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The administration of a third booster dose of messenger ribonucleic acid (mRNA) vaccines against coronavirus disease 2019 (COVID-19) has progressed worldwide. Since January 2022, Japan has faced a nationwide outbreak caused by the Omicron variant, which occurred simultaneously with the progression of mass vaccination with the third booster dose. Therefore, this study evaluated the effectiveness of the third dose of vaccine by reverse transcription-polymerase chain reaction (RT-PCR) test using nasopharyngeal swab samples from adults aged ≥ 18 years tested after having close contact with COVID-19 cases between January and May 2022. Participants who completed only one dose were excluded from the study. Among the 928 enrolled participants, 139 had never been vaccinated, 609 had completed two doses, 180 had completed three doses before the swab test, and the overall RT-PCR test positivity rate in each group was 48.9%, 46.0%, and 32.2%, respectively. The vaccine effectiveness of the third dose to prevent infection after close contact was approximately 40% (95% confidence interval: 20–60%), which was the highest at 10–70 days after receiving the third dose. In conclusion, the effectiveness of the three-dose mRNA COVID-19 vaccine after close contact during the Omicron outbreak is approximately 40%.

Traditional Japanese (Kampo) medicines containing rhubarb rhizome are prescribed for constipation during pregnancy; however, detailed safety information of their use for pregnant women is lacking. The aim of current study was to clarify the association between prescription Kampo-containing rhubarb rhizome (KRR) in the first trimester of pregnancy and congenital malformations in newborns. Using a large Japanese health insurance claims database, we included pregnant women who enrolled the same health insurance society from 3 months before pregnancy to the delivery date, who gave birth between 2010 and 2019, and those with data related to their infants. Pregnant women who were prescribed magnesium oxide (MgO), commonly used for constipation, during the first trimester of pregnancy and their infants were extracted as controls. Associations between KRR prescribed in the first pregnancy trimester and major congenital malformations (MCM) in the infants were examined using multivariate logistic regression analysis. Of 75,398 infants, 4,607 (6.1%) were diagnosed with MCMs within the first year after birth. Furthermore, 9,852 infants were born to women prescribed MgO, among whom 680 (6.9%) had MCMs; 450 infants were born to women prescribed KRR, among whom 28 (6.2%) had MCMs. Multivariate logistic regression analysis identified no difference in MCM risk between the two types of prescriptions [crude odds ratio (OR) 0.895, 95% confidence interval (CI) 0.606–1.322, adjusted OR 0.889, 95% CI 0.599–1.320]. In conclusion, the risk of MCMs did not differ between those prescribed KRR or MgO in the first trimester of pregnancy.

Traditional Japanese (Kampo) medicine containing kernel (KPK) is prescribed for treating menstrual- and pregnancy-related symptoms. However, no safety information is available regarding its use in pregnant women. In this study, we examined the associations of KPK prescriptions during the first trimester of pregnancy with preterm births and major congenital malformations (MCMs) in newborns. From a large-scale Japanese health insurance claims database, we included pregnant women enrolled with the same healthcare insurer from 3 months before pregnancy to the date of delivery, who gave birth between 2010 and 2019, and whose data were linked to their infants. We then selected pregnant women who were prescribed KPK during the first trimester as the exposure group, and those who were prescribed tokishakuyakusan (TSS), commonly used for pregnancy-related symptoms, during the same period as controls. The association between KPK prescriptions and preterm birth or MCM among infants was examined using a multivariate logistic regression analysis. Of the 75,398 infants, TSS and KPK was prescribed to 2,548 (3.38%) and 283 (0.38%) women during the first trimester, respectively. In the TSS group, 311 of 2,491 infants (12.5%) experienced preterm births, whereas 40 of 283 infants (14.1%) in the KPK group experienced preterm births. The risk of preterm birth in the KPK group was not significantly different from that in the TSS group (adjusted risk ratio, 1.122; 95% confidence interval, 0.827-1.521). In the TSS group, 157 of 2,491 infants (6.3%) had MCMs, whereas 15 of 283 infants (5.3%) in the KPK group had MCMs. There was no significant difference in the incidence of MCM in the first year after birth between infants in the KPK and TSS groups (adjusted odds ratio, 0.820; 95% confidence interval, 0.475-1.415). There was no significant difference in the risk of preterm birth or MCMs between pregnant women prescribed KPK and those prescribed TSS during the first trimester.

