Recurrent Drug-induced Liver Injury Caused by the Incidental Readministration of a Kampo Formula Containing Scutellariae Radix

Shimada, Yutaka; Fujimoto, Makoto; Nogami, Tatsuya; Watari, Hidetoshi; Kitahara, Hideyuki; Misawa, Hiroki; Kimbara, Yoshiyuki; Kita, Keiichiro

doi:10.2169/internalmedicine.0275-17

Cited by 11 publications

(8 citation statements)

References 21 publications

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“…The side effects of shosaikoto administration include interstitial pneumonia, liver injury, pseudoaldosteronism, and myopathy . However, in the present study of treatment of the acute phase of pneumonia, no adverse events were observed.…”

Section: Discussioncontrasting

confidence: 60%

Usefulness of shosaikoto for pneumonia in combination with antibiotics

Yamasaki

Suzuki

Ose

et al. 2020

Traditional & Kampo Medicine

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Aim The value of Kampo medicine for the treatment of pneumonia is unclear. The aim of our study is to investigate the usefulness of shosaikoto for pneumonia in combination with antibiotics. Methods We retrospectively compared 39 cases treated only with Western medicine, including antibiotics (conventional group), with 22 cases treated with Western medicine, including antibiotics, and shosaikoto (combination group). We evaluated the duration of antibiotic treatment after admission, the febrile period, and the duration of oxygen treatment. Results The duration of antibiotic treatment was significantly shorter in the combination group (7 ± 2.25 days) than in the conventional group (8.46 ± 2.28 days; P < 0.05), and the febrile period was also significantly shorter in the combination group (2.95 ± 0.92 days) than in the conventional group (4.09 ± 2.08 days; P < 0.05). The duration of oxygen treatment was not shorter in the combination group (3.85 ± 1.77 days) than in the conventional group (4.11 ± 2.25 days; P = 0.951). Conclusion This study suggests that combination therapy with shosaikoto and antibiotics is useful for bacterial pneumonia.

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Section: Discussioncontrasting

confidence: 60%

Usefulness of shosaikoto for pneumonia in combination with antibiotics

Yamasaki

Suzuki

Ose

et al. 2020

Traditional & Kampo Medicine

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“…In addition to metformin, coadministration with SB and mefenamic acid had an anti-inflammatory effect and alleviated gastric damage with minimal pharmacokinetic interaction in rats (10). However, some patients demonstrated increasing liver enzyme levels, several studies reported side effects of SB (17,35), and one reported that a woman who was prescribed herb-drugs containing Scutellariae Radix suffered from liver injury (30). Accord-ingly, more detailed studies should be conducted to explore the side effects of individual variations of coadministered SB and metformin.…”

Section: E56mentioning

confidence: 99%

Combined effects of Scutellaria baicalensis with metformin on glucose tolerance of patients with type 2 diabetes via gut microbiota modulation

Shin

Choi

et al. 2020

American Journal of Physiology-Endocrinology and Metabolism

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Metformin is a widely prescribed antidiabetic agent, whereas Scutellaria baicalensis (SB) is a commonly used medicinal herb for treatment of type 2 diabetes (T2D). Gut microbiota is involved in pathophysiology of metabolic diseases including T2D, and intestinal microbiota may be one of the important therapeutic targets for the ailment. This study was conducted to investigate the effects of SB combined with metformin on treatment of T2D while evaluating changes in the gut microbiota composition. Patients with T2D were randomized into control and treatment groups. Subjects who had already been prescribed metformin were allotted to additional SB (3.52 g/day) group or placebo group. The initial treatment session was 8 wk, and after washout period for 4 wk they were crossed over to the opposite treatment for another 8 wk. The influence of SB and placebo on the intestinal microbiota was analyzed by MiSeq system based on 16S rRNA gene. Glucose tolerance was lower in the SB group than the placebo group. Similarly, the relative RNA expression of TNF-α was significantly reduced after SB treatment. SB treatment influenced the gut microbiota, especially Lactobacillus and Akkermansia, which showed remarkable increases after SB treatment. Some subjects showed high liver enzyme levels after SB treatment, and their microbiota composition at baseline differed with subjects whose liver enzymes were not affected. We also predicted that selenocompound metabolism was increased and naphthalene degradation was decreased after SB treatment. These results suggest that SB with metformin treatment may improve the glucose tolerance and inflammation and influence the gut microbiota community in T2D.

