Multicenter, randomized controlled trial of traditional Japanese medicine, kakkonto with shosaikotokakikyosekko, for mild and moderate coronavirus disease patients

The traditional Japanese (Kampo) medicine, kakkonto with shosaikotokakikyosekko, has antiviral and anti-inflammatory effects. In this randomized trial, patients with mild and moderate coronavirus disease (COVID-19) were randomly allocated to the control group receiving conventional treatment for sym...

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Main Authors: Shin Takayama, Takao Namiki, Ryutaro Arita, Rie Ono, Akiko Kikuchi, Minoru Ohsawa, Natsumi Saito, Satoko Suzuki, Hajime Nakae, Seiichi Kobayashi, Tetsuhiro Yoshino, Tomoaki Ishigami, Koichiro Tanaka, Kotaro Nochioka, Airi Takagi, Masaru Mimura, Takuhiro Yamaguchi, Tadashi Ishii, Akito Hisanaga, Kazuo Mitani, Takashi Ito
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-11-01
Series:Frontiers in Pharmacology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2022.1008946/full
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author Shin Takayama
Takao Namiki
Ryutaro Arita
Rie Ono
Akiko Kikuchi
Minoru Ohsawa
Natsumi Saito
Satoko Suzuki
Hajime Nakae
Seiichi Kobayashi
Tetsuhiro Yoshino
Tomoaki Ishigami
Koichiro Tanaka
Kotaro Nochioka
Airi Takagi
Masaru Mimura
Masaru Mimura
Takuhiro Yamaguchi
Tadashi Ishii
Akito Hisanaga
Kazuo Mitani
Takashi Ito
author_facet Shin Takayama
Takao Namiki
Ryutaro Arita
Rie Ono
Akiko Kikuchi
Minoru Ohsawa
Natsumi Saito
Satoko Suzuki
Hajime Nakae
Seiichi Kobayashi
Tetsuhiro Yoshino
Tomoaki Ishigami
Koichiro Tanaka
Kotaro Nochioka
Airi Takagi
Masaru Mimura
Masaru Mimura
Takuhiro Yamaguchi
Tadashi Ishii
Akito Hisanaga
Kazuo Mitani
Takashi Ito
author_sort Shin Takayama
collection DOAJ
description The traditional Japanese (Kampo) medicine, kakkonto with shosaikotokakikyosekko, has antiviral and anti-inflammatory effects. In this randomized trial, patients with mild and moderate coronavirus disease (COVID-19) were randomly allocated to the control group receiving conventional treatment for symptom relief such as antipyretics and antitussives or the Kampo group receiving mixed extract granules of kakkonto (2.5 g) and shosaikotokakikyosekko (2.5 g) three times a day for 14 days in addition to conventional treatment. The main outcome was the number of days until total symptom relief. The secondary outcome was the number of days until each symptom’s relief and whether the disease progressed to respiratory failure. We enrolled a total of 161 patients (Kampo group, n = 81; control group, n = 80). The results from Kaplan–Meier estimates of symptom relief showed that there are no significant differences between the groups. However, covariate-adjusted cumulative incidence of fever relief considering competitive risk showed that the recovery was significantly faster in the Kampo group than in the control group (HR 1.76, 95% CI 1.03–3.01). Additionally, the risk of disease progression to moderate COVID-19 requiring oxygen inhalation was lower in the Kampo group than in the control group (Risk Difference −0.13, 95% CI −0.27–0.01). No significant drug-related side effects were observed. Kakkonto with shosaikotokakikyosekko is effective for fever relief with suppression of disease progression in COVID-19 patients.Clinical Trial Registration:https://jrct.niph.go.jp/en-latest-detail/jRCTs021200020, identifier [jRCTs021200020]
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spelling doaj.art-479b8d441e994b259618aa6eed0d29482022-12-22T02:28:11ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-11-011310.3389/fphar.2022.10089461008946Multicenter, randomized controlled trial of traditional Japanese medicine, kakkonto with shosaikotokakikyosekko, for mild and moderate coronavirus disease patientsShin Takayama0Takao Namiki1Ryutaro Arita2Rie Ono3Akiko Kikuchi4Minoru Ohsawa5Natsumi Saito6Satoko Suzuki7Hajime Nakae8Seiichi Kobayashi9Tetsuhiro Yoshino10Tomoaki Ishigami11Koichiro Tanaka12Kotaro Nochioka13Airi Takagi14Masaru Mimura15Masaru Mimura16Takuhiro Yamaguchi17Tadashi Ishii18Akito Hisanaga19Kazuo Mitani20Takashi Ito21Department of Education and Support for Regional Medicine (General and Kampo medicine), Tohoku University Hospital, Sendai, JapanDepartment of Japanese-Oriental (Kampo) Medicine, Graduate School of Medicine, Chiba University, Chiba, JapanDepartment of Education and Support for Regional Medicine (General and Kampo medicine), Tohoku University Hospital, Sendai, JapanDepartment of Education and Support for Regional Medicine (General and Kampo medicine), Tohoku University Hospital, Sendai, JapanDepartment of Education and Support for Regional Medicine (General and Kampo medicine), Tohoku University Hospital, Sendai, JapanDepartment of Education and Support for Regional Medicine (General and Kampo medicine), Tohoku University Hospital, Sendai, JapanDepartment of