Background: Olfactory dysfunction is a common symptom in patients with coronavirus disease 2019, and it significantly deteriorates patients’ quality of life. Effective treatments remain unknown. Purpose: To assess the effect of Japanese traditional (Kampo) medicine on coronavirus disease 2019-related olfactory dysfunction. Study Design: Retrospective observational study. Methods: In total, 87 patients aged ≥18 years with coronavirus disease 2019 and severe dysosmia or anosmia (Numeric Rating Scale, ≥7) at isolation facilities in Miyagi Prefecture, Japan, were enrolled from October 2020 to March 2021. Patients were divided into the Kampo group ( N = 52) and the control group ( N = 35) based on the treatment received. Changes in Numeric Rating Scale scores were evaluated at the first visit and 2 weeks after. Results: The median reduction in the olfactory dysfunction score at both 1 and 2 weeks after the first visit was significantly greater in the Kampo group (6 and 8, respectively; p = 0.03) than in the control group (3 and 7, respectively; p = 0.04). We defined improvement in olfactory dysfunction as a median reduction in the olfactory dysfunction score of ≥5. Multiple logistic regression analysis demonstrated that only Kampo treatment was significantly associated with improvement in olfactory dysfunction. Conclusion: This study suggests that Kampo medication promotes early recovery from coronavirus disease 2019-related olfactory dysfunction.

Background. Ninjin’yoeito (NYT), a traditional Japanese (Kampo) medicine that originates from China, has been used to treat qi and blood deficiency based on its original concept. Kampo medicine has been widely used to treat many conditions and disorders combined with western medicine or Kampo medicine alone in modern situation. Aims. We reviewed randomized controlled trials (RCTs) of NYT and discussed various standpoints regarding its use in modern situation. Methods. We searched PubMed, Cochrane Library, and Evidence Reports of Kampo Treatment (EKAT) for articles written in English, and Ichushi, J-Stage, and EKAT for those written in Japanese. Articles published before January 1, 2019, were retrieved using the keywords “ninjinyoeito” and “ninjin’yoeito,” and RCTs were selected from these extracted articles. Result. Of 734 articles, 13 were RCTs, 46 were non-RCTs or studies of other designs, 15 were case reports, and 36 were experimental studies using NYT. NYT was evaluated for its use as a treatment for cancer and related conditions, refractory blood diseases and conditions, and otorhinolaryngologic symptom in 13 RCTs. Based on the use of Kampo medicine in modern situation called as Yasui’s classification, 10 of 13 RCTs were categorized as “the side effects of Western medicinal treatment are mitigated when combined with Kampo treatment” and the remaining 3 were categorized as “treatment effect of Kampo medicine is increased in combination with standard Western medicinal treatment.” Conclusion. Several studies demonstrated the efficacy of NYT in refractory diseases and other conditions, and the accompanied side effects of treatment with western medicine.

Aim To examine the association of the combination of taking neuropsychiatric medications from the onset of pregnancy to mid‐pregnancy and maternal psychological distress at mid‐pregnancy, with children's behavioral problems. Methods Neuropsychiatric medication use from the onset of pregnancy to mid‐pregnancy was defined by the self‐reported name of the neuropsychiatric medication in the questionnaire in early and mid‐pregnancy. Maternal psychological distress was defined by the Kessler Psychological Distress Scale (K6) ≥13 on the questionnaire in mid‐pregnancy. We classified the participants into four categories based on the combination of taking neuropsychiatric medications and psychological distress: “None,” “Medications only,” “K6 ≥ 13 only,” and “Both.” Children's behavioral problems were assessed using the Child Behavior Checklist for Ages 1½–5 (CBCL) at 2 years of age. The clinical ranges of the internalizing and externalizing scales of the CBCL were defined as behavioral problems. We conducted a multivariable logistic regression analysis to examine the associations between the four categories of maternal exposure and children's behavioral problems. Results Compared with the “None” category (n = 9873), the “K6 ≥ 13 only” category (n = 308) was statistically significantly associated with internalizing and externalizing problems. In contrast, the “Medications only” (n = 93) and “Both” (n = 22) categories were not statistically significantly associated with internalizing and externalizing problems, although the point estimates of the odds ratio in the “Both” category were relatively high (1.58 for the internalizing problem and 2.50 for the externalizing problem). Conclusion The category of mothers taking neuropsychiatric medications and having no psychological distress during pregnancy was not associated with children's behavioral problems in the present population.

