Re: Successful treatment for RLS

March 28, 1999

Dear ne:

Thank you for your e-mail.

As I said, a patient does not require varicose veins in order to have RLS, but

if they do (or even have " cosmetic veins) then there is a very high

correlation with RLS (in our experience) that should not be ignored. However

it is the quality of treatment that makes the relief of RLS. Surgery does not

seem to work, and shouldl not even be attempted. But the type of treatment is

beyond discussion at this point.

As regards anyone selling phony " cures " , I despise anyone who raises false

hopes in suffering patients. I do not charge patients whom I can't help, but

that is a rare event. From our perspective, we have had so many pleasent

surprises with our treatment over so many years that we feel obliged to tell

RLS patients in support groups like this. If they are interested, then I am

interested in looking at their problem and examining their RLS limbs.

Sincerely,

McDonagh, M.D.

March 28, 1999

In a message dated 3/28/99 8:04:46 PM Central Standard Time,

DMcdon6452@... writes:

<< rlssupport (AT) onelist (DOT) com >>

Dr. Mc...

You will have to forgive us for being distrustful of a treatment that is so

far from the mainstream of medical advice, especially since most of us have

just found some relief from RLS symptons after years of suffering.

I have RLS/PLMD in my left leg and arm, frequently in my right leg as well,

and occasionally - the really bad one - in my abdomen.

If you would be willing to pay the expenses of a member of this group to come

for consultation, then I think that message would be widely received with

interest within this savvy group and the RLS Organization.

Clayton - 56 Female

March 28, 1999

Hi gang,

There is some evidence via one medical journal article that treating varicose

veins might help RLS symptoms. See it below; all abstracts or summaries that

came up on Medline " Varicose Veins and RLS. "

The Medical Advisor for our RLS Support Group feels it is worth a try in some

cases where varicose veins should be treated any way but when it comes to

Sclerotherapy, he said, if I am remembering right, this is basically a poison

injected and not without its complications even if infrequent like Dr.

Mc claims.

Since this one study was done by an author whose address is the " Vein Center, "

our medical advisor is a little skeptical but willing to listen and keep an

open mind solely because he wants to leave no stone unturned. I posted to Dr.

Buchfuhrer on this since he is in S. CA where the Vein Center is but have not

heard from him.

I suggest Dr. Mc that you contact Dr. Buchfuhrer who we all respect and

see if he can persuaded to refer some patients to you. I think I remember you

being in CA also.

Also, our Medical Advisor suggests if varicose veins exists that are marginal

to treat and all else has failed to alleviate RLS symptoms, maybe it is worth

a try. However, each case has to be judged individually. It cannot be said

every single RLS patient, including the 3 year olds, get dragged out to get

varicose vein treatment even if a negligible problem perhaps not worth the

risk of the treatment.

Now, to Dr. Mc, we have access to some highly credentialed doctors who

are experts on RLS. Many in this group go to one of those doctors. To usurp a

treatment plan for RLS formulated by one of these doctors with all your

postings, it is my impression it is unethical.

Barbara

The effect of Sclerotherapy on Restless Legs Syndrome.

Author: Kanter AH

Address: Vein Center of Orange County, Irvine, CA 92714, USA.

Source: Dermatol Surg, 1995 Apr, 21:4, 328-32

BACKGROUND. Restless Legs syndrome (RLS) is a disorder of unknown etiology

characterized by relentless leg discomfort when stationary, which compels

voluntary leg movement to obtain temporary relief. We have received anecdotal

reports of coincidental relief from symptoms of RLS in patients following

sclerotherapy for varicose vein disease.

OBJECTIVE. To prospectively evaluate the concomitant occurrence of RLS and

varicose veins in a population seeking treatment for varicose veins, and to

assess the therapeutic response of RLS to sclerotherapy.

METHODS. One thousand three hundred and ninety-seven patients were screened

for RLS symptoms by questionnaire and interview, and for saphenous vein

disease by clinical examination, including continuous-wave Doppler.

Sclerotherapy with sodium tetradecyl sulphate was performed on 113 RLS

patients.

