Daflon 500 and Secondary Lymphedema

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Daflon 500 and Secondary Lymphedema

Postby patoco » Wed Jun 21, 2006 7:04 pm

Daflon 500 and Secondary Lymphedema

Lymphedema People



Daflon 500 and Secondary Lymphedema

There has been much talk and discussion on the possible use of Daflon 500 for the treatment of lymphedema and I thought perhaps it mgiht be time to address this issue.

I want readers to understand though, this is for information and does not mean I endorse or oppose this product. Furthermore, even if you shold decide to try it, I would urge you to consult with your physcian and to work with them in your treatment protocol.

Our lymphedema team consists of compliant patients, educated doctors and skilled therapists...

Daflon originally was used in the treatment of chronic venous insufficiency including one of its complications venous ulcers.

Daflon 500 has been studied and shown that it may be beneficial in the treatment of secondary arm lymphedema. Please note, there is nothing to indicate its benefits for primary lymphedema of the legs.
Possible Side Effects May Include:

Side Effects: Stop taking your medicine right away and talk to your doctor if you have any of the following side effects.

Allergic reaction: Itching or hives, swelling in your face or hand, swelling or tingling in your mouth or throat, chest tightness, trouble breathing, or rash.

Other Possible Side Effects: You may have the following side effects, but this medicine may also cause other side effects. Tell your doctor if you have side effects that you think are caused by this medicine.

Nausea (upset stomach), vomiting, abdominal (belly) cramps, diarrhea

What is Daflon 500?

DAFLON 500 mg, is a Micronized Purified Flavonoic Fraction (MPFF) containing 90 % of Diosmin and 10 % of flavonoids expressed as Hesperidin. Hesperidin is extracted from a species of Rutaceae aurantieae of the citrus genus, a type of immature small orange harvested and dried in Spain, North Africa, and China. Diosmin, a member of the flavonoid family, is synthesized starting from this raw material.(1)

Flavonoids are classified as a Benzopyrone.


Drugs or herbal substances commonly used in Alternative Medicine, falls under the broader class of drugs called flavonoids. Some forms have been found useful in assisting in the treatment of cancers because of their ability to act as inhibitors and suppressants of tumor growths. Other types have been shown to help in the treatment of lymphatic developmental disorders. While these agents have been used for lymphedema in Europe and India there continues to be much debate of their effectiveness. In the United States the FDA has yet to approve their use.


Broad spectrum of herbal, substances used in Alternative and Complimentary medicine. Flavonoids which are water soluble (versus
oil soluble as the carotenes are) have demonstrated antioxidant properties and as such may assist the body in eliminating radical
free agents.

These substances were first discovered by Albert Szent-Gyorgi, Ph.D., a Nobel laureate who also discovered vitamin C.

For further information on Benzopyrones, please our page:

Lymphedema Benzopyrones

http://www.lymphedemapeople.com/thesite ... eatmen.htm


Servier.com Daflon 500 page (1)

Please be sure to read this entire article

http://www.servier.com/pro/phlebologie/ ... daflon.asp


Clinical Studies for Arm Lymphedema

Efficacy of Daflon 500 mg in the treatment of lymphedema (secondary to conventional therapy of breast cancer).

Angiology. 1997 Jan;48(1):93-8.

Pecking AP, Fevrier B, Wargon C, Pillion G.

Department of Nuclear Medicine, Centre Rene Hugenin, Saint Cloud, France.

To assess the activity of a purified, micronized, flavonoidic fraction (Dios; Daflon 500 mg*) on upper limb lymphedema occurring after breast cancer therapy, a monocenter, randomized, double-blind, parallel group vs placebo (Plac) trial was carried out. One hundred and four women with lymphedema were included; 94 completed the study (46 Dios, 48 Plac). A subset of 24 patients with more severe lymphedema (10 Dios, 14 Plac) was subjected to a separate analysis. Treatment consisting of Dios or Plac was given two tablets daily over a six-month period. A radionuclide lymphoscintigraphy using technetium-99m was performed at inclusion and at the end of the treatment. The upper limb volume was measured every two months. In the overall population the evolution of parameters was not different between Dios and Plac. In the 24 patients with a more severe lymphedema, the lymphoscintigraphic parameters (m +/- sd) were as follows: lymphatic migration speed was significantly improved by Dios in comparison with Plac (delta Speed cm/minute: 0.84 +/- 0.6 vs 0.14 +/- 0.26, P = 0.005). The half-life of the colloidal compound was significantly improved over time in the Dios group (delta half-life = 10.3 +/- 13.07 minute, P = 0.034) but not in the Plac group (delta half-life = 0.53 +/- 15.51 minute, P = 0.086). The change over time of colloidal clearance was close to significance in the Dios group (delta clearance microL/minute: 2.18 +/- 3.10, P = 0.054) but not in the Plac group (0.11 +/- 2.26, P = 0.86). No significant difference was found for evolution of lymphedema volume, despite a tendency in favor of Dios. This can be related to wide distribution of volume values and small numbers of patients. In conclusion, these results suggest a beneficial therapeutic activity of Dios at the usual dose of two tablets/day in patients affected with more severe lymphedema. The clear improvement of the lymphatic speed illustrates its known lymphokinetic activity. Further studies with a higher dosage could confirm the beneficial activity of this drug in secondary lymphedema.

