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Effect of fire needle therapy on mild-moderate benign prostatic hyperplasia: Protocol for a randomized controlled pilot trial
Benign prostatic hyperplasia (BPH) is the most common non-cancerous disease of the prostate and leads to lower urinary tract symptoms in middle-aged and elderly males. Fire needle therapy could improve the lower urinary tract symptoms associated with mild-moderate BPH in clinical practice. The aim o...
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| Published in: | Medicine (Baltimore) 2020-05, Vol.99 (21), p.e20376-e20376 |
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| Main Authors: | , , , , , , , , , |
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| container_end_page | e20376 |
| container_issue | 21 |
| container_start_page | e20376 |
| container_title | Medicine (Baltimore) |
| container_volume | 99 |
| creator | Zhang, Tao Xun, Yun-Qing Li, Bin Wang, Gui-Ling Wang, Lin-Peng Jia, Lian-Cheng Li, Wei-Guang Liu, Xue-Mei Liu, Hui-Lin Sun, Jing-Qing |
| description | Benign prostatic hyperplasia (BPH) is the most common non-cancerous disease of the prostate and leads to lower urinary tract symptoms in middle-aged and elderly males. Fire needle therapy could improve the lower urinary tract symptoms associated with mild-moderate BPH in clinical practice. The aim of the present pilot study is to assess the preliminary effects of fire needle therapy on mild-moderate BPH.
The present study is a prospective parallel randomized controlled pilot trial. A total of 60 eligible participants will be randomly assigned to a treatment or control group at a 1:1 ratio. The treatment group will receive fire needle therapy and the control group will receive watchful waiting with lifestyle advice and education regarding BPH. Participants will receive intervention for 4 weeks, with a follow-up period of 4 additional weeks. Adverse events will be recorded to assess the safety and tolerability of fire needle therapy for mild-moderate BPH. The primary outcome will be the change in the International Prostate Symptom Score. The secondary outcomes will include the change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device. All outcome measures will be observed at baseline and at 4 and 8 weeks following the beginning of treatment.
The present study will provide evidence of the preliminary effects of fire needle therapy on mild-moderate BPH and indicate an optimal sample size for future studies. |
| doi_str_mv | 10.1097/MD.0000000000020376 |
| format | article |
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The present study is a prospective parallel randomized controlled pilot trial. A total of 60 eligible participants will be randomly assigned to a treatment or control group at a 1:1 ratio. The treatment group will receive fire needle therapy and the control group will receive watchful waiting with lifestyle advice and education regarding BPH. Participants will receive intervention for 4 weeks, with a follow-up period of 4 additional weeks. Adverse events will be recorded to assess the safety and tolerability of fire needle therapy for mild-moderate BPH. The primary outcome will be the change in the International Prostate Symptom Score. The secondary outcomes will include the change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device. All outcome measures will be observed at baseline and at 4 and 8 weeks following the beginning of treatment.
The present study will provide evidence of the preliminary effects of fire needle therapy on mild-moderate BPH and indicate an optimal sample size for future studies.</description><identifier>ISSN: 0025-7974</identifier><identifier>EISSN: 1536-5964</identifier><identifier>DOI: 10.1097/MD.0000000000020376</identifier><identifier>PMID: 32481334</identifier><language>eng</language><publisher>United States: Wolters Kluwer Health</publisher><subject>Acupuncture Therapy ; Adult ; Aged ; Aged, 80 and over ; China ; Clinical Protocols ; Female ; Hot Temperature ; Humans ; Lower Urinary Tract Symptoms - therapy ; Male ; Middle Aged ; Pilot Projects ; Prospective Studies ; Prostatic Hyperplasia - therapy ; Randomized Controlled Trials as Topic - methods ; Study Protocol Clinical Trial ; Treatment Outcome</subject><ispartof>Medicine (Baltimore), 2020-05, Vol.99 (21), p.e20376-e20376</ispartof><rights>Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c310t-b66c34c718455c0539937a156569c18c20b170a660102595fefaacee28c2a71f3</cites><orcidid>0000-0002-8349-9091</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7249880/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7249880/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,733,786,790,891,27957,27958,53827,53829</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32481334$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zhang, Tao</creatorcontrib><creatorcontrib>Xun, Yun-Qing</creatorcontrib><creatorcontrib>Li, Bin</creatorcontrib><creatorcontrib>Wang, Gui-Ling</creatorcontrib><creatorcontrib>Wang, Lin-Peng</creatorcontrib><creatorcontrib>Jia, Lian-Cheng</creatorcontrib><creatorcontrib>Li, Wei-Guang</creatorcontrib><creatorcontrib>Liu, Xue-Mei</creatorcontrib><creatorcontrib>Liu, Hui-Lin</creatorcontrib><creatorcontrib>Sun, Jing-Qing</creatorcontrib><title>Effect of fire needle therapy on mild-moderate benign prostatic hyperplasia: Protocol for a randomized controlled pilot trial</title><title>Medicine (Baltimore)</title><addtitle>Medicine (Baltimore)</addtitle><description>Benign prostatic hyperplasia (BPH) is the most common non-cancerous disease of the prostate and leads to lower urinary tract symptoms in middle-aged and elderly males. Fire needle therapy could improve the lower urinary tract symptoms associated with mild-moderate BPH in clinical practice. The aim of the present pilot study is to assess the preliminary effects of fire needle therapy on mild-moderate BPH.
