Hemorrhoid Management in Women: the Role of Tribenoside+ Lidocaine
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A continuous publication, open access, peer-reviewed journal ACCESS ONLINE REVIEW Hemorrhoid management in women: the role of tribenoside + lidocaine Jan Kestřánek MD Department of Obstetrics and Gynaecology, University Hospital, Charles University, Hradec Kralove, Czech Republic Abstract tolerability have been formally evaluated in several well- conducted studies, some of which were specifically conducted Hemorrhoids are commonly reported in women. However, in women. In particular, tribenoside + lidocaine can be safely despite the high prevalence of hemorrhoids in women administered in postpartum women and in pregnant women and the major impact of this condition on quality of life, after the first trimester of pregnancy. In pregnant women, specific evidence and recommendations on the treatment of the tribenoside/lidocaine combination significantly improved hemorrhoids in women are scant. This paper reviews various both subjective and objective symptoms of hemorrhoids. Fast options in current therapy for hemorrhoids in women— onset of symptom relief was reported from 10 minutes after namely, medical intervention (topical and systemic drug administration, lasting up to 10–12 hours. On these bases, therapy)—and discusses the available clinical evidence for tribenoside + lidocaine can represent a fast, effective, and safe an appropriate use of over-the-counter topical formulations option to treat hemorrhoids when conservative therapy is for the symptomatic treatment of hemorrhoids. Its focus is indicated, and it deserves consideration as a first-line treatment on a medical preparation containing tribenoside + lidocaine, of this disease in clinical practice. available as a rectal cream (tribenoside 5%/lidocaine 2%) and a suppository (tribenoside 400 mg/lidocaine 40 mg) Keywords: hemorrhoids, lidocaine, tribenoside, women’s and marketed under the brand Procto-Glyvenol® (Recordati, medicine. SpA, Italy). Given its rapid comprehensive efficacy on all Citation the different symptoms of hemorrhoids, the tribenoside Kestřánek J. Hemorrhoid management in women: the role of + lidocaine combination can find a place in the treatment tribenoside + lidocaine. Drugs in Context 2019; 8: 212602. of this hemorrhoidal disease. Importantly, its efficacy and DOI: 10.7573/dic.212602 Introduction vaginal birth predispose women to develop symptomatic hemorrhoids for several reasons: hormonal changes, Hemorrhoids affect approximately 25% of the general increased intra-abdominal pressure, straining during population in their lifetime and are associated with several defecation due to constipation, prolonged straining during bothersome symptoms, such as painful defecation, itching the second stage of labor for more than 20 minutes, and with the urge to scratch, and bleeding, which in turn limit giving birth to a baby with a weight over 3800 g.6 The high 1–3 social activities and have a major impact on quality of life. levels of progesterone during pregnancy decrease the The severity of hemorrhoids is classified into four stages, strength of the muscles’ venous walls and reduce the venous according to Goligher’s classification (Table 1). More advanced tone; any combination of increased intra-abdominal pressure, stages of the disease require surgical treatment, while medical increased venous congestion from the weight of the fetus, and management and lifestyle interventions are suitable for grade obstruction of venous returns contribute to the development I/II hemorrhoids, which represent the wide majority (>90%) of pathological changes and incidence of hemorrhoids. of all reported cases. Remarkably, many patients experience Women with this condition may ultimately experience hemorrhoids without seeking medical consultation because of anal incontinence, and also report difficulties in dealing embarrassment or fear, discomfort, and pain associated with with hygienic problems.6 Of note, women may perceive 4 the treatment. hemorrhoids as an embarrassing and sensitive disease, with a In particular, hemorrhoids are commonly reported in women, consequent reluctance to ask for medical attention.6 Despite mostly during pregnancy and postpartum.5 Pregnancy and the high prevalence of hemorrhoids in women and the major Kestřánek J. Drugs in Context 2019; 8: 212602. DOI: 10.7573/dic.212602 1 of 7 ISSN: 1740-4398 REVIEW – Tribenoside + lidocaine for hemorrhoids in women drugsincontext.com As hemorrhoids are such a common condition in women Table 1. Hemorrhoid grading according to and can be associated with both physical symptoms and Goligher’s classification. quality-of-life impairment, prevention is crucial. Dietary modification consisting of adequate fluid and fiber intake Hemorrhoid Features