Efficacy and Safety of Ningmitai Capsules in Patients with Chronic Epididymitis: A Prospective, Parallel Randomized Controlled Clinical Trial
Objectives. To evaluate the efficacy and safety of Ningmitai (NMT) capsules in patients with chronic epididymitis. Methods. This prospective randomized controlled trial included 112 patients diagnosed with chronic epididymitis. The patients were randomized (1 : 1 : 1) to receive levofloxacin (LVX),...
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| creator | Jing, Zhang Liying, Guan Zhenqing, Wang Hui, Zhang Shuai, Liu Dingqi, Sun Qiang, Fu Keqin, Zhang |
| description | Objectives. To evaluate the efficacy and safety of Ningmitai (NMT) capsules in patients with chronic epididymitis. Methods. This prospective randomized controlled trial included 112 patients diagnosed with chronic epididymitis. The patients were randomized (1 : 1 : 1) to receive levofloxacin (LVX), NMT, or NMT combined with LVX for 4 weeks. The patients were followed up at 2 and 4 weeks after initiation of treatment and were evaluated in terms of Chronic Epididymitis Symptom Index (CESI) scores, epididymal nodules, and safety parameters. The primary endpoints were the CESI scores at the end of 2 and 4 weeks of treatment. The secondary endpoints included the mean epididymal nodule diameter and the clinical efficacy rate. Safety was evaluated by hepatorenal function tests and adverse event reports during the trial. Results. After 2 weeks of treatment, the CESI score of the NMT group was significantly lower than that of the LVX group (P |
| doi_str_mv | 10.1155/2021/9752592 |
| format | Article |
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To evaluate the efficacy and safety of Ningmitai (NMT) capsules in patients with chronic epididymitis. Methods. This prospective randomized controlled trial included 112 patients diagnosed with chronic epididymitis. The patients were randomized (1 : 1 : 1) to receive levofloxacin (LVX), NMT, or NMT combined with LVX for 4 weeks. The patients were followed up at 2 and 4 weeks after initiation of treatment and were evaluated in terms of Chronic Epididymitis Symptom Index (CESI) scores, epididymal nodules, and safety parameters. The primary endpoints were the CESI scores at the end of 2 and 4 weeks of treatment. The secondary endpoints included the mean epididymal nodule diameter and the clinical efficacy rate. Safety was evaluated by hepatorenal function tests and adverse event reports during the trial. Results. After 2 weeks of treatment, the CESI score of the NMT group was significantly lower than that of the LVX group (P<0.05). In addition, the clinical efficacy rate of the NMT group was significantly higher than that of the LVX group (55% vs. 8.33%, P<0.0001), indicating that NMT has a rapid effect on chronic epididymitis. After 4 weeks of treatment, there was no significant difference in CESI scores or clinical efficacy rates between the two monotherapy regimens (P>0.05); however, the mean diameter of epididymal nodules was significantly smaller in the NMT group than in the LVX group (P<0.0001). Moreover, after 4 weeks of treatment, the patients in the LVX + NMT group, which had a clinical efficacy rate of 97.22%, had lower CESI scores (both P<0.01) and a smaller epididymal nodule diameter (vs. LVX, P<0.0001; vs. NMT, P<0.05) than those in the other two groups. No adverse events or abnormal hepatorenal function were found during the study. Conclusion. NMT significantly improved CESI scores and epididymal nodule diameter in patients with chronic epididymitis. The combination of NMT and LVX provides a much better effect than monotherapy, and this treatment regimen was well tolerated.]]