A double-blind randomized controlled trial of the local application of vancomycin versus ampicillin powder into the operative field for thoracic and/or lumbar fusions

OBJECTIVERetrospective studies have reported that the local application of vancomycin (VCM) powder into the operative field decreases the incidence of surgical site infection (SSI) in thoracic and/or lumbar fusion. Authors of the present study prospectively evaluated the effects of VCM in patients undergoing thoracic and/or lumbar fusion.METHODSIn this randomized double-blind trial, 230 patients undergoing thoracic and/or lumbar fusion were randomly assigned to the local administration of VCM (interventional group, 1 g) or ampicillin (AMP; control group, 1 g) into the surgical field. The primary outcome was SSI results within 1 year of surgery.RESULTSThe trial was prematurely stopped according to predetermined rules. The results showed one superficial infection (0.9%, Staphylococcus aureus) and one deep infection (0.9%, S. aureus) in the VCM group and two superficial infections (1.8%, Staphylococcus epidermidis and culture negative) and one deep infection (0.9%, methicillin-resistant S. aureus) in the AMP group. No significant differences in infection rates were observed between the groups (p = 0.8).CONCLUSIONSThis double-blind randomized controlled trial demonstrated that the local application of VCM or AMP powder into the operative field in short thoracic and/or lumbar fusion procedures resulted in a similar incidence of SSI.■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: class III.Clinical trial registration no.: UMIN000009377 (umin.ac.jp/ctr)

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Neurofeedback for tinnitus: Study protocol for a double-blind randomized controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both the sound perception and the psychological distress, in a cohort of chronic tinnitus sufferers

10.21203/rs.2.12838/v1 ◽

2019 ◽

Author(s):

Martin Jensen ◽

Eva Hüttenrauch ◽

Jennifer Schmidt ◽

Gerhard Andersson ◽

Mira-Lynn Chavanon ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Control Group ◽

Neurofeedback Training ◽

Double Blind ◽

Sound Perception ◽

Active Comparator ◽

Randomized Controlled ◽

Tinnitus Distress ◽

Training Protocol

Abstract Background Tinnitus is a very common condition, which for some can have debilitating psychological consequences. Although some interventions are helpful in learning how to cope better with the tinnitus, at present there is no cure. Neurofeedback is an emerging treatment modality in tinnitus. Previous studies, utilizing an alpha/delta training protocol have shown promise. However, they were characterized by small sample sizes and lack of neurofeedback control conditions. Therefore, the aim of this study is to investigate, if an alpha/delta neurofeedback training protocol, compared to beta/theta neurofeedback or a diary control group, is effective in reducing, not only the tinnitus sound perception, but also the psychological symptoms associated with the condition. Methods The study is designed as a three-armed, single-blinded randomized controlled trial. Participants are randomly assigned to either an established neurofeedback protocol for tinnitus (alpha/delta training), another neurofeedback protocol as active comparator (beta/theta training) or diary control group. In the four-week intervention period, participants in both neurofeedback groups undergo ten sessions, whereas participants in the diary control group complete a diary bi-weekly. The primary outcomes are between group differences in tinnitus sound percept change, as measured with the Tinnitus Magnitude Index (TMI) and changes in tinnitus distress, measured with the Tinnitus Handicap Inventory (THI), four weeks post baseline. Secondary outcome measures include changes in tinnitus distress, sleep quality, depressive symptoms and whether neurofeedback leads to specific power changes in the trained frequency bands. Discussion This is the first double-blind, randomized controlled trial examining the efficacy of an alpha/delta neurofeedback training protocol in reducing the tinnitus sound percept and the distress associated with the condition. Compared to former studies, the present study is designed to assess both the specificity of an alpha/delta neurofeedback training protocol by including an active comparator, beta/theta neurofeedback training, and in addition to control for placebo effects by inclusion of a diary control group. We hope this study contributes not only to our understanding of the neurological underpinnings of tinnitus, but also to the potentiality of neurofeedback as a therapeutic agent.

