Wednesday, 22 October 2014

Multiple Sclerosis Management - update on the NICE guideline 2014

Multiple sclerosis: management of multiple sclerosis in primary and secondary care - published Oct 2014 https://www.nice.org.uk/guidance/cg186

This guideline replaces the clinical guideline published in 2003 (i.e. NICE or the National Insitute for Health and Care Excellence that also advices on MS treatments has not updated their thinking on the care and treatment of MS patients in over 10 years!). Having said this, here is an overview of their suggestions (see figure); some which I have no comment on or prefer to keep my own counsel.

Advance warning: this is a large blog!



Recommendations

1) When to refer to a consultant neurologist
Refer people suspected of having MS to a consultant neurologist. Speak to the consultant neurologist if you think a person needs to be seen urgently. If a person has an episode of isolated optic neuritis, confirmed by an ophthalmologist, refer them to a consultant neurologist for further assessment.


This should be standard practice, I would go one step further and say that MSers should be under the care of  MS specialists.

2) Initial investigations
Before referring a person suspected of having MS to a neurologist, exclude alternative diagnoses by performing blood tests including:
full blood count, inflammatory markers for example erythrocyte sedimentation rate, C-reactive protein, liver function tests, renal function tests, calcium, glucose, thyroid function tests, vitamin B12, HIV serology.

This is normally performed by your GP's and covers the MS mimics. Why HIV? HIV can mimic any neurological disorder (so can Syphilis, but is less common nowadays) - the National AIDS trust quotes a figure of 98,400 people living with HIV in the UK alone, 22% of whom are unaware of their infection).

3) Information at the time of diagnosis
The consultant neurologist should ensure that people with MS and, with their agreement their family members or carers, are offered oral and written information at the time of diagnosis. This should include, but not be limited to, information about: what MS is
treatments, including disease-modifying therapies symptom management, how support groups, local services, social services and national charities are organised and how to get in touch with them, legal requirements such as notifying the Driver and Vehicle Licensing Agency (DVLA) and legal rights including social care, employment rights and benefits.


This admittedly is a lot to cover at the first visit and is often a shared venture between the neurologist and your MS nurse. Previously the MS societies used to provide a folder which would cover at least the first bit about what is MS? However this appears to have disappeared into the ether as more of us now rely on the internet for our information.The final bit about DVLA is very important and not readily highlighted at the first visit but is a requirement.

4) Provide information and support
Ensure people with MS and their family members or carers have a management plan that includes who to contact if their symptoms change significantly. Explain to people with MS that the possible causes of symptom changes include: another illness such as an infection, further relapse, change of disease status (for example progression).
Vaccinations: Be aware that live vaccinations may be contraindicated in people with MS who are being treated with disease-modifying therapies. Discuss with the person with MS:
the possible benefits of flu vaccination and the possible risk of relapse after flu vaccination if they have relapsing–remitting MS.


Pregnancy: Explain to women of childbearing age with MS that:
relapse rates may reduce during pregnancy and may increase 3–6 months after childbirth before returning to pre-pregnancy rates
pregnancy does not increase the risk of progression of disease.
If a person with MS is thinking about pregnancy, give them the opportunity to talk with a healthcare professional with knowledge of MS about: fertility, the risk of the child developing MS
use of vitamin D before conception and during pregnancy
medication use in pregnancy, pain relief during delivery (including epidurals), care of the child, breastfeeding.


I'm somewhat baffled by the comment on vaccines precipitating a relapse - does that mean NICE believes in the molecular mimicry hypothesis?! Reading between the lines they're probably trying to say don't have the flu vaccine.

5) Lifestyle advice
Exercise: Encourage people with MS to exercise. Advise them that regular exercise may have beneficial effects on their MS and does not have any harmful effects on their MS. For mobility problems and fatigue related to MS, consider supervised exercise programmes involving moderate progressive resistance training and aerobic exercise.

Smoking: Advise people with MS not to smoke and explain that it may increase the progression of disability.


I agree with both points, with exercise, but do this at regular intervals (any runner will agree with this); this would release endorphins and provide positive feedback for the brain for remodelling (cf. stroke patients where brain training is the norm in rehabilitation). And smoking, unless you have fixation with not developing Parkinson's disease, I would strongly discourage.

