No Placebo Effect beyond Regression to the Mean on the Six Minute Walk Test in Pulmonary Arterial Hypertension Trials.

In drug studies, patients are often included when the disease activity is high. This will make any treatment appear to lessen disease activity, although the improvement is biased by selection. This effect is known as regression towards the mean (RTM). We aimed at investigating drug trials in Pulmonary Arterial Hypertension (PAH) using the 6-minute walking distance test (6MWD) as a primary outcome for the phenomenon of RTM. An existing registry of 43 open label studies and 23 randomized controlled trials conducted between 1990 and 2009 was used as the data source. Data analysis was carried out for 18 randomized controlled trials (RCTs) and 24 open label studies out of this registry. Data were analyzed for verum and placebo arms of the RCTs separately, as well as for the open label arms. In the verum arms, the overall effect given as 33.2 m (95% CI: 25.7; 40.6]); 6MWD was slightly lower than the effect in the observational studies, with 44.6 m (95% CI: [25.4; 63.8]). After studying and interpreting the data, we found that regression towards the mean plays only a minor role in PAH studies. In particular, placebo effects in the RCTs were negligibly small, with a mean 6MWD of -2.5 m (95% CI: [-9.8; 4.7]) in the placebo arm. Therefore, our analysis indicates that results of non-randomized observational studies can be regarded as valid tools for gaining valid clinical effects in patients with PAH.

Efficacy of the Alexander Technique in treating chronic non-specific neck pain: a randomized controlled trial.

OBJECTIVE: To test the efficacy of the Alexander Technique, local heat and guided imagery on pain and quality of life in patients with chronic non-specific neck pain. DESIGN: A randomized controlled trial with 3 parallel groups was conducted. SETTING: Outpatient clinic, Department of Internal and Integrative Medicine. SUBJECTS: A total of 72 patients (65 females, 40.7±7.9 years) with chronic non-specific neck pain. INTERVENTIONS: Patients received 5 sessions of the Alexander Technique--an educational method which aims to modify dysfunctional posture, movement and thinking patterns associated with musculoskeletal disorders. Control groups were treated with local heat application or guided imagery. All interventions were conducted once a week for 45 minutes each. MAIN MEASURES: The primary outcome measure at week 5 was neck pain intensity on a 100-mm visual analogue scale; secondary outcomes included neck disability, quality of life, satisfaction and safety. STATISTICS: Analyses of covariance were applied; testing ordered hypotheses. RESULTS: No group difference was found for pain intensity for the Alexander Technique compared to local heat (difference 4.5mm; 95% CI:-8.1;17.1; p=0.48), but exploratory analysis revealed the superiority of the Alexander Technique over guided imagery (difference -12.9 mm; 95% CI:-22.6;-3.1, p=0.01). Significant group differences in favor of the Alexander Technique were also found for physical quality of life (P<0.05). Adverse events mainly included slightly increased pain and muscle soreness. CONCLUSION: The Alexander Technique was not superior to local heat application in treating chronic non-specific neck pain. It cannot be recommended as routine intervention at this time. Further trials are warranted for conclusive judgment.

Efficacy of Caraway Oil Poultices in Treating Irritable Bowel Syndrome--A Randomized Controlled Cross-Over Trial.

BACKGROUND/AIM: Irritable bowel syndrome (IBS) is a frequent gastrointestinal disorder, with only limited evidence regarding self-management approaches. This study tested the efficacy of caraway oil poultices (CarO) for treating IBS. METHODS: This randomized controlled open-label cross-over trial included three treatment periods with hot CarO and hot olive oil poultice (OlivH) or nonheated poultices (OlivC) with olive oil as control interventions. Patients applied each intervention daily for 3 weeks. The primary outcome was symptom severity (IBS-SSS); secondary outcomes included responder rates (improvement ≥ 50 IBS-SSS), quality of life (EQ-5D, IBS-QOL), psychological distress (HADS), adequate relief, and safety. RESULTS: 48 patients with IBS were included (40 females, 53.9 ± 14.4 years). A significant difference was found for symptom severity in favor of CarO compared to OlivC (difference -38.4, 95% CI -73.6, -3.1, p = 0.033), but not compared to OlivH (difference -24.3, 95% CI -56.5, 7.9, p = 0.139). Responder rates were highest for CarO compared to OlivH and OlivC (43.9, 20.0, 18.9%, respectively). Within the CarO, 51.8% reported adequate relief compared to 23.5% (OlivH) and 25.8% (OlivC). One adverse event (gastrointestinal infection) was reported during CarO. CONCLUSION: Hot caraway oil poultices appear effective and safe, although their effects may be a result of the heat application. Patients reported highest levels of subjective benefit from caraway oil poultices, making their use appropriate in the self-management of IBS.

