Evidence map›Paper›PMID 21786113›Full record

ArticleStrahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]2011

Topical use of a silymarin-based preparation to prevent radiodermatitis : results of a prospective study in breast cancer patients.

Martina Becker-Schiebe, Ulrich Mengs, Margitta Schaefer, Michael Bulitta, Wolfgang Hoffmann

Registry-linked trialAbstract readComparative StudyControlled Clinical Trial
PubMed Publisher
In one paragraph

Article in Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al], 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02534129 (Topical Use of a Silibin-based Cream, Difinsa53™, to Prevent Radiation Dermatitis in Patients With Breast Cancer), which is not on this map. Cited by 22 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 3 pooled it
3.2field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02534129 phase1 / phase2terminatednot on this mapstarted 2015, after this paper: background citation

Topical Use of a Silibin-based Cream, Difinsa53™, to Prevent Radiation Dermatitis in Patients With Breast Cancer: A Prospective Study

TypeinterventionalSponsorProTechSure Scientific, Inc.Ran2015 to 2016Enrolled13ConditionsRadiodermatitisArmsDifinsa53, Aquaphor
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Topical agent therapy for prevention and treatment of radiodermatitis: a meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2013
    Pooled it
  4. Trial
  5. Trial
  6. Radiomitigators: Breakthroughs in Post-Radiation Recovery.Antioxidants (Basel, Switzerland) · 2026
    Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Article
  12. A review of therapeutic potentials of milk thistle (Iranian journal of basic medical sciences · 2022
    Review
  13. Review
  14. Silibinin and non-melanoma skin cancers.Journal of traditional and complementary medicine · 2020
    Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Martina Becker-SchiebeKlinik für Radioonkologie und Strahlentherapie, Klinikum Braunschweig, Braunschweig, Germany. m.schiebe@klinikum-braunschweig.de
Ulrich Mengs
Margitta Schaefer
Michael Bulitta
Wolfgang Hoffmann
Klinikum Braunschweig · DEZimmer Biomet (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeMore than 80% of patients with breast cancer undergoing postsurgical radiotherapy (RT) will develop radiodermatitis and approximately 10% of these patients show grade 3 lesions. Side effects may reduce the patient's compliance and can be limiting factors to follow RT protocols. Therefore, there is a high need for more effective prophylactic treatments. In this study, a silymarin-based cream (Leviaderm(®)) was tested in comparison to our standard of care (SOC) at the involved site.

methodsA total of 101 patients were evaluated after breast-conserving surgery followed by RT with 50.4 Gy plus boost 9-16 Gy. Of these, 51 patients were treated with the silymarin-based cream. In addition, 50 patients were documented receiving a panthenol-containing cream interventionally, if local skin lesions occurred. The acute skin reactions were classified according to the RTOG and VAS (Visual Analogue Scale) scores.

resultsThe median time to toxicity was prolonged significantly with silymarin-based cream (45 vs. 29 days (SOC), p < 0.0001). Only 9.8% of patients using silymarin-based cream showed grade 2 toxicity in week 5 of RT in comparison to 52% with SOC. At the end of RT, 23.5% of patients in the silymarin-based study group developed no skin reactions vs. 2% with SOC, while grade 3 toxicity occurred only in 2% in the silymarin-based arm compared to 28% (SOC).

conclusionsSilymarin-based cream Leviaderm(®) may be a promising and effective treatment for the prevention of acute skin lesions caused by RT of breast cancer patients. To confirm the results of this nonrandomized, observational trial, this component should be tested in larger multicenter studies in this setting.

Indexed as

PhytotherapyAgedBreast NeoplasmsCombined Modality TherapyFemaleHumansMastectomy, SegmentalMiddle AgedNeoplasm StagingOintmentsPantothenic AcidPlant ExtractsPremedicationProspective StudiesRadiation-Protective AgentsRadiodermatitisdexpanthenolOintmentsPantothenic AcidPlant ExtractsRadiation-Protective AgentsSilymarin

Identifiers

PMID21786113
OpenAlexW1466435411

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.