Study protocol for a parallel-group, double-blinded, randomized, controlled, noninferiority trial: the effect and safety of hybrid electroconvulsive therapy (Hybrid-ECT) compared with routine electroconvulsive therapy in patients with depression

Abstract Background Electroconvulsive therapy (ECT) is the most rapid and effective treatment for patients with depression, ECT can achieve remarkable antidepressant effects in the initial 3–4 sessions, but significant side effects limit its use. However, recent low-charge electrotherapy (LCE) studies have demonstrated antidepressant or antipsychotic effects with significantly fewer side effects. The aim of this study is to propose a novel two-step charge set strategy for ECT treatment, referred to as Hybrid-ECT, to decrease side effects by using a low charge while preserving treatment efficacy. Methods/design A randomized, double-blinded, standard-controlled, parallel-group design will be carried out. We plan to enroll 112 inpatients diagnosed with depression (unipolar or bipolar) and randomly assign them to conventional ECT (control group) or to Hybrid-ECT (treatment group, 3 ECT sessions followed by LCE sessions (approximately 2.8 joules per session)). We will evaluate participants across a wide variety of domains including clinical symptoms, cognitive, psychological and functional metrics. We will also perform magnetic resonance imaging (MRI) and event-related potential (ERPs) assessments during treatment to explore brain function differences between ECT and LCE. Discussion This research proposes a simple but completely novel ECT strategy that aims to rapidly relieve depressive symptoms and minimize side effects. The mechanism of ECT and LCE will be further discussed. Trial registration Chinese Clinical Trial Registry, Number: ChiCTR1900022905 (Registration date: April 30, 2019).

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The clinical and MRI effect of TNF-α inhibitor in spondyloarthritis patients with hip involvement: a real-world prospective clinical study

10.21203/rs.3.rs-464396/v1 ◽

2021 ◽

Author(s):

Kui Zhang ◽

Yan Zheng ◽

Qing Han ◽

Ying Liu ◽

Weitao Wang ◽

...

Keyword(s):

Clinical Symptoms ◽

Group Versus ◽

Quantitative Mri ◽

Control Group ◽

Prospective Clinical Study ◽

Clinical Trial Registry ◽

Hip Arthritis ◽

Tnf Α ◽

Long Term Follow Up ◽

Basic Treatment

Abstract Background: Hip involvement is an important cause of disability and poor prognostic in patients with spondyloarthritis (SpA). TNF-α inhibitor treatment had been demonstrated to be effective in SpA patients with hip arthritis, however, quantitative assessment with magnetic resonance imaging (MRI) in the long-term follow-up still needs further application.Methods: A total of 239 patients were involved in this study, MTX and SSZ were given as basic treatment. 165 patients received TNF-α inhibitor plus basic treatment and 74 patients received basic treatment only as control. The clinical symptoms were assessed at baseline, week 12, week 24, and week 52. The MRI performances of hip arthritis including bone marrow edema (BME) and synovitis were quantitatively assessed using Hip MRI Inflammation Scoring System (HIMRISS).Results: The clinical symptoms of ESR, CRP, BASDAI, Harris, and ASDAS-ESR of both groups got significant clinical remission at week 52 (p<0.001). However, the disease activity change levels at week 52 in control group were significantly worse than TNF group. In week 52, MRI performance showed significant remission trend in TNF-α inhibitor group versus baseline of which total HIMRISS scores decreased significantly ( 26.49±10.37 vs 20.59±9.41, p<0.001), but the control group only had slight improvement trend (p<0.05).Conclusions: TNF-α inhibitor could significantly and better improve the clinical and MRI manifestation of hip involvement in SpA patients than controls. Quantitative MRI assessment combined with clinical assessment could accurately evaluate the treatment effect of TNF-α for SpA patients with hip involvement, and help to guide targeted treatment.Trial registration: Chinese Clinical Trial Registry, ChiCTR-ONRC-11001846, Registered 28 November 2011. Retrospectively registered http://www.chictr.org.cn/showproj.aspx?proj=7701

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The maintenance of modified electroconvulsive therapy combined with risperidone is better than risperidone alone in preventing relapse of schizophrenia and improving cognitive function

Arquivos de Neuro-Psiquiatria ◽

10.1590/0004-282x20160130 ◽

2016 ◽

Vol 74 (10) ◽

pp. 823-828 ◽

Cited By ~ 7

Author(s):

Ying Yang ◽

Xiaojing Cheng ◽

Qingzhi Xu ◽

Renjun Li ◽

Zengxun Liu ◽

...

