scholarly journals Efficacy and Safety of Electroacupuncture on Treating Depression Related Sleep Disorders: Study Protocol of a Randomized Controlled Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Xuan Yin ◽  
Jian Xu ◽  
Bo Dong ◽  
Jie Ma ◽  
Zeqin Chen ◽  
...  
Keyword(s):  
Sleep Disturbances ◽  
Rating Scale ◽  
Controlled Trial ◽  
Depression Scale ◽  
Sham Acupuncture ◽  
Efficacy And Safety ◽  
Symptom Scale ◽  
Treatment Groups ◽  
Sleep Parameters ◽  
And Control

Background. Depression is frequently accompanied by sleep disturbances including insomnia. Insomnia may persist even after mood symptoms have been adequately treated. Acupuncture is considered to be beneficial to adjust the state of body and mind and restore the normal sleep-awake cycle. This trial is aimed at evaluating the efficacy and safety of electroacupuncture on treating insomnia in patients with depression.Methods. We describe a protocol for a randomized, single-blinded, sham controlled trial. Ninety eligible patients will be randomly assigned to one of 3 treatment groups: treatment group (acupuncture), control A group (superficial acupuncture at sham points), and control B group (sham acupuncture). All treatment will be given 3 times per week for 8 weeks. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes are sleep parameters recorded in the Actigraphy, Hamilton Rating Scale for Depression (HAMD), and Self-Rating Depression Scale (SDS). All adverse effects will be accessed by the Treatment Emergent Symptom Scale (TESS). Outcomes will be evaluated at baseline, 4 weeks after treatment, 8 weeks after treatment, and 4 weeks of follow-up.Ethics. This trial has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2015SHL-KY-21) and is registered withChiCTR-IIR-16008058.

scholarly journals Efficacy and safety of electroacupuncture on treating depression-related insomnia: a study protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e021484 ◽  
Author(s):  
Xuan Yin ◽  
Bo Dong ◽  
Tingting Liang ◽  
Ping Yin ◽  
Xia Li ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Sleep Disorders ◽  
Standard Care ◽  
Rating Scale ◽  
Controlled Trial ◽  
Post Treatment ◽  
Efficacy And Safety ◽  
Symptom Scale ◽  
Hypnotic Medication ◽  
Randomised Controlled

IntroductionSleep disorders including insomnia occur frequently in depressive patients. Acupuncture is a widely recognised therapy to treat depression and sleep disorders in clinical practice. This multicentre randomised controlled trial (RCT) is aimed to investigate the efficacy and safety of electroacupuncture (EA) in the treatment of depression patients with insomnia.Methods and analysisWe describe a protocol for a multicentre RCT. A total of 270 eligible patients in three different healthcare centres in Shanghai will be randomly assigned to one of these three groups: treatment group (EA + standard care), control A group (sham electroacupuncture + standard care) and control B group (standard care). Treatment will be given three times per week for 8 consecutive weeks. The primary outcome is the Pittsburgh Sleep Quality Index. The secondary outcomes are sleep parameters recorded in the actigraphy, Hamilton Rating Scale for Depression score and Self-rating Anxiety Scale score. Daily dose of patients’ antidepressant and sedative-hypnotic medication will be recorded in the dairy. All adverse effects will be assessed by the Treatment Emergent Symptom Scale. Outcomes will be evaluated at baseline, 4 weeks post-treatment and 8 weeks post-treatment, as well as at 1-month, 3-month and 6-month follow-up.Ethics and disseminationThe trial has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2017SHL-KY-04). Written informed consent will be obtained from all participants. The results of this study will be published in peer-reviewed journals or presented at academic conferences.Trial registration numberNCT03122080; Pre-results.

