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.

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.

Effectiveness of focused meditation for patients with chronic low back pain-A randomized controlled clinical trial.

OBJECTIVES: We aimed to evaluate the effectiveness of an 8-week meditation program (focused meditation) in patients with chronic low-back pain. DESIGN: A randomized clinical trial was conducted on 68 patients (55 years;75% female) with chronic low-back pain who scored >40mm on a 100mm Visual-Analogue-Scale. Subjects were allocated to an 8-week meditation program (focused meditation) with weekly 75min classes or to a self-care exercise program with a wait-list offer for meditation. Both groups were instructed to practice at home. Outcomes were assessed baseline and after 4 and 8 weeks. The primary outcome measure was the change in mean back pain at rest after 8 weeks. Secondary outcomes included function, pain-related bothersomeness, perceived stress, quality-of-life (QOL), and psychological outcomes. RESULTS: Twelve (meditation) and 4 (exercise) patients were lost to follow-up. The primary outcome, pain at rest after 8 weeks, was reduced from 59.3±13.9mm to 40.8±21.8mm with meditation vs. 52.9±11.8mm to 37.3±18.2mm with exercise (adjusted group difference: -1.4 (95%CI:11.6;8.8;p=n.s.) Perceived stress was significantly more reduced with meditation (p=0.011). No significant treatment effects were found for other secondary outcomes as pain-related bothersomeness, function, quality-of-life and psychological scores, although the meditation group consistently showed non-significant better improvements compared to the exercise group. CONCLUSIONS: Focused meditation and self-care exercise lead to comparable, symptomatic improvements in patients with chronic low back pain. Future studies should include longer-term follow-ups and develop guided meditation programs to support compliance.

Efficacy and safety of Ayurvedic herbs in diarrhoea-predominant irritable bowel syndrome: A randomised controlled crossover trial.

OBJECTIVE: Herbal medicines have been used widely for the treatment of irritable bowel syndrome (IBS) patients. The aim of this study is to investigate efficacy and safety of an Ayurvedic herbal compound preparation made from: Murraya koenigii (curry), Punica granatum (pomegranate) and Curcuma longa (turmeric), compared to a placebo in patients with diarrhoea predominant IBS. MATERIAL AND METHODS: This trial was conducted as a randomised placebo-controlled crossover trial with randomised sequence of verum and placebo for each patient. Verum and placebo were provided as ground powders and delivered in sealed containers. Patients and outcome assessors were blinded. Patients were advised to ingest the decoction twice daily for 4 weeks. The primary outcome measure was IBS symptom intensity; secondary outcomes included: quality of life, anxiety and depression, compliance and safety. RESULTS: 32 IBS patients were included in the trial (19 females, mean age 50.3±11.9years). Eleven people dropped out during the trial resulting in 37 complete verum and 35 complete placebo phases. No group differences were found between verum and placebo for IBS symptom intensity (difference 24.10; 95% CI: -17.12; 65.32, p=0.26). The same was true for secondary outcomes. Compliance was satisfactory to good and the preparation appeared to be safe, but one third of the patients registered at least one minor adverse event that might be related to the study interventions. CONCLUSION: An Ayurvedic herbal preparation made from Murraya koenigii, Punica granatum and Curcuma longa appeared to be no more effective in improving diarrhoea predominant irritable bowel symptoms than placebo.

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.

Effectiveness of jyoti meditation for patients with chronic neck pain and psychological distress--a randomized controlled clinical trial.

UNLABELLED: Chronic neck pain is a common medical complaint partly mediated by psychosocial distress and having a high socioeconomic impact. There is preliminary evidence that stress reduction by meditation might be beneficial in chronic pain syndromes. We aimed to evaluate the effectiveness of an 8-week meditation program (jyoti meditation) in patients with chronic neck pain by means of a randomized clinical trial. Eighty-nine patients (aged 49.7 ± 10.5 years, 73 female) with chronic neck pain who scored >40 mm on a 100-mm visual analog scale and had concomitant increased perceived stress were randomized to an 8-week meditation program (jyoti meditation) with weekly 90-minute classes (n = 45) or to a home-based exercise program (n = 44) with a wait list offer for meditation. Both groups were instructed to practice at home. Outcomes were assessed at baseline and after 8 weeks. Primary outcome measure was change of mean pain at rest (visual analog scale score) from baseline to week 8. Secondary outcomes included pain at motion, functional disability, pain-related bothersomeness, perceived stress, quality of life, and psychological outcomes. Patients had neck pain for a mean of 11 years. Eighteen patients in the meditation group and 16 patients in the exercise group were lost to follow-up. Meditation training significantly reduced pain when compared to the exercise group after 8 weeks (reduction of 45.5 ± 23.3 mm to 21.6 ± 17.2 mm in the meditation group, and 43.8 ± 22.0 mm to 37.7 ± 21.5 mm in the exercise group; mean difference: 13.2 mm [95% confidence interval: 2.1, 24.4; P = .02]). Pain-related bothersomeness decreased more in the meditation group (group difference 11.0 mm [95% confidence interval: 1.0, 21.0; P = .03]). No significant treatment effects were found for pain at motion, psychological scores, and quality of life, although the meditation group showed nonsignificant greater improvements compared to the exercise group. In conclusion, meditation may support chronic pain patients in pain reduction and pain coping. Further well-designed studies including more active control comparisons and longer-term follow-up are warranted. PERSPECTIVE: This article presents the results of a randomized controlled trial on the clinical effects of an 8-week meditation program or self-care exercise in patients with chronic neck pain. Meditation reduced pain at rest but not disability and might be a useful treatment option for pain management of chronic neck pain.