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Urokinase-Containing Locking Solution in the Prevention of Dialysis Catheter Dysfunction: A Double Blind Randomized Controlled Trial

The Journal of Vascular Access ◽

10.5301/jva.5000737 ◽

2017 ◽

Vol 18 (5) ◽

pp. 436-442 ◽

Cited By ~ 5

Author(s):

Florence Bonkain ◽

Freya Van Hulle ◽

Peter Janssens ◽

Concetta Catalano ◽

Mandelina Allamani ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Incidence Rate ◽

Controlled Trial ◽

Recombinant Tissue Plasminogen Activator ◽

Hemodialysis Patients ◽

Control Group ◽

Double Blind ◽

Systemic Thrombolysis ◽

Randomized Controlled ◽

History Of

Introduction The prophylactic use of recombinant tissue plasminogen activator once weekly reduces the incidence rate of tunneled cuffed catheter (TCC) malfunction and bacteremia as compared to the exclusive use of heparin as locking solution. Restricting the use of prophylactic thrombolytic agents to patients with a history of thrombotic TCC malfunction could be more cost effective. We conduct a multicenter, double-blind, randomized controlled trial and test the hypothesis that weekly use of urokinase lock will reduce the incidence of thrombotic malfunction by 50% in prevalent hemodialysis patients with a history of thrombotic malfunction. Methods Patients with a history of at least two separate TCC thrombotic dysfunctions treated with urokinase lock during the 6 months preceding inclusion are recruited in eight Belgian dialysis units. Patients are randomized in two groups: the control group receiving Taurolock™-HEP500 (heparin 500 IU/mL, taurolidine, citrate 4%) after each hemodialysis session and the treatment group receiving Taurolock-U 25,000 (urokinase 25,000, taurolidine, citrate 4%) once a week and the standard Taurolock-HEP500 at the end of the two others sessions. The primary outcome is the incidence rate of TCC thrombotic dysfunction defined by the use of urokinase. The secondary outcomes are the incidence rate of TCC removal and systemic thrombolysis. For the study, both patients and healthcare staff are blinded to treatment allocation. Conclusions The present trial is the first to investigate the effect of Taurolock-U 25,000 catheter lock once a week as secondary prevention in hemodialysis patients with the highest risk of TCC-related thrombotic dysfunction. Trial Registration ClinicalTrials.gov Identifier: NCT02036255

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Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

Global Journal of Health Science ◽

10.5539/gjhs.v9n5p67 ◽

2016 ◽

Vol 9 (5) ◽

pp. 67

Author(s):

Mansoureh Mirzadeh ◽

Najmeh Shahini ◽

Masoud Kashani Lotf Abadi ◽

Maryam Tavakoli ◽

Arash Javanbakht ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Function ◽

Rating Scale ◽

Controlled Trial ◽

Control Group ◽

P Value ◽

Double Blind ◽

Randomized Controlled ◽

Significant Difference ◽

Schizophrenic Patients

Smoking habits are common in schizophrenic patients. Nicotine can suppress negative symptoms and cognitive impairments. The aim of this study was to determine the efficacy of bupropion on cognitive function in schizophrenic patients. This study is a double blind randomized controlled trial in a large referral psychiatric university hospital in Iran. Ninety smoker schizophrenic patients were randomly allocated (based on DSM -IV TR criteria) in two groups (46 patients for case group and 44 patients in control group). They get risperidone up to 6 mg/d and bupropion up to 400 mg/d .clinical assessment (Positive and Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14th and 28th days of study. Cognitive assessment (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, the days 2nd, 7th, 14th, 28th. All data were analyzed by SPSS Ver. 17 with analytic and descriptive tests. Mean age of patients was 37.66±1.01. Mean duration of disorder was 11.63±.98 years. The scores were significantly lower at the day 28th compared to the beginning of the study in both groups in Wechsler, Stroop color word , Stroop word , Stroop color , BPRS, PANSS p value ≤0.05 .The difference between the two treatments was not significant as indicated by the effect of group, the between-subjects factor p value ≥0.05. In this study, the side effects were examined and there was no significant difference between the two groups p value ≥0.05. Augmentation of bupropion to routine treatment improves cognitive symptoms of schizophrenia in abstinence of tobacco.