6) Disease-modifying therapies
Beta interferon and glatiramer acetate
On the balance of their clinical and cost effectiveness neither beta interferon or glatiramer acetate is recommended for the treatment of multiple sclerosis (MS) in the NHS in England and Wales.

It is likely that patients currently receiving beta interferon or glatiramer acetate for MS, whether as routine therapy or part of a clinical trial, could suffer loss of well being if their treatment is discontinued at a time they did not anticipate. Because of this, all NHS patients who are on therapy at the date of publication of this guidance should have the option to continue treatment until they and their consultant consider it is appropriate to stop, having regard to the criteria established for withdrawal from treatment in the Guidelines of the Association of British Neurologists published in January 2001.

Dimethyl fumarate
Dimethyl fumarate is recommended as an option for treating adults with active relapsing-remitting multiple sclerosis (normally defined as 2 clinically significant relapses in the previous 2 years), only if:
they do not have highly active or rapidly evolving severe relapsing-remitting multiple sclerosis and the manufacturer provides dimethyl fumarate with the discount agreed in the patient access scheme.
People currently receiving treatment initiated within the NHS with dimethyl fumarate that is not recommended for them by NICE in this guidance should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.

Alemtuzumab
Alemtuzumab is recommended as an option, within its marketing authorisation, for treating adults with active relapsing–remitting multiple sclerosis.

Teriflunomide
Teriflunomide is recommended as an option for treating adults with active relapsing–remitting multiple sclerosis (normally defined as 2 clinically significant relapses in the previous 2 years), only if they do not have highly active or rapidly evolving severe relapsing–remitting multiple sclerosis and the manufacturer provides teriflunomide with the discount agreed in the patient access scheme.

Fingolimod
Fingolimod is recommended as an option for the treatment of highly active relapsing–remitting multiple sclerosis in adults, only if: they have an unchanged or increased relapse rate or ongoing severe relapses compared with the previous year despite treatment with beta interferon, and the manufacturer provides fingolimod with the discount agreed as part of the patient access scheme.

The decision on the first line DMTs is a bit a bombshell!!! NHS England is a lapdog to NICE recommendations, so I predict a mad rush to the sales!! I wonder if pharma are aware of this subtle change in the NICE recommendations and are NICE blatantly ignoring the latest findings from the risk-sharing scheme. So it would seem that its oral therapies all the way.

7) Managing multiple sclerosis symptoms

Cognition including memory
Be aware that the symptoms of MS can include cognitive problems, including memory problems that the person may not immediately recognise or associate with their MS. Be aware that anxiety, depression, difficulty in sleeping and fatigue can impact on cognitive problems. If a person with MS experiences these symptoms and has problems with memory and cognition, offer them an assessment and treatment.

Mobility and fatigue
Consider supervised exercise programmes involving moderate progressive resistance training and aerobic exercise to treat people with MS who have mobility problems and/or fatigue.
Mobility and/or fatigue with balance problems:
Consider vestibular rehabilitation for people with MS who have fatigue or mobility problems associated with limited standing balance.
Treatment programmes for mobility and/or fatigue:
Encourage people with MS to keep exercising after treatment programmes end for longer term benefits (see the NICE pathway on behaviour change).
Help the person with MS continue to exercise, for example by referring them to exercise referral schemes.
If more than one of the interventions recommended for mobility or fatigue are suitable, offer treatment based on which the person prefers and whether they can continue the activity after the treatment programme ends.

Mobility
Ensure people with MS and mobility problems have access to an assessment to establish individual goals and discuss ways in which to achieve them. This would usually involve rehabilitation specialists and physiotherapists with expertise in MS.
Do not use fampridine to treat lack of mobility in people with MS because it is not a cost effective treatment.

