18.1治療ガイドライン(案)に対する海外の意見①

「慢性疲労症候群に対する治療法の開発と治療ガイドラインの作成」研究班が今春に出版予定の「日本における筋痛性脳脊髄炎/慢性疲労症候群(ME/CFS)治療ガイドライン」案に対して、当法人は外部評価を求められました。2017年12月には一般からのパブリックコメントを募集していましたので、当法人ではガイドライン案の重要な部分と、当法人のガイドライン案への反対表明の記者会見の記事を英訳し、海外の専門医や患者団体からも意見を送って頂けるように呼びかけました。何回かに分けてご紹介致します。

国際ME/CFS学会副会長のDr. Lily Chu(米国)の意見

段階的運動療法(GET)と認知行動療法(CBT)は有効ではなく、むしろ有害であるという見解を、国際ME/CFS学会 (IACFS/ME)として発表する準備をしているところで、それを示す資料を送って下さいました。さらに、日本のガイドライン案に対しても見解をまとめて下さることになりました(意見をまとめるのに少し時間がかかりますが)。CDCでは医療関係者向けにME/CFSについての情報を新たに作成していますし、イギリスでも新たなガイドラインを作成中であることを知らせて下さいました。

The IACFS/ME Board is currently working on a position statement addressing GET/ CBT. The purpose of our statement is to provide support for patients, clinicians, scientists, and groups to point out why GET/CBT is ineffective and even harmful in ME/CFS. We hope to publish our statement in a journal but that will likely not be completed until late or even early next year. In the meantime, below are some resources you can refer to:

1) IACFS/ME 2014 Primer which does not emphasize GET/CBT
http://iacfsme.org/portals/0/pdf/Primer_Post_2014_conference.pdf

2) News article about the US Centers for Disease Control and Prevention removing GET as treatment: note that CDC is working on revising educational materials so new information is not available yet on their website
https://www.npr.org/sections/health-shots/2017/10/02/554369327/for-people-with-chronic-fatigue-syndrome-more-exercise-isnt-better  https://www.statnews.com/2017/09/25/chronic-fatigue-syndrome-cdc/

3) United Kingdom government re-assessing whether GET is an effective treatment:
http://www.meassociation.org.uk/2017/09/breaking-news-nice-decides-to-fully-update-its-guideline-on-mecfs-20-september-2017/

4) Fatigue article showing that CBT/GET does not have much more efficacy than usual care: note this is a re-analysis of PACE data using the PACE authors’ ORIGINAL criteria for recovery:
The Journal of Health Psychology also had a whole special issue this year about the flaws of PACE.
http://journals.sagepub.com/toc/hpqa/22/9

5) Surveys showing more than 50% of patients feel their health is worsened with GET. The 2013 survey I conducted and “formal exercise program” covers GET or similarly-administered programs: in the US, 62% of subjects said it made their health worse. The point that needs to be made is regardless of what trials show, if a treatment is making potentially 50% of patients worse when put into practice, doesn’t the latter evidence trump the former? In the US, if a drug or treatment causes harm once released on a wide scale even if the trials show it is safe, it is often taken off the shelves or treatment plans until we can figure out why it is harmful.

a) Worldwide surveys over 10 years covering thousands of patients:
http://iacfsme.org/PDFS/Reporting-of-Harms-Associated-with-GET-and-CBT-in.aspx

b) US 2013 survey:
http://iacfsme.org/portals/0/pdf/FDA-AugustFinalReportforUS-Version2.pdf
http://iacfsme.org/portals/0/pdf/FDA_Survey_Results_Word_Version_July2013%20_2_.pdf

c) Norwegian 2014 survey:
http://www.me-foreningen.info/wp-content/uploads/2016/09/ME-Nat-Norwegian-Survey-Abr-Eng-Ver.pdf

6) The US federal agency Agency for Healthcare Quality and Research published an addendum in July 2016 to their review of treatments for ME/CFS. They found that the evidence for GET was insufficient for Fukuda criteria whereas the data for Oxford criteria was stronger. They suggested that future trials not use Oxford criteria because it was too broad. The US National Institutes for Health (which fund research) also agree with discarding Oxford. https://www.ncbi.nlm.nih.gov/books/NBK379582/

米国マサチューセッツME/CFS患者会理事長のCharmian Proskauerの意見

当法人がHPで発表した意見にすべて同意して下さり、患者を段階的運動療法から守ることが非常に大事だと強調されました。米国疾病管理予防センター(CDC)のDr. Beth Ungerに日本のガイドラインの問題について話し、CDC内で議論して頂けるようにお願いして下さいました。また、CDCではME/CFSの治療ガイドラインを作成していること、医療関係者向けの新しい情報を2018年2月に発表予定であることを知らせて下さいました。

I have also passed your email along to Dr. Beth Unger, who heads the CDC’s section on ME/CFS. She said she would discuss this situation with her leadership.

The CDC has begun to explore the process of creating treatment guidelines for ME/CFS. This will take several years, apparently. The new material on the CDC website for health care providers is targeted for Feb 2018 publication.

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