CORE-Hom: a powerful and exhaustive database of clinical trials in homeopathy.

The CORE-Hom database was created to answer the need for a reliable and publicly available source of information in the field of clinical research in homeopathy. As of May 2014 it held 1048 entries of clinical trials, observational studies and surveys in the field of homeopathy, including second publications and re-analyses. 352 of the trials referenced in the database were published in peer reviewed journals, 198 of which were randomised controlled trials. The most often used remedies were Arnica montana (n = 103) and Traumeel(®) (n = 40). The most studied medical conditions were respiratory tract infections (n = 126) and traumatic injuries (n = 110). The aim of this article is to introduce the database to the public, describing and explaining the interface, features and content of the CORE-Hom database.

Effects of phlebotomy-induced reduction of body iron stores on metabolic syndrome: results from a randomized clinical trial.

BACKGROUND: Metabolic syndrome (METS) is an increasingly prevalent but poorly understood clinical condition characterized by insulin resistance, glucose intolerance, dyslipidemia, hypertension, and obesity. Increased oxidative stress catalyzed by accumulation of iron in excess of physiologic requirements has been implicated in the pathogenesis of METS, but the relationships between cause and effect remain uncertain. We tested the hypothesis that phlebotomy-induced reduction of body iron stores would alter the clinical presentation of METS, using a randomized trial. METHODS: In a randomized, controlled, single-blind clinical trial, 64 patients with METS were randomly assigned to iron reduction by phlebotomy (n = 33) or to a control group (n = 31), which was offered phlebotomy at the end of the study (waiting-list design). The iron-reduction patients had 300 ml of blood removed at entry and between 250 and 500 ml removed after 4 weeks, depending on ferritin levels at study entry. Primary outcomes were change in systolic blood pressure (SBP) and insulin sensitivity as measured by Homeostatic Model Assessment (HOMA) index after 6 weeks. Secondary outcomes included HbA1c, plasma glucose, blood lipids, and heart rate (HR). RESULTS: SBP decreased from 148.5 ± 12.3 mmHg to 130.5 ± 11.8 mmHg in the phlebotomy group, and from 144.7 ± 14.4 mmHg to 143.8 ± 11.9 mmHg in the control group (difference -16.6 mmHg; 95% CI -20.7 to -12.5; P < 0.001). No significant effect on HOMA index was seen. With regard to secondary outcomes, blood glucose, HbA1c, low-density lipoprotein/high-density lipoprotein ratio, and HR were significantly decreased by phlebotomy. Changes in BP and HOMA index correlated with ferritin reduction. CONCLUSIONS: In patients with METS, phlebotomy, with consecutive reduction of body iron stores, lowered BP and resulted in improvements in markers of cardiovascular risk and glycemic control. Blood donation may have beneficial effects for blood donors with METS. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01328210 Please see related article: http://www.biomedcentral.com/1741-7015/10/53.

Iyengar yoga for distressed women: a 3-armed randomized controlled trial.

Distress is an increasing public health problem. We aimed to investigate the effects of an Iyengar yoga program on perceived stress and psychological outcomes in distressed women and evaluated a potential dose-effect relationship. Seventy-two female distressed subjects were included into a 3-armed randomized controlled trial and allocated to yoga group 1 (n = 24) with twelve 90 min sessions over 3 months, yoga group 2 (n = 24) with 24 sessions over 3 months, or a waiting list control group (n = 24). The primary outcome was stress perception, measured by Cohen Stress Scale; secondary outcomes included state trait anxiety, depression, psychological and physical quality of life (QOL), profile of Mood States, well being, and bodily complaints. After three months, women in the yoga groups showed significant improvements in perceived stress (P = 0.003), state trait anxiety (P = 0.021 and P = 0.003), depression (P = 0.008), psychological QOL (P = 0.012), mood states being (P = 0.007), and bodily complaints well(P = 0.012) when compared to controls. Both yoga programs were similarly effective for these outcomes; however, compliance was better in the group with fewer sessions (yoga group 1). Dose effects were seen only in the analysis of group-independent effects for back pain, anxiety, and depression. These findings suggest that Iyengar yoga effectively reduces distress and improves related psychological and physical outcomes. Furthermore, attending twice-weekly yoga classes was not superior to once-weekly classes, as a result of limited compliance in the twice-weekly group.

