Efficacy of a herbal preparation in patients with functional dyspepsia: A meta-analysis of double-blind,randomized, clinical trials

A meta-analysis was performed of double-blind, randomized clinical studies that evaluated the efficacy of the herbal preparation Iberogast in patients with functional dyspepsia. All studies had the same duration and used the same dosage of active treatment and the same primary outcome measure, a dyspepsia-specific gastrointestinal symptom score. Of the 592 trial participants, 196 were treated with Iberogast and 192 with placebo or cisapride (positive control). The individual studies all showed a substantial improvement of symptoms with Iberogast but varying results regarding its statistically significant superiority to placebo. The meta-analysis of all studies, however, demonstrated a clear, highly significant overall therapeutic effect of Iberogast in the treatment of functional dyspepsia. Tolerability of the preparation was excellent.     

健脾活血方治疗功能性消化不良脾胃气虚伴血瘀证的临床疗效

目的探究健脾活血方治疗功能性消化不良脾胃气虚伴血瘀证的临床疗效。方法 124例功能性消化不良脾胃气虚伴血瘀证患者依照随机数字表法分为观察组和对照组,每组各62例。对照组患者给予多潘立酮,每天3次,每次10mg,餐前口服。7d为1个疗程,给予4个疗程。观察组接受健脾活血方,1周为1个疗程,服用4个疗程。结果观察组的总有效率87.5%优于对照组的68.1%,差异有统计学意义(χ2=7.87,P0.05);观察组的中医症候有效率为87.5%优于对照组的68.1%,差异有统计学意义(χ2=4.91,P0.05)。结论健脾活血方治疗功能性消化不良脾胃气虚伴血瘀证临床疗效明显,该方案具有一定的可行性。     

健胃消食口服液联合多潘立酮片治疗对小儿功能性消化不良患儿临床症状及腹胀积分的影响

目的探讨健胃消食口服液联合多潘立酮片治疗对小儿功能性消化不良患儿临床症状及腹胀积分的影响。方法选取120例小儿功能性消化不良患儿,随机分为研究组60例和对照组60例。对照组只采用多潘立酮片治疗,研究组采用健胃消食口服液联合多潘立酮片治疗。比较2组患儿的临床效果。结果研究组总有效率为96.7%,显著高于对照组的83.3%(P0.05);研究组患儿各项临床症状消失时间均显著短于对照组(P0.05);2组治疗后症状积分均较治疗前显著降低,且研究组较对照组改善更为显著(P0.05)。结论多潘立酮片联合健胃消食口服液治疗小儿功能性消化不良效果好,安全性高。     

Adaptogenic potential of a polyherbal natural health product: report on a longitudinal clinical trial

Stress is a risk factor for a number of diseases and is an important predictor of health in general. Herbal medicines have been used as adaptogens to regulate and improve the stress response and there is evidence to support the use of herbal medicines for this purpose. We conducted an open-label longitudinal study on the natural health product, OCTA(c), a compound mixture of eight herbs, to determine its effects on perceptions of stress. Eighteen participants were enrolled in the study and were followed over a period of 3 months. Primary endpoints included scores from four validated questionnaires (SF-36v2, PSS, STAI and BDI-II), serum DHEA, ALT, AST and creatinine all measured at 12 weeks. Seventeen patients completed the study. Except for the physical summary score of the SF36 questionnaire, all the subjective scores indicated a highly significant (P < 0.0001) improvement in the participants' ability to cope with stress. No adverse effects were reported and there was no evidence of damage to the liver or kidney based on serum markers. Initial evidence for this polyherbal compound supports its potential as an effective 'adaptogenic' aid in dealing with stress. Further research using a randomized controlled design is necessary to confirm the findings from this pilot study.     

Administration of Ratanhia-based herbal oral care products for the prophylaxis of oral mucositis in cancer chemotherapy patients: a clinical trial

Oral complications are a common side effect of cancer chemotherapy, as antineoplastic agents affect both the immune system and the oral mucosa. This study demonstrates preventive and therapeutic effects of dental treatment and regular use of Weleda Ratanhia-Mundwasser((R)) (herbal mouthwash) and Weleda Pflanzen-Zahngel((R)) (herbal toothgel) on oral mucositis during chemotherapy. Thirty-two female patients with breast cancer starting on chemotherapy were evaluated in this study. Plaque index, gingival index, degree of mucositis and 10 single symptoms were monitored once weekly for four consecutive weeks. After four weeks, plaque and gingival indexes were slightly decreased compared to baseline values. The degree of mucositis was increased by one grade in 15.6 % of the patients and over 70 % remained without symptoms. On the whole, single symptoms decreased from day 7 since beginning of chemotherapy to day 28. Mucositis symptoms were moderate in severity, and the results indicate a positive influence of using Weleda Ratanhia-Mundwasser and Weleda Pflanzen-Zahngel. Further studies might be promising.     

