of ACU and OM in patients with AD. METHODS: In a three-armed, single-centre, randomized controlled open explorative clinical trial, adult patients with AD received ACU, OM or no study intervention (control group; CG) plus routine care. Outcomes included disease severity (SCORing Atopic Dermatitis; SCORAD), itching intensity (visual analogue scale; VAS), frequency of topical corticosteroid (TCS) use over 7 days and cost-effectiveness. Endpoints were analysed by analysis of covariance adjusted for the respective baseline value and TCS use. RESULTS: Overall, 121 patients (92 women, 29 men) with a mean ± SD age of 31.4 ± 10.5 years were randomized. After 12 weeks, the adjusted means (95% CI) for ACU, OM and control were, respectively, 22.3 (18.3-26.3), 26.4 (22.6-30.2) and 23.7 (19.9-27.5) for SCORAD (P = 0.32); 27.9 (19.5-36.4), 35.0 (26.9-43.0) and 42.3 (34.7-50.0) for VAS itching (P < 0.05); and 2.3 (0.8-3.9), 1.9 (0.4-3.5) and 4.3 (2.6-6.0), for TCS use (P = 0.10). ACU and OM were not cost-effective compared with the CG. CONCLUSION: Although no differences in disease severity were found, our findings indicate that ACU might reduce itching in patients with AD. Furthermore, ACU and OM showed a trend towards reducing TCS use.

The effect of active visual art therapy on health outcomes: protocol of a systematic review of randomised controlled trials.

BACKGROUND: Art therapy is a form of complementary therapy to treat a wide variety of health problems. Existing studies examining the effects of art therapy differ substantially regarding content and setting of the intervention, as well as their included populations, outcomes, and methodology. The aim of this review is to evaluate the overall effectiveness of active visual art therapy, used across different treatment indications and settings, on various patient outcomes. METHODS: We will include randomised controlled studies with an active art therapy intervention, defined as any form of creative expression involving a medium (such as paint etc.) to be actively applied or shaped by the patient in an artistic or expressive form, compared to any type of control. Any treatment indication and patient group will be included. A systematic literature search of the Cochrane Library, EMBASE (via Ovid), MEDLINE (via Ovid), CINAHL, ERIC, APA PsycArticles, APA PsycInfo, and PSYNDEX (all via EBSCOHost), ClinicalTrials.gov and the WHO's International Clinical Trials Registry Platform (ICTRP) will be conducted. Psychological, cognitive, somatic and economic outcomes will be used. Based on the number, quality and outcome heterogeneity of the selected studies, a meta-analysis might be conducted, or the data synthesis will be performed narratively only. Heterogeneity will be assessed by calculating the p-value for the chi2 test and the I2 statistic. Subgroup analyses and meta-regressions are planned. DISCUSSION: This systematic review will provide a concise overview of current knowledge of the effectiveness of art therapy. Results have the potential to (1) inform existing treatment guidelines and clinical practice decisions, (2) provide insights to the therapy's mechanism of change, and (3) generate hypothesis that can serve as a starting point for future randomised controlled studies. SYSTEMATIC REVIEW REGISTRATION: PROSPERO ID CRD42021233272.

The effect of osteopathic medicine on pain in musicians with nonspecific chronic neck pain: a randomized controlled trial.

BACKGROUND: Nonspecific chronic neck pain (cNP) is common in adult violinists and violists and is often treated with osteopathic medicine (OM), although the effectiveness of this treatment has not been determined to date. This study aimed to evaluate the effectiveness and safety of OM in adult violinists and violists with cNP. METHODS: In a two-armed randomized controlled single-center open trial, adult violinists and violists, including music students, with cNP (⩾12 weeks) were randomized to either five individualized OM sessions (OM group) or to no intervention (control group, CG) in the outpatient clinic for integrative medicine, Charité - Universitätsmedizin Berlin, Germany. All patients received a musicians' medicine consultation and paracetamol on demand. The primary outcome parameter was the neck pain intensity on a visual analog scale (VAS, 0-100 mm, 0 = no pain, 100 = worst imaginable pain) after 12 weeks. Secondary outcomes included neck pain disability (Neck Disability Index, NDI, 0-100%) after 12 weeks. The last follow-up visit was after 52 weeks. Statistical analysis included analysis of covariance adjusted for respective baseline value. RESULTS: Altogether, 62 outpatients were included [OM group (n = 28), CG (n = 34); 81% female; mean age, 41.6 ± 11.1 years; mean baseline neck pain, 55.9 ± 11.6 mm]. After 12 weeks, OM was associated with an improvement in the OM group versus the CG in neck pain on the VAS [14.6 mm (95% confidence interval 8.0; 21.2) versus 40.8 mm (34.7; 46.9), p < 0.001, Cohen's d = 1.4], and neck pain disability as determined by the NDI [8.8% (6.7; 10.8) versus 17.2% (15.3; 19.1), p < 0.001]. Some improvements were maintained until 52 weeks of follow-up. No serious adverse events were observed. CONCLUSIONS: The results of this study suggest that OM might be effective in reducing pain intensity in adult violinists and violists with nonspecific cNP. Further studies should investigate the efficacy of OM in comparison with a sham procedure and with other effective therapy methods in high-quality multicenter trials. TRIAL REGISTRATION: WHO Trial Registration https://apps.who.int/trialsearch/NoAccess.aspx?aspxerrorpath=/trialsearch/Trial2.aspx by German Clinical Trials Register DRKS00009258, Universal Trial Number (UTN): U1111-1173-5943.

