Evidence map›Paper›PMID 36434692›Full record

Trial reportBMC complementary medicine and therapies2022

Randomized double-blind placebo-controlled multicenter trial for the effects of a polyherbal remedy, Yokukansan (YiganSan), in smokers with depressive tendencies.

Maki Komiyama, Yuka Ozaki, Hiromichi Wada, Hajime Yamakage, Noriko Satoh-Asahara, Akihiro Yasoda, Yoichi Sunagawa, Tatsuya Morimoto, Shinji Tamaki, Masahiro Suzuki and 6 more

Open access · goldAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC complementary medicine and therapies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 1 country.

Maki KomiyamaClinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-Cho, Fukakusa, Fushimi-Ku, Kyoto, 612-8555, Japan.
Yuka OzakiClinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-Cho, Fukakusa, Fushimi-Ku, Kyoto, 612-8555, Japan.
Hiromichi WadaClinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-Cho, Fukakusa, Fushimi-Ku, Kyoto, 612-8555, Japan.
Hajime YamakageClinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-Cho, Fukakusa, Fushimi-Ku, Kyoto, 612-8555, Japan.
Noriko Satoh-AsaharaClinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-Cho, Fukakusa, Fushimi-Ku, Kyoto, 612-8555, Japan.
Akihiro YasodaClinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-Cho, Fukakusa, Fushimi-Ku, Kyoto, 612-8555, Japan.
Yoichi SunagawaDivision of Molecular Medicine, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.
Tatsuya MorimotoDivision of Molecular Medicine, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.
Shinji TamakiNational Hospital Organization NaraMedical Center, Nara, Japan.
Masahiro SuzukiDepartment of Clinical Research, National Hospital Organization Saitama Hospital, Saitama, Japan.
Takuo ShibayamaDepartment of Respiratory Medicine, National Hospital Organization OkayamaMedical Center, Okayama, Japan.
Toru KatoDepartment of Clinical Research, National Hospital Organization TochigiMedical Center, Tochigi, Japan.
Yasumasa OkadaDivision of Internal Medicine and Laboratory of Electrophysiology, Murayama Medical Center, Tokyo, Japan.
Toshiyuki KitaDepartment of Respiratory Medicine, National Hospital OrganizationKanazawa Medical Center, Kanazawa, Japan.
Yuko TakahashiClinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-Cho, Fukakusa, Fushimi-Ku, Kyoto, 612-8555, Japan.
Koji HasegawaClinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-Cho, Fukakusa, Fushimi-Ku, Kyoto, 612-8555, Japan. koj@kuhp.kyoto-u.ac.jp.ORCID http://orcid.org/0000-0001-7618-4043
Kyoto Medical Center · JPNational Hospital Organization · JPUniversity of Shizuoka · JPKanazawa Medical Center · JPMurayama Medical Center · JPNara City Hospital · JP

Funding

National Hospital Organization Grant-in-Aid for Clinical Research
6 · The paper itself

Abstract

backgroundSmoking and depression are closely related and form a vicious cycle. Yokukansan (YiganSan) is a polyherbal remedy that has the effect of calming neuropsychiatric symptoms such as anger and irritation. To examine the efficacy of Yokukansan during smoking cessation (SC) therapy in smokers with depressive tendencies but without major depressive disorders requiring pharmacotherapy.

methodsA multicenter, double-blind, randomized, placebo-controlled, parallel-group comparison trial was conducted between June 2016 and May 2020 at 12 centers of the National Hospital Organization, Japan. This trial targeted smokers who first visited the SC outpatient clinics, did not receive any pharmacological treatment at the psychiatric or psychosomatic department, and scored 39 or more on the self-rating depression scale (SDS). Participants (n = 198) were randomly assigned to either the Yokukansan or placebo groups. The trial drug was initiated with the start of the SC treatment and continued for 12 weeks. The primary outcome was the high success rate of the SC treatment, and the secondary outcomes included changes in scores of the SDS and the Profile of Mood States (POMS) instrument.

resultsThe success rate of the SC treatment was similar between the placebo (63%) and Yokukansan (67%) groups (P = .649). The SDS scores (placebo: mean difference [MD] = -3.5, 95% confidence interval [CI][-5.8, -1.2], d = 0.42; Yokukansan: MD = -4.6, 95%CI[-6.8, -2.3], d = 0.55), and the "tension-anxiety" POMS-subscale scores (placebo: MD = -1.6, 95%CI[-2.5, -0.7], d = 0.52; Yokukansan: MD = -1.6, 95%CI[-2.9, -0.3], d = 0.36) showed significant improvement in both groups after the SC treatment. However, "depression-dejection" improved in the Yokukansan group (MD = -1.9, 95%CI[-3.1, -0.7], d = 0.44) but not in the placebo group (MD = -0.1, 95%CI[-1.0, 0.7], d = 0.04). Significant improvement in "fatigue" was noted in the Yokukansan group (MD = -2.1, 95%CI[-3.4, -0.9], d = 0.47) but not in the placebo group (MD = -0.5, 95%CI[-1.8, 0.8], d = 0.11). The time × group interaction on the improvement in "depression-dejection" was significant (P = .019).

conclusionsYokukansan does not increase the SC treatment's success rate but has additional positive effects on the psychological states due to the SC treatment in smokers with depressive tendencies but without apparent mental disorders.

trial registrationID: UMIN000027036. Retrospectively registered at UMIN on April 18, 2017.

Indexed as

Drugs, Chinese HerbalMajor Depressive DisorderDouble-Blind MethodHumansSmokersDrugs, Chinese HerbalYi-Gan SanProfile of moods states (POMS)Psychological effectsSelf-rating depression scale (SDS)

Identifiers

PMID36434692
PMCPMC9701004
OpenAlexW4310051333

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.