Fatigue
Assess and offer treatment to people with MS who have fatigue for anxiety, depression, difficulty in sleeping, and any potential medical problems such as anaemia or thyroid disease. For more information see the NICE pathways on generalised anxiety disorder and depression.
Explain that MS-related fatigue may be precipitated by heat, overexertion and stress or may be related to the time of day.
Offer amantadine to treat fatigue in people with MS.
Consider mindfulness-based training, cognitive behavioural therapy or fatigue management for treating MS-related fatigue.
Advise people that aerobic, balance and stretching exercises including yoga may be helpful in treating MS-related fatigue.
Do not use vitamin B12 injections to treat fatigue in people with MS.
Consider a comprehensive programme of aerobic and moderate progressive resistance activity combined with cognitive behavioural techniques for fatigue in people with MS with moderately impaired mobility (an EDSS score of greater than or equal to 4).


Spasticity
In people with MS assess and offer treatment for factors that may aggravate spasticity such as constipation, urinary tract or other infections, inappropriately fitted mobility aids, pressure ulcers, posture and pain.
Encourage people with MS to manage their own spasticity symptoms by explaining how doses of drugs can be adjusted within agreed limits.
Ensure that the person with MS:
has tried the drug at an optimal dose, or the maximum dose they can tolerate stops the drug if there is no benefit at the maximum tolerated dose has their drug treatment reviewed at least annually once the optimal dose has been reached.
Consider baclofen or gabapentin as a first-line drug to treat spasticity in MS depending on contraindications and the person's comorbidities and preferences. If the person with MS cannot tolerate one of these drugs consider switching to the other.
Consider a combination of baclofen and gabapentin for people with MS if: individual drugs do not provide adequate relief or
side effects from individual drugs prevent the dose being increased.
Consider tizanidine or dantrolene as a second-line option to treat spasticity in people with MS.
Consider benzodiazepines as a third-line option to treat spasticity in MS and be aware of their potential benefit in treating nocturnal spasms.
Do not offer Sativex to treat spasticity in people with MS because it is not a cost effective treatment.
If spasticity cannot be managed with any of the above pharmacological treatments, refer the person to specialist spasticity services.


Most of this is self-explanatory. I'd like to focus your attention again on exercise and mindfulness programmes not only for mobility and fatigue but also pain management. 
It goes without saying that the 'mouse doctor' will not be impressed on their take on Sativex! And fampridine seriously? It's the only thing us clinicians have to offer for our progressive patients.

8) Treatments that should not be used
Vitamin D
Do not offer vitamin D solely for the purpose of treating MS.
Omega fatty acids compounds
Do not offer omega-3 or omega-6 fatty acid compounds to treat MS. Explain that there is no evidence that they affect relapse frequency or progression of MS.
Interventional procedure for use only in the context of research
NICE has published guidance on percutaneous venoplasty for chronic cerebrospinal venous insufficiency for multiple sclerosis (NICE interventional procedure guidance 420), which should be used only in the context of research.


I declare that I take 'A-Z multivitamins and Omega 3 - no Vitamin D - only because my levels are normal'. One of my colleagues takes the following: 'A-Z multivitamins, minerals, omega 3, primrose oil, zinc, selenium, vitamin C (only in winter months!), and folic acid' - and I declare she can provide an excuse for all of them!

18 comments:

  1. Re. " Recommendations

    1) When to refer to a consultant neurologist
    Refer people suspected of having MS to a consultant neurologist. Speak to the consultant neurologist if you think a person needs to be seen urgently."
    I was seen by a neurology registrar when I presented my first symptom. Unfortunately he didn't ask me enough questions. He went out the room for a few minutes to speak to his supervisor and came back in. Unfortunately I deteriorated a few days later as he didn't ask enough questions. It would have been good if his supervisor came into the room and examined me and ran through lots of questions. A promp list of questions to ask patient and them to tick off such as Have you had a recent infection or illness? etc would have stopped me deteriorating.
    Then when I had my follow up appt 4 weeks later again the second registrar didn't ask hardly any questions, prompt sheet of questions needed again. I think new patients with suspected MS need to be seen by a consultant neurologist rather than registrar. More established MS patients then yes fine to be seen and examined by a registrar. I have written to the hospital with my feedback. I think I was just very unlucky.

