Gastric preparation for magnetically controlled capsule endoscopy: A prospective,randomized single-blinded controlled trial

Background and aimsMagnetically controlled capsule endoscopy (MCE) is a novel technique for which there is no agreed gastric preparation. We aimed to determine an optimal standardized gastric preparation regimen.Methods120 patients referred for MCE were randomly assigned to gastric preparation with either water alone (A), water with simethicone (B) or water, simethicone and pronase (C). Image quality was assessed using cleanliness and visualization scores, higher scores equating to better image quality.ResultsThe total cleanliness scores were (mean ± SD) 15.83 ± 2.41 (A), 21.35 ± 1.23 (B), and 20.82 ± 1.90 (C). The total visualization scores (mean ± SD) were 10.75 ± 2.02 (A), 15.20 ± 1.32 (B), and 15.08 ± 1.86 (C). While the image quality of the whole stomach in groups B and C were significantly better than group A (P < 0.0001), there was no statistical difference between group B and C (P > 0.05). MCE detected positive findings in 21 (52.5%), 27 (67.5%) and 21 (53.8%) patients in group A, B and C respectively, with no significant difference between groups (P > 0.5).ConclusionsSimethicone swallowed with water prior to MCE produced the optimal gastric mucosal image quality. The addition of pronase had no demonstrable additional benefit.     

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.     

Mindfulness instruction for HIV-infected youth: a randomized controlled trial

HIV-infected youth experience many stressors, including stress related to their illness, which can negatively impact their mental and physical health. Therefore, there is a significant need to identify potentially effective interventions to improve stress management, coping, and self-regulation. The object of the study was to assess the effect of a mindfulness-based stress reduction (MBSR) program compared to an active control group on psychological symptoms and HIV disease management in youth utilizing a randomized controlled trial. Seventy-two HIV-infected adolescents, ages 14–22 (mean age 18.71 years), were enrolled from two urban clinics and randomized to MBSR or an active control. Data were collected on mindfulness, stress, self-regulation, psychological symptoms, medication adherence, and cognitive flexibility at baseline, post-program, and 3-month follow-up. CD4+ T lymphocyte and HIV viral load (HIV VL) counts were also pulled from medical records. HIV-infected youth in the MBSR group reported higher levels of mindfulness (P?=?.03), problem-solving coping (P?=?.03), and life satisfaction (P?=?.047), and lower aggression (P?=?.002) than those in the control group at the 3-month follow-up. At post-program, MBSR participants had higher cognitive accuracy when faced with negative emotion stimuli (P?=?.02). Also, those in the MBSR study arm were more likely to have or maintain reductions in HIV VL at 3-month follow-up than those in the control group (P?=?.04). In our sample, MBSR instruction proved beneficial for important psychological and HIV-disease outcomes, even when compared with an active control condition. Lower HIV VL levels suggest improved HIV disease control, possibly due to higher levels of HIV medication adherence, which is of great significance in both HIV treatment and prevention. Additional research is needed to explore further the role of MBSR for improving the psychological and physical health of HIV-positive youth.     

Efficacy and safety of using premedication with simethicone/Pronase during upper gastrointestinal endoscopy examination with sedation: A single center,prospective, single blinded,randomized controlled trial

Background and Aim

To investigate the efficacy and safety of premedication with simethicone/Pronase during esophagogastroduodenoscopy (EGD) with sedation.

Methods

Six hundred and ten patients were randomly allocated to two groups based on type of premedication given. Premedication used in the control group was 10 mL lidocaine hydrochloride mucilage (LHM, N = 314) and premedication used in the intervention group was 80 mL simethicone/Pronase solution plus 10 mL lidocaine hydrochloride mucilage (SP/LHM, N = 296). EGD was done under sedation. Visibility scores, number of mucosal areas that needed cleansing, water consumption for cleansing, time taken for examination, diminutive lesions, pathological diagnosis, patients’ gag reflex and oxygenation (pulse oximetry) were recorded.

