Between-group Difference In Mean Change Research Articles

Self-Acupressure for Older Adults With Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial.

This double-blind randomized controlled trial aimed to test the efficacy of self-administered acupressure for pain and physical function improvement for older adults with knee osteoarthritis (OA). Participants were community-dwelling adults with symptomatic knee OA (n = 150, mean age 73 years), randomized to 1 of 3 groups: verum acupressure, sham acupressure, or usual care. Participants in the verum and sham groups, but not those in the usual care group, were taught to self-apply acupressure once daily, 5 days/week for 8 weeks. Assessments were collected during center visits at baseline, and at 4 and 8 weeks. In addition, pain level was assessed weekly by phone using a numeric rating scale (NRS). Outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (primary), and subjective and objective physical function measures and the NRS and physical function measures (secondary). Linear mixed regression analysis was conducted to test between-group differences in mean changes from baseline for the outcomes at 8 weeks. Compared with usual care, both verum and sham acupressure participants experienced significant improvements in WOMAC pain (mean difference -1.27 units [95% confidence interval (95% CI) -1.95, -0.58] and -1.24 units [95% CI -1.92, -0.55], respectively), NRS pain (-0.74 units [95% CI -1.24, -0.24] and -0.51 units [95% CI -1.01, -0.01], respectively), and WOMAC function (-4.83 units [95% CI -6.99, -2.67] and -4.21 units [95% CI -6.37, -2.04], respectively) at 8 weeks. There were no significant differences between the verum and sham acupressure groups on any of the outcomes. Self-administered acupressure is superior to usual care in pain and physical function improvement for older adults with knee OA. The reason for the benefits is unclear, and the placebo effect may play a role.

Effects of the Nordic Hamstring exercise on sprint capacity in male football players: a randomized controlled trial

ABSTRACT This assessor-blinded, randomized controlled superiority trial investigated the efficacy of the 10-week Nordic Hamstring exercise (NHE) protocol on sprint performance in football players. Thirty-five amateur male players (age: 17–26 years) were randomized to a do-as-usual control group (CG; n = 17) or to 10-weeks of supervised strength training using the NHE in-season (IG; n = 18). A repeated-sprint test, consisting of 4 × 6 10 m sprints, with 15 s recovery period between sprints and 180 s between sets, was conducted to evaluate total sprint time as the primary outcome. Secondary outcomes were best 10 m sprint time (10mST) and sprint time during the last sprint (L10mST). Additionally, peak eccentric hamstring strength (ECC-PHS) and eccentric hamstring strength capacity (ECC-CAPHS) were measured during the NHE. Ten players were lost to follow-up, thus 25 players were analyzed (CG n = 14; IG n = 11). Between-group differences in mean changes were observed in favor of the IG for sprint performance outcomes; TST (−0.649 s, p = 0.056, d = 0.38), 10mST (−0.047 s, p = 0.005, d = 0.64) and L10mST (−0.052 s, p = 0.094, d = 0.59), and for strength outcomes; ECC-PHS (62.3 N, p = 0.006, d = 0.92), and ECC-CAPHS (951 N, p = 0.005, d = 0.95). In conclusion, the NHE showed small-to-medium improvements in sprint performance and large increases in peak eccentric hamstring strength and capacity. Trial Registration Number: NCT02674919

The Effect of Vitamin D Supplementation on Bone Metabolic Markers in Chronic Kidney Disease.

