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A double-blind, randomized, placebo-controlled, single-center clinical trial of jiaotaiwan for the treatment of insomnia symptoms caused by disharmony of the heart and kidney

Background: Jiaotaiwan (JTW) is a classical tranquillizing prescription in traditional Chinese medicine (TCM) for the treatment of insomnia symptoms caused by disharmony of the heart and kidney (ISDHK). This study aimed to evaluate the effectiveness and safety of JTW for treating ISDHK in a double-b...

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Autores principales: Xia, Nengzhi, Jiang, Chengrou, Zhou, Yiwei, Huang, Qun, Hu, Lufeng, Zeng, Haihuan, Luo, Lin, Yuan, Zhengzhong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9672088/
https://www.ncbi.nlm.nih.gov/pubmed/36408238
http://dx.doi.org/10.3389/fphar.2022.1011003
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author Xia, Nengzhi
Jiang, Chengrou
Zhou, Yiwei
Huang, Qun
Hu, Lufeng
Zeng, Haihuan
Luo, Lin
Yuan, Zhengzhong
author_facet Xia, Nengzhi
Jiang, Chengrou
Zhou, Yiwei
Huang, Qun
Hu, Lufeng
Zeng, Haihuan
Luo, Lin
Yuan, Zhengzhong
author_sort Xia, Nengzhi
collection PubMed
description Background: Jiaotaiwan (JTW) is a classical tranquillizing prescription in traditional Chinese medicine (TCM) for the treatment of insomnia symptoms caused by disharmony of the heart and kidney (ISDHK). This study aimed to evaluate the effectiveness and safety of JTW for treating ISDHK in a double-blind, randomized, placebo-controlled trial. Methods: From September 2018 to February 2020, 128 participants with ISDHK were included in this single-center clinical trial. All participants were equally and randomly divided into either the JTW group (2-g JTW granules, b.i.d. for 7 days) or placebo group (2-g placebo granules, b.i.d. for 7 days). Pittsburgh Sleep Quality Index (PSQI) scores were set as the primary outcome, and polysomnography (PSG), (1)H-magnetic resonance spectroscopy ((1)H-MRS), blood tests, and Disharmony of Heart and Kidney Scoring System (DHKSS) and clinical global impression (CGI) scores were used as secondary outcomes. Laboratory tests were used to evaluate the safety of JTW. All data were collected at baseline and posttreatment. Results: A total of 106 participants completed this clinical trial. Symptom relief was more apparent in the JTW group than the placebo group (PSQI total score: 9.34 ± 3.578 vs. 10.98 ± 3.073, respectively; p = 0.006). However, no PSG changes were observed between the two groups (p > 0.05). Higher CGI and lower DHKSS scores were observed after JTW treatment. Serum melatonin was increased in patients with ISDHK after JTW treatment (JTW, 339.09 ± 256.894 vs. placebo, 219.59 ± 169.045; p = 0.004). There were significant posttreatment differences in metabolites in the left cerebellum between the two groups (myoinositol: JTW, 13.47 ± 2.094 vs. placebo, 12.48 ± 2.449; p = 0.021; choline: JTW, 3.96 ± 0.657 vs. placebo, 3.65 ± 0.562; p = 0.008). In terms of safety, JTW had no noticeable adverse effects relative to placebo. Conclusion: JTW was effective and well tolerated for the treatment of ISDHK. The development of large-scale trials with longer follow-up durations is recommended to provide further evidence. Clinical Trial Registration: clinicaltrials.gov, identifier ChiCTR1800019239