The benefit of a mechanical needle stimulation pad in patients with chronic neck and lower back pain: two randomized controlled pilot studies.

Objectives. The objective was to investigate whether a treatment with a needle stimulation pad (NSP) changes perceived pain and/or sensory thresholds in patients with chronic neck (NP) and lower back pain (BP). Methods. 40 patients with chronic NP and 42 patients with chronic BP were equally randomized to either treatment or waiting list control group. The treatment group self-administered a NSP over a period of 14 days. Pain ratings were recorded on numerical rating scales (NRSs). Mechanical detection thresholds (MDTs) and pressure pain thresholds (PPTs) were determined at the site of maximal pain and in the adjacent region, vibration detection thresholds (VDT) were measured at close spinal processes. The Northwick Park Neck Pain Questionnaire (NPQ) and the Oswestry Disability Index (ODI) were utilized for the NP and BP study, respectively. Results. NRS ratings were significantly reduced for the treatment groups compared to the control groups (NP: P = .021 and BP: P < .001), accompanied by a significant increase of PPT at pain maximum (NP: P = .032 and BP: P = .013). There was no effect on VDT and MDT. The NPQ showed also a significant improvement, but not the ODI. Conclusions. The mechanical NSP seems to be an effective treatment method for chronic NP and BP.

Effectiveness of traditional Chinese "gua sha" therapy in patients with chronic neck pain: a randomized controlled trial.

OBJECTIVE: Gua sha is a traditional East Asian healing technique where the body surface is press-stroked with a smooth-edged instrument to intentionally raise therapeutic petechiae. A traditional indication of Gua sha is neck pain; no data from controlled trials exist to support this claim. The researchers aimed to investigate the effectiveness of Gua sha in the symptomatic treatment of chronic neck pain. DESIGN: The study was designed as an open randomized controlled clinical trial. SETTING: The study was set in Kliniken Essen-Mitte, Academic Teaching Hospital of the University Duisburg-Essen, Germany. SUBJECTS: Forty-eight outpatients (58.5±8.0 years; 41 female) with chronic mechanical neck pain were the subjects of the study. INTERVENTION: Patients were randomized into Gua sha (N=24) or control groups (N=24) and followed up for 7 days. Gua sha patients were treated once with Gua sha, while control patients were treated with a local thermal heat pad. OUTCOME MEASURES: Primary outcome was change of neck pain severity after 1 week as assessed by visual analog scale. Secondary outcomes included pain at motion, the neck disability index (NDI) and quality-of-life (Short-Form [36] Health Survey). RESULTS: Neck pain severity after 1 week improved significantly better in the Gua sha group compared with the control group (group difference -29.9 mm, 95% confidence interval: -43.3; -16.6 mm; P<0.001). Significant treatment effects were also found for pain at motion, scores on the NDI, and dimensions of quality-of-life. The treatment was safe and well tolerated. CONCLUSION: Gua sha has beneficial short-term effects on pain and functional status in patients with chronic neck pain. The value of Gua sha in the long-term management of neck pain and related mechanisms remains to be clarified.

Homeopathic treatment of elderly patients--a prospective observational study with follow-up over a two year period.