Keyword(s):

Cognitive Function ◽

Relapse Rate ◽

Electroconvulsive Therapy ◽

Verbal Memory ◽

Visual Memory ◽

Clinical Symptoms ◽

Control Group ◽

Significant Difference ◽

Modified Electroconvulsive Therapy ◽

Experimental Group

ABSTRACT Objective To evaluate the effect of maintenance modified electroconvulsive therapy (MECT) on schizophrenic patients. Methods From June 2012 to June 2014, 62 patients with schizophrenia, who had recovered from a successful course of acute MECT, were recruited. Thirty-one patients received maintenance MECT and risperidone, as the experimental group. Another 31 patients were enrolled in the control group, and received risperidone only. The effects on cognitive functions, clinical symptoms and relapse rate were determined. Results Patients in the experimental group had a lower relapse rate and longer relapse-free survival time than the controls. Relative to the baseline evaluation, patients showed statistically significant improvement in verbal memory and visual memory. At the final assessment, the scores of verbal and visual memory were remarkably lower in the experimental group than the controls but there was no significant difference in other tests. Conclusion Maintenance MECT plus medication is superior to medication alone in preventing relapse and improving cognitive function.

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Synbiotics and Treatment of Asthma: A Double-Blinded, Randomized, Placebo-Controlled Clinical Trial

10.31661/gmj.v8i0.1350 ◽

2019 ◽

Vol 8 ◽

pp. 1350

Author(s):

Maryam Hassanzad ◽

Keyvan Maleki Mostashari ◽

Hosseinali Ghaffaripour ◽

Habib Emami ◽

Samane Rahimi limouei ◽

...

Keyword(s):

Clinical Trial ◽

Side Effects ◽

Control Group ◽

Controlled Clinical Trial ◽

Positive Effects ◽

Outpatient Visits ◽

Significant Difference ◽

Asthma In Children ◽

Double Blinded ◽

Experimental Group

Background: We examined the efficiency and safety of a specific synbiotic compound, brand name Kidilact®, in the treatment of asthma in children 12 years of age or younger. Materials and Methods: This double-blinded, randomized, placebo-controlled clinical trial was conducted in Tehran, Iran, from May 22, 2016, to May 21, 2017. One hundred children, 12 years of age or younger, who suffered from mild to moderate asthma were recruited in this study. The subjects were randomly divided into two groups; the experimental group received a sachet of Kidilact®, and the control group received a sachet of placebo once a day for six months. Both groups were compared in terms of the frequency of asthma attacks that were severe enough to require administration of fast-acting medications, the number of outpatient visits for asthma-related problems, and the frequency of hospitalization due to exacerbated symptoms of asthma. Results: There were fewer complaints of drug-induced side effects, e.g., vomiting, headache, stomachache, and diarrhea, exacerbated cough, and constipation in the experimental group than in the control group. Overall, a significantly greater number of participants in the experimental group were satisfied with the therapeutic intervention than those in the control group, as verified by the participants and their parents/guardians self-report. There was no significant difference between both groups in the frequency of asthma attacks and hospitalization due to exacerbated symptoms of asthma. The only significant difference between both groups was the count of outpatient visits. While the control group made 55 outpatient visits to the hospital, participants in the experimental group visited the hospital only 19 times (P=0.001). Conclusion: Results of our study indicates that synbiotic compound Kidilact® generally alleviates the symptoms of asthma in children of 12 years of age or younger, resulting in less frequent outpatient visits to the hospital due to asthma-related problems while rarely causing any side effects. Due to ease of use, the rarity of side effects, and their indirect positive effects on quality of life of asthmatic patients, we recommend that synbiotics be incorporated in regular treatment and management of children with asthma. [GMJ.2019;8:e1350]

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Comparison of the efficacy of oral oxycodone and oral codeine in the treatment of post-craniotomy pain – a randomized, double-blind trial

10.21203/rs.2.15934/v1 ◽

2019 ◽

Author(s):

Rui Min Lee ◽

Beatrice Chin Ling Lim ◽

Chin Ted Chong ◽

Mandy Pei-Pei Lim

Keyword(s):

