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RESEARCH ARTICLES
Effect of Ayurveda gut therapy protocol in managing dysbiosis of children with autism: study protocol for a randomized controlled trial
Dinesh Karayil Subramanian, Anita Patel, Madathaniyil Joseph George, Swapna Chitra Sugunanandagopan, Santhi Krishna, Sujitha Variyattukunnu Kelu, Jayakrishnan Kalluvirath, Archana Madhavi
October-December 2020, 5(4):58-64
DOI:10.4103/2542-3932.304945  
Background and objectives: Emerging evidences indicate an invariable relationship between gut dysbiosis and neurobehavioral symptoms of autism spectrum disorder. In India, Ayurveda is widely accepted among the complementary and alternative medicine. This study aimed to assess the efficacy of an Ayurveda gut therapy protocol in autism spectrum disorder. Subjects and methods: In this randomized controlled trial, 60 children with autism spectrum disorder admitted to Vaidyaratnam P S Varier Ayurveda College, India will be randomly assigned to intervention and control groups. The intervention group will undergo Ayurveda gut therapy protocol for 30 days and interdisciplinary interventions for 2 months, whereas the control group will undergo only interdisciplinary interventions for 2 months. A final assessment will be done on the 60 th day. Patient recruitment began in July 2018. The primary and secondary outcome measure will be completed in January 2021 and the study will be completed in September 2022. The study was approved by the Institutional Ethical Committee of Vaidyaratnam P S Varier Ayurveda College, India (Proceedings No: IEC/CI/24/17) on May 4, 2017. Protocol version: 1.0. Outcome measures: The expected primary outcome is to assess the quality and quantity of the gut microbes through 16s rRNA sequencing. The secondary outcome expected is the changes in the neurobehavioral symptoms assessed through the Childhood Autism Rating Scale and also changes in the gastrointestinal symptoms assessed through Ayurveda Gut Health Assessment Questionnaire. Discussion: The current protocol discusses the relationship between Autism and gut dysbiosis and its management through Ayurveda, and provides evidence for the rationality of using Ayurveda gut therapy as an alternative therapy for autism spectrum disorder in clinical practice. Trial registration: The study was registered with Clinical Trial Registry of India (registration No. CTRI/2018/05/014017, registered on May 21, 2018).
  8,432 211 -
RESEARCH ARTICLE
Spectrum of MRI brain findings in subacute sclerosing panencephalitis
Sidra Kaleem Jafri, Yousuf Husen, Khalid Ahmed, Shahnaz Hamid Ibrahim
October-December 2017, 2(4):124-128
DOI:10.4103/2542-3932.217490  
Background and objectives: Subacute sclerosing panencephalitis (SSPE) is a progressive catastrophic neurodegenerative disease because of persistent measles viral infection in the brain. This study was designed to determine the spectrum of magnetic resonance imaging (MRI) findings in subacute sclerosing panencephalitis. Design: Case series. Methods: We described the brain MRI findings in 20 pediatric patients with confirmed SSPE with their clinical and electroencephalogram (EEG) correlates. This study was conducted at Aga Khan University Hospital, Karachi, Pakistan between January 2006 and June 2016. Diagnosis of SSPE was on the basis of the clinical signs and symptoms, the characteristic EEG patterns (burst suppression in the early stage and a diffuse, random, slow arrhythmia pattern in the late stage), and high titers of measles antibody in the cerebro-spinal fluid. Results: The mean age at presentation was 7.4 ± 3.3 years. MRI abnormalities included diffuse white matter changes (n = 8), subcortical T2 hyperintesities in both grey and white matter in 1 patient and the brainstem changes in 2 patients. MRI was normal in 8/20 patients. Magnetic resonance spectroscopy (MRS) was performed in 4 patients out of whom 1 patient showed reduced N-acetyl aspartate (NAA) peak with elevated choline peak and inverted doublet lactate peak, 1 showed only reduced NAA, 1 showed isolated choline peak and 1 patient had a normal MRS. Conclusion: MRI brain to date is supportive in understanding the pathology of SSPE. MRI can be normal in patients with SSPE if done early on at the start of the disease.
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RESEARCH ARTICLES
Description of Guillain-Barre syndrome on the basis of clinical features using Hughes scoring system among children in Karachi, Pakistan
Prem Chand, Farida Jan, Sidra Kaleem, Mohammad Tahir Yousafzai, Shahnaz Ibrahim
April-June 2017, 2(2):45-49
DOI:10.4103/2542-3932.205193  
Background: Guillain-Barre syndrome (GBS) is an acquired inflammatory polyneuropathy characterized by rapidly progressive symmetrical flaccid limb weakness and areflexia. Here, we aimed to describe GBS on the basis of clinical features using Hughes scoring system (HSS) in children. Methods: We conducted a descriptive study, retrieving medical records of children between 2–16 years old admitted with GBS during January 2011–December 2013 at Aga Khan University Hospital, Karachi. Information on demographics, predisposing factors of GBS, clinical features at presentation, investigations, managements, short- and long-term outcomes were recorded on data extraction sheet. Ethical approval was obtained before data collection. Results: Totally 31 children with GBS (21 males) were admitted during the study period. The mean age was 6.7 years. Thirteen cases were seen in summer (January–October) followed by 11 in spring (March–May) and 7 in winter (November–February). Preceding illnesses including upper respiratory tract infections in 15 and diarrhea was seen in 4 patients. None of the patients had history of prior immunization. The nerve conduction study/electromyography showed acute inflammatory demyelinating polyradiculoneuropathy in 18 (58%), acute motor axonal neuropathy in 8 (25.8%), acute motor and sensory axonal neuropathy in 3 (9.7%) and Miller Fisher syndrome in 2 (6.5%) patients. Twenty-one patients had received intravenous immunoglobulin, four had plasmapharesis, four had both while two patients received none of these. Ventilator support was required by seven patients. Tracheostomy was performed on two patients. The HSS was calculated at 3-month follow-up. Nineteen children (61.2%) had an HSS score of 0–1, eight had a score of 2–5 (25.8%), and four patients were lost to follow-up. Conclusion: HSS is a good tool to identify and follow children with GBS. More than two-thirds of the patients had recovered complete mobility at 3-month follow-up.
