★イギリスのAction for ME(患者団体)代表のSonya Choudhuryの意見
Action for M.E.では、日本の治療ガイドライン案を強く懸念し、患者に害を与える可能性を心配して、色々と資料を送って下さいました。現在、ME/CFSに有効だと証明された治療法は存在しないこと、PACE trial には疑問が投げかけられていること、患者の重症度別による治療法が示されていないこと、到達可能な最高水準の健康を享受する権利が患者にあること、抗うつ薬を推奨することの弊害についても書いて下さいました。
Action for M.E. is extremely concerned about the proposed “Treatment Guidelines for ME/CFS for Japan,” issued by the Research Committee for the Development of Treatments and Treatment Guidelines for ME/CFS, and their potentially harmful impact on patients. These guidelines recommend graded exercise therapy (GET) as a blanket clinical treatment for ME/CFS, including the severely affected, based on a literature review that failed to take into account the complexity of the condition.
There is no conclusive evidence base at this time for treatments for ME/CFS, including GET. In the past decade, a considerable body of research has been published in the UK, US, Australia and elsewhere that shows mixed evidence, highlighted by a meta-analysis Cochrane review on GET (Larun et al 2017, Cochrane Database of Systematic Reviews). This review recognises the “considerable heterogeneity” in results across all trials, highlighting clearly that sub-groups of patients are either not benefitting from, or are reacting adversely to, GET.
The Cochrane review concludes that there is a significant effect on fatigue and physical functioning only when data from the PACE trial (White et al, 2011, The Lancet) is included – but repeated questions continue to be raised by researchers, clinicians and people with M.E. who have concerns about the methodology and conduct of the trial, its clinical value, and the impact on patients who feel that their concerns have been dismissed. Even if the critique of the PACE trial is not taken into account and the figures are taken as they stand, at face value the trial only moderate clinical benefit for patients from GET for a minority of patients.
Most worryingly of all, the “Treatment Guidelines for ME/CFS for Japan” make no effort to differentiate between mild, moderate and severe ME/CFS when it comes to treatment, including GET. There have been no research studies into the efficacy of GET for those who are severely affected, and there is no evidence for any effective treatments for this extremely vulnerable patient group.
Any guideline for health professionals, for any health condition, must inherently upload the universally recognised right to health, reiterated by Dr Tedros Adhanom Ghebreyesus, WHO Director General, on Human Rights Day in December 2017, who said: “The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.”
Related to this is the ethical principle that access to biomedical care must not be restricted for anyone who has a significant possibility of needing it, including children and adults with ME/CFS. Given the lack of consensus about the efficacy of GET as a treatment for those with mild/moderate ME/CFS, and its complete lack of evidence in relation to severe ME/CFS, any organisation issuing clinical guidelines for the condition, in any country, has an ethical obligation to inform patients of the full range of views on biological care and management strategies for ME/CFS.
We share concerns about the use of antidepressants for treating ME/CFS patients. The National Health System (NHS) in the UK and clinical recommendations in other countries such as the US, clearly state that antidepressants do not cure ME/CFS but may be helpful for specific symptoms such as pain or depression caused by the illness. Not every person with ME/CFS has these symptoms and therefore it is not something that is routinely prescribed or recommended. As this is not made clear in the document, our concern is that the guidance is misleading.