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Cochrane Database of Systematic Reviews

Intervenciones tópicas para el liquen escleroso genital

Information

DOI:
https://doi.org/10.1002/14651858.CD008240.pub2Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 07 December 2011see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Skin Group

Copyright:
  1. Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Ching‐Chi Chi

    Correspondence to: Department of Dermatology and Centre for Evidence‐Based Medicine, Chang Gung Memorial Hospital, Chiayi, Taiwan

    [email protected]

    [email protected]

  • Gudula Kirtschig

    Institute of General Medicine and Interprofessional Care, University of Tübingen, Tübingen, Germany

  • Maha Baldo

    Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK

  • Fabia Brackenbury

    c/o Cochrane Skin Group, University of Nottingham, Nottingham, UK

  • Fiona Lewis

    Department of Dermatology, Wexham Park Hospital, Heatherwood & Wexham Park NHS Foundation Trust, Slough, UK

    St John's Institute of Dermatology, St Thomas' Hospital, London, UK

  • Fenella Wojnarowska

    Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK

Contributions of authors

Link with the editorial base and co‐ordinating contributions from co‐authors ‐ CC
Drafting the protocol ‐ CC, MB, GK, FW, FL, and FB
Dialogue with the Trials Search Co‐ordinator ‐ CC
Identifying relevant titles and abstracts from the searches ‐ CC and GK
Obtaining copies of the trials ‐ CC
Selecting the trials ‐ CC and GK
Extracting the data ‐ CC and GK
Entering the data into RevMan ‐ CC
Carrying out the analysis ‐ CC and GK
Interpreting the data ‐ CC, GK, and FW
Drafting the final review ‐ CC with contribution from all
Updating the review ‐ CC

Sources of support

Internal sources

  • Vrije Universiteit Medisch Centrum, Netherlands.

  • St John's Institute of Dermatology, UK.

External sources

  • British Society for the Study of Vulval Disease, UK.

    Funding

  • Chang Gung Memorial Hospital‐Chiayi (CMRPG690041), Taiwan.

    Funding

Declarations of interest

None known.

Acknowledgements

The Cochrane Skin Group editorial base would like to thank the following people who commented on this update: our Key Editor Michael Bigby, our Statistical Editor Jo Leonardi‐Bee, our Methodological Editor Sarah Garner, Hazel Bell and Sallie Neill who were the clinical referees, and Jack Tweed who was the consumer referee.

Version history

Published

Title

Stage

Authors

Version

2011 Dec 07

Topical interventions for genital lichen sclerosus

Review

Ching‐Chi Chi, Gudula Kirtschig, Maha Baldo, Fabia Brackenbury, Fiona Lewis, Fenella Wojnarowska

https://doi.org/10.1002/14651858.CD008240.pub2

2010 Jan 20

Topical interventions for genital lichen sclerosus

Protocol

Ching‐Chi Chi, Maha Baldo, Gudula Kirtschig, Fabia Brackenbury, Fiona Lewis, Fenella Wojnarowska

https://doi.org/10.1002/14651858.CD008240

Differences between protocol and review

After discussion with our consumer author (FB), we made amendments in the Background to stress that lichen sclerosus can affect the quality of the sex lives of people with this condition, including painful sex and less pleasurable sex. This issue is under‐investigated, and in the Implications for research we encourage researchers to examine this aspect in future trials.

We revised the Description of the intervention to describe what the treatments are, how they work, and their side‐effects.

We have updated some references in the Background text.

In the protocol, we prespecified the first primary outcome as 'participant‐rated global degree of improvement'. However, the global scale may not pick up the various effects of interventions on different symptoms (itching, pain, pain in sex, etc). One trial (Bracco 1993) did not report the degree of improvement; instead, they reported the number of participants who had improvement or remission of symptoms. We, therefore, revised the outcome as 'participant‐rated improvement or remission of symptoms' and reported effects on various symptoms, respectively, if the trialists provided relevant data.

In the protocol, we planned a time point of outcome measurement at three to six months into therapy. In one trial (Kiss 2001), outcome measurement was made at five weeks into therapy, which was earlier than we had planned to make the measurement, so although the Kiss trial was too short according to our review protocol, we made the decision to include the trial in our review. In this trial, a significant difference in the clinical score of phimosis was detected (Kiss 2001). Therefore, inclusion of the trial conducted shorter than originally planned did not appear to affect the validity of our review (i.e. if this trial had not found a significant therapeutic benefit from mometasone furoate in the short study period, we may have been led to say that this intervention was not effective). However, the fact is that even over the shorter study period it did have a beneficial effect, so inclusion of this trial has not led to a false negative conclusion regarding mometasone furoate.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.