></description><identifier>ISSN: 1741-427X</identifier><identifier>EISSN: 1741-4288</identifier><identifier>DOI: 10.1155/2021/9752592</identifier><identifier>PMID: 33854561</identifier><language>eng</language><publisher>United States: Hindawi</publisher><subject>Adverse events ; Antibiotics ; Chronic illnesses ; Clinical medicine ; Clinical trials ; Disease ; Epididymitis ; Levofloxacin ; Mental disorders ; Pain ; Patients ; Safety ; Software ; Ultrasonic imaging ; Urogenital system ; Variance analysis</subject><ispartof>Evidence-based complementary and alternative medicine, 2021, Vol.2021, p.9752592-6</ispartof><rights>Copyright © 2021 Zhang Jing et al.</rights><rights>Copyright © 2021 Zhang Jing et al. This is an open access article distributed under the Creative Commons Attribution License (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. https://creativecommons.org/licenses/by/4.0</rights><rights>Copyright © 2021 Zhang Jing et al. 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c448t-7fea0369e87415bd6ad678d170be75011d6677f976a5821cfed4cdc4f899db573</citedby><cites>FETCH-LOGICAL-c448t-7fea0369e87415bd6ad678d170be75011d6677f976a5821cfed4cdc4f899db573</cites><orcidid>0000-0002-3476-6480 ; 0000-0002-6596-5052</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/PMC8021469/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8021469/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,4024,27923,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33854561$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Andrade-Cetto, Adolfo</contributor><contributor>Adolfo Andrade-Cetto</contributor><creatorcontrib>Jing, Zhang</creatorcontrib><creatorcontrib>Liying, Guan</creatorcontrib><creatorcontrib>Zhenqing, Wang</creatorcontrib><creatorcontrib>Hui, Zhang</creatorcontrib><creatorcontrib>Shuai, Liu</creatorcontrib><creatorcontrib>Dingqi, Sun</creatorcontrib><creatorcontrib>Qiang, Fu</creatorcontrib><creatorcontrib>Keqin, Zhang</creatorcontrib><title>Efficacy and Safety of Ningmitai Capsules in Patients with Chronic Epididymitis: A Prospective, Parallel Randomized Controlled Clinical Trial</title><title>Evidence-based complementary and alternative medicine</title><addtitle>Evid Based Complement Alternat Med</addtitle><description><![CDATA[Objectives. To evaluate the efficacy and safety of Ningmitai (NMT) capsules in patients with chronic epididymitis. Methods. This prospective randomized controlled trial included 112 patients diagnosed with chronic epididymitis. The patients were randomized (1 : 1 : 1) to receive levofloxacin (LVX), NMT, or NMT combined with LVX for 4 weeks. The patients were followed up at 2 and 4 weeks after initiation of treatment and were evaluated in terms of Chronic Epididymitis Symptom Index (CESI) scores, epididymal nodules, and safety parameters. The primary endpoints were the CESI scores at the end of 2 and 4 weeks of treatment. The secondary endpoints included the mean epididymal nodule diameter and the clinical efficacy rate. Safety was evaluated by hepatorenal function tests and adverse event reports during the trial. Results. After 2 weeks of treatment, the CESI score of the NMT group was significantly lower than that of the LVX group (P<0.05). In addition, the clinical efficacy rate of the NMT group was significantly higher than that of the LVX group (55% vs. 8.33%, P<0.0001), indicating that NMT has a rapid effect on chronic epididymitis. After 4 weeks of treatment, there was no significant difference in CESI scores or clinical efficacy rates between the two monotherapy regimens (P>0.05); however, the mean diameter of epididymal nodules was significantly smaller in the NMT group than in the LVX group (P<0.0001). Moreover, after 4 weeks of treatment, the patients in the LVX + NMT group, which had a clinical efficacy rate of 97.22%, had lower CESI scores (both P<0.01) and a smaller epididymal nodule diameter (vs. LVX, P<0.0001; vs. NMT, P<0.05) than those in the other two groups. No adverse events or abnormal hepatorenal function were found during the study. Conclusion. NMT significantly improved CESI scores and epididymal nodule diameter in patients with chronic epididymitis. The combination of NMT and LVX provides a much better effect than monotherapy, and this treatment regimen was well tolerated.]]