Mucolytic-antifoam solution for reduction of artifacts during endoscopic ultrasonography: a randomized controlled trial.

Gastric mucus and air bubbles are frequent sources of artifacts during endoscopic ultrasonography (EUS). To reduce these artifacts, we prepared a mucolytic-antifoam solution consisting of simethicone, acetylcysteine, and sodium bicarbonate and performed a prospective randomized and controlled trial comparing this solution (21 patients) to a placebo (22 patients) during EUS. Eight patients in the drug group received a perfect score for both mucolytic and antifoam effect compared with none in the placebo group (p less than 0.001). For overall rating, the drug group received a total of 10 excellents and 9 goods compared with 9 goods, 10 satisfactories, and 1 unacceptable in the placebo group (p less than 0.001). There were no complications associated with the solution. In conclusion, a mucolytic-antifoam solution improved endoscopic visualization and reduced artifacts during EUS study. Its routine use during EUS procedures is therefore recommended.     

Sacolene in cholera: a double blind randomized controlled trial.

Methylated casein (Sacolene), a diarrhoea remedy used in Europe, has shown an antisecretory effect in cholera-induced secretion in animals and benefit in diarrhoea in humans. In this placebo controlled trial Sacolene was evaluated in 78 male adults with severe cholera who, after initial i.v. therapy received Sacolene or placebo, 4 g at start and 2 g 4 hourly until cessation of diarrhoea, along with oral rehydration therapy and repeat i.v. therapy if indicated. No antibiotics were given during the study. The purging rate and diarrhoea duration were similar in the 2 groups. The proportion of patients requiring repeat courses of i.v. therapy in the study group was 46% compared with 69% in controls (i.e. reduced by 23%, p = 0.04). While the severity of purging was not reduced, the proportion of patients requiring repeat i.v. therapy was reduced by Sacolene therapy. The latter finding may indicate some benefit from Sacolene in cholera, though this requires confirmation.     

A randomized controlled trial of acarbose in hepatic encephalopathy.

BACKGROUND & AIMS: Hepatic encephalopathy in cirrhosis is contributed to by toxic products deriving from the proteolytic bacterial flora-related degradation of dietary nitrogen substances. Acarbose is a novel hypoglycemic agent acting through the inhibition of glucose absorption in the gut and the promotion of intestinal saccharolytic bacterial flora at the expense of proteolytic flora. We assessed whether acarbose exerts a beneficial effect on hepatic encephalopathy and on postprandial hyperglycemia in cirrhotic patients with low-grade hepatic encephalopathy and type 2 diabetes mellitus. METHODS: One hundred seven cirrhotic patients with grade 1-2 hepatic encephalopathy and type 2 diabetes mellitus were randomized to acarbose 100 mg 3 times daily or placebo for 8 weeks; after a 2-week washout period, treatments were switched, and patients were followed for 8 more weeks. Ammonia blood levels, Reitan's number connection test, intellectual function, fasting and postprandial glucose levels, glycated hemoglobin values, and C peptide values were determined 2 weeks before and 4, 8, 11, 14, and 18 weeks after treatment. RESULTS: (1) Acarbose significantly decreased ammonia blood levels and improved Reitan's test score and intellectual function score compared with placebo (P < .01). (2) Acarbose caused a 33% decrease in fasting glucose level and an approximately 50% decrease in postprandial glucose level compared with placebo (P < .01). (3) Acarbose significantly lowered glycated hemoglobin values and postprandial C peptide compared with baseline values, whereas placebo did not. (4) No change in biochemical parameters of liver function was observed after acarbose treatment. CONCLUSIONS: Acarbose is a safe and effective drug in cirrhotic patients with low-grade hepatic encephalopathy and type 2 diabetes mellitus.     