BACKGROUND: Very little is known about the range of diagnoses, course of treatment and long-term outcome in elderly patients who choose to receive homeopathic medical treatment. We investigated homeopathic practice in an industrialised country under everyday conditions.The aim of the study was to determine the spectrum of diagnoses and treatments, as well as to describe the course of illness over time among older patients who chose to receive homeopathic treatment. METHODS: In this subgroup analysis of a prospective, multicentre cohort study totally including 3981 patients treated by homeopathic physicians in primary care practices in Germany and Switzerland, data was analysed from all patients > 70 years consulting the physician for the first time. The main outcome measures were: assessment by patient of the severity of complaints (numeric rating scales) and quality of life (SF-36) and by the physician of the severity of diagnoses (numeric rating scales) at baseline, and after 3, 12, and 24 months. RESULTS: A total of 83 patients were included in the subgroup analysis (41% men, mean age 73.2 +/- (SD) 3.1 years; 59% women, 74.3 +/- 3.8 years).98.6 percent of all diagnoses were chronic with an average duration of 11.5 +/- 11.5 years. 82 percent of the patients were taking medication at baseline.The most frequent diagnoses were hypertension (20.5%, 11.1 +/- 7.5 years) and sleep disturbances (15.7%, 22.1 +/- 25.8 years).The severity of complaints decreased significantly between baseline and 24 months in both patients (from 6.3 (95%CI: 5.7-6.8) to 4.6 (4.0-5.1), p < 0.001) and physicians' assessments (from 6.6 (6.0-7.1) to 3.7 (3.2-4.3), p < 0.001); quality of life (SF 36) and the number of medicines taken did not significantly change. CONCLUSION: The severity of disease showed marked and sustained improvements under homeopathic treatment, but this did not lead to an improvement of quality of life. Our findings might indicate that homeopathic medical therapy may play a beneficial role in the long-term care of older adults with chronic diseases and studies on comparative effectiveness are needed to evaluate this hypothesis.

Placebo effect sizes in homeopathic compared to conventional drugs - a systematic review of randomised controlled trials.

BACKGROUND: It has been hypothesised that randomised, placebo-controlled clinical trials (RCTs) of classical (individualised) homeopathy often fail because placebo effects are substantially higher than in conventional medicine. OBJECTIVES: To compare placebo effects in clinical trials on homeopathy to placebo effects on trials of conventional medicines. METHODS: We performed a systematic literature analysis on placebo-controlled double-blind RCTs on classical homeopathy. Each trial was matched to three placebo-controlled double-blind RCTs from conventional medicine (mainly pharmacological interventions) involving the same diagnosis. Matching criteria included severity of complaints, choice of outcome parameter, and treatment duration. Outcome was measured as the percentage change of symptom scores from baseline to end of treatment in the placebo group. 35 RCTs on classical homeopathy were identified. 10 were excluded because no relevant data could be extracted, or less than three matching conventional trials could be located. RESULTS: In 13 matched sets the placebo effect in the homeopathic trials was larger than the average placebo effect of the conventional trials, in 12 matched sets it was lower (P=0.39). Additionally, no subgroup analysis yielded any significant difference. CONCLUSIONS: Placebo effects in RCTs on classical homeopathy did not appear to be larger than placebo effects in conventional medicine.

Homeopathic treatment of patients with dysmenorrhea: a prospective observational study with 2 years follow-up.

PURPOSE: Evaluating homeopathic treatment for dysmenorrhea. METHODS: Prospective multicenter observational study in primary care, using standardized questionnaires to record for 2 years diseases, quality of life, medical history, consultations, all treatments, other health services use. RESULTS: Fifty-seven physicians treated 128 women (age 32.4 +/- 7.5 years, mean +/- SD) and 11 girls (13.7 +/- 4.0). Women had dysmenorrhea for 11.6 +/- 9.0 (girls 3.1 +/- 1.5) years. Patients received 7.5 +/- 6.5 (5.9 +/- 3.7) homeopathic prescriptions. Diagnoses and complaints severity improved markedly [at 24 months, dysmenorrhea relieved by > 50% of baseline rating in 46.1% (59) of the women and 45.5% (5) of the girls] with large effect sizes (24 months: Cohen's d from 1.18 to 2.93). In addition, QoL improved (24 months: SF-36 physical component score: 0.25, mental component score 0.25, KINDL sum score 0.27). Conventional medication changed little and use of other health services decreased. CONCLUSIONS: Patients with dysmenorrhea improved under homeopathic treatment. Controlled studies should investigate efficacy and effectiveness.

Homeopathic treatment of patients with chronic sinusitis: A prospective observational study with 8 years follow-up.

