Dayes IS, Whelan TJ, Julian JA, et al. Randomized trial of decongestive lymphatic therapy for the treatment of lymphedema in women with breast cancer. J Clin Oncol. 2013;31(30):3758-3763.
A randomized trial was performed to evaluate if significant improvement in lymphedema reduction in women with secondary upper extremity (UE) lymphedema associated with breast cancer treatment can consistently be achieved by using a more conservative approach, namely the use of compression garments, compared to the use of complete decongestive therapy (CDT), namely manual lymphatic drainage (MLD).
A total of 103 women previously treated for breast cancer and with a diagnosis of lymphedema were randomly assigned to the study. Of those 103 participants, 95 were evaluable and included in the study.
Study Parameters Assessed
Lymph fluid volumes were calculated by arm circumference measurements. Patients with a minimum of 10% volume difference between their arms were randomly assigned to either compression garments (control) or daily MLD and bandaging followed by compression garments (experimental).
Primary Outcome Measures
The primary outcome measurement was percentage of reduction in excess arm volume from baseline to 6 weeks. Mean reduction of excess arm volume was 29.0% in the experimental group and 22.6% in the control group (difference, 6.4%; 95% confidence interval [CI]: –6.8%-20.5%; P=0.34). Absolute volume loss was 250 mL and 143 mL in the experimental and control groups, respectively (difference, 107 mL; 95% CI: 13-203 mL; P=0.03).
The 6-week trial of 95 participants did not demonstrate a significant improvement (50% loss or greater between the 2 groups) in lymphedema with decongestive therapy compared with a more conservative approach of compression garments alone.
There have been a number of randomized control trial studies conducted over the last 10 years that have compared the efficacy of 2 fundamental components of CDT: MLD and the application of multilayered compression bandages and/or garments, with the latter described as the “more conservative approach.” In this research study, the “more conservative approach”—ie, the use of compression garments worn on the UE—is being heralded as suitably efficient in reducing limb volume in the treatment intervention of women who present with symptoms of lymphedema post–sentinel node dissection or post–axillary lymph node dissection. The conclusion drawn from this study also implies that the application of MLD does not significantly improve the outcome of volume reduction in the UE over a 6-week period.
Success in treatment should include improved physiological functioning of the local lymphatic system and not exclusively be based on volume reduction achieved by the work of a compression garment.
While the authors of the study admit to its shortcomings in terms of sample size, there are other significant shortcomings in the clinical selection criteria of this study and many other similar studies that are worth noting.
- Early onset of lymphedema is not only clinically relevant in the UE but also in the entire trunk territory of the local distribution of the lymphatic system,1 which includes the breast, chest, lateral trunk, and upper thoracic region on the ipsilateral side.
- The onset of lymphedema is not only the direct result of lymph node removal but also the result of local inflammation and proliferation from local tissue injury2 both in the axilla and the breast/chest areas and from the altered and restricted hemodynamics of the normal healing processes of the local lymphatic territory.
- Volume reduction is not the only measurement of success in treating lymphedema. The physiological benefits of MLD in treating the local lymphatic system and surrounding tissue injury in the chest/breast/thoracic regions outweigh the use of mechanical compression to simply reduce volume in the UE.
Compression garments, by virtue of the mechanical pressure they exert on the interstitial spaces within the limb, are always going to result in volume reduction. The volume reduction achieved by compression garments can, in some cases, be far more profound than volume reduction achieved by MLD alone, especially in the short term. But unless the compression garments are worn continuously over time with appropriate compliance from the patient, the sustainability of volume reduction can only be measured for a relatively short period of time.
It really is a fundamental problem that almost all research in efficacy of treatment for patients with breast cancer with postoperative lymphedema is based on volume measurements of the UE. While one can agree that increased limb volume provides the most tangible objective measurement data for the expression of lymphedema, to base all of our treatment success in the measurement of volume reduction shows a short sightedness with regards to additional symptom involvement resulting from local lymphatic system failure. The system’s influence on surrounding healing systems and on the functioning of surrounding neuromusculoskeletal systems are equally important.
With this being said, there is a tendency within the profession to package the diagnosis of lymphedema and treatment response into what is already considered a very linear model of care, CDT. Research shows that a more integrated approach to managing the lymphatic system within the neuromusculoskeletal system yields far better clinical outcomes3 than the clinical outcomes of treatments designed solely around CDT. Furthermore, by removing MLD from the CDT model of care, practitioners are running the risk of minimizing the physiological benefits of MLD in patient treatment.
