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Peer-reviewedCC BYFrontiers in Medicine

Efficacy and safety of intralesional corticosteroids alone or in combination with other treatments for the management of keloids: a systematic review and meta-analysis

9 affiliations
  1. 1College of Medicine, Alfaisal University, Riyadh, Saudi Arabia
  2. 2College of Pharmacy, Alfaisal University, Riyadh, Saudi Arabia
  3. 3Primary Health Care, Ministry of Health, Riyadh, Saudi Arabia
  4. 4Jahra Hospital, Ministry of Health, Al Jahra, Kuwait
  5. 5Fawanya Hospital, Ministry of Health, Al Fawanya, Kuwait
  6. 6College of Medicine, King Khalid University, Abha, Saudi Arabia
  7. 7Aseer Central Hospital, Ministry of Health, Abha, Saudi Arabia
  8. 8Dammam Medical Complex, Dammam, Saudi Arabia
  9. 9King Fahad Medical City, Riyadh, Saudi Arabia

Abstract

BackgroundKeloids continue to present a therapeutic challenge despite several proposed treatment modalities, and there is a lack of current evidence-based guidelines to inform disease management. Therefore, we conducted this systematic review and meta-analysis to compare intralesional corticosteroid monotherapy against combination therapies containing intralesional corticosteroids regarding their efficacy and safety.MethodsWe searched PubMed, Scopus, and Web of Science using the Medical Subject Headings (MeSH) terms with the following keywords: “Corticosteroids” AND “Keloid” AND “Intralesional” from inception until May 2026 to identify the studies included in this systematic review and meta-analysis. The screening process was conducted based on inclusion and exclusion criteria established using the PICOS criteria as follows: P (population): patients with keloids; I (intervention): a combination of intralesional corticosteroids and any other therapy or drug; C (comparison): intralesional corticosteroids alone; O (outcomes): any efficacy and safety outcome; and S (study design): randomized controlled trials, non-randomized trials, and observational cohort studies.ResultsA total of 20 studies were included in the current systematic review and meta-analysis, comprising 15 randomized controlled trials, 2 non-randomized controlled trials, and 3 cohort studies. The analysis of each outcome included only a subset of the included studies, as not all studies reported all outcomes. The analysis favored combination treatment over intralesional corticosteroids alone regarding clinical improvement or efficacy, with an odds ratio of 2.71 (95% CI: 1.8, 4.09; p < 0.00001, I2 = 17%). Combination therapy was observed to be associated with greater baseline improvement in clinical signs of keloids, such as pain, itching, pigmentation, and height or thickness, with a mean difference (MD) of 0.67 (95% CI: 0.27, 1.06, p = 0.0009, I2 = 69%), a standardized mean difference of 0.41 (95% CI: 0.06, 0.77, p = 0.02, I2 = 0%), an MD of 0.66 (95% CI: 0.4, 0.92, p < 0.00001, I2 = 33%), and an MD of 0.15 (95% CI: 0.06, 0.23, p = 0.0005, I2 = 85%), respectively, with I2 = 85%, p < 0.00001.ConclusionCombination therapies with intralesional corticosteroids showed greater efficacy and safety than monotherapy across various outcomes. Subgroup analysis indicates that effects vary by co-intervention: corticosteroids (CS) plus 5-fluorouracil (5-FU) had favorable efficacy, adverse events, and height outcomes; Vancouver Scar Scale change favored CS plus excision, 5-FU, and platelet-rich plasma. Significant subgroup differences, heterogeneity, and limited data warrant cautious interpretation. Clinical and methodological differences, treatment variations, and inclusion of non-randomized studies limit certainty and generalizability. Evidence does not universally favor combination therapies over monotherapy. Among adjuncts, 5-FU combinations show consistent benefit, but more trials are needed to identify the best regimen.Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD420261439889, identifier CRD420261439889.

