Evidence map›Paper›PMID 30343411›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2019

Effectiveness and safety of a product containing diosmin, coumarin, and arbutin (Linfadren®) in addition to complex decongestive therapy on management of breast cancer-related lymphedema.

Angelo Cacchio, Rosa Prencipe, Marina Bertone, Luciana De Benedictis, Luciano Taglieri, Erika D'Elia, Cesidia Centoletti, Giancarlo Di Carlo

Abstract readPragmatic Clinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Review
  10. Fatigue and sleep quality improvement through complete decongestive therapy in postmastectomy lymphedema: An investigative analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Article
  11. Article
  12. Disability prevalent conditions in women.Revista da Associacao Medica Brasileira (1992) · 2023
    Article
  13. Article
  14. Review
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

8 authors.

Angelo CacchioDepartment of Life, Health & Environmental Sciences, School of Medicine, University of L'Aquila, L'Aquila, Italy. angelo.cacchio@univaq.it.ORCID http://orcid.org/0000-0001-8850-7938
Rosa PrencipeRehabilitation Service ex Polio Centre, ASL 01 Avezzano-Sulmona, L'Aquila, Avezzano, Italy.
Marina BertoneRehabilitation Service, "Serafino Rinaldi" Territorial Assistance Hospital of Pescina, ASL 01 Avezzano-Sulmona, L'Aquila, Pescina, Italy.
Luciana De BenedictisRehabilitation Service, "Serafino Rinaldi" Territorial Assistance Hospital of Pescina, ASL 01 Avezzano-Sulmona, L'Aquila, Pescina, Italy.
Luciano TaglieriRehabilitation Service, "Serafino Rinaldi" Territorial Assistance Hospital of Pescina, ASL 01 Avezzano-Sulmona, L'Aquila, Pescina, Italy.
Erika D'EliaRehabilitation Service, "Serafino Rinaldi" Territorial Assistance Hospital of Pescina, ASL 01 Avezzano-Sulmona, L'Aquila, Pescina, Italy.
Cesidia CentolettiRehabilitation Service ex Polio Centre, ASL 01 Avezzano-Sulmona, L'Aquila, Avezzano, Italy.
Giancarlo Di CarloDepartment of Life, Health & Environmental Sciences, School of Medicine, University of L'Aquila, L'Aquila, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo assess the effectiveness and safety of a product containing diosmin, coumarin, and arbutin (Linfadren®) in addition to complex decongestive therapy (CDT) on the management of patients with a breast cancer-related lymphedema (BCRL).

methodsFifty outpatients (average age of 56.2 ± 2.7 years, range 28-71) with a BCRL were enrolled for this study. Patients were randomly assigned (1:1 ratio) to receive either CDT consisting of skin care, manual lymphatic drainage, remedial exercises, and elastic compression garment (control group, n = 25) or CDT plus Linfadren® (study group, n = 25). Patients were evaluated before and after treatment and 3 months after the end of treatment. Primary outcomes were reduction of upper limb excess volume (EV) and percentage reduction of excess volume (%REV). Secondary outcomes were improvement in Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, and patient's perception of treatment effectiveness (PPTE).

resultsAddition of Linfadren® to CDT yielded an additional reduction of primary outcomes both after treatment (EV, - 521 ml vs. - 256 ml, P < 0.0001; %REV, - 66.4% vs. - 34%, P = 0.02) and at 3-month follow-up (EV, - 59 ml vs. + 24 ml, P < 0.0001; %REV, - 73.6% vs. - 31.4%, P = 0.004). Moreover, statistically significant differences were found between the two groups for the secondary outcomes after treatment (QuickDASH, P = 0.006; PPTE, P = 0.03) and at 3-month follow-up (QuickDASH, P = 0.006; PPTE, P = 0.02). No patient showed adverse events.

conclusionsLinfadren® in addition to CDT was a safe and effective therapy for reducing BCRL and was better than CDT alone.

Indexed as

AdultAgedArbutinBreast Cancer LymphedemaCombined Modality TherapyCompression BandagesCoumarinsDiosminDrainageExercise TherapyFemaleHumansMassageMiddle AgedSkin CareTreatment OutcomeArbutinCoumarinsDiosminBreast cancerComplex decongestive therapyCoumarinDiosminLymphedemaManual lymphatic drainage

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.