Relief of pain and trismus in patients treated with naproxen or acetylsalicylic acid after tonsillectomy

1988 ◽  
Vol 102 (1) ◽  
pp. 39-42 ◽  
Author(s):  
S. Kristensen ◽  
K. Tveteraas ◽  
P. Hein ◽  
H. B. Poulsen ◽  
K. E. Outzen
Keyword(s):  
Clinical Trial ◽  
Acetylsalicylic Acid ◽  
Pain Intensity ◽  
Sleep Disturbances ◽  
Significant Positive Correlation ◽  
Controlled Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Significant Difference ◽  
Therapeutic Gain

AbstractThe pain-relieving efficacy of naproxen and acetylsalicylic acid (ASA) in tonsillectomized patients was compared in a double blind parallel clinical trial comprising 83 patients, among whom 42 were treated with naproxen and 41 with ASA. The patients were treated post-operatively for two days with either naproxen suppositories 500 mg. twice, or ASA effervescent tablets 1000 mg. three times, daily.The therapeutic gain was evaluated by recording the intensity of pain, reduced ability to open the mouth (trismus), consumption of supplementary analgesic (parcetamol), and pain-related sleep disturbances.The statistical analysis of the results revealed no differences in pain intensity, consumption of additional analgesics or pain-related sleep disturbances in the two treatment groups. A considerable degree of trismus was demonstrated in most of the tonsillectomized patients. This reduced ability to open the mouth was gradually overcome in the naproxen group while it remained unchanged in the ASA group, however, no statistical significant difference could be demonstrated. Additionally, no significant positive correlation between pain intensity and trismus was proven. The pain-relieving effect, however, was unsatisfactory in both the naproxen and the ASA group, and clinical controlled trial studies of alternative analgetics in tonsillectomized patients are still to be encouraged.

scholarly journals Effect of Exercise Program on Fatigue and Depression among Geriatric Patients Undergoing Hemodialysis

2019 ◽  
Vol 8 (2) ◽  
pp. 23
Author(s):  
Soad Hassan Abd Elhameed ◽  
Doaa El Sayed Fadila
Keyword(s):  
Geriatric Patients ◽  
Controlled Trial ◽  
Geriatric Depression Scale ◽  
Depression Scale ◽  
Exercise Program ◽  
Structured Interview ◽  
University Hospital ◽  
Control Group ◽  
Control Groups ◽  
And Control

Background: Fatigue is one of the foremost common complications faced the hemodialysis elderly patients. Fatigue not only impact the daily lives and activities of patients but it conjointly influences their quality of life, which can afterwards result in magnified depression, tiny social interactions and increase dependency on others.Aim: Determine the effect of exercise program on fatigue and depression among geriatric patients undergoing hemodialysis.Design: Randomized controlled trial (pretest post-test) design was used.Setting: The study was carried out in the dialysis units of Mansoura University Hospital and New Mansoura General Hospital.Subjects: A purposive sample of 62 geriatric patients undergoing hemodialysis was selected and randomly allocated into two equal groups, study group (n = 31) and control group (n =31).Tools: Three tools were used; Structured interview questionnaire sheet, Multidimensional Fatigue Inventory Scale and Geriatric Depression Scale Short Form.Results: The mean age of the study and control groups was 63.45±4.49 and 64.7±5.25 respectively. A high statistically significant change in fatigue and depression score (pre and post 2 months) between the study and the control groups was observed (P=0.000). Moreover, a statistically significant relation was observed between fatigue and age of the hemodialysis geriatric patients after implementation of the exercise program (P= 0.002).Conclusion: Implementation of the exercise program proved to be effective in improving the level of fatigue and depression among geriatric patients undergoing hemodialysis in the study group.Recommendation: Encourage geriatric patients undergoing hemodialysis to perform regularly range of motion and relaxation exercises in order to alleviate fatigue and overcome depression.  

scholarly journals Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Hongyu Yue ◽  
Shuang Zhou ◽  
Huangan Wu ◽  
Xuan Yin ◽  
Shanshan Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Control Group ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Symptom Scale ◽  
Significance Level

Abstract Background Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. Method This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). All analyses will be based on ITT principle and performed with the statistical software SPSS (version 24.0) by t test, rank-sum test, chi-square, and so on. A two-sided significance level will be set at 5%. Discussion This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. Trial registration ChiCTR ChiCTR1900026395. Registered on 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068

Traditional Acupuncture for Reflex Sympathetic Dystrophy: A Randomised, Sham-Controlled, Double-Blind Trial

1995 ◽  
Vol 13 (2) ◽  
pp. 78-80 ◽  
Author(s):  
E Ernst ◽  
KL Resch ◽  
V Fialka ◽  
D Ritter-Dittrich ◽  
Y Alcamioglu ◽  
...  
Keyword(s):  
Reflex Sympathetic Dystrophy ◽  
Rating Scale ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Outcome Variable ◽  
Controlled Study ◽  
Double Blind ◽  
Subjective Success ◽  
Group A

