Efficacy and mechanism of acupuncture for ischemic poststroke depression: Study protocol for a multicenter single-blinded randomized sham-controlled trial
Poststroke depression is a serious and common complication of stroke, especially the ischemic poststroke depression. Antidepressants are used in poststroke depression, and acupuncture may be an alternative approach. However, the efficacy and mechanism of acupuncture for poststroke depression has not...
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| creator | Lu, Hai Li, Menghan Zhang, Bo Ren, Xuesong Meng, Lina Bai, Weijing Wang, Li Wang, Zhenzhen Ding, Shaojie Gan, Yuanyuan Zhang, Zhilong Li, Peifang Wang, Linpeng Meng, Zhihong Zhao, Hong Wang, Fei Zhang, Chunhong |
| description | Poststroke depression is a serious and common complication of stroke, especially the ischemic poststroke depression. Antidepressants are used in poststroke depression, and acupuncture may be an alternative approach. However, the efficacy and mechanism of acupuncture for poststroke depression has not been confirmed.
This is a multicenter, central-randomized, single-blind, sham-controlled clinical trial. We will allocate 208 subjects aged between 40 and 80 years old, diagnosed with initial poststroke depression (PSD) within 6 months to 2 groups randomly in a ratio of 1:1. Patients in the experimental group will be treated with traditional acupuncture and placebo pills, whereas the others in the control group will be treated with sham-acupoints acupuncture and antidepressant (fluoxetine hydrochloride tablets). All will be given acupuncture and/or medication treatment for 12 weeks, and then received 12-week follow-up. Patients will be evaluated with the 17-item Hamilton Depression Scale and Se1f-rating Depression Scale for depression state, National Institute of Health Stroke Scale for neurological deficit, Modified Barthel Index for activities of daily living, Treatment Emergent Symptom Scale for side effects of treatments, diagnosis and evaluation criteria of traditional Chinese medicine for stroke (try out) for curative effects of stroke, and clinical global impression for synthesize effect before and the 2nd, 4th, 8th, and 12th week of treatment, 24th week of follow-up. Study on mechanisms of acupuncture will be revealed through the diversity of brain metabolites (choline-containing compounds [Cho], N-acetylaspartate [NAA], myoinositol, glutamine and glutamate complex, creatine [Cr], Cho/Cr, Cho/NAA, Cr/NAA) in bilateral dorsolateral prefrontal cortex and anterior cingulate cortex monitored by proton magnetic resonance spectroscopy, and serum monoamine neurotransmitters (5-hydroxytryptamine, norepinephrine, dopamine) and cytokines (brain-derived neurotrophic factor [BDNF], interleukin [IL]-4, IL-6, IL-10, IL-18, IL-1β, tumor necrosis factor alpha) before and the 12th week of treatment. Baseline characteristics of patients will be summarized by groups and compared with chi-square for categorical variables, and 2-sample t tests or Wilcoxon rank-sum test for the continuous variables. Primary and secondary outcomes according to the measurement times are applicable to univariate repetitive measurement deviation analysis or 2-sample t tests, or Wilcoxon rank-sum |
| doi_str_mv | 10.1097/MD.0000000000014479 |
| format | Article |
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This is a multicenter, central-randomized, single-blind, sham-controlled clinical trial. We will allocate 208 subjects aged between 40 and 80 years old, diagnosed with initial poststroke depression (PSD) within 6 months to 2 groups randomly in a ratio of 1:1. Patients in the experimental group will be treated with traditional acupuncture and placebo pills, whereas the others in the control group will be treated with sham-acupoints acupuncture and antidepressant (fluoxetine hydrochloride tablets). All will be given acupuncture and/or medication treatment for 12 weeks, and then received 12-week follow-up. Patients will be evaluated with the 17-item Hamilton Depression Scale and Se1f-rating Depression Scale for depression state, National Institute of Health Stroke Scale for neurological deficit, Modified Barthel Index for activities of daily living, Treatment Emergent Symptom Scale for side effects of treatments, diagnosis and evaluation criteria of traditional Chinese medicine for stroke (try out) for curative effects of stroke, and clinical global impression for synthesize effect before and the 2nd, 4th, 8th, and 12th week of treatment, 24th week of follow-up. Study on mechanisms of acupuncture will be revealed through the diversity of brain metabolites (choline-containing compounds [Cho], N-acetylaspartate [NAA], myoinositol, glutamine and glutamate complex, creatine [Cr], Cho/Cr, Cho/NAA, Cr/NAA) in bilateral dorsolateral prefrontal cortex and anterior cingulate cortex monitored by proton magnetic resonance spectroscopy, and serum monoamine neurotransmitters (5-hydroxytryptamine, norepinephrine, dopamine) and cytokines (brain-derived neurotrophic factor [BDNF], interleukin [IL]-4, IL-6, IL-10, IL-18, IL-1β, tumor necrosis factor alpha) before and the 12th week of treatment. Baseline characteristics of patients will be summarized by groups and compared with chi-square for categorical variables, and 2-sample t tests or Wilcoxon rank-sum test for the continuous variables. Primary and secondary outcomes according to the measurement times are applicable to univariate repetitive measurement deviation analysis or 2-sample t tests, or Wilcoxon rank-sum test.