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.

Introducing a computer-assisted, digital tongue-imaging device for standardization of traditional tongue diagnosis.

BACKGROUND: In Traditional Chinese Medicine (TCM) tongue diagnosis and pulse diagnosis are the major diagnostic methods up till now. As western research has tended to focus on acupuncture, attempts to standardize the classic diagnostic methods have been few. METHODS: A digital camera with a ring flash was fixed in a frame, so that the tongue-lens-distance and illumination were kept constant. A pilot study testing the inter-methods reliability, test-retest reliability, and interrater reliability of 2 observers was conducted: the tongues (1 ×) as well as the tongue images (2 ×) from 76 patients from our ward were assessed with a standardized rating list in a randomized order by both observers, who were mutually blinded. As primary outcome measure we used agreement beyond chance (Cohen's kappa). RESULTS: The colors of the tongue body / the tongue coating were the main criteria for the authentic reproduction of the tongue in our images. Inter-methods reliability for the color of the tongue body/coating was kappa 0.35 / 0.34 (p < 0.001) for observer 1 and 0.59 / 0.57 (p < 0.001) for observer 2. Test-retest reliability for the color of the tongue body / the tongue coating was kappa 0.53 / 0.48 (p< 0.001) for observer 1 and 0.65 / 0.62 (p < 0.001) for observer 2. Interrater reliability was generally low. CONCLUSIONS: The introduced device represents a first step towards standardization of tongue diagnosis. However, inter-methods as well as test-retest reliability vary between observers and different morphological characteristics.

Standardized versus Individualized Acupuncture for Chronic Low Back Pain: A Randomized Controlled Trial.

We aimed to compare the effectiveness of standardized and individualized acupuncture treatment in patients with chronic low back pain. A single-center randomized controlled single-blind trial was performed in a general medical practice in Germany run by a Chinese-born medical doctor trained in western and Chinese medicine. One hundred and fifty outpatients with chronic low back pain were randomly allocated to two groups (78 standardized and 72 individualized acupuncture). Patients received either standardized acupuncture or individualized acupuncture. Treatment encompassed between 10 and 15 treatments based on individual symptoms with two treatments per week. The main outcome measure was the area under the curve (AUC) summarizing eight weeks of daily rated pain severity measured with a visual analogue scale (0 mm = no pain, 100 mm = worst imaginable pain). No significant differences between groups were observed for the AUC (individualized acupuncture mean: 1768.7 (95% CI, 1460.4; 2077.1); standardized acupuncture 1482.9 (1177.2; 1788.7); group difference, 285.8 (-33.9; 605.5) P = 0.080). In this single-center trial, individualized acupuncture was not superior to standardized acupuncture for patients suffering from chronic pain. As a next step, a multicenter noninferiority study should be performed to investigate whether standardised acupuncture treatment for chronic low back pain might be applicable in a broader usual care setting. This trial is registered with ClinicalTrials.gov NCT00758017.

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.

Can a multimodal mind-body program enhance the treatment effects of physical activity in breast cancer survivors with chronic tumor-associated fatigue? A randomized controlled trial.

UNLABELLED: Background. Chronic fatigue is one of the most restricting symptoms following primary breast cancer treatment, but clinical studies on symptom management are rare. The objective was to evaluate the impact of a multimodal mind-body program (MMMT), including moderate physical activity as compared with a walking intervention alone, on chronic fatigue symptoms of women with stage I to IIIA breast cancer. PATIENTS AND METHODS: Sixty-four women (mean age = 56.7 years) suffering from chronic fatigue after active tumor treatment were randomly assigned to either an experimental or a control (n = 32 each) intervention (10 weeks). Fatigue, quality of life (QoL), functional well-being, anxiety, and depression were measured with standard questionnaires at baseline, after 10 weeks, and after 3 months. RESULTS: Compared with baseline, both groups had reduced fatigue scores after treatment without any significant difference between groups (posttreatment, Δ = -0.3, confidence interval = -1.6 to 1.0, P = .678; follow-up, Δ = -0.4, confidence interval = -1.8 to 0.9, P = .510). All patients also improved regarding QoL and general functional well-being. CONCLUSION: Since both interventions reduced fatigue symptoms and enhanced QoL to a similar extent, we observed no verifiable add-on effect of the MMMT regarding fatigue symptoms. Considering the higher costs with additional expenditure related to MMMT, home-based walking intervention is recommended.

