Tips and tricks of anorectal care with topical lidocaine (octose-dan) administration: retrospective, anecdotical, spontaneous, and observational study.

Abstract

Background: The local symptomatic treatment of anorectal diseases encloses a wide variety of creams, ointments, suppositories, irrigation fluids etc, based essentially on anaesthetics, antioedema, phlebotomids, keratolytic and coating agents, anti-inflammatories, steroids, aiming at achieving fast improvement and at least partial pain remission especially soon after stool. Unfortunately, the method of blending different chemicals pooled in a single formulation often prevents the full curative effect of each active principle: in fact, the stechiometric balance of these melting pots does not achieve the full dose-effect of each one; furtherly the patients would be warned to use only effective evidence-based products, preventing the risk of skin and mucosa sen-sitization in the long run when different chemical or herbal compounds are together administered. On the basis of the literature review, we focused our study on a single drug-medication whose properties go beyond the classic anaesthetic claim: lidocaine 5%.

Materials and methods: In our anecdotical, spontaneous, and observational study, 30 patients both sexes (15 males and 15 females), recruited from the Second Opinion Medical Consulting Network for a spontaneous anecdotical post marketing evaluation of grade 1,2,3 haemorrhoids (n=23), anal fistulas (n=2) and fissures (n=5) treatment with a 5% lidocaine ointment (Octosedan Laboratori Baldacci S.p.A., Italy) for two months; the primary endpoints of the investigation were tolerability and effectiveness to relieve pain, itching, soiling and discomfort at rest or during and after stool emission. The most commonly reported symptom was bleeding, present in 20 patients with prevalence in women. In 13 patients (43,33%) the "wet anus" with or without soiling was present, while 12 patients (40%) complained of intermittent itching. In 7 patients (23,33%) hemorrhoidal thrombosis with prevalent (6/ 7) heavy pain, was recorded.

Results: 28/30 treated patients had significantly symptom impro-vement (p<0.0001), 10 (33,33%) patients were addressed to surgical therapy for persistence of symptoms, (7 at the end of the therapeutic cycle 3, spontaneously asking to anticipate surgery before the end of the trial) 4 clinical cases fairly improved but accepted a further surgical revaluation three months later. Of the 19 patients previously treated with flavonoids or heparinoid therapy with unsatisfactory results, 9 (30%) participants found benefit from the new treatment. Of the 5 patients whose anal fissures healed primarily, only 1 patient developed a recurrent fissure within 6 months. Octosedan administration relieved the pain after 5 days with a tolerable life quality and promoted fissures healing in one month. No adverse effects of the treatment were recorded.

Conclusions: The local symptomatic treatment of haemorrhoids grade one, two, three and of the fissures, and the fistulas with the plain formula: lidocaine 5%; excipient: cetilic acid macrogol, water;( gently administered into and around the anal verge 3-5 minutes before voiding the bowel and reapplied soon after having cleaned and rinsed the anus&perineal area with neutral liquid soap for two months of treatment,) showed highly significant effect (p<0.0001) and highlights the quality of monotherapy on multiple steps of anorectal care.