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“…Furthermore, there have been many case reports of liver injury induced by Kampo formulas that contain Scutellariae Radix [14–18]. We also reported a case of recurrent drug-induced liver injury caused by the incidental readministration of a Kampo formula containing Scutellariae Radix [19]. The challenge test provides a definitive etiologic diagnosis of drug-induced liver injury.…”

Section: Resultsmentioning

confidence: 98%

“…Cases in which so-called “unintentional challenge tests” were performed incidentally have also been reported. In such cases, the patient took (or the physician prescribed) a Kampo formula containing Scutellariae Radix without realizing that it might result in a challenge test [14–16, 18, 19]. Therefore, the involvement of an immunoallergic mechanism in liver injury induced by Kampo medicine, at least by Scutellariae Radix, has been suggested, as liver injury recurs upon readministration for a short period.…”

Section: Resultsmentioning

confidence: 99%

Adverse Events Associated with Ethical Kampo Formulations: Analysis of the Domestic Adverse-Event Data Reports of the Ministry of Health, Labor, and Welfare in Japan

Shimada

Fujimoto

Nogami

et al. 2019

Evidence-Based Complementary and Alternative Medicine

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Objectives. Traditional Japanese Kampo medicines have been integrated into the Japanese national health-care system. In Japan, the Ministry of Health, Labor, and Welfare’s website discloses adverse drug-event data that have been obtained from medical personnel reports investigated by the Pharmaceutical and Medical Devices Agency. Using these data, we investigated adverse events associated with ethical Kampo formulations. Methods. Reports of adverse events associated with ethical Kampo formulations from the domestic adverse-event data were obtained from July 30, 2003, to March 31, 2018. Adverse events were then categorized, and the relationships between categories of adverse events and crude drugs were analyzed. Results. There were 4,232 reported adverse events associated with ethical Kampo formulations. The numbers of events by category were as follows: events related to liver injury, 1,193; lung injury, 1,177; pseudoaldosteronism, 889; mesenteric phlebosclerosis, 223; drug eruption, 185; and others, 565. Among events related to both liver injury and lung injury, approximately 70% were suspected to be induced by Kampo formulations containing Scutellariae Radix. The pseudoaldosteronism-related events, which are induced by Glycyrrhizae Radix, included several events related to muscle injury, heart failure, and arrhythmia. Events related to mesenteric phlebosclerosis, believed to be induced by long-term use of Kampo formulas containing Gardeniae Fructus, increased remarkably during the study period. Among the events related to drug eruption, approximately 35% were suspected to be induced by Kampo formulations containing Ephedrae Herba. Conclusion. Kampo medicines may cause various adverse events. The present results provide valuable information regarding adverse events associated with Kampo medicines from the viewpoint of patient safety.

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Recurrent Drug-induced Liver Injury Caused by the Incidental Readministration of a Kampo Formula Containing Scutellariae Radix

Cited by 11 publications

References 21 publications

Usefulness of shosaikoto for pneumonia in combination with antibiotics

Usefulness of shosaikoto for pneumonia in combination with antibiotics

Combined effects of Scutellaria baicalensis with metformin on glucose tolerance of patients with type 2 diabetes via gut microbiota modulation

Adverse Events Associated with Ethical Kampo Formulations: Analysis of the Domestic Adverse-Event Data Reports of the Ministry of Health, Labor, and Welfare in Japan

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