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

ABSTRACT: 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].

SUBMITTER: Takayama S

PROVIDER: S-EPMC9682103 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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

Takayama Shin S Namiki Takao T Arita Ryutaro R Ono Rie R Kikuchi Akiko A Ohsawa Minoru M Saito Natsumi N Suzuki Satoko S Nakae Hajime H Kobayashi Seiichi S Yoshino Tetsuhiro T Ishigami Tomoaki T Tanaka Koichiro K Nochioka Kotaro K Takagi Airi A Mimura Masaru M Yamaguchi Takuhiro T Ishii Tadashi T Hisanaga Akito A Mitani Kazuo K Ito Takashi T

Frontiers in pharmacology 20221109

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 t ...[more]

PMID: 36438822

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Project description:BackgroundHearing loss is a growing health concern worldwide. Hearing aids (HAs) are the treatment of choice for hearing rehabilitation in most cases of mild-to-moderate hearing loss. However, many patients with hearing loss do not use HAs due to their high cost, stigma, and inaccessibility. Since smartphones are widely used, many apps that mimic the amplification function of HAs have been introduced. Smartphone-based HA apps (SHAAs) are affordable and easy to access. However, the audiological benefit of SHAAs has not been determined.ObjectiveWe compared the audiological performance between an SHAA and a conventional HA in a prospective, multicenter randomized controlled trial.MethodsPatients with mild-to-moderate hearing loss were prospectively enrolled from 2 tertiary hospitals and randomly assigned to either an SHAA (Petralex; IT4YOU Corp LLC) or a conventional HA (Siya 1 miniRITE; Oticon A/S). For the cross-over study design, participants used the alternate device and repeated the same 2-month trial. Audiological measurements were obtained using hearing tests, real-ear measurements, and the hearing-in-noise test (HINT). Subjective satisfaction was evaluated using the Abbreviated Profile of Hearing Aid Benefit (APHAB) and International Outcome Inventory for Hearing Aids (IOI-HA).ResultsOverall, 63 participants were screened and 38 completed the study. In sound-field audiometry testing, the SHAA showed a 20- to 60-dB gain in the low-to-high frequencies of the hearing threshold level. The HA provided adequate gain in the middle-to-high frequencies (55, 65, and 75 dB in real-ear measurements), which is the sound level for most speaking volumes. However, the SHAA could not improve word recognition at 50 dB. The HA showed better audiological performance than the SHAA in both quiet and noisy conditions in the HINT. The IOI-HA scores were significantly improved by both the HA and SHAA versus unaided conditions. Among the SHAA users, 37% (14/38), 42% (16/38), 24% (9/38), and 32% (12/38) showed improvement in APHAB scores for ease of communication, reverberation, background noise, and aversiveness of sounds, respectively. There were no differences in adverse events between the 2 study groups.ConclusionsThe HA showed better performance than the SHAA in word recognition and the HINT. However, the SHAA was significantly better than unaided hearing in terms of amplification. The SHAA may be a useful hearing assistance device for patients with mild-to-moderate hearing loss when listening to soft sounds in quiet conditions. The SHAA demonstrated poorer performance than the HA in the mid- to high-frequency sounds that are important for word recognition, sound quality, and hearing in noisy conditions. Further development of the signal technology of SHAAs is needed to improve the sound quality of mid- to high-frequency sounds and overcome noisy environments.

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Dataset Information

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

Publications

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

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