Acupuncture has been suggested as helpful in reflex sympathetic dystrophy (RSD), but no controlled study has yet been published. The hypothesis of this randomised, double-blind, sham-controlled trial, therefore, was that traditional Chinese acupuncture improves subjective as well as objective signs in this condition. Patients were included when suffering from clinically and scintigraphically confirmed acute RSD of the upper or lower limb, with a history between one and four months. They were randomly assigned to either traditional acupuncture (group A) or sham acupuncture (group S). Treatments were applied five times a week for three weeks, each session lasting for 30 minutes. Both groups received identical standard treatments in addition. The primary outcome variable had been pre-defined to be pain, as measured by visual analogue scale assessed before each treatment. Subjective success was also recorded by the patients on a rating scale. Due to force of circumstances, only 14 patients were entered into the study, therefore no test statistics could be performed and the data was evaluated descriptively. At baseline, pain was almost identical in both groups. During the course of the study, patients in group A demonstrated a more pronounced reduction of pain: 28.6% ± 1.9 vs 17.9% ± 2.4 (Mean ± SEM). Similarly, subjective success was rated to favour traditional acupuncture. It is concluded that acupuncture may be useful in the management of pain in patients with acute RSD, but that the present results are not conclusive. Larger, rigorous studies are required to answer the question.

scholarly journals Effects of bright light therapy for depression during pregnancy: a randomised, double-blind controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038030
Author(s):  
Babette Bais ◽  
Astrid M Kamperman ◽  
Hilmar H Bijma ◽  
Witte JG Hoogendijk ◽  
Jan L Souman ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Pregnant Women ◽  
Rating Scale ◽  
Controlled Trial ◽  
Depression Scale ◽  
Bright Light ◽  
Light Therapy ◽  
Secondary Outcome ◽  
Bright Light Therapy ◽  
Double Blind

ObjectivesApproximately 11%–13% of pregnant women suffer from depression. Bright light therapy (BLT) is a promising treatment, combining direct availability, sufficient efficacy, low costs and high safety for both mother and child. Here, we examined the effects of BLT on depression during pregnancy.DesignRandomised, double-blind controlled trial.SettingPrimary and secondary care in The Netherlands, from November 2016 to March 2019.Participants67 pregnant women (12–32 weeks gestational age) with a DSM-5 diagnosis of depressive disorder (Diagnostic and Statistical Manual of Mental Disorders).InterventionsParticipants were randomly allocated to treatment with either BLT (9000 lux, 5000 K) or dim red light therapy (DRLT, 100 lux, 2700 K), which is considered placebo. For 6 weeks, both groups were treated daily at home for 30 min on awakening. Follow-up took place weekly during the intervention, after 6 weeks of therapy, 3 and 10 weeks after treatment and 2 months postpartum.Primary and secondary outcome measuresDepressive symptoms were measured primarily with the Structured Interview Guide for the Hamilton Depression Scale—Seasonal Affective Disorder. Secondary measures were the Hamilton Rating Scale for Depression and the Edinburgh Postnatal Depression Scale. Changes in rating scale scores of these questionnaires over time were analysed using generalised linear mixed models.ResultsMedian depression scores decreased by 40.6%–53.1% in the BLT group and by 50.9%–66.7% in the DRLT group. We found no statistically significant difference in symptom change scores between BLT and DRLT. Sensitivity and post-hoc analyses did not change our findings.ConclusionsDepressive symptoms of pregnant women with depression improved in both treatment arms. More research is necessary to determine whether these responses represent true treatment effects, non-specific treatment responses, placebo effects or a combination hereof.Trial registration numberNTR5476.

scholarly journals Electroacupuncture Versus Gabapentin for Hot Flashes Among Breast Cancer Survivors: A Randomized Placebo-Controlled Trial

2015 ◽  
Vol 33 (31) ◽  
pp. 3615-3620 ◽  
Author(s):  
Jun J. Mao ◽  
Marjorie A. Bowman ◽  
Sharon X. Xie ◽  
Deborah Bruner ◽  
Angela DeMichele ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Survivors ◽  
Breast Cancer Survivors ◽  
Controlled Trial ◽  
Hot Flashes ◽  
Sham Acupuncture ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Nocebo Effects