Musculoskeletal disorders and complaints in professional musicians: a systematic review of prevalence, risk factors, and clinical treatment effects.

PURPOSE: Musicians' practice and performance routines reportedly lead to musculoskeletal complaints and disorders (MCD) that impact their wellbeing and performance abilities. This systematic review aims to assess the prevalence, risk factors, prevention and effectiveness of treatments for MCD in professional musicians and consider the methodological quality of the included studies. METHODS: A systematic literature search was performed in December 2017 using electronic databases and supplemented by a hand search. Case-control studies, cohort studies, cross-sectional studies, interventional studies and case reports investigating the prevalence, risk factors, prevention or treatment effects of MCD in professional musicians or music students (age ≥ 16 years) were included. Quality assessments of the included studies were performed using an adapted version of the "Study Quality Assessment Tools" from the National Heart, Lung, and Blood Institute. RESULTS: One case-control study, 6 cohort studies, 62 cross-sectional studies, 12 interventional studies and 28 case reports were included and assessed for methodological quality. The study designs, terminology, and outcomes were heterogeneous, as the analyses mostly did not control for major confounders, and the definition of exposure was often vague. Therefore, evidence that being a professional musician is a risk factor for MCD as well as the causal relationship between these factors remains low despite the fact that a large number of studies have been performed. CONCLUSIONS: Studies with high internal and external validity regarding the prevalence, risk factors and effectiveness of the prevention or treatment of MCD in professional musicians are still missing. Further high-quality observational and interventional studies are required.

Acupuncture in Patients with Allergic Asthma: A Randomized Pragmatic Trial.

BACKGROUND: Although the available evidence is insufficient, acupuncture is used in patients suffering from chronic asthma. The aim of this pragmatic study was to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone. METHODS: Patients with allergic asthma were included in a randomized controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1-7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0-100). Outcome parameters were assessed at baseline and at 3 and 6 months. RESULTS: A total of 1,445 patients (mean age 43.8 [SD 13.5] years, 58.7% female) were randomized and included in the analysis (184 patients randomized to acupuncture and 173 to control, and 1,088 in the nonrandomized acupuncture group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5-1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0-4.0]; mental 4.0 [2.1-6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group. CONCLUSIONS: In patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone.

A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis--trial intervention including physician and treatment characteristics.

BACKGROUND: In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial's participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers and physicians. METHODS: ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) was a three-armed, randomised, controlled multicentre trial. 422 SAR patients were randomised to semi-standardised acupuncture plus rescue medication (RM, cetirizine), sham acupuncture plus RM or RM alone. We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture. During the trial, acupuncturists were asked to diagnose all of their patients according to Chinese Medicine (CM) as a basis for the semi-standardised, individualized intervention in the acupuncture group. Every acupuncture point used in this trial had to be documented after each session RESULTS: Acupuncture was administered in outpatient clinics by 46 (mean age 47 ± 10 years; 24 female/ 22 male) conventionally-trained medical doctors (67% with postgraduate specialization such as internal or family medicine) with additional extensive acupuncture training (median 500 hours (1st quartile 350, 3rd quartile 1000 hours with 73% presenting a B-diploma in acupuncture training (350 hours)) and experience (mean 14 years in practice). The most reported traditional CM diagnosis was 'wind-cold invading the lung' (37%) and 'wind-heat invading the lung' (37%), followed by 'lung and spleen qi deficiency' (9%). The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group (15.7 ± 2.5 vs. 10.0 ± 1.6). CONCLUSIONS: The trial interventions were provided by well educated and experienced acupuncturists. The different number of needles in both intervention groups could be possibly a reason for the better clinical effect in SAR patients. For future trials it might be more appropriate to ensure that acupuncture and sham acupuncture groups should each be treated by a similar number of needles. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00610584.