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Systemic lupus erythematosus is easily misdiagnosed as subacute combined degeneration
Hui Zhang, Yitao He, Yi Guo
January-March 2019, 4(1):14-16
DOI:10.4103/2542-3932.252278  
Background and objective: Systemic lupus erythematosus is likely the cause of neurological dysfunction manifested as subacute combined degeneration. The objective of this article is to report the clinical manifestation of systemic lupus erythematosus manifested as subacute combined degeneration. Methods: We retrospectively analyzed the clinical data of a 37-year-old female patient with systemic lupus erythematosus accompanied by subacute combined degeneration who received treatment at Shenzhen People's Hospital, China. This study met the requirements of the Declaration of Helsinki and the patient gave informed consent. Results: The patient initially presented the symptoms of numbness and weakness of both upper and lower limbs and urinary retention. The patient's physical signs involved peripheral nerve, and posterior and lateral columns of the spinal cord. Blood test revealed anemia and low folate level. Her clinical manifestation was consistent with subacute combined degeneration. But serum antinuclear antibodies (ANA), anti-double-stranded DNA (anti-dsDNA) antibodies, anti-Ro/Sjögren's antibodies (anti-Ro/SSA) and anti-La/Sjögren's antibodies (anti-La/SSB) were found to be positive. Finally, the diagnosis of systemic lupus erythematosus was considered. Conclusion: Systemic lupus erythematosus can cause a variety of neurological defect symptoms, especially in female patients. Tests for autoantibodies should be performed to reduce misdiagnosis rate.
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Mindfulness-based cognitive therapy for University students with depression, anxiety, and stress symptoms: a randomized controlled trial
Alessandra Almeida Assumpcao, Carolina Silva Pena, Carmem Beatriz Neufeld, Maycoln M Teodoro
July-September 2019, 4(3):51-59
DOI:10.4103/2542-3932.263668  
Background and objectives: Early detection and intervention of depression, anxiety and stress symptoms in college can reduce the incidence of future mental health problems, thereby achieving better academic performance and having a positive effect on future career. The effect of Mindfulness-Based Cognitive Therapy (MBCT) on stress, depression and anxiety symptoms in this population has not been fully studied. The study aims to evaluate the efficacy of MBCT in treating depression, anxiety and stress symptoms in college students. Subjects and methods: This is a randomized parallel-controlled trial. University students with depressive, anxiety and stress symptoms were randomized into MBCT group and wait-list control (control) group. The MBCT took place in a weekly meeting within 6 weeks and was delivered in groups constituted by 5–11 participants. Each meeting took 90 minutes. The primary outcomes were the Beck Depression Inventory-II, the Beck Anxiety Inventory, and the Perceived Stress Scale. The secondary outcomes were the Rosenberg Self-Esteem Scale, and the 12-Item Health Survey scores. The study protocol was approved by the Ethics Committee of Federal University of Minas Gerais, in Belo Horizonte, Brazil (approval No. 2.025.573) on April 20, 2017. Results: The MBCT intervention had a statistically significant reduction in depression levels at post-treatment, and the treatment gains were maintained in follow-up (P < 0.05). Besides, the intervention increased the quality of life in post-test follow-up (P < 0.05). Conclusion: The MBCT helps college students learn how to manage adverse emotional states, especially, depression. It also helps improving their quality of life. Trial registration: This trial was registered in the Brazilian Clinical Trial Registry (http://www.ensaiosclinicos.gov.br) (registration No. RBR-4mmvpc) on July 21, 2017. Funding: This study was supported by Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES; to AAA).
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RESEARCH ARTICLE
Trauma Interventions using Mindfulness Based Extinction and Reconsolidation (TIMBER) psychotherapy prolong the therapeutic effects of single ketamine infusion on post-traumatic stress disorder and comorbid depression: a pilot randomized, placebo-controlled, crossover clinical trial
Basant K Pradhan, Irving W Wainer, Ruin Moaddel, Marc C Torjman, Michael Goldberg, Michael Sabia, Tapan Parikh, Andres J Pumariega
July-September 2017, 2(3):80-90
DOI:10.4103/2542-3932.211589  
Background and objectives: Trauma memories lay at the core in etiopathogenesis of post-traumatic stress disorder (PTSD). Using pharmacological and cognitive behavioral treatments that specifically target trauma memories can improve the outcome. Ketamine has been shown to rapidly improve symptoms in PTSD and comorbid depression, but unfortunately these effects are short-lived. Trauma Interventions using Mindfulness Based Extinction and Reconsolidation (TIMBER) psychotherapy is a type of mindfulness based cognitive behavioral therapy that targets the trauma memories. TIMBER psychotherapy in combination with (R,S)-ketamine are increasingly used to treat PTSD and comorbid depression. This study aims to determine if the combination of (R,S)-ketamine chemotherapy and TIMBER psychotherapy would produce a positive synergistic response in patients with PTSD. Design: This is a randomized, placebo-controlled, cross-over clinical study. Methods: Because response to ketamine alone is short-lived, this study combined TIMBER with a single infusion of 0.5 mg/kg (R,S)-ketamine to sustain its therapeutic effects. Ten patients with chronic and refractory PTSD were randomly assigned to two groups (n = 5 each): TIMBER-K group patients received ketamine infusion in combination with 12 TIMBER sessions (3 sessions in the first week followed by 9 sessions conducted on a weekly basis) and TIMBER-P group patients received placebo (normal saline infusion) in combination with 12 TIMBER sessions. The patients in the TIMBER-P group were switched to those in the TIMBER-K group after they experienced a sustained relapse. Outcome measures: PTSD Checklist (PCL), Clinician Administered PTSD Scale for DSM-IV (CAPS), the 17-item Hamilton Rating Scale for Depression (Ham-D-17, clinician rated), Beck Anxiety Inventory (BAI), and Montreal Cognitive Assessment (MoCA) at baseline and 8 hours after infusion were used to investigate if ketamine selectively affected trauma memories leaving the general memory intact. The mindfulness interventions in TIMBER were personalized based on subject's scores on Assessment Scale for Mindfulness Interventions which was administered at baseline, and after 5 sessions and 9 sessions (completion) of TIMBER. In this study, scores on CAPS and PCL scales were the primary outcome measures. Results: In the acute phase trial ( first 3 months after infusion), nine out of 10 subjects showed robust response in primary outcome measures (PCL and CAPS scores for PTSD) and in the secondary outcome measures (Ham-D-17 and Beck Anxiety Inventory for depression and anxiety respectively) with a sustained response of 31.78 ± 18.29 days. The TIMBER-K group had a more sustained response (33 ± 22.98 days) compared to the TIMBER-P group (25 ± 16.8 days, P = 0.545). After switch from TIMBER-P group to TIMBER-K, patients experienced significantly prolonged response (49 vs. 25 days, P = 0.028). There were no intolerable side effects or dropouts during the 18-month follow-up period. Conclusion: TIMBER psychotherapy augmented with low dose (R,S)-ketamine prolongs the therapeutic effects of the later and may be a valuable treatment option for PTSD. Trial registration: ClinicalTrials.gov identifier: NCT02766192
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STUDY PROTOCOL
Homeopathic prophylaxis for recurrent urinary tract infections following spinal cord injury: study protocol for a randomized controlled trial
Jürgen Pannek, Susanne Pannek-Rademacher, Mohinder S Jus, Jörg Krebs
October-December 2016, 1(4):191-195
DOI:10.4103/2468-5577.193147  
Background: Virtually many patients with spinal cord injury (SCI) suffer from neurogenic lower urinary tract dysfunction (NLUTD). Although the most severe consequence of NLUTD, damage of renal function, can be treated effectively today, urinary tract infections (UTI) are the most common urologic problems in SCI patients. They severely impair the quality of life, and no evidence-based prophylaxis exists. The goal of this study is to assess the usefulness of adjunctive homeopathic treatment for the reduction of UTI in patients with SCI. Methods/Design: A prospective randomized controlled trial is designed to assess whether adjunctive treatment with classical homeopathy leads to a relevant reduction of the rate of UTI in patients with SCI. In addition, it will be assessed if homeopathic treatment will significantly improve patient satisfaction and quality of life. Fifty patients with SCI and recurrent (3 or more) UTI per year will be recruited from the patients of the neuro-urology of the Swiss paraplegic Centre in Nottwil, Switzerland. All patients will be randomly allocated into two groups: patients in the homeopathy group (n = 25) will receive standard of-care prophylaxis combined with homeopathic treatment; the control group (n = 25) will receive standard of-care prophylaxis alone. Standard of-care prophylaxis consists of cranberry products and urine acidification. Homeopathic treatment consists of a homeopathic medication; the remedy is chosen individually based on the homeopathic case taking. Patients do not routinely present to the homeopaths during the study, but can contact them if a UTI occurs during the course of the study. Primary outcome are the UTI rate, and secondary outcomes are quality of life and satisfaction with the treatment over a follow-up period of 1 year. Discussion: There is a high demand for effective UTI prophylaxis in patients with SCI, because UTI are associated with an increased morbidity and even mortality. The results of the study will significantly add to our knowledge not only about UTI prevention, but the clinical value of homeopathy. Trial registration: ClinicalTrials.gov identifier: NCT01477502, registered on 17 November 2011. Ethics: The "Ethikkommission Nordwest- und Zentralschweiz (EKNZ): PB_2016-00054" approved this study protocol. Informed consent: Patients will sign an informed consent prior to participation in the study.