Purpose Hot flashes are a common and debilitating symptom among survivors of breast cancer. This study aimed at evaluating the effects of electroacupuncture (EA) versus gabapentin (GP) for hot flashes among survivors of breast cancer, with a specific focus on the placebo and nocebo effects. Patients and Methods We conducted a randomized controlled trial involving 120 survivors of breast cancer experiencing bothersome hot flashes twice per day or greater. Participants were randomly assigned to receive 8 weeks of EA or GP once per day with validated placebo controls (sham acupuncture [SA] or placebo pills [PPs]). The primary end point was change in the hot flash composite score (HFCS) between SA and PP at week 8, with secondary end points including group comparisons and additional evaluation at week 24 for durability of treatment effects. Results By week 8, SA produced significantly greater reduction in HFCS than did PP (−2.39; 95% CI, −4.60 to −0.17). Among all treatment groups, the mean reduction in HFCS was greatest in the EA group, followed by SA, GP, and PP (−7.4 v −5.9 v −5.2 v −3.4; P = < .001). The pill groups had more treatment-related adverse events than did the acupuncture groups: GP (39.3%), PP (20.0%), EA (16.7%), and SA (3.1%), with P = .005. By week 24, HFCS reduction was greatest in the EA group, followed by SA, PP, and GP (−8.5 v −6.1 v −4.6 v −2.8; P = .002). Conclusion Acupuncture produced larger placebo and smaller nocebo effects than did pills for the treatment of hot flashes. EA may be more effective than GP, with fewer adverse effects for managing hot flashes among breast cancer survivors; however, these preliminary findings need to be confirmed in larger randomized controlled trials with long-term follow-up.

scholarly journals Efficacy and safety of Jie-du-qing-nao granules for first-episode schizophrenics: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Ziyan Li ◽  
Yanzhe Ning ◽  
Pei Chen ◽  
Yi Zhang ◽  
Dongqing Yin ◽  
...  
Keyword(s):  
Negative Symptoms ◽  
Complete Blood Count ◽  
Controlled Trial ◽  
First Episode ◽  
Control Group ◽  
Study Group ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Symptom Scale ◽  
Double Blind

Abstract BackgroundAt present, the focus and difficulty of schizophrenia (SCZ) treatment is to improve cognitive function and negative symptoms. Jie-du-qing-nao granules(JQG) , a traditional Chinese medicine(TCM) prescription , has a good clinical effectiveness in enhancing the cognition and negative symptoms of patients with SCZ. However, its clear effectiveness and safety have not been adequately supported by clinical studies. The main objective of this study is to explore the efficacy and safety of JQG for first-episode schizophrenics.Methods/designThis trial is a prospective, randomized, single-centered, parallel-controlled clinical study with double-blind design. A total of 96 eligible participants will be randomly assigned to either the study group or the control group in a ratio of 1:1. Participants allocated to the study group will receive JQG and aripiprazole, control group will receive placebo and aripiprazole. The treatment course will last 12 weeks, with follow-up every 4 weeks. Outcome measurements include Positive and Negative Syndrome Scale (PANSS), self face test , MATRICS Consensus Cognitive Battery (MCCB), TNFα, IL-6, IL-1β, BDNF, vital signs, complete blood count, liver and kidney function tests, urinalysis, and electrocardiograph. Adverse reactions will be evaluated using the Treatment Emergent Symptom Scale (TESS).DiscussionThis study will provide evidence for the efficacy and safety of JQG as a complementary approach, which can be initiated following with antipsychotics therapy. Trial registration Chinese Clinical Trial Registry, ID: ChiCTR1900028250 . Registered on December 16, 2019, http://www.chictr.org.cn/edit.aspx?pid=41880&htm=4 .

scholarly journals Evaluation on Immediate Analgesic Efficacy and Safety of Kai-Hou-Jian Spray (Children 'S Type) In Treating Sore Throat Caused By Acute Pharyngitis and Tonsillitis In Children: Study Protocol For A Randomized Controlled Trial