Acupuncture in patients suffering from allergic asthma: is it worth additional costs?

OBJECTIVES: Acupuncture is increasingly used in patients with allergic asthma, but there is a lack of evidence on the cost-benefit relationship of this treatment. The aim of this study was to assess economic aspects of additional acupuncture treatment in patients with allergic bronchial asthma compared to patients receiving routine care alone. DESIGN, SUBJECTS, INTERVENTION, OUTCOME MEASURES: In a randomized controlled trial, patients with allergic bronchial asthma were either allocated to a group receiving acupuncture immediately or a waiting-list control group. Both groups were free to use routine care treatment. The resource consumption, costs, and health-related quality of life were evaluated at baseline, and after 3 and 6 months by using statutory health insurance information and standardized questionnaires. Main economic outcome parameters were direct and indirect cost differences during the study period and the incremental cost-effectiveness ratio (ICER) of acupuncture treatment. RESULTS: Three hundred and six (306) patients (159 acupuncture; 147 controls) were included (mean age 46.5±13.11 years, female 57.2%) and were comparable at baseline. Acupuncture treatment was associated with significantly higher costs compared to control patients (overall costs: €860.76 [95% confidence interval (CI) 705.04-1016.47] versus €518.80 [95% CI 356.66-680.93]; p=0.003; asthma-related costs: €517.52 [95% CI 485.63-549.40] versus €144.87 [95% CI 111.70-178.05]; p<0.001). These additional costs seem essentially driven by acupuncture costs themselves (€378.40 [95% CI 367.10-389.69]). However, acupuncture was associated with superior effectiveness in terms of quality-adjusted life years (QALYs). Resulting ICER lay between €23,231 (overall) and €25,315 (diagnosis-specific) per additional QALY. When using German acupuncture prices of year 2012, the ICER would improve to €12.810 (overall) versus €14,911 (diagnosis-specific) per QALY gained. CONCLUSIONS: Treating patients who have allergic bronchial asthma with acupuncture in addition to routine care resulted in additional costs and better effects in terms of patients' quality of life. Acupuncture therefore seems to be a useful and cost-effective add-on treatment.

Homeopathy for depression: a randomized, partially double-blind, placebo-controlled, four-armed study (DEP-HOM).

BACKGROUND: The specific clinical benefit of the homeopathic consultation and of homeopathic remedies in patients with depression has not yet been investigated. AIMS: To investigate the 1) specific effect of individualized homeopathic Q-potencies compared to placebo and 2) the effect of an extensive homeopathic case taking (case history I) compared to a shorter, rather conventional one (case history II) in the treatment of acute major depression (moderate episode) after six weeks. METHODS: A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2×2 factorial design with a six-week study duration per patient was performed. RESULTS: A total of 44 from 228 planned patients were randomized (2∶1∶2∶1 randomization: 16 homeopathic Q-potencies/case history I, 7 placebo/case history I, 14 homeopathic Q-potencies/case history II, 7 placebo/case history II). Because of recruitment problems, the study was terminated prior to full recruitment, and was underpowered for the preplanned confirmatory hypothesis testing. Exploratory data analyses showed heterogeneous and inconclusive results with large variance in the sample. The mean difference for the Hamilton-D after 6 weeks was 2.0 (95%CI -1.2;5.2) for Q-potencies vs. placebo and -3.1 (-5.9;-0.2) for case history I vs. case history II. Overall, no consistent or clinically relevant results across all outcomes between homeopathic Q-potencies versus placebo and homeopathic versus conventional case taking were observed. The frequency of adverse events was comparable for all groups. CONCLUSIONS: Although our results are inconclusive, given that recruitment into this trial was very difficult and we had to terminate early, we cannot recommend undertaking a further trial addressing this question in a similar setting. Prof. Dr. Claudia Witt had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. TRIAL REGISTRATION: clinicaltrials.gov identifier NCT01178255. Protocol publication: http://www.trialsjournal.com/content/12/1/43.

Cost-effectiveness for acupuncture in seasonal allergic rhinitis: economic results of the ACUSAR trial.