The present study is a prospective parallel randomized controlled pilot trial. A total of 60 eligible participants will be randomly assigned to a treatment or control group at a 1:1 ratio. The treatment group will receive fire needle therapy and the control group will receive watchful waiting with lifestyle advice and education regarding BPH. Participants will receive intervention for 4 weeks, with a follow-up period of 4 additional weeks. Adverse events will be recorded to assess the safety and tolerability of fire needle therapy for mild-moderate BPH. The primary outcome will be the change in the International Prostate Symptom Score. The secondary outcomes will include the change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device. All outcome measures will be observed at baseline and at 4 and 8 weeks following the beginning of treatment.
The present study will provide evidence of the preliminary effects of fire needle therapy on mild-moderate BPH and indicate an optimal sample size for future studies.</description><subject>Acupuncture Therapy</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>China</subject><subject>Clinical Protocols</subject><subject>Female</subject><subject>Hot Temperature</subject><subject>Humans</subject><subject>Lower Urinary Tract Symptoms - therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pilot Projects</subject><subject>Prospective Studies</subject><subject>Prostatic Hyperplasia - therapy</subject><subject>Randomized Controlled Trials as Topic - methods</subject><subject>Study Protocol Clinical Trial</subject><subject>Treatment Outcome</subject><issn>0025-7974</issn><issn>1536-5964</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNpdUctuFTEMjRCI3ha-AAllyWZKMnnNsEBCbSlIrWAB68g34_QGZSZDkot0kfh3glrKwxtbx_bx4xDyjLNTzkbz8vr8lP2xngmjH5ANV0J3atTyIdk0VHVmNPKIHJfyhTEuTC8fkyPRy4ELITfkx4X36CpNnvqQkS6IU0Rad5hhPdC00DnEqZvT1ICKdItLuFnomlOpUIOju8OKeY1QAryiH3OqyaVIfcoUaIZlSnP4jhN1aak5xdjCNcRUac0B4hPyyEMs-PTOn5DPby8-nb3rrj5cvj97c9U5wVnttlo7IZ3hg1TKMSXGURjgSis9Oj64nm25YaA14-3iUXn0AA6xbykw3IsT8vqWd91vZ5wctmUg2jWHGfLBJgj238wSdvYmfbPtXeMwsEbw4o4gp697LNXOoTiMERZM-2J7yYZBajaoVipuS137Ucno78dwZn8JZ6_P7f_Cta7nf2943_NbKfET6u-WDg</recordid><startdate>20200522</startdate><enddate>20200522</enddate><creator>Zhang, Tao</creator><creator>Xun, Yun-Qing</creator><creator>Li, Bin</creator><creator>Wang, Gui-Ling</creator><creator>Wang, Lin-Peng</creator><creator>Jia, Lian-Cheng</creator><creator>Li, Wei-Guang</creator><creator>Liu, Xue-Mei</creator><creator>Liu, Hui-Lin</creator><creator>Sun, Jing-Qing</creator><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>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-8349-9091</orcidid></search><sort><creationdate>20200522</creationdate><title>Effect of fire needle therapy on mild-moderate benign prostatic hyperplasia: Protocol for a randomized controlled pilot trial</title><author>Zhang, Tao ; Xun, Yun-Qing ; Li, Bin ; Wang, Gui-Ling ; Wang, Lin-Peng ; Jia, Lian-Cheng ; Li, Wei-Guang ; Liu, Xue-Mei ; Liu, Hui-Lin ; Sun, Jing-Qing</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c310t-b66c34c718455c0539937a156569c18c20b170a660102595fefaacee28c2a71f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Acupuncture Therapy</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>China</topic><topic>Clinical Protocols</topic><topic>Female</topic><topic>Hot Temperature</topic><topic>Humans</topic><topic>Lower Urinary Tract Symptoms - therapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pilot Projects</topic><topic>Prospective Studies</topic><topic>Prostatic Hyperplasia - therapy</topic><topic>Randomized Controlled Trials as Topic - methods</topic><topic>Study Protocol Clinical