The present research is designed to investigate efficacy and mechanism of traditional acupuncture therapy on ischemic PSD, also to explore the correlation between cerebra metabolic and serologic factors, and ischemic PSD. With this research, we are looking forward to find out an appropriate alternative nondrug therapy for PSD people to alleviate the adverse effects and drug dependence caused by antidepressants.</description><identifier>ISSN: 0025-7974</identifier><identifier>EISSN: 1536-5964</identifier><identifier>DOI: 10.1097/MD.0000000000014479</identifier><identifier>PMID: 30762770</identifier><language>eng</language><publisher>United States: the Author(s). Published by Wolters Kluwer Health, Inc</publisher><subject>Activities of Daily Living ; Acupuncture Therapy - methods ; Adult ; Aged ; Antidepressive Agents - therapeutic use ; Brain - pathology ; Cytokines - biosynthesis ; Depression - drug therapy ; Depression - etiology ; Depression - therapy ; Female ; Fluoxetine - therapeutic use ; Humans ; Male ; Middle Aged ; Neurotransmitter Agents - biosynthesis ; Psychiatric Status Rating Scales ; Research Design ; Single-Blind Method ; Stroke - complications ; Study Protocol Clinical Trial</subject><ispartof>Medicine (Baltimore), 2019-02, Vol.98 (7), p.e14479-e14479</ispartof><rights>the Author(s). Published by Wolters Kluwer Health, Inc.</rights><rights>Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc. 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4057-6e8ded88713d3f123167e3fcfc599d724e2ac70d33d28262ff0fd102c6c5eceb3</citedby><cites>FETCH-LOGICAL-c4057-6e8ded88713d3f123167e3fcfc599d724e2ac70d33d28262ff0fd102c6c5eceb3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6408034/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6408034/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30762770$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lu, Hai</creatorcontrib><creatorcontrib>Li, Menghan</creatorcontrib><creatorcontrib>Zhang, Bo</creatorcontrib><creatorcontrib>Ren, Xuesong</creatorcontrib><creatorcontrib>Meng, Lina</creatorcontrib><creatorcontrib>Bai, Weijing</creatorcontrib><creatorcontrib>Wang, Li</creatorcontrib><creatorcontrib>Wang, Zhenzhen</creatorcontrib><creatorcontrib>Ding, Shaojie</creatorcontrib><creatorcontrib>Gan, Yuanyuan</creatorcontrib><creatorcontrib>Zhang, Zhilong</creatorcontrib><creatorcontrib>Li, Peifang</creatorcontrib><creatorcontrib>Wang, Linpeng</creatorcontrib><creatorcontrib>Meng, Zhihong</creatorcontrib><creatorcontrib>Zhao, Hong</creatorcontrib><creatorcontrib>Wang, Fei</creatorcontrib><creatorcontrib>Zhang, Chunhong</creatorcontrib><title>Efficacy and mechanism of acupuncture for ischemic poststroke depression: Study protocol for a multicenter single-blinded randomized sham-controlled trial</title><title>Medicine (Baltimore)</title><addtitle>Medicine (Baltimore)</addtitle><description>Poststroke depression is a serious and common complication of stroke, especially the ischemic poststroke depression. Antidepressants are used in poststroke depression, and acupuncture may be an alternative approach. However, the efficacy and mechanism of acupuncture for poststroke depression has not been confirmed.