Stage 2 lymphedema, by definition, is an irreversible stage of lymphedema that precedes stage 3, during which the volume changes within the limb are accompanied by both severe secondary skin disease and a much higher risk of infection within the tissues.4 It is the “irreversibility” of stage 2 and stage 3 lymphedema that is so frustrating within the current curative model of care, which is the default mechanism of delivery of treatment. Additionally, the curative model of care is strongly advocated by medical insurance companies with their definitions of “medical necessity” and what it means that a patient “shows improvement,” as well as the cost-effectiveness concerns of the burden of protracted treatment in chronic disease processes. With these constructs of care and delivery in mind, it is tempting to discredit the efficacy of MLD5 and move on to a more hands-off approach to patient care by applying multilayered compression bandaging and/or providing compression garments to at-risk patients in lieu of comprehensive MLD. This temptation is further seconded by the desire to measure effectiveness of treatment by one objective measurement parameter only: volume reduction.
Given that the lymphatic system affects and is affected by the neuromusculoskeletal system within the lymphatic territory, additional significant and relevant objective measurement data should always be considered in comprehensive evaluation and treatment of patients who are at risk for the onset of lymphedema and/or who have acquired stage 1 or stage 2 of lymphedema. Other measurement data should include range of motion of all joints in the affected UE, pain measurements of the UE relating to daily living activity and function, neural tension measurements, and muscle strength measurements.
From a physiological perspective, the lymphatic system is vital for balancing fluid dynamics, fluid equilibrium, and the efficient movement of cellular matter during the healing processes of the soft tissues within the territory injured by surgery. We as medical practitioners have a responsibility to maximize the optimal healing capabilities of the lymphatic system as it recovers from its acute postoperative injury. We have a responsibility for the distribution of volume reduction to be throughout the ipsilateral lymphatic territory (not only the UE) and for the reduction in volume to be sustainable over time. Success in treatment should include improved physiological functioning of the local lymphatic system and not exclusively be based on volume reduction achieved by the work of a compression garment.
It is vital that we continue to acknowledge the importance of our most powerful and only access point to the lymphatic system, MLD.6 While compression addresses the condition of lymphedema and helps reduce volume, MLD accesses the lymphatic system and evokes physiological responses that optimize the healing of that system. MLD, therefore, especially needs to be performed in the early stages of lymphedema onset in at-risk oncology patients presenting with stage 0 and stage 1 lymphedema.7 When we are more appropriately focused on the treatment of the lymphatic system, we are more able to shift away from primarily seeking out volume reduction in the UE to focus instead on optimal tissue healing in the entire lymphatic territory. Our clinical application becomes more directed toward including MLD “into rehabilitation paradigms for the treatment of somatic dysfunction and pathologies”7 of the lymphatic system.
Given that the lymphatic system is the primary drainage system for the removal of cellular byproducts when it is acutely injured, this fundamental process can become impaired. The result is a mixed edema in the region of injury in the form of inflammatory exudate, as well as excess lymph fluid that collects in the area resulting from the disabled lymphatic system. MLD is a powerful manual therapy technique that has been shown, amongst a myriad of benefits, to
- increase the ability of the local lymphatic system to remove biochemical metabolites and waste from injured tissue;
- enhance the hemodynamics of the normal healing processes of the injured tissue;
- move a higher volume of fluid within a specific unit of time, thus enabling effective edema reduction in the lymphatic territory; and
- increase parasympathetic vagotonic response of the system, thereby enhancing biochemical stress relief in the healing tissues.8
Without the mechanical forces exerted onto the superficial lymphatic system through the use of MLD, the mechanoreceptors and proprioceptors of the system are insufficiently stimulated,9 and the healing processes and capabilities of the injured tissue and the lymphatic system itself are significantly slowed down and impaired. Without MLD, these slowed hemodynamic healing processes in the region, as well as the overall functional loss of the lymphatic system from lymph node removal, carry the potential for chronic fluid accumulation. No matter how mild or severe the accumulation in the tissues of the UE and the anterior/posterior chest area is, the patient is likely at a greater lifetime risk of acquiring stage 2 lymphedema.
Lymphedema and its irreversibility are potentially distracting to us, as is the clinical reliance on illustrating volume reduction in a limb. It is so easy to do with the use of compression garments, especially over a 6-week period or a 6-month period or even a 12-month period, the timeframes for many studies. Time is a key factor here. Chronic diseases cannot be treated effectively in such short time increments. There is a dire need for more long-term studies that follow patients for 3 years, 5 years, and 10 years.
Of more concern than the short timeframes into which evidence-based practice has been squeezed is the fact that we run the risk of being irresponsible by not providing the best treatment that we can to a patient. This has ethical implications, especially if we have the skills to provide medically necessary care within CDT, of which MLD is a vital component. Our skill set is not so much in measuring circumferential volume and supplying a patient with a compression garment with an instruction to wear it daily during waking hours, but much more in performing manual therapy in the form of MLD and using this well-researched technique to improve the healing capabilities of the local tissue injury as well as the acute injury to the lymphatic system within a lymphatic territory.