Topical imiquimod compared with conization to treat cervical high-grade squamous intraepithelial lesions: Multicenter, randomized controlled trial

Polterauer, Stephan; Reich, Olaf; Widschwendter, Andreas; Hadjari, Laudia; Bogner, Gerhard; Reinthaller, Alexander; Joura, Elmar A.; Trutnovsky, Gerda; Ciresa-Koenig, Alexandra; Ganhoer-Schimboeck, Julia; Boehm, Ina; Berger, Regina; Langthaler, Eva; Aberle, Stephan W.; Heinze, Georg; Gleiß, Andreas; Grimm, Christoph

doi:10.1016/j.ygyno.2022.01.033

Cited by 18 publications

(33 citation statements)

References 16 publications

(24 reference statements)

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“…Using the remaining 37 citations, cross reference searching identified two further appropriate citations. Thus, in summary, 39 citations reporting on diagnostic and therapeutic interventions in women with cervical dysplasia within a controlled trial setting were included in this review [ 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 ]. Among them, we found 5 PCTs [ 13 , 14 , 15 , 16 , 17 ] and 28 RCTs [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , …”

Section: Resultsmentioning

confidence: 99%

“…The clinical characteristics of individual studies reporting on therapeutic procedures in women with cervical dysplasia are shown in Table 2 . We identified 20 RCTs with 3355 participants [ 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 ] and one PCT with 297 participants [ 17 ]. in total, 4 RCTs found that alternative electrosurgical techniques such as Straight Wire Excision of the Transformation Zone (SWETZ), Contour-Loop Excision of the Transformation Zone (C-LETZ), and True Cone Biopsy Electrode Excision (TCBEE) were comparable to the standard LEEP/LLETZ procedure with minimal differences regarding specimen fragmentation and endocervical resection margin status [ 26 , 27 , 28 , 31 ].…”

Section: Resultsmentioning

confidence: 99%

“…Cryotherapy as well as thermoablation were found to be safe and efficacious in women with LSIL, especially in women with HIV infection [ 30 , 32 , 36 , 39 ], but LLETZ was superior when treating HSIL [ 34 ]. Topical imiquimod was efficacious for the treatment of LSIL/HSIL but was less effective than surgery [ 40 , 45 ].…”

Section: Resultsmentioning

confidence: 99%

“…Figure 2 shows the methodological quality of all 21 RCTs. In 6/21 trials, there was a significant risk of bias [ 24 , 25 , 28 , 36 , 43 , 45 ], limiting the validity of the results. Figure 3 shows the overall and specific bias risks given as a percentage of all RCTs.…”

Section: Resultsmentioning

confidence: 99%

“…Therefore, evidence-based diagnostic and therapeutic interventions for LSIL/HSIL are an important worldwide medical need. In order to clarify what progress has been made in this field during the last decade, we systematically searched the literature between 2012 and 2021 and identified 39 high-quality controlled trials, RCTs, and PCTs, reporting on diagnostic and therapeutic interventions in women with cervical dysplasia [ 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 ]. Among them, we found 5 PCTs [ 13 , 14 , 15 , 16 , 17 ] and 28 RCTs [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , ...…”

Section: Discussionmentioning

confidence: 99%

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Innovative Diagnostic and Therapeutic Interventions in Cervical Dysplasia: A Systematic Review of Controlled Trials

Hecken

Rezniczek

Tempfer

2022

Cancers

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Cervical dysplasia is a common precancerous lesion affecting 1% to 2% of women worldwide. Significant progress in the diagnosis and treatment of cervical dysplasia have been made in the last decade. We performed a systematic literature search of the databases PubMed and Cochrane Central Register of Controlled Trials to identify controlled clinical trials reporting on the efficacy and safety of diagnostic and therapeutic interventions for cervical dysplasia. Data were analyzed according to PRISMA guidelines. In total, 33 studies reporting on 5935 women were identified. We recommend intravenous or intracervical lidocaine for pain reduction during colposcopically-directed cervical biopsies but not topical lidocaine, music, or video colposcopy. Monsel’s solution might be used to control bleeding after cervical biopsies. The acetic acid test should be scored 1 min after the application of acetic acid and should be followed by Lugol’s iodine test for an optimal yield of LSIL/HSIL. LEEP/LLETZ remains the standard and techniques such as SWETZ, C-LETZ, and TCBEE are not superior. LEEP/LLETZ should be performed under local anesthesia and with direct colposcopic vision. Cryotherapy and thermoablation might be used in women with LSIL, especially in women with HIV infection, but LEEP/LLETZ remains the standard for HSIL. Topical imiquimod remains an experimental procedure. In conclusion, significant progress has been made in the last decade regarding both diagnostic interventions as well as therapeutic interventions for women with cervical dysplasia. Based on >30 controlled clinical trials, we were able to formulate specific and evidence-based recommendations.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 3 more Smart Citations

Innovative Diagnostic and Therapeutic Interventions in Cervical Dysplasia: A Systematic Review of Controlled Trials

Hecken

Rezniczek

Tempfer

2022

Cancers

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Topical imiquimod cream for the treatment of cervical intraepithelial neoplasia

Oo,

Soe,

Myint Lwin

et al. 2024

Cochrane Database of Systematic Reviews

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The efficacy of topical imiquimod in high‐grade cervical intraepithelial neoplasia: A systematic review and meta‐analysis

Sande

Kengsakul

Koeneman

et al. 2023

Intl J Gynecology & Obste

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ObjectiveA major side effect of cervical excision for high‐grade cervical intraepithelial neoplasia (CIN) is premature birth. A non‐invasive treatment for reproductive age women is warranted. The aim of the present study was to determine the efficacy of topical imiquimod in the treatment of high‐grade CIN, defined as a regression to ≤CIN 1, and to determine the clearance rate of high‐risk human papillomavirus (hr‐HPV), compared with surgical treatment and placebo.MethodsDatabases were searched for articles from their inception to February 2023.The study protocol number was INPLASY2022110046. Original studies reporting the efficacy of topical imiquimod in CIN 2, CIN 3 or persistent hr‐HPV infections were included. The study followed the Preferred Reporting Items for Systematic Reviews and Meta‐analyses checklist.ResultsFive studies were included (n = 463). Histological regression to ≤CIN 1 was 55% in imiquimod versus 29% in placebo, and 93% in surgical treatment. Imiquimod‐treated women had a greater odds of histological regression to ≤CIN 1 than placebo (odds ratio [OR] 4.17, 95% confidence interval [CI] 2.03–8.54). In comparison to imiquimod, surgical treatment had an OR of 14.81(95% CI 6.59–33.27) for histological regression to ≤CIN 1. The hr‐HPV clearance rate was 53.4% after imiquimod and 66% after surgical treatment (95% CI 0.62–23.77).ConclusionsThe histological regression rate is highest for surgical treatment followed by imiquimod treatment and placebo.

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Topical imiquimod compared with conization to treat cervical high-grade squamous intraepithelial lesions: Multicenter, randomized controlled trial

Cited by 18 publications

References 16 publications

Innovative Diagnostic and Therapeutic Interventions in Cervical Dysplasia: A Systematic Review of Controlled Trials

Innovative Diagnostic and Therapeutic Interventions in Cervical Dysplasia: A Systematic Review of Controlled Trials

Topical imiquimod cream for the treatment of cervical intraepithelial neoplasia

The efficacy of topical imiquimod in high‐grade cervical intraepithelial neoplasia: A systematic review and meta‐analysis

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