This is a multicenter, central-randomized, single-blind, sham-controlled clinical trial. We will allocate 208 subjects aged between 40 and 80 years old, diagnosed with initial poststroke depression (PSD) within 6 months to 2 groups randomly in a ratio of 1:1. Patients in the experimental group will be treated with traditional acupuncture and placebo pills, whereas the others in the control group will be treated with sham-acupoints acupuncture and antidepressant (fluoxetine hydrochloride tablets). All will be given acupuncture and/or medication treatment for 12 weeks, and then received 12-week follow-up. Patients will be evaluated with the 17-item Hamilton Depression Scale and Se1f-rating Depression Scale for depression state, National Institute of Health Stroke Scale for neurological deficit, Modified Barthel Index for activities of daily living, Treatment Emergent Symptom Scale for side effects of treatments, diagnosis and evaluation criteria of traditional Chinese medicine for stroke (try out) for curative effects of stroke, and clinical global impression for synthesize effect before and the 2nd, 4th, 8th, and 12th week of treatment, 24th week of follow-up. Study on mechanisms of acupuncture will be revealed through the diversity of brain metabolites (choline-containing compounds [Cho], N-acetylaspartate [NAA], myoinositol, glutamine and glutamate complex, creatine [Cr], Cho/Cr, Cho/NAA, Cr/NAA) in bilateral dorsolateral prefrontal cortex and anterior cingulate cortex monitored by proton magnetic resonance spectroscopy, and serum monoamine neurotransmitters (5-hydroxytryptamine, norepinephrine, dopamine) and cytokines (brain-derived neurotrophic factor [BDNF], interleukin [IL]-4, IL-6, IL-10, IL-18, IL-1β, tumor necrosis factor alpha) before and the 12th week of treatment. Baseline characteristics of patients will be summarized by groups and compared with chi-square for categorical variables, and 2-sample t tests or Wilcoxon rank-sum test for the continuous variables. Primary and secondary outcomes according to the measurement times are applicable to univariate repetitive measurement deviation analysis or 2-sample t tests, or Wilcoxon rank-sum test.
The present research is designed to investigate efficacy and mechanism of traditional acupuncture therapy on ischemic PSD, also to explore the correlation between cerebra metabolic and serologic factors, and ischemic PSD. With this research, we are looking forward to find out an appropriate alternative nondrug therapy for PSD people to alleviate the adverse effects and drug dependence caused by antidepressants.</description><subject>Activities of Daily Living</subject><subject>Acupuncture Therapy - methods</subject><subject>Adult</subject><subject>Aged</subject><subject>Antidepressive Agents - therapeutic use</subject><subject>Brain - pathology</subject><subject>Cytokines - biosynthesis</subject><subject>Depression - drug therapy</subject><subject>Depression - etiology</subject><subject>Depression - therapy</subject><subject>Female</subject><subject>Fluoxetine - therapeutic use</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neurotransmitter Agents - biosynthesis</subject><subject>Psychiatric Status Rating Scales</subject><subject>Research Design</subject><subject>Single-Blind Method</subject><subject>Stroke - complications</subject><subject>Study Protocol Clinical Trial</subject><issn>0025-7974</issn><issn>1536-5964</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkd1uFSEUhYmxscfqE5gYXmAqfzPMeGFi2vqTtOmFej3hwKaDZWACjM3xUXxaaY-2VW5gw1rfBhZCryg5pmSQby5Oj8nDoELI4Qna0JZ3TTt04inaEMLaRg5SHKLnOX-vIi6ZeIYOOZEdk5Js0K8za51WeodVMHgGPang8oyjxUqvyxp0WRNgGxN2WU8wO42XmEsuKV4DNrAkyNnF8BZ_KavZ4SXFEnX0dxaF59UXpyEUSDi7cOWh2XoXDBicasc4u591mSc1NzqGCvW-1iU55V-gA6t8hpd_5iP07cPZ15NPzfnlx88n788bLUgrmw76Sut7SbnhljJOOwncaqvbYTD1vcCUlsRwbljPOmYtsYYSpjvdgoYtP0Lv9txl3c5gbi-blB-X5GaVdmNUbvz3JLhpvIo_xk6QnnBRAXwP0CnmnMDeeykZb6MaL07H_6OqrteP2957_mZTBWIvuIm-fl--9usNpHEC5ct0x2vlwBpG6EAYbUlTd4TkvwH_7qTx</recordid><startdate>20190201</startdate><enddate>20190201</enddate><creator>Lu, Hai</creator><creator>Li, Menghan</creator><creator>Zhang, Bo</creator><creator>Ren, Xuesong</creator><creator>Meng, Lina</creator><creator>Bai, Weijing</creator><creator>Wang, Li</creator><creator>Wang, Zhenzhen</creator><creator>Ding, Shaojie</creator><creator>Gan, Yuanyuan</creator><creator>Zhang, Zhilong</creator><creator>Li, Peifang</creator><creator>Wang, Linpeng</creator><creator>Meng, Zhihong</creator><creator>Zhao, Hong</creator><creator>Wang, Fei</creator><creator>Zhang, Chunhong</creator><general>the