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Efficacy and safety of ozone therapy administered by autologous blood transfusion for acute ischemic stroke: study protocol for a multi-center open-label large-sample parallel randomized controlled trial
Jing Qiu, Hui-sheng Chen
April-June 2016, 1(2):37-42
DOI:10.4103/2468-5577.181233  
Background: There is still a lack of effective treatments for acute ischemic stroke. Our pre-clinical studies suggest that ozone therapy administered by autologous blood transfusion is a convenient and safe treatment for ischemic stroke, and is popular with patients, but its therapeutic benefits are not clear. We hypothesized that ozone therapy administered by autologous blood transfusion for ischemic stroke is safe and effective, and propose a protocol for a prospective, multi-center, open-label, large-sample, parallel, randomized, non-blinded controlled trial. Methods/Design: This will be a multi-center, open-label, large-sample, parallel, randomized controlled trial. We intend to recruit 5,000 patients with acute ischemic stroke in 30 centers (including General Hospital of Shenyang Military Region, China). Patients will be randomly allocated to a control group (n = 2,500; conventional stroke therapy) or an ozone therapy group (n = 2,500; ozone therapy administered in addition to conventional therapy). The primary outcome will be a modified Rankin Scale score 0-2 at 90 days. Secondary outcomes will be National Institute of Health Stroke Scale score at 14 days, blood lipid and glucose concentrations and coagulation function at 14 days, and the incidence of post-stroke pneumonia, recurrent stroke and other vascular events in the first 90 days after stroke. Discussion: We hope that our results will illuminate the therapeutic benefits of ozone therapy administered by autologous blood transfusion for acute ischemic stroke. Trial registration: This trial was registered at Chinese Clinical Trial Registry (registration No. ChiCTR-ICR-15007093) on 18 September 2015.
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Role of DLBS1033 in the management of acute ischemic stroke patients: study protocol for a randomized controlled study
Maruli Simangunsong, Bihantoro , Zola Wijayanti, Echa Aisyah, Novarida Mustikawati, Raymond R Tjandrawinata, Prihatini Hendri, Nurul Hidayah, Liana W Susantos, Fenny , Deni Purnama
April-June 2016, 1(2):50-61
DOI:10.4103/2468-5577.181235  
Background: In Indonesia, the incidence of stroke is growing rapidly every year and it becomes a burden to the government. Medications improving neurological function are required, in order to increase patient's quality of life. There were an enzyme (lumbrokinase) secreted from the alimentary tract of earthworm and it has anti-thrombotic and thrombolytic effect so that it can be beneficial in the management and prevention of stroke. DLBS1033 is a standardized bioactive protein fraction derived from Lumbricus rubellus through a patented technology of extraction. DLBS1033 has been shown to have antithrombosis and thrombolytic activities. The safety profile of DLBS1033 was also demonstrated in toxicology studies, animal studies, and in healthy adult subjects. Based on its mechanism of action and safety profile, DLBS1033 can be considered beneficial on acute ischemic stroke patients. Through this clinical study, we will evaluate the efficacy and safety of the product in acute ischemic stroke management. Methods/Design: This is a prospective, randomized, double-blind, and controlled clinical study to investigate the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy alone in the management of acute ischemic stroke. Patients included into the study will be randomized into two groups and receive either standard therapy alone (as control group) or standard therapy plus DLBS1033 (as DLBS1033 group). Functional outcomes will be measured using the Modified Rankin Scale (MRS) and The Modified National Institutes of Health Stroke (mNIHSS). Discussion: The study is expected to be a medical breakthrough in acute ischemic stroke management. Therefore, the morbidity and mortality of this disease can be lowered. Trial registration: ClinicalTrials.gov identifier: NCT02362984; registered on 3 February 2015.
  4,752 427 -
Mood stabilizers and/or antipsychotic drugs for the treatment of manic episodes in bipolar I disorder: study protocol for a randomized controlled trial
Kangguang Lin, Ting Li, Kun Chen, Weicong Lu, Jiehua Kong, Guiyun Xu
April-June 2016, 1(2):76-82
DOI:10.4103/2468-5577.181238  
Background: In clinical practice, it is important to quickly and effectively treat manic episodes in patients with bipolar I disorder. Therefore, it is necessary to formulate an effective therapeutic protocol combining two or more drugs in order to rapidly alleviate symptoms within a short time frame (1 week). In this clinical trial protocol, the antipsychotics quetiapine, olanzapine and ziprasidone and the mood stabilizers valproate, oxcarbazepine and lithium will be used to treat manic episodes to investigate the efficacy and safety of these two types of drugs when used alone or in combination. Methods/Design: This trial will be performed at Guangzhou Brain Hospital, China. A total of 120 patients with bipolar I disorder, exhibiting manic or mixed episodes, will undergo two phases of medication. In the first phase, patients will be randomly assigned to receive oral valproate, oxcarbazepine, lithium, quetiapine, olanzapine or ziprasidone. In the second phase, combination drug treatment will be given, i.e., each patient will receive a combination of mood stabilizers and antipsychotics. Treatment will be given for a total of 6 weeks. Primary outcome measures will include changes in the Young Mania Rating Scale (YMRS) scores and dropout rates. Secondary outcome measures will include disease progression and the efficacy of treatment as evaluated with the Clinical Global Impression Scale, symptom severity as evaluated with the Global Assessment Scale, and anxiety and depression symptoms as evaluated with the Hamilton Anxiety Scale and the Hamilton Depression Scale, respectively. Discussion: This trial will provide preliminary evidence on the comparative efficacy and effectiveness of the commonly prescribed drugs, with attempts at optimizing pharmacological treatments of manic and mixed episodes. Trial registration: ClinicalTrials.gov identifier: NCT01893229; registered on 2 July 2013.
