Randomized Double-Blind Clinical Trial Comparing Clobetasol and Dexamethasone for the Topical Treatment of Symptomatic Oral Chronic Graft-Versus-Host Disease

Patients who undergo allogeneic stem cell transplantation frequently develop an immunologic disease caused by the reactivation of the graft to the host tissues. This disease is called graft-versus-host disease (GVHD) and it is usually a systemic disorder. In a large proportion of cases, oral disorders that are related to a chronic phase of GVHD (cGVHD) occur, and their treatment involves the use of topical immunosuppressive drugs. Several medications have been studied for this purpose, but only a small number of clinical trials have been published. The present study is a randomized, double-blind clinical trial that compares topical clobetasol and dexamethasone for the treatment of symptomatic oral cGVHD. Patients were randomly assigned to treatment with clobetasol propionate .05% or dexamethasone .1 mg/mL for 28 days. In both arms, nystatin 100,000 IU/mL was administered with the corticosteroid. Oral lesions were evaluated by the modified oral mucositis rating scale (mOMRS) and symptoms were registered using a visual analogue scale. Thirty-five patients were recruited, and 32 patients were randomized into the study groups: 18 patients (56.3%) to the dexamethasone group and 14 patients (43.8%) to the clobetasol group. The use of clobetasol resulted in a significant reduction in mOMRS total score (P = .04) and in the score for ulcers (P = .03). In both groups, there was significant symptomatic improvement but the response was significantly greater in the clobetasol group (P = .02). In conclusion, clobetasol was significantly more effective than dexamethasone for the amelioration of symptoms and clinical aspects of oral lesions in cGVHD.     

A Randomized Clinical Trial of Nefopam versus Ketorolac Combined With Oxycodone in Patient-Controlled Analgesia after Gynecologic Surgery

Objectives: Nefopam is a centrally-acting non-opioid analgesic, which has no effect on bleeding time and platelet aggregation. There has been no study about nefopam and oxycodone combination for postoperative analgesia. In this study, we present efficacy and side effects of nefopam/oxycodone compared with ketorolac/oxycodone in patient-controlled analgesia (PCA) after gynecologic surgery.Methods: 120 patients undergoing gynecologic surgery were divided randomly into two groups: Nefopam group treated with oxycodone 1 mg and nefopam 1 mg bolus; and Ketorolac group treated with oxycodone 1 mg and ketorolac 1.5 mg bolus. After the operation, a blinded observer assessed the pain with a numeric rating scale (NRS), infused PCA dose and sedation score at 1, 4, 24, and 48 h, nausea, vomiting, headache, shivering, pruritus and delirium at 6, 24 and 48 h, and satisfaction at 48 h after the operation.Results: Nefopam group showed less nausea than Ketorolac group within 6 h after the operation. There were no significant differences in demographic data and other complications between both groups. At 48 h after operation, satisfaction and the infused PCA volumes of Nefopam group (34.0± 19.7 ml) showed no significant differences compared to Ketorolac group (30.7± 18.4 ml, P-value= 0.46).Conclusion: Nefopam showed a similar efficacy and lower incidence of nausea within 6 h after the operation to that of ketorolac in PCA. Nefopam may be a useful analgesic drug for the opioid-based PCA after gynecologic surgery. Further evaluation of accurate equivalent dose of nefopam as well as pharmacokinetics of bolus administration is required.     

Evaluation of Atorvastatin for the Treatment of Patients With Asthma: A Double-Blind Randomized Clinical Trial

Purpose

Statins are known as cholesterol-lowering agents, but have been suggested for the treatment of asthma because of their anti-inflammatory effects. In this study, the potential therapeutic effects of atorvastatin were investigated in asthmatic patients.

Methods

A total of 62 patients with persistent mild to moderate asthma who presented at asthma clinics of Arak University of Medical Sciences were recruited in a double-blind randomized clinical trial. The asthma clinical control score was assessed based on the standardized Asthma Control Test. Lung volume, i.e., percentage of forced expiratory volume in one second (FEV1%) and percentage of forced vital capacity (FVC%), and peripheral blood eosinophils were also measured. The intervention group was treated with atorvastatin 40 mg per day for 8 weeks, while the control group received a placebo. Asthma controller treatments were not changed. At the beginning and end of the study, serum cholesterol and triglyceride levels were measured to evaluate adherence of the patients to the treatment.