Results

SP/LHM has significantly lower total visibility score than LHM (7.978 ± 1.526 vs 6.348 ± 1.097, P < 0.01). During the procedure, number of intragastric areas that needed cleansing and amount of water consumed were significantly less in the SP/LHM than in the LHM group (P < 0.01). In SP/LHM (P = 0.01), endoscopy procedure duration was significantly longer. Although there was no significant difference in rate of detection of diminutive lesions between LHM and SP/LHM, the endoscopist carried out more biopsies in SP/LHM. This led to a higher rate of diagnosis of atrophic gastritis (P = 0.014) and intestinal metaplasia (P = 0.024). There was no significant difference in gag reflex (P = 0.604) and oxygenation during the endoscopy procedure for either group of patients.

Conclusion

Routine use of premedication with simethicone/Pronase should be recommended during EGD with sedation.     

止血粉预防内镜黏膜下剥离术后迟发性出血的随机对照试验

目的探讨内镜黏膜下剥离术(endoscopic submucosal dissection,ESD)术后创面喷洒止血粉对迟发性出血的预防作用。方法2017年6月至2018年8月,在苏州大学附属第一医院总院、榆林市第二医院接受ESD治疗者作为研究对象,计划纳入试验组、对照组各100例,以随机信封方式在ESD手术开始后进行分组,ESD结束后试验组创面予止血粉喷洒,对照组则不予处理。主要观察试验组止血粉喷洒用时、用量及其不良事件,并对比分析2组的手术时间、迟发性出血(术后30 d内)发生率、早期迟发性出血(术后48 h内)发生率以及术后住院时间。结果初始纳入200例患者,有1例中途退出、3例转外科手术,最终共有196例纳入数据分析,其中试验组97例、对照组99例,2组的基线资料具有可比性(P均>0.05)。试验组止血粉喷洒时间(68.78±19.75)s,用量(2.51±0.93)g,有1例(1.03%)出现止血粉输送管路堵塞,术后随访30 d未发生止血粉相关不良事件。手术时间试验组为(61.92±11.71)min,对照组为(59.76±11.01)min(t=1.330,P=0.185);迟发性出血发生率试验组为1.03%(1/97),对照组为8.08%(8/99)(P=0.035);试验组无早期迟发性出血,对照组发生率为6.06%(6/99)(P=0.029);试验组术后住院时间为(4.57±0.85)d,对照组为(4.86±1.37)d(t=1.778,P=0.077)。结论ESD术后创面喷洒止血粉能有效预防迟发性出血的发生,尤其是对早期迟发性出血的预防作用更为显著,但喷洒装置的效能还有待进一步提高。     

Magnetic imaging-assisted colonoscopy vs conventional colonoscopy: A randomized controlled trial

AIM: To compare magnetic imaging-assisted colonoscopy (MIC) with conventional colonoscopy (CC).METHODS: Magnetic imaging technology provides a computer-generated image of the shape and position of the colonoscope onto a monitor to give visual guidance to the endoscopist. It is designed to improve colonoscopy performance and tolerability for patients by enabling visualization of loop formation and endoscope position. Recently, a new version of MIC technology was developed for which there are limited data.To evaluate this latest generation of MIC among experienced rather than inexperienced or trainee endoscopists, a prospective randomized trial was performed using only gastroenterologists with therapeutic endoscopy training. Consecutive patients undergoing elective outpatient colonoscopy were randomized to MIC or CC, with patients blinded to their group assignment. Endoscopic procedural metrics and quantities of conscious sedation medications were recorded during the procedures. The procedure was classified as “usual” or “difficult” by the endoscopist at the conclusion of each case based on the need for adjunctive maneuvers to facilitate endoscope advancement. After more than one hour post-procedure, patients completed a 10 cm visual analogue pain scale to reflect the degree of discomfort experienced during their colonoscopy. The primary outcome was patient comfort expressed by the visual analogue pain score. Secondary outcomes consisted of endoscopic procedural metrics as well as a sedation score derived from standardized dose increments of the conscious sedation medications.RESULTS: Two hundred fifty-three patients were randomized and underwent MIC or CC between September 2011 and October 2012. The groups were similar in terms of the indications for colonoscopy and patient characteristics. There were no differences in cecal intubation rates (100% vs 99%), insertion distance-to-cecum (82 cm vs 83 cm), time-to-cecum (6.5 min vs 7.2 min), or polyp detection rate (47% vs 52%) between the MIC and CC groups. The primary outcome of mean pain score (1.0 vs 0.9 out of 10, P = 0.41) did not differ between MIC and CC groups, nor did the mean sedation score (8.2 vs 8.5, P = 0.34). Within the subgroup of cases considered more challenging or difficult, time-to-cecum was significantly faster with MIC compared to CC, 10.1 min vs 13.4 min respectively (P = 0.01). Sensitivity analyses confirmed a similar pattern of overall findings when each endoscopist was considered separately, demonstrating that the mean results for the entire group were not unduly influenced by outlier results from any one endoscopist.CONCLUSION: Although the latest version of MIC resulted in faster times-to-cecum within a subgroup of more challenging cases, overall it was no better than CC in terms of patient comfort, sedation requirements and endoscopic procedural metrics, when performed in experienced hands.     

