UK, London: RECRUITING NOW: SAFFE trial on enhancing slow-wave sleep in CFS using Xyrem

[Scarecrow]

No, that is not what I'm saying. The NHS does not diagnose ME. What it does do is diagnose chronic fatigue (or what it calls CFS/ME) and lumps everyone into that category.

Most people in the UK diagnosed by the NHS would conform to NICE criteria.

https://www.nice.org.uk/guidance/cg53/chapter/1-Guidance#diagnosis

1.2.1.2 Healthcare professionals should consider the possibility of CFS/ME if a person has:

• fatigue with all of the following features:
  • new or had a specific onset (that is, it is not lifelong)
  • persistent and/or recurrent
  • unexplained by other conditions
  • has resulted in a substantial reduction in activity level
  • characterised by post-exertional malaise and/or fatigue (typically delayed, for example by at least 24 hours, with slow recovery over several days)
    
    and
• one or more of the following symptoms:
  • difficulty with sleeping, such as insomnia, hypersomnia, unrefreshing sleep, a disturbed sleep–wake cycle
  • muscle and/or joint pain that is multi-site and without evidence of inflammation
  • headaches
  • painful lymph nodes without pathological enlargement
  • sore throat
  • cognitive dysfunction, such as difficulty thinking, inability to concentrate, impairment of short-term memory, and difficulties with word-finding, planning/organising thoughts and information processing
  • physical or mental exertion makes symptoms worse
  • general malaise or 'flu-like' symptoms
  • dizziness and/or nausea
  • palpitations in the absence of identified cardiac pathology.

1.3 Diagnosis
1.3.1 Making a diagnosis
1.3.1.1 A diagnosis should be made after other possible diagnoses have been excluded and the symptoms have persisted for:

• 4 months in an adult
• 3 months in a child or young person; the diagnosis should be made or confirmed by a paediatrician.

1.3.1.2 When a diagnosis of CFS/ME is made, healthcare professionals should provide honest, realistic information about CFS/ME and encourage cautious optimism.

• Most people with CFS/ME will improve over time and some people will recover and be able to resume work and normal activities.
• However, others will continue to experience symptoms or relapse and some people with severe CFS/ME may remain housebound.
• The prognosis in children and young people is more optimistic.

1.3.1.3 The diagnosis of CFS/ME should be reconsidered if none of the following key features are present:

• post-exertional fatigue or malaise
• cognitive difficulties
• sleep disturbance
• chronic pain.

So if you do a study on NHS patients with CFS/ME, and make it so they have to stay in hospital for 5-days 3 times, you are likely to end up with a cohort with a lot of chronic fatigue patients, and very few ME patients.

And, as @Sasha has already pointed out, you are incorrect about the trial. Patients have to meet CCC (and CDC) to be included.

 

[ukxmrv]

That's good news about the criteria. When the info was sent to me originally it said

We are currently looking for people who:
• Have a current diagnosis of chronic fatigue syndrome
• Are aged between the ages of 25 and 65
• Have a good grasp of the English language
• Can take part in a research study at Imperial College London

 

[Sasha]

That's good news about the criteria. When the info was sent to me originally it said

We are currently looking for people who:
• Have a current diagnosis of chronic fatigue syndrome
• Are aged between the ages of 25 and 65
• Have a good grasp of the English language
• Can take part in a research study at Imperial College London

I'd like to see researchers who are recruiting for trials being explicit about their criteria in their recruitment material, rather than just in their protocols - otherwise patients might assume they'd be wasting their time.

 

[Scarecrow]

I'd like to see researchers who are recruiting for trials being explicit about their criteria in their recruitment material, rather than just in their protocols - otherwise patients might assume they'd be wasting their time.

I was just about to make the same point.

How much damage has been done by the rename to CFS all those years ago and those jokers with their Oxford research criteria?

 

[heapsreal]

One thing for sure is that very little research is done on sleep in cfsme even though it's a common symptom. I'm sure if more research was done they could find better and safer drugs to help improve sleep dysfunction. Maybe even better monitoring equipment that individuals could use at home that can tell us our sleep quantity and quality each night. I think this could help us work out what meds are helpful for us individually.

 

[justy]

My worry is that if they have a relatively well cohort then we will have no idea how the drug will work for someone who is more severely affected. When I was very mildly affected I could tolerate most drugs and they mainly had normal effects on me - now I tolerate little and have to only take micro doses fo some drugs for them to be effective, and I know I am not alone in this.