BACKGROUND: Allergic rhinitis (AR) is a frequent allergic disorder with a significant economic effect on health care costs and productivity. OBJECTIVE: To assess the cost-effectiveness of acupuncture for patients with seasonal AR (SAR) in Germany. METHODS: The present analysis was part of the Acupuncture in Seasonal Allergic Rhinitis (ACUSAR) trial, a 3-arm randomized, controlled, multicenter trial in patients with SAR, comparing acupuncture plus rescue medication (RM), penetrating sham acupuncture plus RM, and a control group receiving RM alone. Measures for health economic analyses were costs and health-related quality of life. Incremental cost-effectiveness ratio was calculated for different scenarios on the duration of acupuncture effects and was expressed as costs per quality-adjusted life-year gained. The study was conducted from society's and from a third-party payer's perspective. RESULTS: From 422 initially randomized patients, a total of 364 patients with complete data on costs and quality of life were included in the health economic evaluation. Patients receiving acupuncture or sham acupuncture caused higher costs than patients in the RM group. Patients in the acupuncture group gained significantly more quality-adjusted life-years compared with the RM group. Depending on different scenarios, the incremental cost-effectiveness ratio for acupuncture patients was between €31,241 (approximately US $38.569) and €118,889 (approximately US $146,777) from society's perspective and between €20,807 (approximately US $25,688) and €74,585 (approximately US $92.080) from a third-party payer's perspective. CONCLUSION: Acupuncture is an effective intervention that results in improved quality of life in patients with SAR. However, in times of limited resources for health care, acupuncture for AR may not be a cost-effective intervention. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00610584.

Comparative effectiveness of homoeopathic vs. conventional therapy in usual care of atopic eczema in children: long-term medical and economic outcomes.

BACKGROUND: One in five children visiting a homeopathic physician suffers from atopic eczema. OBJECTIVES: We aimed to examine the long-term effectiveness, safety and costs of homoeopathic vs. conventional treatment in usual medical care of children with atopic eczema. METHODS: In this prospective multi-centre comparative observational non-randomized rater-blinded study, 135 children (48 homoeopathy, 87 conventional) with mild to moderate atopic eczema were included by their respective physicians. Depending on the specialisation of the physician, the primary treatment was either standard conventional treatment or individualized homeopathy as delivered in routine medical care. The main outcome was the SCORAD (SCORing Atopic Dermatitis) at 36 months by a blinded rater. Further outcomes included quality of life, conventional medicine consumption, safety and disease related costs at six, 12 and 36 months after baseline. A multilevel ANCOVA was used, with physician as random effect and the following fixed effects: age, gender, baseline value, severity score, social class and parents' expectation. RESULTS: The adjusted mean SCORAD showed no significant differences between the groups at 36 months (13.7 95% CI [7.9-19.5] vs. 14.9 [10.4-19.4], p = 0.741). The SCORAD response rates at 36 months were similar in both groups (33% response: homoeopathic 63.9% vs. conventional 64.5%, p = 0.94; 50% response: 52.0% vs. 52.3%, p = 0.974). Total costs were higher in the homoeopathic versus the conventional group (months 31-36 200.54 Euro [132.33-268.76] vs. 68.86 Euro [9.13-128.58], p = 0.005). CONCLUSIONS: Taking patient preferences into account, while being unable to rule out residual confounding, in this long-term observational study, the effects of homoeopathic treatment were not superior to conventional treatment for children with mild to moderate atopic eczema, but involved higher costs.

Acupuncture in patients with seasonal allergic rhinitis: a randomized trial.

UNLABELLED: Chinese translation BACKGROUND: Acupuncture is frequently used to treat seasonal allergic rhinitis (SAR) despite limited scientific evidence. OBJECTIVE: To evaluate the effects of acupuncture in patients with SAR. DESIGN: Randomized, controlled multicenter trial. (ClinicalTrials.gov: NCT00610584) SETTING: 46 specialized physicians in 6 hospital clinics and 32 private outpatient clinics. PATIENTS: 422 persons with SAR and IgE sensitization to birch and grass pollen. INTERVENTION: Acupuncture plus rescue medication (RM) (cetirizine) (n = 212), sham acupuncture plus RM (n = 102), or RM alone (n = 108). Twelve treatments were provided over 8 weeks in the first year. MEASUREMENTS: Changes in the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the RM score (RMS) from baseline to weeks 7 and 8 and week 16 in the first year and week 8 in the second year after randomization, with predefined noninferiority margins of -0.5 point (RQLQ) and -1.5 points (RMS). RESULTS: Compared with sham acupuncture and with RM, acupuncture was associated with improvement in RQLQ score (sham vs. acupuncture mean difference, 0.5 point [97.5% CI, 0.2 to 0.8 point; P < 0.001]; RM vs. acupuncture mean difference, 0.7 point [97.5% CI, 0.4 to 1.0 point; P < 0.001]) and RMS (sham vs. acupuncture mean difference, 1.1 points [97.5% CI, 0.4 to 1.9 points; P < 0.001]; RM vs. acupuncture mean difference, 1.5 points [97.5% CI, 0.8 to 2.2 points; P < 0.001]). There were no differences after 16 weeks in the first year. After the 8-week follow-up phase in the second year, small improvements favoring real acupuncture over the sham procedure were noted (RQLQ mean difference, 0.3 point [95% CI, 0.03 to 0.6 point; P = 0.032]; RMS mean difference, 1.0 point [95% CI, 0.2 to 1.9 points; P = 0.018]). LIMITATION: The study was not powered to detect rare adverse events, and the RQLQ and RMS values were low at baseline. CONCLUSION: Acupuncture led to statistically significant improvements in disease-specific quality of life and antihistamine use measures after 8 weeks of treatment compared with sham acupuncture and with RM alone, but the improvements may not be clinically significant.

