Patient Education and Self-Care for the Management of Jaw Pain upon Awakening: A Randomized Controlled Clinical Trial Comparing the Effectiveness of Adding Pharmacologic Treatment with Cyclobenzaprine or Tizanidine

Aims: To compare the effectiveness of adding cyclobenzaprine, tizanidine, or placebo to patient education and a self-care management program for patients with myofascial pain and specifically presenting with jaw pain upon awakening. Methods: Forty-five patients with a diagnosis of myofascial pain based on the guidelines of the American Academy of Orofacial Pain participated in this 3-week study. The subjects were randomly assigned into one of three groups: placebo group, TZA group (tizanidine 4 mg), or CYC group (cyclobenzaprine 10 mg). Patients were evaluated for changes in pain intensity, frequency, and duration by using the modified Severity Symptoms Index and changes in sleep quality with the use of the Pittsburgh Sleep Quality Index. Data were analyzed by ANOVA and post-hoc or nonparametric statistical tests as appropriate. Results: All three groups had a reduction in pain symptoms and improvement of sleep quality based on a comparison of pretreatment and treatment scores. However, no significant differences among the groups were observed at the posttreatment evaluation. Conclusion: The use of tizanidine or cyclobenzaprine in addition to self-care management and patient education was not more effective than placebo for the management of patients with myofascial jaw pain upon awakening.

Pilates in Heart Failure Patients: A Randomized Controlled Pilot Trial

Background: Conventional cardiac rehabilitation program consist of 15 min of warm-up, 30 min of aerobic exercise and followed by 15 min calisthenics exercise. The Pilates method has been increasingly applied for its therapeutic benefits, however little scientific evidence supports or rebukes its use as a treatment in patients with heart failure (HF). Purpose: Investigate the effects of Pilates on exercise capacity variables in HF. Methods: Sixteen pts with HF, left ventricular ejection fraction 27 +/- 14%, NYHA class III were randomly assigned to conventional cardiac rehabilitation program (n = 8) or mat Pilates training (n = 8) for 16 weeks of 30 min of aerobic exercise followed by 20 min of the specific program. Results: At 16 weeks, pts in the mat Pilates group and conventional group showed significantly increase on exercise time 11.9 +/- 2.5 to 17.8 +/- 4 and 11.7 +/- 3.9 to 14.2 +/- 4 min, respectively. However, only the Pilates group increased significantly the ventilation (from 56 +/- 20 to 69 +/- 17 L/min, P= 0.02), peak VO2 (from 20.9 +/- 6 to 24.8 +/- 6 mL/kg/min, P= 0.01), and O-2 pulse (from 11.9 +/- 2 to 13.8 +/- 3 mL/bpm, P= 0.003). The Pilates group showed significantly increase in peak VO2 when compared with conventional group (24.8 +/- 6 vs. 18.3 +/- 4, P= 0.02). Conclusions: The result suggests that the Pilates method may be a beneficial adjunctive treatment that enhances functional capacity in patients with HF who are already receiving standard medical therapy.

Inward-Inclined Implant Platform for the Amplified Platform-Switching Concept: 18-Month Follow-up Report of a Prospective Randomized Matched-Pair Controlled Trial

Purpose: This prospective randomized matched-pair controlled trial aimed to evaluate marginal bone levels and soft tissue alterations at implants restored according to the platform-switching concept with a new inward-inclined platform and compare them with external-hexagon implants. Materials and Methods: Traditional external-hexagon (control group) implants and inward-inclined platform implants (test group), all with the same implant body geometry and 13 mm in length, were inserted in a standardized manner in the posterior maxillae of 40 patients. Radiographic bone levels were measured by two independent examiners after 6, 12, and 18 months of prosthetic loading. Buccal soft tissue height was measured at the time of abutment connection and 18 months later. Results: After 18 months of loading, all 80 implants were clinically osseointegrated in the 40 participating patients. Radiographic evaluation showed mean bone losses of 0.5 +/- 0.1 mm (range, 0.3 to 0.7 mm) and 1.6 +/- 0.3 mm (range, 1.1 to 2.2 mm) for test and control implants, respectively. Soft tissue height showed a significant mean decrease of 2.4 mm in the control group, compared to 0.6 mm around the test implants. Conclusions: After 18 months, significantly greater bone loss was observed at implants restored according to the conventional external-hexagon protocol compared to the platform-switching concept. In addition, decreased soft tissue height was associated with the external-hexagon implants versus the platform-switched implants. INT J ORAL MAXILLOFAC IMPLANTS 2012;27:927-934.