BACKGROUND: An evaluation of homeopathic treatment and the outcomes in patients suffering from sinusitis for >or=12 weeks in a usual care situation. METHODS: Subgroup analysis including all patients with chronic sinusitis (ICD-9: 473.9; >or=12 weeks duration) of a large prospective multicentre observational study population. Consecutive patients presenting for homeopathic treatment were followed-up for 2 years, and complaint severity, health-related quality of life (QoL), and medication use were regularly recorded. We also present here patient-reported health status 8 years post initial treatment. RESULTS: The study included 134 adults (mean age 39.8 +/- 10.4 years, 76.1% women), treated by 62 physicians. Patients had suffered from chronic sinusitis for 10.7 +/- 9.8 years. Almost all patients (97.0%) had previously been treated with conventional medicine. For sinusitis, effect size (effect divided by standard deviation at baseline) of complaint severity was 1.58 (95% CI 1.77; 1.40), 2.15 (2.38; 1.92), and 2.43 (2.68; 2.18) at 3, 12, and 24 months respectively. QoL improved accordingly, with SF-36 changes in physical component score 0.27 (0.15; 0.39), 0.35 (0.19; 0.52), 0.44 (0.23; 0.65) and mental component score 0.66 (0.49; 0.84), 0.71 (0.50; 0.92), 0.65 (0.39; 0.92), 0.74 (0.49; 1.00) at these points. The effects were still present after 8 years with SF-36 physical component score 0.38 (0.10; 0.65) and mental component score 0.74 (0.49; 1.00). CONCLUSION: This observational study showed relevant improvements that persisted for 8 years in patients seeking homeopathic treatment because of sinusitis. The extent to which the observed effects are due to the life-style regulation and placebo or context effects associated with the treatment needs clarification in future explanatory studies.

Regression toward the mean--a detection method for unknown population mean based on Mee and Chua's algorithm.

BACKGROUND: Regression to the mean (RTM) occurs in situations of repeated measurements when extreme values are followed by measurements in the same subjects that are closer to the mean of the basic population. In uncontrolled studies such changes are likely to be interpreted as a real treatment effect. METHODS: Several statistical approaches have been developed to analyse such situations, including the algorithm of Mee and Chua which assumes a known population mean mu. We extend this approach to a situation where mu is unknown and suggest to vary it systematically over a range of reasonable values. Using differential calculus we provide formulas to estimate the range of mu where treatment effects are likely to occur when RTM is present. RESULTS: We successfully applied our method to three real world examples denoting situations when (a) no treatment effect can be confirmed regardless which mu is true, (b) when a treatment effect must be assumed independent from the true mu and (c) in the appraisal of results of uncontrolled studies. CONCLUSION: Our method can be used to separate the wheat from the chaff in situations, when one has to interpret the results of uncontrolled studies. In meta-analysis, health-technology reports or systematic reviews this approach may be helpful to clarify the evidence given from uncontrolled observational studies.

Who controls the placebo? Introducing a Placebo Quality Checklist for pharmacological trials.

Randomised placebo-controlled trials (RCT) are an invaluable tool for testing the efficacy of new treatment strategies. The choice of placebo in an RCT can affect not only patients' physical and psychological response to a particular intervention, but also the trial setting, the success of patient blinding to the intervention, and therefore the outcome of the study and the efficacy of treatment in general. Therefore the placebo is intrinsically tied to the trial's methodology and results. However, although placebos are an important component in randomised trials, their quality is often left unquestioned. A placebo which was not properly validated may even have specific effects that lead to false negative results. To address this deficit, we propose a measure of placebo quality using the term placebo to assess the physical aspect of a dummy treatment used in the placebo group of a randomised controlled trial (RCT). The Placebo Quality Checklist (PQC) described here may help investigators select an appropriate placebo and help both investigators and critical readers interpret the findings of studies with more care.

How healthy are chronically ill patients after eight years of homeopathic treatment?--Results from a long term observational study.

BACKGROUND: Homeopathy is a highly debated but often used medical treatment. With this cohort study we aimed to evaluate health status changes under homeopathic treatment in routine care. Here we extend former results, now presenting data of an 8-year follow-up. METHODS: In a prospective, multicentre cohort study with 103 homeopathic primary care practices in Germany and Switzerland, data from all patients (age >1 year) consulting the physician for the first time were observed. The main outcome measures were: The patients' perceived change in complaint severity (numeric rating scales from 0 = no complaint to 10 = maximal severity) and quality of life as measured by the SF-36 at baseline, and after 2 and 8 years. RESULTS: A total of 3,709 patients were studied, 73% (2,722 adults, 72.8% female, age at baseline 41.0 +/- 12.3; 819 children, 48.4% female, age 6.5 +/- 4.0) contributed data to the 8-year follow-up. The most frequent diagnoses were allergic rhinitis and headache in adults, and atopic dermatitis and multiple recurrent infections in children. Disease severity decreased significantly (p < 0.001) between baseline, 2 and 8 years (adults from 6.2 +/- 1.7 to 2.9 +/- 2.2 and 2.7 +/- 2.1; children from 6.1 +/- 1.8 to 2.1 +/- 2.0 and 1.7 +/- 1.9). Physical and mental quality of life sores also increased considerably. Younger age, female gender and more severe disease at baseline were factors predictive of better therapeutic success. CONCLUSION: Patients who seek homeopathic treatment are likely to improve considerably. These effects persist for as long as 8 years.