Results

The asthma control score did not significantly differ between the intervention and control groups (P=0.06). Difference in FEV1%, FVC%, and blood eosinophil count between the intervention and control groups were not statistically significant (P>0.05). The differences in post-treatment cholesterol and low-density lipoprotein cholesterol levels were significant (P<0.05).

Conclusions

Our study shows that atorvastatin is not effective in the treatment of persistent mild to moderate asthma.     

西酞普兰合并氯氮平治疗精神分裂症阴性症状的临床研究

目的:观察西酞普兰合并氯氮平治疗精神分裂症阴性症状的疗效和不良反应。方法:将61例精神分裂症阴性症状患者随机分为研究组(西酞普兰 氯氮平)和对照组(氯氮平 安慰剂),进行双盲研究。在治疗前、治疗后3、6、9、12周末,采用阳性和阴性症状量表(PANSS)和药物治疗不良反应量表(TESS)评定疗效和不良反应。结果:治疗12周末,研究组的显效率高于对照组(56．7％比25．8％,X2= 6．00,P=0．014)。从第3周末起,阴性因子分、一般精神病理分和总分均为研究组小于对照组(P<0．05或P<0．01),但是各时点阳性因子分的组间差异均不显著(P>0．05)。两组的不良反应发生率差异无统计学意义。结论:西酞普兰合并氯氮平治疗精神分裂症阴性症状的疗效比单用氯氮平好,并且不增加不良反应。     

Randomized Controlled Clinical Trial of Blood Glucose Awareness Training (BGAT III) in Switzerland and Germany

Although both diabetes and the efficacy of medical management are international issues, psycho-educational interventions might be culturally bound. Blood Glucose Awareness Training (BGAT) is a psycho-educational program for patients with type 1 diabetes mellitus. It is focused on improving recognition and management of extreme blood glucose levels, and is the best documented American psycho-educational program for this purpose. A randomized controlled clinical trial of BGAT's long-term benefits in a non-American setting has been lacking. One hundred and eleven adults with type 1 diabetes mellitus from Switzerland and Germany participated. After a 6 months baseline assessment, subjects were randomly assigned to receive either 2 months of BGAT (n = 56) or a physician-guided self-help control intervention (n = 55). BGAT improved recognition of low (p = 0.008), high (p = .03), and overall blood glucose (p = 0.001), and reduced frequency of severe hypoglycemia (p = 0.04), without compromising metabolic control. BGAT reduced both the external locus of control (p < 0.02) and fear of hypoglycemia (p < 0.02). BGAT was efficacious in reducing adverse clinical events and achieving clinically desirable goals in a European, as well as American setting.     

当归补血汤治疗肿瘤化疗不良反应随机对照临床试验的Meta分析

目的 系统评价目前当归补血汤治疗肿瘤化疗不良反应的疗效和安全性。方法 电子检索中国期刊全文数据库（CNKI）、万方数据库、中文科技期刊全文数据库（VIP）、中国生物医学文献服务系统（SinoMed）、美国国立医学图书馆（PubMed）、TheCochrane Library,截止2017年12月。应用Cochrane Risk of bias量表评价纳入研究的质量,釆用RevMan5.3软件进行Meta分析。结果 最终纳入14篇文献,包括1369例患者,Meta分析结局指标结果显示:白细胞水平升高[     

The Use of the Number Needed to Treat (NNT) in Randomized Clinical Trials in Psychological Treatment

[Clin Psychol Sci Prac 17: 41–47, 2010]
There are many psychological treatments available for clinicians to implement with their clients, with numerous reports of which works best for whom. Clients have access to information regarding interventions and can benefit from easy-to-understand, yet powerful explanations of the results of treatment evaluations. The number needed to treat (NNT) is a potentially useful statistic, although it is highly underreported. A review of the Journal of Consulting and Clinical Psychology between 2000 and 2008 found that, of the 100 articles reviewed, four reported the NNT. Despite the need for powerful and intelligible statistics, behavioral scientists have yet to adopt and report the NNT in their results.     