Clinical Effects of Scalp Electrical Acupuncture in Stroke: A Sham-Controlled Randomized Clinical Trial

Objectives: The majority of individuals who survive a stroke are disabled because of persisting neurological impairments. The objective of this study was to evaluate the efficacy of subcutaneous electrical stimulation of the scalp in spontaneous functional recovery of patients with chronic ischemic stroke, by evaluating clinical, neurological, and functional findings. Subjects and methods: Sixty-two (62) subjects who were at least 18 months postdiagnosis of ischemic stroke were randomized to receive 10 sessions of placebo or active low-frequency electrical stimulation (2/100 Hz) using subcutaneous acupuncture needles over the scalp. Functional and neurological evaluations were indexed by the Barthel, Rankin, and National Institutes of Health Stroke Scale (NIHSS). Results: Results show that there was a significant difference in functional improvement between the sham and active group as indexed by NIHSS scale. The active group had a larger functional improvement after 10 sessions of scalp electrical acupuncture. The other two functional scales (Rankin and Barthel) failed to show significant differences between the two treatment groups. Conclusions: These results support further testing of scalp electrical acupuncture for the treatment of stroke as well further mechanistic studies to understand mechanisms associated with the observed improvement. Further studies need to consider longer follow-up assessments to investigate potential functional changes associated with electrical acupuncture.

A randomized placebo-controlled trial of oxybutynin for the initial treatment of palmar and axillary hyperhidrosis

Introduction: Video-assisted thoracic sympathectomy provides excellent resolution of palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of oxybutynin, an anticholinergic medication that competitively antagonizes the muscarinic acetylcholine receptor, can be used to treat palmar hyperhidrosis with fewer side effects. Objective: This study evaluated the effectiveness and patient satisfaction of oral oxybutynin at low doses (5 mg twice daily) compared with placebo for treating palmar hyperhidrosis. Methods: This was prospective, randomized, and controlled study. From December 2010 to February 2011, 50 consecutive patients with palmar hyperhidrosis were treated with oxybutynin or placebo. Data were collected from 50 patients, but 5 (10.0%) were lost to follow-up. During the first week, patients received 2.5 mg of oxybutynin once daily in the evening. From days 8 to 21, they received 2.5 mg twice daily, and from day 22 to the end of week 6, they received 5 mg twice daily. All patients underwent two evaluations, before and after (6 weeks) the oxybutynin treatment, using a clinical questionnaire and a clinical protocol for quality of life. Results: Palmar and axillary hyperhidrosis improved in >70% of the patients, and 47.8% of those presented great improvement. Plantar hyperhidrosis improved in >90% of the patients. Most patients (65.2%) showed improvements in their quality of life. The side effects were minor, with dry mouth being the most frequent (47.8%). Conclusions: Treatment of palmar and axillary hyperhidrosis with oxybutynin is a good initial alternative for treatment given that it presents good results and improves quality of life. (J Vasc Surg 2012;55:1696-700.)

A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): study protocol for a randomized double-blind controlled trial

Abstract Background Cardiovascular disease is the leading cause of death in Brazil, and hypertension is its major risk factor. The benefit of its drug treatment to prevent major cardiovascular events was consistently demonstrated. Angiotensin-receptor blockers (ARB) have been the preferential drugs in the management of hypertension worldwide, despite the absence of any consistent evidence of advantage over older agents, and the concern that they may be associated with lower renal protection and risk for cancer. Diuretics are as efficacious as other agents, are well tolerated, have longer duration of action and low cost, but have been scarcely compared with ARBs. A study comparing diuretic and ARB is therefore warranted. Methods/design This is a randomized, double-blind, clinical trial, comparing the association of chlorthalidone and amiloride with losartan as first drug option in patients aged 30 to 70 years, with stage I hypertension. The primary outcomes will be variation of blood pressure by time, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new subclinical atherosclerosis and sudden death. The study will last 18 months. The sample size will be of 1200 participants for group in order to confer enough power to test for all primary outcomes. The project was approved by the Ethics committee of each participating institution. Discussion The putative pleiotropic effects of ARB agents, particularly renal protection, have been disputed, and they have been scarcely compared with diuretics in large clinical trials, despite that they have been at least as efficacious as newer agents in managing hypertension. Even if the null hypothesis is not rejected, the information will be useful for health care policy to treat hypertension in Brazil. Clinical trials registration number ClinicalTrials.gov: NCT00971165

A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems

Methods We conducted a phase I, multicenter, randomized, double-blind, placebo-controlled, multi-arm (10) parallel study involving healthy adults to evaluate the safety and immunogenicity of influenza A (H1N1) 2009 non-adjuvanted and adjuvanted candidate vaccines. Subjects received two intramuscular injections of one of the candidate vaccines administered 21 days apart. Antibody responses were measured by means of hemagglutination-inhibition assay before and 21 days after each vaccination. The three co-primary immunogenicity end points were the proportion of seroprotection >70%, seroconversion >40%, and the factor increase in the geometric mean titer >2.5. Results A total of 266 participants were enrolled into the study. No deaths or serious adverse events were reported. The most commonly solicited local and systemic adverse events were injection-site pain and headache, respectively. Only three subjects (1.1%) reported severe injection-site pain. Four 2009 influenza A (H1N1) inactivated monovalent candidate vaccines that met the three requirements to evaluate influenza protection, after a single dose, were identified: 15 μg of hemagglutinin antigen without adjuvant; 7.5 μg of hemagglutinin antigen with aluminum hydroxide, MPL and squalene; 3.75 μg of hemagglutinin antigen with aluminum hydroxide and MPL; and 3.75 μg of hemagglutinin antigen with aluminum hydroxide and squalene. Conclusions Adjuvant systems can be safely used in influenza vaccines, including the adjuvant monophosphoryl lipid A (MPL) derived from Bordetella pertussis with squalene and aluminum hydroxide, MPL with aluminum hydroxide, and squalene and aluminum hydroxide.

