Treatment of chronic anal fissure: a feasibility study on Levorag® Emulgel versus Diltiazem gel 2%

Nordholm-Carstensen, Andreas; Perregaard, Helene; Wahlstrøm, Kirsten Lykke; Hagen, Kikke Bartholin; Hougaard, Helene Tarri; Krarup, Peter‐Martin

doi:10.1007/s00384-020-03515-z

Cited by 8 publications

(8 citation statements)

References 14 publications

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“…A total of 189 records were reviewed for inclusion, after applying the selection criteria, 17 articles were selected [26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41], 12 evaluated the use of calcium channel blockers [31][32][33][34][35][36][37][38][39][40][41][42][43], and 5 evaluated botulinum toxin [26][27][28][29][30] (Fig. 1).…”

Section: Resultsmentioning

confidence: 99%

“…A total of 189 records were reviewed for inclusion, after applying the selection criteria, 17 articles were selected [26–41], 12 evaluated the use of calcium channel blockers [31–43], and 5 evaluated botulinum toxin [26–30] (Fig. 1).…”

Section: Resultsmentioning

confidence: 99%

“…The available common treatment options, such as nitroglycerin ointment relax the sphincter muscle; however, side effects such as severe headaches limit its administration [42]. Therefore, calcium medications like calcium channel blockers and topical diltiazem were introduced [43, 44]. Nonetheless, some controversy remains about the evidence in favor or against the available treatment alternatives; a study of long-term outcomes and follow-up could resolve this evaluating effectiveness and adverse events, aim of this review, and meta-analysis.…”

Section: Discussionmentioning

confidence: 99%

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Clinical Outcomes of Medical Management Options for Chronic Anal Fissures in a Long-Term Follow-up: Systematic Review and Meta-Analysis

Sierra-Arango¹,

Hoz-Valle²,

Espinosa³

et al. 2023

Dig Dis

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Background: Topical treatments and botulinum toxin injections are valid options for the management of patients with chronic anal fissures (CAF) but little is known about the efficacy in a long-term follow-up. The aim of this meta-analysis was evaluate the effectiveness, given to clinical outcomes of medical treatments in adults. Method: this manuscript was developed according to PRISMA [23, 25] and registered in PROSPERO (Registration number: CRD42020120386). A systematic literature search was conducted through MEDLINE, EMBASE, Web of Science, and Cochrane Library databases. Randomized control trials that compared medical treatment were identified; publications had to have a clinical definition of CAF with at least one of the following signs or symptoms: visible sphincter fibers at the base of the fissure, anal papillae, sentinel piles, and indurated margins. The symptoms had to be chronic for at least 4 weeks. Results: 17 randomized trials met the inclusion criteria. Diltiazem showed a superior effect compared with glycerin (RR = 1.16 [95% CI = 1.05-1.30]; I2 = 18%), and with fewer adverse effects (RR = 0.13 [95% CI = 0 , 04-0.042]; I2 = 87%). Similar results were evidenced with the use of nifedipine compared with lidocaine (RR = 4.53 [95% CI = 2.99-6.86]; I2 = 28%). Botulinum toxin did not show statistically significant differences compared to glycerin (RR = 0.81 [95% CI = 0.02-29.36]; I2 = 93%) or isosorbide dinitrate (RR = 1.45 [CI 95% = 0.32-6.54]; I2 = 85%). Regarding recurrence, nifedipine was superior to lidocain (RR = 0.18 [95% CI = 0.08-0.44]; I2 = 31%). Conclusions: Calcium channel blockers performed well regarding the healing of CAF when compared to others in long-term follow-up. The superiority of botulinum toxin was not evidenced compared to topical treatments. More studies are needed to better assess recurrence rates.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Clinical Outcomes of Medical Management Options for Chronic Anal Fissures in a Long-Term Follow-up: Systematic Review and Meta-Analysis

Sierra-Arango¹,

Hoz-Valle²,

Espinosa³

et al. 2023

Dig Dis

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“…Nordholm-Cartensen et al ( 24 ) reported a healing rate of 52% in a randomized clinical trial of patients with chronic anal fissures, although the number of patients in the Levorag group (26 patients) was smaller than the estimated sample size and the study's power was only 70%. Furthermore, the RCT did not provide a clear definition of “fissure healing.”…”