Use of active forms of vitamin D is advocated in patients with chronic kidney disease (CKD) for treatment of mineral bone disease because of the presumption that native forms of vitamin D would not undergo significant activation to calcitriol, the most active biological form of vitamin D. We present secondary analysis looking at bone turnover in subjects who completed the randomized, double blind, placebo-controlled trial investigating the effect of cholecalciferol supplementation on vascular function in nondiabetic CKD stage G3-G4 and vitamin D ≤20 ng/mL (Clinical Trials Registry of India: CTRI/2013/05/003648). Patients were randomized (1:1) to receive either two directly observed oral doses of 300,000 IU of cholecalciferol or matching placebo at baseline and 8 weeks. Of the 120 subjects enrolled, 58 in the cholecalciferol group and 59 in the placebo group completed the study. At 16 weeks, the serum 25(OH)D and 1,25(OH)2 D levels increased in the cholecalciferol group but not in the placebo group (between-group difference in mean change: 23.40 ng/mL; 95% CI, 19.76 to 27.06; p < 0.001, and 14.98 pg/mL; 95% CI, 4.48 to 27.18; p = 0.007, respectively). Intact parathyroid hormone (iPTH) decreased in the cholecalciferol group (between-group difference in mean change -100.73 pg/mL (95% CI, -150.50 to -50.95; p < 0.001). Serum total and bone-specific alkaline phosphatase (SAP, BAP) and serum C-terminal cross-linked collagen type I telopeptides (CTX-1) were significantly reduced in cholecalciferol group (between group difference for change in mean: -20.25 U/L; 95% CI, -35.14 to -5.38 U/L; p = 0.008 for SAP; -12.54 U/L; 95% CI, -22.09 to -2.98 U/L; p = 0.013 for BAP; and -0.21 ng/mL; 95% CI, -0.38 to -0.05 ng/mL; p = 0.05 for CTX-1). Correlation analysis showed significant correlation of Δ25(OH)D with ΔiPTH (r = -0.409, p < 0.0001), Δ1,25(OH)2 D (r = 0.305, p = 0.001), ΔSAP (r = -0.301, p = 0.002), ΔBAP (r = -0.264, p = 0.004), and ΔCTX-1 (r = -0.210, p = 0.0230). Cholecalciferol supplementation corrects vitamin D deficiency and is effective in lowering serum intact parathyroid hormone and bone turnover markers in early stages of CKD. © 2017 American Society for Bone and Mineral Research.

A Randomized Trial of Vitamin D Supplementation on Vascular Function in CKD

Vitamin D deficiency associates with mortality in patients with CKD, and vitamin D supplementation might mitigate cardiovascular disease risk in CKD. In this randomized, double-blind, placebo-controlled trial, we investigated the effect of cholecalciferol supplementation on vascular function in 120 patients of either sex, aged 18-70 years, with nondiabetic CKD stage 3-4 and vitamin D deficiency (serum 25-hydroxyvitamin D ≤20 ng/ml). We randomized patients using a 1:1 ratio to receive either two directly observed oral doses of cholecalciferol (300,000 IU) or matching placebo at baseline and 8 weeks. The primary outcome was change in endothelium-dependent brachial artery flow-mediated dilation at 16 weeks. Secondary outcome measures included changes in pulse wave velocity and circulating biomarkers. Cholecalciferol supplementation significantly increased endothelium-dependent brachial artery flow-mediated dilation at 16 weeks, whereas placebo did not (between-group difference in mean change: 5.49%; 95% confidence interval, 4.34% to 6.64%; P<0.001). Intervention also led to significant favorable changes in pulse wave velocity and circulating IL-6 levels. Thus, in nondiabetic patients with stage 3-4 CKD and vitamin D deficiency, vitamin D supplementation may improve vascular function. This study is registered with the Clinical Trials Registry of India (no.: CTRI/2013/05/003648).

The Chronic Care for Wet Age Related Macular Degeneration (CHARMED) Study: A Randomized Controlled Trial

BackgroundIn real life, outcomes in wet age related macular degeneration (W-AMD) continue to fall behind the results from randomized controlled trials. The aim of this trial was to assess if outcomes can be improved by an intervention in healthcare organization following recommendations of the Chronic Care Model (CCM).MethodsMulti-centered randomized controlled clinical trial. The multifaceted intervention consisted in reorganization of care (delivery by trained chronic care coaches, using reminder systems, performing structured follow-up, empowering patients in self-monitoring and giving decision-support). In the control usual care was continued. Main outcome measures were changes in ETDRS visual acuity, optical coherence tomography (OCT) macular retinal thickness and quality of life (NEI VFQ-25 questionnaire).Results169 consecutive patients in Swiss ophthalmology centers were included. Mean ETDRS baseline visual acuity of eyes with W-AMD was 57.8 (± 18.7). After 12 months, the between-group difference in mean change of ETDRS visual acuity was -4.8 (95%CI: -10.8 to +1.2, p = 0.15); difference in mean change of OCT was +14.0 (95% CI -39.6 to 67.6, p = 0.60); difference in mean change of NEI VFQ-25 composite score mean change was +2.1(95%CI: -1.3 to +5.5, p = 0.19).ConclusionsThe intervention aiming at improving chronic care was not associated with favorable outcomes within 12 months. Other approaches need to be tested to close the evidence-performance gap in W-AMD.Trial RegistrationControlled-Trials.com ISRCTN32507927

Effect of increased water intake on plasma copeptin in patients with chronic kidney disease: results from a pilot randomised controlled trial

ObjectivesIncreased water intake may have a beneficial effect on the kidney through suppression of plasma vasopressin. We examined the effect of increased water intake on plasma copeptin (a marker of...