Culturally sensitive patient-centred educational programme for self-management of type 2 diabetes: A randomized controlled trial

ObjectiveTo assess the effectiveness of a culturally sensitive, structured education programme (CSSEP) on biomedical, knowledge, attitude and practice measures among Arabs with type two diabetes.Research designs and methodsA total of 430 patients with type II diabetes mellitus living in Doha, Qatar were enrolled in the study. They were randomized to either intervention (n = 215) or a control group (n = 215). A baseline and one-year interval levels of biomedical variables including HbA1C, lipid profile, urine for microalbuminuria; in addition to knowledge, attitude and practice (KAP) scores were prospectively measured. The intervention was based on theory of empowerment, health belief models and was culturally sensitive in relation to language (Arabic), food habits and health beliefs. It consisted of four educational sessions for each group of patients (10–20 patients per session), lasting for 3–4 h. The first session discussed diabetes pathophysiology and complications; while the second session discussed healthy life style incorporating the Idaho plate method; and the third session dealt with exercise benefits and goal setting and the fourth session concentrated enhancing attitude and practice using counselling techniques. Outcomes were assessed at base line and 12 months after intervention.ResultsAfter 12 months participation in the intervention was shown to have led to a statistically significant reduction in HbA1C in the (CSSEP) group (?0.55 mmol/L, P = 0.012), fasting blood sugar (?0.92 mmol/L, P = 0.022), body mass index (1.70, P = 0.001) and albumin/creatinine ratio (?3.09, P < 0.0001) but not in the control group. The intervention group also had improvement in Diabetes knowledge (5.9%, P < 0.0001), attitude (6.56%, P < 0.0001), and practice (6.52%, P = 0.0001).ConclusionThis study demonstrates the effectiveness of culturally sensitive, structured, group-based diabetes education in enhancing biomedical and behavioural outcomes in Diabetic patients.     

Effects of nasal irrigation after endoscopic transsphenoidal resection in patients with pituitary adenomas: A randomized controlled trial

Purpose:We aimed to explore the methods to reduce or prevent nasal complications after endoscopic transsphenoidal pituitary adenoma resection. We also examined the effects of nasal irrigation after this procedure was performed.Methods:A randomized controlled trial was performed. Sixty patients of a tertiary hospital were enrolled in this study. The subjects were randomly divided into a control group and an intervention group. The subjects of the control group were given routine guidance, and 20 mL of normal saline was atomized through inhalation. The gauze was removed 7 days after surgery. The patients of the intervention group were given 50 mL of a 2% saline solution at 37°C to 38°C for bilateral nasal irrigation for 1 week. After that, patients were given 50 mL of a 0.9% normal saline solution at 37°C to 38°C for bilateral nasal irrigations. The complications of the two groups were collected at baseline, 1 week after intervention, 1 month, and 3 months after intervention. The data were analyzed using the chi-square test.Results:A 1-month after intervention, there were significant differences in dysosmia, epistaxis, and nasal adhesion between the intervention and control groups. A 3-month after intervention, only olfactory disturbances were significantly different between the two groups.Conclusions:Nasal irrigation helps reduce the incidence of complications such as epistaxis and nasal adhesions in the early postoperative period. It can also promote the elimination or reduction of olfactory disturbances.     

