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Concept: Controlling for a variable


This study aimed to provide a long-term cost comparison of patients using additional homeopathic treatment (homeopathy group) with patients using usual care (control group) over an observation period of 33 months.

Concepts: Controlling for a variable, Scientific control, Scientific method, Retrospective, Economics, Homeopathy


Meditation is associated with positive health behaviors and improved cognitive control. One mechanism for the relationship between meditation and cognitive control is changes in activity of the anterior cingulate cortex-mediated neural pathways. The error-related negativity (ERN) and error positivity (Pe) components of the scalp-recorded event-related potential (ERP) represent cingulate-mediated functions of performance monitoring that may be modulated by mindfulness meditation. We utilized a flanker task, an experimental design, and a brief mindfulness intervention in a sample of 55 healthy non-meditators (n = 28 randomly assigned to the mindfulness group and n = 27 randomly assigned to the control group) to examine autonomic nervous system functions as measured by blood pressure and indices of cognitive control as measured by response times, error rates, post-error slowing, and the ERN and Pe components of the ERP. Systolic blood pressure significantly differentiated groups following the mindfulness intervention and following the flanker task. There were non-significant differences between the mindfulness and control groups for response times, post-error slowing, and error rates on the flanker task. Amplitude and latency of the ERN did not differ between groups; however, amplitude of the Pe was significantly smaller in individuals in the mindfulness group than in the control group. Findings suggest that a brief mindfulness intervention is associated with reduced autonomic arousal and decreased amplitude of the Pe, an ERP associated with error awareness, attention, and motivational salience, but does not alter amplitude of the ERN or behavioral performance. Implications for brief mindfulness interventions and state vs. trait affect theories of the ERN are discussed. Future research examining graded levels of mindfulness and tracking error awareness will clarify relationship between mindfulness and performance monitoring.

Concepts: Controlling for a variable, Scientific control, Nervous system, Scientific method, Psychology, Brain, Blood pressure, Autonomic nervous system


INTRODUCTION: The elastic ligature is the most used method for the out-patient treatment of haemorrhoids, with excellent results in control of bleeding. However, the recurrences in prolapse vary between 15 and 40%. We propose a new method for applying the elastic ligatures. PATIENTS: A total of 17 patients with grade iii haemorrhoids were chosen for the vertical ligatures (VL). The first elastic band was placed 3 to 4cm from the pectineal line and 1 or 2 more in the root of the haemorrhoid group. Another 34 randomly selected patients were used as a control group. Data collected included, demographic details, number of bands and sessions, pain scale, complications and results. The patients were followed up at week one, week 3, and 3 months and one year after the intervention. RESULTS: A total of 12 males and 5 females, with a median age of 46 years, were treated with VL. The median follow-up was 10 (from 8 to 19) months. A median of 3 sessions and 7 elastic bands were used, with 6 patients having moderate pain that required analgesic treatment. None of the patients needed urgent treatment for pain or bleeding. There was a complete response to bleeding in 15 patients (88.2%) and to prolapse in 14 (82.2%). Two patients required haemorrhoidectomy due to treatment failure. The measurements of therapeutic effect after one year were: number needed to treat (NNT) of 4 (95% CI, 2 to 22), for prolapse, and NNT of 4 (95% CI, 2 a 15), for bleeding. CONCLUSIONS: Elastic ligatures could become a new treatment option for Grade iii haemorrhoids, improving control of bleeding and prolapse.

Concepts: Controlling for a variable, Scientific control, Patient, Pain, Demographics, Prolapse, Hemorrhoid, Rubber band


The aim of the present study was to evaluate the effect of 15% alcohol dependence on ligature-induced alveolar bone loss and TNF- secretion in Wistar rats. Thirty-three male Wistar rats aged 45-60 days (mean weight=253 g) were randomly allocated test or control groups. Test group (n=18) received 15% alcohol as liquid intake and control group (n=15) received water during the experimental period. TNF-α was analyzed by ELISA assay in 11 animals per group. After 14 days of alcohol/water intake, alcohol dependency was assessed and silk ligatures were placed around the left second upper molars. Ligature presence and body weight were checked weekly. After 40 days, animals were sacrificed and the maxillae were defleshed for morphometric analysis using standardized images. All animals in the test group displayed signs of alcohol dependency at day 14. No statistically significant differences in final body weight (334.83±21.38 vs. 322.48±30.65 g, p=0.20) were observed between groups. In relation to alveolar bone loss, no statistically significant difference was observed among test and control groups both for ligated teeth (0.76±0.06 vs. 0.74±0.10 mm, p=0.60) and unligated teeth (0.41±0.16 vs. 0.35±0.05 mm, p=0.22). The TNF-α secretion also did not display statistically significant differences between test and control groups (10.78±1.84 vs. 12.13±2.11 pg/mL, p=0.12). It may be concluded that 15% alcohol dependency was not capable to alter alveolar bone loss and TNF-α secretion in Wistar rats.

Concepts: Controlling for a variable, Scientific control, Scientific method, Statistics, Statistical significance, Alcoholism, ELISA, Teeth


Does increasing incomes improve health? In 1999, the UK government implemented minimum wage legislation, increasing hourly wages to at least £3.60. This policy experiment created intervention and control groups that can be used to assess the effects of increasing wages on health. Longitudinal data were taken from the British Household Panel Survey. We compared the health effects of higher wages on recipients of the minimum wage with otherwise similar persons who were likely unaffected because (1) their wages were between 100 and 110% of the eligibility threshold or (2) their firms did not increase wages to meet the threshold. We assessed the probability of mental ill health using the 12-item General Health Questionnaire. We also assessed changes in smoking, blood pressure, as well as hearing ability (control condition). The intervention group, whose wages rose above the minimum wage, experienced lower probability of mental ill health compared with both control group 1 and control group 2. This improvement represents 0.37 of a standard deviation, comparable with the effect of antidepressants (0.39 of a standard deviation) on depressive symptoms. The intervention group experienced no change in blood pressure, hearing ability, or smoking. Increasing wages significantly improves mental health by reducing financial strain in low-wage workers. © 2016 The Authors. Health Economics published by John Wiley & Sons Ltd.