Publication Types:
Clinical Trial
Randomized Controlled Trial

MeSH Terms:
Breast Neoplasms/complications
Breast Neoplasms/therapy
Diosmin/therapeutic use*
Double-Blind Method
Drug Combinations
Flavonoids/therapeutic use*
Hesperidin/therapeutic use*
Lymphedema/drug therapy*
Middle Aged

Drug Combinations
S 5682

PMID: 8995350 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/quer ... t=Citation


Clinical efficacy of micronized purified flavonoid fraction (MPFF) in edema.

Angiology 2000 Jan; 51: 25-9

Olszewski W.

Department of Surgical Research and Transplantology, Polish Academy of Sciences, Warsaw.

Swelling is one of the most frequent complaints of patients in daily clinical practice; leg edema is its objective confirmation. It can be associated with several diseases. Micronized purified flavonoid fraction (MPFF) is a phlebotropic drug commonly used to treat the signs and symptoms associated with chronic venous insufficiency (CVI). It has confirmed its clinical efficacy in different groups of patients suffering from edema: idiopathic cyclic edema, CVI-associated edema, postmastectomy lymphedema and might be beneficial in some of drug-induced edema. In a double-blind, placebo-controlled, randomized study including 30 outpatients suffering from idiopathic cyclic edema syndrome, MPFF 1000 mg/day for 6 weeks, normalized the capillary permeability, assessed by the Landis isotope test, in 3 out of 4 patients (p=0.01). The decrease in capillary hyperpermeability led to a clinically significant decrease in weight and edema. In 200 patients with functional or organic venous insufficiency of the lower limbs, a double-blind, placebo-controlled, randomized study with MPFF 1000 mg/day for 2 months provided strong evidence of a marked improvement in symptoms and signs. A significant reduction in supramalleolar edema (assessed by circumference measurement) was observed, whatever the origin of CVI: functional or organic. MPFF efficacy was also demonstrated in another randomized, multicenter controlled trial in 320 patients suffering from chronic venous insufficiency. In this study, a significant decrease in circumference of the most affected leg was observed after 2 months of treatment (p<0.001), whatever the schedule of administration of MPFF (1000 mg once daily or bid). The benefit of MPFF on edema has been further confirmed by the volometer technique (opto-electronic measuring system) which was performed in a population of 30 patients suffering from CVI and treated by MPFF 1000 mg/day over a 6-week period. The mean volume of the more affected lower leg decreased significantly after a 6-week period of treatment, correlating to a significant improvement in clinical symptoms. MPFF has been also tested on another type of edema, upper limb lymphedema secondary to mastectomy, during a double-blind, placebo-controlled, randomized study in 104 patients. MPFF 1000 mg/day improved all lymphoscintigraphic parameters such as half-life and clearance of the labelled colloid. With regard to evolution of lymphedema volume, a tendency in favor of MPFF was observed in the subgroup of patients with more severe lymphedema. Based on its action on capillary hyperpermeability, MPFF has been used with attractive results when combined with classic treatment for a pilot study carried out in patients with advanced breast cancer (n=21) or ovarian carcinoma (n=3), treated with docetaxel, which causes severe edema as a side effect, even when associated with corticoids. Further trials are under way to assess the possible benefit of MPFF in such patients. These results in different types of edema confirm that, by acting on all parameters involved in edema, veins, lymphatics, and microcirculation, MPFF represents a drug of choice for treating CVI-associated edema.

PMID: 10667640 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/quer ... query_hl=2


Safety and security of Daflon 500 mg in venous insufficiency and in hemorrhoidal disease.

Angiology, 1994 June

Meyer OC.

Service de Rhumatologie, Hopital Bichat, Paris, France.