Effects of probiotics on gastrointestinal complications and nutritional status of postoperative patients with esophageal cancer: A protocol of randomized controlled trial

Background:Gastrointestinal complications and malnutrition are common problems that affect postoperative rehabilitation and survival of patients with esophageal cancer. Evidence has shown that probiotics have a positive effect on improving gastrointestinal complications and nutritional status of patients with esophageal cancer after surgery, but there is a lack of prospective studies on this topic. We designed this prospective randomized controlled trial to evaluate the effects of probiotics on gastrointestinal complications and nutritional status in patients with postoperative esophageal cancer.Methods:This is a prospective, randomized, double-blind, placebo-controlled trial. It was approved by the Clinical Research Ethics Committee of our hospital. 192 patients will be randomly divided into probiotics group and the placebo group in a 1:1 ratio. After operation, probiotics and placebo will be given orally for 8 weeks. The indexes of nutritional status and incidence of digestive tract complications will be recorded and the data will be analyzed by SPSS 18.0 software.Discussion:This study will evaluate the effect of probiotics on gastrointestinal complications and nutritional status of postoperative patients with esophageal cancer. The results of this study will provide clinical basis for the use of probiotics in postoperative treatment of esophageal cancer.Trial registration:OSF Registration number: D DOI 10.17605/OSF.IO/QHW86     

Usefulness of the clip-flap method of endoscopic submucosal dissection: A randomized controlled trial

AIM To prospectively investigate the efficacy and safety of clipflap assisted endoscopic submucosal dissection(ESD) for gastric tumors.METHODS From May 2015 to October 2016, we enrolled 104 patients with gastric cancer or adenoma scheduled for ESD at Shiga University of Medical Science Hospital. We randomized patients into two subgroups using the minimization method based on location of the tumor(upper, middle or lower third of the stomach), tumor size( 20 mm or 20 mm) and ulcer status: ESD using an endoclip(the clip-flap group) and ESD without an endoclip(the conventional group). Therapeutic efficacy(procedure time) and safety(complication: Gastrointestinal bleeding and perforation) were assessed. RESULTS En bloc resection was performed in all patients. Four patients had delayed bleeding(3.8%) and two had perforation(1.9%). No significant differences in en bloc resection rate(conventional group: 100%, clip flap group: 100%), curative endoscopic resection rate(conventional group: 90.9%, clip flap group: 89.8%, P = 0.85), procedure time(conventional group: 70.8 ± 46.2 min, clip flap group: 74.7 ± 53.3 min, P = 0.69), area of resected specimen(conventional group: 884.6 ± 792.1 mm~2, clip flap group: 1006.4 ± 1004.8 mm~2, P = 0.49), delayed bleeding rate(conventional group: 5.5%, clip flap group: 2.0%, P = 0.49), or perforation rate(conventional group: 1.8%, clip flap group: 2.0%, P = 0.93) were found between the two groups. Lessexperienced endoscopists did not show any differences in procedure time between the two groups.CONCLUSION For patients with early-stage gastric tumors, the clipflap method has no advantage in efficacy or safety compared with the conventional method.     

替米沙坦治疗轻中度高血压的临床疗效和安全性--多中心随机对照临床试验

目的：（1）比较替米沙坦40mg或80mg与氯沙坦50mg或100mg每天一次口服治疗轻中度高血压的疗效和安全性；（2）评价替米沙坦40mg每天一次口服治疗轻中度高血压的24h降压效果及谷／峰比值。方法：（1）多中心、随机、双盲、双模拟平行分组试验。330例轻中度高血压（95mm Hg≤舒张压＜110mm Hg，收缩压＜180mm Hg,1mm Hg=0.133kPa)患被随机分入替米沙坦组（164例）和氯沙坦组（166例），分别每天一次口服替米沙坦40mg或氯沙坦50mg。4周后如坐位舒张压≥90mm Hg，则改为替米沙坦80mg或氯沙坦100mg每天一次口服。（2）开放试验。同样条件的20例患服用替米沙坦40mg共6周，于替米沙坦治疗前后各进行24h动态血压监测。结果：（1）治疗8周末，替米沙坦组的坐位收缩压及舒张压下降幅度大于氯沙坦组（12．5mm Hg vs 9.4mm Hg,P=0.037及10.9mm Hg vs 9.3mm Hg,P=0.030);(2)替米沙坦降低轻中度高血压的总有效率高于氯沙坦（70．1％ vs 58.7%,P=0.020);(3)替米沙坦级瑟氯沙坦组的不良事件发生率相似（23．2％ vs 22.9%,P=0.952);(4)替米沙坦40mg每天一次口服，其收缩压的谷／峰比值为66．5％，舒张压的谷／峰比值为76．8％；24h平均血压下降10．2／7．8mm Hg，用药末6h的平均血压下降10.0/9.2mm Hg。结论：（1）替米沙坦40mg或80mg每天一次口服治疗轻中度高血压安全有效；（2）替米沙坦适合每天一次服用，其降压作用可维持24h。     

