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2742-2751-Tribenoside and Lidocaine in the Local Treatment Of

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2742-2751-Tribenoside and Lidocaine in the Local Treatment Of European Review for Medical and Pharmacological Sciences 2016; 20: 2742-2751 Tribenoside and lidocaine in the local treatment of hemorrhoids: an overview of clinical evidence Z. LORENC1, Ö. GÖKÇE2 1General, Colorectal and Trauma Surgery Silesian Medical University Katowice, Poland 2Department of Surgery, Yeditepe University, Istanbul, Turkey Abstract. – OBJECTIVE: The combination of Key Words: tribenoside+lidocaine (Procto-Glyvenol®) is a Tribenoside, Lidocaine, Hemorrhoids. medical preparation for the local treatment of hemorrhoids, delivered as a suppository or rec- tal cream. This product has been used for de- cades in the therapy of hemorrhoids. This re- Introduction view discusses available evidence on the use of tribenoside/lidocaine in clinical practice. Hemorrhoid disease is one of the most common MATERIALS AND METHODS: Papers were re- proctological conditions in Western countries1. Its trieved by a PubMed search, using different com- prevalence is as high as 36% of the general pop- binations of pertinent keywords (e.g. tribeno- ulation, with a higher incidence in middle-aged side AND hemorrhoids), without any limitations 1,2 in terms of publication date and language. Docu- people of high socioeconomic status . It has been ments from Authors’ personal collection of liter- estimated that about 50% of the general popula- ature could also be considered. Papers were se- tion will experience symptomatic hemorrhoids lected for inclusion according to their relevance at some points in their life3. In addition, pregnant for the topic, as judged by the Authors. women are at high risk of developing hemorrhoid RESULTS: The efficacy of the combination of disease4,5. The prevalence of hemorrhoids in preg- tribenoside+lidocaine in relieving symptoms nant woman ranges from 25% to 35%, and up to caused by hemorrhoids and its safety have been assessed in several clinical studies on 85% of pregnant women experience hemorrhoids 6 patients of either gender, either versus its two in the third trimester . Other subjects at particu- individual components (tribenoside and lido- lar risk of developing hemorrhoids are elderly and caine) or versus steroids in the same setting. those with high body mass index7,8. Five studies compared the combination treat- For what concerns clinical presentation and ment with each of its single components, and symptoms, hemorrhoids can cause anal discharge of these, three studies compared tribenoside+ lidocaine with a tribenoside-free semi-place- and itching. Moreover, internal hemorrhoids may bo preparation containing only lidocaine, and cause objective symptoms such as prolapse or rec- two studies compared this combination with tal bleeding, while external hemorrhoids can re- lidocaine-free preparations containing only sult in subjective symptoms including pain, burn- tribenoside. Tribenoside+lidocaine was com- ing and itching due to engorgement and throm- pared with steroid-containing preparations in bosis9. six studies. Last, two studies evaluated the ef- The severity of hemorrhoids is classified into ficacy and tolerability of the tribenoside+lido- 10 caine combination in women with hemorrhoids four stages, according to Goligher . More ad- as a consequence of pregnancy or delivery. vanced stages of disease require surgical treat- All the above-mentioned studies were well- ment, while medical management and lifestyle conducted and can provide a comprehensive interventions are suitable for grade I/II hemor- evaluation of tribenoside+lidocaine in the treat- rhoids, which represent the wide majority (>90%) ment of hemorrhoids. of all reported cases1,8,9. CONCLUSIONS: Enough evidence exists to recommend the use of this combination therapy In particular, dietary and lifestyle changes, as a fast, effective and safe option for the local which require a high patient compliance, are usu- treatment of low-grade hemorrhoids. ally considered the first step for any conservative 2742 Corresponding Author: Özcan Gokçe, MD; e-mail: [email protected] Tribenoside+lidocaine in the local treatment of hemorrhoids: an overview of clinical evidence strategy; however, evidence supporting these system. Tribenoside seems to share the positive interventions is anecdotal1. Fiber supplemen- pharmacological properties ascribed to gluco- tation can play a role as a supportive treatment corticoids and non-steroidal anti-inflammatory of hemorrhoids, in particular as stool softeners, agents, yet is free from the undesirable effects on when combined with other therapies11,12. Phyto- the gastro-intestinal system, the connective tis- therapy has been widely tested for the therapy of sue or the body’s defence system15. Remarkably, low-grade