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Comparison of Single Antibiotic Paste Nitrofurantoin and Calcium Hydroxide Paste as Intracanal Medicaments in Alleviating Post-Operative Pain in Patients with Symptomatic Irreversible Pulpitis -A Randomized Controlled Trial

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2021/v33i46a32891 ◽

2021 ◽

pp. 484-494

Author(s):

Hira Abbasi ◽

Abhishek Lal ◽

Ammara Shamim Jaffrani

Keyword(s):

Randomized Controlled Trial ◽

Calcium Hydroxide ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Pain Scores ◽

Post Operative Pain ◽

Group 2 ◽

Irreversible Pulpitis ◽

Group 1

Aims: This study aims to compare the efficacy in alleviating pain between intracanal medicaments, namely Nitrofurantoin and Calcium Hydroxide Paste. Study Design: Randomized Controlled Trial. Place and Duration of Study: Sample: Department of Operative Dentistry, Sir Syed College of Medical Sciences, Pakistan, between January 2021 and May 2021. Methodology: 60 patients were randomly divided into 3 groups, each group having 20 patients as following: Group 1: Nitrofurantoin, Group 2: Calcium Hydroxide and Group 3: Control. Preoperative pain was recorded using a numerical pain scale. After access preparation, chemomechanical preparation was performed with subsequent placement of intracanal medicaments. Pre-operative pain score was initially recorded, followed by post-operative pain at 12, 24, 48, and 72 hours, respectively. Root canal treatment was performed in single rooted teeth with patients suffering from symptomatic irreversible pulpitis Results: Majority of the patients in all 3 groups were initially presented with moderate to severe pre-operative pain. After 72 hours post-operatively, 50% patients in Group 1 reported no pain, while 5% patients in both Group 2 and 3 had no pain. Pain significantly subsided in Group 1 as compared to Group 2 and 3. Regarding age and gender, both had no significant relationship with the pain scores in all of the 3 groups Conclusion: Nitrofurantoin has been proven to be an effective intracanal medicament in alleviating immediate post-operative pain in patients with symptomatic irreversible pulpitis as compared to calcium hydroxide. While the control group with no intracanal medicament showed little reduction in pain scores. So, nitrofurantoin can be used as a substitute to currently available standard intracanal medicaments.

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Contributions of auriculotherapy in smoking cessation: a pilot study

Revista da Escola de Enfermagem da USP ◽

10.1590/s0080-6234201400005000015 ◽

2014 ◽

Vol 48 (5) ◽

pp. 883-890

Author(s):

Roberta de Paiva Silva ◽

Erika de Cássia Lopes Chaves ◽

Sandra Cristina Pillon ◽

Andréia Maria Silva ◽

Denis da Silva Moreira ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Pilot Study ◽

Controlled Trial ◽

Control Group ◽

Double Blind ◽

Future Studies ◽

Randomized Controlled ◽

And Control ◽

Experimental Group

Objective To evaluate the contribution of auriculotherapy in smoking cessation. Method Double-blind randomized controlled trial, conducted with 30 smokers allocated into two groups: Experimental Group (21 participants received 10 sessions of auriculotherapy at specific points for smoking) and Control Group (nine participants received auriculotherapy in points that have no effect on the focus of research). Results Auriculotherapy contributed in reducing the number of cigarettes smoked in 61.9% of participants (p=0.002), in reducing the difficult to abstain from smoking in places where it is forbidden by 38% (p=0.050) and in not smoking when ill 23.8% (p=0.025). Conclusion Given the efficacy only in terms of reducing the number of cigarettes smoked and other parameters, we suggest that future studies consider the use of auriculotherapy combined with other treatment methods, in order to achieve better results in cessation/abstinence.