RESULTS. RLS symptoms were present in 22% (312/1,397), with a Doppler-negative

to Doppler-positive ratio of 3:2. One hundred and eleven of the 113 treated

patients (98%) reported initial relief from RLS symptoms. Follow-up thus far

shows a recurrence rate of 8% and 28% at 1 and 2 years, respectively.

CONCLUSIONS. RLS is common in patients with both saphenous and nontruncal

varicose vein disease, and can respond frequently and rapidly to

sclerotherapy. This subpopulation of RLS sufferers should be considered for

phlebological evaluation and possible treatment before being consigned to

chronic drug therapy.

Late complications of asymptomatic deep venous thrombosis.

Author: Andersen M; Wille-J‡rgensen P

Address: Department of Clinical Physiology and Nuclear Medicine, Bispebjerg

Hospital, University of Copenhagen, Denmark.

Source: Eur J Surg, 1991 Sep, 157:9, 527-30

Abstract: Forty-one patients who had all participated in studies about

prophylaxis of postoperative deep venous thrombosis (DVT) were investigated

5-8 years after operation. Twenty-five had had asymptomatic DVT detected by

125I-fibrinogen uptake test or 99mTc plasmin scintigraphy and verified by

phlebography, four of which were bilateral. They received anticoagulant

treatment for three months. Sixteen patients had normal screening tests.

At the follow up legs in which DVT had previously been diagnosed were compared

with normal legs in patients who did not have DVT. There was no significant

difference in subjective symptoms between the two groups of legs, although

there were more complaints of oedema and restlessness in legs in which DVT had

been diagnosed and varicose veins were more common.

When the incidence of varicose veins before the operation and at the follow up

was compared, more patients who had had a DVT had developed varicose veins.

Blood volume and venous refilling time were measured by strain gauge

plethysmography, and were significantly lower in those with a history of DVT

than in normal legs. The results indicate impaired venous function in patients

who previously had had asymptomatic DVT treated with anticoagulants.

Evaluation of clinical efficacy of a venotonic drug: lessons of a therapeutic

trial with hemisynthesis diosmin in " heavy legs syndrome "

Author: Carpentier PH; Mathieu M

Address: Laboratoire de MÆedecine Vasculaire, UniversitÆe ph Fourier,

Grenoble.

Source: J Mal Vasc, 1998 Apr, 23:2, 106-12

Abstract: Venous-type symptoms, i.e. painful sensation of heavy, swollen or

restless legs, influenced by orthostatism and warm environment, significantly

alters quality of life of a large proportion of women. Although the condition

is frequently associated with chronic venous insufficiency, no demonstrable

hemodynamic abnormality of the superficial as well as deep venous systems of

the lower limbs can be found in many patients. The pathogenesis of this

syndrome remains unknown, and there is no objective measurement of any

biological nor hemodynamic parameters that can be used for its assessment.

Diosmine and other flavane derivatives have been shown beneficial in this

condition using various discomfort indexes. The aim of this work was to

compare the therapeutic efficacy of two formulations of the same compound

diosmine. In the analysis, particular attention was paid to the signification

and usefulness of discomfort scales. This study was a double-blind, placebo-

controlled therapeutic trial, comparing the efficacy of a new formulation,

hemisynthesis diosmine 600 mg, one tablet per day taken in the morning, versus

the usual tablet formulation of 300 mg taken twice a day (morning and

evening). Treatment blindness was assured by the double placebo method. Two

parallel groups were treated 28 days with one or the other treatment.

Randomization was performed with stratification by center.

The main evaluation criteria were a composite scale of venous type symptoms

(i.e. the sum of individual score 0-4 of each symptom), and a visual analog

auto-evaluation scale quoted each week by the patient. The global opinion of

the physician on treatment adequacy to the clinical situation, and the degree

of patient satisfaction (four grade scales) were used as subsidiary criteria.

In order to increase the homogeneity of the study sample, inclusion was

restricted to non-menopaused women aged 18 years and over, having given

written informed consent, complaining of distressing sensation of heavy legs,

without history of venous thrombosis, varicose veins, superficial or deep

venous reflux at the duplex-scan examination.

