Rupi Sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland: A meta-analysis and trial sequential analysis

Objective: To evaluate the efficacy and safety of Rupi Sanjie (RPSJ) capsule plus the conventional surgical operation for treatment of hyperplasia nodule of mammary gland. Methods: A meta-analysis was conducted on randomized controlled trials (RCT) related to RPSJ capsule plus surgical operation...

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Autores principales:	Bao-Yong Lai, Xiao-Hua Pei
Formato:	article
Lenguaje:	EN
Publicado:	Editorial Board of Journal of Hainan Medical University 2021
Materias:	rupi sanjie capsule hyperplasia nodule of mammary gland rcts meta-analysis trial sequential analysis Medicine R
Acceso en línea:	https://doaj.org/article/292465cc1b7d4aff914cb791b3bdc774
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spelling	oai:doaj.org-article:292465cc1b7d4aff914cb791b3bdc7742021-12-01T05:17:32ZRupi Sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland: A meta-analysis and trial sequential analysis1007-1237https://doaj.org/article/292465cc1b7d4aff914cb791b3bdc7742021-10-01T00:00:00Zhttp://www.hnykdxxb.com/PDF/202120/08.pdfhttps://doaj.org/toc/1007-1237Objective: To evaluate the efficacy and safety of Rupi Sanjie (RPSJ) capsule plus the conventional surgical operation for treatment of hyperplasia nodule of mammary gland. Methods: A meta-analysis was conducted on randomized controlled trials (RCT) related to RPSJ capsule plus surgical operation in the treatment of hyperplasia nodule of mammary gland. The methodological quality of eligible RCTs was assessed according to the criteria from the Cochrane Handbook for Systematic Reviews of Interventions. RevMan5.3 and Stata14.0 were used for data analyses. Trial sequential analysis was performed to estimate the sample size of systematic review base on TSA software v0.9. Results: Twenty-two RCTs were totally included in this study, involving 2135 patients. The result showed the clinical recurrence rate of RPSJ capsule plus surgical treatment group was significantly lower than surgical treatment alone group (RR: 0.25, 95%CI [0.17, 0.37], P＜0.01). The clinical cure rate and total effective rate were higher in RPSJ capsule plus surgical treatment group than the conventional surgical treatment group (RR: 1.63, 95%CI [1.46, 1.82], P＜0.01); (RR: 1.29, 95%CI [1.22, 1.37], P ＜0.01). Application of RPSJ capsule decreased the occurrence of adverse events including nausea, vomiting, irregular menstruation, constipation, dizziness, and headache etc. (RR: 0.90, 95%CI [0.54, 1.49], P=0.68). The results of trial sequential analysis demonstrated that the current available data did not reach the expected value. Conclusion: RPSJ capsule plus the conventional surgical treatment was more effective in reducing the clinical recurrence rate, and improving the total clinical effective rate and clinical cure rate, with a decrease in the occurrence of adverse events.Bao-Yong LaiXiao-Hua PeiEditorial Board of Journal of Hainan Medical Universityarticlerupi sanjie capsulehyperplasia nodule of mammary glandrctsmeta-analysistrial sequential analysisMedicineRENJournal of Hainan Medical University, Vol 27, Iss 20, Pp 37-43 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	rupi sanjie capsule hyperplasia nodule of mammary gland rcts meta-analysis trial sequential analysis Medicine R
spellingShingle	rupi sanjie capsule hyperplasia nodule of mammary gland rcts meta-analysis trial sequential analysis Medicine R Bao-Yong Lai Xiao-Hua Pei Rupi Sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland: A meta-analysis and trial sequential analysis
description	Objective: To evaluate the efficacy and safety of Rupi Sanjie (RPSJ) capsule plus the conventional surgical operation for treatment of hyperplasia nodule of mammary gland. Methods: A meta-analysis was conducted on randomized controlled trials (RCT) related to RPSJ capsule plus surgical operation in the treatment of hyperplasia nodule of mammary gland. The methodological quality of eligible RCTs was assessed according to the criteria from the Cochrane Handbook for Systematic Reviews of Interventions. RevMan5.3 and Stata14.0 were used for data analyses. Trial sequential analysis was performed to estimate the sample size of systematic review base on TSA software v0.9. Results: Twenty-two RCTs were totally included in this study, involving 2135 patients. The result showed the clinical recurrence rate of RPSJ capsule plus surgical treatment group was significantly lower than surgical treatment alone group (RR: 0.25, 95%CI [0.17, 0.37], P＜0.01). The clinical cure rate and total effective rate were higher in RPSJ capsule plus surgical treatment group than the conventional surgical treatment group (RR: 1.63, 95%CI [1.46, 1.82], P＜0.01); (RR: 1.29, 95%CI [1.22, 1.37], P ＜0.01). Application of RPSJ capsule decreased the occurrence of adverse events including nausea, vomiting, irregular menstruation, constipation, dizziness, and headache etc. (RR: 0.90, 95%CI [0.54, 1.49], P=0.68). The results of trial sequential analysis demonstrated that the current available data did not reach the expected value. Conclusion: RPSJ capsule plus the conventional surgical treatment was more effective in reducing the clinical recurrence rate, and improving the total clinical effective rate and clinical cure rate, with a decrease in the occurrence of adverse events.
format	article
author	Bao-Yong Lai Xiao-Hua Pei
author_facet	Bao-Yong Lai Xiao-Hua Pei
author_sort	Bao-Yong Lai
title	Rupi Sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland: A meta-analysis and trial sequential analysis
title_short	Rupi Sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland: A meta-analysis and trial sequential analysis
title_full	Rupi Sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland: A meta-analysis and trial sequential analysis
title_fullStr	Rupi Sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland: A meta-analysis and trial sequential analysis
title_full_unstemmed	Rupi Sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland: A meta-analysis and trial sequential analysis
title_sort	rupi sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland: a meta-analysis and trial sequential analysis
publisher	Editorial Board of Journal of Hainan Medical University
publishDate	2021
url	https://doaj.org/article/292465cc1b7d4aff914cb791b3bdc774
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Rupi Sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland: A meta-analysis and trial sequential analysis

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