针刺治疗腹泻型肠易激综合征的随机对照试验

目的:客观评价针刺治疗腹泻型肠易激综合征(IBS)的临床疗效.方法:采用前瞻性、随机、平行对照设计,将120例符合诊断标准、纳入标准的D-IBS患者,按1∶1随机分为两组,每组60例.治疗组予针刺结合得舒特处理;对照组予假针刺结合得舒特处理,连续4wk.记录治疗前、治疗后2及4wk两组患者腹痛、腹部不适、大便性状等症状变化,应用ELISA技术检测治疗前、后患者血浆血管活性肠肽(VIP)的变化.结果:从总体疗效分析,治疗组疗效明显优于对照组(96%vs76%).治疗组能有效改善患者腹痛、腹部不适及大便性状改变等症状,经统计学比较,治疗组优于对照组(1.32±0.17vs3.37±0.49,P=0.000;0.95±0.06vs3.34±0.24,P=0.000;0.48±0.15vs3.64±0.78,P=0.000).治疗前,两组患者血浆VIP表达均呈上升趋势,VIP变化无明显差异(P=0.891);治疗后,治疗组血浆VIP表达呈下降趋势,与治疗前比较有统计学意义(42.72μg/L±12.78μg/Lvs105.12μg/L±21.01μg/L,P=0.000).对照组治疗后血浆VIP表达未见明显变化,与治...     

Acupuncture for patients with mild hypertension: A randomized controlled trial

Acupuncture may be beneficial for patients with mild hypertension, but the evidence is not convincing. We aimed to examine the effect of acupuncture on blood pressure (BP) reduction in patients with mild hypertension. We conducted a multicenter, single‐blind, sham‐controlled, randomized trial in eleven hospitals in China. The trial included 428 patients with systolic blood pressure (SBP) from 140 to 159 mm Hg and/or with diastolic blood pressure (DBP) from 90 to 99 mm Hg. The patients were randomly assigned to receive 18 sessions of affected meridian acupuncture (n = 107) or non‐affected meridian acupuncture (n = 107) or sham acupuncture (n = 107) during 6 weeks, or to stay in a waiting‐list control (n = 107). All patients received 24‐hour ambulatory blood pressure monitoring at weeks 6, 9, and 12. We included 415 participants in the intention‐to‐treat analysis. The two acupuncture groups were pooled in the analysis, since they had no difference in all outcomes. SBP decreased at week 6 in acupuncture group vs sham acupuncture vs waiting‐list group (7.2 ± 11.0 mm Hg vs 4.1 ± 11.5 mm Hg vs 4.1 ± 13.2 mm Hg); acupuncture was not superior to sham acupuncture (mean difference 2.7 mm Hg, 95% CI 0.4 to 5.9, adjusted P = 0.103) or waiting‐list control (2.9 mm Hg, 95% CI −0.2 to 6.0, adjusted P = 0.078). However, acupuncture was superior to sham acupuncture (3.3 mm Hg, 95% CI 0.2 to 6.3, adjusted P = 0.035) and waiting‐list control (4.8 mm Hg, 95% CI 1.8 to 7.8, P < 0.001) at week 9. Acupuncture had a small effect size on the reduction of BP in patients with mild hypertension.     