Side Effects ◽

Analogue Scale ◽

Controlled Trial ◽

Similar Efficacy ◽

Control Group ◽

Double Blind Trial ◽

Double Blind ◽

Scale Scores ◽

Double Blinded ◽

Experimental Group

Abstract Background Post-craniotomy pain has been reported to be moderate to severe. Management of post-craniotomy pain is often inadequate, yet limited by the side effects of opioids. We aim to find out the efficacy of oral oxycodone as compared to oral codeine for the treatment of post-craniotomy pain in our institution.Methods A randomized, double blinded controlled trial was used to evaluate the efficacy of oral oxycodone versus oral codeine. 40 patients were randomized to the control group of codeine (n = 20) or the experimental group receiving oxycodone (n = 20) in addition to regular oral paracetamol for both groups of patients.Results There was no difference in the visual analogue scale scores at 24 hours (2.78 versus 1.85, p = 0.11) or side effects in the oxycodone group compared with the codeine group.Conclusions Oral oxycodone had similar efficacy as oral codeine in the management of post-craniotomy pain.

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Magnitude of Reduction and Speed of Remission of Suicidality for Low Amplitude Seizure Therapy (LAP-ST) Compared to Standard Right Unilateral Electroconvulsive Therapy: A Pilot Double-Blinded Randomized Clinical Trial

Brain Sciences ◽

10.3390/brainsci9050099 ◽

2019 ◽

Vol 9 (5) ◽

pp. 99 ◽

Cited By ~ 4

Author(s):

Nagy A. Youssef ◽

Dheeraj Ravilla ◽

Cherishma Patel ◽

Mark Yassa ◽

Ramses Sadek ◽

...

Keyword(s):

Side Effects ◽

Electroconvulsive Therapy ◽

Rating Scale ◽

Treatment Guidelines ◽

Descriptive Analysis ◽

A Priori ◽

Bipolar Disorders ◽

Double Blinded ◽

Low Amplitude ◽

Cognitive Side Effects

Background: Although treatment guidelines support use of electroconvulsive therapy (ECT) for acute suicidality, it is associated with cognitive side effects. The effect of Low Amplitude Seizure Therapy (LAP-ST) on suicidality is unknown. Our prior precision LAP-ST (pLAP-ST) performing titrating in the current domain has provided initial proof of concept data in humans of its advantage in terms of reduction of cognitive side effects. The aims of this report are to: 1) compare LAP-ST (at 500mA) versus standard Right Unilateral (RUL) ECT (at 900 mA) in terms of magnitude of remission of suicidality in a randomized allocation and 2) compare the speed of remission of suicidality between LAP-ST versus RUL ECT. Methods: Patients were randomized to either LAP-ST or RUL ECT. The scores pertaining to the suicidal ideation (SI) item on the Montgomery-Åsberg Depression Rating Scale (MADRS) were analyzed using descriptive analysis and no confirmatory statistical analysis was performed due to a priori sample size limitations for this pilot study. SI item remission was defined as 2 or below on this item. Results: Eleven patients with major depressive episode (MDE) of mainly unipolar or bipolar disorders signed consent. Of these, 7 were eligible and were randomized and included in the analysis; all were actively suicidal at baseline (suicide item above 2), except 1 patient who had suicide item at 2 in the RUL ECT group. Suicidality remitted on average by session 3 and remission occurred for all patients by session 4. The SI mean score improvement from baseline to endpoint for LAP-ST was 5.1 and for RUL ECT was 3.0. Conclusions: LAP-ST has larger effect size and speed of remission of suicidality compared to standard RUL ECT. Future studies are warranted for replicating these findings. (ClinicalTrials.gov ID: NCT02583490).

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The efficacy and safety of silymarin in the treatment of chemotherapy-induced peripheral neuropathy, a randomized double-blinded clinical trial

10.22541/au.162837649.93180154/v1 ◽

2021 ◽

Author(s):

Ramin Shekarriz ◽

Hojjat Ghorbani ◽

Mahmoud Mousazadeh ◽

Khatereh Vahedi ◽

Ebrahim Salehifar

Keyword(s):