Medical studies are great, but when is the medical community going to wake up to what M.E is like for the majority of sufferers who could never take part in a trial like this, or who risk making themselves worse by doing so. So many Drs think it does just equate to 'being tired' having 'a bit less energy' and having pain. There is not enough focus on the mod and severe patients EVER.

 

[Sasha]

My worry is that if they have a relatively well cohort then we will have no idea how the drug will work for someone who is more severely affected. When I was very mildly affected I could tolerate most drugs and they mainly had normal effects on me - now I tolerate little and have to only take micro doses fo some drugs for them to be effective, and I know I am not alone in this.

Medical studies are great, but when is the medical community going to wake up to what M.E is like for the majority of sufferers who could never take part in a trial like this, or who risk making themselves worse by doing so. So many Drs think it does just equate to 'being tired' having 'a bit less energy' and having pain. There is not enough focus on the mod and severe patients EVER.

I understand your frustration! But I think it's the case that they've got to start somewhere. The question then becomes, if they get positive results, whether they're able to look at severe patients.

There is not enough focus on the mod and severe patients EVER.

That's why I'm so keen on the study in my signature!

 

[Scarecrow]

For decades, psychiatrists in the UK have been conducting behavioural trials using the dodgy Oxford criteria and subjective measures, and have lectured us on sleep hygiene and our behaviour generally.

Now a psychiatrist (and neuropsychopharmacologist) comes along with a biomedical trial using CCC and objective measures (brain wave activity and ability to perform tasks) as well as subjective patient reports.

I genuinely can't understand the reaction from some of us here. I'm not including the points made about sensitivity to medications, which are well made and important.

 

[msf]

I think the collective feeling is that it's too little, too late. On the other hand, given the state of ME research for much of the last 50 years, perhaps we should feel positive about any serious attempts to help us.

 

[Sasha]

I think the collective feeling is that it's too little, too late. On the other hand, given the state of ME research for much of the last 50 years, perhaps we should feel positive about any serious attempts to help us.

I think that if we let everything be coloured by (understandable) resentment over how little has been done for us in the past, we'll end up greeting every good new thing as though it's a piece of shit and I think we've seen a lot of that lately.

I think it's important not to drive researchers away who are, as msf says, seriously trying to help us with the resources available to them. It's not their fault that they're having to start where they are and that we're 20 or 30 years behind where we should be.

I think we should welcome this kind of initiative.

 

[msf]

The problem I have with the British researchers is that they seem reluctant to build on the work of researchers in other countries, and are therefore further behind than they need to be.

 

[Scarecrow]

I think the collective feeling is that it's too little, too late. On the other hand, given the state of ME research for much of the last 50 years, perhaps we should feel positive about any serious attempts to help us.

I understand the 'too little, too late' sentiment but surely any step in the right direction is to be welcomed?

The problem I have with the British researchers is that they seem reluctant to build on the work of researchers in other countries, and are therefore further behind than they need to be.

Jeez, now I feel I've transgressed twice over. First of all for daring to have mild M.E. (but have been moderate) and now it's because I'm British!

Whether or not your statement is justified, I really have no opinion. But I do know that it's not a fair criticism of this particular trial, which is building on the work of research in the USA and elsewhere. It's taking the conclusions of other studies (reduced slow wave sleep in pwME) and trying to find a therapeutic solution.

 

[leokitten]

I agree with those who've stated that just because you don't have insomnia doesn't mean you are having refreshing sleep, I think we don't even realize how much sleep disturbance this illness gives us.

Getting extended periods of refreshing sleep over many days in a row in addition to aggressive resting while awake does have a significant effect on PEM and symptoms for people with milder ME (which I have). The problem is it just doesn't last and you go back to where you started the moment you stop this forced "hibernation". The longer you do it the longer the PEM and symptom improvement lasts but it takes like 2 weeks of hibernation in order to get just a few days of reduced PEM and symptoms so it becomes impossible to maintain.

Just wanted to put this out there to complement the info given by people here with moderate or severe ME who say refreshing sleep doesn't seem to improve symptoms.

Although this is a worthwhile research study I don't believe Xyrem will ever be approved or used clinically in any widespread way.

Xyrem is just GHB. Xyrem was already rejected by the FDA for treatment of sleep disturbances in fibromyalgia even though research showed it worked. It's because it's a dangerous medication, as people here have stated here with even slight overdose it can cause depressed breathing and loss of consciousness. The FDA panel said that they thought it was dangerous to have over 4 million people in the U.S. getting prescribed this drug for safety reasons.