Education and Support for Regional Medicine (General and Kampo medicine), Tohoku University Hospital, Sendai, JapanDepartment of Education and Support for Regional Medicine (General and Kampo medicine), Tohoku University Hospital, Sendai, JapanDepartment of Emergency and Critical Care Medicine, Akita University Graduate School of Medicine, Akita, JapanDepartment of Respiratory Medicine, Japanese Red Cross Ishinomaki Hospital, Ishinomaki, JapanCenter for Kampo Medicine, Keio University School of Medicine, Tokyo, JapanDepartment of Cardiology, Yokohama City University Hospital, Yokohama, JapanDepartment of Traditional Medicine, Faculty of Medicine, Toho University, Tokyo, JapanDepartment of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, JapanClinical Research Data Center, Tohoku University Hospital, Sendai, JapanCenter for Kampo Medicine, Keio University School of Medicine, Tokyo, Japan0Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan1Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, JapanDepartment of Education and Support for Regional Medicine (General and Kampo medicine), Tohoku University Hospital, Sendai, Japan2Hospital Bando, Bando, Japan3Medical Corporation Mitani Family Clinic, Osaka, Japan4Akashi Clinic Kanda, Tokyo, JapanThe traditional Japanese (Kampo) medicine, kakkonto with shosaikotokakikyosekko, has antiviral and anti-inflammatory effects. In this randomized trial, patients with mild and moderate coronavirus disease (COVID-19) were randomly allocated to the control group receiving conventional treatment for symptom relief such as antipyretics and antitussives or the Kampo group receiving mixed extract granules of kakkonto (2.5 g) and shosaikotokakikyosekko (2.5 g) three times a day for 14 days in addition to conventional treatment. The main outcome was the number of days until total symptom relief. The secondary outcome was the number of days until each symptom’s relief and whether the disease progressed to respiratory failure. We enrolled a total of 161 patients (Kampo group, n = 81; control group, n = 80). The results from Kaplan–Meier estimates of symptom relief showed that there are no significant differences between the groups. However, covariate-adjusted cumulative incidence of fever relief considering competitive risk showed that the recovery was significantly faster in the Kampo group than in the control group (HR 1.76, 95% CI 1.03–3.01). Additionally, the risk of disease progression to moderate COVID-19 requiring oxygen inhalation was lower in the Kampo group than in the control group (Risk Difference −0.13, 95% CI −0.27–0.01). No significant drug-related side effects were observed. Kakkonto with shosaikotokakikyosekko is effective for fever relief with suppression of disease progression in COVID-19 patients.Clinical Trial Registration:https://jrct.niph.go.jp/en-latest-detail/jRCTs021200020, identifier [jRCTs021200020]https://www.frontiersin.org/articles/10.3389/fphar.2022.1008946/fullkakkontoshosaikotokakikyosekkoKampo medicinesCOVID-19herbal medicine
spellingShingle Shin Takayama
Takao Namiki
Ryutaro Arita
Rie Ono
Akiko Kikuchi
Minoru Ohsawa
Natsumi Saito
Satoko Suzuki
Hajime Nakae
Seiichi Kobayashi
Tetsuhiro Yoshino
Tomoaki Ishigami
Koichiro Tanaka
Kotaro Nochioka
Airi Takagi
Masaru Mimura
Masaru Mimura
Takuhiro Yamaguchi
Tadashi Ishii
Akito Hisanaga
Kazuo Mitani
Takashi Ito
Multicenter, randomized controlled trial of traditional Japanese medicine, kakkonto with shosaikotokakikyosekko, for mild and moderate coronavirus disease patients
Frontiers in Pharmacology
kakkonto
shosaikotokakikyosekko
Kampo medicines
COVID-19
herbal medicine
title Multicenter, randomized controlled trial of traditional Japanese medicine, kakkonto with shosaikotokakikyosekko, for mild and moderate coronavirus disease patients
title_full Multicenter, randomized controlled trial of traditional Japanese medicine, kakkonto with shosaikotokakikyosekko, for mild and moderate coronavirus disease patients
title_fullStr Multicenter, randomized controlled trial of traditional Japanese medicine, kakkonto with shosaikotokakikyosekko, for mild and moderate coronavirus disease patients
title_full_unstemmed Multicenter, randomized controlled trial of traditional Japanese medicine, kakkonto with shosaikotokakikyosekko, for mild and moderate coronavirus disease patients
title_short Multicenter, randomized controlled trial of traditional Japanese medicine, kakkonto with shosaikotokakikyosekko, for mild and moderate coronavirus disease patients
title_sort multicenter randomized controlled trial of traditional japanese medicine kakkonto with shosaikotokakikyosekko for mild and moderate coronavirus disease patients
topic kakkonto
shosaikotokakikyosekko
Kampo medicines
COVID-19
herbal medicine
url https://www.frontiersin.org/articles/10.3389/fphar.2022.1008946/full
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