Evaluating the efficacy of endoscopic sphincterotomy on biliary-type sphincter of Oddi dysfunction: A retrospective clinical trial

BACKGROUNDAlthough endoscopic sphincterotomy (EST) has a positive therapeutic effect on biliary-type sphincter of Oddi dysfunction (SOD), some patients still have little relief after EST, which implies that other functional abdominal pain may also be present with biliary-type SOD and interfere with the diagnosis and treatment of it.AIMTo retrospectively assess EST as a treatment for biliary-type SOD and analyze the importance of functional gastrointestinal disorder (FGID) in guiding endoscopic treatment of SOD.METHODSClinical data of 79 patients with biliary-type SOD (type I and type II) treated with EST at Affiliated Hospital of Guizhou Medical University from January 2014 to January 2019 were retrospectively collected to evaluate the clinical therapeutic effect of EST. The significance of relationship between FGID and biliary-type SOD was analyzed.RESULTSSeventy-nine patients with biliary-type SOD received EST, including 29 type 1 patients and 50 type 2 patients. The verbal rating scale-5 (VRS-5) scores before EST were all 3 or 4 points, and the scores decreased after EST; the difference was statistically significant (P < 0.05). After EST, the serum indexes of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and total bilirubin in biliary-type SOD were significantly lower than before (P < 0.05). After EST, 67 (84.8%) and 8 (10.1%) of the 79 patients with biliary-type SOD had obviously effective (VRS-5 = 0 points) and effective treatment (VRS-5 = 1-2 points), with an overall effectiveness rate of 94.9% (75/79). There was no difference in VRS-5 scores between biliary-type SOD patients with or without FGID before EST (P > 0.05). Of 12 biliary-type SOD (with FGID) patients, 11 had abdominal pain after EST; of 67 biliary-type SOD (without FGID) patients, 0 had abdominal pain after EST. The difference was statistically significant (P <0.05). The 11 biliary-type SOD (with FGID) patients with recurrence of symptoms, the recurrence time was about half a year after the EST, and the symptoms were significantly relieved after regular medical treatment. There were 4 cases of post-endoscopic retrograde cholangiopancreatography pancreatitis (5.1%), and no cholangitis, bleeding or perforation occurred. Patients were followed up for 1 year to 5 years after EST, with an average follow-up time of 2.34 years, and there were no long-term adverse events such as sphincter of Oddi restenosis or cholangitis caused by intestinal bile reflux during the follow-up.CONCLUSIONEST is a safe and effective treatment for SOD. For patients with type I and II SOD combined with FGID, single EST or medical treatment has limited efficacy. It is recommended that EST and medicine be combined to improve the cure rate of such patients.     

The effect of family-authored diaries on posttraumatic stress disorder in intensive care unit patients and their relatives: A randomised controlled trial (DRIP-study)

BackgroundCritical illness and mechanical ventilation may cause patients and their relatives to experience symptoms of posttraumatic stress, anxiety, and depression due to fragmentation of memories of their intensive care unit (ICU) stay. Intensive care diaries authored by nurses may help patients and relatives process the experience and reduce psychological problems after hospital discharge; however, as patients particularly appreciate diary entries made by their relatives, involving relatives in authoring the diary could prove beneficial.ObjectivesThe objective of this study was to explore the effect of a diary authored by a close relative for a critically ill patient.MethodsThe study was a multicenter, block-randomised, single-blinded, controlled trial conducted at four medical-surgical ICUs at two university hospitals and two regional hospitals. Eligible for the study were patients ≥18 years of age, undergoing mechanical ventilation for ≥24 h, staying in the ICU ≥48 h, with a close relative ≥18 years of age. A total of 116 relatives and 75 patients consented to participate. Outcome measures were scores of posttraumatic stress symptoms, anxiety, depression, and health-related quality of life three months after ICU discharge.ResultsRelatives had 26.3% lower scores of posttraumatic stress in the diary group than in the control group (95% confidence interval: 4.8–% to 52.2%). Patients had 11.2% lower scores of posttraumatic stress symptoms in the diary group (95% confidence interval: −15.7% to 46.8%). There were no differences between groups in depression, anxiety, or health-related quality of life.ConclusionA diary written by relatives for the ICU patient reduced the risk of posttraumatic stress symptoms in relatives. The diary had no effect on depression, anxiety, or health-related life quality. However, as the diary was well received by relatives and proved safe, the diary may be offered to relatives of critically ill patients during their stay in the ICU.     