In-Patient Treatment of Fibromyalgia: A Controlled Nonrandomized Comparison of Conventional Medicine versus Integrative Medicine including Fasting Therapy.

Fibromyalgia poses a challenge for therapy. Recent guidelines suggest that fibromyalgia should be treated within a multidisciplinary therapy approach. No data are available that evaluated multimodal treatment strategies of Integrative Medicine (IM). We conducted a controlled, nonrandomized pilot study that compared two inpatient treatment strategies, an IM approach that included fasting therapy and a conventional rheumatology (CM) approach. IM used fasting cure and Mind-Body-Medicine as specific methods. Of 48 included consecutive patients, 28 were treated with IM, 20 with CM. Primary outcome was change in the Fibromyalgia Impact Questionnaire (FIQ) score after the 2-week hospital stay. Secondary outcomes included scores of pain, depression, anxiety, and well being. Assessments were repeated after 12 weeks. At 2 weeks, there were significant improvements in the FIQ (P < 0.014) and for most of secondary outcomes for the IM group compared to the CM group. The beneficial effects for the IM approach were reduced after 12 weeks and no longer statistically significant with the exception of anxiety. Findings indicate that a multimodal IM treatment with fasting therapy might be superior to CM in the short term and not inferior in the mid term. Longer-term studies are warranted to assess the clinical impact of integrative multimodal treatment in fibromyalgia.

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.

Metabolic and psychological response to 7-day fasting in obese patients with and without metabolic syndrome.

BACKGROUND: Extended modified fasting is a frequently practiced tradition in Europe. It is claimed to improve the cardiometabolic state and physical and psychological well-being by an evolutionary co-developed adaptation response. We aimed to investigate the cardiometabolic and psychological effects of a 7-day fast and differences of these responses between patients with or without metabolic syndrome (MetS). METHODS: We investigated 30 female subjects (49.0 ± 8.1 years, BMI 30.4 ± 6.7 kg/m(2)) with (n = 12) and without (n = 18) MetS. All subjects participated in a 7-day fast according to Buchinger with a nutritional energy intake of 300 kcal/day and stepwise reintroduction of solid food thereafter. Outcomes were assessed baseline and after fasting and included measures of metabolic and glucoregulatory control, adipokines as well as psychological well-being as assessed by Profile of Mood States (POMS) and Hospital Anxiety and Depression Scale (HADS). RESULTS: Mean weight decreased from 85.4 ± 18.8 kg to 79.7 ± 18.2 kg accompanied by systolic/diastolic blood pressure (BP) reduction of -16.2 mm Hg (95% CI: -9.1; -23.3 mm Hg) and -6.0 mm Hg (95% CI: -1.8; -10.3 mm Hg), each p < 0.001 and p = 0.005. Fasting led to marked decreases of levels of LDL-cholesterol, leptin, and insulin and increases of levels of adiponectin, leptin receptors, and resistin. Fasting-induced mood enhancement was reflected by decreased anxiety, depression, fatigue, and improved vigor. Patients with MetS showed some greater changes in B P, LDL-cholesterol, triglycerides, adiponectin, leptin, and sleep quality. Fasting was well-tolerated. CONCLUSIONS: Our results point to marked beneficial responses to 7-day modified fasting and a potential role in the prevention of the MetS. Randomized trials with longer observation periods should test the clinical effectiveness of fasting in metabolic diseases.

Randomized-controlled trial comparing yoga and home-based exercise for chronic neck pain.