Daflon 500 mg is a new flavonoid vasoprotector venotonic agent whose active principle is micronized and contains 90% diosmin and 10% flavonoids expressed as hesperidin. In animal studies, the safety of Daflon 500 mg is shown by an LD50 (lethal dose 50) of more than 3 g/kg, ie, 180 times the daily therapeutic dose, as well as by the absence of any toxic effect after repeated oral dosing for thirteen and twenty-six weeks, using a dose representing 35 times the daily dosage, in the rate and primate. Daflon 500 mg has no mutagenic action nor any significant effect on reproductive function. Gastrointestinal tolerance is good when administered orally in the rat. Transplacental passage and passage into breast milk are minimal. In the rat, 0.003% of the administered dose has been found in each fetus and 1% in breast milk. Clinical trials fulfill international scientific requirements and have collected more than 2850 patients treated with Daflon 500 mg at the dosage of two tablets per day for six weeks to one year. The proportion of patients with side effects (10% of those treated), essentially of a gastrointestinal or autonomic nature and leading to a rate of only 1.1% trial dropouts, is less than described in 225 patients given a placebo (13.9%) in controlled trials. Satisfactory clinical acceptability already confirmed in the short term was equally found in long-term treatment. Hemodynamic parameters (systolic and diastolic blood pressure) as well as laboratory parameters (hematology, liver and renal function, metabolic) were uninfluenced even by prolonged treatment for one year at the dosage of two tablets per day.(ABSTRACT TRUNCATED AT 250 WORDS)

PMID: 8203791 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/quer ... t=Abstract


Benzo-pyrones for reducing and controlling lymphoedema of the limbs.

Badger C, Preston N, Seers K, Mortimer P.

BACKGROUND: Lymphoedema is the accumulation of excess fluid in the body caused by obstruction of the lymphatic drainage mechanisms. It can be caused by a number of factors, including congenital predisposition, parasitic infection or surgery. Lymphoedema is chronic and progressive and affects a significant proportion of the population. The standard treatment regimes include compression hosiery, skin care and exercise. The use of drugs in treatment, particularly benzo-pyrones, has gained favour over the last ten years. Benzo-pyrones, originally developed for use in vascular medicine, are prescribed to reduce vascular permeability and thus the amount of fluid forming in the subcutaneous tissues. Advocates for this treatment method believe that, as a result of reducing filtration, the drugs have some beneficial effect on pain and discomfort in the swollen areas. Proponents also claim that these drugs increase macrophage activity, encouraging the lysis of protein, which in turn reduces the formation of fibrotic tissue in the lymphoedematous limb. OBJECTIVES: To assess the effectiveness of benzo-pyrones compared to placebo or to different benzo-pyrones in reducing limb volume, pain and discomfort in lymphoedematous limbs. To assess the effect of benzo-pyrones on the quality of affected tissues and on the patient's quality of life and, finally, to establish the incidence of adverse effects SEARCH STRATEGY: We searched the Cochrane Breast Cancer Group register (September 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4,2003), MEDLINE, EMBASE, CINAHL, UnCover, PASCAL, SIGLE, reference lists produced by The British Lymphology Society, the National Research Register (NRR) and The International Society of Lymphology congress proceedings. SELECTION CRITERIA: Types of studies considered for review were randomised controlled trials testing Paroven, coumarin, Venastat, Cyclo 3 Fort or Daflon versus placebo (with both groups having or not having standard physical treatment DATA COLLECTION AND ANALYSIS: Eligibility for inclusion was confirmed by two blinded reviewers who screened the papers independently using a checklist of criteria relating to the randomisation and blinding of the trial. Both reviewers extracted data from the eligible studies using a data extraction form. MAIN RESULTS: Overall, 15 trials were included that evaluated the role of benzo-pyrones. Three trials of oxerutin were found. Each tested the drug over 6 months using the same dose of drug against placebo. Two were crossover trials and one a parallel group trial with a total number of 127 participants and data available for only 81 of them. There were insufficient data provided in any of the trials to calculate the per cent reduction or increase in baseline excess limb volume. Standard deviations or confidence intervals and the numbers in the groups at the different stages of the trial were missing for all the data in two of the reports and for much of the data in the third, making any attempt at meta-analysis impossible.One trial testing Cyclo 3 Fort (approved name) over 3 months was found and involved 57 patients but provided insufficient data to allow a proper analysis of its findings. A single trial of Daflon (approved name) was found, lasting 6 months and involving 104 participants; once again there was insufficient information provided in the report to reach a conclusion about the effectiveness of the drug. Three trials of coumarin combined with troxerutin were found and tested two different doses of the drug against each other with no placebo, however, numbers of participants in the trial groups and baseline data were not provided. Eight trials of coumarin were identified. Two of the reports were confirmed as reporting the same trial and a further trial potentially also referred to the same trial but this was unconfirmed. A further two papers appeared to refer to the same trial but this was not confirmed. Three trials involved the same researcher. Five studies were conducted in India or China and they added anti-filarial dia or China and they added anti-filarial drugs to the interventions tested. The numbers of participants withdrawn and the numbers included in the analyses in all these trials were not extractable; the reporting of outcome measures in most of the trials was not clear. Loprinzi's 1999 trial in the USA reported the conduct of the trial and its findings with more detail, however, its conclusions were very much at odds with the findings of the other trials, finding that no difference was observed between those on the active preparation (coumarin) and placebo in any of the outcomes under investigation. This trial also reported a case of hepato-toxicity in a patient receiving the active preparation. REVIEWERS' CONCLUSIONS: Meta-analysis was not performed due to the poor quality of the trials. It is not possible to draw conclusions about the effectiveness of Benzopyrones in reducing limb volume, pain, or discomfort in lymphoedematous limbs from these trials.

