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Journal ArticleDOI

Effects of manual lymphatic drainage on breast cancer-related lymphedema: A systematic review and meta-analysis of randomized controlled trials

TL;DR: The current evidence from RCTs does not support the use of MLD in preventing or treating lymphedema, and clinical and statistical inconsistencies between the various studies confounded the evaluation of the effect ofMLD on breast-cancer-related lyMPhedema.
Abstract: Lymphedema is a common complication of axillary dissection for breast cancer. We investigated whether manual lymphatic drainage (MLD) could prevent or manage limb edema in women after breast-cancer surgery. We performed a systematic review and meta-analysis of published randomized controlled trials (RCTs) to evaluate the effectiveness of MLD in the prevention and treatment of breast-cancer-related lymphedema. The PubMed, EMBASE, CINAHL, Physiotherapy Evidence Database (PEDro), SCOPUS, and Cochrane Central Register of Controlled Trials electronic databases were searched for articles on MLD published before December 2012, with no language restrictions. The primary outcome for prevention was the incidence of postoperative lymphedema. The outcome for management of lymphedema was a reduction in edema volume. In total, 10 RCTs with 566 patients were identified. Two studies evaluating the preventive outcome of MLD found no significant difference in the incidence of lymphedema between the MLD and standard treatment groups, with a risk ratio of 0.63 and a 95% confidence interval (CI) of 0.14 to 2.82. Seven studies assessed the reduction in arm volume, and found no significant difference between the MLD and standard treatment groups, with a weighted mean difference of 75.12 (95% CI, −9.34 to 159.58). The current evidence from RCTs does not support the use of MLD in preventing or treating lymphedema. However, clinical and statistical inconsistencies between the various studies confounded our evaluation of the effect of MLD on breast-cancer-related lymphedema.

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Journal ArticleDOI
TL;DR: To assess the efficacy and safety of MLD in treating breast cancer-related lymphedema, six trials were included and it was found that participants with mild-to-moderate BCRL were better responders to MLD than were moderate- to-severe participants.
Abstract: Background More than one in five patients who undergo treatment for breast cancer will develop breast cancer-related lymphedema (BCRL). BCRL can occur as a result of breast cancer surgery and/or radiation therapy. BCRL can negatively impact comfort, function, and quality of life (QoL). Manual lymphatic drainage (MLD), a type of hands-on therapy, is frequently used for BCRL and often as part of complex decongestive therapy (CDT). CDT is a fourfold conservative treatment which includes MLD, compression therapy (consisting of compression bandages, compression sleeves, or other types of compression garments), skin care, and lymph-reducing exercises (LREs). Phase 1 of CDT is to reduce swelling; Phase 2 is to maintain the reduced swelling. Objectives To assess the efficacy and safety of MLD in treating BCRL. Search methods We searched Medline, EMBASE, CENTRAL, WHO ICTRP (World Health Organization's International Clinical Trial Registry Platform), and Cochrane Breast Cancer Group's Specialised Register from root to 24May 2013. No language restrictions were applied. Selection criteria We included randomized controlled trials (RCTs) or quasi-RCTs of women with BCRL. The intervention was MLD. The primary outcomes were (1) volumetric changes, (2) adverse events. Secondary outcomes were (1) function, (2) subjective sensations, (3) QoL, (4) cost of care. Data collection and analysis We collected data on three volumetric outcomes. (1) LE (lymphedema) volume was defined as the amount of excess fluid left in the arm after treatment, calculated as volume in mL of affected arm post-treatment minus unaffected arm post-treatment. (2) Volume reduction was defined as the amount of fluid reduction in mL from before to after treatment calculated as the pretreatment LE volume of the affected arm minus the post-treatment LE volume of the affected arm. (3) Per cent reduction was defined as the proportion of fluid reduced relative to the baseline excess volume, calculated as volume reduction divided by baseline LE volume multiplied by 100. We entered trial data into ReviewManger 5.2 (RevMan), pooled data using a fixed-effect model, and analyzed continuous data as mean differences (MDs) with 95% confidence intervals (CIs). We also explored subgroups to determine whether mild BCRL compared to moderate or severe BCRL, and BCRL less than a year compared to more than a year was associated with a better response to MLD. Main results Six trials were included. Based on similar designs, trials clustered in three categories. (1) MLD + standard physiotherapy versus standard physiotherapy (one trial) showed significant improvements in both groups from baseline but no significant between-groups differences for per cent reduction. (2) MLD + compression bandaging versus compression bandaging (two trials) showed significant per cent reductions of 30% to 38.6% for compression bandaging alone, and an additional 7.11% reduction forMLD (MD7.11%, 95% CI 1.75% to 12.47%; two RCTs; 83 participants). Volume reduction was borderline significant (P = 0.06). LE volume was not significant. Subgroup analyses was significant showing that participants with mild-to-moderate BCRL were better responders to MLD than were moderate-to-severe participants. (3) MLD+ compression therapy versus nonMLDtreatment + compression therapy (three trials) were too varied to pool. One of the trials compared compression sleeve plus MLD to compression sleeve plus pneumatic pump. Volume reduction was statistically significant favoringMLD (MD 47.00 mL, 95% CI 15.25 mL to 78.75 mL; 1 RCT; 24 participants), per cent reduction was borderline significant (P= 0.07), and LE volume was not significant. A second trial compared compression sleeve plus MLD to compression sleeve plus selfadministered simple lymphatic drainage (SLD), and was significant forMLD for LE volume (MD -230.00 mL, 95% CI -450.84 mL to -9.16 mL; 1 RCT; 31 participants) but not for volume reduction or per cent reduction. A third trial of MLD + compression bandaging versus SLD + compression bandaging was not significant (P = 0.10) for per cent reduction, the only outcome measured (MD 11.80%, 95% CI -2.47% to 26.07%, 28 participants). MLD was well tolerated and safe in all trials. Two trials measured function as range of motion with conflicting results. One trial reported significant within-groups gains for both groups, but no between-groups differences. The other trial reported there were no significant within-groups gains and did not report between-groups results. One trial measured strength and reported no significant changes in either group. Two trials measured QoL, but results were not usable because one trial did not report any results, and the other trial did not report between-groups results. Four trials measured sensations such as pain and heaviness. Overall, the sensations were significantly reduced in both groups over baseline, but with no between-groups differences. No trials reported cost of care. Trials were small ranging from 24 to 45 participants. Most trials appeared to randomize participants adequately. However, in four trials the person measuring the swelling knew what treatment the participants were receiving, and this could have biased results. Authors' conclusions MLD is safe and may offer additional benefit to compression bandaging for swelling reduction. Compared to individuals with moderate to-severe BCRL, those with mild-to-moderate BCRL may be the ones who benefit from adding MLD to an intensive course of treatment with compression bandaging. This finding, however, needs to be confirmed by randomized data. In trials where MLD and sleeve were compared with a nonMLD treatment and sleeve, volumetric outcomes were inconsistent within the same trial. Research is needed to identify themost clinically meaningful volumetric measurement, to incorporate newer technologies in LE assessment, and to assess other clinically relevant outcomes such as fibrotic tissue formation. Findings were contradictory for function (range of motion), and inconclusive for quality of life. For symptoms such as pain and heaviness, 60% to 80% of participants reported feeling better regardless of which treatment they received. One-year follow-up suggests that once swelling had been reduced, participants were likely to keep their swelling down if they continued to use a custom-made sleeve. (Less)

