ResearchPad - 1685 https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Electroacupuncture for treatment-resistant insomnia: study protocol for a randomised, controlled, assessor-blinded, pilot clinical trial]]> https://www.researchpad.co/article/elastic_article_9112 A considerable number of insomnia patients experience sleep disturbance even with long-term use of hypnotic medication. Previous studies have indicated that electroacupuncture (EA) could be an efficacious treatment for managing insomnia. However, few trials have been conducted to evaluate the effectiveness and safety of EA for treatment-resistant insomnia. This pilot study aims to explore the feasibility and preliminary effectiveness and safety of EA as an adjunct treatment for treatment-resistant insomnia.Methods and analysisThis is a multicentre, randomised, usual care controlled and assessor-blinded pilot study protocol. Fifty patients presenting with sleep problems who have been taking hypnotic medication for more than 3 months will be randomly allocated to either an EA group or a usual care group at a 1:1 ratio. The EA group will undergo 12 EA treatment sessions twice a week for 6 weeks whereas the usual care group will not receive EA treatment. All the participants will receive a brochure containing educational information on sleep hygiene. The primary outcome will be the measured mean change of the total score of the Insomnia Severity Index from the baseline to week 7. The secondary outcome regarding sleep quality will be measured using the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Moreover, we will assess the quality of life, the direct and indirect cost of treating insomnia for economic evaluation. After 4 weeks, the subjects will visit the research sites for a follow-up assessment.Ethics and disseminationEthical approval of this study protocol was established by the institutional review boards of the each involved study site. All potential subjects will be provided written informed consent. The results of this study will be accessible in peer-reviewed publications and be presented at academic conference.Trial registration numberKCT0003235. ]]> <![CDATA[Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial]]> https://www.researchpad.co/article/Naad84d52-6afa-4a24-bf94-87d1ad9537ea

Introduction

Insomnia with short sleep duration has a more serious negative impact on patient health. The existing literature suggests that medication therapy is more effective for this phenotype of insomnia compared with cognitive–behavioural therapy. However, the potential side effects of hypnotic medications hinder their clinical application. Acupuncture has been widely used in the treatment of insomnia, but it remains unclear whether it has therapeutic efficacy for insomnia with short sleep duration. The purpose of this trial is to evaluate the efficacy and safety of acupuncture for insomnia with short sleep duration.

Methods and analysis

This study is designed as a randomised, single-centre, single-blinded, placebo acupuncture controlled trial involving 152 participants. Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group. Then, patients in each group will be randomly assigned to two subgroups, the treatment group (acupuncture) and the control group (placebo acupuncture), in a 1:1 ratio with 38 subjects in each subgroup. The primary outcome is the Pittsburgh Sleep Quality Index and the Insomnia Severity Index. Secondary outcomes are actigraphy, the Beck Anxiety Inventory, the Beck Depression Inventory and the Fatigue Severity Scale. All adverse effects will be assessed by the Treatment Emergent Symptom Scale. Outcomes will be evaluated at baseline, post treatment, as well as at 1-week and 1-month follow-up.

Ethics and dissemination

This protocol has been approved by the ethics committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine (no. 2019-17). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals for publications.

Trial registration number

ChiCTR1900023473; Pre-results.

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<![CDATA[Actions of annatto-extracted tocotrienol supplementation on obese postmenopausal women: study protocol for a double-blinded, placebo-controlled, randomised trial]]> https://www.researchpad.co/article/Nea5758ef-1ccf-44d8-81a3-2084f5417098

Introduction

Obesity is a major health concern in postmenopausal women, and chronic low-grade inflammation contributes to the development of obesity. Cellular studies and high-fat-diet-induced obese mouse model mimicking obesity show the antiobesity effect of annatto-extracted tocotrienols (TT) with antioxidant capability. We aim to assess the safety and efficacy of TT consumption for lipid-related parameters in obese postmenopausal women.