The Short-Term Effect of a Lymphatic Pump Protocol on Blood Cell Counts in Nursing Home Residents With Limited Mobility: A Pilot Study

Lymphatic pump techniques have the potential to alter blood cell counts and thus enhance immune function in elderly adults with diminished mobility. To test whether an osteopathic manipulative treatment (OMT) protocol designed to enhance immune function will have an effect on lymphocyte and lymphocyte subset counts compared with a sham control group. The study design was a single-session, randomized, controlled clinical trial comparing a standardized lymphatic pump protocol with a light-touch protocol. Participants were assigned to 1 of 2 groups by using a 1:1 allocation ratio. The study was conducted in 2 rural long-term care facilities in Missouri. Residents in the long-term care facilities who were aged 60 years or older and who were confined to a bed or wheelchair for most of their waking hours. Twenty residents were recruited to participate in the study, and 10 were randomly assigned to each group. Baseline blood samples were obtained. Then each patient received a 6-minute study protocol treatment. Thirty minutes after completion, posttreatment blood samples were obtained. The OMT protocol consisted of 3 osteopathic techniques: myofascial release to the thoracic inlet, the splenic pump, and the pedal lymphatic pump. The light touch protocol was applied to the same body areas as the OMT protocol for 6 minutes. A pretreatment and posttreatment lymphocyte subset panel, complete blood cell count, and automated white blood cell count differential was obtained from each participant. There was a statistically significant between-group difference in mean change for platelet counts: counts in the OMT group decreased by a mean (standard deviation) of 15,400 (7947) platelets per microliter and the light touch group increased by 4,700 (17,857) platelets per microliter (P=.004). The between-group differences for the mean (standard deviation) absolute lymphocyte cell count, red blood cell count, hemoglobin level, and hematocrit measures all decreased, but the changes were not statistically significant relative to the control group. The OMT protocol used in this pilot study modestly reduced platelet counts in nursing home residents with limited mobility.

Neurostimulation for Parkinson's Disease with Early Motor Complications

BackgroundSubthalamic stimulation reduces motor disability and improves quality of life in patients with advanced Parkinson's disease who have severe levodopa-induced motor complications. We hypothesized that neurostimulation would be beneficial at an earlier stage of Parkinson's disease.MethodsIn this 2-year trial, we randomly assigned 251 patients with Parkinson's disease and early motor complications (mean age, 52 years; mean duration of disease, 7.5 years) to undergo neurostimulation plus medical therapy or medical therapy alone. The primary end point was quality of life, as assessed with the use of the Parkinson's Disease Questionnaire (PDQ-39) summary index (with scores ranging from 0 to 100 and higher scores indicating worse function). Major secondary outcomes included parkinsonian motor disability, activities of daily living, levodopa-induced motor complications (as assessed with the use of the Unified Parkinson's Disease Rating Scale, parts III, II, and IV, respectively), and time with good mobility and no dyskinesia.ResultsFor the primary outcome of quality of life, the mean score for the neurostimulation group improved by 7.8 points, and that for the medical-therapy group worsened by 0.2 points (between-group difference in mean change from baseline to 2 years, 8.0 points; P=0.002). Neurostimulation was superior to medical therapy with respect to motor disability (P<0.001), activities of daily living (P<0.001), levodopa-induced motor complications (P<0.001), and time with good mobility and no dyskinesia (P=0.01). Serious adverse events occurred in 54.8% of the patients in the neurostimulation group and in 44.1% of those in the medical-therapy group. Serious adverse events related to surgical implantation or the neurostimulation device occurred in 17.7% of patients. An expert panel confirmed that medical therapy was consistent with practice guidelines for 96.8% of the patients in the neurostimulation group and for 94.5% of those in the medical-therapy group.ConclusionsSubthalamic stimulation was superior to medical therapy in patients with Parkinson's disease and early motor complications. (Funded by the German Ministry of Research and others; EARLYSTIM ClinicalTrials.gov number, NCT00354133.)