represents the primary approach to patients at high risk of degree hemorrhoid disease.9 Grade I The anal cushions bleed but do not prolapse. In patients with overt hemorrhoids, hygienic and dietary Grade II The anal cushions prolapse through measures should be taken to prevent constipation, with the anus on straining but reduce the aim of maintaining soft, bulked stools that pass easily spontaneously. without straining during defecation.9 A diet high in fibers, Grade III The anal cushions prolapse through approximately 20–35 g/day, or intake of fiber supplements, the anus on straining or exertion and such as maltodextrin-resistant fruit oligosaccharides, require manual replacement into the psyllium, methylcellulose, or calcium polycarbophil can be anal canal. recommended. There have been several randomized Grade IV The prolapse stays out at all times and controlled trials (RCTs) studying the relationship between is irreducible. dietary fiber and constipation. Some studies reported that Acutely thrombosed, incarcerated dietary fiber can increase stool frequency, improve stool internal hemorrhoids and consistency, and have no obviously adverse effects. However, incarcerated, thrombosed in another study, dietary fiber was not found more effective hemorrhoids involving circumferential than placebo in therapeutic success, and it might increase rectal mucosal prolapse are also the frequency of abdominal pain. Furthermore, large trials fourth-degree hemorrhoids. examining the effect of dietary fiber in the treatment of constipation are needed, the possible influential factors should be considered, and more gastrointestinal symptoms impact of this condition on quality of life, specific evidence and adverse events should be reported before dietary fiber is and recommendations on the treatment of hemorrhoids in formally recommended.10 women are scant.5 This paper discusses current options in the therapy for hemorrhoids in women—namely, medical In addition to a high-fiber diet, it is also important to increase intervention (topical and systemic drug therapy)—and fluid intake, which adds moisture to stool, thus reducing discusses the available clinical evidence for an appropriate use constipation. Of note, no studies have been published so of over-the-counter topical formulations for the symptomatic far showing that increasing liquid volume is effective as a treatment of hemorrhoids with a focus on the combination of treatment in euhydrated subjects with chronic constipation. tribenoside + lidocaine, which has been demonstrated to be a Nevertheless, inadequate fluid intake or excessive fluid loss fast, effective, and tolerated option for the local treatment of from diarrhea, vomiting, or febrile illness may cause hardening low-grade hemorrhoids.7 of the stool and is considered to be an important cause of constipation, especially in infants.11 Increasing liquid intake is commonly recommended for constipated children, adults, Selection of evidence and elderly subjects. Although the effects of fluid intake on Papers considered for this review were retrieved by a PubMed constipation have never been fully studied or understood, the 12 search, using different combinations of pertinent keywords recommendation has remained mostly out of tradition. (e.g., tribenoside and hemorrhoids), without any limitations on Finally, the use of polyethylene glycol (PEG/macrogol 4000), an publication date or language. Documents from the authors’ osmotic laxative, can also be considered a safe and effective personal collection of literature could also be considered. treatment, even during pregnancy. In this respect PEG/ Papers were selected for inclusion according to their relevance macrogol should be considered a first-line option, due to its for the topic, as judged by the author. minimal absorption and elimination in the urine without being metabolized.13 Lastly, moisturizing and cleansing wipes can Management of hemorrhoids in be used as a replacement for toilet paper by providing a cool, soothing sensation around the back passage.14 Formulations women: state of the art (either wipes or intimate soap/gel) containing extract of In women with hemorrhoids, symptoms include pain, itching, Ruscus aculeatus, well known for its soothing properties, and and intermittent bleeding from the anus; quality of life can devoid of alcohol, can provide relief for people suffering from vary from mild physical and psychological discomfort to hemorrhoids. Extract of Ruscus aculeatus has been documented difficulty in dealing with everyday activities, depending on the to be effective in increasing venous tone because of its severity of pain.6,8 anti-inflammatory and astringent properties.15 Kestřánek J. Drugs in Context 2019; 8: 212602. DOI: 10.7573/dic.212602 2 of 7 ISSN: 1740-4398 REVIEW – Tribenoside + lidocaine for hemorrhoids