Red wine polyphenols do not improve obesity‐associated insulin resistance: A randomized controlled trial

Preclinical studies have suggested that polyphenols extracted from red wine (RWPs) favourably affect insulin sensitivity, but there is controversy over whether RWPs exert similar effects in humans. The aim of the present study was to determine whether RWPs improve insulin sensitivity in obese volunteers. Obese (body mass index >30 kg/m²) volunteers were randomly allocated to RWPs 600 mg/d (n = 14) or matched placebo (n = 15) in a double‐blind parallel‐arm study for 8 weeks. The participants were investigated at baseline and at the end of the study. Insulin sensitivity was determined using a hyperinsulinaemic‐euglycaemic clamp (M‐value), a mixed‐meal test (Matsuda index), and homeostatic model assessment of insulin resistance (HOMA‐IR). RWPs elicited no significant changes in M‐value (RWP group: median [interquartile range; IQR] baseline 3.0 [2.4; 3.6]; end of study 3.3 [2.4; 4.8] vs placebo group: median [IQR] baseline 3.4 [2.8; 4.4]; end of study 2.9 [2.8; 5.9] mg/kg/min; P = .65), in Matsuda index (RWP group: median [IQR] baseline 3.3 [2.2; 4.8]; end of study 3.6 [2.4; 4.8] vs placebo group: median [IQR] baseline 4.0 [3.0; 6.0]; end of study 4.0 [3.0; 5.2]; P = .88), or in HOMA‐IR. This study showed that 8 weeks of RWP supplementation did not improve insulin sensitivity in 29 obese volunteers. Our findings were not consistent with the hypothesis that RWPs ameliorate insulin resistance in human obesity.     

Etomidate and midazolam for reduction of anterior shoulder dislocation: a randomized,controlled trial

STUDY OBJECTIVE: We determine whether patients with acute, anterior shoulder dislocation undergoing emergency department procedural sedation and analgesia (PSA) with intravenous etomidate would experience a reduced time of impaired consciousness when compared with a group of patients receiving intravenous midazolam. METHODS: This study was a prospective, double-blinded, randomized, institutional review board-approved trial of ED patients with anterior shoulder dislocation. Patients were randomized to receive intravenous boluses of etomidate (0.1 mg/kg) or midazolam (0.033 mg/kg) during PSA. The primary outcome for comparison was PSA duration. RESULTS: Forty-six patients with anterior shoulder dislocation were enrolled: 22 in the etomidate group and 24 in the midazolam group. Three patients sustained reduction without physician or sedative intervention. Two patients were excluded from protocol because of unavailable study drug or fracture dislocation. The median lowest modified postanesthetic recovery score observed during PSA was 5 (95% confidence interval [CI] 4 to 7) in the etomidate group and 6 (95% CI 6 to 7) in the midazolam group. The median time of PSA for patients receiving etomidate was 10 minutes (95% CI 8 to 15) compared with 23 minutes (95% CI 16 to 30) for patients receiving midazolam, with a difference between the group medians of 13 minutes (95% CI 5 to 22). Reduction success was achieved in 37 (90%) of 41 patients: 2 did not experience reduction with etomidate and 2 did not experience reduction with midazolam. There were 15 PSA complications reported. CONCLUSION: Etomidate provides effective PSA for reduction of ED patients with anterior shoulder dislocation. When compared with midazolam, etomidate use confers a significantly shorter period of PSA.     

Different effects of red wine and gin consumption on inflammatory biomarkers of atherosclerosis: a prospective randomized crossover trial. Effects of wine on inflammatory markers

BACKGROUND: No intervention studies have explored the anti-inflammatory effects of different alcoholic beverages on markers of atherosclerosis. We embarked on a randomized, crossover, single-blinded trial to evaluate the effects of wine and gin on inflammatory biomarkers of atherosclerosis. METHODS AND RESULTS: Forty healthy men (mean age, 37.6 years) consumed 30 g ethanol per day as either wine or gin for 28 days. Before and after each intervention, we measured the expression of lymphocyte function-associated antigen 1 (LFA-1), Mac-1, very late activation antigen 4 (VLA-4), and monocyte chemoattractant protein (MCP-1) in monocytes, as well as the soluble vascular cell adhesion molecule-1 (VCAM-1), intercellular adhesion molecule-1 (ICAM-1), interleukin-1alpha (IL-1alpha), C-reactive protein (hs-CRP) and fibrinogen. After either gin or wine consumption, plasma fibrinogen decreased by 5 and 9%, respectively, and cytokine IL-1alpha by 23 and 21%. The expression of LFA-1 (-27%), Mac-1 (-27%), VLA-4 (-32%) and MCP-1 (-46%) decreased significantly after wine, but not after gin. Wine reduced the serum concentrations of hs-CRP (-21%), VCAM-1 (-17%) and ICAM-1 (-9%). CONCLUSIONS: Both wine and gin showed anti-inflammatory effects by reducing plasma fibrinogen and IL-1alpha levels. However, wine had the additional effect of decreasing hs-CRP, as well as monocyte and endothelial adhesion molecules.     