As I've stated so many times here on PR, there are other much safer drugs that also robustly increase SWS. I take some and they have made a huge improvement in my sleep. My sleep was, no pun intended, a nightmare before and definitely contributed to making my ME worse until I got it fixed.

 

[Scarecrow]

As I've stated so many times here on PR, there are other much safer drugs that also robustly increase SWS. I take some and they have made a huge improvement in my sleep. My sleep was, no pun intended, a nightmare before and definitely contributing to making me ME worse until I got it fixed.

I'm sorry but I've missed those posts. Could you say what the meds are? I would like to ask my doctor for sleep meds but don't want to be merely unconscious. I would like to have the quality restored.

 

[leokitten]

@Scarecrow I take a combo of tiagabine + gabapentin + clonidine + LDN which works great for me. There are also others such as trazodone etc.

See these two threads:

http://forums.phoenixrising.me/inde...receptor-agonists-to-prevent-tolerance.37529/

http://forums.phoenixrising.me/index.php?threads/so-seriously-why-cant-i-sleep.37364/

I list meds there and also reference some papers.

 

[out2lunch]

As a note of caution, Xyrem is a DANGEROUS drug! Here in the US it is a third grade controlled substance. I was put in it about seven years ago. It is not easy to get it here and is very controlled.

I had a major adverse reaction the sixth night of taking it. I had hallucinations and went through a major manic episode that lasted a few days. I never experienced anything like it before. Had my husband not stopped me from taking it that night, I probably would have stopped breathing.

I have since heard from another ME patient with a similar reaction to Xyrem.

At least it seems like this study is taking place in a hospital under supervision but I would be very weary of other patients taking it at home.

Count me in the bad reaction category. I took Xyrem about 10 years ago for my fibro, which did help with my pain, even though it worsened my fatigue (important reason why, which I'll explain later). My sleep was deeper on the drug, but... and this is a big one... it slowly turned me into a paranoid and delusional individual. I became increasingly fearful of everyone, including my friends and family, believing they were "out to get me," conspiring against me, etc.

Years later, after I had been diagnosed with moderate sleep apnea/hypopnea, I discussed what Xyrem had done to me with my new sleep neurologist. He said the pain improved because of the deeper sleep, but the fatigue worsened because the drug worsened my sleep apnea. He also said about 15% of his patients who've tried Xyrem experience altered moods, behaviors, and frank psychotic episodes. And the patients who were more sensitive to medication side effects were the ones who had these bad reactions. Gee... aren't most of us in the ME/CFS/FMS camp sensitive to drugs and chemicals? MCSS and all that jazz?

Giving someone Xyrem without knowing if they have a sleep disordered breathing problem is bad enough. So many of us with ME/CFS also have fibro, which is often accompanied by Ehlers-Danlos, a major contributing factor to sleep apnea/hypopnea via lax tissue in the airway. But giving Xyrem to someone with chemical and drug sensitivities is a recipe for disaster.

Quite frankly, I'm surprised that any research team would want to venture down this road again with our patient population. Makes me think they either don't understand or don't respect our bodies' inability to handle substances of this nature. And when you get right down to brass tacks, Xyrem is nothing more than GHB. Which has been used as a cleaning solvent industrially for decades. Not exactly something that MCSS patients should be ingesting, I would think.

 

[msf]

Scarecrow, I didn't really understand the British comment - I am also British, and the actions of the NHS or the British medical establishment have no effect on how I feel about being British. RE: it being an unfair characterization of this study, you may be right in this case, but I would rather see someone in the UK following up the studies that are looking into the roots of the disease than following up on those that suggest symptomatic treatments. I think people know that Xyrem can work in ME, not sure we really need a trial to prove that.

 

[msf]

If they were keen on doing a study on sleeping drugs in ME, I think a comparative study of several sleeping drugs would have been much more useful.

 

[Scarecrow]

I would rather see someone in the UK following up the studies that are looking into the roots of the disease than following up on those that suggest symptomatic treatments.

While I agree with you about ultimate causation, I'd still be happy with symptomatic treatment.

If they were keen on doing a study on sleeping drugs in ME, I think a comparative study of several sleeping drugs would have been much more useful.

 

[leokitten]

I don't believe any autoimmune disease has a cure (I could be wrong but it's very few if any) yet many people with autoimmune disease live happy and productive lives with effective treatments that reduce or eliminate symptoms and/or have disease modifying capabilities.