Marjorie Georges, Houda Miled Ben Achour, Sara Adel Adly, Robin Trouiller, Ravi Shrivastava
Objective: Internal hemorrhoids are a widespread vascular disease for which currently there is no satisfactory curative treatment available. The pathology involves the disintegration of the supporting tissue of the anal cushions, causing venous dilation, blood stagnation in the hemorrhoid, formation of edematous venous plexus covered by mucosa, and inflammation. An effective treatment must therefore be multi-target and capable of acting on all the pathology parameters simultaneously. We evaluated the clinical efficacy of a topical, osmotically active filmogen medical device (VB-Gy-ip) directed at minimizing edema, inflammation and volume of the lesions, concomitantly.
Methods: The study was a multi-centric, randomized, placebo-controlled, double-blind trial on patients suffering from internal hemorrhoids. 1 to 2 ml of test product, presented as a viscous solution containing VB-Gy-ip, presented in 50 ml tubes, was applied manually into the rectum, 3 to 4 times per day, for 14 consecutive days. Xanthan gum solution was used, in identical manner, as placebo or comparator product. The effects on the hemorrhoidal size, pain intensity, rectal bleeding, prolapse, defecation discomfort, irritation and itching were quantified using a 0 (no symptoms) to 10 (severe symptoms) scoring scale. Study design included 36 test product patients versus 18 placebo patients. Product safety and acceptability were also evaluated. All patients were re-examined on Day 21 to assess the eventual reversibility of the effects observed.
Results: Although regular and frequent use of xanthan gum gel helped reduce internal hemorrhoid symptoms appreciably, the test product remarkably induced very fast and statistically significant regression of all the clinical signs without any side effects.
Conclusion: An ideal treatment for internal hemorrhoid should simultaneously reduce edema, pain, inflammation, and the size of the lesion without any irritation or side effects. VB-Gy-ip is a completely new class of multi-target treatment for internal hemorrhoids, representing a big hope for millions of patients suffering from this pathology.