></description><subject>Adverse events</subject><subject>Antibiotics</subject><subject>Chronic illnesses</subject><subject>Clinical medicine</subject><subject>Clinical trials</subject><subject>Disease</subject><subject>Epididymitis</subject><subject>Levofloxacin</subject><subject>Mental disorders</subject><subject>Pain</subject><subject>Patients</subject><subject>Safety</subject><subject>Software</subject><subject>Ultrasonic imaging</subject><subject>Urogenital system</subject><subject>Variance analysis</subject><issn>1741-427X</issn><issn>1741-4288</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>RHX</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kV1rFDEUhgdRbK3eeS0BbwS7NslMJhkvhDKsH1C0aAXvQjYf3VMyyZjMtKz_wf9sll0X9cKrHJIn7znveavqKcGvCGHsjGJKzjrOKOvoveqY8IYsGirE_UPNvx1Vj3K-wZh2nPOH1VFdC9awlhxXP5fOgVZ6g1Qw6Itydtqg6NBHCNcDTApQr8Y8e5sRBHSpJrBhyugOpjXq1ykG0Gg5ggGzKTjk1-gcXaaYR6snuLWn5UtS3luPPpcGcYAf1qA-hinFcltKD0VCeXSVQPnH1QOnfLZP9udJ9fXt8qp_v7j49O5Df36x0E0jpgV3VuG67awoBtnKtMq0XBjC8cpyhgkxbcu563irmKBEO2sabXTjRNeZFeP1SfVmpzvOq8EaXTyVKeWYYFBpI6MC-fdLgLW8jrdSlGU3bVcEXuwFUvw-2zzJAbK23qtg45wlZaSmDeeEFPT5P-hNnFMo9rYU7hhnbCt4uqN0WV5O1h2GIVhuc5bbnOU-54I_-9PAAf4dbAFe7oA1BKPu4P9yvwA6_LIC</recordid><startdate>2021</startdate><enddate>2021</enddate><creator>Jing, Zhang</creator><creator>Liying, Guan</creator><creator>Zhenqing, Wang</creator><creator>Hui, Zhang</creator><creator>Shuai, Liu</creator><creator>Dingqi, Sun</creator><creator>Qiang, Fu</creator><creator>Keqin, Zhang</creator><general>Hindawi</general><general>Hindawi Limited</general><scope>RHU</scope><scope>RHW</scope><scope>RHX</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7T5</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88G</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M2M</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-3476-6480</orcidid><orcidid>https://orcid.org/0000-0002-6596-5052</orcidid></search><sort><creationdate>2021</creationdate><title>Efficacy and Safety of Ningmitai Capsules in Patients with Chronic Epididymitis: A Prospective, Parallel Randomized Controlled Clinical Trial</title><author>Jing, Zhang ; Liying, Guan ; Zhenqing, Wang ; Hui, Zhang ; Shuai, Liu ; Dingqi, Sun ; Qiang, Fu ; Keqin, Zhang</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c448t-7fea0369e87415bd6ad678d170be75011d6677f976a5821cfed4cdc4f899db573</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adverse events</topic><topic>Antibiotics</topic><topic>Chronic illnesses</topic><topic>Clinical medicine</topic><topic>Clinical trials</topic><topic>Disease</topic><topic>Epididymitis</topic><topic>Levofloxacin</topic><topic>Mental disorders</topic><topic>Pain</topic><topic>Patients</topic><topic>Safety</topic><topic>Software</topic><topic>Ultrasonic imaging</topic><topic>Urogenital system</topic><topic>Variance analysis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jing, Zhang</creatorcontrib><creatorcontrib>Liying, Guan</creatorcontrib><creatorcontrib>Zhenqing, Wang</creatorcontrib><creatorcontrib>Hui, Zhang</creatorcontrib><creatorcontrib>Shuai, Liu</creatorcontrib><creatorcontrib>Dingqi, Sun</creatorcontrib><creatorcontrib>Qiang, Fu</creatorcontrib><creatorcontrib>Keqin, Zhang</creatorcontrib><collection>Hindawi Publishing Complete</collection><collection>Hindawi Publishing Subscription Journals</collection><collection>Hindawi Publishing Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Immunology Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Psychology Database (Alumni)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Psychology Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Evidence-based