Patients with other causes of pain in the lower limbs, taking analgesic

medications or requiring elastic stocking were not included. 255 patients

participated in the trial. Eighteen withdrew, equally distributed in both

groups (6 lost, 5 interfering diseases, and two dropouts for side effects,

namely headache and gastric pain). Twenty additional patients complained of

detrimental events not requiring treatment withdrawal, equally distributed

between both groups, and mainly involving digestive functions. The results

confirmed a similar efficacy of the two drug regimens, and a small but

significantly better improvement of the patients' auto-evaluation of their

discomfort on the analogic scale (p = 0.021) for hemisynthesis diosmine 600

mg, mainly during the first two weeks; for all four criteria, the gamma risk

showed that the once-a-day 600 mg preparation at least as effective as 300 mg

twice daily (p < 0.001).

On a methodological point of view, the comparison of evaluation criteria

showed that the composite scale, although giving the feeling of a

comprehensive and quantitative appraisal of the discomfort in the legs, was

almost equivalent to a standard four grade rating of heaviness, which appeared

as the central symptom of this condition. Auto-evaluation through an analogic

scale proved to be more informative, more sensitive, less influenced by the

physician's feelings and allow easier assessment of the time-course of the

drug's effects.

Global evaluations by the patient and the physician did not give additional

information but could be used as quality criteria, assessing the coherence of

the results obtained with the scales. This study demonstrated a similar

efficacy of the two drug regimens, with a more rapid effectiveness of the 600

mg preparation taken once a day. Auto-evaluation on the analog scale proved to

be the most informative and effe

Venous pain, 30 years after the 1st International Congress of Phlebology in

Chambéry

Author: Griton P; Cloarec M

Address: Hôpital Tenon-Paris-Policlinique.

Source: Phlebologie, 1992 Jan-Mar, 45:1, 21-30; discussion 30-1

Abstract: In 1960, the first International Conference of Phlebology, organised

at Chambéry by Jean Marmasse under the egis of R. Tournay included only three

subjects in its programme, one of which was: " venous pain " . What is the status

of venous pain thirty years on? Can we compare our current concepts with work

from past years? Have we advanced in knowledge and in its clinical and

therapeutic applications? All these questions are even more worthy of

consideration bearing in mind world-wide increased interest in Phlebology and

its even richer future.

The Chambéry Conference established a clear pattern with: two basic reports:

" pain due to essential varicose veins and to trophic disorders " (C. Huriez, F.

Desmons, M. Thoreux) and " pain in phlebitis " (R. Fontaine); three analytical

and differential reports " pain due to interlinked arterial and venous

disorders " (F. Piulachs), " pain in the lower limbs due to interlinked

gynecological and venous disorders " (A. Bret, R. Legros) and " pain due to the

association of osteoarticular and rheumatic disorders or of neuralgia in

venous disease patients " (J. Forestier); and nine other studies, the following

being worthy of particular attention: a very interesting report by R. Tournay:

" Pain in venous disorders of the lower limbs related to their treatment " ; and

two papers: " pain of " cellulite " type and the metameric disposition of the

lower limbs in relation to functional disorders of the ovary " (S. Bourgeois),

and " exercise pain and rest pain in varicose vein sufferers " (J. Marmasse);

three German reports (F. Jaeger, F. Maid-Fischer and D. Gross) on the

pathogenesis and mechanisms of venous pain; and the report of M. Comel

" epiesthesia and histoangeological correlations " . Since that time, venous pain

has no longer figured in the same format on the programme of any international

conference, nor at meetings of the French Society of Phlebology.

Progress has thus occurred insidiously... Mention may be made of the following

with regard to essential varicose veins: some progress in knowledge of cramps,

phlebalgia and venous paresthesiae; attribution to venous syndromes of

" restless legs " , which have been such a source of intrigue for the past

hundred years, and interest in inflammatory pain of the superficial venous

system and of subcutaneous cellular tissue in relation with venous

insufficiency, as well as ulcer pain. However, it is in the area of acute deep

venous thrombosis that everything has been disrupted. Firstly, with the

established certainty that the clinical picture leads to errors in more than

50 p. cent of cases, both by excess and default. (ABSTRACT TRUNCATED AT 400

WORDS)

March 28, 1999

Dear :

My intentions are to examine some RLS patients who live close to Chicago.

