Question

Comparing some of the recommendations on the use of specific drugs in the new NICE guideline to those in the previous 2007 NICE guideline, I see that melatonin is no longer given a possible recommendation for sleep disturbance in the 2021 guideline and the “do not use” instruction in the 2007 guideline no longer applies to antiviral drugs, fludrocortisone, steroids and thyroxine.

Does this mean that doctors can no longer prescribe melatonin but that they can now prescribe amphetamines, antiviral drugs, steroids, etc for people with ME?

Answer

Just as the NICE Guideline Committee reviewed all the clinical trial evidence on the safety and efficacy of CBT and GET, we also reviewed evidence from all the relevant clinical trials that have assessed drugs, vitamins and supplements as possible treatments for the underlying disease process in ME/CFS, as well as symptom-relieving drugs such as melatonin for more severe sleep disturbance.

As with CBT and GET, all the evidence from clinical trials was rated as being of low or very low quality. Consequently, the committee decided that it could not recommend any of these very speculative treatments that are sometimes prescribed by doctors. At the same time, it was decided to restrict the very specific “do not use” label to two specific non-drug treatments: GET and the Lightning Process.

NICE guidelines are exactly what they say on the tin – they are guidelines. They are not mandatory instructions to health professionals. So doctors are still allowed to use their clinical judgement to prescribe treatments that are not recommended by NICE if they believe there is a good case for doing so and the benefits and risks have been properly discussed with the patient. However, if a doctor prescribes a treatment that NICE has said should not be used, and a patient then suffers harm as a result, the prescribing doctor could well end up defending a medical negligence claim.

The practical effect of these changes is that a doctor can still prescribe melatonin for more severe sleep disturbance if he/she chooses to do so. But the doctor may then have to justify the decision. The recommendation in the 2007 guideline was always a bit of a mystery to me – as there is no solid clinical trial evidence to demonstrate safety and efficacy of melatonin in ME/CFS and NICE does not normally recommend treatments without this sort of evidence.

The change in relation to the seven “Do not use” drugs in the 2007 guideline means that they could now be prescribed. This certainly makes sense in relation to the possible use of fludrocortisone in the treatment of PoTS. However, my personal view is that the use of antiviral drugs in ME/CFS is still very speculative – even though there is some evidence to support their use in specific situations. As antiviral drugs can have serious side-effects, I think they should normally only be prescribed by hospital specialists who are experienced in using them.

Given the fact that thyroxine can cause serious side-effects, I do not believe that it should be prescribed to people with ME/CFS who have normal thyroid function tests. And given the lack of sound evidence from clinical trials, and the potential to upset hormonal balance still further, I do not believe that doctors should be prescribing high-dose or low-dose steroids outside a research setting. The same applies to amphetamine-like stimulants such as dexamphetamine and methylphenidate.

See also: 

• • Treatments: Drug Sensitivities and Side Effects.
  • Treatments: Prescribed Drugs and Informed Consent.
  • Treatments: Prescribed Drugs and Weight Gain.

More information

We have detailed information written by Dr Shepherd and available to download or order from the website shop:

• We encourage everyone with ME/CFS or who cares for someone with the condition to familiarise themselves with the NICE Guideline and its recommendations. An easy-read version of the guideline has been produced and is available to download for free: An ME Association Summary of the 2021 NICE Clinical Guideline for ME/CFS.
  • Think about the guideline's recommendations and how they might apply to your own situation. Discuss them with your GP or local ME/CFS specialist service. Please let us know how you get on and how they are received: Feedback@meassociation.org.uk
• The ME Association ME/CFS/PVFS Clinical and Research Guide (The ‘Purple Book') summarises and references the clinical trials that have assessed the use of antiviral drugs and hydrocortisone.
• We have two leaflets from the extensive range of literature relevant to the topics being discussed:
  • We explain Postural Orthostatic Tachycardia Syndrome (PoTS), how it relates to orthostatic intolerance, why it affects some people with ME/CFS, and how it can be diagnosed and treated – including the use of fludrocortisone.
  • We examine thyroid disease, review the symptoms and their overlap with ME/CFS, thyroid function testing, and the treatments that are available.