General Acteoside of Rehmanniae Leaves in the Treatment of Primary Chronic Glomerulonephritis: A Randomized Controlled Trial

The objective of the study was to investigate the effectiveness and efficacy of the randomized, parallel, and controlled trial of Traditional Chinese Medicine, general acteoside of Rehmanniae leaves, compared with piperazine ferulate in the treatment of primary chronic glomerulonephritis. Rehmanniae leaves and piperazine ferulate can reduce proteinuria and erythrocyturia effectively in the treatment of primary chronic glomerulonephritis. A total of 400 patients diagnosed with primary chronic glomerulonephritis were recruited from outpatient clinics and were randomly assigned to the treatment group (general acteoside of Rehmanniae leaves, two 200mg tablets, bid) or the control group (piperazine ferulate, four 50-mg tablets, bid ). The primary outcome was 24-h urinary protein. Secondary outcome measures included estimated glomerular filtration rate (eGFR), erythrocyturia, and electrolytes. After 8 weeks of treatment, the treatment group and the control group showed a mean reduction in 24-h proteinuria of 34.81% and 37.66%. The 95% CI of difference of the mean reduction in 24-h proteinuria between the two groups was [−11.50%, 5.80%]. No significant differences were found between the two groups in the erythrocyturia reduction. Neither group showed obvious changes between baseline and 8 weeks in eGFR or electrolytes. Adverse events occurred at a similarly low rate in the treatment group (1.5%) and control group (2.5%, P = 0.7238). Both general acteoside of Rehmanniae leaves and piperazine ferulate can reduce proteinuria and erythrocyturia effectively in the treatment of primary chronic glomerulonephritis.     

Quality of life in heart failure patients undergoing hybrid comprehensive telerehabilitation versus usual care – results of the Telerehabilitation in Heart Failure Patients (TELEREH-HF) Randomized Clinical Trial

IntroductionHybrid comprehensive telerehabilitation (HCTR) consisting of telecare (with psychological telesupport), telerehabilitation and remote monitoring of implantable devices might be an innovative option improving heart failure (HF) patients’ quality of life (QoL) and emotional health. The aim of the study was to investigate the influence of HCTR on various facets of QoL in HF patients in comparison with usual care (UC) alone.Material and methodsThe present analysis formed part of a multicenter, randomized trial that enrolled 850 HF patients (NYHA I–III, LVEF ≤ 40%). Patients were randomized 1 : 1 to HCTR plus UC or UC only. Patients underwent either an HCTR program or UC with observation. The psychological intervention in the HCTR group included supportive psychological counseling via mobile phone. The Medical Outcome Survey Short Form 36 Questionnaire was used to assess QoL. Measurements were made before and after a 9-week intervention (HCTR group)/observation (UC group).ResultsAfter the intervention, the HCTR group showed significant improvement in overall QoL, physical domain (PD) of QoL, and 4 areas of QoL (physical functioning (PhF), role functioning related to physical state (RF), general health (GH), vitality (VI)). A significant positive change in QoL in the UC group was observed only in VI and social functioning. There were also significant differences in QoL after 9-week intervention/observation between the two groups. The results showed greater improvement in HCTR for overall QoL (p = 0.009), PD of QoL (p = 0.0003) and three specific areas of QoL: PhF (p = 0.001), RF (p = 0.003), bodily pain (BP) (p = 0.015).ConclusionsIn comparison to UC, HCTR resulted in improvement in overall QoL, PD of QoL and 3 specific areas of QoL: PhF, RF and BP.     