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RESEARCH ARTICLES
Mindfulness training programme for undergraduate and graduate students with depression, anxiety and stress symptoms: Study protocol for a randomized controlled trial
Alessandra Almeida Assumpcao, Carmem Beatriz Neufeld, Maycoln M Teodoro
July-September 2018, 3(3):89-96
DOI:10.4103/2542-3932.238434  
Background and objectives: High prevalence rates of depression, anxiety and stress symptoms in undergraduate and graduate students have been pointed out as a growing concern in the literature. The high indexes of these psychopathological symptoms are considered a serious health problem, since they imply losses in the institutional, social and family spheres. Research on mindfulness interventions has demonstrated positive results in treating these symptoms. The study aims to evaluate the efficacy of mindfulness training programme in the treatment of depression, anxiety and stress symptoms in undergraduate and graduate students. Design: This is a randomized parallel-design controlled trial. Methods: Undergraduate and graduate students from the Federal University of Minas Gerais with depressive, anxiety and stress symptoms will be randomized into control and training group (n = 24/group). Mindfulness training will take place in a weekly meeting within 6 weeks and will be in a group format constituted by 8-12 participants. Each meeting will take 90 minutes. The control group will also receive the intervention after 6 weeks in the wait list condition. Outcome measures: The primary outcomes are Beck Depression Inventory-II, Beck Anxiety Inventory, and Perceived Stress Scale scores. The secondary outcomes are Rosenberg Self-Esteem Scale, and 12-item Short-Form Health Survey scores. Discussion: This trial will evaluate the efficacy of mindfulness training programme for undergraduate and graduate students with depressive, anxious and stress symptoms. This will help to improve mental health and the quality of life, as well as reducing psychological and social burdens for this population. Ethics and dissemination: The study protocol was approved by the Ethics Committee of Federal University of Minas Gerais, in Belo Horizonte, Brazil on April 20th, 2017, approval number 2.025.573. The committee will audit the progression of the research. The investigation results will be disseminated on peer review scientific journals. Trial registration: This trial was registered in the Brazilian Clinical Trial Registry (http://www.ensaiosclinicos.gov.br) (registration No. RBR-4mmvpc) on July 21st, 2017.
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STUDY PROTOCOL
Effect of intravenous acetaminophen on post-operative opioid-related complications: study protocol for a randomized, placebo-controlled trial
Wael Saasouh, Nelroy Jones, Taylor Stang, Karen Hovsepyan, Christine Chang, Alparslan Turan
October-December 2016, 1(4):154-163
DOI:10.4103/2468-5577.193142  
Background: Unrelieved post-operative pain leads to physiological and psychological consequences which worsen outcomes. Patients still report a 31% incidence of severe pain and 47% incidence of moderate pain after surgery. Multimodal analgesia aims to improve satisfaction while reducing side effects. Opioids are the most common treatment for post-operative pain; however, acute tolerance and opioid-induced hyperalgesia increase opioid requirements and the risk of side effects. Previous studies with acetaminophen have shown consistent and clinically important opioid-sparing effects but were unable to demonstrate significant reductions in opioid-related adverse events (inadequate sample sizes, poorly monitored complications). Specifically, we propose to test the primary hypothesis that total duration of hypoxia (defined as saturation of peripheral oxygen (SpO 2 ) < 90%) is less in patients receiving intravenous acetaminophen than placebo. Methods/Design: A total of 528 patients undergoing elective open or laparoscopic abdominal surgery will be included in this prospective, randomized, double-blinded, placebo-controlled trial. Patients who have renal disease, liver disease, acetaminophen allergy, are on warfarin therapy, or are receiving regional blocks will be excluded. The incidence and duration of hypoxic events will be the primary outcome of the study. Secondary outcomes include opioid consumption, pain scores, post-operative nausea and vomiting, sedation, fatigue, respiratory rate, movement, and cost-benefit analysis. We will use a ViSi mobile device (Sotera Wireless, San Diego, CA, USA) that will provide continuous non-invasive pulseoximetry, blood pressure, skin temperature, and patient position. Respiratory function will be measured using an ExSpiron (Respiratory Motion Inc., Waltham, MA, USA) monitor which provides continuous non-invasive monitoring of tidal volume, respiratory rate, and minute ventilation. Discussion: The outcomes will reveal the effect of peri-operative IV acetaminophen use on post-operative opioid-related complications. Continuous non-invasive monitoring of vital signs is expected to accurately assess opioid-related complications after major abdominal surgery and provide reliable results correlated with opioid use. The use of novel technology in the post-operative setting permits the collection of a dense amount of data and eliminates gaps in post-operative vital sign measurements. Trial registration: ClinicalTrials.gov identifier: NCT02156154, registered on 3 June 2014. Ethics: The study protocol was approved by the Cleveland Clinic Institutional Review Board (IRB) on 28 April 2014, approval number 14-241. Informed consent: Written informed consent will be obtained from participants or their guardians.