Methods and analysis

Eligible obese postmenopausal women will be randomly assigned to placebo group (430 mg olive oil) and TT group (DeltaGold Tocotrienol 70%) for 24 weeks. In the present study, the primary outcome is total/regional fat mass and visceral adipose tissue. The secondary outcomes include lipid profile in serum, mRNA expression of fatty acid synthase and carnitine palmitoyltransferase 1A in fat tissue, oxylipins and endocannabinoids in plasma and adipose tissue, abundance and composition of intestinal microbiome in faeces, high-sensitivity C-reactive protein (hs-CRP) in serum and leptin in serum. Every participant will be evaluated at 0 (prior to starting intervention) and 24 weeks of intervention, except for serum lipid profile and hs-CRP at 0, 12 and 24 weeks. ‘Intent-to-treat’ principle is employed for data analysis. Hierarchical linear modelling is used to estimate the effects of dietary TT supplementation while properly accounting for dependency of data and identified covariates. To our knowledge, this is the first randomised, placebo-controlled, double-blinded study to determine dietary TT supplementation on an obese population. If successful, this study will guide the future efficacy TT interventions and TT can be implemented as an alternative for obese population in antiobesity management.

Ethics and dissemination

This study has been approved by the Bioethics Committee of the Texas Tech University Health Sciences Center, Lubbock. An informed consent form will be signed by a participant before enrolling in the study. The results from this trial will be actively disseminated through academic conference presentation and peer-reviewed journals.

Trial registration number

NCT03705845.

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<![CDATA[Comparison of efficacy and safety between electroacupuncture at ‘four sacral points’ and conventional electroacupuncture for the treatment of urinary incontinence after stroke: study protocol for a randomised controlled trial]]> https://www.researchpad.co/article/5c19afc3d5eed0c484c47815

Introduction

Electroacupuncture at ‘four sacral points’, also known as electrical pudendal nerve stimulation therapy, combines the advantages of pudendal nerve neuromodulation and the technique of deep insertion of long acupuncture needles. It has been used to treat stress urinary incontinence, female urgency-frequency syndrome, idiopathic urgency urinary incontinence and neurological bladders in previous studies. Here, we describe the protocol for a randomised controlled trial for evaluation of the efficacy and safety of electroacupuncture at ‘four sacral points’ for the management of urinary incontinence after stroke.

Methods and analysis

This is an open-label randomised controlled trial with blinded assessments and analyses. A total of 140 eligible patients will be randomly allocated to two groups. The treatment group (n=70) will receive electroacupuncture at ‘four sacral points’ along with routine medical care, while the control group will receive conventional electroacupuncture along with routine medical care. Twenty treatment sessions will occur over a period of 4 weeks. The primary outcome measures will be the self-recorded findings in an incontinent episode diary at baseline and at 4 weeks after baseline. The secondary outcome measures will be the International Consultation on Incontinence Questionnaire Urinary Incontinence—Short Form (ICIQ-UI SF) score and the Barthel Activities of Daily Living Index (Barthel ADL Index) score at baseline and at 4 and 28 weeks after baseline.

Ethics and dissemination

This protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval No. 2018-K-059–01). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals.

Trial registration number

ChiCTR-IOR-17012847; Pre-result.

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<![CDATA[Effects of traditional Chinese exercise on cardiac rehabilitation after percutaneous coronary intervention: study protocol for network meta-analysis of randomised controlled trials]]> https://www.researchpad.co/article/5c9e56ecd5eed0c48423ecd7

Introduction

Coronary heart disease (CHD) is the most common cause of death worldwide. Percutaneous coronary intervention (PCI) has been shown to reduce mortality in patients with CHD. However, there are still recurrences of cardiovascular events after PCI. Cardiac rehabilitation (CR) in patients with established CHD is associated with reductions in cardiovascular mortality and hospital admissions, as well as improved quality of life. More and more clinical trials suggest that traditional Chinese exercise (TCE) plays a positive role in patients post-PCI. The primary purposes of the current study are to conduct a network meta-analysis of randomised trials to determine the effects of TCE in patients after PCI, and to separately compare the effects of tai chi, baduanjin and yijinjing on CR after PCI.