Clinical Outcomes Following Treatment of Non-contained Intrabony Defects with Enamel Matrix Derivative (EMD) or Guided Tissue Regeneration (GTR). A 12-month Randomized Controlled Clinical trial

The purpose of this study is to compare the healing of deep, non-contained intrabony defects (i.e., with a ?80% 1-wall component and a residual 2- to 3-wall component in the most apical part) treated with either an enamel matrix derivative (EMD) or guided tissue regeneration (GTR) after 12 months.

A randomized, controlled clinical trial on the clinical, microbiological, and staining effects of a novel 0.05% chlorhexidine/herbal extract and a 0.1% chlorhexidine mouthrinse adjunct to periodontal surgery

BACKGROUND: Chlorhexidine (CHX) rinsing after periodontal surgery is common. We assessed the clinical and microbiological effects of two CHX concentrations following periodontal surgery. MATERIALS AND METHODS: In a randomized, controlled clinical trial, 45 subjects were assigned to 4 weeks rinsing with a 0.05 CHX/herbal extract combination (test) or a 0.1% CHX solution. Clinical and staining effects were studied. Subgingival bacteria were assessed using the DNA-DNA checkerboard. Statistics included parametric and non-parametric tests (p<0001 to declare significance at 80% power). RESULTS: At weeks 4 and 12, more staining was found in the control group (p<0.05 and p<0.001, respectively). A higher risk for staining was found in the control group (crude OR: 2.3:1, 95% CI: 1.3 to 4.4, p<0.01). The absolute staining reduction in the test group was 21.1% (9 5% CI: 9.4-32.8%). Probing pocket depth (PPD) decreases were significant (p<0.001) in both groups and similar (p=0.92). No rinse group differences in changes of bacterial counts for any species were found between baseline and week 12. CONCLUSIONS: The test CHX rinse resulted in less tooth staining. At the study endpoint, similar and high counts of periodontal pathogens were found.

The effect of different implant neck configurations on soft and hard tissue healing: a randomized-controlled clinical trial

Objective: To compare the soft and hard tissue healing and remodeling around tissue-level implants with different neck configurations after at least 1 year of functional loading. Material and methods: Eighteen patients with multiple missing teeth in the posterior area received two implants inserted in the same sextant. One test (T) implant with a 1.8 mm turned neck and one control (C) implant with a 2.8 mm turned neck were randomly assigned. All implants were placed transmucosally to the same sink depth of approximately 1.8 mm. Peri-apical radiographs were obtained using the paralleling technique and digitized. Two investigators blinded to the implant type-evaluated soft and hard tissue conditions at baseline, 6 months and 1 year after loading. Results: The mean crestal bone levels and soft tissue parameters were not significantly different between T and C implants at all time points. However, T implants displayed significantly less crestal bone loss than C implants after 1 year. Moreover, a frequency analysis revealed a higher percentage (50%) of T implants with crestal bone levels 1–2 mm below the implant shoulder compared with C implants (5.6%) 1 year after loading. Conclusion: Implants with a reduced height turned neck of 1.8 mm may, indeed, lower the crestal bone resorption and hence, may maintain higher crestal bone levels than do implants with a 2.8 mm turned neck, when sunk to the same depth. Moreover, several factors other than the vertical positioning of the moderately rough SLA surface may influence crestal bone levels after 1 year of function.

Open or submerged healing of implants with platform switching: a randomized, controlled clinical trial

The temporal pattern of bone-level alterations in conventionally restored implants is dependent upon healing mode (open or submerged). This study examined the influence of healing on marginal bone levels at implants with a medium-rough surface including the implant collar and a clearance-fit implant-abutment connection restored according to a platform-switching concept.

Reporting of consistency of blood pressure control in randomized controlled trials of antihypertensive drugs: a systematic review of 1372 trial reports

Hypertension is a powerful treatable risk factor for stroke. Reports of randomized controlled trials (RCTs) of antihypertensive drugs rightly concentrate on clinical outcomes, but control of blood pressure (BP) during follow-up is also important, particularly given that inconsistent control is associated with a high risk of stroke and that antihypertensive drug classes differ in this regard.