Fantastic news from Dr Andy Berkowski and Dr John Winkelman.
The draft guidelines for treatment of RLS have been released. You can watch the video of the two doctors discussing the recommendations.
There is a STRONG recommendation for IV iron infusions.
There is a CONDITIONAL recommendation AGAINST dopamine agonists, making the point that in some cases, eg end of life care, it may be appropriate to accept the short term relief from RLS.
I haven't yet listened to the full video.as I was too excited and wanted to share the news. I couldn't initially access the American Academy of Sleep written draft guidelines as you have to be a member, but RLSLearner has added the link. THANKYOU.
I'll report back after listening to the whole video.
Let's hope the rest of the world wakes up an listens.
I've added a link to the draft guidelines so you can send in your comments. Thanks to RLSLearner for the link.
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Joolsg
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Thanks so much for that link. I couldn't find it initially. I was too over excited.Now I've read through the guidelines, I'm a little deflated to see that methadone and Buprenorphine are not listed in the treatment section. I've written to Andy Berkowski to ask why that is.
He has always been very positive about Buprenorphine. Also Dr Winkelman runs the Massachussetts Opioid RLS register, and most of the participants are taking methadone.
I guess not enough published evidence for benefit. Maybe being cautious and wanting to avoid criticism. But meant to be an evidence based recommendation.
Good morning and I can understand your excitement about the "breaking news".
i have read the whole study and like you i was generally encouraged but disappointed that buprenorphine not more strongly advocated. however they did say a new study will be published "shortly" on buprenorphine.
Whilst i don't think there was anything you didn't already know I am sure itis a document which will help "the cause"
Do you thik a study such as this reaches UK neurologists? I doubt many GPs would have time or inclination to read?
I was a bit confused (perhaps my lack of research experience) by the term under "harms" which was..... AEs leading to study withdrawal" . does that mean the AEs were so significant that the patient should stop the use of?
I don't think so Davchar. They are stating that some patients found the Adverse effects of a particular drug to be so terrible that the patient withdrew from a particular study. We see that here. Some people stop taking a drug very early on as they can't tolerate the adverse effects. For example, dizziness or weight gain on pregabalin. Panic attacks on Oxycodone, etc.The study is noting Adverse Effects for each drug they are duscussing in the study, and they then reach a conclusion for each drug, stating whether they believe the risks outweigh the benefits, or vice versa.
Thanks for sharing Joolsg! This is definitely a step in the right direction. I particularly found the “ Future Direction” section interesting. Dr. Berkowski mentioned one of them being “treatment of augmentation” which I feel is extremely important. The number of posts begging for help on HU alone is enough to depress anyone. The grit -your -teeth -and -deal -with -it approach from some doctors is just barbaric.
Also the evaluation of brain iron is significant. Overall, we can be very thankful to a handful of these fine doctors!
I absolutely agree. I just wish other doctors would read the research and stop prescribing dopamine agonists. Even top neurologists mistakenly believe Rotigitone patch & low dose Ropinirole/Pramipexole don't cause augmentation. As you say, we see it every single day.
Well they asked for comments - the whole point of releasing the draft. So I sent this - Dear AASM,
Re : Draft of the Restless Legs Syndrome (RLS) and Periodic Limb Movement Disorder (PLMD) Guidelines
I am sure this Guideline will be a great step forward and be very useful to doctors managing RLS. Maybe even more so for doctors not very familiar with managing RLS and for their educated patients to share with them.
Not commenting on Buprenorphine and Methadone is the biggest concern. For those patients trying to get their local doctor to prescribe these medications, especially for withdrawing from Dopamine Agonists when augmenting, it will be a blow. Lack of publications? Publications too recent? But Dipyridamole gets a “conditional” with very few publications. Peroneal nerve stimulation has few and recent publications. Concern about only recommending long-acting opioids as conditional instead of strong? Surely not timidity over recommending opioids? For those of use trying to get more freedom to prescribe opioids like Buprenorphine and Methadone against their listing this does not help.
But thank you for your hard work on this, I am sure there are reasons.
You can comment as a RLS sufferer and your difficulty getting Bup/Methadone if you want.
I asked Dr Berkowski and he confirmed it is because there have not yet been randomised, controlled trials of Buprenorphine or methadone. The guidelines are draft at this stage and hopefully a Buprenorphine trial in the USA might be completed before the final version.
Dr Berkowski is very much in favour of Buprenorphine and has written about it on his website. He prefers it to other opioids because of its long half life and lower rates of respiratory depression.
I'm still trying to get trials here in the UK. It's incredibly frustrating.
But we desperately need all the help we can get on methadone and Buprenorphine.
Thank you so very much Julesg for all the work and support you give for us RL sufferers. I started 5mg methadone mid January. It works so well. Yet I am a bit anxious about being on it long term or having to come of it, for whatever reason. Having now been able to sleep for past 2 mths I cannot bear the thought of all night RL ever again. It would be great to get some trials over the line! Thanks again.