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]

Long COVID symptoms, especially brain fog, significantly impair patient quality of life (QOL); however, effective treatments remain elusive. Japanese traditional medicine (JTM, usually called Kampo medicine) is often used adjunctively to treat patients with diverse manifestations of long COVID. To evaluate the effectiveness of JTM in treating long COVID using a comprehensive QOL assessment. This single-center, prospective observational study evaluated QOL changes in patients with symptoms persisting beyond 28 days from the onset of COVID-19 (long COVID) who visited our general medicine outpatient department between October 2021 and August 2024. The treatment plan was determined by the attending physician based on the patient's condition. The health-related QOL (HR-QOL) was comprehensively assessed using EuroQol-5 demensions-5levels (EQ-5D-5L) scores (ranging from -0.025 to 1.000, with higher values indicating better HR-QOL) at baseline and 3 months after the first visit. The formulations and factors associated with QOL changes were analyzed using multivariate logistic regression analyses. We analyzed 112 patients. The most common symptoms were fatigue (83.9%). The median (interquartile range) HR-QOL of the entire cohort significantly increased from 0.711 (0.561-0.711) at baseline to 0.833 (0.671-0.890) at 3 months ( < 0.0001); the proportion of patients exceeding the national standard significantly increased from 7.1% to 20.4% ( = 0.0037). The brain fog patients group (50.0%, = 56), the median (interquartile range) HR-QOL of the entire cohort significantly increased from 0.677 (0.551-0.770) at baseline to 0.750 (0.623-0.846) at 3 months ( < 0.005). However, the proportion of patients achieving the Japanese average HR-QOL did not show improvement significantly. A total of 101 patients (90.2%) were treated with JTM, and a combination of kamikihito and saikokeishito was administered to 20 patients. Multivariate regression analysis revealed that the combination usage was associated with greater improvements in the HR-QOL in all patients (odds ratio 5.4) and brain fog patients' group (odds ratio 6.1). Long COVID treatment involving JTM improved the patients' QOL at 3 months. The combination of kamikihito with saikokeishito may be a potential treatment option for long COVID. However, a randomized controlled trial is required to confirm its efficacy.

Background Japanese traditional (Kampo) medicines containing ephedra may be used to treat colds during pregnancy. There are reports that ephedrine, a component of ephedra, has a risk of teratogenicity; however, the evidence remains equivocal. Objective This study aimed to evaluate the risk of major congenital malformations (MCMs) associated with exposure to Kampo medicines containing ephedra during the first trimester of pregnancy using the Tohoku Medical Megabank Project Birth and Three-Generation Cohort Study (TMM BirThree Cohort Study). Methods To 23,730 mother–infant pairs who participated in the TMM BirThree Cohort Study from July 2013 to March 2017, questionnaires in early and middle pregnancy were distributed approximately at weeks 12 and 26 of pregnancy, respectively. Infants' risk of MCMs in women who used Kampo medicines containing ephedra or acetaminophen during the first trimester was assessed, and the odds ratios (ORs) were estimated with unadjusted and adjusted analyses. Results Among 20,879 women, acetaminophen and Kampo medicines containing ephedra were used in 665 (3.19%) and 376 (1.80%) women, respectively, in the first trimester. Among the infants born to the mothers who used acetaminophen or Kampo medicine containing ephedra during the first trimester, 11 (1.65%) and 8 (2.13%), respectively, had overall MCMs. OR of overall MCMs was higher in women who used Kampo medicines containing ephedra than in those who used acetaminophen in the first trimester (adjusted OR, 1.45; 95% confidence interval (CIs), 0.57–3.71); however, the difference was not statistically significant. Conclusions In this study, there was no statistically significant association between the use of Kampo medicines containing ephedra during the first trimester of pregnancy and the risk of MCMs. Although some point estimates of ORs exceeded 1.00, the absolute magnitude of any increased risks would be low.

Background A recent investigation reported that 92.7% Japanese family physicians have prescribed Kampo medicine (KM). KM can treat a wide variety of conditions from mental disorders to physical weaknesses. However, the characteristics and course of patients treated with KM at the Department of General Medicine remain unclear. Aims To investigate the characteristics and course of patients treated with KM in our hospital. Methods Data on medical history, complaints, course after Kampo treatment, and Hamilton Depression Rating Scale (HAM‐D) scores were retrogradely collected. The background of patients who received Kampo treatment was compared to that of patients who did not. Result Of 362 patients, 51 were treated with KM. Symptoms for which KM was prescribed included pain, general malaise, or sensory disturbance of extremities. All patients treated with KM were screened and initially diagnosed with a functional disorder or noncritical condition. KM including a crude drug of saiko such as hochuekkito, shigyakusan, shosaikoto, and yokukansan, was frequently prescribed for patients. Subjective symptoms showed improvement (53%) and no change (47%), while worsening was not observed in any patient. HAM‐D scores showed that patients treated with KM had higher anxiety levels and related symptoms as well as a higher frequency of mental disorders prior to presenting at the hospital. Conclusion Most complaints of the patients treated with KM were pain, general malaise, and sensory disturbance. KM is more likely to be prescribed in patients with health‐related anxiety or a history of mental disorders. Kampo medicine is more likely to be prescribed in patients with health‐related anxiety or a history of mental disorders who visit the Department of General Medicine.