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Accuracy and efficacy of diagnosis using clinical characteristics integrated with metabolomics in patients with polycystic ovary syndrome: study protocol for a randomized controlled trial

10.21203/rs.2.12197/v2 ◽

2019 ◽

Author(s):

Cheng-Ming Ni ◽

Wen-Long Huang ◽

Yan-min Jiang ◽

Juan Xu ◽

Ru Duan ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Polycystic Ovary Syndrome ◽

Clinical Characteristics ◽

Polycystic Ovary ◽

Controlled Trial ◽

Control Group ◽

Ovary Syndrome ◽

Randomized Controlled ◽

Group 2 ◽

Group 1

Abstract Background Polycystic ovary syndrome (PCOS) is defined as a complex endocrine syndrome, and the mechanisms underlying its various clinical signs and symptoms are still poorly understood. It is critical to precisely diagnose the phenotypes of PCOS in order to provide patients with individualized therapy[1, 2] . However, the criteria by which to diagnose different phenotypes, which are mostly based on symptoms, physical examination, and laboratory evaluation, remain unclear. The aim of this study is to compare the accuracy and precision of metabolomic markers with common clinical characteristics to determine a more effective way to diagnose and treat two subgroups, one based on clinical indexes and another based on metabolomic indexes[3], of PCOS patients. The effects of different the interventions based on the two subgroups will also be observed. Methods This is a prospective, multicenter, analyst-blinded, randomized controlled trial. There will be one healthy control group and two parallel experimental arms in this study: (1) people without PCOS (health control group); (2) PCOS patients diagnosed based on clinical indexes (group 1); (3) PCOS patients diagnosed based on metabolomic indexes (group 2). A total of 276 eligible people will be recruited, including 60 healthy people and 216 PCOS patients, who will be randomly assigned to different diagnosis groups in a 1:1 ratio. Patients in the two different diagnosis groups will be divided into two different subgroups based on their clinical characteristics (group 1 based on clinical indexes, group 2 based on metabolomic indexes); thereafter, they will receive a 6-month different treatment. The primary outcome for experimental groups will be the treatment effect of PCOS. Discussion The purpose of this trial is to determine whether integrated metabolomic indexes are more accurate and effective than clinical characteristics in the diagnosis of the phenotypes of reproductive females with PCOS. This trial will therefore contribute to the provision of a solid foundation for the precise clinical diagnosis of two PCOS subgroups, as well as for future research on individualized PCOS therapy.

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Efficacy of acetaminophen with and without oxycodone for analgesia in nonoperative treatment of extremity fractures in adults: Protocol for a double-blind randomized clinical trial

10.21203/rs.2.317/v1 ◽

2019 ◽

Author(s):

Tao Gao ◽

Hongyi Zhu ◽

Changqing Zhang ◽

Yimin Chai ◽

Cheng Guo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Nonoperative Treatment ◽

Secondary Outcome ◽

Control Group ◽

Double Blind ◽

Randomized Controlled ◽

Limb Fracture ◽

Self Rating ◽

Limb Fractures

Abstract Background: Opioids and acetaminophen are both widely used to relieve pain after nonoperative treatment of limb fractures, but evidence for superiority of opioids versus acetaminophen is lacking. In this study we aim to determine whether acetaminophen is noninferior to the acetaminophen/oxycodone combination for pain relief after nonoperative fixation of an extremity limb fracture. We hypothesize that acetaminophen is noninferior to the acetaminophen/oxycodone combination. Methods: A double-blind, randomized controlled trial will be conducted. Power analysis determined that 1,226 participants will be needed (p<0.05, power 90%). Patients with acute limb fracture who receive nonoperative treatment will be recruited and randomly allocated into two groups: the intervention group will receive oral oxycodone (5 mg)/acetaminophen (325 mg), and the control group will receive acetaminophen (650 mg) only. The primary outcome measure will be scores on the 11-point Numeric Rating Scale (NRS-11) over 14 days. Secondary outcome measures are scores on the Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), EuroQol five dimensions’ questionnaire (EQ-5d), self-rated satisfaction with the analgesia produced, self-reported nighttime sleep duration, number of intervention or control pills used, total duration for taking intervention or control medication. Change of pain scores and the number of times that analgesic drugs were taken in the two groups will be statistically evaluated with t-student tests according to their fracture site. Discussion: This study will be a randomized controlled trial that is adequately powered to test the hypothesis that acetaminophen is noninferior to the combination of acetaminophen and oxycodone in relieving objectively measured pain after nonoperative treatment of limb fractures in adults. It is hopeful to provide a safe and effective analgesic plan for such patients. Trial Registration: ChiCTR registry: ChiCTR1800017015 ( http://www.chictr.org.cn/showproj.aspx?proj=28612). Registered on 8 July 2018. Keywords: Opioids, acetaminophen, fracture, nonoperative treatment.