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    Replies
    1. Sorry to hear about this, I hope things are on the mend? It is a fine balance between providing good patient care and the training of future doctors. What you're astutely picking up with your list is a way of improving neurology training. Trainee doctors need to see new patients, but the key here is that the clinic is supervised and new cases are discussed with a senior. Failing this the follow up visit is there for a re-evaluation. Neurological diseases present in very odd ways, not one of my MSers coming to see me for instance in a single clinic had the same presentation. Creating a list poses a lot of problems and if adopted widely can lead to an automaton way of thinking which runs the danger of missing cases. For example, the 'FACE' campaign for stroke would bring in people with paralysis after an epileptic attack, pneumonia, parkinson's, barin tumours, MSers; none of whom needed to be thrombolysed!

      I feel that medicine is advancing at a pace and we're constantly playing catch up to update our trainees. It's is a war between service provision which the hospital managers care about and training of junior staff. We now teach our registrars at 8am in the morning and our SHOs during lunchtime as these are their only free times without clashes from their rotas! 10 years ago this was not the case.

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    2. This is not just happening in neurology, it's happening with cancer too. I didn't even see a doctor.

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    3. Thanks. I wish I went to A&E after both these appointments are got second opinions. The first registrar when he suspected I had MS should of handed me over to a consultant neurologist (prefably MS neurologist). I would of happily waited to see one in the waiting room if no one could see me straight away. The problem was I was suffering from severe stress and had tension in my arms and hands (it's written on my examination sheet). At this point I had the severe stress for 4.5 weeks. I was not sleeping well due to my housemate being up until 4am every night (cause of my stress). My first symptom was triggered by an infection. The registrar didn't ask me if I had a recent infection, and he didn't ask me if I was sleeping ok. He didn't ask me any questions about my stress. I didn't know I had MS at this point and I didn't know my housemate keeping me up until 4am every night when I was unwell would be relevant to tell him. Two days before my MRI scan I deteriorated and visited outpatients (I was unwell), I said to the staff at outpatients I am a patient of this clinic and have been unwell in the night. I was advised I coudn't be seen and I could leave my details. I left my details and went home. No one suggested A&E to me and for some reason I didn't think of it. The registrar got my message but didn't phone me to see why I returned to outpatients. I got my MRI results by phone he didn't ask me why I returned to outpatients. I didn't remember at this point me deteriorating and returning to outpatients (due to the stress, relapse, anxiety and sleep deprevation). My mother came and met me and we travelled to my parents home. I arrived at my parents home and the severe stress, anxiety and sleep deprevation was shocking that day. I went to bed and had a 12 month severe relapse. I got to start my steroid tablets on the 32nd day of my symptom. I've not been able to work and this is proof stress triggers relapses and how our thoughts and emotions effect our bodies (psychoneuroimmunology).

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    4. Many MSers would agree with you on this - the first presentation is most often traumatic and it takes a while for your confidence to return. Most neurologists now refer to an MS doctorpromptly; this is a requirement as stated in the 'National service framework for long-term conditions'; an NHS hospitals quality requirements document.

      Most psychologists now have training in 'mindfulness' and your GP can refer your for this. Good luck.

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    5. In my case, it was just confirmation of what I'd suspected/known for over 15 long years prior to diagnosis. It even says this in my medical file, as I was back and forth to Queens Square trying to get a diagnosis, where it's even stated I 'categorically' did not have MS. In the end I paid privately. I've practice's Zen meditation for most of my life, and this may also have something to do with it. This is not to denigrate that the experience other people with MS have on first presentation must be traumatic but for me it was sheer relief I wasn't bonkers! I guess the nearest I can come to this is that every relapse, I think 'oh heck is this the time I won't fully recover', but then I think 'OK, whatever happens, I have or will find the resources to deal with it.' Mind you, as the MS is sensory/visual so far, I can't say I'd be so 'zen' if it affected my mobility, I'd hope so though. That's what meditation gives me. I'm glad the NHS is taking mindfulness seriously, for me it has never been in doubt.

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    6. I think my meditation helps with my lifestyle choices, it makes me think I want to be the best person I can be even though I have MS. It helps me de-stress, helps resolve my anxiety, helps my sleep, it may have a positive effect on the immune system (modulating). It stopped my sleep apnea not sure how it did that.

