I have been a patient of Dr. Diego García-Borreguero and I can tell you that he is an eminence as a neurologist and psychiatrist when it comes to sleep disorders. It has its own clinic in 2 provinces of Spain (Madrid and Bilbao) and also in Santiago de Chile, its clinic in Madrid is called Instituto del Sueño and is based at Paseo de la Habana 151; telephone +34 913 45 41 29. You can find it online, and also consult on line.
As for serum iron infusions, I have to tell you that 35% of the patients obtain a total improvement and should not take medication for at least one year, another 35% obtain a partial improvement with a notable reduction in the dose of medication. Unfortunately there are 30% of patients who do not obtain positive results.
The price of each infusion is around 1000 euros and it takes at least two to achieve positive results.
I know patients who have been treated by him and have fortunately changed their situation completely, from leading a miserable life to not having to take medication, repeating an infusion a year.
Unfortunately due to my conditions I could not undergo this therapy.
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Arjiji
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I recently read that Dr Earley in the US has demonstrated that ferric carboximaltose infusions can be effective for up to 60% of people and effects can last up to 24 weeks.
This corroborates what Dr GB has found.
It's a great shame that health insurers and public health providers do not recognise this as yet.
For many sufferers the personal cost is prohibitive.
When you say that 2 infusions are needed- is this because levels do not rise sufficiently after one dose? In the USA, most people require only one infusion which generally raises ferritin levels above 350.
INTRAVENOUS TREATMENT OF FERRIC CARBOXIMALTOSE IN RLS: (Conference by Dr. Diego García-Borreguero)
Intravenous (IV) iron has been used as a treatment to reduce the symptoms of Restless Legs Syndrome (RLS), but two double-blind trials of a frequently prescribed iron formulation, iron sucrose, did not show long-lasting efficacy.
This study evaluates the efficacy and safety of a new IV iron formulation (ferric carboxymaltose, FCM) with molecular properties that may make iron more available for absorption in the brain than iron sucrose.
In this 28-day, multicenter, randomized, placebo-controlled trial, 46 patients with RLS were discontinued from all RLS treatments. Twenty-four received 500 mg of FCM in two doses 5 days apart and 22 received an equivalent placebo.
On day 28, those who received placebo received a single dose of 1000 mg FCM IV and those who did not respond to initial treatment received a third dose of 500 mg FCM. Patients were followed up for 24 weeks or until they required additional RLS treatment.
FCM significantly improved primary and secondary outcomes compared to placebo: lower mean (SD) of the International Severity Scale of the Restless Legs Syndrome (SDI) study group from 8.9 (8.52) versus 4.0 (6.11) , p = 0.040;
The Global Clinical Change Inventory (CGI-1) improved a lot or a lot 48.3% versus 14.3%, p = 0.004.
The quality of life also improved significantly. Of the 24 with initial iron treatment, 45% improved and 29% remitted (IRLS ≤ 10) on day 28, and 25% continued without other RLS medications at 24 weeks after treatment.
The single dose of 1000 mg on day 28 produced the same degree of response to treatment as the divided dose, but the added dose of 500 mg for those who did not respond to initial treatment showed little benefit. There were no significant adverse events.
Addendum: (I apologize because in my previous post I made a mistake in the percentages of patients who obtained total and partial success in the study)
Indeed the cost of this treatment is high and difficult to pay for many people since it is not paid by the National Health System, nor by private insurers. And that is so because it is still an experimental treatment.
The high cost is due to the fact that the infusions are performed in a hospital center and under the supervision of a hematologist.
And answering Jools, a single infusion of 1000 mg IV FCM would be enough to raise iron levels in brain deposits, but to avoid possible toxic effects or intolerance reactions in the patient, it is preferred to perform two infusions of 500 mlg.
Of course leaving the economic benefit without commenting.
Thanks Arjiji. From when is this report? I suspect it is one of the studies reviewed in the iron for rls paper by the RLSSG. Am I correct?
Also, although these studies are very valuable, they mainly use people with RLS without previous treatment. Don't know whether that was the case here. But most people on this forum are 'difficult' cases, mostly with refractory RLS and often with relatively high susceptibility to side effects. I am just saying that averages from published studies have a somewhat limited values for the 'difficult cases'. On the good side, it is a very low risk treatment very worth trying, if one can get it organised.
Allen RP, Adler CH, Du W, Butcher A, Bregman DB, Earley CJClinical efficacy and safety of IV ferric carboxymaltose (FCM) treatment of RLS: a multi-centred, placebo-controlled preliminary clinical trial. Sleep Med. 2011 Oct;12(9):906-13. Epub 2011 Oct 5.
I wonder if - as Lotte suggests - the percentage of successful cases is lower in a cohort suffering from refractory rls and in particular whether a previous augmentation presentation would be of significance in the likely outcome. I (gloomily) suspect albeit without anything other than anecdotal evidence to support the theory - that a history of augmentation is likely to reduce the prospects of successful reduction of symptoms following iv infusion of iron.
On a separate but connected note, I think that Dr. Buchfuhrer now habitually has the full infusion of 1000mg done in one go as the incidence of toxic shock is so low.
Hi Arjiji This is based on a fairly old paper. I would have thought that someone would have followed this up to see what patient history indicates the probable success of the treatment. I haven't searched for any papers that refer to this 2011 work.
The other thing I had heard about Dr. Diego García-Borreguero referred to his development of a method of trans cranial ultrasound that would determine the concentration of iron in the brain (without an autopsy). This was unfairly dismissed by one imaging person I spoke to as very unlikely to work. Has anyone found a reference to his technique that explains how it works? It sounds like a very valuable thing to measure in order to treat an RLS patient.
The intravenous iron infusion treatment described sounds like the same as I had done in Australia for $400 Euros and as far as I could tell there was no public money assisting with that. Mine was a single infusion of sufficient iron to raise my ferritin to about 350. Does anyone know what makes it dearer and if its worth paying more for? Mine didn't help me so now I am left wondering if I got a "cheapie" that left out the most important step.
Hi Graham, I think the fe-carboxymaltose paper Arjiji reders to is one of the papers reviewed in the seminal paper about iron for RLS by the IRLSSG: sciencedirect.com/science/a.... They discuss the pros and cons of the various types of IV iron that have veen researched.
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