今日の臨床サポート

漢方薬のエビデンス

著者: 新井一郎 日本薬科大学 薬学部

監修: 田妻進 広島大学病院 総合内科・総合診療科

著者校正/監修レビュー済:2020/11/12

概要・推奨   

  1. 漢方は、古代中国医学をもとに、我が国で独自に成立した伝統医療である。そのため、現在の漢方医学・漢方薬は、現在の中国医学(中医学)・中国薬と同じではない。漢方治療をエビデンスに基づいて行う場合、我が国における漢方治療のエビデンスは参考にしてもよいが、中国における中医学のエビデンスを、そのまま用いることは適切ではない。
  1. 現代の医療用漢方製剤は、我が国における煎じ薬での使用経験をもとに承認された医薬品であり、その効能効果は治験の結果に基づいたものではない。
  1. 漢方製剤の効能効果は、症状名+疾患名で表現されている場合が多い。漢方治療の目標はあくまでも症状名であり、疾患名は経験的に使用されてきた応用疾患例を示したものである。ただ、保険申請・審査には、この疾患名の方が用いられる場合が多い。
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薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、
著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適用の査定において保険適用及び保険適用外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適用の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
新井一郎 : 特に申告事項無し[2021年]
監修:田妻進 : 特に申告事項無し[2021年]

各論

医療とエビデンス  
  1. 1991年に、カナダのマクマスター大学のGordon Henry GuyattがEBM(Evidence-Based Medicine)の概念を提唱する前からも、医療は、当然、エビデンスに基づいて行われてきた。それでは、新しい概念であるEBMは、それまでの「エビデンスに基づいて行われてきた医療」と、何が違っていたのであろうか。EBMが新しく示した概念は、単にエビデンスに基づいて医療を行うことではなく、エビデンスを判断するための物差し(エビデンス・グレード)を設け、その中で相対的に高いエビデンスをもつ医療を行うべきであるとしたことである。この中で、それまで影響力の大きかった「偉い先生の個人的意見」はエビデンスではあるものの、グレードの低いエビデンスと位置づけられることになった。また、EBMを実現させるための方法として、臨床論文の網羅的検索とその批判的吟味が重要であるとした。その後、EBMは、「統計学的に差があった医療を患者個人に押し付ける」という批判に対し、患者の価値観の尊重を加えることとした。また、報告バイアス回避のために、臨床試験登録制度やランダム化比較臨床試験報告の記載内容の標準化(CONSORT声明)など、臨床試験の入り口と出口の整備が行われた。そして、臨床論文の網羅的検索とその中から最良の医療の抽出を医療者個人にかわって行う、「エビデンスに基づく診療ガイドライン」の作成方法が整備された。診療ガイドラインにおける推奨度の作成においては、試験デザインと有効性に加え、「益と害」での評価やGRADEシステムが追加された。EBMは、これらの追加・修正を受けることで、今日、医療者が日常診療で実践できるようになったわけである。
漢方・中国医学の歴史と臨床エビデンス  
  1. それでは、漢方治療においては、エビデンスはどのようにとらえられてきたのであろうか。当然、漢方治療も、エビデンスをもとに受け継がれてきたことは間違いない。太古からの薬草治療におけるエビデンスの積み重ねが、現在の漢方治療を形成しており、「長い歴史の中で、有効性・安全性のエビデンスのある漢方薬は生き残り、そうでないものは淘汰されてきた。したがって、現在に受け継がれている漢方薬は、有効で安全なものである」ということが、現在も信じられている。この考え方は正しいであろうか。

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文献 

著者: Yoshiharu Motoo, Ichiro Arai, Kiichiro Tsutani
雑誌名: PLoS One. 2014;9(8):e104422. doi: 10.1371/journal.pone.0104422. Epub 2014 Aug 13.
Abstract/Text BACKGROUND: The Committee for Evidence-based Medicine (EBM) of the Japan Society for Oriental Medicine started compiling Evidence Reports of Kampo Treatment (EKAT) in 2007. EKAT is a compilation of structured abstracts of randomized controlled trials (RCTs), along with comments by a third party reviewer. As of 31 December, 2012, there were 378 RCTs of Kampo medicines in Japan. The primary research question of this study is "How frequently is Kampo diagnosis used in RCTs of Kampo medicines?" The secondary research question is "When is Kampo diagnosis used in RCTs?"
MATERIALS AND METHODS: The structured abstract (SA) of each RCT article was reviewed to examine how Kampo diagnosis was used in RCTs, especially how Kampo diagnosis was used in the randomization process.
RESULTS: Kampo diagnosis was used before randomization in 27 RCTs (7.1%), after randomization in 31 RCTs (8.2%), and not used in 320 RCTs (84.7%). Before randomization, Kampo diagnosis was used as a criterion for inclusion in 10 RCTs, criterion for exclusion in 9 RCTs, and criteria for both inclusion and exclusion in 2 RCTs. Kampo formulas were determined according to Kampo diagnosis in 7 RCTs. After randomization, subgroup analyses according to Kampo diagnosis were done in 27 RCTs, and grade of disease severity at Kampo diagnosis was used for analysis as an endpoint in 4 RCTs.
CONCLUSIONS: Kampo diagnosis was used before randomization only in approximately 15% of RCTs, and the number of RCT articles using Kampo diagnosis after randomization was almost the same as that before randomization. Further studies to determine the good RCTs conforming to CONSORT requirements and good systematic reviews conforming to PRISMA requirements are needed to clarify the significance of Kampo diagnosis.