The effects of vigorous exercise training on physical function in children with arthritis: A randomized,controlled, SINGLE‐BLINDED trial

Objective

To examine the effectiveness of high‐intensity aerobic training compared with low‐intensity training in terms of energy cost of locomotion, peak oxygen uptake, peak power, and self‐reported physical function in children with juvenile idiopathic arthritis (JIA).

Methods

Eighty children with JIA, ages 8–16 years, were enrolled in a randomized, single‐blind controlled trial. Both groups participated in a 12‐week, 3‐times–weekly training program consisting of high‐intensity aerobics in the experimental group and qigong in the control group. Subjects underwent exercise testing measuring submaximal oxygen uptake at 3 km/hour (VO _2submax) as the primary outcome, maximal oxygen uptake, and peak power at the beginning and end of the program. Physical function was measured using the Child Health Assessment Questionnaire (C‐HAQ).

Results

The exercise program was well tolerated in both groups. There was no difference in VO _2submax or any other exercise testing measures between the groups through the study period and no indication of improvement. Both groups showed significant improvements in C‐HAQ with no difference between the groups. Adherence was higher in the control group than the experimental group.

Conclusion

Our findings suggest that activity programs with or without an aerobic training component are safe and may result in an important improvement in physical function. The intensity of aerobic training did not seem to provide any additional benefits, but higher adherence in the qigong program may suggest that less intensive regimens are easier for children with JIA to comply with, and provide a degree of benefit equivalent to more intensive programs.     

The efficacy and safety of silver needle in the treatment of rheumatoid arthritis: A protocol of randomized controlled trial

Background:Rheumatoid arthritis is a kind of chronic crippling disease, the condition is complex, the course of the disease is repeated, seriously affecting the quality of life of patients. Adverse reactions and drug resistance associated with conventional treatment can no longer meet the clinical need. Therefore, complementary and alternative therapies need to be explored. The evidence shows that silver needle therapy has advantages in the treatment of rheumatoid arthritis, but there is a lack of standard clinical studies to verify this conclusion.Methods:This is a prospective randomized controlled trial to study the efficacy and safety of silver needles in the treatment of rheumatoid arthritis. Approved by the Clinical Research Ethics Committee of our hospital. The patients are randomly divided into a treatment group (silver needle treatment group) or control group (routine western medicine treatment group). The patients are followed up for 2 months after 4 weeks of treatment. Observation indicators include: TCM symptom score, HAQDI score, DAS-28 score, laboratory indicators, adverse reactions and so on. Data will be analyzed using the statistical software package SPSS version 18.0 (Chicago, IL).Discussion:This study will evaluate the clinical efficacy of a silver needle in the treatment of rheumatoid arthritis. The results of this study will provide a reliable reference for the clinical use of a silver needle in the treatment of rheumatoid arthritis.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/4X5QB     

Self-management groups for people with dementia and their spousal caregivers. A randomized,controlled trial. Baseline findings and feasibility

BackgroundNo previous studies have investigated the effectiveness and feasibility of self-management groups for people with dementia and their caregivers.PurposeWe present the baseline findings of a randomized controlled trial examining the effectiveness of a psychosocial group intervention to enhance self-management skills of persons with dementia and their spouses and have evaluated the feasibility of the intervention.Subjects and methodsAltogether 136 individuals with dementia living with their spousal caregivers in the community were recruited from the memory clinics. They were randomized into two arms: group-based self-management intervention (n = 67 couples) and controls (n = 69 couples). The patients and spouses met in separate closed groups once a week for 8 weeks. Intervention sessions were based on discussions, including topics according to participants’ preferences. Their aim was to enhance participants’ self-efficacy, problem-solving skills and peer support. Anonymous feedback from the intervention group was collected at 3 months.ResultsThe mean age of participants with dementia was 76.8 years, 51 (38%) were females, and 98 (72%) were at a mild stage of dementia. Cognitive status was poorer in the intervention group than in controls [MMSE; 19.9 (SD 5.7) vs. 21.7 (SD 3.7), P = 0.04]. The participation rate in-group sessions was high among patients (93%, range 86–98%) and caregivers (93%, range 86–99%). Participants described the group sessions as beneficial and supportive.ConclusionWe have successfully randomized 136 dyads in a self-management group rehabilitation trial. The feedback from participants was favourable, and the drop-out rate during the first 3 months was low.     