Integrative TCM Conservative Therapy for Low Back Pain due to Lumbar Disc Herniation: A Randomized Controlled Clinical Trial

Low back pain due to lumbar disc herniation (LDH) is very common in clinic. This randomized controlled trial was designed to investigate the effects of integrative TCM conservative therapy for low back pain due to LDH. A total of 408 patients with low back pain due to LDH were randomly assigned to an experimental group with integrative TCM therapy and a control group with normal conservative treatment by the ratio of 3 : 1. The primary outcome was the pain by the visual analogue scale (VAS). The secondary outcome was the low back functional activities by Chinese Short Form Oswestry Disability Index (C-SFODI). Immediately after treatment, patients in the experimental group experienced significant improvements in VAS and C-SFODI compared with the control group (between-group difference in mean change from baseline, −16.62 points, P < 0.001 in VAS; −15.55 points, P < 0.001 in C-SFODI). The difference remained at one-month followup, but it is only significant in C-SFODI at six-month followup (−7.68 points, P < 0.001). No serious adverse events were observed. These findings suggest that integrative TCM therapy may be a beneficial complementary and alternative therapy for patients with low back pain due to LDH.

Chinese Massage Combined with Herbal Ointment for Athletes with Nonspecific Low Back Pain: A Randomized Controlled Trial

Non-specific low back pain (NLBP) is an increasing health problem for athletes. This randomized controlled trial was designed to investigate the effects of Chinese massage combined with herbal ointment for NLBP. 110 athletes with NLBP were randomly assigned to experimental group with Chinese massage combined with herbal ointment or control group with simple massage therapy. The primary outcome was pain by Chinese Short Form McGill Pain Questionnaire (C-SFMPQ). The secondary outcome was local muscle stiffness by Myotonometer. After 4 weeks, the experimental group experienced significant improvements in C-SFMPQ and in local muscle stiffness compared with control group (between-group difference in mean change from baseline, −1.24 points, P = 0.005 in sensory scores; −3.14 points, P < 0.001 in affective scores; −4.39 points, P < 0.001 in total scores; −0.64 points, P = 0.002 in VAS; −1.04 points, P = 0.005 in local muscle stiffness during relaxation state). The difference remained at one month followup, but it was only significant in affective scores (−2.83 points, P < 0.001) at three months followup. No adverse events were observed. These findings suggest that Chinese massage combined with herbal ointment may be a beneficial complementary and alternative therapy for athletes with NLBP.

Double-blind, randomized trial comparing efficacy and safety of continuing olanzapine versus switching to quetiapine in overweight or obese patients with schizophrenia or schizoaffective disorder

We examined the potential risks and benefits of switching from olanzapine to quetiapine in mentally stable, obese, or overweight patients with schizophrenia or schizoaffective disorder. Patients receiving olanzapine were randomized to continuing olanzapine treatment (N =68; 7.5-20 mg/day) or switching to quetiapine (N =65; 300-800 mg/day). Time to relapse was the primary study objective; secondary objectives included changes in weight, metabolic parameters, and psychiatric symptoms, and discontinuation rates. No significant difference in time to relapse was observed (p =0.293), but significantly more patients remained on treatment in the olanzapine group compared with the quetiapine group (70.6% vs 43.1%; p =0.002). Olanzapine-treated patients had significantly lower rates of study discontinuation for lack of efficacy and psychiatric adverse events (AEs) compared to quetiapine (2.94% vs 15.38%, p =0.015). Significantly more patients in the olanzapine group experienced an increase in BMI ≥1 kg/m(2). Olanzapine-treated patients experienced significantly greater increases in weight from Weeks 2 through 13. Switching patients with stable disease from olanzapine to quetiapine did not significantly shorten time to relapse, but produced more frequent study discontinuations due to lack of efficacy or psychiatric AEs with moderate but variable improvement in weight and no significant between-group differences in mean changes in metabolic laboratory parameters.

Aripiprazole monotherapy in patients with rapid-cycling bipolar I disorder: an analysis from a long-term, double-blind, placebo-controlled study