Differential effects of relaxation techniques on ultraweak photon emission.

BACKGROUND: Evidence has accumulated favoring the possible role of oxidative stress in the pathogenesis of many chronic diseases. Meditation is utilized as an adjunct to conventional medical treatment for several clinical conditions. A few studies suggest a role of long-term meditation in the control of the free-radical metabolism. Many techniques for recording reactive oxygen species (ROS) have been made available. However, most are invasive and none are applicable to all conditions. Attention has recently been drawn to spontaneous ultraweak photon emission (UPE). However, the application of this method in meditation studies is very limited. OBJECTIVE: The present study recorded spontaneous UPE at multiple anatomic locations of subjects with long-term experience in transcendental meditation (TM) and compared this with a group that practiced other meditation techniques (OMT) and with subjects having no meditation experience. METHODS: The study examined the anatomic pattern of UPE of 20 subjects practicing TM, compared to 20 subjects practicing OMT, and 20 control subjects with no experience in meditation. Subjects were men who were reported to be healthy and nonsmokers. Meditation was not practiced on the day prior to recording. UPE was recorded in a dark room, using a highly sensitive, cooled photomultiplier system designed for manipulation in three directions. The protocol for the multisite registration of UPE included recording 12 anatomic locations, including the anterior torso, head, neck, and hands. RESULTS: Data demonstrated emission intensities in the TM and OMT groups that were 27% and 17% lower, respectively, compared to the control group. The decrease was recorded at all anatomic locations. The percent emission contribution of each location to total emission was very similar for the three groups. CONCLUSIONS: Data supported the hypothesis that persistent meditation resulted in decreased UPE. However, the determination of oxidation levels as the source of group differences needs to be verified further to confirm our hypothesis.

Effectiveness of Ayurvedic Massage (Sahacharadi Taila) in Patients with Chronic Low Back Pain: A Randomized Controlled Trial.

OBJECTIVES: Ayurveda is one of the oldest comprehensive healthcare systems worldwide. Ayurvedic massage and physical therapy are frequently used to treat patients with chronic pain syndromes and disorders of the musculoskeletal system. This study aimed to evaluate the effectiveness of Ayurvedic massage in nonspecific chronic low back pain by means of a randomized clinical trial. DESIGN: Sixty-four patients (mean age, 54.8 years; 49 women and 15 men) with chronic low back pain who scored >40 mm on a 100-mm visual analogue scale (VAS) were randomly assigned to a 2-week massage group with 6 hours of Ayurvedic massage and external treatment (n = 32) or to a 2-week local thermal therapy group (n = 32). The study observation period was 4 weeks, consisting of a 2-week intervention phase followed by a 2-week follow-up phase. OUTCOME MEASURES: Primary outcome measure was the change of mean pain (VAS) from baseline to week 4. Secondary outcomes included pain-related bothersomeness, the Roland Disability Questionnaire, quality of life (Medical Outcomes Study 36-Item Short Form), the Hanover Functional Ability Questionnaire for measuring back pain-related disability, and psychological outcomes. Outcomes were assessed at baseline and after 2 and 4 weeks. RESULTS: Mean back pain (primary outcome) at week 2 was significantly reduced from 53.4 ± 18.5 to 21.6 ± 18.2 in the massage group and from 55.3 ± 12.9 to 41.8 ± 19.8 in the standard thermal therapy group (mean group difference, -18.7; 95% confidence interval, -28.7 to -8.7; p < 0.001). While beneficial effects on pain-related bothersomeness and psychological well-being were also apparent, the Ayurvedic intervention did not improve function or disability in the short-term observation period. Both programs were safe and well tolerated. CONCLUSIONS: Ayurvedic external treatment is effective for pain-relief in chronic low back pain in the short term. Further studies with longer observation periods are needed to evaluate the long-term effects of the Ayurvedic external treatment approach on function and disability.