I am outraged and dumbfounded that large-scale clinical double-blind trials regarding methadone and buprenorphine have not been carried out long ago in both the US and UK. What could be more causative for one losing one's faith in the medical profession? Hot damn, I'm mad!
It is infuriating. They could trial methadone against Buprenorphine. I've even written to the MS Society in the UK to ask if they'll help fund trials. They have lots of money, whereas rls.org and RLS-UK have very little!
30% of MS patients and Parkinson's patients also have RLS.
I guess they better get these trials done. Not having them mentioned in the guidelines will not help suffers get them. Hopefully they can make a comment on them in the discussion so the draft is seen as supportive.
yes, we'll said! As in my reply to Joolsg - I have just started methodone after trying the other meds to no avail. It is an enormous relief to be finally sleeping all night after having 1 to 2 hrs broken sleep and walking nights for 3 yrs, not to mention a lifetime of milder RL. But I was nervous to start methadone and now, 2 mths in, I am still a little anxious about the long term use and the awful thought of ever having to come of them for whatever reason! Trials would be great. I do hope they will comment in the draft. Both sufferers of RL and their doctors need help to feel confident this is the right solution.
Thank you Jools.
And RLSLearner for the link.
It's good to have a document that sets out recommendations / evidence so clearly. I agree that it is frustrating that the required evidence isn't there for buprenorphine/methadone given that it seems to help so many.
The PLMD component of the draft guidelines were of most interest to me. In particular the statement:
"The value of independent treatment of PLMS in the context of RLS is now of unclear significance, with the current focus being treatment of the symptoms of RLS rather than the sleep-related limb movements."
Thanks Joolsg - It is worth noting that Iron infusions are not without their risks. Each person must weigh up the pros and cons.
Author: Jess Jamieson
A group of women in Australia are collectively on a mission to help raise awareness to others of the dangers of iron infusions, after suffering for months to years with chronic hypophosphatemia, which has left them with long-term disabilities.
When you think of iron infusions, you think of vitality and a quick fix, but not too many of those administering infusions disclose, or are educated on, the hidden dangers of the iron infusion itself. Up to 92% of people can develop low phosphorus from iron infusions, which can lead to months of debilitating issues and temporary disability.
Iron infusion therapy is used to treat iron deficiency which is not responding to the first-line oral iron therapy. However, studies show it can also cause severe renal wasting of phosphate resulting in severe hypophosphatemia in some patients.
Despite the growing number of case reports, this side effect is not well-known to healthcare professionals. The product labeling information sheet does mention that hypophosphatemia can be a side effect, but also says that this side effect is usually transient and asymptomatic.
There is a growing number of people who develop severe, symptomatic, and prolonged hypophosphatemia after an intravenous iron infusion for severe iron deficiency.
The symptoms of hypophosphatemia depend on its severity. Some people with mild hypophosphatemia may have generalized mild to moderate muscle weakness or body aches/pains.
Severe hypophosphatemia can cause muscle pain and bone pain which can be mistaken for iron flu, muscular weakness, an altered mental state such as experiencing confusion or irritability, numbness, or reflexive weakness, difficulty breathing, or shortness of breath, and seizures.
Severe hypophosphatemia can also result in coma and death if not treated. If you’re experiencing symptoms of severe hypophosphatemia, it is recommended to get to the nearest hospital as soon as possible and have your fasting serum phosphate levels checked.
Going forward:
- Clinicians prescribing iron infusions should be aware of the common side effect of hypophosphatemia, which could be mild, moderate, or severe.
- Patients receiving iron infusion should be educated concerning this potential side effect.
- Pre-existing vitamin D deficiency, low calcium levels, low phosphate levels, or raised parathyroid hormone levels may be risk factors, and these should be tested, evaluated, and corrected before administering intravenous iron.
- Patients may require phosphate and active vitamin D (calcitriol) replacement along with monitoring for a long period after iron infusion-induced hypophosphatemia.
- Every incident should be reported to the Therapeutic Goods Administration (TGA) so that the true prevalence and management thereof can be ascertained.
Sources:
- E Ifie, S O Oyibo, H Joshi and O O Akintade Symptomatic hypophosphatemia after intravenous iron therapy: an underrated adverse reaction. PubMed doi: 10.2147/TCRM.S243462
- MA Libre, SS Karkare, and N Hadker Hypophosphatemia Associated with Intravenous Iron Therapies for Iron Deficiency Anemia: A Systematic Literature Review. PubMed doi: 10.1530/EDM-19-0065
I absolutely agree that there are side effects to IV iron infusions Goldy. In the UK, most iron infusions are given in.a hospital and are almost impossible to obtain. So far,the majority of the UK medical Profession is unaware of the benefits of iron infusions for RLS.The side effect of hypophosphatemia is lowest with FDI formulation.
Thanks for pointing this out Goldy. From my experience, i know they're not as innocuous as some people believe. After my 5th (or thereabouts) iron infusion in May last year, I developed mild hypophosphatemia. That seemed to be the start of a run of bad health for me, with some unusual and unexplained symptoms. It lasted at least 6 months and I had to take time off work. I can't say for sure that the poor health was a result of the hypophosphatemia/ infusion. It has however made me leery of having another one. I also know that the more infusions one has, the greater the likelihood of developing hypophosphatemia.