205 citations

Journal ArticleDOI
TL;DR: An overview of the recent developments in the diagnosis, treatment, and prevention of cancer-related lymphedema is provided in this article, which includes current trends in therapeutic and surgical treatment options as well as longer-term management.
Abstract: This article provides an overview of the recent developments in the diagnosis, treatment, and prevention of cancer-related lymphedema. Lymphedema incidence by tumor site is evaluated. Measurement techniques and trends in patient education and treatment are also summarized to include current trends in therapeutic and surgical treatment options as well as longer-term management. Finally, an overview of the policies related to insurance coverage and reimbursement will give the clinician an overview of important trends in the diagnosis, treatment, and management of cancer-related lymphedema.

198 citations


Cites methods from "Effects of manual lymphatic drainag..."

  • ...A more recent meta-analysis of 10 randomized controlled trials (total of 566 patients) of MLD for the treatment and prevention of breast cancer-related lymphedema reported that MLD was not beneficial for the prevention of postoperative lymphedema.(159) The authors found wide variability in the studies’ definitions of lymphedema, and the differences between the affected and unaffected extremities at the time of lymphedema diagnosis ranged from 3% to 20%....

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Journal ArticleDOI
TL;DR: Key Clinical Points Lymphedema after Breast Cancer Treatment Breast cancer–related lyMPhedema is the most common form of lympherema in the United States and other developed nations.
Abstract: Key Clinical Points Lymphedema after Breast Cancer Treatment Breast cancer–related lymphedema is the most common form of lymphedema in the United States and other developed nations. Axillary lymph-...