二甲双胍单药及不同联合用药方案治疗2型糖尿病的随机对照研究

目的 观察二甲双胍单药及不同联合用药方案治疗2型糖尿病的临床疗效。方法 回顾分析2017年1月~2018年6月在我院接受治疗的108例2型糖尿病患者临床资料,依据治疗方案分为A、B、C组,各36例,A组采用二甲双胍单药治疗,B组采用二甲双胍联合格列吡嗪缓释片治疗,C组采用二甲双胍联合沙格列汀治疗,比较3组治疗总有效率,记录患者空腹血糖（FPG）、餐后2h血糖（2 hPG）、糖化血红蛋白（HbA1c）水平及低血糖发生情况。结果 A组治疗总有效率为97.22%、B组为94.44%、C组为94.44%,差异无统计学意义（P＞0.05）;治疗后3组FPG、2 hPG、HbA1c水平均下降,与治疗前比较差异有统计学意义（P＜0.05）,C组FPG、2 hPG水平以及B组FPG水平改善均优于A组,差异有统计学意义（P＜0.05）,B、C组间各指标对比,差异无统计学意义（P＞0.05）; A、C组夜间均未发生低血糖,B组发生4例低血糖,发生率为11.11%,C组肝肾功能异常3例,发生率为8.33%。结论 二甲双胍单药及不同联合用药方案治疗2型糖尿病均能获得较好的疗效,但联合用药可以发挥协同作用,更好的控制血糖水平,临床可依据患者具体情况选择治疗方案。     

维思通治疗复发性精神分裂症的临床对照研究

目的探讨维思通治疗复发性精神分裂症的疗效的安全性。方法收集复发性精神分裂症72例,首发精神分裂症70例,皆符合CCMD-3和ICD-10的诊断标准,两者进行对照,观察共12周。采用简明精神病评定量表（BPRS）评定疗效。采用副反应量表（TESS）评定不良反应。结果维思通对治疗复发性精神分裂症的疗效、副作用,依从性与治疗首发精神分裂症无显著性差异。结论维思通治疗复发性精神分裂症安全可靠,有效率高,依从性好的新型抗精神病药。     

A Randomized Controlled Trial of Oral Administration of Tetanus Toxoid (TT) Versus Tetanus and Reduced Diphtheria (Td) in Pregnant Women

Introduction  The present study was designed as a randomized clinical trial to compare the immunogenicity, reactogenicity, and efficacy of tetanus toxoid (TT) and the combined tetanus and reduced diphtheria (Td) in pregnant women in four rural communities in Egypt. The pregnant women in each four villages received either TT or Td randomly. Both TT and Td vaccines are manufactured by the Egyptian Company for Biological Products & Vaccines (VACSERA) in Egypt. A total of 131 pregnant women were enrolled during the time of antenatal care visit (at 20 weeks gestational age of pregnancy) in one of four health units in Abu Homos district, Beheira Governorate, Egypt. Discussion  Unimmunized women received two random doses of either TT or Td 8 weeks apart during their pregnancy. Outpatient follow-up for adverse reactions occurred at the third day after each vaccine dose as either local effects such as pain, redness, and swelling or systematic effects such as fever, malaise, and headache or body aches which was served as primary safety endpoint. Blood was collected three times from each woman for determination of antibody titer against tetanus and diphtheria by using enzyme-linked immunosorbent assay technique. The first sample was collected immediately before the first dose, the second before the second dose, and the third sample 1 week after delivery. Active surveillance home visits to all study participants were done twice: the first home visit during the first week after delivery and the second 1 month after labor to report the health status of the mother and the baby. A total of 122 pregnant women received two ordinary doses with interdose intervals within the allowable range and three blood samples were collected in each protocol analysis (62 in the TT group and 60 in the Td group). There was no statistically significant difference between groups in the percentage of reporting a primary safety endpoint (fever, malaise, body ache, headache) or local reactions at the site of injection as redness and swelling, at third day after each dose. While in the Td group, after doses I and II, there was significant reporting pain at injection site as compared with TT group, home visits clinical examination revealed that the mothers and children were normal on in both groups. However, in the TT group, some children suffered from physiological jaundice. In all women in the two groups, protective immunity for tetanus was acquired, which reflected in neutralization of antibodies at titer (>0.10 IU/ml) after complete vaccination; however, the tetanus geometric mean titers postdoses I and II were significantly higher in TT vaccines group (P < 0.001). The postvaccination seroprotection titer (>0.10 IU/ml) in diphtheria was significantly higher in Td group than the TT group; diphtheria geometric mean titers of postdose II were significantly higher in Td vaccines as compared to the other group (P < 0.0001). From this results, we can conclude that the use of Td vaccine improves immunogenicity for both tetanus and diphtheria more than the use of TT vaccine alone and we can recommend to replace TT in immunization of pregnant women.     