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Efficacy of Gastroplegia Patch on treating postoperative gastroplegia: A multicenter, double-blind, randomized controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.10110 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 10110-10110

Author(s):

Tian Zhou ◽

Qin Zhou ◽

Yanbin Wang ◽

Yingjiang Ye ◽

Yantao Tian ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Controlled Trial ◽

Cancer Patients ◽

Controlled Trial ◽

Tube Feeding ◽

Control Group ◽

Double Blind ◽

Randomized Controlled ◽

Patch Group ◽

Gastroenterological Cancer

10110 Background: Postoperative gastroplegia is common in digestive cancer patients and there were no effective treatments. Gastroplegia Patch is an external-used Chinese Herbal Medicine recipe. It has been applied clinically for more than ten years, which showed good effect. We conducted this study to verify its safety and efficacy on the symptoms of postoperative gastroplegia. Methods: This clinical trial was designed as a multi-center, double-blind, superior effect, randomized controlled trial. It has been registered in ISRCTN (No.18291857) before initiation and was monitored by the third party. Patient inclusion criteria: 1. Gastroenterological cancer patient who was diagnosed as post-surgery gastroplegia, could not eat and need tube feeding (parenteral nutrition or with Jejunum nutrient canal); 2. The local identification of abdomen is cold pattern, which means this kind of patient prefers heat to cold, likes hot food and hates cold ones. Eligible participants were randomized into two arms, placebo arm and Patch arm, respectively. Beside the basic treatments (nutrition support, gastrointestinal decompression, promoting gastric dynamics medicine), placebo or Gastroplegia Patch was applied in control group or Patch group, respectively. Placebos or the patches were allocated at two acupuncture points ( Zhongwan and Shenque). The intervention course was 14 days or reached primary endpoint. The primary endpoint was able to eat without tube feeding. Results: All the 120 eligible participants (60 per arm) were recruited from four AAA hospitals in Beijing, China. Analysis was conducted based on intent-to-treat strategy. After the intervention, 68.33% of the participants in the Patch group were able to eat without tube feeding, which significantly higher than that of 41.67% in the control group (p = 0.003). It took 8 days on average in the Patch group to show effect, which significantly faster than that of 10 days in the control group (p = 0.017). The incidences of adverse events were compatible between the two arms (p = 0.244). Conclusions: Gastroplegia Patch is safe and effective in treating postoperative gastroplegia in gastroenterological cancer patients with cold syndrome. Clinical trial information: 18291857.

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Effects of Multidisciplinary Team Care Based on 5E’s Renal Rehabilitation for Peritoneal Dialysis Patients in Guangxi Zhuang Autonomous Region of China: A Randomized Controlled Trial

Blood Purification ◽

10.1159/000496823 ◽

2019 ◽

Vol 48 (2) ◽

pp. 115-123 ◽

Cited By ~ 1

Author(s):

Yixin Luo ◽

Yanlin Huang ◽

Xiuyu Chen ◽

Gang Meng ◽

Yongsheng Zhang

Keyword(s):