Octreotide enhances portal pressure reduction induced by propranolol in cirrhosis: a randomized, controlled trial

BACKGROUND: In vitro, octreotide potentiates vasoconstriction in isolated, preconstricted, mesenteric arterial vessels. In cirrhotic patients, portal pressure (HVPG) reduction induced by propranolol is partly due to splanchnic vasoconstriction. AIM: To evaluate HVPG effects of octreotide administration in cirrhotic patients receiving long-term propranolol. PATIENTS AND METHODS: A randomized, controlled trial. First study: a total of 28 patients were studied at baseline and 30 and 60 minutes after octreotide (200 mug) (N = 14) or placebo (N = 14) and then treated with propranolol for approximately 30 days (106 +/- 5 mg/day). Second study: after baseline evaluation patients received octreotide or placebo as they were assigned to in the first study and measurements repeated 30 and 60 minutes later. RESULTS: In the first study baseline HVPG was 18.7 +/- 0.9 mmHg and decreased to 17.1 +/- 1.1 mmHg and 17.1 +/- 1.0 mmHg (both P < 0.05 vs baseline) at 30 and 60 minutes after octreotide, respectively. Eight patients decreased their HVPG after octreotide. In the second study baseline HVPG was 15.6 +/- 1.3 mmHg (P < 0.01 vs baseline HVPG in first study) and decreased to 14.1 +/- 1.2 mmHg and 14.1 +/- 1.3 mmHg (25.7 +/- 5% lower than baseline HVPG in the first study, P < 0.01) (both P < 0.05 vs baseline) at 30 and 60 minutes after octreotide, respectively. Nine patients (2 responders/7 nonresponders to propranolol) decreased their HVPG after octreotide. Octreotide effects may be mediated by potentiation and additive mechanisms. CONCLUSIONS: Octreotide enhances HVPG reduction induced by propranolol in cirrhotic patients.     

Telemonitoring in asthma control: a randomized controlled trial

Objective: Telemonitoring seems to be a useful tool for patients’ management. The aim of our project was to test the applicability and potential effects of a 12-month telemonitoring of patients with asthma supported by information and communication technologies. Methods: We included 100 patients with asthma followed in the outpatient pulmonary clinic in a randomized controlled clinical trial. The patients’ data were collected by study questionnaires and lung function tests at the inclusion and at the end of interventional period. In the interventional group, asthma control test (ACT) and peak expiratory flow measurements (PEF) were stimulated to be regularly reported by Short Message Service (SMS). As a response to reported values, the patients automatically received a preformed text or a call from a study nurse in case of detected predefined critical values. Results: The compliance of reporting PEF and ACT values was higher than 80% in 96% of patients. Although we did not detect significant differences in ACT score improvement between the two study groups, we found more prominent improvement of ACT score in the subgroup of patients with two or more exacerbations prior to inclusion in the interventional group, compared to the control group. 40 (78%) patients in the interventional group listed at least one positive effect of telemonitoring on management of asthma. Conclusions: The developed program for home monitoring of patients with asthma was applicable and offered the patients support in managing their disease. Further studies with more selected patients are needed to confirm its usefulness in improving asthma control.     

Acupuncture in chronic epicondylitis: a randomized controlled trial

OBJECTIVE: To evaluate the clinical efficacy of acupuncture in the treatment of chronic lateral epicondylitis. METHODS: In a randomized, investigator- and patient-blinded, controlled clinical study, 23 patients were treated with real acupuncture and 22 patients received sham acupuncture. Patients each received 10 treatments, with two treatments per week. The primary outcome variables were maximal strength, pain intensity (verbal rating scale) and disability scale (Disabilities of the Arm, Shoulder and Hand questionnaire). Patients were examined at baseline (1 week before the start of treatment) and at follow-up 2 weeks and 2 months after the end of treatment. RESULTS: There was no significant difference between the groups at baseline for any outcome parameter. Two weeks and 2 months after the end of treatment, there were significant reductions in pain intensity and improvements in the function of the arm and in maximal strength in both treatment groups. At the 2-week follow-up these differences were significantly greater for all outcome parameters in the group treated with real acupuncture. At 2 months the function of the arm was still better in this group than in the sham acupuncture group; however, the differences in pain intensity and maximal strength between the groups were no longer significant. CONCLUSION: In the treatment of chronic epicondylopathia lateralis humeri, acupuncture in which real acupuncture points were selected and stimulated was superior to non-specific acupuncture with respect to reduction in pain and improvement in the functioning of the arm. These changes are particularly marked at early follow-up.     