Publication Types:

PMID: 15106192 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/quer ... query_hl=2
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Re: Daflon 500

Postby alaska » Tue Jun 27, 2006 2:10 pm

I've been using Daflon 500 for Chronic Venous Insufficiency (lower legs) for almost two years. My doctor knows that I'm using it. I believe it has helped me a lot, although I can't be sure of that. My CVI improved under Daflon, and didn't get any worse for about a year and a half. Since I dropped down to one pill/day my CVI has worsened. I was going to go back to 2 pills/day after my new supply arrived.

As far as I know one cannot purchase Daflon 500 in the USA. Is anyone else on this list using Daflon? Yesterday I received a shock when I got a letter from U.S. Customs. They have confiscated my latest order of Daflon 500 ($150 worth) because it is not approved by the FDA. The FDA has had 12 years to approve or disapprove it and they have done NOTHING because it isn't made by a US pharmaceutical. My order was coming from Thailand and I was wondering why it was late, as I've been out of pills for a few days. Customs gave me the option of allowing them to destroy it, or send it to the FDA. Our government and the FDA have really let us down! The US pharmaceutical industry owns the FDA and our elected officials.

I keep my legs elevated most of the day, and I am wearing extra-compression socks (the $400 ones, which my insurance company won't pay for), so there is not much more I can do. I sure don't want to go back to having open sores, but it looks like I'm headed in that direction, thanks to the police state we now live in. Dick
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Daflon 500

Postby patoco » Wed Jun 28, 2006 6:38 pm

Hi Alaska

Super welcome to our family.

There have been quite a number of clinical studies that show Daflon 500 to be very helpful and beneficial for edema from CVI....you would surely think that with all the documentation that it would be available to patients.

Can't believe you had a batch that was actually seized...amazing...wish they were that concerned about all the pot, cocaine and heroin coming into this country.

I haven't found a place yet....but I am looking and will send you a private mail if I can find a place.

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Re: Daflon 500

Postby alaska » Wed Jun 28, 2006 7:41 pm

[quote="patoco"]Hi Alaska

Can't believe you had a batch that was actually seized...

Our FDA protects us from highly dangerous drugs like Daflon (which is just some bark & herbs, I think) and allows notallowed to be sold in NEARLY EVERY STORE IN AMERICA which they know will kill you. Our pharmaceutical industry, our politicians, and the FDA are all in bed together. Dick
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Postby joanne johnson » Thu Jun 29, 2006 1:15 pm

Hi Alaska,
I read your posts and was a bit baffled. I had never heard of the drug Daflon. Is there a similar drug sold in the U.S. that would work for you? We all have edema and could use a drug like Daflon to help us. Sorry you lost your batch.
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Postby alaska » Thu Jun 29, 2006 11:42 pm

[quote="joanne johnson"]Hi Alaska,
Is there a similar drug sold in the U.S. that would work for you?

There is a similar product sold in America called Veinicin. I actually used it for a while. But then I read some troublesome reports on its manufacturer, and decided to get the original Daflon that is made in France by Servier. Veinicin might be OK, I don't know, but you can google it and then google its manufacturer and decide for yourself.

One other product I take for CVI is "Nature's Way Leg Veins Tru-Opc", 60 Caps/bottle. It's quite inexpensive if you buy 6 bottles at a time from Vitacost.com (about half the price my supermarket charges). It has ingredients that have been shown to help leg veins. Dick
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