Randomized Controlled Trial ◽

Peritoneal Dialysis ◽

Multidisciplinary Team ◽

Controlled Trial ◽

Advisory Council ◽

Self Management ◽

Control Group ◽

Study Group ◽

Randomized Controlled ◽

Group 1

Background: The number of patients with peritoneal dialysis (PD) in China has been increasing year after year, but there are still some challenge in the management of PD patients, and the efficient and effective method has yet to be developed. Multidisciplinary team (MDT) is to create a standardized, individualized, and continuous integrated treatment program for the patients, to ensure the best efficacy and improve patient outcomes. 5E’s renal rehabilitation was originally developed by the Life Options Rehabilitation Advisory Council in 1997 to achieve better management of PD patients. However, there is still no relevant study combining these 2 methods and applying to PD patients so far. Methods: A randomized controlled trial was undertaken in the nephrology department of the First Affiliated Hospital of Guangxi Medical University. We recruited 146 patients according to inclusion and exclusion criteria and divided them into study group (n = 73) and control group (n = 73) using SPSS random number. The control group received routine care and follow-up, while the study group received MDT care based on 5E’s renal rehabilitation. The self-management scale for PD patients and the incidence of dialysis-related peritonitis were compared before discharge and 12 months after discharge. Results: T tests showed that there were no significant differences between the 2 groups in the 5 subscales of Self-management Scale for PD patients at the baseline measures (p > 0.05). However, after 12 months of intervention, the study group gained higher scores in the 5 subscales while the control group declined. And the study group improved statistically significant compared with the control group on “Solution bag replacement (t = 3.103, p = 0.002),” “Troubleshooting during operation (t = 3.978, p ≤ 0.001),” “Diet management (t = 3.201, p = 0.002),”and “Emotion management and return to social life (t = 3.552, p = 0.001)” subscales. Moreover, the peritonitis occurrence rate of the study group (1/68.1 patient month) was statistically significantly lower than that of control group (1/29.4 patient month; p = 0.047). Conclusions: MDT care based on 5E’s renal rehabilitation is beneficial for patients undergoing PD and helpful to improve self-management ability and reduce the incidence of peritonitis.

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Laser Acupuncture Alleviates Symptoms and Improves Quality of Life in Women with Overactive Bladder: A Double-Blind, Pilot Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/1705964 ◽

2020 ◽

Vol 2020 ◽

pp. 1-11

Author(s):

Yu-Wei Chang ◽

Tsia-Shu Lo ◽

Hsin-Ning Chang ◽

Yi-Hsien Shiao ◽

Yuan-Chieh Yeh

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Overactive Bladder ◽

Controlled Trial ◽

Laser Acupuncture ◽

Control Group ◽

Double Blind ◽

Randomized Controlled ◽

Experimental Group

Objective. The aim of this study was to investigate the clinical efficacy of laser acupuncture for the treatment of women with overactive bladder (OAB) in Taiwan. Methods. A double-blind randomized controlled trial was conducted on female patients with OAB symptoms referred from gynecologists, and subjects were divided into two groups using blocked randomization. LaserPan (RJ-Laser, Germany) was applied to seven selected acupuncture points. The subjects received laser acupuncture 3 times per week for 3 weeks, 9 sessions in total. Basic patient data, Overactive Bladder Symptom Score (OABSS), Incontinence Impact Questionnaire (IIQ-7), and Urogenital Distress Inventory (UDI-6) scores were recorded prior to first treatment and at the end of 3rd, 6th, and 9th treatments. Results. Thirty patients were enrolled, and twenty-seven patients completed all treatments in this study. The OABSS total score of the experimental group decreased significantly by 3.13 (p≤0.001), 4.60 (p≤0.001), and 3.79 (p≤0.001) after 3rd, 6th, and 9th treatments, respectively, compared with that of the control group. The IIQ-7 score declined significantly from baseline by 4.57 (p=0.003) and 3.63 (p=0.023) after 3rd and 6th treatments, respectively, compared with that of the control group. Similarly, the UDI-6 score of the experimental group exhibited a significant decrease from baseline by 1.90 (p=0.042) and 2.25 (p=0.025) after 6th and 9th interventions, respectively, compared with that of the control group. Conclusions. This study demonstrates that laser acupuncture can alleviate OAB symptoms and improve quality of life. This noninvasive device could be an effective therapy for women with OAB.

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