After others read of their successes, others may feel encouraged to come. Your

point on relief coming from outside the mainstream of advice is well taken.

However, mainstream thinking on RLS has not been very fruitful according to

what I have read with this group. This is especially so with our history of

success.

Thank you for your feedback.

Sincerely,

McDonagh, M.D.

March 28, 1999

Dear on:

Thank you for your e-mail. Briefly, all of the symptoms you mentioned are

attenuated by our treatment.

I have spoken about RLS to many medical groups over the years, however, as

many of your group have noticed there is not much knowledge or interest in the

subject. There is an article written by a former student of mine on our

treatment. It was a research project I gave him during his training with our

group. The reference is:

Kanter, A., Resolution of " Restless Leg Syndrome " after sclerotherapy, etc, in

the Journal of Dermatologic Surgery&Oncology, 17:1, p93, 1991

Sincerely,

McDonagh, M.D.

March 28, 1999

Dear ,

Thank you for your e-mail explaining your treatment. I visited your website,

and I find that it

does provide an interesting perspective on our disorder. Many of us have

addressed the problem

from a neurological vantage point.

I wondered if you have any data on the efficacy of your treatment on PLMD (or

PLMS). I

understand that something like 85% of subjects manifesting RLS also manifest

PLMD. Have you

found that your successful treatment of the RLS has also attenuated the muscle

twitches,

kicking, jerking, etc. during sleep? I, myself, have both maladies, but I find

that the PLMD is

the more difficult one to treat.

In your bio you mentioned that you had published articles on your treatment.

Would you please

send me citations of your publications? I can get hard copies of articles

through a regional

medical library, and I read everything on sleep disorders that I can get my

hands on.

I look forward to hearing from you and to reading your studies.

on, 65, the Carolinas, USA

DMcdon6452@... wrote:

> From: DMcdon6452@...

>

> Recently, I wrote a letter to some thirty members of this RLS group explaining

> our success at treating this condition, citing that " normal " appearing veins

> in the legs appear to be responsible for the symptoms. I was merely trying to

> " test the waters " for interest in a very promising and safe treatment. But to

> my great surprize there was no interest. There was much mistrust and

> criticism. I expected openness. We have been treating this condition since

> about 1982 with tremendous success and little or insignificant recurrence.

> Because the

> responsible veins appear " normal " is probably the reason why RLS has been

> elusive for so long. We have not seen or treated RLS of the hands or arms, but

> I would not be surprised to find the same predisposing factors.

>

> I am looking for a few " extreme " cases of arm and leg symptoms (in this RLS

> support group) to examine and see if they have the typical findings common to

> all of our other rls cases. If so, we can elect to proceed with treatment of

> one limb and compare the difference. There are no significant side effects to

> our treatment. For further info you can see our web page www.veinclinics.com,

> then go to " Treatment " and then to RLS.

> Sincerely,

> McDonagh, M.D.

> Chicago, IL

>

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> This forum is for support only. The information posted to this List is for

support purposes

> and is not intended to replace the examination, diagnosis and treatment of a

licensed

> physician and no such claims are inferred.

March 29, 1999

Dear Barbara:

Thank you for your very detailed response to my statements, even though you

appear to be skeptical, angry, mistrustful and critical. The Dr. Kanter you

mentioned, who wrote the article in the JDSO medical journal in 1991, was a

student of mine about ten years ago in Chicago. I gave him the research task

of investigating and tabulating RLS while he was in training with me. As you

know this was a peer review article, but in spite of it, few patients with RLS

ever heard of it. Pity.

Because of my experience in this field (20years) I feel correct in telling

this group about the success of our treatment. If a few RLS sufferers come and

get relief and then tell other RLS patients then I believe I will have done

enough. It will succeed on its own merits. However, I can't prove that it will

work on you, and because of that and your skepticism, you would probably be

best served if you stay on your present treatment regimen.

I think your use of the word " poison " in describing sclerosants is an

unfortunate error because the one we like to use (sodium tetradecyl sulfate)

is considered one of the safest medications in the PDR. I don't know of any

that would fall into the category you mentioned.