Methods and analysis

Studies will be retrieved from the following databases: PubMed, Embase, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Data, Chinese BioMedical Database and Chinese Science and Technology Periodicals Database, from inception to December 2018. We will include randomised controlled trials that are related to the effects of TCE therapies in patients after PCI. The primary outcomes will be all-cause mortality, revascularisations, health-related quality of life and hospitalisations. Two reviewers will independently select eligible articles. For each included article, two reviewers will independently extract the data and assess the risk of bias by using the Cochrane risk of bias tool. Bayesian network meta-analyses will be conducted to pool all treatment effects. The ranking probabilities for the optimal intervention of various treatments (tai chi, baduanjin or yijinjing) will be estimated by the mean ranks and surface under the cumulative ranking curve. The Grading of Recommendations Assessment, Development and Evaluation System will be used to assess the quality of evidence.

Ethics and dissemination

The results will be disseminated through peer-reviewed publications. They will provide consolidated evidence to inform clinicians on the potential functions of TCE in CR, and to provide reliable evidence for the application of TCE.

Trial registration number

CRD42018088415.

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<![CDATA[Acupuncture point injection treatment of primary dysmenorrhoea: a randomised, double blind, controlled study]]> https://www.researchpad.co/article/5af80aef463d7e7ed0704f70

Objective

To determine if injection of vitamin K3 in an acupuncture point is optimal for the treatment of primary dysmenorrhoea, when compared with 2 other injection treatments.

Setting

A Menstrual Disorder Centre at a public hospital in Shanghai, China.

Participants

Chinese women aged 14–25 years with severe primary dysmenorrhoea for at least 6 months not relieved by any other treatment were recruited. Exclusion criteria were the use of oral contraceptives, intrauterine devices or anticoagulant drugs, pregnancy, history of abdominal surgery, participation in other therapies for pain and diagnosis of secondary dysmenorrhoea. Eighty patients with primary dysmenorrhoea, as defined on a 4-grade scale, completed the study. Two patients withdrew after randomisation.

Interventions

A double-blind, double-dummy, randomised controlled trial compared vitamin K3 acupuncture point injection to saline acupuncture point injection and vitamin K3 deep muscle injection. Patients in each group received 3 injections at a single treatment visit.

Primary and secondary outcome measures

The primary outcome was the difference in subjective perception of pain as measured by an 11 unit Numeric Rating Scale (NRS). Secondary measurements were Cox Pain Intensity and Duration scales and the consumption of analgesic tablets before and after treatment and during 6 following cycles.

Results

Patients in all 3 groups experienced pain relief from the injection treatments. Differences in NRS measured mean pain scores between the 2 active control groups were less than 1 unit (−0.71, CI −1.37 to −0.05) and not significant, but the differences in average scores between the treatment hypothesised to be optimal and both active control groups (1.11, CI 0.45 to 1.78) and (1.82, CI 1.45 to 2.49) were statistically significant in adjusted mixed-effects models. Menstrual distress and use of analgesics were diminished for 6 months post-treatment.

Conclusions

Acupuncture point injection of vitamin K3 relieves menstrual pain rapidly and is a useful treatment in an urban outpatient clinic.

Trial registration number

NCT00104546; Results.

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<![CDATA[Effectiveness and safety of modified ‘Huoxue Shugan’ formulas on coronary heart disease combined with depression: protocol for a systematic review]]> https://www.researchpad.co/article/5c19afcad5eed0c484c479bd

Objective

To assess the clinical effectiveness and safety of modified ‘Huoxue Shugan’ (HXSG) formulas used as Chinese herbal medicine in treating patients with coronary heart disease (CHD) and depression.

Methods

A systematic literature search of articles up to March 2018 will be performed in the following electronic databases: PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure, Chinese Scientific Journals Database, Chinese Biomedical Database, Chinese Biomedical Literature Service System and Wanfang Database. Inclusion criteria are as follows: randomised controlled trials of modified HXSG formulas in patients with CHD and depression. The primary outcome measures will be CHD-related clinical evaluation (frequency of acute angina, severity of angina pectoris, ECG changes, dose of nitroglycerin) and the scores or amount of reduction in scales measuring depression (ie, the Hamilton Depression Scale or other widely used depression scales). The safety outcome measures will be adverse events, liver and kidney function. RevMan V.5.3 software will be used for data synthesis, sensitivity analyses, subgroup analyses and risk of bias assessment. A funnel plot will be developed to evaluate reporting bias. Stata V.12.0 will be used for meta-regression and Egger tests. We will use the Grading of Recommendations Assessment, Development and Evaluation system to assess the quality of evidence.