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BibTeX
@article{alshamari2026efficacy,
  title = {{Efficacy and safety of intralesional corticosteroids alone or in combination with other treatments for the management of keloids: a systematic review and meta-analysis}},
  author = {Naif Abed Alshamari and Alanoud AlDaej and Asmaa Yaser Mallisho and Reemana Waleed Alsudais and Moudi Nayef Alhajraf and Danah Mohammad and Ahmed Turki Al-Turki and Mousa Amer Alshehri and Reem T. Alshammari and Abdullah N. AlBarrak},
  journal = {Frontiers in Medicine},
  year = {2026},
  month = oct,
  doi = {10.3389/fmed.2026.1930913},
  url = {https://doi.org/10.3389/fmed.2026.1930913},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Efficacy and safety of intralesional corticosteroids alone or in combination with other treatments for the management of keloids: a systematic review and meta-analysis
AU  - Naif Abed Alshamari
AU  - Alanoud AlDaej
AU  - Asmaa Yaser Mallisho
AU  - Reemana Waleed Alsudais
AU  - Moudi Nayef Alhajraf
AU  - Danah Mohammad
AU  - Ahmed Turki Al-Turki
AU  - Mousa Amer Alshehri
AU  - Reem T. Alshammari
AU  - Abdullah N. AlBarrak
PY  - 2026
DA  - 2026/10/26
JO  - Frontiers in Medicine
DO  - 10.3389/fmed.2026.1930913
UR  - https://doi.org/10.3389/fmed.2026.1930913
AB  - BackgroundKeloids continue to present a therapeutic challenge despite several proposed treatment modalities, and there is a lack of current evidence-based guidelines to inform disease management. Therefore, we conducted this systematic review and meta-analysis to compare intralesional corticosteroid monotherapy against combination therapies containing intralesional corticosteroids regarding their efficacy and safety.MethodsWe searched PubMed, Scopus, and Web of Science using the Medical Subject Headings (MeSH) terms with the following keywords: “Corticosteroids” AND “Keloid” AND “Intralesional” from inception until May 2026 to identify the studies included in this systematic review and meta-analysis. The screening process was conducted based on inclusion and exclusion criteria established using the PICOS criteria as follows: P (population): patients with keloids; I (intervention): a combination of intralesional corticosteroids and any other therapy or drug; C (comparison): intralesional corticosteroids alone; O (outcomes): any efficacy and safety outcome; and S (study design): randomized controlled trials, non-randomized trials, and observational cohort studies.ResultsA total of 20 studies were included in the current systematic review and meta-analysis, comprising 15 randomized controlled trials, 2 non-randomized controlled trials, and 3 cohort studies. The analysis of each outcome included only a subset of the included studies, as not all studies reported all outcomes. The analysis favored combination treatment over intralesional corticosteroids alone regarding clinical improvement or efficacy, with an odds ratio of 2.71 (95% CI: 1.8, 4.09; p < 0.00001, I2 = 17%). Combination therapy was observed to be associated with greater baseline improvement in clinical signs of keloids, such as pain, itching, pigmentation, and height or thickness, with a mean difference (MD) of 0.67 (95% CI: 0.27, 1.06, p = 0.0009, I2 = 69%), a standardized mean difference of 0.41 (95% CI: 0.06, 0.77, p = 0.02, I2 = 0%), an MD of 0.66 (95% CI: 0.4, 0.92, p < 0.00001, I2 = 33%), and an MD of 0.15 (95% CI: 0.06, 0.23, p = 0.0005, I2 = 85%), respectively, with I2 = 85%, p < 0.00001.ConclusionCombination therapies with intralesional corticosteroids showed greater efficacy and safety than monotherapy across various outcomes. Subgroup analysis indicates that effects vary by co-intervention: corticosteroids (CS) plus 5-fluorouracil (5-FU) had favorable efficacy, adverse events, and height outcomes; Vancouver Scar Scale change favored CS plus excision, 5-FU, and platelet-rich plasma. Significant subgroup differences, heterogeneity, and limited data warrant cautious interpretation. Clinical and methodological differences, treatment variations, and inclusion of non-randomized studies limit certainty and generalizability. Evidence does not universally favor combination therapies over monotherapy. Among adjuncts, 5-FU combinations show consistent benefit, but more trials are needed to identify the best regimen.Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD420261439889, identifier CRD420261439889.
SN  - 2296-858X
ER  -