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    7. Instead of the question prompt list for registrars then how about a new patient questionnaire? Or Neurology appointment questionnaire? I was sitting waiting for my appointment for a while and normally do (20 mins or so). I could fill in the form which has questions.

      1) Have you had a recent infection or illness? Yes / No Within the last seven weeks. Please add details.
      2) Are you sleeping ok? Yes/ No If not please add details.
      3) Any problems with bowel and /or bladder?
      4) Any weakness?
      5) Any nausea or vomiting?
      6) Any fever or night sweats?
      7) More questions
      8) Anything else or other symptoms? Please add details.

      Of course the registrar needs to verbally ask these questions too. I would say they really need to know and ask the core questions. I would say at least 60% of my relapses are triggered by symptomatic infections.
      When I go to see the dentist, I normally fill in a questionnaire every six months about my health and dental health. When I have my MRI scan I have a questionnaire to fill in each time.

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    8. In my case unfortunately the GP referred me as non-urgent to the hospital when I had double vision. I didn't know then that double vision is an urgent same day referral and neither did my parents. I got to see the registrar 17 days later. I made a complaint about that GP and he finally responded saying he apologises for any distress caused and now understands he should have referred me as same day referral. I had full trust in that GP and I was very naive. Of course if I hadn't have been suffering from the weeks of severe stress it would not of mattered that much. Now my body is not in a good state and I am truely gutted. It just shows how damaging stress can be to an MSer and that patients what ever the illness need to be on the ball and keep going back for a second opinion. My psychiatrist thinks I should write about my experience.

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  2. Regarding comment 4) Provide information and support.
    Advise the MSer that stress can stress trigger relapses. It can exacerbate symptoms. This is a priority to let them know.

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    Replies
    1. I agree with your comment, also 'mindfulness' needs to be highlighted as a way of dealing with this.

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  3. Thank you, Neuro Doc:-), it is an interesting summary of what NICE considers to be cost-effective and adequately documented treatments.
    I am surprised by vit D recommendation ( ...do not offer...). Well, one can always say that it should be used in most patients as osteoporosis prevention. There are studies showing low BMD in newly diagnosed MS patients. Shall we wait until MSers fall and break some bones 10 years later?
    J

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  4. This is often what happens when you bring together a group of experts into one room, the 'biggies' who shout the loudest often get their point across. The scientists can be overlooked - spending their time staring at petri-dishes and talking to themselves, disconnected from reality. I just hope our colleagues -GPs are better informed, or there will be a pike of correspondence saying that their formulary does not stock x,y,z as it's not recommended by NICE!

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  5. Thanks a lot for your effort Neuro Doc.
    But should we take flu jab or not?
    I think flu jab is a universal reccomendation everywhere in the world for MSers...

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    Replies
    1. The flu jab should be OK! The statement refers to live vaccines (bacterial - BCG, typhoid, cholera; viral - MMR, polio, yellow fever, rotavirus, Japanese encephalitis, VZV; also check the live attenuated ones). With some of the newer agents still in clinical trial your trial nurse should be able to tell you of the individual recommendations.

      The reason behind the recommendation is that being on an immunsupressant prevents you from responding to the vaccine and mounting an adequate immune response. Majority of our MS treatments cause lymphopenia which affects the formation of a memory response as well.

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    2. I don't get the flu jab because up to now despite some very bad doses of flu, it doesn't trigger relapses for me. A raised body temperature from flu or anything seems to have zilch affect, well apart from the usual crappy flu symptoms. Even then, I don't know if anyone else with MS gets this, I will flu 'crash' for a couple of hours while my body fights it, then be back to normal - it will be like this every day for the time I have the flu virus in my body (usually five/six days of yo-yo-ing). Hope it stays this way.

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  6. "The scientists can be overlooked - spending their time staring at petri-dishes and talking to themselves, disconnected from reality."

    The results gained by scientists are frequently ignored by our clinical colleagues who because they think they know best, then set up ill-considered clinical trials that ignore the science and kill the potential drug/therapy because it wasn't done properly (See anti-CD4 trial, CUPID etc etc).

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    Replies
    1. The reality is you may say that this is exactly what has happened, it's probably time we asked NICE (nicely) to be more transparent with they way they evaluate science?

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