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SUMMARY
Hemorrrhoids result from dilation of the
submucosal vascular tissue in the distal anal canal. These dilated blood
vessels may remain inside the anal canal (internal hemorrhoids) or or may
protrude outside the anus (external hemorrhoids). Persistent vascular dilation
may lead to severe inflammation with associated pain and discomfort. Anti and
pro-inflammatory cytokines flood hemorrhoidal surface but if vascular oedema is
not removed, inflammation persists and hemorrhoids become chronic.
Theoretically, it should not be difficult to remove vascular oedema and the
concentration of pro- inflammatory cytokines from the hemorrhoidal surface, but
even modern medicine is not capable to find a drug which can act simultaneously
on vascular oedema, inflammation, pain, and hydration without serious
side-effects. A few scientists in France imagined using a non-irritant and
highly osmotic liquid solution as a film over the hemorrhoidal surface to extract-out
oedematous liquid and to clean hemorrhoidal surface through outcoming liquid
flow. They observed that minimizing oedema and cleaning inflammatory cytokines
through a mechanical and totally safe process produces excellent results within
a few days. Being topical, such a treatment cannot induce any side effects. The
authors are convinced that such a simple, safe, and multi-target therapeutic
approach should revolutionize future treatment of haemorrhoids.
Hemorrhoids are a frequent pathological condition
with a considerable burden [1]. Although not a life-threatening disease, the
manifestation of hemorrhoids is associated with significant discomfort, having
a huge impact on the normal day-by-day routine of the patient. It even has
historical relevance since it might be the reason why the French emperor,
Napoleon Bonaparte, lost the battle of Waterloo in 1815 [2]. Indeed, he had
severe hemorrhoidal pain on that day.
Hemorrhoids occur
when the veins of the rectum or anus become dilated or enlarged. Depending on
the location of these oedematous blood vessels in relation to the anal dentate
line, they classify as internal (essentially above the dentate line) or
external (mostly below the dentate line). External hemorrhoids are most
uncomfortable, because the overlying skin becomes irritated and erodes.
Eventually, a blood clot forms inside an external hemorrhoid, causing sudden
and severe pain. If the clot dissolves, the remaining excess skin might cause
itch or become irritated [3,4]. Internal hemorrhoids are also associated with
pain during bowel movements, as well as an inevitable rectal bleeding.
So far, therapeutic
options are diverse, ranging from dietary and lifestyle modifications to
operating-room procedures. However, surgery is only cogitated for advanced
stages of disease and it can be associated with appreciable complications,
counteracting its efficacy. On the other side, pharmacological or non-operative
treatments are, in fact, symptomatic treatments often associated with
disappointing chances of success and may have side-effects [5,6]. In the
absence of any curative treatment, hemorrhoids tend to become chronic and
inflamed, leading to, among other things, the formation of edematous vascular
sinusoids, tissue destruction and pain.
We believe that understanding
of the pathophysiology underlying the manifestation of internal or external
hemorrhoids is key to find the ideal treatment. In this context, it is
described that, during the initial phase of hemorrhoid disease,
anti-inflammatory cytokines are secreted, particularly on the hemorrhoidal
surface, to suppress inflammation but if the process continues, then,
pro-inflammatory cytokines are produced to maintain the inflammation [4]. After
a few weeks, pro-inflammatory cytokines dominate an inflammatory cascade, and
healing becomes extremely difficult [7,8].
We idealize that the
best therapeutic strategy should act on the origin of the disease and,
subsequently, allow the recovery of all the symptoms. In other words, the ideal
approach should enhance the elimination of the edema, a crucial step to
minimize the size of the haemorrhoids and to normalize tissue physiology.
Concomitantly, it should suppress inflammation to ease pain, irritation,
itching, and bleeding. Healing of damaged tissue further requires keeping the
tissue hydrated and infection-free. In order to avoid systemic effects, topical
route is desirable.
Nevertheless, it is
practically impossible for a single drug to fulfill all these basic
requirements at a time, which explains why an efficient pharmacological
treatment is lacking [9]. In addition, due to the differences in anatomical
structure, location, and physiopathology of internal and external hemorrhoids,
the treatment strategies must also be different. For example, in the specific
case of internal hemorrhoids, the location of lesions challenges the use of any
long- acting topical medication, while, in the case of external hemorrhoids, a
topical treatment is desirable.