disease, but studies supporting these tribenoside exhibits anticoagulant and inhibito- interventions are of modest methodological qual- ry activity against inflammatory mediators such ity1. Medical treatment is mainly based on the use as histamine and prostaglandins, thus providing of topical preparations, containing anti-inflam- benefit to microcirculation, reducing capillary matory drugs including steroids, anesthetics, as- permeability and improving vascular tone14. An tringents, and/or antiseptics9. However, in most in vitro study, specifically aimed at investigating cases no randomized trials have been conducted the molecular bases of the efficacy of tribenoside to assess the efficacy and safety of different in- in the treatment of hemorrhoids, showed that the terventions which in some cases – e.g., steroids – expression of laminin α5, a major component of are associated with the potential onset of adverse the basement membrane disrupted in this disease, events1,9. was four times higher in the tribenoside-treated The combination of tribenoside+lidocaine cells than in controls14. Collectively, these findings (Procto-Glyvenol®, Recordati, Italy) is a medical suggest that tribenoside interacts with epidermal preparation for the local treatment of hemorrhoids, cells and regulates the expression and localization delivered as a suppository or rectal cream13. This of laminins, thus helping reconstruct basement product has been used for decades in the thera- membrane in wound healing of hemorrhoids. py of hemorrhoids, and its efficacy and safety are On the other hand, lidocaine is a widely-used supported by a number of well-conducted studies local anesthetic which relieves pain, burning and and broad clinical experience. itching caused by hemorrhoids1,16. This molecule This review discusses available evidence on the use is characterized by a fast (few minutes) onset of of tribenoside/lidocaine in patients with hemorrhoids. its surface anesthetic action, providing rapid re- lief from pain and itching16. Selection of Evidence Therefore, this combination therapy combines Papers for consideration for the present review the rapid local anesthetic action exerted by lido- were retrieved by a PubMed search, using dif- caine with the efficacy of tribenoside in promot- ferent combinations of pertinent keywords (e.g. ing local healing and favoring the recovery of tribenoside AND hemorrhoids), without any lim- local vessels to normal conditions. This double itations in terms of publication date and language. mechanism of action allows to control both sub- Documents from Authors’ personal collection of jective (e.g., pain and discomfort) and objective literature could also be considered. Papers were (e.g., prolapse and bleeding) symptoms of hem- selected for inclusion according to their relevance orrhoids reducing inflammation and improving for the topic, as judged by the Authors. vascular tone. Clinical Pharmacology Overview of Clinical Evidence Tribenoside is a saccharide derivative which has The efficacy of the combination of tribeno- been extensively used for the treatment of hemor- side+lidocaine in relieving symptoms caused by rhoids14. Several studies have shown that tribeno- hemorrhoids and its safety have been assessed in side possesses a unique spectrum of pharmaco- several clinical studies on patients of either gen- logical activities, and in particular anti-inflam- der, either versus its two individual components matory, mild analgesic, antitoxic, wound-healing, (tribenoside and lidocaine) or versus steroids in fibrinolysis-promoting, anti-arthritic, amine-re- the same setting17-27. lease-inhibitory, membrane-stabilizing and veno- Table I provides an overview of those studies. tropic properties have been reported15. Notewor- Of note, 5 studies compared the combination treat- thy, unlike corticosteroids or nonsteroidal anti-in- ment with each of its single components. Of these, flammatory agents, tribenoside does not present 3 studies compared tribenoside+lidocaine with a untoward effects on the gastrointestinal system, tribenoside-free semi-placebo preparation contain- the connective tissue or the immune system, ing only lidocaine17-19, and 2 studies compared this and does not affect the prostaglandin-synthetase combination with lidocaine-free preparations con- 2743 Z. Lorenc, Ö. Gökçe 2744 Table I. Overview of the identified studies on the combination of tribenoside + lidocaine (TL). Total number Study Design of patients Treatment Main outcomes Rizzi et al17 I. Double blind study 177 All applied up to 10 days: • Clinical efficacy rated as “good” in Analysis of 4 different studies: comparing TL cream with I. 28 I. Tribenoside 5% + lidocaine 2% cream 13 patients on tribenoside + semi-placebo cream with II. 60 vs. lidocaine 2% lidocaine, compared with 4 patients lidocaine only III. 44 II. Tribenoside 5%
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