PMID 25119187  PLoS One. 2014;9(8):e104422. doi: 10.1371/journal.pone.・・・
著者: Masanori Nishioka, Mitsuo Shimada, Nobuhiro Kurita, Takashi Iwata, Shinya Morimoto, Kozo Yoshikawa, Jun Higashijima, Tomohiko Miyatani, Toru Kono
雑誌名: Int J Clin Oncol. 2011 Aug;16(4):322-7. doi: 10.1007/s10147-010-0183-1. Epub 2011 Jan 22.
Abstract/Text BACKGROUND: Oxaliplatin is now considered a standard treatment for advanced or unresectable colorectal cancer, but its main dose-limiting toxicity is sensory neuropathy. The OPTIMOX (stop and go) approach offers a reasonable strategy, but the preventive agent is not established. It is reported that the Kampo medicine, Goshajinkigan (GJG), has recently been considered an effective agent for the neuropathy of taxanes and for vibration sensation in patients with diabetic neuropathy. The aim of this study was to clarify the efficacy of GJG for peripheral neuropathy associated with oxaliplatin therapy.
PATIENTS AND METHOD: From 2007, 45 patients treated with modified FOLFOX6 for non-resectable or recurrent colorectal cancer participated in the study. Twenty-two patients (GJG group) received oral administration of 7.5 g/day of GJG every day during mFOLFOX6 therapy and 23 patients (control group) did not receive GJG. Neuropathy was evaluated during every course according to DEB-NTC (Neurotoxicity Criteria of Debiopharm).
RESULTS: The median number of cycles per patient in the GJG group was 13 (range 4-32), and in the control group was 12 (range 4-28). The cumulative dose of oxaliplatin was 1105 mg/m(2) (GJG group) and 1120 mg/m(2) (control group). The incidence of grade 3 peripheral neuropathy in the GJG group was significantly lower than in the control group (p < 0.01, log-rank test). The incidence of grade 3 peripheral neuropathy after 10 courses was 0% in the GJG group and 12% in the control group, and after 20 courses was 33% in the GJG group and 75% in the control group. The percentage of grade 2 and 3 peripheral neuropathy in the GJG group was lower than that in the control group. There were no differences in adverse effects between the two groups except for peripheral neuropathy and influence on tumor response.
CONCLUSION: The Kampo medicine, Goshajinkigan, is useful in preventing neuropathy in non-resectable or recurrent colorectal cancer patients treated with a FOLFOX regimen.

PMID 21258836  Int J Clin Oncol. 2011 Aug;16(4):322-7. doi: 10.1007/s1・・・
著者: Toru Kono, Taishi Hata, Satoshi Morita, Yoshinori Munemoto, Takanori Matsui, Hiroshi Kojima, Hiroyoshi Takemoto, Mutsumi Fukunaga, Naoki Nagata, Mitsuo Shimada, Junichi Sakamoto, Hideyuki Mishima
雑誌名: Cancer Chemother Pharmacol. 2013 Dec;72(6):1283-90. doi: 10.1007/s00280-013-2306-7.
Abstract/Text PURPOSE: Oxaliplatin-induced peripheral neurotoxicity (OPN) is frequent and potentially severe, but successful treatment of this condition is still an unmet clinical need. We aimed to determine whether treatment with goshajinkigan (TJ-107), a traditional Japanese medicine, is better than placebo in preventing OPN in patients with advanced or recurrent colorectal cancer patients treated with standard FOLFOX regimens.
METHODS: In this phase 2, randomized, double-blind, placebo-controlled study, patients undergoing oxaliplatin-based chemotherapy were randomized to receive either oral TJ-107 (7.5 g) or matching placebo daily. The severity of OPN was assessed according to the Common Toxicity Criteria for Adverse Events at baseline, every 2 weeks until the 8th cycle, and every 4 weeks thereafter until the 26th week. The primary endpoint was the incidence of grade 2 or greater OPN until the 8th cycle of chemotherapy.
RESULTS: Analyses were done by intention to treat. Eighty-nine patients were randomly assigned to receive either TJ-107 (n = 44) or placebo (n = 45) between May 2009 and March 2010. The incidence of grade 2 or greater OPN until the 8th cycle was 39 and 51 % in the TJ-107 and placebo groups, respectively (relative risk (RR), 0.76; 95 % CI, 0.47–1.21). The incidence of grade 3 OPN was 7 % (TJ-107) vs. 13 % (placebo) (0.51, 0.14–1.92). No concerns regarding toxicity emerged with TJ-107 treatment.
CONCLUSIONS: TJ-107 appears to have an acceptable safety margin and a promising effect in delaying the onset of grade 2 or greater OPN without impairing FOLFOX efficacy.

