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Hemorrhoid & piles

HEMORRHOIDS & PILES

 

Physiopathology:

The anal area is highly vascularized & fragile. An injury may lead to the protrusion of a strangulated blood vessel. Arteries being more elastic compared to the veins, more liquid enters & starts accumulating progressively in the lesion. Continuous dilation leads to the formation of an edematous mass & surface inflammation. In the absence of lesion regression, more & more pro-inflammatory cytokines invade the lesion, cause chronic inflammation & lesion  becomes chronic. Only removing edema & inflammation may help recovery.

 

Ideal Treatment Approach:

Therefore, an effective treatment must be MULTI-TARGET. It should also be topical to avoid side effects, safe, non-irritant, with 4 main effects on the lesion:

  1. Clean   2. Hydrate   3. Neutralize mainly pro-inflammatory cytokines    4. Reduce oedema, pain & irritation

 

Class IIa Medical Device : External hemorrhoids: 30-ml liquid spray – Internal hemorrhoids: 50-ml tube containing gel

Currently Available Treatments:     

There is no non-irritant & strong topical anti-edematous drug yet discovered.

All the currently available treatments such as: anti-inflammatory drugs, antiseptics, saline solutions, oral venotonics & corticosteroids, oral flavonoids, sclerotherapy, rubber band legation, infrared coagulation, radiofrequency ablation, & cryotherapy are symptomatic, painful, tissue-damaging & expensive. In fact, there is no specific treatment.

VITROBIO‘s Completely NEW Therapeutic Approach:

For the last 20 years, Vitrobio has been conducting R&D to conceive a topical treatment for hemorrhoids capable of instantly cleaning and hydrating the lesion; inducing exudation of liquid from the dilated blood vessels so as to reduce their volume & allow them to resume their normal physiology & functions; thereby reducing pain, irritation, itching & bleeding.

Vitrobio discovered & patented (Patents: PCT/FR99/01340 in 1997 & N° WO 00/74668 A1 in 2000) a strongly hypertonic yet non-irritant solution (VB-Gy) so as to induce exudation of fluid from the dilated blood vessels to reduce it’s volume & to keep the lesion hydrated. This solution was further rendered filmogen (PCT/EP2013/061835 in 2013) for a long lasting (5-6h) effect.

The mechanical cleaning action of the solution removes all the contaminants, including inflammatory proteins from the surface of hemorrhoids. Reducing lesion volume & keeping it always hydrated help reduce pain & inflammation.

Posology: Topical 30-ml spray on the external lesions (3-4 sprays, 3-4 times/day). For internal lesions, topical gel (50-ml tube) for application on hemorrhoids located slightly inside the anal orifice (3-4 times/day). Class IIa Medical Device in EU. Totally safe.

Contra-indications: do not use in patients under 8 years old.

Side effects: Slight and transient local irritation during the first 1-2 minutes after application. This medical device contains glycerol which can cause digestive disorders (e.g. diarrhea) in case of extensive use on internal hemorrhoids.

Clinical efficacy studies:

  • A multi-centric, double blind, placebo controlled, randomized clinical trial was conducted by Nexus Clinical Research to evaluate the efficacy and safety of PILESEPTINE GEL v/s xanthan gum solution for a period of 14-days (+ reversibility observations on day 21). Results showed that although regular and frequent use of xanthan gum helped reduce hemorrhoidal symptoms appreciably, the test product induced fast & statistical regression of all the clinical signs (hemorrhoidal size, pain intensity, rectal bleeding, prolapse, defecation discomfort, irritation & itching) without any side effects. (Study N° NEX/HER-IHMR/OBS/2016. Study dates: 19/07/2016-10/09/2016. 54 patients (18-65 years).

 

  • A comparative, randomized, double blind, parallel group, observational clinical trial was conducted by Nexus Clinical Research to evaluate efficacy and safety of PILESEPTINE SPRAY v/s Saline solution in the treatment of patients suffering from external hemorrhoids. Parameters studied: hemorrhoid size, pain & itching intensity, rectal bleeding, defecation discomfort. The results show that overall symptoms were reduced by an average of 80%. No side effects were noted in any of the patients. (Study N° NEX/HER-EHMR/OBS/2016. Study dates: 22/07/2016-26/09/2016. 54 patients (18-65 yo))
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