Quality Of Life ◽

Side Effects ◽

Intervention Group ◽

Gastrointestinal Symptoms ◽

Treated Group ◽

Control Group ◽

Significant Difference ◽

Eortc Qlq ◽

Double Blinded

Aim: The aim of this study was to evaluate the efficacy and side effects of silymarin in the treatment of CIPN. Methods: Patients who referred to outpatient oncology department of a referral educational hospital affiliated to Mazandaran University of Medical Sciences and experienced CIPN were randomized to receive silymarin or placebo. Intervention group received 140 mg of the Silymarin twice daily accompanied and 300 mg/day Gabapentin, whereas control group received 300 mg/day of Gabapentin and placebo twice daily for 3 months. The grade of neuropathy was determined according to the CTCAE criterion. The improvement of neuropathy was defined as the reduction of at least one neuropathic score. The visual analogue scale (VAS) was used to assess the severity of patients’ pain and the EORTC-QLQ-C30 criterion was used to assess the quality of life. Patients were evaluated initially and at the follow up visit 3 months after the enrollment. Results: A total of 80 patients were enrolled in the study. There was no significant difference between the groups in terms of severity of neuropathy at baseline. At the end of the study, the number of people with improved neuropathy in the silymarin group was 82.8% patients, which was significantly higher than 48.4% observed in the patients received placebo (P= 0.005). The silymarin-treated group showed a significant reduction in pain compared with those receiving placebo. Despite the improvement in quality of life in the intervention group compared to the comparison group, this difference was not statistically significant. Gastrointestinal symptoms were the only reported side effects with a similar incidence in two groups. Conclusion: The present data demonstrate the potential clinical use of silymarin as an adjuvant therapy to reduce CIPN symptoms.

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Auricular vagal nerve stimulation in peripheral arterial disease patients

VASA ◽

10.1024/0301-1526/a000660 ◽

2017 ◽

Vol 46 (6) ◽

pp. 462-470 ◽

Cited By ~ 3

Author(s):

Gerald Hackl ◽

Andreas Prenner ◽

Philipp Jud ◽

Franz Hafner ◽

Peter Rief ◽

...

Keyword(s):

Primary Endpoint ◽

Nerve Stimulation ◽

Short Form ◽

Therapeutic Option ◽

Arterial Disease ◽

Walking Distance ◽

Control Group ◽

Sf 36 ◽

Peripheral Arterial ◽

Double Blinded

Abstract. Background: Auricular nerve stimulation has been proven effective in different diseases. We investigated if a conservative therapeutic alternative for claudication in peripheral arterial occlusive disease (PAD) via electroacupuncture of the outer ear can be established. Patients and methods: In this prospective, double-blinded trial an ear acupuncture using an electroacupuncture device was carried out in 40 PAD patients in Fontaine stage IIb. Twenty patients were randomized to the verum group using a fully functional electroacupuncture device, the other 20 patients received a sham device (control group). Per patient, eight cycles (1 cycle = 1 week) of electroacupuncture were performed. The primary endpoint was defined as a significantly more frequent doubling of the absolute walking distance after eight cycles in the verum group compared to controls in a standardized treadmill testing. Secondary endpoints were a significant improvement of the total score of the Walking Impairment Questionnaire (WIQ) as well as improvements in health related quality of life using the Short Form 36 Health Survey (SF-36). Results: There were no differences in baseline characteristics between the two groups. The initial walking distance significantly increased in both groups (verum group [means]: 182 [95 % CI 128–236] meters to 345 [95 % CI 227–463] meters [+ 90 %], p < 0.01; control group [means]: 159 [95 % CI 109–210] meters to 268 [95 % CI 182–366] meters [+ 69 %], p = 0.01). Twelve patients (60 %) in the verum group and five patients (25 %) in controls reached the primary endpoint of doubling walking distance (p = 0.05). The total score of WIQ significantly improved in the verum group (+ 22 %, p = 0.01) but not in controls (+ 8 %, p = 0.56). SF-36 showed significantly improvements in six out of eight categories in the verum group and only in one of eight in controls. Conclusions: Electroacupuncture of the outer ear seems to be an easy-to-use therapeutic option in an age of increasingly invasive and mechanically complex treatments for PAD patients.

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Possibilities of correction of menopausal disorders in women with the use of medicine Menopace

HEALTH OF WOMAN ◽

10.15574/hw.2016.111.95 ◽

2016 ◽

pp. 95-100

Author(s):

G.I. Reznichenko ◽

◽

N.Yu. Reznichenko ◽

V.Yu. Potebnya ◽

K.I. Kovalenko ◽

...