脑安胶囊与阿司匹林预防卒中的随机对照试验

目的评价脑安胶囊与阿司匹林预防卒中的效果。方法以多中心的形式，在基线调查时筛检出≥40岁、有卒中危险因素暴露和血流动力学异常的卒中高危个体4415例，以村和居委会为单位随机分为脑安胶囊组（1656例），阿司匹林50（1348例）、75mg组（1411例）。3组在指导一般干预措施的基础上，分别给予相应的干预药物，阿司匹林两组分别口服阿司匹林50、70mg，1次／d；脑安胶囊组口服脑安胶囊1～2粒／次，2次／d。平均干预16个月。随访观察卒中的发病，比较各组发病率的差异。结果脑安胶囊组，阿司匹林50、75mg组的卒中发病率分别为6．43、12．92和10．37（1000^-1·人年^-1）。脑安胶囊组卒中发病率显著低于阿司匹林50mg组（P=0．035），分别比阿司匹林50、75mg组下降了50．2％和38．0％。3个干预组复查时收缩压和舒张压较基线水平均下降，P〈0．01。药物不良反应脑安胶囊组较阿司匹林组轻。结论脑安胶囊对卒中高危个体的干预效果优于阿司匹林。     

1% Hydrocortisone ointment is an effective treatment of pruritus ani: a pilot randomized controlled crossover trial

Background Pruritus ani (PA) is a common condition which is difficult to treat in the absence of obvious predisposing factors. There is paucity of evidence-based guidelines on the treatment of this condition. We examined whether 1% hydrocortisone ointment is an effective treatment for PA. Materials and methods A pilot randomized, double-blind, placebo-controlled, crossover trial was carried out. Eleven patients consented to take part in the trial and ten completed the study. After a 2-week run-in period, patients with primary PA were randomly allocated to receive 1% hydrocortisone ointment or placebo for 2 weeks followed by the opposite treatment for a further 2-week period. There was a washout period of 2 weeks between treatments. The primary outcome measure was reduction in itch using a visual analogue score (VAS). The secondary outcome measures were improvement in quality of life measured using a validated questionnaire (Dermatology Life Quality Index, DLQI) and improvement in clinical appearance of the perianal skin using the Eczema Area and Severity Index (EASI) score. Results Treatment with 1% hydrocortisone ointment resulted in a 68% reduction in VAS compared with placebo (P = 0.019), a 75% reduction in DLQI score (P = 0.067), and 81% reduction in EASI score (P = 0.01). Conclusion A short course of mild steroid ointment is an effective treatment for PA. Previous publication: These data appeared in abstract form in Gastroenterology, 2003, 124(S1):A190 (abstract number S1295).     

Electronic monitoring of adherence as a tool to improve blood pressure control. A randomized controlled trial

BACKGROUND: Poor adherence to antihypertensive drug regimens is believed to be a major contributor to treatment failure. Electronic monitoring of adherence may improve adherence and allow differentiation between those who are nonadherent and those who are pharmacologically nonresponsive. This study was designed to evaluate the effectiveness of electronic monitoring of adherence in lowering blood pressure (BP) in comparison with usual care. METHODS: A total of 258 patients with high BP despite use of antihypertensive medication were randomly assigned to either continuation of usual care (with adjustment in antihypertensive medication if necessary) or to the introduction of electronic monitoring. Adherence to antihypertensive medication was monitored for 2 months without medication changes. The primary outcome measure was the proportion of patients who reached target BP levels after a 5-month follow-up period. RESULTS: At 5 months, 50.6% of the patients in the usual care group reached adequate BP, v 53.7% in the electronic monitoring group (P = .73). The percentages of patients with drug additions or increases in dosage were higher in the usual care group compared with those in whom adherence was monitored (P < .01). CONCLUSION: These data show that electronic monitoring in comparison to usual care results in similar BP control but leads to fewer drug changes and less drug use. This result is likely to be achieved by improving adherence. Hence a strategy that includes electronic monitoring has the potential to prevent unnecessary treatment escalation in patients with poor adherence.