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The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus and an increase in the normalization of CIN II lesions compared to expectant management.
In this pilot study, we will include 60 patients with newly diagnosed CIN II. Patients will be counseled according to standard guidelines between a LLETZ, imiquimod or expectant management. Patients choosing for expectant management will be asked to participate in the study and will be treated with medical grade honey. Patients choosing for expectant management but not participating in the study and thus not using medicinal honey will be asked for the control arm. Follow-up assessment takes place in accordance with the national guideline (first check-up is after 6 months). In addition, swabs for vaginal microbiota analysis will be taken at 0 and 6 months. Immunohistochemical stainings for the local immune infiltrate will be performed on biopsies taken during regular colposcopy at t=0. This exploratory study aims to investigate if there is a potential effect of honey and provides insight into its mechanisms of action.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical grade honey formulation (MGH) (L-Mesitran®) for CIN II | Experimental | Daily application of 5 grams (with applicator) for 3 months. Then weekly application (5 grams with applicator) for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical grade honey formulation (MGH) (L-Mesitran®) | Drug | Daily application of 5 grams (with applicator) for the first 3 months, followed by weekly application of 5 grams for the following 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance of hr-HPV | The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Regression of CIN II | Defined as a regression to Pap 1 | 12-24 months |
| Clearance of hr-HPV and normalization of cytology (KOPAC) | Normalization of cytology (KOPAC) (depending on NVOG/RIVM flowchart). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jordy Mongula, dr. | Contact | +31621872080 | 19264 | j.mongula@zuyderland.nl |
| Jasmijn Prop, Drs. | Contact | +31524787337 | j.prop@zuyderland.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuyderland MC | Recruiting | Heerlen | Limburg | 6149 PC | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40707147 | Derived | Prop J, De Vos van Steenwijk P, Lardenoije CMJG, Cremers NAJ, Morre SA, Mongula J. Effect of medical-grade honey (L-Mesitran) for cervical intraepithelial neoplasia II: protocol for a multicentre cohort pilot study (HONEY FOR CIN II study). BMJ Open. 2025 Jul 24;15(7):e104585. doi: 10.1136/bmjopen-2025-104585. |
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Deidentified participant data will be shared.
Data will be available after publication of results.
The data sharing plan includes that data (deidentified participant data) is available upon reasonable request from the corresponding author. This data could be used for further research or a meta-analysis on the use of medical grade honey for CIN II lesions. Data will be available after publication of results. Data can be available from the corresponding author J.N.M.M. Prop (https://orcid.org/0009-0009-8506-5797).'
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In this pilot study, we will include 60 patients with newly diagnosed CIN II. Patients will be counseled according to standard guidelines between a LLETZ, imiquimod or expectant management. Patients choosing for expectant management will be asked to participate in the study and will be treated with medical grade honey. Patients choosing for expectant management but not participating in the study and thus not using medicinal honey will be asked for the control arm. Follow-up assessment takes place in accordance with the national guideline (first check-up is after 6 months). In addition, swabs for vaginal microbiota analysis will be taken at 0 and 6 months. Immunohistochemical stainings for the local immune infiltrate will be performed on biopsies taken during regular colposcopy at t=0. This exploratory study aims to investigate the potential effect of honey and provides insight into its mechanisms of action.
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| 12-24 months |
| Characteristics of the vaginal microbiome | Species specific and diversity analysis, changes due to honey and relationship with the other outcomes measures | 0-6 months |
| Cervical immune status | Immunohistochemical stains on colposcopy biopsies for T and Myeloid cells | 0 months |
| Human vaginal gene expression profiles | RNA quantity and quality of 20 patients | 0 and 6 months |
| Quality of life, side-effects and compliance with medical grade honey | 0, 6, 12 and 24 months |
| Maastricht University Medical Centre+ | Not yet recruiting | Maastricht | Limburg | 6229 HX | Netherlands |
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