Ethics and dissemination

This systematic review does not require ethics approval and will be submitted to a peer-reviewed journal.

PROSPERO registration number

CRD42018089641.

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<![CDATA[Chinese herbal medicine for postpartum constipation: a protocol of systematic review and meta-analysis]]> https://www.researchpad.co/article/5c644691d5eed0c484c2c036

Introduction

Constipation is one of the most common gastrointestinal symptoms in postpartum mothers. The choice of treatments for postpartum constipation remains a challenging clinical problem. Chinese herbal medicine has become increasingly popular as an alternative therapy for constipation. This systematic review aims to evaluate the efficacy and safety of Chinese herbal medicine for postpartum constipation.

Methods and analysis

We will search PubMed (1946 to present), EMBASE (1974 to present), Cochrane Central Register of Controlled Trials (all years), Web of Science (1900 to present), Chinese Biomedical Literatures Database (1978 to present), China National Knowledge Infrastructure (1979 to present) and WANFANG data (1998 to present) to identify any eligible study. No restriction will be put on the language, publication date or status of the study. The primary outcome will be the spontaneous bowel movement. Secondary outcomes will be stool consistency, quality of life, transit time, relief of constipation symptoms and adverse events. We will perform the meta-analysis when more than one trial examines the same intervention and outcomes with comparable methods in similar populations. If the heterogeneity is not significant statistically (p>0.10 or I2<50%), the fixed-effect model will be built to estimate the overall intervention effects. Otherwise, the random-effect model will be used to provide more conservative results.

Ethics and dissemination

No ethical issues are foreseen because no primary data will be collected. The results will be published in a peer-reviewed scientific journal.

PROSPERO registration number

CRD42018093741

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<![CDATA[A 6-year comparative economic evaluation of healthcare costs and mortality rates of Dutch patients from conventional and CAM GPs]]> https://www.researchpad.co/article/5ba6e50740307c489cbf7a1c

Objectives

To compare healthcare costs and mortality rates of Dutch patients with a conventional (CON) general practitioner (GP) and patients with a GP who has additionally completed training in complementary and alternative medicine (CAM).

Design

Comparative economic evaluation.

Setting

Database from the Dutch insurance company Agis.

Participants

1 521 773 patients (98.8%) from a CON practice and 18 862 patients (1.2%) from a CAM practice.

Main outcome measures

Annual information on five types of healthcare costs for the years 2006–2011: care by GP, hospital care, pharmaceutical care, paramedic care and care covered by supplementary insurance. Healthcare costs in the last year of life. Mortality rates.

Results

The mean annual compulsory and supplementary healthcare costs of CON patients are respectively €1821 (95% CI 1813 to 1828) and €75.3 (95% CI 75.1 to 75.5). Compulsory healthcare costs of CAM patients are €225 (95% CI 169 to 281; p<0.001; 12.4%) lower and result mainly from lower hospital care costs (€165; 95% CI 118 to 212; p<0.001) and lower pharmaceutical care costs (€58; 95% CI 41 to 75; p<0.001), especially in the age categories 25–49 and 50–74 years. The costs in the last year of life of patients with CAM, GPs are €1161 (95% CI −138 to 2461; p<0.1) lower. This difference is entirely due to lower hospital costs (€1250; 95% CI 19 to 2481; p<0.05). The mean annual supplementary costs of CAM patients are €33 (95% CI 30 to 37; p<0.001; 44%) higher. CAM patients do not have lower or higher mortality rates than CON patients.

Conclusions

Dutch patients whose GP additionally completed training in CAM on average have €192 (10.1%) lower annual total compulsory and supplementary healthcare costs and do not live longer or shorter than CON patients.

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