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spelling pubmed-96720882022-11-19 A double-blind, randomized, placebo-controlled, single-center clinical trial of jiaotaiwan for the treatment of insomnia symptoms caused by disharmony of the heart and kidney Xia, Nengzhi Jiang, Chengrou Zhou, Yiwei Huang, Qun Hu, Lufeng Zeng, Haihuan Luo, Lin Yuan, Zhengzhong Front Pharmacol Pharmacology Background: Jiaotaiwan (JTW) is a classical tranquillizing prescription in traditional Chinese medicine (TCM) for the treatment of insomnia symptoms caused by disharmony of the heart and kidney (ISDHK). This study aimed to evaluate the effectiveness and safety of JTW for treating ISDHK in a double-blind, randomized, placebo-controlled trial. Methods: From September 2018 to February 2020, 128 participants with ISDHK were included in this single-center clinical trial. All participants were equally and randomly divided into either the JTW group (2-g JTW granules, b.i.d. for 7 days) or placebo group (2-g placebo granules, b.i.d. for 7 days). Pittsburgh Sleep Quality Index (PSQI) scores were set as the primary outcome, and polysomnography (PSG), (1)H-magnetic resonance spectroscopy ((1)H-MRS), blood tests, and Disharmony of Heart and Kidney Scoring System (DHKSS) and clinical global impression (CGI) scores were used as secondary outcomes. Laboratory tests were used to evaluate the safety of JTW. All data were collected at baseline and posttreatment. Results: A total of 106 participants completed this clinical trial. Symptom relief was more apparent in the JTW group than the placebo group (PSQI total score: 9.34 ± 3.578 vs. 10.98 ± 3.073, respectively; p = 0.006). However, no PSG changes were observed between the two groups (p > 0.05). Higher CGI and lower DHKSS scores were observed after JTW treatment. Serum melatonin was increased in patients with ISDHK after JTW treatment (JTW, 339.09 ± 256.894 vs. placebo, 219.59 ± 169.045; p = 0.004). There were significant posttreatment differences in metabolites in the left cerebellum between the two groups (myoinositol: JTW, 13.47 ± 2.094 vs. placebo, 12.48 ± 2.449; p = 0.021; choline: JTW, 3.96 ± 0.657 vs. placebo, 3.65 ± 0.562; p = 0.008). In terms of safety, JTW had no noticeable adverse effects relative to placebo. Conclusion: JTW was effective and well tolerated for the treatment of ISDHK. The development of large-scale trials with longer follow-up durations is recommended to provide further evidence. Clinical Trial Registration: clinicaltrials.gov, identifier ChiCTR1800019239 Frontiers Media S.A. 2022-11-04 /pmc/articles/PMC9672088/ /pubmed/36408238 http://dx.doi.org/10.3389/fphar.2022.1011003 Text en Copyright © 2022 Xia, Jiang, Zhou, Huang, Hu, Zeng, Luo and Yuan. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Xia, Nengzhi
Jiang, Chengrou
Zhou, Yiwei
Huang, Qun
Hu, Lufeng
Zeng, Haihuan
Luo, Lin
Yuan, Zhengzhong
A double-blind, randomized, placebo-controlled, single-center clinical trial of jiaotaiwan for the treatment of insomnia symptoms caused by disharmony of the heart and kidney
title A double-blind, randomized, placebo-controlled, single-center clinical trial of jiaotaiwan for the treatment of insomnia symptoms caused by disharmony of the heart and kidney
title_full A double-blind, randomized, placebo-controlled, single-center clinical trial of jiaotaiwan for the treatment of insomnia symptoms caused by disharmony of the heart and kidney
title_fullStr A double-blind, randomized, placebo-controlled, single-center clinical trial of jiaotaiwan for the treatment of insomnia symptoms caused by disharmony of the heart and kidney
title_full_unstemmed A double-blind, randomized, placebo-controlled, single-center clinical trial of jiaotaiwan for the treatment of insomnia symptoms caused by disharmony of the heart and kidney
title_short A double-blind, randomized, placebo-controlled, single-center clinical trial of jiaotaiwan for the treatment of insomnia symptoms caused by disharmony of the heart and kidney
title_sort double-blind, randomized, placebo-controlled, single-center clinical trial of jiaotaiwan for the treatment of insomnia symptoms caused by disharmony of the heart and kidney
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9672088/
https://www.ncbi.nlm.nih.gov/pubmed/36408238
http://dx.doi.org/10.3389/fphar.2022.1011003
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