A prospective, randomized, three arm, open label study comparing the safety and efficacy of PP110, a novel treatment for hemorrhoids ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2015-12

AUTHORS

Ehud Klein, Ron Shapiro, Jose Ben-Dahan, Moshe Simcha, Yosef Azuri, Ada Rosen

ABSTRACT

BACKGROUND: Hemorrhoids are a common disorder that affects the quality of life of millions of people worldwide. The effectiveness of OTC medication is limited and they mainly provide symptomatic relief. In order to treat this ailment, we formulated PP110 Gel and Wipes, as a novel treatment for hemorrhoids. PP110 is based on known active ingredients with a topical film-forming agent designed to provide physical protection and prolonged tissue contact with the active ingredients. METHODS: PP110 Gel, PP110 Wipes and the comparator Preparation-H® were used on three patient cohorts. Treatment was administered once daily for PP110, and three-four times daily for Preparation-H®, for 14 days. Six different clinical parameters relating to common symptoms of hemorrhoids were monitored. RESULTS: PP110 Gel was significantly better than Preparation-H® in reducing bleeding (Δ = 6 %), providing pain relief (Δ = 10 %) and controlling itching (Δ = 11 %). These three parameters are considered as the most common distressing symptoms for hemorrhoids patients, demonstrating that PP110 is superior to conventional treatment. CONCLUSION: This study demonstrated the efficacy of the PP110 Gel in treating hemorrhoids and its superiority to conventional treatments. The PP110 film-based formulation provides a slow-release mechanism and as a consequence, a prolonged therapeutic window. PP110 was both more effective in reducing hemorrhoids symptoms and more convenient to use, in that it only required application once per day. More... »

PAGES

6

References to SciGraph publications

  • 2012-02. The prevalence of hemorrhoids in adults in INTERNATIONAL JOURNAL OF COLORECTAL DISEASE
  • 2009-11. Diagnosis and management of lower gastrointestinal bleeding in NATURE REVIEWS GASTROENTEROLOGY & HEPATOLOGY
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s40591-015-0043-5

    DOI

    http://dx.doi.org/10.1186/s40591-015-0043-5

    DIMENSIONS

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    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/26191413


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    136 Surgery A Chaim Sheba Md ctr aff. Sackler school of medicine Tel-Aviv university, Tel-Aviv, Israel
    137 Surgery A Meir Hospital Kfar-Saba (affiliated to Sackler Medical School, Tel-Aviv University), Tel-Aviv, Israel
    138 rdf:type schema:Organization
    139 https://www.grid.ac/institutes/grid.416216.6 schema:alternateName Maccabi Health Care Services
    140 schema:name Director of Surgery Service Line, Maccabi Health Services, Tel-Aviv, Israel
    141 rdf:type schema:Organization
    142 https://www.grid.ac/institutes/grid.425380.8 schema:alternateName Maccabi Institute for Health Services Research
    143 schema:name Maccabi Healthcare, Tel-Aviv, Israel
    144 rdf:type schema:Organization
     




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