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RESEARCH ARTICLES
Cordyceps sinensis combined with duloxetine improves sleep symptoms in patients with depression: a randomized, double-blind, placebo-controlled study
Xu Chen, Xiao-Long Zhang, Chang-Ming Wang, Lei Feng, Gang Wang
October-December 2018, 3(4):136-145
DOI:10.4103/2542-3932.245217  
Background and objectives: Patients with depression can experience sleep disorder. Current treatments for depression, such as duloxetine and selective serotonin reuptake inhibitors, not only have a slow onset of action but also are associated with side effects such as dizziness, blurred vision, and ataxia. The main active ingredient of cordyceps sinensis, cordycepin, may have antidepressant effects, as well as pro-immunity, anti-inflammatory, anti-tumor, anti-fatigue, and anti-viral properties. In this randomized controlled trial, we investigate the safety and effectiveness of cordyceps sinensis (containing approximately 1.0% cordycepin) in combination with duloxetine in treating sleep disorder in patients with depression. Methods: In this randomized, double-blind, placebo-controlled, prospective trial, we plan to include 286 patients with depression receiving treatment at Beijing Anding Hospital of Capital Medical University, China. These patients are randomly assigned to undergo cordyceps sinensis combined with duloxetine or placebo combined with duloxetine. Duloxetine is assigned in an open manner, while cordyceps sinensis and placebo are assigned in a double-blind manner. Participants or their legal guardians are informed of the study protocol and medication and sign informed consent. A total of 246 patients were included in the polit study. Results: The primary outcome measure is the proportion of patients with ≥ 50% difference in 17-item-Hamilton Depression Rating Scale total score after 6 weeks of treatment relative to baseline. The secondary outcome measures are complete remission rate after 6 weeks of treatment; effectiveness rate after 1, 2, and 4 weeks of treatment; changes in Athens Insomnia Scale score, 17-item-Hamilton Depression Rating Scale total score, Arizona Sexual Experience Scale score, Mini-International Neuropsychiatric Interview suicide score, Digit Symbol Substitution Test score, Perceived Deficits Questionnaire-Depression score, 16-item Quick Inventory of Depressive Symptomatology Self-Report Scale score, 7-item Generalized Anxiety Disorder Scale score, and Sheehan Disability Scale score after 1, 2, 4, and 6 weeks of treatment relative to baseline; changes in Insight and Treatment Attitude Questionnaire score, and time and proportion of sleep drug use during the study period after 6 weeks of treatment relative to baseline; electroencephalogram results after 2 and 6 weeks of treatment; and blood biomarkers, safety indicators, and adverse events after 6 weeks of treatment. Results of a pilot study (during 2012–2016) involving 246 patients with depression receiving duloxetine 60 mg/d or fluoxetine 20 mg/d revealed that there was a similar percentage difference in 17-item-Hamilton Depression Rating Scale total score after 6 weeks of treatment relative to baseline and a similar incidence of drug use-related adverse events for both treatments. Discussion: We plan to perform a future study involving 286 patients to validate that cordyceps sinensis combined with duloxetine can effectively improve sleep symptoms of depression. The trial will provide data to support the clinical application of cordyceps sinensis. Ethics and registration: This study was approved by Hospital Ethics Committee, Beijing Anding Hospital of Capital Medical University, China (approval No. 2017-79-2017111-2) on December 20, 2017. This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR-INR-17014074). Protocol version: 3.0.
  4,469 308 -
Epilepsy-related researches in Web of Science from 2011 to 2020: a bibliometric analysis

April-June 2020, 5(2):32-36
DOI:10.4103/2542-3932.285359  
Background and objective: Epilepsy is a refractory disease of the nervous system. This article aimed to analyze the global trend of epilepsy research and the contribution of China to this research. Methods: This paper used “epilepsy, seizure, status epilepticus, SUDEP” to retrieve epilepsy-related articles indexed in the Web of Science from 2011 to 2020, classified and analyzed the global epilepsy-related articles. Results: This paper analyzed 65,270 articles on epilepsy research, showing that Epilepsy Behavior and Epilepsy Research were journals with the largest number of articles concerning epilepsy research in the world and China, respectively. The number of published epilepsy-related articles accounts for 5.43% of the global published articles and 3.29% of the published articles in China. The United States Department of Health Human Services and the National Institutes of Health jointly sponsored 15,713 of these articles, ranking first worldwide in the published epilepsy-related articles. Among 5206 articles published in China, 2696 articles (46.42%) were supported by the National Natural Science Foundation of China. Conclusion: This study has reference significance for researchers in this field to understand the 10-year overview of epilepsy researches and formulate future research directions.
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STUDY PROTOCOL
Scalp acupuncture twisting manipulation for treatment of hemiplegia after acute ischemic stroke in patients: study protocol for a randomized, parallel, controlled, single-blind trial
Liang Tian, Xiao-zheng Du, Jin-hai Wang, Zhen-chang Zhang, Qi Yan, Lei Wang, Run-jie Sun, Bo Yuan, Xing-lan Li, Ting-zhuo Zhang
July-September 2016, 1(3):98-106
DOI:10.4103/2468-5577.187075  
Background: Acupuncture can be used in clinical practice to promote motor recovery in patients with acute ischemic stroke and paralysis. It is an economical, safe, and effective method that can be easily implemented in clinical settings. However, although scalp acupuncture is an easy-to-perform micro-needle therapy, its efficacy in the treatment of hemiplegia resulting from acute ischemic stroke remains disputed. Methods/Design: This is a randomized parallel-controlled single-blind trial. It will be performed at the Department of Neurology, Second Hospital, Lanzhou University, China. Seventy-two patients suffering from acute ischemic stroke with paralysis will be randomly assigned to undergo 14 days of either conventional drug treatment (control group) or conventional drug treatment combined with scalp acupuncture that uses the twirling-needle method (once a day, 6 consecutive days followed by 1 day off per week). The primary outcome is the difference in National Institutes of Health Stroke Scale (NIHSS) scores between just after the stroke and 14 days after treatment. Secondary outcomes include motor recovery (assessed by the Fugl-Meyer Motor Scale) and activities of daily living (assessed by the Barthel index). Discussion: Objectively evaluating the efficacy of twirling-needle scalp acupuncture in the treatment of hemiplegia after acute ischemic stroke will provide evidence for assessing whether this method can improve motor recovery from hemiplegia resulting from acute ischemic stroke. Trial registration: This trial has been registered on 11 March 2016 in the Chinese Clinical Trial Registry (registration number: ChiCTR-IOR-16008083). Ethics: This trial has been approved by Ethics Committee, Second Hospital, Lanzhou University of China (approval number: 2016A-003) and will be performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from the patients and their relatives.
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Intensive versus nonintensive insulin therapy for hyperglycemia after traumatic brain injury: study protocol for a randomized controlled trial
Wen-xue Wang, Ai-min Li, Jian-wei Wang, Xin Kang, Guang-hui Fu, Yu-liang Liu
January-March 2016, 1(1):12-17
DOI:10.4103/2455-7765.173001  
Background: Hyperglycemia after traumatic brain injury is a physiological and metabolic disorder that may further aggravate secondary injury to the brain. Various experiences in the effective treatment of hyperglycemia after traumatic brain injury have been described. For example, the early use of intensive insulin therapy can control the blood glucose concentration within the target range, which has a direct protective effect on severe traumatic brain injury. However, some studies have arrived at different conclusions. Therefore, we aim to verify the therapeutic efficacy of intensive insulin therapy versus nonintensive insulin therapy on hyperglycemia after severe traumatic brain injury. Methods/Design: A randomized, controlled, double-blind study has been designed for completion at Oriental Hospital of Lianyungang, China. Sixty patients with hyperglycemia after severe closed traumatic brain injury will be randomized into an intensive insulin therapy group and a nonintensive insulin therapy group. The intensive insulin therapy group will then be divided into three subgroups based on the following target blood glucose levels: 4.4-7.0 mM (strict control group), 7.1-10.0 mM (moderate control group), and 10.1- 3.0 mM (slight control group). In the intensive insulin therapy group, the blood glucose levels will be monitored and controlled using the Yale Insulin Infusion Protocol, and a micropump will be used for intravenous injection of insulin. The nonintensive insulin therapy group will be given subcutaneous insulin injections. The primary endpoint will be the blood glucose levels, and the secondary endpoints will be mortality, activities of daily living, and prognosis. Discussion: This study will be powered to confirm the advantages of intensive insulin therapy in controlling blood glucose levels, reducing mortality, and improving prognosis in patients with hyperglycemia after severe traumatic brain injury. Trial registration: ClinicalTrials.gov identifier: NCT02161055; registered on 5 June 2014.