Author(s). Published by Wolters Kluwer Health, Inc</general><general>Wolters Kluwer Health</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>20190201</creationdate><title>Efficacy and mechanism of acupuncture for ischemic poststroke depression: Study protocol for a multicenter single-blinded randomized sham-controlled trial</title><author>Lu, Hai ; Li, Menghan ; Zhang, Bo ; Ren, Xuesong ; Meng, Lina ; Bai, Weijing ; Wang, Li ; Wang, Zhenzhen ; Ding, Shaojie ; Gan, Yuanyuan ; Zhang, Zhilong ; Li, Peifang ; Wang, Linpeng ; Meng, Zhihong ; Zhao, Hong ; Wang, Fei ; Zhang, Chunhong</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4057-6e8ded88713d3f123167e3fcfc599d724e2ac70d33d28262ff0fd102c6c5eceb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Activities of Daily Living</topic><topic>Acupuncture Therapy - methods</topic><topic>Adult</topic><topic>Aged</topic><topic>Antidepressive Agents - therapeutic use</topic><topic>Brain - pathology</topic><topic>Cytokines - biosynthesis</topic><topic>Depression - drug therapy</topic><topic>Depression - etiology</topic><topic>Depression - therapy</topic><topic>Female</topic><topic>Fluoxetine - therapeutic use</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neurotransmitter Agents - biosynthesis</topic><topic>Psychiatric Status Rating Scales</topic><topic>Research Design</topic><topic>Single-Blind Method</topic><topic>Stroke - complications</topic><topic>Study Protocol Clinical Trial</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lu, Hai</creatorcontrib><creatorcontrib>Li, Menghan</creatorcontrib><creatorcontrib>Zhang, Bo</creatorcontrib><creatorcontrib>Ren, Xuesong</creatorcontrib><creatorcontrib>Meng, Lina</creatorcontrib><creatorcontrib>Bai, Weijing</creatorcontrib><creatorcontrib>Wang, Li</creatorcontrib><creatorcontrib>Wang, Zhenzhen</creatorcontrib><creatorcontrib>Ding, Shaojie</creatorcontrib><creatorcontrib>Gan, Yuanyuan</creatorcontrib><creatorcontrib>Zhang, Zhilong</creatorcontrib><creatorcontrib>Li, Peifang</creatorcontrib><creatorcontrib>Wang, Linpeng</creatorcontrib><creatorcontrib>Meng, Zhihong</creatorcontrib><creatorcontrib>Zhao, Hong</creatorcontrib><creatorcontrib>Wang, Fei</creatorcontrib><creatorcontrib>Zhang, Chunhong</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Medicine (Baltimore)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lu, Hai</au><au>Li, Menghan</au><au>Zhang, Bo</au><au>Ren, Xuesong</au><au>Meng, Lina</au><au>Bai, Weijing</au><au>Wang, Li</au><au>Wang, Zhenzhen</au><au>Ding, Shaojie</au><au>Gan, Yuanyuan</au><au>Zhang, Zhilong</au><au>Li, Peifang</au><au>Wang, Linpeng</au><au>Meng, Zhihong</au><au>Zhao, Hong</au><au>Wang, Fei</au><au>Zhang, Chunhong</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and mechanism of acupuncture for ischemic poststroke depression: Study protocol for a multicenter single-blinded randomized sham-controlled trial</atitle><jtitle>Medicine (Baltimore)</jtitle><addtitle>Medicine (Baltimore)</addtitle><date>2019-02-01</date><risdate>2019</risdate><volume>98</volume><issue>7</issue><spage>e14479</spage><epage>e14479</epage><pages>e14479-e14479</pages><issn>0025-7974</issn><eissn>1536-5964</eissn><abstract>Poststroke depression is a serious and common complication of stroke, especially the ischemic poststroke depression. Antidepressants are used in poststroke depression, and acupuncture may be an alternative approach. However, the efficacy and mechanism of acupuncture for poststroke depression has not been confirmed.