Trial</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhang, Tao</creatorcontrib><creatorcontrib>Xun, Yun-Qing</creatorcontrib><creatorcontrib>Li, Bin</creatorcontrib><creatorcontrib>Wang, Gui-Ling</creatorcontrib><creatorcontrib>Wang, Lin-Peng</creatorcontrib><creatorcontrib>Jia, Lian-Cheng</creatorcontrib><creatorcontrib>Li, Wei-Guang</creatorcontrib><creatorcontrib>Liu, Xue-Mei</creatorcontrib><creatorcontrib>Liu, Hui-Lin</creatorcontrib><creatorcontrib>Sun, Jing-Qing</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</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>Zhang, Tao</au><au>Xun, Yun-Qing</au><au>Li, Bin</au><au>Wang, Gui-Ling</au><au>Wang, Lin-Peng</au><au>Jia, Lian-Cheng</au><au>Li, Wei-Guang</au><au>Liu, Xue-Mei</au><au>Liu, Hui-Lin</au><au>Sun, Jing-Qing</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of fire needle therapy on mild-moderate benign prostatic hyperplasia: Protocol for a randomized controlled pilot trial</atitle><jtitle>Medicine (Baltimore)</jtitle><addtitle>Medicine (Baltimore)</addtitle><date>2020-05-22</date><risdate>2020</risdate><volume>99</volume><issue>21</issue><spage>e20376</spage><epage>e20376</epage><pages>e20376-e20376</pages><issn>0025-7974</issn><eissn>1536-5964</eissn><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><abstract>Benign prostatic hyperplasia (BPH) is the most common non-cancerous disease of the prostate and leads to lower urinary tract symptoms in middle-aged and elderly males. Fire needle therapy could improve the lower urinary tract symptoms associated with mild-moderate BPH in clinical practice. The aim of the present pilot study is to assess the preliminary effects of fire needle therapy on mild-moderate BPH.
The present study is a prospective parallel randomized controlled pilot trial. A total of 60 eligible participants will be randomly assigned to a treatment or control group at a 1:1 ratio. The treatment group will receive fire needle therapy and the control group will receive watchful waiting with lifestyle advice and education regarding BPH. Participants will receive intervention for 4 weeks, with a follow-up period of 4 additional weeks. Adverse events will be recorded to assess the safety and tolerability of fire needle therapy for mild-moderate BPH. The primary outcome will be the change in the International Prostate Symptom Score. The secondary outcomes will include the change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device. All outcome measures will be observed at baseline and at 4 and 8 weeks following the beginning of treatment.
The present study will provide evidence of the preliminary effects of fire needle therapy on mild-moderate BPH and indicate an optimal sample size for future studies.</abstract><cop>United States</cop><pub>Wolters Kluwer Health</pub><pmid>32481334</pmid><doi>10.1097/MD.0000000000020376</doi><orcidid>https://orcid.org/0000-0002-8349-9091</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Medicine (Baltimore), 2020-05, Vol.99 (21), p.e20376-e20376 |
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| language | eng |
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| source | LWW Online; IngentaConnect Journals; PubMed Central |
| subjects | Acupuncture Therapy Adult Aged Aged, 80 and over China Clinical Protocols Female Hot Temperature Humans Lower Urinary Tract Symptoms - therapy Male Middle Aged Pilot Projects Prospective Studies Prostatic Hyperplasia - therapy Randomized Controlled Trials as Topic - methods Study Protocol Clinical Trial Treatment Outcome |
| title | Effect of fire needle therapy on mild-moderate benign prostatic hyperplasia: Protocol for a randomized controlled pilot trial |
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