complementary and alternative medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jing, Zhang</au><au>Liying, Guan</au><au>Zhenqing, Wang</au><au>Hui, Zhang</au><au>Shuai, Liu</au><au>Dingqi, Sun</au><au>Qiang, Fu</au><au>Keqin, Zhang</au><au>Andrade-Cetto, Adolfo</au><au>Adolfo Andrade-Cetto</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and Safety of Ningmitai Capsules in Patients with Chronic Epididymitis: A Prospective, Parallel Randomized Controlled Clinical Trial</atitle><jtitle>Evidence-based complementary and alternative medicine</jtitle><addtitle>Evid Based Complement Alternat Med</addtitle><date>2021</date><risdate>2021</risdate><volume>2021</volume><spage>9752592</spage><epage>6</epage><pages>9752592-6</pages><issn>1741-427X</issn><eissn>1741-4288</eissn><abstract><![CDATA[Objectives. To evaluate the efficacy and safety of Ningmitai (NMT) capsules in patients with chronic epididymitis. Methods. This prospective randomized controlled trial included 112 patients diagnosed with chronic epididymitis. The patients were randomized (1 : 1 : 1) to receive levofloxacin (LVX), NMT, or NMT combined with LVX for 4 weeks. The patients were followed up at 2 and 4 weeks after initiation of treatment and were evaluated in terms of Chronic Epididymitis Symptom Index (CESI) scores, epididymal nodules, and safety parameters. The primary endpoints were the CESI scores at the end of 2 and 4 weeks of treatment. The secondary endpoints included the mean epididymal nodule diameter and the clinical efficacy rate. Safety was evaluated by hepatorenal function tests and adverse event reports during the trial. Results. After 2 weeks of treatment, the CESI score of the NMT group was significantly lower than that of the LVX group (P<0.05). In addition, the clinical efficacy rate of the NMT group was significantly higher than that of the LVX group (55% vs. 8.33%, P<0.0001), indicating that NMT has a rapid effect on chronic epididymitis. After 4 weeks of treatment, there was no significant difference in CESI scores or clinical efficacy rates between the two monotherapy regimens (P>0.05); however, the mean diameter of epididymal nodules was significantly smaller in the NMT group than in the LVX group (P<0.0001). Moreover, after 4 weeks of treatment, the patients in the LVX + NMT group, which had a clinical efficacy rate of 97.22%, had lower CESI scores (both P<0.01) and a smaller epididymal nodule diameter (vs. LVX, P<0.0001; vs. NMT, P<0.05) than those in the other two groups. No adverse events or abnormal hepatorenal function were found during the study. Conclusion. NMT significantly improved CESI scores and epididymal nodule diameter in patients with chronic epididymitis. The combination of NMT and LVX provides a much better effect than monotherapy, and this treatment regimen was well tolerated.]]></abstract><cop>United States</cop><pub>Hindawi</pub><pmid>33854561</pmid><doi>10.1155/2021/9752592</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0002-3476-6480</orcidid><orcidid>https://orcid.org/0000-0002-6596-5052</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Evidence-based complementary and alternative medicine, 2021, Vol.2021, p.9752592-6 |
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| source | PubMed Central Open Access; EZB-FREE-00999 freely available EZB journals; Wiley Online Library (Open Access Collection); PubMed Central; Alma/SFX Local Collection |
| subjects | Adverse events Antibiotics Chronic illnesses Clinical medicine Clinical trials Disease Epididymitis Levofloxacin Mental disorders Pain Patients Safety Software Ultrasonic imaging Urogenital system Variance analysis |
| title | Efficacy and Safety of Ningmitai Capsules in Patients with Chronic Epididymitis: A Prospective, Parallel Randomized Controlled Clinical Trial |
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