基于正常行走模式的功能性电刺激对脑卒中患者行走功能即时影响的随机对照研究

目的:通过三维步态分析系统,观察基于正常行走模式的功能性电刺激(FES)对脑卒中患者行走功能的即时影响,为其临床应用及推广提供依据。方法:将符合入组条件的47例脑卒中患者随机分为电刺激组(16例)、安慰电刺激组(15例)和对照组(16例)。电刺激组给予基于正常行走模式设计的四通道FES助行仪治疗,患者戴机行走5min;刺激肌肉分别为偏瘫侧胫前肌、股四头肌、腓肠肌及腘绳肌。安慰电刺激组的电刺激位置及行走时间与电刺激组相同,行走(5min)过程中没有电流输出;对照组不给予电刺激,只让患者行走5min。三组患者分别在治疗前及治疗5min后接受三维步态检查,并对结果进行分析。结果:三组组内治疗后与治疗前比较:电刺激组的步行周期、支撑时间、步行速度、步频、踝背伸角度、踝关节触地时角度均有改善(P0.05);安慰电刺激组仅在踝关节背伸和踝关节触地时角度有改善(P0.05);对照组所有参数均无改善,且跨步长缩短、踝关节背伸角度降低(P0.05)。三组组间比较:治疗后只有触地时踝关节背伸角度差异有显著性意义(P0.05)。进一步进行治疗前后变化率的组间比较,发现三组患者患侧步行周期、支撑时间、步行速度、步频、步长、跨步长、触地时踝关节背伸角度的差异均有显著性意义(P0.05)。结论:应用基于正常行走模式的FES治疗5min即可改善脑卒中患者的即时步行功能,长期效果尚待研究。     

New rules meet established sickness certification practice: a focus-group study on the introduction of functional assessments in Norwegian primary care

OBJECTIVE: To explore how general practitioners view and handle new standards for functional assessments in sickness certification practice. DESIGN: Qualitative study using focus group interviews. Data were analysed according to Giorgi's phenomenological approach and supported by theories on knowledge. SETTING: General practitioners from three neighbouring counties in Norway. SUBJECTS: Four focus groups with a total of 23 participants were recruited through the Norwegian Medical Association and its Continuous Medical Education system. RESULTS: The participants reported difficulties and reluctance to act in accordance with new functional assessment demands on both a practical and a conceptual level. In established sickness certification practice functional assessment was described as an unspoken part of the medical examination. After the introduction of formal, written functional assessments they identified problems of terminology, communication, and trust. Strategies were developed to circumvent these problems. CONCLUSIONS: A gap was noticeable between the participants' established practice and the new standards' demand for a more theoretical and communicative functional assessment. The general lack of training, being confronted with new terminology, and increasingly high pressure to reduce sickness absences create an atmosphere of insecurity when assessing function.     

Lasting effect of an oral hygiene care program for patients with stroke during in-hospital rehabilitation: a randomized single-center clinical trial

Purpose: Because the oral hygiene is poorly prioritized in the immediate post-stroke period, we implemented an oral hygiene care program (OHCP) for stroke in-patients and evaluated its persistence after discharge.

Method: In all, 62 patients with stroke who were admitted to the rehabilitation ward were randomly assigned to two groups: 33 patients to the intervention group and 29 to the control group. The OHCP, including tooth brushing education and professional tooth cleaning, was administered to the intervention group twice a week six times during in-hospital rehabilitation. Oral health status was examined both at baseline and three months after discharge from the hospital. Oral hygiene status was examined at three- to four-day intervals five times during the hospitalization period.

Results: After OHCP, oral hygiene status including the plaque index, calculus index, and O’Leary plaque index improved significantly in the intervention group, compared to the control group (p?p?Conclusions: An OHCP conducted during in-hospital rehabilitation was effective in improving oral health and plaque control performance among patients with stroke, with effects still seen three months after discharge from the hospital.

