Dvostruko slijepa randomizirana studija o učinkovitosti topičke primjene 2% lidokaina u liječenju simptomatskih hemoroida [Double blinded randomized clinical trial of the efficacy of topical 2% lidocaine for the treatment of symptomatic hemorrhoids]

Kekez, Tihomir (2017) Dvostruko slijepa randomizirana studija o učinkovitosti topičke primjene 2% lidokaina u liječenju simptomatskih hemoroida [Double blinded randomized clinical trial of the efficacy of topical 2% lidocaine for the treatment of symptomatic hemorrhoids]. PhD thesis, Sveučilište u Zagrebu.

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Abstract

Hemorrhoids are the most common ailment affecting the male gender. This condition affects 38.93% of the general population and is even more common in middle aged individuals with higher social-economic status. It is estimated that at least half this population is affected by hemorrhoids at least once in their lifetime. Topical hemorrhoid therapy is the most frequently prescribed first line treatment by the general practitioner and is the most common type of therapy sought by the patient in the beginning stages. There have been no documented randomized clinical studies that observed the quality and success of using perianal lidocaine as treatment and therefore this method is based on empirical findings without any quality clinical proof. We can state that the topical treatment of hemorrhoids is not a medically founded pharmacologic practice, but rather, remains an empirically based treatment without proof of effectiveness. In the American Gastroenterological Association guidelines for diagnosing and treating hemorrhoids, under the topical treatment section, the following is stated: Over the counter topical and suppository products have become more present in the empirical treatment of symptoms associated with hemorrhoids, without any information supporting their use. The goal of this study is to conduct a randomized clinical study on the effectiveness of using local lidocaine compared with a placebo in reducing hemorrhoid symptoms. The main goal is to determine the effectiveness of topical lidocaine use in patients with symptomatic hemorrhoids who, due to this ailment, have changes in the degree of disease and changes/increase in symptoms (pain, itch, bleeding, swelling and comfort are subjective symptoms which we observed and objectified using the validated analogue Corrects scale) The results of this study show that lidocaine, when used as a topical treatment has the identical effect on symptoms using the Corrects scale on days 1,3 and 7 after application as the placebo. If we stratify the individual symptoms such as pail, itch, swelling, bleeding and comfort, we see that lidocaine when compared with the placebo is not effective in reducing hemorrhoid symptoms. Furthermore, there is no significant difference in the general patients’ health status nor on the subjective decrease in symptoms between the two groups at 1,3 and 7 days after topical application. In both groups there was no noted improvement in the degree of disease and therefore we can conclude that neither lidocaine nor the placebo can influence the morphologic changes in hemorrhoid tissue.

Abstract in Croatian

Hemoroidi su najčešća tegoba koja muči ljudski rod. Ta tegoba pogađa 38,93% opće populacije, a još je češća u ljudi srednje dobi i višeg socioekonomskog statusa. Procjenjuje se da polovica opće populacije ima jedan ili više napadaja hemoroida tijekom života. Topička terapija hemoroida je najčešće propisivana prva linija terapije od strane liječnika kao i prva linija samomedikacije koju pacijanti traže. Do sada nije objavljena klinička randomizirana studija o učinkovitosti topičke perianalne primjene lidokaina tako da je topičko liječenje lidokainom bazirano na empirijskim spoznajama bez kvalitetnog kliničkog dokaza. Možemo reći da topičko liječenje hemoroida nije medicinski utemeljena opcija farmakološkog liječenja hemoroida nego je još uvijek empirijski temeljena, bez dokaza o djelotvornosti. U smjernicama Američke gastroenterološke asocijacije o dijagnostici i liječenju hemoroida u poglavlju o topičkom liječenju navodi se sljedeće: bezreceptni topički pripravci i čepići postali su sveprisutni u empirijskom liječenju hemoroidalnih simptoma, no podataka koji potkrepljuju njihovu uporabu nema. Cilj ovog istraživanja je provesti randomiziranu kliničku studiju o učinkovitosti lokalne primjene lidokaina u usporedbi s placebom za smanjivanje hemoroidalnih tegoba. Primarni ishod je utvrđivanje učinkovitosti topičke primjene lidokaina u terapiji simptomatskih hemoroida praćenjem promjena u stupnju hemoroida i promjena u težini simptoma koje hemoroidi uzrokuju (bol, svrbež, krvarenje, otok i nelagoda su subjektivne tegobe koje smo objektivizirali pomoću validirane analogne Corrects ljestvice) Rezultati studije pokazuju da lidokain primijenjen topički ima identični učinak na Corrects ljestvicu ukupnih hemoroidalnih simptoma 1, 3 i 7 dan nakon topičke primjene kao i placebo. Ako stratificiramo pojedine simptome kao što su bol, svrbež, otok, krvarenje i nelagoda vidimo da lidokain u usporedbi s placebom nije učinkovitiji u smanjivanju hemoroidalnih tegoba. Nadalje nema značajne razlike na opće stanje bolesnika kao i na subjektivno poboljšanje bolesnika između dvije grupe 1, 3 i 7 dan topičke primjene. U obje grupe nije došlo do smanjenje stupanja hemoroida te možemo zaključiti da niti lidokain niti placebo ne mogu utjecati na morfološke promjene u hemoroidalnom tkivu.

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