PMID 24121454  Cancer Chemother Pharmacol. 2013 Dec;72(6):1283-90. doi・・・
著者: Eiji Oki, Yasunori Emi, Hiroshi Kojima, Jun Higashijima, Takeshi Kato, Yasuhiro Miyake, Masanori Kon, Yutaka Ogata, Kenichi Takahashi, Hideyuki Ishida, Hiroshi Saeki, Yoshihisa Sakaguchi, Takeharu Yamanaka, Toru Kono, Naohiro Tomita, Hideo Baba, Ken Shirabe, Yoshihiro Kakeji, Yoshihiko Maehara
雑誌名: Int J Clin Oncol. 2015 Aug;20(4):767-75. doi: 10.1007/s10147-015-0784-9. Epub 2015 Jan 28.
Abstract/Text BACKGROUND: Peripheral sensory neurotoxicity is a frequent adverse effect of oxaliplatin therapy. Calcium and magnesium (Ca/Mg) infusions are frequently used as preventatives, but a recent phase III trial failed to show that they prevent neurotoxicity. We therefore conducted a multicenter randomized phase III trial to compare fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) with and without Goshajinkigan (GJG), a traditional Japanese herbal medicine (Kampo), to determine GJG's potential for reducing peripheral neuropathy in patients with colorectal cancer.
METHODS: Patients with colon cancer who were undergoing adjuvant therapy with infusional mFOLFOX6 were randomly assigned to GJG (7.5 mg three times daily) or placebo in a double-blind manner. The primary endpoint was the time to grade 2 or greater neuropathy, which was determined at any point during or after oxaliplatin-based therapy using version 3 of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
FINDINGS: An interim analysis was performed when 142 of the planned 310 patients had been enrolled and the safety assessment committee recommended that the study be discontinued. One hundred eighty-two patients were evaluable for response. They included 89 patients in the GJG group and 93 patients in the placebo group. The incidence of grade 2 or greater neurotoxicity was 50.6 % in the GJG group and 31.2 % in the placebo group. A Cox proportional hazards analysis indicated that the use of GJG was significantly associated with the incidence of neuropathy (hazard ratio, 1.908; p = 0.007).
CONCLUSION: Goshajinkigan did not prevent oxaliplatin-associated peripheral neuropathy in this clinical trial. The clinical study was therefore terminated.

PMID 25627820  Int J Clin Oncol. 2015 Aug;20(4):767-75. doi: 10.1007/s・・・
著者: Nobuaki Hoshino, Koya Hida, Riki Ganeko, Yoshiharu Sakai
雑誌名: Int J Colorectal Dis. 2017 May;32(5):737-740. doi: 10.1007/s00384-016-2727-y. Epub 2016 Nov 26.
Abstract/Text PURPOSE: Chemotherapy-induced peripheral neuropathy (CIPN) is an issue for both cancer patients and specialists, and the number of cases of CIPN is growing with the increasing number of cancer patients worldwide. CIPN is often caused by common anticancer drugs such as taxanes and platinum analogs. These are key drugs for various cancers including colorectal and gastric cancers. However, there are currently no effective drugs to prevent CIPN. Goshajinkigan, a Japanese traditional herbal medicine (Kampo), is a promising drug which is used to treat diabetic neuropathy in Japan. This systematic review will assess the efficacy and safety of Goshajinkigan for reducing CIPN in cancer patients receiving chemotherapy.
METHODS AND ANALYSIS: We will conduct a comprehensive search of relevant randomized controlled trials in Scopus, Ovid MEDLINE, Cochrane Central Register of Controlled Trials, and ICHUSHI. Two review authors will independently assess studies for inclusion and consult a third review author if necessary. The risk of bias of the included studies will be assessed according to the Cochrane risk of bias tool. We will investigate heterogeneity using forest plots and the chi-square test. When there are enough studies and any heterogeneity, we will use a random-effects model. Otherwise, we will use a fixed-effects model.
ETHICS AND DISSEMINATION: This is a protocol for systematic review and meta-analysis and does not need ethics approval. We will disseminate the findings of this review through publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER: PROSPERO CRD42016045224.