Keyword(s):

General Condition ◽

Clinical Symptoms ◽

Average Score ◽

Control Group ◽

Climacteric Syndrome ◽

Basic Subgroup ◽

Menopausal Syndrome ◽

Natural Menopause ◽

Surgical Menopause ◽

Observation Period

The objective: to determine the efficacy of medicine «Menopace» in treatment of women with natural and surgical menopause. Patients and methods. 20 women (I group) with a natural menopause were examined (basic subgroup consisted of 10 patients who used Menopace for 3 months; control subgroup consisted of 10 patients). 20 women (II group) with surgical menopause were examined (basic subgroup consisted of 10 patients who received Menopace for 3 months; control subgroup consisted of 10 patients). Results. The average score of neurovegetative and emotional manifestations of climacteric syndrome during the observation period decreased in women with natural and surgical menopause who used Menopace, compared with subgroups of patients who had not used the medicine. Conclusions. 1. The use of the medicine Menopace in women with natural menopause after 3 months showed the disappearance of clinical symptoms of climacteric syndrome in 70% of the cases, and significant improvement in general condition in 30% of cases. 2. During surgical menopause after 1 month of treatment with Menopace manifestations of sweating were observed 4.5 times less often than in control group, tides were observed 7 times less often than in control group. Neurovegetative and psychoemotional symptoms of menopause were absent in 80% of women after 3 months of treatment and in 20% of cases significant improvement was shown. 3. The obtained results give grounds to recommend wide use of Menopace in practical work for the treatment of menopausal syndrome during natural and surgical menopause. Key words: menopause, therapy, Menopace.

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Effects of Virgin Coconut Oil as Adjunct Therapy in the Treatment of Allergic Rhinitis

Journal of Clinical and Health Sciences ◽

10.24191/jchs.v1i1.5850 ◽

2016 ◽

Vol 1 (1) ◽

pp. 22

Author(s):

Nazli Zainuddin ◽

Nurul Azira Mohd Shah ◽

Rosdan Salim

Keyword(s):

Allergic Rhinitis ◽

Side Effects ◽

Coconut Oil ◽

Test Group ◽

Nasal Symptom ◽

Control Group ◽

Virgin Coconut Oil ◽

Control Groups ◽

Significant Difference ◽

And Control

Introduction: The role of virgin coconut oil in the treatment of allergic rhinitis is controversial. Thus, the aim of the present study is to determine the effects of virgin coconut oil ingestion, in addition to standard medications, on allergic rhinitis. We also studied the side effects of consumption of virgin coconut oil. Methods: Fifty two subjects were equally divided into test and control groups. All subjects received a daily dose of 10mg of loratadine for 28 days. The test group was given 10ml of virgin coconut oil three times a day in addition to loratadine. The symptoms of allergic rhinitis were scored at the beginning and end of the study. Results:, the symptom score were divided into nasal and non-nasal symptom scores. Sneezing score showed a significant difference, however the score was more in control group than test group, indicating that improvement in symptom was more in control group. The rest of the nasal symptom and non-nasal symptom score showed no significant difference between test and control groups. Approximately 58% of the test subjects developed side effects from consumption of virgin coconut oil, mainly gastrointestinal side effects. Conclusion: In the present study, ingestion of virgin coconut oil does not improve the overall and individual symptoms of allergic rhinitis, furthermore it has side effects.

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Chinese Herbal Medicine Dingji Fumai Decoction for Ventricular Premature Contraction: A Real-World Trial

BioMed Research International ◽

10.1155/2020/5358467 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Bo Liang ◽

Fei-Hu Zou ◽

Ling Fu ◽

Hui-Ling Liao

Keyword(s):

Herbal Medicine ◽

Chinese Herbal Medicine ◽

Clinical Symptoms ◽

Medication Compliance ◽

Controlled Trial ◽

Ventricular Premature Contraction ◽

Traditional Chinese Medicine Syndrome ◽

Chinese Herbal ◽

Double Blinded

Background. Chinese herbal medicine Dingji Fumai Decoction (DFD) is widely clinically used for ventricular premature contraction (VPC). This real-word trial was designed to assess the safety and effectiveness of DFD for VPC. Methods. This was a double-blinded, randomized placebo-controlled trial. Patients with VPC were randomized (1 : 1) to treatment with DFD combined with metoprolol (DFD arm) or metoprolol combined with placebo (MET arm). A primary end point was a composite of clinical symptoms and signs determined by the traditionalChinese medicine syndrome score and the number of VPC determined by the Holter examination. Second outcomes were adverse events, medication compliance, and laboratory examination. Results. 144 patients were randomized to DFD arm (76 patients) or MET arm (68 patients), and 136 cases (71 in DFD arm and 65 in MET arm) finally completed this trial. After a 12-week follow-up, DFD arm significantly decreased traditional Chinese medicine syndrome score and the number of VPC compared with MET arm (P=0.003 and 0.034, respectively). There was no adverse drug effect and patient medication compliance was good. Conclusions. Superiority with DFD arm for VPC was demonstrated over MET arm for both the safety and effectiveness end points.

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