Diosmin is a dietary supplement used to aid treatment of
hemorrhoids and venous diseases, i.e.,
chronic venous insufficiency including spider and varicose veins, leg swelling (
edema),
stasis dermatitis and
venous ulcers.[1] The mechanism of action of Diosmin and other phlebotonics is undefined,[1] and
clinical evidence of benefit is limited.[1] Diosmin is not recommended for treating the
rectal mucosa, skin irritations, or wounds, and should not be used to treat
dermatitis,
eczema, or
urticaria.[1] Diosmin is not recommended for use in children or women during
pregnancy.[1] There is moderate-quality evidence that diosmin or other phlebotonics improved leg and ankle swelling and lower leg pain,[2] and low-quality evidence for treating
hemorrhoids.[1][3]
In 2017, the American Working Group in Chronic Venous Disease recommended use of micronized purified flavonoid fraction (
diosmiplex) as a
medical food for chronic venous disease symptoms and
venous ulcers, having "beneficial outcomes without serious adverse events", alone or combined with
compression therapy, concurring with the previous guidance of the International European Society for Vascular Surgery.[4] The
German Dermatological Society indicated that Diosmin may be used with other treatments for symptoms of
chronic venous diseases.[5]
The
American Society of Colon and Rectal Surgeons mentions phlebotonics as a possible treatment for symptoms of hemorrhoid grades I to II, as there is only moderate-quality evidence of effectiveness with "expectations of minimal harm", while having no evidence of long-term benefit.[3][6] French,[7][8] Indian,[9] Portuguese,[10] and Italian[11] professional societies of
coloproctology issued similar recommendations regarding phlebotonics for hemorrhoids.
Adverse effects
In some 10% of users, diosmin causes mild
gastrointestinal disorders or skin irritations (hives, itching), stomach pain, nausea, heart
arrhythmias, or
anemia.[1] Preliminary research indicates no evidence of
toxicity.[1] The US
Food and Drug Administration (FDA) concluded in 2001 that there was inadequate evidence on which to base an expectation of safety.[12] As of 2013[update], the FDA did not revise this position.[13]
Regulatory status
Diosmin is distributed in the U.S. as a dietary supplement called
Daflon.[1] Diosmin is not approved as a
prescription drug in the United States,[1] although it is available as over-the-counter or prescription-only drug in Europe sold under name Detralex[14] among others. Phlebotonics are not approved in Germany,[5] and are restricted in Spain only for the treatment of chronic venous diseases.[15]
^
abPerera N, Liolitsa D, Iype S, Croxford A, Yassin M, Lang P, et al. (August 2012). "Phlebotonics for haemorrhoids". The Cochrane Database of Systematic Reviews (8): CD004322.
doi:
10.1002/14651858.CD004322.pub3.
PMID22895941.
S2CID28445593.
^Bush R, Comerota A, Meissner M, Raffetto JD, Hahn SR, Freeman K (April 2017). "Recommendations for the medical management of chronic venous disease: The role of Micronized Purified Flavanoid Fraction (MPFF)". Phlebology (Professional society guidelines). 32 (1_suppl): 3–19.
doi:
10.1177/0268355517692221.
PMID28211296.
S2CID24389276. Only recently has a standardized formulation MPFF been available in the United States (Vasculera—Primus Pharmaceuticals, Inc.).
^Davis BR, Lee-Kong SA, Migaly J, Feingold DL, Steele SR (March 2018). "The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids". Diseases of the Colon and Rectum (Professional society guidelines). 61 (3): 284–292.
doi:
10.1097/DCR.0000000000001030.
PMID29420423.
S2CID4198610.
^Higuero T (December 2017). "Treatment of hemorroïdal disease: new french guidelines". La Revue du Praticien (in French). 67 (10): 1059–1062.
PMID30512599.
^Trompetto M, Clerico G, Cocorullo GF, Giordano P, Marino F, Martellucci J, et al. (October 2015). "Evaluation and management of hemorrhoids: Italian society of colorectal surgery (SICCR) consensus statement". Techniques in Coloproctology. 19 (10): 567–75.
doi:
10.1007/s10151-015-1371-9.
hdl:10447/208054.
PMID26403234.
S2CID30827065.
^New Dietary Ingredients in Dietary Supplements, U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Nutritional Products, Labeling, and Dietary Supplements February 2001 (Updated September 10, 2001)
[1], Memorandum
[2]
^Garg N, Gloviczki P (2013). "55 - Chronic Venous Insufficiency". Vascular Medicine: A Companion to Braunwald's Heart Disease (Second ed.). Elsevier Health Sciences. pp. 652–666.
doi:
10.1016/B978-1-4377-2930-6.00055-0.
ISBN9781437729306.
^"Detralex". Štátny ústav pre kontrolu liečiv. Retrieved 1 April 2024.