奥氮平与无抽搐电休克治疗女性躁狂发作的随机对照研究

目的比较奥氮平冲击疗法与无抽搐电休克治疗(MECT)对女性躁狂发作的疗效和安全性。方法 50例住院女性患者随机分为奥氮平组和MECT组,奥氮平组每晚服药,第1天20mg/d,以后依据患者耐受情况调整到15~30mg/d。MECT组:在第1天,第2天,第3天,第5天,第7天,第9天行无抽搐电休克治疗,共6次。在基线,第1天,第3天,第6天,第9天,第14天,第21天分别采用杨氏躁狂量表(YMRS)评估疗效,采用不良反应量表(TESS)评定不良反应。基线和终点进行血常规,尿常规,血生化,甲状腺功能及心电图检查,以评价安全性。结果采用重复测量的方差分析比较两组治疗前后YMRS分值变化以及组间有无差异,结果显示奥氮平组治疗后YMRS总分显著下降(F=274.7,P0.01),MECT组治疗后YMRS总分也显著下降(F=350.9,P0.01),两组组间比较无显著差异(F=2.0,P=0.163)。奥氮平组有效21例,MECT组有效23例,两组间无显著性差异(χ2=0.758,P0.05);奥氮平组痊愈18例,MECT组痊愈19例,两组间也无显著性差异(χ2=0.104,P0.05)。两组之间不良事件的总发生率没有显著差异(P0.05)。结论奥氮平冲击疗法对急性躁狂发作有效,安全性好,与MECT相比无明显差异,是一种安全、有效、符合快速综合治疗要求的治疗急性躁狂发作的新方法。     

Experiential Virtual Scenarios With Real-Time Monitoring (Interreality) for the Management of Psychological Stress: A Block Randomized Controlled Trial

Background

The recent convergence between technology and medicine is offering innovative methods and tools for behavioral health care. Among these, an emerging approach is the use of virtual reality (VR) within exposure-based protocols for anxiety disorders, and in particular posttraumatic stress disorder. However, no systematically tested VR protocols are available for the management of psychological stress.

Objective

Our goal was to evaluate the efficacy of a new technological paradigm, Interreality, for the management and prevention of psychological stress. The main feature of Interreality is a twofold link between the virtual and the real world achieved through experiential virtual scenarios (fully controlled by the therapist, used to learn coping skills and improve self-efficacy) with real-time monitoring and support (identifying critical situations and assessing clinical change) using advanced technologies (virtual worlds, wearable biosensors, and smartphones).

Methods

The study was designed as a block randomized controlled trial involving 121 participants recruited from two different worker populations—teachers and nurses—that are highly exposed to psychological stress. Participants were a sample of teachers recruited in Milan (Block 1: n=61) and a sample of nurses recruited in Messina, Italy (Block 2: n=60). Participants within each block were randomly assigned to the (1) Experimental Group (EG): n=40; B1=20, B2=20, which received a 5-week treatment based on the Interreality paradigm; (2) Control Group (CG): n=42; B1=22, B2=20, which received a 5-week traditional stress management training based on cognitive behavioral therapy (CBT); and (3) the Wait-List group (WL): n=39, B1=19, B2=20, which was reassessed and compared with the two other groups 5 weeks after the initial evaluation.

Results

Although both treatments were able to significantly reduce perceived stress better than WL, only EG participants reported a significant reduction (EG=12% vs CG=0.5%) in chronic “trait” anxiety. A similar pattern was found for coping skills: both treatments were able to significantly increase most coping skills, but only EG participants reported a significant increase (EG=14% vs CG=0.3%) in the Emotional Support skill.