This is a multicenter, central-randomized, single-blind, sham-controlled clinical trial. We will allocate 208 subjects aged between 40 and 80 years old, diagnosed with initial poststroke depression (PSD) within 6 months to 2 groups randomly in a ratio of 1:1. Patients in the experimental group will be treated with traditional acupuncture and placebo pills, whereas the others in the control group will be treated with sham-acupoints acupuncture and antidepressant (fluoxetine hydrochloride tablets). All will be given acupuncture and/or medication treatment for 12 weeks, and then received 12-week follow-up. Patients will be evaluated with the 17-item Hamilton Depression Scale and Se1f-rating Depression Scale for depression state, National Institute of Health Stroke Scale for neurological deficit, Modified Barthel Index for activities of daily living, Treatment Emergent Symptom Scale for side effects of treatments, diagnosis and evaluation criteria of traditional Chinese medicine for stroke (try out) for curative effects of stroke, and clinical global impression for synthesize effect before and the 2nd, 4th, 8th, and 12th week of treatment, 24th week of follow-up. Study on mechanisms of acupuncture will be revealed through the diversity of brain metabolites (choline-containing compounds [Cho], N-acetylaspartate [NAA], myoinositol, glutamine and glutamate complex, creatine [Cr], Cho/Cr, Cho/NAA, Cr/NAA) in bilateral dorsolateral prefrontal cortex and anterior cingulate cortex monitored by proton magnetic resonance spectroscopy, and serum monoamine neurotransmitters (5-hydroxytryptamine, norepinephrine, dopamine) and cytokines (brain-derived neurotrophic factor [BDNF], interleukin [IL]-4, IL-6, IL-10, IL-18, IL-1β, tumor necrosis factor alpha) before and the 12th week of treatment. Baseline characteristics of patients will be summarized by groups and compared with chi-square for categorical variables, and 2-sample t tests or Wilcoxon rank-sum test for the continuous variables. Primary and secondary outcomes according to the measurement times are applicable to univariate repetitive measurement deviation analysis or 2-sample t tests, or Wilcoxon rank-sum test.
The present research is designed to investigate efficacy and mechanism of traditional acupuncture therapy on ischemic PSD, also to explore the correlation between cerebra metabolic and serologic factors, and ischemic PSD. With this research, we are looking forward to find out an appropriate alternative nondrug therapy for PSD people to alleviate the adverse effects and drug dependence caused by antidepressants.</abstract><cop>United States</cop><pub>the Author(s). Published by Wolters Kluwer Health, Inc</pub><pmid>30762770</pmid><doi>10.1097/MD.0000000000014479</doi><oa>free_for_read</oa></addata></record> |
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| ispartof | Medicine (Baltimore), 2019-02, Vol.98 (7), p.e14479-e14479 |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; Wolters Kluwer Open Health; IngentaConnect Free/Open Access Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central; Alma/SFX Local Collection |
| subjects | Activities of Daily Living Acupuncture Therapy - methods Adult Aged Antidepressive Agents - therapeutic use Brain - pathology Cytokines - biosynthesis Depression - drug therapy Depression - etiology Depression - therapy Female Fluoxetine - therapeutic use Humans Male Middle Aged Neurotransmitter Agents - biosynthesis Psychiatric Status Rating Scales Research Design Single-Blind Method Stroke - complications Study Protocol Clinical Trial |
| title | Efficacy and mechanism of acupuncture for ischemic poststroke depression: Study protocol for a multicenter single-blinded randomized sham-controlled trial |
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