Are the effects of homeopathy attributable to a statistical artefact? A reanalysis of an observational study.

Background. Cohort studies have reported that patients improve considerably after individualised homeopathic treatment. However, these results may be biased by regression to the mean (RTM). Objective. To evaluate whether the observed changes in previous cohort studies are due to RTM and to estimate RTM adjusted effects. Methods. SF-36 quality-of-life (QoL) data from a German cohort of 2827 chronically diseased adults treated by a homeopath were reanalysed by Mee and Chua's modified t-test. Results. RTM adjusted effects, standardized by the respective standard deviation at baseline, were 0.12 (95% CI: 0.06-0.19, P < 0.001) in the mental and 0.25 (0.22-0.28, P < 0.001) in the physical summary score. Small-to-moderate effects were confirmed for the most individual diagnoses in physical, but not in mental component scores. Under the assumption that the true population mean equals the mean of all actually diseased patients, RTM adjusted effects were confirmed for both scores in most diagnoses. Conclusions. Changes in QoL after treatment by a homeopath are small but cannot be explained by RTM alone. As all analyses made conservative assumptions, true RTM adjusted effects are probably larger than presented.

Pulsatile dry cupping in patients with osteoarthritis of the knee - a randomized controlled exploratory trial.

INTRODUCTION: Cupping is used in various traditional medicine forms to relieve pain in musculoskeletal diseases. The aim of this study was to investigate the effectiveness of cupping in relieving the symptoms of knee osteoarthritis (OA). METHODS: In a two-group, randomized controlled exploratory pilot study patients with a clinically and radiological confirmed knee OA (Kellgren-Lawrence Grading Scale: 2-4) and a pain intensity > 40 mm on a 100 mm visual analogue scale (VAS) were included. 40 Patients were randomized to either 8 sessions of pulsatile dry cupping within 4 weeks or no intervention (control). Paracetamol was allowed on demand for both groups. Outcomes were the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score, the pain intensity on a VAS (0 mm = no pain to 100 mm = maximum intensity) and Quality of Life (SF-36) 4 and 12 weeks after randomization. Use of Paracetamol was documented within the 4-week treatment period. Analyses were performed by analysis of covariance adjusting for the baseline value for each outcome. RESULTS: 21 patients were allocated to the cupping group (5 male; mean age 68 ± SD 7.2) and 19 to the control group (8 male; 69 ± 6.8). After 4 weeks the WOMAC global score improved significantly more in the cupping group with a mean of 27.7 (95% confidence interval 22.1; 33.3) compared to 42.2 (36.3; 48.1) in the control group (p = 0.001). After 12 weeks the WOMAC global score were still significantly different in favor for cupping (31.0 (24.9; 37.2) vs. 40.8 (34.4; 47.3) p = 0.032), however the WOMAC subscores for pain and stiffness were not significant anymore. Significantly better outcomes in the cupping group were also observed for pain intensity on VAS and for the SF-36 Physical Component Scale compared to the control group after 4 and 12 weeks. No significant difference was observed for the SF-36 Mental Component Scale and the total number of consumed Paracetamol tablets between both groups (mean 9.1, SD ± 20.0 vs. 11.5 ± 15.9). CONCLUSION: In this exploratory study dry cupping with a pulsatile cupping device relieved symptoms of knee OA compared to no intervention. Further studies comparing cupping with active treatments are needed. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01057043.

Efficacy of injections with Disci/Rhus toxicodendron compositum for chronic low back pain--a randomized placebo-controlled trial.

BACKGROUND: 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. METHODOLOGY/PRINCIPAL FINDINGS: 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. CONCLUSIONS/SIGNIFICANCE: The homeopathic preparation was not superior to placebo. Compared to no treatment injections resulted in significant and clinical relevant chronic back pain relief. TRIAL REGISTRATION: ClinicalTrials.gov NCT00567736.