OBJECTIVES: Chronic neck pain is a significant public health problem with only very few evidence-based treatment options. There is growing evidence for the effectiveness of yoga for relieving musculoskeletal disorders. The aim of this study was to evaluate the effect of Iyengar yoga compared with exercise on chronic nonspecific neck pain. METHODS: Patients were randomly assigned to either yoga or exercise. The yoga group attended a 9-week yoga course and the exercise group received a self-care manual on home-based exercises for neck pain relief. The main outcome measure was the present neck pain intensity (100 mm visual analog scale). Secondary outcome measures included functional disability (Neck Disability Index), pain at motion (visual analog scale), health-related quality of life (Short Form-36 questionnaire), cervical range of motion, proprioceptive acuity, and pressure pain threshold. RESULTS: Fifty-one patients (mean age 47.8 y ; 82.4% female) were randomized to yoga (n=25) and exercise (n=26) intervention. After the study period, patients in the yoga group reported significantly less neck pain intensity compared with the exercise group [mean difference: -13.9 mm (95% CI, -26.4 to -1.4), P=0.03]. The yoga group reported less disability and better mental quality of life. Range of motion and proprioceptive acuity were improved and the pressure pain threshold was elevated in the yoga group. DISCUSSION: Yoga was more effective in relieving chronic nonspecific neck pain than a home-based exercise program. Yoga reduced neck pain intensity and disability and improved health-related quality of life. Moreover, yoga seems to influence the functional status of neck muscles, as indicated by improvement of physiological measures of neck pain.

Yoga for chronic neck pain: a pilot randomized controlled clinical trial.

UNLABELLED: Yoga has been found effective in the treatment of chronic low back pain. We aimed to evaluate the effectiveness of Iyengar yoga in chronic neck pain by means of a randomized clinical trial. Seventy-seven patients (aged 47.9 ± 7.9, 67 female) with chronic neck pain who scored >40 mm on a 100-mm visual analog scale (VAS) were randomized to a 9-week Iyengar yoga program with weekly 90-minute classes (n = 38) or to a self-care/exercise program (n = 38). Patients were examined at baseline and after 4 and 10 weeks. The primary outcome measure was change of mean pain at rest (VAS) from baseline to week 10. Secondary outcomes included pain at motion, functional disability, quality of life (QOL), and psychological outcomes. Twelve patients in the yoga group and 11 patients in the self-care/exercise group were lost to follow-up, with higher study nonadherence in the self-care group (5 versus 10 patients). Mean pain at rest was reduced from 44.3 ± 20.1 to 13.0 ± 11.6 at week 10 by yoga and from 41.9 ± 21.9 to 34.4 ± 21.1 by self-care/exercise (group difference: -20.1, 95% confidence interval: -30.0, -10.1; P < .001). Pain at motion was reduced from 53.4 ± 18.5 to 22.4 ± 18.7 at week 10 by yoga and from 49.4 ± 22.8 to 39.9 ± 21.5 by self-care/exercise (group difference: -18.7, 95% confidence interval: -29.3, -8.1; P < .001). Significant treatment effects of yoga were also found for pain-related apprehension, disability, QOL, and psychological outcomes. Sensitivity analyses suggested minimal influence of dropout rates. Both programs were well tolerated. In this preliminary trial, yoga appears to be an effective treatment in chronic neck pain with possible additional effects on psychological well-being and QOL. The effectiveness of yoga in chronic neck pain should be further tested by comparative effectiveness studies with longer observation periods. PERSPECTIVE: This article presents the results of a randomized controlled trial on the clinical effects of a 9-week yoga program or self-care exercise in patients with chronic neck pain. Yoga led to superior pain relief and functional improvements and might be a useful treatment option for chronic neck pain.

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.

Randomized controlled pilot study: pain intensity and pressure pain thresholds in patients with neck and low back pain before and after traditional East Asian "gua sha" therapy.

Gua Sha is a traditional East Asian healing technique where the body surface is "press-stroked" with a smooth-edged instrument to raise therapeutic petechiae that last 2-5 days. The technique is traditionally used in the treatment of both acute and chronic neck and back pain. This study aimed to measure the effects of Gua Sha therapy on the pain ratings and pressure pain thresholds of patients with chronic neck pain (CNP) and chronic low back pain (CLBP). A total of 40 patients with either CNP or CLBP (mean age 49.23 ± 10.96 years) were randomized to either a treatment group (TG) or a waiting list control group (WLC). At baseline assessment (T1), all patients rated their pain on a 10 cm visual analog scale (VAS). Patients' pressure pain thresholds (PPT) at a site of maximal pain (pain-maximum) and an adjacent (pain-adjacent) site were also established. The treatment group then received a single Gua Sha treatment. Post-intervention measurements were taken for both groups at T2, seven days after baseline assessment (T1), using the same VAS and PPT measurements in precisely the same locations as at T1. Final analysis were conducted with 21 patients with CNP and 18 patients with CLBP. The study groups were equally distributed with regard to randomization. Patients in both the CNP and the CLBP treatment groups reported pain reduction (p < 0.05) and improved health status from their one Gua Sha treatment, as compared to the waiting list group. Pain sensitivity improved in the TG in CNP, but not in CLBP patients, possibly due to higher pressure sensitivity in the neck area. No adverse events were reported. These results suggest that Gua Sha may be an effective treatment for patients with chronic neck and low back pain. Further study of Gua Sha is warranted.