Conclusions

Our findings provide initial evidence that the Interreality protocol yields better outcomes than the traditionally accepted gold standard for psychological stress treatment: CBT. Consequently, these findings constitute a sound foundation and rationale for the importance of continuing future research in technology-enhanced protocols for psychological stress management.

Trial Registration

ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT01683617","term_id":"NCT01683617"}}NCT01683617; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT01683617","term_id":"NCT01683617"}}NCT01683617 (Archived by WebCite at http://www.webcitation.org/6QnziHv3h).     

A Randomized Controlled Trial of the Clinical Utility of Genotypic Resistance Testing in Patients with Limited Prior Exposure to Antiretroviral Drugs

Abstract

Purpose: To assess the clinical utility of genotypic resistance testing among HIV-1-infected patients with limited prior exposure to antiretroviral drugs. Method: Patients experiencing virological failure were randomly allocated to either centralized genotypic resistance testing or to no testing and were followed for a minimum of 1 year. Results: 55 patients were recruited from 14 centers in the United Kingdom. There were no demonstrable differences between the groups in terms of virological or immunological response. For patients allocated to resistance testing, there was an increased tendency to recycle previously used drugs. Conclusion: The study did not demonstrate a benefit of genotypic resistance testing in this population, although statistical power was low. However, testing did alter prescribing behavior, and clinical effects may become manifest in the longer term.     

西酞普兰结合心理治疗对产后抑郁疗效观察

目的：比较单用西酞普兰与西酞普兰结合心理疗法治疗产后抑郁的临床疗效。方法：将58例符合CCMD-3抑郁症诊断标准的产后抑郁患者随机分成两组，分别给予单用西酞普兰20mg／日与西酞普兰20mg／日结合心理治疗，疗程6周。治疗前及治疗后1、2、4、6周末分别用汉密顿抑郁量表（HAMD）进行评定。结果：单用西酞普兰与西酞普兰结合心理疗法治疗产后抑郁均有比较理想的效果，但后者疗效更佳（t=2.24-6、64，P〈0．05）。结论：两酞普兰结合心理疗法治疗产后抑郁效果更好。     

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial

BackgroundThe well-being of breast cancer patients and reporting of adverse events require close monitoring. Mobile apps allow continuous recording of disease- and medication-related symptoms in patients undergoing chemotherapy.ObjectiveThe aim of the study was to evaluate the effects of a mobile app on patient-reported daily functional activity in a supervised and unsupervised setting.MethodsWe conducted a randomized controlled study of 139 breast cancer patients undergoing chemotherapy. Patient status was self-measured using Eastern Cooperative Oncology Group scoring and Common Terminology Criteria for Adverse Events. Participants were randomly assigned to a control group, an unsupervised group that used a mobile app to record data, or a supervised group that used the app and reviewed data with a physician. Primary outcome variables were change in daily functional activity and symptoms over three outpatient visits.ResultsFunctional activity scores declined in all groups from the first to second visit. However, from the second to third visit, only the supervised group improved, whereas the others continued to decline. Overall, the supervised group showed no significant difference from the first (median 90.85, IQR 30.67) to third visit (median 84.76, IQR 18.29, P=.72). Both app-using groups reported more distinct adverse events in the app than in the questionnaire (supervised: n=1033 vs n=656; unsupervised: n=852 vs n=823), although the unsupervised group reported more symptoms overall (n=4808) in the app than the supervised group (n=4463).ConclusionsThe mobile app was associated with stabilized daily functional activity when used under collaborative review. App-using participants could more frequently report adverse events, and those under supervision made fewer and more precise entries than unsupervised participants. Our findings suggest that patient well-being and awareness of chemotherapy adverse effects can be improved by using a mobile app in collaboration with the treating physician.ClinicalTrialClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT02004496","term_id":"NCT02004496"}}NCT02004496; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT02004496","term_id":"NCT02004496"}}NCT02004496 (Archived by WebCite at http://www.webcitation.org/6k68FZHo2)