Introduction: Keloid disease presents a significant burden for patients and a significant therapeutic challenge for clinicians. Multiple treatments have been proposed, but with the increasing drive towards effective use of resources, therapeutic options need to be evaluated in terms of the levels of evidence supporting their use.
Aim: To retrieve and review the primary clinical studies evaluating keloid disease therapy over the last 25 years and assign levels of evidence for the treatment modalities evaluated.
Method: A Medline search was conducted to identify all primary clinical studies evaluating the treatment of keloid disease, published in English since 1980 (excluding single case reports). Studies were assigned a level of evidence (LOE-1, highest quality to LOE-5, lowest) adapted from the Oxford Centre for Evidence-based Medicine.
Results: 13 (12%) of 112 studies retrieved were assigned LOE-2, 99 (88%) assigned LOE-4. There were no LOE-1 studies. Ten of the LOE-2 studies evaluated silicone-based therapy or laser therapy. Most studies evaluating steroids, cryosurgery, laser therapy and post-surgical adjuvant therapy provide level 4 evidence.
Conclusion: High quality research in evaluating keloid therapy is lacking. There is a definite need for well designed and properly reported randomised controlled trials, to provide clinicians with a sound body of evidence on which to inform decision making.