• Implications for Rehabilitation

• Initial oral hygiene status and plaque control performance were poor in stroke patients who were in rehabilitation center.

• An oral hygiene care program during in-hospital rehabilitation was effective in improving oral hygiene status and plaque control performance among stroke patients at three months after discharge.

• Repeated tooth brushing education and professional tooth cleaning were necessary to improve plaque control performance of stroke patients.

     

临床护理路径对急性心肌梗死患者影响的荟萃分析

目的对临床护理路径在急性心肌梗死(acute myocardial infarction,AMI)患者中的应用进行荟萃分析。方法计算机检索Pubmed、Elsevier、CNKI、CBM、万方数据库,收集运用临床路径护理AMI患者的随机对照研究,进行文献质量评价后,采用Revman 5.1.2统计软件进行分析。结果共纳入文献6篇,病例共523例。临床护理路径组与传统健康教育组在患者平均住院时间(MD=-3.90,Z=3.94,P0.01)、平均住院费用(SMD=-4.09,Z=3.79,P0.01)、健康知识达标率[OR=6.54,95%CI(2.80,15.28),P0.01]、满意率[OR=5.27,95%CI(2.37,11.72),P0.01]、并发症发生率[OR=0.25,95%CI(0.11,0.59),P0.01]方面,差异均有统计学意义。结论应用临床护理路径,可减少AMI患者住院时间及住院费用,提高患者健康知识达标率及满意率,降低患者并发症。但由于纳入文献总体质量不高,有待更多大样本的、多中心合作的、设计严谨的随机对照试验来进一步证实其有效性。     

The effect of a family-based participatory care program on anxiety in patients with acute coronary syndrome in coronary care units: A randomised controlled clinical trial

BackgroundAdmission to the coronary care units (CCUs) and the patient's reduced interaction with family are regarded as important sources of anxiety. Family participation in care programs is pivotal to patient outcomes.ObjectivesThe present study was conducted to determine the effect of a care program based on family participation on anxiety in patients with acute coronary syndrome.MethodsThis randomised controlled trial was conducted on 90 patients in CCUs and their families. The patients were randomly assigned to one of the following three groups: routine care, control, and intervention. Routine care measures were provided to the routine care group, increased participation of the family was ensured in the control group, and a family-based participatory care program was implemented in the intervention group with the interaction of the nurse, patient, and family based on five principles, including presence, determination of needs, communication, participation in decision-making, and cooperation in care. The patients’ anxiety was measured in the three groups on day 1 and 3 days after the admission to the CCU using the Spielberger State-Trait Anxiety Inventory.ResultsThe patients’ mean state anxiety score before the intervention was 44.4 ± 12.7, 46.6 ± 12.4, and 45.5 ± 12.1 in the routine care, control, and intervention groups, respectively, with no significant differences between them (P = 0.81). After adjusting for anxiety before the intervention and study hospital, the mean (before–after) changes in anxiety score in the three groups showed that anxiety was significantly lower in the intervention group than in the other groups (P < 0.05).ConclusionIncreased family presence alone has no effect on the patients’ anxiety, but the family’s participation and interaction with the care team can affect anxiety levels in cardiac patients in CCUs and improve the care processes.Trial registration: Iranian Registry of Clinical Trials, Trial No. IRCT201105146481N1.     

我国临床路径相关研究的文献计量学分析

目的：了解近年来我国临床路径研究趋势和发展现状,为临床路径的进一步研究和发展提供参考。方法以CMB、CNKI、VIP、万方学术论文数据库为平台,检索我国临床路径研究的相关文献。结果共检索出相关文献4811篇,文献刊载量呈逐年上升趋势,核心文献刊载量1929篇,核心文献刊载比率呈下降趋势;研究内容涉及临床、护理、医院管理、教育培训等多个方面,护理类临床路径相关研究刊载量最大,共1567篇,占32．57％。结论临床路径的相关研究发展迅速,内容向纵深扩展,但各研究领域发展不平衡;临床路径相关配套制度、信息化管理设施不到位,缺乏有效临床路径实施效果评估系统。     