Section: Discussionmentioning

confidence: 98%

Safety and efficacy of Levorag emulgel in the treatment of anal fissures using a validated scoring system

et al. 2023

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IntroductionAnal fissure is one of the most common anal disease characterized by intense anal pain, and deterioration of patients quality of life. Treatment is mainly based on the topical administration of calcium antagonist or nitric oxide ointments, and in cases refractory to medical treatment patients can undergo surgery. This study aims to assess the efficacy and safety of Levorag emulgel in the treatment of acute and chronic fissures using of a validated scoring system.Material and MethodsA prospective observational study was carried out on patients with anal fissures between February and May 2022. The efficacy of the treatment was evaluated using the REALISE score, a new validated scoring system that rates VAS for pain, NSAID use, pain duration, bleeding, and quality of life (QoL), recorded after 10, 20 and 30 days from the beginning of treatment.ResultsForty patients (median age 46 years, IQR 29–57, 70% women) with acute (22, 55%) or chronic (18, 45%) anal fissures entered the study. The median anal pain score according to the VAS scale decreased significantly from 7 (IQR 4.7–8) at baseline to 1 (IQR 0–3.2, p = 0.05) after 20 days. At the 30-day proctological examination, 22 patients (61%) were pain free (median VAS of 0, IQR 0–1.2, p < 0.05). Pain duration after defecation measured according to the REALISE score, showed a significant decrease after 10 days, from a median value of 2 (IQR 1–4) to 1 (IQR 1–1.2) (p < 0.005). The median value of the REALISE score decreased significantly, from 15 (IQR 11–19.25) at first proctological evaluation to 4 (IQR 4–6, p = 0.139) after 30 days of treatment. At day 30, complete fissure healing was achieved in 30 patients (80%). The healing rate was 82% and 78% in patients with acute and chronic anal fissures, respectively.ConclusionThe use of Levorag® Emulgel may represent a safe and effective non-invasive first line treatment in patients affected by acute or chronic anal fissure.

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“…Histopathological assessment showed marked improvement in the skin histological architecture after 16 days of OB emulgel treatment. Nordholm-Carstensen A et al [12], compare the standard treatment, diltiazem gel 2%, with Levorag® Emulgel for chronic anal fissures in a single-blinded, randomised, controlled, clinical trial with a non-inferiority design. Patients with a chronic anal fissure were randomised to treatment with diltiazem or Levorag® Emulgel twice daily for 8 weeks.…”

Section: Topical Applicationsmentioning

confidence: 99%

Overview of Emulgel as Emergent Topical Delivery: Recent Applications and Advancement

Amgaonkar¹,

Kochar²,

Chandewar³

et al. 2021

JPRI

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Emulgel is an emerging delivery system with added advantages over other topical delivery systems which is proven to be boon for cosmetics and dermatology. Emulgels are emulsion which is converted to Gel, which will make it a non greasy and enhances patient compliance. The amalgamation of the two systems would be advantages in term of high drug loading capacity and low skin irritation, site specific targeting avoiding first-pass metabolism and increase in bioavailability. Work carried out by researchers proved that, Emulgel/ Nanoemulgel loaded with drugs has been found effective in many topical disorders and it is emerging as potential drug delivery system in area of dermatology. In the present review current research works that carried out on Emulgel and nano emulgels are discussed and also highlighted the recent applications of Emulgel in transdermal as well as dental, ocular, vaginal, and other delivery system.

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Treatment of chronic anal fissure: a feasibility study on Levorag® Emulgel versus Diltiazem gel 2%

Cited by 8 publications

References 14 publications

Clinical Outcomes of Medical Management Options for Chronic Anal Fissures in a Long-Term Follow-up: Systematic Review and Meta-Analysis

Clinical Outcomes of Medical Management Options for Chronic Anal Fissures in a Long-Term Follow-up: Systematic Review and Meta-Analysis

Safety and efficacy of Levorag emulgel in the treatment of anal fissures using a validated scoring system

Overview of Emulgel as Emergent Topical Delivery: Recent Applications and Advancement

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