Reliability of Enderlein's darkfield analysis of live blood.

CONTEXT: In 1925, the German zoologist Günther Enderlein, PhD, published a concept of microbial life cycles. His observations of live blood using darkfield microscopy revealed structures and phenomena that had not yet been described. Although very little research has been conducted to explain the phenomena Dr. Enderlein observed, the diagnostic test is still used in complementary and alternative medicine. OBJECTIVE: To test the interobserver reliability and test-retest reliability of 2 experienced darkfield specialists who had undergone comparable training in Enderlein blood analysis. SETTING: Inpatient clinic for internal medicine and geriatrics. METHODS: Both observers assessed 48 capillary blood samples from 24 patients with diabetes. The observers were mutually blind and assessed their findings according to a specific item randomization list that allowed observers to specify whether Enderlein structures were visible or not. RESULTS: The interobserver reliability for the visibility of various structures was kappa = .35 (95% CI: .27-.43), the test-retest reliability was kappa = .44 (95% CI: .36-.53). CONCLUSIONS: This pilot study indicates that Enderlein darkfield analysis is very difficult to standardize and that the reliability of the diagnostic test is low.

Brachialgia paraesthetica nocturna can be relieved by "wet cupping"--results of a randomised pilot study.

BACKGROUND: Centuries ago cupping was one of the most used medical therapies worldwide but it is now regarded as an antiquated and unsafe treatment. Nevertheless it is widely used especially in Germany and China. OBJECTIVE: To investigate the effectiveness of "wet cupping" of a defined connective tissue area (over the Musculus trapezius) in patients suffering from brachialgia paresthetica nocturna. DESIGN: Monocenter, randomised, controlled, sequential clinical trial. SETTING: Section of pain management at the District Hospital of Rüdersdorf, Germany. PATIENTS: Brachialgia-patients of both sexes without age restictions were eligible if they suffered from chronical tonsillar irritations and showed pathologic indurations of the connective tissue area. INTERVENTIONS: The active group was "wet cupped" once, i.e. the skin first was scarified and then blood was drawn by applying vacuum cupping glasses. The control group was left untreated. MAIN OUTCOME MEASURE: Pre- to post-treatment change of brachialgia severeness, calculated from 1-week averages of the means of three subscales (pain, tingling and numbness), each assessed on a 0-10 numeric analogue scale. RESULTS: N=20 patients were randomised (13 women, median age 47 years). Treatment effects can be found in the active (-2.3+/-1.9 score points) but not in the control group (+0.5+/-1.0 points; p=0.002; triangle test). The results are supported by secondary outcome criteria. Adverse events were not documented in any patient. CONCLUSIONS: This study suggests short-term effects of a single wet cupping therapy, which remain at least for 1 week. As the trial lacks of an adequate and blinded placebo therapy the findings are potentially biased.

Does potentized HgCl2 (Mercurius corrosivus) affect the activity of diastase and alpha-amylase?

BACKGROUND: Homeopathic drugs even with dilutions beyond 10(23) (high potencies) are frequently used, although their working mechanism is still unknown. Curative information preserved in solvent structure is postulated to exert biologic effects. OBJECTIVE: The objective was to test for a stimulating or inhibiting effect of high potencies of the homeopathic remedy HgCl2 (Mercurius corrosivus) on two sugar hydrolases. METHODS: High potencies were produced using stepwise dilution plus shaking. Controls included potentized solvent (aqua bidestillata), equimolar dilutions without shaking, and enzyme-free references. Tested were potencies with dilution factors 1:200 (CC) on diastase extract from winter barley, and 1:100 (C) on alpha-amylase from hog pancreas. Enzyme activity was colorimetrically determined by Lugol's iodine-starch reaction. RESULTS: An inhibiting effect of HgCl2 on enzyme activities was observed only in low potencies and dilutions. Statistically significant differences between potencies and controls were not found in randomized and blinded experiments. CONCLUSIONS: This experimental design provided independent reproducible results of cell-free in vitro assays. However, it did not indicate an effect of potentized HgCl2 on hydrolases. Demonstrating potency effects may require additional experimental features.