Teaching the one-minute preceptor. A randomized controlled trial

OBJECTIVE: The One-Minute Preceptor (OMP) model of faculty development is used widely to improve teaching, but its effect on teaching behavior has not been assessed. We aim to evaluate the effect of this intervention on residents' teaching skills. DESIGN: Randomized controlled trial. SETTING: Inpatient teaching services at both a tertiary care hospital and a Veterans Administration Medical Center affiliated with a University Medical Center. PARTICIPANTS: Participants included 57 second- and third-year internal medicine residents that were randomized to the intervention group (n = 28) or to the control group (n = 29). INTERVENTION: The intervention was a 1-hour session incorporating lecture, group discussion, and role-play. MEASUREMENTS AND MAIN RESULTS: Primary outcome measures were resident self-report and learner ratings of resident performance of the OMP teaching behaviors. Residents assigned to the intervention group reported statistically significant changes in all behaviors (P <.05). Eighty-seven percent of residents rated the intervention as "useful or very useful" on a 1-5 point scale with a mean of 4.28. Student ratings of teacher performance showed improvements in all skills except "Teaching General Rules." Learners of the residents in the intervention group reported increased motivation to do outside reading when compared to learners of the control residents. Ratings of overall teaching effectiveness were not significantly different between the 2 groups. CONCLUSIONS: The OMP model is a brief and easy-to-administer intervention that provides modest improvements in residents' teaching skills.     

Hospital- versus community-based syringe exchange: a randomized controlled trial.

This study examined the effect of syringe exchange program setting on the injection practices, health status, and health service utilization patterns of injection drug users (IDUs) recruited from a public urban hospital. One hundred sixty-six participants were randomized to either community- or hospital-based syringe exchange services. Poisson regression models were used to compare service utilization between groups. In both conditions, risky drug use practices decreased, and physical health functioning improved over time. Hospital-based syringe exchange program (SEP) attendees had 83% more inpatient admissions (p < .0001) and 22% more ambulatory care visits (p < .0001) than those assigned to the community-based SEP condition. Syringe exchange services that are integrated into public hospital settings may serve as a valuable strategy to engage hard to reach IDU populations in behavioral interventions designed to reduce HIV risk transmission behaviors and increase access to, or engagement in, the use of secondary and tertiary preventive medical care.     

The efficacy of platelet-rich plasma in arthroscopic rotator cuff repair: A protocol of randomized controlled trial

Background:Platelet-rich plasma (PRP), an autologous platelet concentrate (contain a large number of growth factors), has been widely investigated in healing and rebuilding the bone and tendon tissue. The objective of this prospective randomized research is to study and then compare the long-term effectiveness of the repair of arthroscopic rotator cuff without and with the platelet-rich plasma. It is assumed that there is no difference in the clinical results between patients receiving the repair of arthroscopic rotator cuff and the patients who do not receive PRP enhancement.Methods:This current study is a prospective, single-center, controlled, and randomized experiment. This study was reviewed and permitted via the institutional review committee of our hospital. All the patients will receive the written informed consent in order to involve in our clinical experiment. Patients were selected from the patients who received the repair of arthroscopic rotator cuff. Patients who meet the following conditions will be included in this study: ages ranges from 18 to 55; patients with complete tear of rotator cuff confirmed during operation; the patients agreed to wear the abduction stent for 4 weeks after operation; the preoperative count of platelet count is >150,000. All patients were evaluated at follow-up and baseline for the scores of Constant-Murley (CM) and American Shoulder and Elbow Surgeons (ASES), the numerical rating scale (NRS), and retear rate. The analysis is implemented with the SPSS 16.0 (SPSS Inc., Chicago, IL), the significance level remain at P < .05.Conclusions:The results of this study will provide useful new information on whether PRP is effective in the arthroscopic rotator cuff repair patients.Trial registration:This study protocol was registered in Research Registry (researchregistry6108).     