Concepts: Controlling for a variable, Scientific control, Longitudinal study, Economics, Employment, Minimum wage, British Household Panel Survey, Wage


This Swedish registry study showed that women who had undergone bariatric surgery had a higher risk of preterm birth than did women in a control group matched for presurgery body-mass index.

Concepts: Controlling for a variable, Scientific control, Childbirth, Obesity


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 Identifier: NCT01057043.

Concepts: Controlling for a variable, Scientific control, Scientific method, Osteoarthritis, Paracetamol, Acupuncture, Randomization, Control


This study evaluated an intervention for people with aphasia delivered in a novel virtual reality platform called EVA Park. EVA Park contains a number of functional and fantastic locations and allows for interactive communication between multiple users. Twenty people with aphasia had 5 weeks' intervention, during which they received daily language stimulation sessions in EVA Park from a support worker. The study employed a quasi randomised design, which compared a group that received immediate intervention with a waitlist control group. Outcome measures explored the effects of intervention on communication and language skills, communicative confidence and feelings of social isolation. Compliance with the intervention was also explored through attrition and usage data.

Concepts: Controlling for a variable, Scientific control, Sociology, Simulated reality, Communication, Programming language, Virtual reality, Interactivity


Hepatic veno-occlusive disease, also called sinusoidal obstruction syndrome (VOD/SOS), is a potentially life-threatening complication of hematopoietic stem cell transplantation (HSCT). Untreated hepatic VOD/SOS with multi-organ failure (MOF) is associated with >80% mortality. Defibrotide has shown promising efficacy treating hepatic VOD/SOS with MOF in phase 2 studies. This phase 3 study investigated the safety and efficacy of defibrotide in adult and pediatric patients with established hepatic VOD/SOS and advanced MOF. Patients (n=102) given 25 mg/kg/day defibrotide were compared with 32 historical controls identified out of 6867 medical charts of HSCT patients by a blinded independent medical review committee. Baseline characteristics between groups were well balanced. The primary objective was to compare survival at Day+100 post-HSCT; observed rates equaled 38.2% in the defibrotide group and 25.0% in the control group (estimated difference of 23.0%; 95.1% confidence interval [CI] 5.2%-40.8%; P=.0109, using a propensity-adjusted analysis based on 4 prognostic factors of survival). Observed Day+100 complete response (CR) rates equaled 25.5% for defibrotide and 12.5% in the controls (19.0% difference using similar methodology; 95.1% CI 3.5-34.6; P=.0160). Defibrotide was generally well-tolerated with manageable toxicity. Related adverse events included hemorrhage or hypotension; there was no difference in the incidence of common hemorrhagic adverse events (including pulmonary alveolar [11.8% and 15.6%] and gastrointestinal [7.8% and 9.4%]) between the defibrotide and control groups, respectively. Defibrotide was associated with significant improvement in Day+100 survival and CR rate. The historical-control methodology offers a novel, meaningful approach for phase 3 evaluation of orphan diseases associated with high mortality. This study is registered to as NCT00358501.

Concepts: Controlling for a variable, Scientific control, Scientific method, Epidemiology, Clinical trial, Bleeding, Hematopoietic stem cell transplantation, Hematopoietic stem cell


OBJECTIVE: To examine whether acupuncture treatment would improve outcome in chronic Achilles tendinopathy. METHODS: A randomized, controlled trial at two centers of 64 randomized patients aged 18 to 70 years with chronic Achilles tendinopathy was conducted from July 2007 to April 2010, with follow-up until October, 2010. These patients were randomly allocated into an acupuncture treatment group (acupuncture group) and an eccentric exercises group (control group). The validated Victorian Institute of Sports Assessment- Achilles (VISA-A) questionnaire was completed at baseline and 8, 16, and 24 weeks. The pain at rest and after activity was accessed at baseline and 8 weeks with Visual Analogue Scale (VAS). RESULTS: After randomization into the acupuncture group or control group, one patient was loss of follow-up. The mean VISA-A score improved significantly after 8 weeks in the acupuncture group to 67.1 points [95% confidence interval (CI), 64.1-70.2] and in the control group to 48.5 points (95% CI, 45.5-51.6) with an additional 18.6 points increase in acupuncture treatment patients (P =0.0000). Acupuncture treatment resulted in a significant increase from baseline in VISA-A of 25.8 after 16 weeks and 28.4 after 24 weeks. Whereas, in the control group the increase from baseline in VISA-A were 10.0 and 16.6 after 16 and 24 weeks, respectively (P =0.0000). The VAS diminished by 2.0 cm after activity, and by 1.5 cm at rest after 8 weeks in the control group. In the acupuncture group, the pain scores diminished significantly more than in the control group, with pain reduction of 3.7 cm after activity (P =0.0000) and 3.2 cm at rest (P =0.0000). CONCLUSION: Acupuncture intervention could improve pain and activity in patients with chronic Achilles tendinopathy compared with eccentric exercises.

Concepts: Controlling for a variable, Scientific control, Randomized controlled trial, Acupuncture, Randomness, Randomization, Control, Applications of randomness