2021 ◽  
Author(s):  
Yan-ning Ma ◽  
Cheng-liang Zhong ◽  
Siyuan Hu ◽  
Qiu-han Cai ◽  
Sheng-xuan Guo
Keyword(s):  
Randomized Controlled Trial ◽  
Sore Throat ◽  
Rating Scale ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Effective Rate ◽  
Efficacy And Safety ◽  
Acute Pharyngitis ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Background: Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients’ quality of life. However, there is no proven effective or safe method to treat it. It is necessary to find an excellent strategy to reduce sore throat and reduce the burden of acute illness. We designed the randomized controlled trial with the characteristics of traditional Chinese medicine (TCM) to determine the clinical positioning of Kai-Hou-Jian spray (children 's type) (KHJS) through evidence-based research. This trial aims to evaluate the immediate analgesic efficacy of KHJS on sore throat caused by acute pharyngitis and tonsillitis (wind-heat syndrome/heat exuberance in lung and stomach syndrome) in children, and to observe its safety. Methods/design: This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. It will include 240 children with acute pharyngitis/tonsillitis from 7 study sites across China. All participants are randomly assigned to two parallel treatment groups, one with KHJS and the other with placebo sprays, for 5 consecutive days. The primary outcome is the time of analgesic onset. Secondary outcomes include duration of analgesic effect, area under time curve of 0-3 hours Wong-Baker FACES Pain Rating Scale (WBS) score (AUC0-3h), rate of analgesic onset, rate of disappearance of sore throat, changes of WBS score (in days), effective rate of pharyngeal signs, and effective rate of TCM syndrome. The incidence of adverse events during the trial is the primary safety outcome. In addition, vital signs and laboratory tests before and after medication are monitored.Discussion: To our knowledge, this will be the first clinical trial to explore the immediate analgesic efficacy of a Chinese patent medicine spray for acute pharyngitis/tonsillitis induced sore throat in children in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it prove the efficacy and safety of KHJS in the treatment of sore throat caused by acute pharyngitis/tonsillitis in children, but it might also provide evidence for the treatment of acute sore throat with Chinese herbal medicine.Trial registration: ChiCTR2000031599. Registered on 5 April 2020, http://www.chictr.org.cn/showproj.aspx?proj=50385

scholarly journals The efficacy and safety of electro-acupuncture for alleviating chemotherapy-induced peripheral neuropathy in colorectal cancer patients: study protocol for a pilot single-blinded, randomized sham-controlled trial

2019 ◽  
Author(s):  
Kaiyin Chan ◽  
Louisa Lui ◽  
Kaling Yu ◽  
Kwongwai Lau ◽  
Manchi Lai ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Hong Kong ◽  
Peripheral Neuropathy ◽  
Chinese Medicine ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Efficacy And Safety ◽  
Colorectal Cancer Patients

Abstract Background: Colorectal cancer is the most common cancer in Hong Kong. Oxaliplatin-based chemotherapy is a major first-line conventional therapy for advanced and metastatic colorectal cancer. However, oxaliplatin causes chemotherapy-induced peripheral neuropathy (CIPN). Acupuncture has long been used to alleviate limb numbness in Chinese Medicine Practice. This pilot study aims to examine the efficacy and safety of acupuncture for alleviating CIPN in colorectal cancer patients in Hong Kong. Methods/Design: This is a pilot single-blinded, randomized, sham-controlled trial. Eighty-four eligible patients, who are Hong Kong Chinese aged ≥18 years diagnosed with colorectal cancer and undergoing oxaliplatin-based chemotherapy, will be randomized in a ratio of 1:1 to electro-acupuncture group and sham-controlled group. During a 12-week treatment period, patients in electro-acupuncture group will undergo electro-acupuncture once a week from the first cycle of chemotherapy, patients in control group will receive sham-acupuncture, and the patients in both groups will be followed up for twelve weeks. The primary outcome measure is the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOC-Ntx) questionnaire. The secondary outcome measures include numerical rating scale (NRS) for numbness/pain, vibration and light touch sense test, quality of life questionnaire-C30 of European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) and Constitution of Chinese Medicine Questionnaire (CCMQ). Discussion: The study will compare electro-acupuncture with sham acupuncture to explore the feasibility for electro-acupuncture in improving symptoms caused by chemotherapy-induced peripheral neuropathy.

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