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Use of low-dose dexmedetomidine in general anesthesia improves postoperative recovery of patients with supratentorial tumors: study protocol for a randomized controlled trial
Yue Yun, Ling Pei
January-March 2016, 1(1):18-24
DOI:10.4103/2455-7765.173005  
Background: Favorable quality of recovery from general anesthesia in neurosurgical patients is an important goal for anesthesiologists. Dexmedetomidine is an emerging anesthetic adjuvant characterized by a stable hemodynamic recovery period, and neither its sedative nor analgesic effects influence evaluation of neurological function. We hypothesize that a bolus injection of low-dose dexmedetomidine during general anesthesia within minutes before the end of surgery in patients undergoing craniotomy can improve the quality of recovery from general anesthesia, thereby benefitting the evaluation of early-stage neurological function after surgery. Methods/Design: Patients with supratentorial tumors who have undergone craniotomy under general anesthesia at the Department of Neurosurgery, First Affiliated Hospital of China Medical University are included in this randomized controlled trial. A sample size of 150 patients is needed. Patients in the experimental group are randomly assigned to receive intravenous bolus injection of low- and medium-dose dexmedetomidine (0.4 and 0.8 ΅g/kg, respectively). Patients in the control group receive equal doses of physiological saline. The primary outcome of the study is the quality of recovery from general anesthesia, including awakening time, degree of sedation, spontaneous breathing recovery time, and coughing and bucking at the time of tracheal extubation. Secondary outcomes include postoperative analgesic effects, hemodynamic indices, anesthesia time, operation time, and neurological function assessment. Discussion: The results from this trial will provide optimal evidence for intravenous bolus injections of dexmedetomidine at a dose that can improve the quality of recovery from general anesthesia after craniotomy for supratentorial tumors. Trial registration: ClinicalTrails.gov identifier: NCT02007798; registered on 6 December 2013.
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Migraine prevention by noninvasive electrical fastigial nucleus stimulation: a multi-center, randomized, double-blind, sham-controlled trial
Juan Yang, Shu Ou, Jie Zhang, Wei-wei Dong, Jian Wang, Jin-he Lou
July-September 2016, 1(3):107-115
DOI:10.4103/2468-5577.187076  
Background: Migraine is a global disease with a high morbidity rate, and while there is medication for migraine prevention, it has many side effects. Thus there is a need to find a non-drug therapy to prevent migraine in patients with frequent attacks of migraine, severe pain, and poor drug control. Cortical spreading depression (CSD) is an important pathological mechanism behind migraine. Electrical fastigial nucleus stimulation (FNS) can reportedly inhibit the occurrence and propagation of CSD, and therefore can be used to prevent migraine. Methods/Design: This is a prospective, multi-center, randomized, double-blind, sham-controlled trial. It will be performed at Chengdu Second People's Hospital, the Second Affiliated Hospital of Chongqing Medical University, Chongqing Fourth People's Hospital, the First Affiliated Hospital of Chongqing Medical University, and Chongqing People's Hospital, China. The approach is to randomly allocate 80 eligible migraine patients to undergo 3 months of either noninvasive electrical FNS (pulse width 90 μs, frequency 1.8 kHz, and output current 10 mA) or ineffective sham-stimulation (using the same stimulation equipment; pulse width 90 μs, frequency 10 kHz, and output current 0.18 mA). The primary outcomes are: change in monthly migraine days between the run-in month and 3 rd month of treatment, and percentage of patients having at least a 50% reduction of monthly migraine days in the 3 rd month of treatment. The secondary outcomes are: change between average monthly migraine days across 3 months of treatment and monthly migraine days in the 3 rd month of treatment, Visual Analogue Scale score in the 3 rd month of treatment, change in monthly anti-migraine drug use between the run-in month and 3 rd month of treatment, migraine disability assessment questionnaire score, accompanying symptoms, and adverse reactions. Discussion: In previous studies on electrical FNS for the treatment of various brain injuries, sample sizes have been small with inclusion of only a small number of institutions and non-rigorous trial protocols. Accordingly, the data obtained were not very reliable. In this study, we will validate the efficacy of electrical FNS in migraine prevention using a multi-center, randomized, double-blinded, controlled trial. Our findings will provide evidence for clinical application of this method. Trial registration: The trial protocol was registered at Chinese Clinical Trial Registry (www.chictr.org.cn) (registration number: ChiCTR-ICR-15006273) on 5 April 2015. Ethics: This trial was approved by the Ethics Committee of Chengdu Second People's Hospital, China on 9 April 2015 (approval number: 2015010), and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from participants or their guardians.
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REVIEWS
Anxiety sensitivity and substance-related disorders: a narrative review
Omid Saed, Sahel Khakpoor
July-September 2020, 5(3):37-41
DOI:10.4103/2542-3932.295802  
Anxiety sensitivity means fear of anxiety-related sensations which is one of the important factors in the development and maintenance of substance-related disorders. Studies support the underlying, mediating, and moderating role of this construct in the etiology of substancerelated disorders. This review suggests that anxiety sensitivity can play a role in this group of disorders in different ways, such as fear of body sensations, fear of cognitive dyscontrol, and fear of socially observable anxiety symptoms. Finally, high anxiety sensitivity can interfere with the treatment of substance-related disorders as an underlying vulnerability and increase the likelihood of relapse in this group of people.