144 citations

Journal ArticleDOI
28 Mar 2019
TL;DR: As a result of surgery or radiotherapy as treatment for cancer, functional components of the lymphatic system are partially removed or damaged, resulting in lymphoedema (accumulation of extracellular fluid in tissues).
Abstract: Lymphoedema is an oedematous condition with a specific and complex tissue biology. In the clinical context of cancer, the pathogenesis of lymphoedema ensues most typically from the modalities employed to stage and treat the cancer (in particular, surgery and radiotherapy). Despite advances in cancer treatment, lifelong lymphoedema (limb swelling and the accompanying chronic inflammatory processes) affects approximately one in seven individuals treated for cancer, although estimates of lymphoedema prevalence following cancer treatment vary widely depending upon the diagnostic criteria used and the duration of follow-up. The natural history of cancer-associated lymphoedema is defined by increasing limb girth, fibrosis, inflammation, abnormal fat deposition and eventual marked cutaneous pathology, which also increases the risk of recurrent skin infections. Lymphoedema can substantially affect the daily quality of life of patients, as, in addition to aesthetic concerns, it can cause discomfort and affect the ability to carry out daily tasks. Clinical diagnosis is dependent on comparison of the affected region with the equivalent region on the unaffected side and, if available, with pre-surgical measurements. Surveillance is indicated in this high-risk population to facilitate disease detection at the early stages, when therapeutic interventions are most effective. Treatment modalities include conservative physical strategies that feature complex decongestive therapy (including compression garments) and intermittent pneumatic compression, as well as an emerging spectrum of surgical interventions, including liposuction for late-stage disease. The future application of pharmacological and microsurgical therapeutics for cancer-associated lymphoedema holds great promise.

106 citations

Journal ArticleDOI
TL;DR: The purpose of this report is to provide an overview of the ongoing research in and the current understanding of the inflammatory manifestations of lymphedema.
Abstract: Lymphedema results from lymphatic insufficiency leading to a progressive inflammatory process that ultimately manifests as discomfort, recurrent infections, and, at times, secondary malignancy. Collectively, these morbidities contribute to an overall poor quality of life. Although there have been recent advances in microsurgical interventions, a conservative palliative approach remains the mainstay of treatment for this disabling disease. The absence of a cure is due to an incomplete understanding of the pathophysiological changes that result in lymphedema. A histological hallmark of lymphedema is inflammatory cell infiltration and recent studies with animal models and clinical biopsy specimens have suggested that this response plays a key role in the pathology of the disease. The purpose of this report is to provide an overview of the ongoing research in and the current understanding of the inflammatory manifestations of lymphedema.

98 citations


Cites background from "Effects of manual lymphatic drainag..."

  • ...The primary treatment for lymphedema is a conservative approach known as complete decongestive therapy (CDT), which includes physical therapy, manual lymphatic drainage, and skin care [5,6]....

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References
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Journal ArticleDOI
TL;DR: This paper examines eight published reviews each reporting results from several related trials in order to evaluate the efficacy of a certain treatment for a specified medical condition and suggests a simple noniterative procedure for characterizing the distribution of treatment effects in a series of studies.

33,234 citations


"Effects of manual lymphatic drainag..." refers methods in this paper

  • ...A pooled estimate of the RR was calculated using the DerSimonian and Laird random-effects model [24]....

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Journal ArticleDOI
TL;DR: An Explanation and Elaboration of the PRISMA Statement is presented and updated guidelines for the reporting of systematic reviews and meta-analyses are presented.
Abstract: Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.

25,711 citations


"Effects of manual lymphatic drainag..." refers methods in this paper

  • ...The meta-analysis was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines [22]....

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Journal ArticleDOI
TL;DR: Two simple formulas are found that estimate the mean using the values of the median, low and high end of the range, and n (the sample size) and these hope to help meta-analysts use clinical trials in their analysis even when not all of the information is available and/or reported.
Abstract: Usually the researchers performing meta-analysis of continuous outcomes from clinical trials need their mean value and the variance (or standard deviation) in order to pool data. However, sometimes the published reports of clinical trials only report the median, range and the size of the trial. In this article we use simple and elementary inequalities and approximations in order to estimate the mean and the variance for such trials. Our estimation is distribution-free, i.e., it makes no assumption on the distribution of the underlying data. We found two simple formulas that estimate the mean using the values of the median (m), low and high end of the range (a and b, respectively), and n (the sample size). Using simulations, we show that median can be used to estimate mean when the sample size is larger than 25. For smaller samples our new formula, devised in this paper, should be used. We also estimated the variance of an unknown sample using the median, low and high end of the range, and the sample size. Our estimate is performing as the best estimate in our simulations for very small samples (n ≤ 15). For moderately sized samples (15 70), the formula range/6 gives the best estimator for the standard deviation (variance). We also include an illustrative example of the potential value of our method using reports from the Cochrane review on the role of erythropoietin in anemia due to malignancy. Using these formulas, we hope to help meta-analysts use clinical trials in their analysis even when not all of the information is available and/or reported.

6,384 citations


"Effects of manual lymphatic drainag..." refers methods in this paper

  • ...When necessary, standard deviations (SDs) were estimated based on the reported confidence interval (CI) limits, standard error, or range values [23]....

