Evidence map›Paper›PMID 21885537›Full record

Trial reportBMJ (Clinical research ed.)2011

Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial.

Nele Devoogdt, Marie-Rose Christiaens, Inge Geraerts, Steven Truijen, Ann Smeets, Karin Leunen, Patrick Neven, Marijke Van Kampen

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02609724 (Effectiveness of Fluoroscopy-guided Manual Lymph Drainage), which is not on this map. Cited by 37 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 11 pooled it
4.2field-weighted citation impact, top 5% 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.

NCT02609724 nacompletednot on this mapstarted 2016, after this paper: background citation

Effectiveness of Fluoroscopy-guided Manual Lymph Drainage (MLD) Versus Traditional MLD or Placebo MLD, as Part of Decongestive Lymphatic Therapy, for the Treatment of Breast Cancer-related Lymphoedema (BCRL): a Randomised Controlled Trial

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2016 to 2020Enrolled194ConditionsBreast Neoplasm, LymphedemaArmsInformation, Skin care, Compression therapy, Fluoroscopy-guided MLD, Traditional MLD
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 11 syntheses or guidelines pooled it, 115 citations in OpenAlex.

  1. Pooled it
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  4. Manual lymphatic drainage treatment for lymphedema: a systematic review of the literature.Journal of cancer survivorship : research and practice · 2021
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Guideline
  8. Manual lymphatic drainage for lymphedema following breast cancer treatment.The Cochrane database of systematic reviews · 2015
    Pooled it
  9. Pooled it
  10. Guideline
  11. Pooled it
  12. Trial
  13. Trial
  14. Trial
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  17. Review
  18. Article
  19. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Nele DevoogdtDepartment of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium. nele.devoogdt@uzleuven.be
Marie-Rose Christiaens
Inge Geraerts
Steven Truijen
Ann Smeets
Karin Leunen
Patrick Neven
Marijke Van Kampen
KU Leuven · BEArtesis Plantijn Hogeschool Antwerpen · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine the preventive effect of manual lymph drainage on the development of lymphoedema related to breast cancer.

designRandomised single blinded controlled trial.

settingUniversity Hospitals Leuven, Leuven, Belgium.

participants160 consecutive patients with breast cancer and unilateral axillary lymph node dissection. The randomisation was stratified for body mass index (BMI) and axillary irradiation and treatment allocation was concealed. Randomisation was done independently from recruitment and treatment. Baseline characteristics were comparable between the groups.

interventionFor six months the intervention group (n = 79) performed a treatment programme consisting of guidelines about the prevention of lymphoedema, exercise therapy, and manual lymph drainage. The control group (n = 81) performed the same programme without manual lymph drainage.

main outcome measuresCumulative incidence of arm lymphoedema and time to develop arm lymphoedema, defined as an increase in arm volume of 200 mL or more in the value before surgery.

resultsFour patients in the intervention group and two in the control group were lost to follow-up. At 12 months after surgery, the cumulative incidence rate for arm lymphoedema was comparable between the intervention group (24%) and control group (19%) (odds ratio 1.3, 95% confidence interval 0.6 to 2.9; P = 0.45). The time to develop arm lymphoedema was comparable between the two group during the first year after surgery (hazard ratio 1.3, 0.6 to 2.5; P = 0.49). The sample size calculation was based on a presumed odds ratio of 0.3, which is not included in the 95% confidence interval. This odds ratio was calculated as (presumed cumulative incidence of lymphoedema in intervention group/presumed cumulative incidence of no lymphoedema in intervention group)×(presumed cumulative incidence of no lymphoedema in control group/presumed cumulative incidence of lymphoedema in control group) or (10/90)×(70/30).

conclusionManual lymph drainage in addition to guidelines and exercise therapy after axillary lymph node dissection for breast cancer is unlikely to have a medium to large effect in reducing the incidence of arm lymphoedema in the short term. Trial registration Netherlands Trial Register No NTR 1055.

Indexed as

Exercise TherapyLymphAdultAgedBelgiumBreast NeoplasmsDrainageFemaleHumansIncidenceKaplan-Meier EstimateLymphedemaLymph NodesMiddle AgedPractice Guidelines as TopicSingle-Blind Method

Identifiers

PMID21885537
PMCPMC3164214
OpenAlexW2165993348

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.