Effects of endurance and resistance training on total daily energy expenditure in young women: a controlled randomized trial

There exists considerable controversy regarding the impact of different modes of exercise training on total daily energy expenditure (TEE). To examine this question, young, nonobese women were randomly assigned to a supervised 6-month program of endurance training, resistance training, or control condition. TEE was measured before and 10 d after a 6-month exercise program was completed with doubly labeled water. Body composition was determined from dual energy x-ray absorptiometry, maximum aerobic capacity from a treadmill test to exhaustion, and muscular strength from one-repetition maximum tests. Results showed that body composition did not change in endurance-trained women, but maximum aerobic capacity increased by 18%. Resistance-trained women increased muscular strength and fat-free mass (1.3 kg). TEE did not significantly change when measured subsequent to the endurance or resistance training programs. Absolute resting metabolic rate increased in resistance-trained women but not when adjusted for fat-free mass. No change in physical activity energy expenditure was found in any of the groups. These results suggest that endurance and resistance training does not chronically alter TEE in free-living young women. Thus, the energy-enhancing benefits of exercise training are primarily derived from the direct energy cost of exercise and not from a chronic elevation in daily energy expenditure in young, nonobese women.     

Interventions to maintain cardiac risk control after discharge from a cardiovascular risk reduction clinic: A randomized controlled trial

Aims

To evaluate the efficacy of two maintenance strategies compared to usual care after discharge from a pharmacist-led cardiovascular risk reduction clinic (CRRC).

Methods

Open-label, randomized-controlled trial of 200 consecutive CRRC patients that met clinic discharge criteria (HbA1c ≤7% (53 mmol/mol); blood pressure ≤140/80 mmHg for those with diabetes and ≤140/90 mmHg for those without diabetes; and an LDL-cholesterol ≤2.59 mmol/l). Participants were randomized to either [1] quarterly group medical visits or [2] quarterly CRRC individual clinic visits, or [3] a usual care control arm with the standard primary care alone first in a 1:1:1 ratio, followed by a 2:2:1 ratio after first 100 patients. Primary outcome measures were time to failure for guideline recommended goals of HbA1c and blood pressure over 12-months.

Results

Of the 200 participants randomized, 89% had diabetes and were similar in other cardiovascular risk factors. After 1-year, the HbA1c failure rate was 0.36 [95% CI, 0.28–0.47] per quarter for the group medical visit arm, 0.24 [95% CI, 0.18–0.33] per quarter for the quarterly CRRC individual arm and, 0.82 [95% CI, 0.69–0.96] per quarter for the usual care control arm, p < 0.001. The rate of failure for blood pressure was 0.31 [95% CI, 0.23–0.41] per quarter for the group medical visit arm, 0.22 [95% CI, 0.16–0.30] per quarter for the CRRC individual arm and, 0.53 [95% CI, 0.40–0.71] per quarter the control arm, p < 0.001.

Conclusion

After discharge from a CRRC program, both individual and group interventions are more effective in maintaining glycemia and blood pressure control for patients with diabetes than usual care after 1-year of follow-up.     

Music for colonoscopy: A single-blind randomized controlled trial

Background

Several methods have been reported to minimize patient discomfort during colonoscopy, none are currently recommended by clinical practice guidelines. We performed a single-blind randomized controlled trial to assess the efficacy of music for colonoscopy.

Methods

109 patients were randomized to music-delivering or mute headphones before and during colonoscopy. Physicians were blinded to the trial. Sedation was given on demand. Primary outcome was pain measured on linear analogue scale from 0 to 10. Secondary endpoints were the difficulty of the procedure, need of sedation, overall patient satisfaction and willingness to repeat the procedure.

Results

Mean pain score was 5.9 ± 2.2 in the control group vs. 3.8 ± 1.9 in the music group (p < 0.00001); correspondingly overall satisfaction and willingness to repeat the procedure were significantly improved by music and the difficulty perceived by physicians was significantly reduced. Total administered midazolam was 36 mg in the control group vs. 13 in the music group (p < 0.007), pethidine was 860 mg vs. 465 mg (p = 0.07) and patients requiring sedation were 22 vs. 9, respectively (p = 0.003). A multivariable analysis to adjust treatment effect for potential confounding factors confirmed the significant beneficial effect of music.

Conclusions

Music significantly reduces discomfort and should be routinely offered to patients undergoing colonoscopy.