AimsRapid-cycling bipolar disorder is difficult to treat and associated with greater morbidity than non-rapid-cycling disease. This post hoc analysis evaluated 28 patients with rapid-cycling bipolar I disorder from a 100-week, double-blind, placebo-controlled study assessing long-term efficacy, safety and tolerability of aripiprazole in patients with bipolar I disorder (most recently manic/mixed).MethodsFollowing ≥ 6 consecutive weeks’ stabilisation with open-label aripiprazole, patients were randomised (1 : 1) to aripiprazole or placebo. Patients completing 26 weeks treatment without relapse could continue for a further 74 weeks. Primary end-point was time to relapse for manic, mixed or depressive symptoms, defined as discontinuation due to lack of efficacy. Safety assessments included adverse event (AE) monitoring and changes in weight and lipid, glucose and prolactin levels.ResultsOf the 28 patients (aripiprazole, n = 14; placebo, n = 14) with rapid-cycling bipolar disorder, 12 (aripiprazole, n = 7; placebo, n = 5) completed the initial 26-week treatment period and three (all aripiprazole treated) completed the 100-week, double-blind period. Time to relapse was significantly longer with aripiprazole vs. placebo at week 26 [log-rank p = 0.033; 26-week hazard ratio = 0.21 (95% CI: 0.04, 1.03)] and week 100 [log-rank p = 0.017; 100-week hazard ratio = 0.18 (95% CI: 0.04, 0.88)]. The most commonly reported AEs with aripiprazole during the 100 weeks (≥ 10% incidence and twice placebo) were anxiety (n = 4), sinusitis (n = 4), depression (n = 3) and upper respiratory infection (n = 3). One aripiprazole-treated patient discontinued due to an AE (akathisia). There were no significant between-group differences in mean changes in weight or metabolic parameters.ConclusionIn this small, post hoc subanalysis, aripiprazole maintained efficacy and was generally well tolerated in the long-term treatment of rapid-cycling bipolar disorder. Further research with prospectively designed and adequately powered trials is warranted.

Effect of ultra-low-dose transdermal estradiol on breast density in postmenopausal women

Women with higher mammographic breast density have increased risk for breast cancer, and there is some evidence that a change in breast density may be a marker for change in risk for breast cancer. The purpose of this study was to determine whether 2 years of treatment with ultra-low-dose transdermal estradiol results in a change in breast density. The Ultra-Low-dose Transdermal Estradiol Assessment was a randomized, blinded, placebo-controlled trial of 2 years of treatment with unopposed ultra-low-dose (0.014 mg/d) transdermal estradiol for prevention of osteoporosis in 417 postmenopausal women with no history of breast cancer who had not had a hysterectomy. We obtained mammograms at baseline and after 1 and 2 years of treatment from 276 of the participants. Right craniocaudal views were analyzed at a central radiology facility by a trained clinician blinded to treatment group and order of acquisition. Contour analysis was performed to define dense areas versus fatty tissue. Between-group differences in mean change in percent breast density from baseline to 1 and to 2 years of follow-up were assessed using linear regression models adjusted for clinical site. Participants were 66 +/- 5 years old and 94% were white. The average percent breast density at baseline was 34%. There was no significant difference between treatment groups in change in percent breast density after 1 year (between-group difference, 0.1%; 95% confidence interval, -1.3% to 1.6%) or 2 years of treatment (0.8%; -0.6% to 2.1%). Two years of treatment with ultra-low-dose transdermal estradiol did not increase breast density.

Effects of Recombinant Human Erythropoietin on Renal Function in Chronic Renal Failure Predialysis Patients

A study was undertaken to ascertain the effects of recombinant human erythropoietin (r-HuEPO) on renal function in chronic renal failure predialysis patients. The effect of improvement of anemia by r-HuEPO on the rate of decline in renal function in predialysis patients has not been previously studied prospectively in a large number of patients using reliable measures of glomerular filtration rate (GFR). To investigate the efficacy, safety, and impact of r-HuEPO therapy in chronic renal insufficiency patients, a 48-week, randomized, open-label, multicenter study was initiated in 83 anemic, predialysis (serum creatinine 3 to 8 mg/dL) patients. Serial GFRs were measured using 125I-iothalamate clearance. Forty patients were randomized to the untreated arm and 43 patients to the treatment arm (50 U/kg r-HuEPO subcutaneously three times weekly). Baseline characteristics were comparable for the r-HuEPO-treated and untreated groups. During this 48-week study, GFR, mean arterial blood pressure, and daily protein intake were not significantly different between the two groups. There was a statistically significant increase in hematocrit for the r-HuEPO-treated group that was not associated with acceleration of deterioration in residual renal function. This was demonstrated by the lack of a significant (P = 0.376) between-group difference in mean change in GFR from baseline to last available value for the r-HuEPO-treated (-2.1 +/- 3.2 mL/min) and untreated (-2.8 +/- 3.5 mL/min) groups. This study concludes that r-HuEPO therapy improves anemia in predialysis patients and does not accelerate the rate of progression to end-stage renal disease.