You are correct in mentioning that we own many of these centers that

specialize in the treatment of venous disorders. That is our strength in terms

of quality control. Presently we are conducting a five year multidoctor,

multicenter, scientific study on the long term efficacy of sclerotherapy.

However, my connection with this group is on my own behalf only because I feel

strongly that the relationship between RLS and " innocent looking veins " is a

real one. I am looking for a few patients with RLS who have no obvious vein

disorder. A large percentage of our RLS patients come to us for cosmetic

reasons only. They were surprised to find that their physical discomforts

disappeared on the leg we were treating. This is not anecdotal but scientific

and clinical observation.

Sincerely,

McDonagh, M.D.

March 29, 1999

Yes, , we have presented our data at medical conferences. One of my former

students, Dr. Kanter, published and article on RLS in the Journal of

Dermatologic and Surgical Oncology . Reference # 17:1, p93, 1991.

Sincerely,

McDonagh, M.D.

March 29, 1999

--- DMcdon6452@... wrote:

> From: DMcdon6452@...

>

> much mistrust and

> criticism. I expected openness. We have been

> treating this condition since

> about 1982 with tremendous success and little or

> insignificant recurrence.

Have you published your findings in peer reviewed journals or presented

at conferences? If not, why are you withholding your findings?

--

_________________________________________________________

March 29, 1999

In a message dated 3/29/99 3:17:59 PM !!!First Boot!!!, DMcdon6452@...

writes:

<< I am looking for a few patients with RLS who have no obvious vein

disorder. A large percentage of our RLS patients come to us for cosmetic

reasons only. They were surprised to find that their physical discomforts

disappeared on the leg we were treating. This is not anecdotal but scientific

and clinical observation.

Sincerely,

McDonagh, M.D. >>

You know, every legitimate e-mail list that I have ever participated in

eventually, one way or the other, makes the following rules concerning their

list:

1. No advertisement/spamming is allowed on the list, especially any

advertisement that financially profits someone. People on the list who

advertise to fellow list members and stand to financially gain from their

list-mates misery/problem/disease/etc. should be booted from the list!

Advertisment/spamming on the list, no matter how well meant and no matter how

promising should be considered unethical and not tolerated! Help us Jodi!!!!

2. Religious debates should be held elsewhere or via private e-mail. No one

should use the list to " witness " to and/or try to convert other list-mates,

this includes Buddha or whoever. We are here to discuss RLS.........not

salvation of our souls. We need salvation of our bodies from RLS!

3. No political debates! This only leads to flame-wars and such. Nothing

will be gained and nothing will be solved! It is fine to discuss the politics

of RLS, government research, ADA and related matters.

IMHO

RAINBOWPED@...

March 29, 1999

Dear Dr. :

" No matter how well meant or how promising, they should be booted from the

list, etc " . How cynical can you get? I have noticed an interesting feature

common to optimists and pessimists: they are both correct. It depends on your

attitude what you attract to you in this life. (Attitude is everything, as

some wise man once said). What is your prejudice as to how a promising

treatment/cure should look like? Do you expect something for nothing? What do

you sell your services for since you are also a doctor? I do not believe that

it is " unethical " , as you have described it, to point some people in the right

direction, especially as I have declared that I do not charge patients when I

can't help them, and that is rare with RLS. Philosophically, this has always

been my policy. I am emotionally moved to inform patients who are severely

bothered by RLS, including those who have failed to respond to neurologic

remedies and can't sleep at night, especially those whose insurance companies

are willing to pay for effective treatment. (This is how you are employed

also).

My intentions are to inform an RLS group, such as this, of a promising

alternative. Hopefully, some severe and near-hopeles cases will see my message

and act accordingly. If it works well for them and they tell others, then so

be it. That is a valid contribution to mankind. What is your reason for

employment?

Personally, I am disappointed in you because you too are a doctor. I expect

more from colleagues who are supposed to be compassionate to humanity. And for

your information, my financial upside from this effort is miniscule to say the

least. This is a very small group of people compared to my 13 vein treatment

centers. My objective is to inform them of their options, and then leave them

alone if they wish to pursue the traditional therapeutic regimens.

Sincerely,

McDonagh, M.D.

March 29, 1999