PMID 27889823  Int J Colorectal Dis. 2017 May;32(5):737-740. doi: 10.1・・・
著者: Akira Kuriyama, Koji Endo
雑誌名: Support Care Cancer. 2018 Apr;26(4):1051-1059. doi: 10.1007/s00520-017-4028-6. Epub 2017 Dec 26.
Abstract/Text PURPOSE: Chemotherapy-induced peripheral neuropathy (CIPN) limits the dose of chemotherapy and reduces patients' quality of life. Goshajinkigan is a Japanese herbal medicine used to alleviate neuropathy and general pain. A clinical guideline for prevention and management of CIPN stated that the prophylactic efficacy of goshajinkigan against CIPN was inconclusive. We conducted a systematic review to examine whether goshajinkigan prevents CIPN in patients receiving neurotoxic chemotherapy.
METHODS: We searched PubMed, EMBASE, Ichushi, and the Cochrane Central Register of Controlled Trials for eligible trials. Randomized controlled trials that examined the efficacy and safety of goshajinkigan for prevention of CIPN were included. Our primary outcomes were incidence of CIPN, response to chemotherapy, and adverse effects. We pooled data using a random effects model.
RESULTS: We analyzed five trials involving a total of 397 patients. When evaluated with Neurotoxicity Criteria of Debiopharm, goshajinkigan was associated with reduced incidence of CIPN of grade ≥ 1 (risk ratio [RR] 0.43; 95% CI, 0.27 to 0.66) and grade 3 (RR 0.42; 95% CI, 0.25 to 0.71), but this beneficial association was not found for grade ≥ 2 of CIPN. Goshajinkigan was not associated with reduced incidence of CIPN when assessed with the National Cancer Institute Common Terminology Criteria for Adverse Events, or improved response to chemotherapy. Goshajinkigan was well tolerated based on one trial.
CONCLUSIONS: Goshajinkigan is unlikely to prevent CIPN in patients undergoing neurotoxic chemotherapy. Given the low quality and insufficient amount of the evidence, use of goshajinkigan as standard of care is not currently recommended.

PMID 29280005  Support Care Cancer. 2018 Apr;26(4):1051-1059. doi: 10.・・・
著者: Yoshiharu Motoo, Ichiro Arai, Ichinosuke Hyodo, Kiichiro Tsutani
雑誌名: Complement Ther Med. 2009 Jun;17(3):147-54. doi: 10.1016/j.ctim.2008.09.003. Epub 2008 Nov 14.
Abstract/Text BACKGROUND AND AIMS: Kampo (Japanese herbal) medicines are often used in clinical practice in Japan. However, it is unclear how Kampo medicines are quoted and evaluated in current clinical practice guidelines (CPGs). Here, we systematically reviewed Japanese CPGs, and aimed to reveal how Kampo medicines are described in the CPGs.
MATERIALS AND METHODS: We reviewed the quasi-comprehensive list of Japanese CPGs available from the Toho University Medical Media Center (TUMMC) having the largest data base on Japanese CPGs, and also used a hand search. CPGs containing Kampo products were classified into three types based on how Kampo was handled. CPGs that provided recommendations based on evidence were classified as "type A". Those which cited references but did not provide any recommendations were classified as "type B". Those which described the Kampo practice or Kampo-related terms without providing any relevant references were classified as "type C".
RESULTS: By the end of March of 2007, 35 (10.1%) of 346 CPGs listed by TUMMC contained descriptions of Kampo products. We discovered one Kampo-related CPGs in a hand search process. Of these 36 CPGs, 6 were "type A", 13 were "type B", and 17 were "type C". Although results from pertinent randomized controlled trials (RCTs) were available, we noticed that some well-known RCTs studying Kampo medicines are missing in corresponding CPGs.
CONCLUSIONS: We revealed that the citation rate of Kampo medicines in CPGs was approximately 10% and that some pivotal trials for Kampo medicines were not quoted in CPGs. Kampo medicines in CPGs should be assessed more comprehensively and scientifically.

PMID 19398068  Complement Ther Med. 2009 Jun;17(3):147-54. doi: 10.101・・・

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