Not having any success with Zofran for nausea and so i will have to go for cannabis oil. I cannot find the post when you said what you took and the link for the supplier. Could you please forward me his information please?
What specifically put you off Zofran? It doesn't for me relieve the nausea and leaves me feeling rotten with hot & cold sweats.
thanks very much for this. Am now wondering: do you know if there is an official U.K. Royal College of ‘whatever’ Guideline to diagnosis, treatment & care of RLS?
There are NHS and NICE guidance. Both are outdated. Both still mention dopamine agonists, despite the Mayo Clinic Algorithm and the new American Sleep Academy guidelines making it clear that dopamine agonists should no longer be first line treatment.As most UK doctors aren't taught anything about RLS during training, it's not surprising.
RLS -UK has been trying to get NICE to update the guidance, with little success so far.
Hi Jools. I need a bit of advice again! I have had an email from my Pain Clinic Specialist Nurse today who had spoken to her Consultant. I'm so upset because I told her that the patches are causing a bad rash so would they prescribe the tablet's because the Buprenorphine is helping the RLS. The answer is "No ! He does not recommend Buprenorphine. " I spoke to my Dr. yesterday and he is not allowed to prescribe Buprenorphine tablet's! The Dr. wants me to take Cetirizine to combat the rash and keep trying with the patches . However, the Pain Clinic ( who were the one's who misdiagnosed my lung cancer for 15 month's and who have now diagnosed me with PTSD because of that ! ) want me to take either MST or another pill...Will have to come back in a minute with the name! I'm so upset I can't think straight! Sorry ! They also said Tramadol but I can't take that ! So are these going to make the RLS come back and make it worse? I'm so scared of it coming back badly the way it was before. I started crying when I spoke to my Dr. yesterday because I told him that if I go back to that , I don't know what I will do ! Having other problems like the vertebral fracture's with nerve damage +++ I can't bear being up all night because the pain is horrendous. This dithering about my medication has been going on for too long and I'm going to write to more Scottish M.P. s because the restrictions on Opioid medication is ridiculous if we are monitored which we would be. It's our life and our bodies so , if the medication is the only thing that works then let us have it especially when we are informed! My Dr. knows that I have tried to learn as much as I can about RLS or any other health issues so that I can try to help myself and others. I have asked to see a Neurologist. Sorry ! I'm extremely upset.
Thank you , in advance, for any advice. Will go an look at the other suggested medication.
Tapentadol is an opioid medication and shouldn't make your RLS worse. Cetirizine is safe for RLS.I am so sorry you are going through this. I just do not understand why Buprenorphine patches are allowed, but not pills.
You are not alone. There are several patients in England who have been refused Buprenorphine.
There doctors are afraid of 'addiction' or 'dependence'.
Dr Winkelman's opioid study is proving that low dose opioids do NOT cause addiction OR tolerance. We stay on the same LOW dose for decades.
And of course we are dependent on our meds, in the same way we were dependent on dopamine agonists!
I am angry on your behalf.
I have asked King's College Hospital to do a trial of Buprenorphine so it can be licensed for RLS. I'm still waiting to hear back.
I've also been speaking to the BBC and the Sleep Charity to try to change things.
RLS-UK are trying to force teaching of RLS and the meds that help, but they're up against a medical profession resistant to change and to patients knowing more than doctors.
Thank you so much Jools. My G.P.'s prescribed me Diconal 30 year's ago, a very strong Opioid and I had that for Endometriosis and 3 major Endo ops which left me with nerve damage and adhesions in my stomach. I didn't take it every day until I got lung cancer but we didn't know that for 15 month's but I was in so much pain. I was made to feel like a hypochondriac for 15 month's and it was the Pain Clinic who had the tumour on an Xray but I have , now, been told by them that it isn't their " policy " to look at the whole Xray but only the area that they are dealing with. At that time it was pain I had under my rib's. When I saw the Xray 15 month's later when I got pneumonia, even I could see the tumour! They didn't have a problem then prescribing Diconal or Dipipanone and Cyclizine...I ended up on 30 mg a day because I got used to them but then the Dr.s stopped them, with no warning and I went through cold turkey. I detest a lot of the medical profession because they have put me through hell and now, the Pain Clinic are doing it again! The Dr. told me yesterday that the patches have caused my skin to be red and blotchy and there are hard lumps and apparently the blood vessel's are infected. So , I can still get the patches but not the pill's ! The Dr. can't prescribe Buprenorphine tablet's without the Pain Clinic agreeing to it . Sorry to rant but I'm a cross between so angry and so upset.And ....breathe! Thank you, again, Jools. I will let you and the RLS Society know if I get a response from the M.P.'s . A close friend is also going to write to M.P.s and contact the BBC and other's so, I will let you all know if anything happens.
Take care please. I would be so much worse without your advice and the help and support I've had from other's here. xx
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