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Journal Article
TL;DR: This International Society of Lymphology (ISL) Consensus Document is the current revision of the 1995 Document for the evaluation and management of peripheral lymphedema, and presents a Consensus that embraces the entire ISL membership, rises above national standards, identifies and stimulates promising areas for future research and represents the best judgment of the ISL members on how to approach patients with peripheral lyMPhedema.
Abstract: This International Society of Lymphology(ISL) Consensus Document is the currentrevision of the 1995 Document for theevaluation and management of peripherallymphedema (1) for discussion at the XXIVInternational Congress of Lymphology. It isbased upon modifications: [A] suggested andpublished following the 1997 XVI InternationalCongress of Lymphology (ICL) inMadrid, Spain (2) discussed at the 1999 XVIIICL in Chennai, India (3) and considered/confirmed at the 2000 (ISL) ExecutiveCommittee meeting in Hinterzarten, Germany(4); [B] derived from integration ofdiscussions and written comments obtainedduring and following the 2001 XVIII ICL inGenoa, Italy as modified at the 2003 ISLExecutive Committee meeting in Cordoba,Argentina (5); [C] suggested from comments,criticisms, and rebuttals as published in theDecember 2004 issue of Lymphology (6);[D] discussed in both the 2005 XX ICL inSalvador, Brazil and the 2007 XXI ICL inShanghai, China and modified at the 2008Executive Committee Meeting in Naples, Italy(7,8); and [E] modified from discussions andwritten comments from the 2009 XXII ICLin Sydney, Australia, the 2011 XXIII ICL inMalmo, Sweden and 2012 ExecutiveCommittee Meetings.The document attempts to amalgamatethe broad spectrum of protocols advocatedworldwide for the diagnosis and treatment ofperipheral lymphedema into a coordinatedproclamation representing a “Consensus” ofthe international community. The document is not meant to override individual clinicalconsiderations for problematic patients nor tostifle progress. It is also not meant to be alegal formulation from which variations definemedical malpractice. The Society understandsthat in some clinics the method of treatmentderives from national standards while inothers access to medical equipment andsupplies is limited, and therefore the suggestedtreatments are impractical. Adaptability andinclusiveness does come at the price thatmembers can rightly be critical of what theysee as vagueness or imprecision in definitions,qualifiers in the choice of words (e.g., the useof “may... perhaps... unclear”, etc.) andmention (albeit without endorsement) oftreatment options supported by limited harddata. Most members are frustrated by thereality that NO treatment method has reallyundergone a satisfactory meta-analysis(let alone rigorous, randomized, stratified,long-term, controlled study). With this understanding,the absence of definitive answersand optimally conducted clinical trials, andwith emerging technologies and newapproaches and discoveries on the horizon,some degree of uncertainty, ambiguity, andflexibility along with dissatisfaction withcurrent lymphedema evaluation and managementis appropriate and to be expected.We continue to struggle to keep the documentconcise while balancing the need for depthand details. With these considerations inmind, we believe that this latest versionpresents a Consensus that embraces the entireISL membership, rises above national standards, identifies and stimulates promisingareas for future research and represents the best judgment of the ISL membership on how to approach patients with peripheral lymphedema as of 2013. Therefore the document has been, and should continue to be, challenged and debated in the pages of Lymphology (e.g., as Letters to the Editor), and ideally will remain a continued focal point for robust discussion at local, national and international conferences in lymphology and related disciplines. We further anticipate as experience evolves and new ideas and technologies emerge that this “living document” will undergo further periodic revision and refinement as the practiceand theories of medicine and specificallylymphology change and advance.

603 citations

Journal ArticleDOI
TL;DR: The data from this randomised study support the use of SNB in patients with clinically node negative breast cancer.
Abstract: This study is the first large prospective RCT of sentinel node biopsy (SNB) compared with standard axillary treatment (level I-III axillary lymph node dissection or four node sampling), which includes comprehensive and repeated quality of life (QOL) assessments over 18 months. Patients (n = 829) completed the Functional Assessment of Cancer Therapy - Breast (FACT-B+4) and the Spielberger State/Trait Anxiety Inventory (STAI) at baseline (pre-surgery) and at 1, 3, 6, 12, and 18 months post-surgery. There were significant differences between treatment groups favouring the SNB group throughout the 18 months assessment. Patients in the standard treatment group showed a greater decline in Trial Outcome Index (TOI) scores (physical well-being, functional well-being and breast cancer concerns subscales in FACT-B+4) and recovered more slowly than patients in the SNB group (p 0.05). For 6 months post-surgery younger patients reported less favourable QOL scores (p < 0.001) and greater levels of anxiety (p < 0.01). In view of the benefits regarding arm functioning and quality of life, the data from this randomised study support the use of SNB in patients with clinically node negative breast cancer.

468 citations