NATURVEDA
SAS conceived and
patented a glycerol-based hypertonic filmogen solution (VB-Gy), 18 times more
osmotic than sea water yet not irritant. It is capable of creating a highly
osmotically active film over the hemorrhoidal surface, attracting hypotonic
liquid from any live semi-permeable biological membrane, and thus acting as a
strong anti-edematous bandage for topical application [10]. Precisely, the
hemorrhoidal wall is a semi-permeable and distended with excessive hypotonic
liquid. Therefore, the treatment of this condition would benefit from a
solution that could attract hypotonic liquid from the inner parts, reducing their
volume and keeping the outer hemorrhoidal surface hydrated, helping to relief
the pain, irritation and itching. In the case of internal hemorrhoids, however,
VB-Gy eventually dilutes due to the strong hypotonic liquid outflow it
generates. Consequently, VB-Gy per se,
might fail to achieve the required osmotic pressure on the surface to provoke
exudation of hypotonic liquid from the hemorrhoidal mucosa. Therefore, the
strategy adopted was to render the VB-Gy filmogen, flexible and resistant to
dilution, by adding a small quantity of natural polymeric ingredients,
essential oils and reducing, at same time, its water content.
The innovation
underlying this treatment is the fact that the conceived and patented VB-Gy-
based formulations exert a mechanical rather than a pharmacological effect over
the hemorrhoidal mucosa, constituting a new generation of multi-target,
anti-edematous, anti- inflammatory topic treatment. This treatment ultimately
produces symptomatic relief and creates a proper environment for healing.
Moreover, Glycerol is a common and natural food ingredient, non-toxic (orally
and topically) and several tests showed that it is non-irritant, attributing to
VB-Gy a desirable safety profile, deprived from severe adverse effects.
The therapeutic
potential of this new approach to treat hemorrhoids was nicely corroborated by
clinical studies [11]. Indeed, it was recently demonstrated that the topical
application of hypertonic and osmotically active VB-Gy to patients diagnosed
with hemorrhoids provided a clear and fast improvement of the symptomatology.
We highlight the remarkable decrease of hemorrhoids’ size as a consequence of
the exudation of the liquid accumulated on the hemorrhoid lesion, the relief of
pain and overall discomfort (e.g. itching, irritation). More importantly, the
beneficial effect exerted by the VB-Gy topical application persisted beyond the
treatment period (usually 14 days), as confirmed by the follow up consultation
on day 21 after the beginning of the treatment.
This is an innovative and yet simple and logical approach that represents an outstanding achievement, raising a big hope for those dealing with the risk of hemorrhoid manifestation.
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Everhart JE, Ruhl CE (2009)
Burden of Digestive Diseases in the United States Part II: Lower
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741-754.
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Welling DR, Wolff BG, Dozois
RR (1988) Piles of defeat. Napoleon at Waterloo. Dis Colon Rectum 31: 303-305.
3.
Lohsiriwat V (2015)
Treatment of hemorrhoids: A coloproctologist’s view. World J Gastroenterol
21: 9245-9252.
4.
Lohsiriwat V (2013) Approach
to Hemorrhoids. Curr Gastroenterol 15: 332.
5.
Mounsey AL, Henry SL (2009)
Clinical inquiries. Which treatments work best for hemorrhoids? J Fam Pract 58:
492-493.
6.
Maloku H, Gashi Z, Lazovic
R, Islami H, Juniku-Shkololli (2014) A Laser Hemorrhoidoplasty Procedure vs
Open Surgical Hemorrhoidectomy: a Trial Comparing 2 Treatments for Hemorrhoids
of Third and Fourth Degree. Acta Inform Med 22: 365-367.
7.
Hardy A, Cohen CRG (2014)
The acute management of haemorrhoids. Ann R Coll Surg Engl 96: 508-511.
8.
Dinarello CA (2010)
Anti-inflammatory Agents: Present and Future. Cell 140: 935-950.
9. Tafti LD, Shariatpanahi SM, Damghani MM, Javadi B (2017) Traditional
Persian topical medications for gastrointestinal diseases, Iran. J Basic Med
Sci 20: 222-241.
10.
Shrivastava R (1999)
Non-solid composition for local application.
11.
Georges M, Ben Achour HM,
Adly SA, Trouiller R, Shrivastava R (2017) Clinical Efficacy of a New
Generation of Multi-Target, Anti-Edematous, Anti-Inflammatory, Tissue Repairing
Topical Polymeric Liquid Bandage for the Treatment of Internal Hemorrhoids. J
Clin Exp Dermatol Res 8: 1-9.
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