  3,773 186 -
STUDY PROTOCOL
Transcutaneous auricular vagus nerve stimulation for food craving: study protocol for a phase II randomized, sham-controlled clinical trial
Ruth Bartelli Grigolon, Quirino Cordeiro, Alisson Paulino Trevizol
July-September 2017, 2(3):91-98
DOI:10.4103/2542-3932.211590  
Background and objectives: Obesity is one of the most important diseases around the world and it is an increasing issue for public health. Food craving is a usually noticeable symptom that is described as a “strong desire or urge to eat”. The vagus nerve and its relations to the neurocircuitry of the reward system play essential roles in the regulation of food intake. Transcutaneous stimulation of the auricular branch of the vagus nerve (taVNS) was previously described for its neuromodulatory effects in neuropsychiatric disorder. This study aims to investigate the effects of transcutaneous auricular vagus nerve stimulation on food craving in patients with obesity. Design: A two-arm, triple-blinded, randomized, sham-controlled phase II trial. Methods: This will be conducted at The Center for Neuromodulation Studies, Federal University of São Paulo, Brazil. Fifty-four subjects with food craving will be assigned to either: 1) a 10-session treatment protocol of real taVNS, or 2) a 10-session treatment protocol of sham taVNS. Participants will be evaluated for outcome measures before and after intervention, with a follow-up visit of 30 days after the end of treatment. Outcome measures: The primary outcome measure will be changes in food craving evaluated by Food Craving Questionnaire-State and Trait. The secondary outcomes will be improvement of anthropometric measures (body mass index and hip/waist ratio), metabolic profile (blood pressure, cholesterol and triglycerides levels and fasting glucose), dietary habits (dietary diary and Food Craving Inventory) and depressive symptoms (Inventory for Depressive Symptoms), and quantitative electroencephalography and heart rate variability. Discussion: To the best of our knowledge, there are no studies on the effects of taVNS on alleviating craving symptoms. Given the epidemiological situation and economic and social burdens, the possibility of modulating the reward system neurocircuitry through the vagus nerve using an easy-to-operate, low-cost, safe and potential at-home use method represents a breakthrough in the treatment of obesity. Ethics and dissemination: The study will be approved by the ethics committee from the Federal University of São Paulo, Brazil. Patient recruitment will initiate in October 2017; analysis of primary outcome measures will be completed in October 2018 and the study will be finished in October 2019. Dissemination plans include presentations at scientific conferences and scientific publications. Trial registration: ClinicalTrials.gov identifier: NCT03217929; registered on July 11th, 2017.
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RESEARCH ARTICLES
Serum levels of high-sensitivity C-reactive protein in acute ischemic stroke and its subtypes: a prospective case-control study
Davinder Singh Rana, Ish Anand, Anuradha Batra, Prahlad Kumar Sethi, Seema Bhargava
October-December 2018, 3(4):128-135
DOI:10.4103/2542-3932.245216  
Background and objectives: Studies in different populations have shown that ischemic stroke can trigger an acute phase response resulting in a rise of plasma concentration of C-reactive protein (CRP) and high level of high-sensitivity CRP (hsCRP) is a risk factor for ischemic stroke. The objective of this study was to investigate the association of high hsCRP levels (≥ 1 mg/L) with ischemic stroke and its subtypes in Indian patients. Methods: This prospective observational case-control study included 150 patients (96 males, 54 females; aged 24–81 years) with first acute ischemic stroke who were admitted within 72 hours after onset, and 150 age- and sex-matched healthy controls. The study was conducted from July 2016 to July 2017. The patients were classified according to Trial of ORG 10172 in Acute Stroke Treatment classification. hsCRP levels were assessed in all included stroke patients. Results: The mean serum level of hsCRP was significantly higher in patients with first acute ischemic stroke than in healthy controls (P < 0.001). The mean serum level of hsCRP was higher in patients who had more severe stroke on admission. The prevalence of high serum level of hsCRP was highest in large-artery atherosclerosis (35.2%), followed by in cardioembolic (28.2%) stroke. The mean serum level of hsCRP was highest in large-artery atherosclerosis, followed by in stroke of undetermined etiology and cardioembolic subtype. High serum level of hsCRP was significantly associated with hypertension and age (P < 0.001 or P < 0.05). Multiple Logistic regression analysis revealed that high level of hsCRP was independently associated with acute ischemic stroke [odds ratio (OR) = 3.87, 95% confidence interval (CI): 2.39–6.27]. High hsCRP level was strongly associated with cardioembolic stroke (OR = 4.97, 95% CI: 2.5–9.65), large-artery atherosclerosis (OR = 4.75, 95% CI: 2.57–8.81), and stroke of undetermined etiology (OR = 3.36, 95% CI: 1.72–6.54). Conclusion: High hsCRP level is strongly associated with acute ischemic stroke and its subtypes, and it is an independent predictor of acute ischemic stroke. Ethics: The study was approved by the Sir Ganga Ram Hospital Ethics Committee (EC/07/14/701) on July 5, 2014.
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STUDY PROTOCOL
The optimal time window for the use and dosage of nimodipine for acute massive cerebral infarction: study protocol for a randomized controlled trial
Run-hui Li
January-March 2016, 1(1):1-5
DOI:10.4103/2455-7765.172998  
Background: A neuroprotective effect of nimodipine on acute cerebral infarction has been confirmed, but there are few reports regarding the therapeutic effect of nimodipine on acute massive cerebral infarction. There is also no consensus on the optimal time window for the use and dosage of nimodipine. This trial is planned to answer these questions using a double-blind randomized controlled design. Methods/Design: This is a double-blind randomized controlled trial. The experiments will be conducted in the Department of Neurology, Central Hospital Affiliated to Shenyang Medical College of China. One hundred patients with acute massive cerebral infarction will be randomly assigned to a control group and a treatment group. Patients in the control and treatment groups will receive intravenous infusion of citicoline and intravenous infusion of nimodipine (10 mg/d) respectively, for 7 consecutive days. Simultaneously, to determine the appropriate time window for treatment with nimodipine, patients in the treatment group will be divided into four subgroups according to the time of nimodipine administration: < 3 hours, 3-6 hours, 6-24 hours, and > 24 hours. The main outcome measures are: the National Institutes of Health Stroke Scale and the Rankin scale will be used to assess the severity and recovery of neurological impairment, respectively. Cranial computed tomography and magnetic resonance imaging will be used to evaluate brain lesions and the Barthel index will be used to assess the activities of daily living. Secondary outcome measures are heart rate and blood pressure. Discussion: It is hoped that the experimental results can determine the best application time window and dosage of nimodipine for acute massive cerebral infarction. Trial registration: ClinicalTrials.gov identifier: NCT02248233; registered on 22 September 2014.