功能性电刺激改善脑卒中早期患者偏瘫下肢功能的随机对照研究

目的：探讨功能性电刺激（FES）对脑卒中偏瘫患者下肢功能的影响。方法：37例脑卒中早期患者分层后随机分为FES组（19例,年龄60.8±10.8岁,病程25.9±21.3d）和对照组（18例,年龄64.1±9.7岁,病程22.7±16.6d）。2组常规治疗相同,对照组不给予任何电刺激,FES组采用日本生产的低频电刺激治疗仪（KR7型）治疗,电极放在患侧胫前肌及腓骨长、短肌的运动点上;刺激参数为频率30Hz,脉宽200μs,通电/断电比5s/5s,波升/波降（1s/1s）,电流以患者最大耐受强度为限。治疗每天1次,每次30min,共3周（15次）。用综合痉挛量表（CSS）评定踝关节痉挛,Fugl-Meyer运动评定量表中下肢部分（FMA）评定下肢运动功能,脑卒中患者姿势评定量表（PASS）和Berg平衡量表（BBS）评定平衡功能。结果：2组患者一般资料及治疗前各项评定结果差异无显著性意义。治疗2周和3周后,FES组与对照组（FESvs对照）CSS、FMA评分差异有显著性意义（P〈0.05）,增加率为2周时CSS：8.9%±23.2%vs36.3%±47.3%,FMA：105.5%±75.7%vs51.4%±47.3%。3周时CSS：10.4%±18.3%vs47.7%±56.4%,FMA：127.1%±89.4%vs64.3%±51.8%。结论：FES能延缓早期脑卒中患者偏瘫下肢痉挛的发生、减轻痉挛程度,改善下肢运动能力。     

功能性电刺激改善脑卒中患者上肢功能的随机对照研究

摘要 目的：探讨功能性电刺激（FES）对脑卒中偏瘫患者上肢功能的远期影响。 方法：37例初发脑卒中患者分层后随机分为FES组(n=19)和对照组(n=18)。2组常规治疗相同,对照组不给任何电刺激,FES组给予功能性电刺激治疗,一组电极放在患侧前臂背侧远端1/3与1/2处,一组电极放在三角肌中部与冈上肌中部;刺激参数为频率30Hz,脉宽300?滋s,通电/断电比5s/5s,波升／波降1s/1s,强度0—90mA,并随患者感觉而定。治疗每天1次,每次30min,共3周（15次）。入选患者分别于治疗前、治疗后第1个月、3个月、6个月接受以下量表评定：Fugl-Meyer运动功能评定量表中上肢部分（FMA）、改良Barthel指数（MBI）、肩部肌群肌力（MMT）。2组患者一般资料及治疗前各项评定结果差异无显著性意义。 结果：治疗后第1个月、3个月2组在MMT、FMA、MBI差异均有显著性意义（P<0.05）;治疗后第6个月,2组在FMA、MBI差异有显著性意义（P<0.05）,在MMT差异有近似显著性意义(P=0.052)。 结论：FES可以改善初发早期脑卒中患者偏瘫上肢的运动功能,提高日常生活活动能力,疗效可以持续6个月以上。 关键词 脑卒中;功能性电刺激;上肢;随机对照研究 中图分类号：R493,R741 文献标识码：A 文章编号：1001-1242（2010）-02-0152-04     

Evaluation of clinical efficacy of continuous care with improved insulin injection techniques on patients with diabetes mellitus: a randomized controlled trial

ObjectiveTo investigate the clinical effect of continuous care with improved insulin injection techniques on patients with diabetes mellitus.MethodsThis randomized controlled trial enrolled patients with diabetes mellitus. They were randomly assigned to a control or observation group. Patients in the control group received conventional continuous nursing. Patients in the observation group were given optimized insulin injection education and continuous nursing on the same basis as the conventional nursing used in the control group. Blood glucose-related outcomes, knowledge of insulin injections and adverse events were recorded.ResultsA total of 96 patients with diabetes mellitus were enrolled in the study (n = 48 per group). There were no significant differences between the two groups in terms of sex, age and glycosylated haemoglobin (HbA_1c). Compared with the control group, continuous care combined with optimized insulin injection techniques significantly reduced blood glucose target time, fasting blood glucose, 2-h postprandial blood glucose and HbA_1c. The proportions of patients reporting a subcutaneous mass, insulin leakage and hypoglycaemic events were significantly lower in the observation group; and pain scores were significantly reduced compared with the control group.ConclusionsContinuous care and optimization of insulin injection techniques can help patients achieve better diabetes-related outcomes.Study Registration Number: ChiCTR2200057166.