  3,530 378 2
Efficacy of electroacupuncture at the Hegu (LI4) and Taichong (LV3) acupoints in the treatment of migraine: study protocol for a randomized controlled trial
Jian Pei, Jun Wang, Qin-hui Fu, Wei-wei Dong, Xiao-xin You, Ming Dai, Yi Song
April-June 2016, 1(2):83-90
DOI:10.4103/2468-5577.181239  
Background: Acupuncture is a relatively safe treatment for pain, and its analgesic effects have been confirmed. Electroacupuncture (EA) has been widely used to treat migraine because of its continuous and highly controllable stimulation. However, few rigorously designed randomized controlled trials have evaluated the efficacy of EA at the Hegu (LI4) and Taichong (LV3) acupoints in the treatment of migraine. Methods/Design: A prospective, single-center, single-blind randomized controlled trial will be performed at Longhua Hospital, Shanghai University of Traditional Chinese Medicine. Ninety-two patients with migraine will be randomly assigned to either undergo EA treatment (20 EA stimulations at the Hegu and Taichong acupoints; EA group, n = 46) or receive oral flunarizine (control group, n = 46). The primary outcome will be the Migraine Disability Assessment questionnaire score after 10 and 20 EA stimulations. The secondary outcomes will be the Medical Outcomes Study 36-item short form health survey score, Visual Analogue Scale score, and peripheral blood concentrations of plasma nitric oxide, calcitonin gene-related peptide, and nuclear factor-kappa B after 10 and 20 EA stimulations. Discussion: This trial is powered to investigate the efficacy of EA at the Hegu and Taichong acupoints in alleviating headache symptoms in patients with migraine and the interventional effects of this therapy on quality of life and social functioning to search for a more effective method of treating migraine. Trial registration: This trial protocol was registered at ClinicalTrial.gov (identifier: NCT02580968) on 30 July 2015. It was approved by the ethics committee of Longhua Hospital of Shanghai University of Traditional Chinese Medicine, China (approval No. 14401971300).
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Efficacy of spontaneous laughter in the post-operative treatment of pain and anxiety in children: study protocol for a randomized controlled trial
Magda Ruth Pérez Cervantes, Chiharu Murata, Volkmar Wanzke Del Angel
July-September 2016, 1(3):137-143
DOI:10.4103/2468-5577.187080  
Background: Studies have demonstrated the efficacy of laughter in contributing to a better quality of life. Strategies can be optimized to elevate tolerance to pain and to combat stress, thereby reducing the impacts of stress, such as the increase in arterial tension, reduction in perfusion of the non-motor organs, an increase in cellular metabolism, and a greater risk of infections. Despite the increased interest in this topic, there is still a need for more research, because many of such studies are limited by diverse methodological problems, such as lack of objective evaluations, clear distinction between laughter and humor, and establishment of dosage of the therapies (frequency and time). The objective of the current study is to determine the efficacy of spontaneous laughter in improving the post-operative prognosis for pediatric patients after minor surgery. Post-operative pain will be evaluated by the Visual Analog Scale, and urinary cortisol levels, duration of hospital stay, and anxiety by the State-Trait Anxiety Inventory for Children. Methods/Design: The study will be an open, randomized controlled trial, having three parallel arms: conventional post-operative management with analgesics; a second control group consisting of conventional treatment with an accompaniment that does not induce laughter; and an experimental group based on conventional treatment plus laughter therapy. Pediatric patients (6-14 years of age; n = 70 per group), hospitalized for minor surgery in a Mexico City hospital, will be randomly assigned to one of the three groups. Generalized linear models will be constructed to determine the adjusted effects of laughter therapy on the intensity of pain, anxiety, and duration of hospital stay. Discussion: To the best of our knowledge, no clinical trial to determine the effect of laughter therapy exists in which the effect of the vehicle is controlled. Here, we controlled this potential confounding factor by establishing a control group "accompaniment without laughter". As a secondary outcome variable, measurement of urinary cortisol levels will provide objective evidence to complement the subjective measurement of the pain as perceived by the patient. As a co-variable, the duration of effective laughter will provide greater robustness to this study. Trial registration: This trial was registered at ClinicalTrials.gov (identifier: NCT02563587) on 28 September 2015. Informed consent: The research protocol of this study has been approved by the Ethics Committee of the Hospital General Naval de Alta Especialidad de la Secretaría de Marina de la Armada de México (approval number: 076). This research adheres to the guidelines set forth in the NORMA Oficial Mexicana NOM-012-SSA3-2012 and in the Declaration of Helsinki.
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RESEARCH ARTICLES
Deep-brain magnetic stimulation as add-on treatment to lithium carbonate in the treatment of bipolar depression: study protocol for a randomized, double-blind, sham-controlled trial
Le Xiao, Gang Wang, Lei Feng
July-September 2018, 3(3):102-111
DOI:10.4103/2542-3932.238436  
Background and objectives: Bipolar disorder is a highly prevalent mental disorder. In clinical practice, mood stabilizers such as lithium carbonate are the conventional treatment for bipolar disorder. However, these drugs have slow onset of action and are not sufficiently effective in the acute phase. Deep-brain magnetic stimulation was hypothesized to have significant therapeutic effects in patients with major depressive disorder by entrainment of neural oscillations. In previous clinical trials, deep-brain magnetic stimulation showed good outcomes in the treatment of unipolar depression. However, randomized controlled trials that verify these results are lacking. Therefore, the current proposal intends to address this issue. Design: A single-center, randomized, double-blind, sham-controlled trial. Methods: Sixty patients aged 18–60 years who have been diagnosed with bipolar disorder at Beijing Anding Hospital, Capital Medical University of China, will be included and randomly divided into experimental and control groups (n = 30 per group). Patients in the experimental group will be treated with deep-brain magnetic stimulation plus lithium carbonate for 2 weeks followed by subsequent treatment with only lithium carbonate for 4 weeks. Patients in the control group will be treated with the same protocol, except they will receive sham stimulation. Outcome measures: The primary outcome measure is the change in score on the 17-Item Hamilton Rating Scale for Depression at weeks 2 and 6. The secondary outcome measures include response rate, complete remission rate (clinical cure rate), and changes in scores on the Hamilton Anxiety Rating Scale, 16-Item Quick Inventory of Depressive Symptomatology Self-Report, Generalized Anxiety Disorder-7, 9-Item Patient Health Questionnaire, Young Mania Rating Scale, Clinical Global Impression-Bipolar Disorder, and Montreal Cognitive Assessment at visit points relative to baseline scores. The safety evaluation indicators are the incidence of adverse events and the rate of manic switch. Discussion: The trial will verify the effectiveness of deep-brain magnetic stimulation with lithium carbonate in the treatment of bipolar disorder, providing evidence as to whether this combined therapy has the potential to be new alternative treatment for bipolar disorder. Ethics and dissemination: The trial was approved by the Ethics Committee of Beijing Anding Hospital, Capital Medical University in China (approval No. 201777FS-2) on October 27, 2017. Design of the trial was completed on June 28, 2017, and the trial registration was completed at the Chinese Clinical Trial Registry on November 10, 2017. Recruitment was initiated in January 2018 and it is expected to be completed in December 2018. Follow-up visit will end in June, 2019. Data analysis will be completed in December 2019. The results of the study will be disseminated through presentations at scientific meetings and/or in peer-reviewed publications. Anonymized trial data will be available indefinitely at www.figshare.com. Trial registration: The trial has been registered with the Chinese Clinical Trial Registry (Registration No. ChiCTR-INR-17013338) and the version number is 2.1.
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