Editor- Improving patient quality of life is a key objective of dialysis therapy. A relatively unheralded benefit of short daily (or frequent) dialysis might be the beneficial effects on the restless legs syndrome (RLS). Here, Dr. Bertrand Jaber describes the preliminary results from the FREEDOM Study published recently in CJASN.
Dr. Jaber is Vice
Chair of Medicine for Clinical Affairs at St. Elizabeth's Medical Center in
Boston, MA, and Associate Professor of Medicine at Tufts University School of
Medicine. He is Director of the Kidney and Dialysis Research Laboratory at St.
Elizabeth's Medical Center. Dr. Jaber has extensive expertise in dialysis
device-related research, cytokine and leukocytes biology in acute and chronic
kidney disease.
Dr. Jaber currently serves as Chair of the Acute Kidney Injury Advisory Group for the
American Society of Nephrology. He is a former member of the Renal Disease and
Detoxification Committee of the Association for the Advancement of Medical
Instrumentation, and the National Kidney Foundation’s Kidney Disease Outcomes
Quality Initiative (K/DOQI) Advisory Board. Dr. Jaber has previously served on
the Scientific Program Committee of the Annual Clinical Meetings of the
National Kidney Foundation, and has directed its annual Hemodialysis Course. He
is the recipient of numerous awards and has authored more than 130 original
publications, reviews and editorials in peer-reviewed scientific journals. Dr.
Jaber has authored several textbook chapters. He currently serves as co-editor
for the American Journal of Kidney Diseases.
COMMENTARY - Effect of
At-Home of Short Daily Hemodialysis on Restless Legs Syndrome - Dr. Bertrand Jaber
Restless
legs syndrome or RLS is a common and vexing problem in dialysis patients (1). Symptoms
consist of achy or crawling paresthesias in the lower extremities, occasionally
bordering on pain, which occur exclusively during rest and inactive seated or
recumbent wakefulness. Movement of
the legs usually yields prompt relief of the symptoms. Frequently encountered
coexisting symptoms include, sleep disturbances resulting in sleep
fragmentation and sleep deprivation, anxiety, and depressive symptoms. RLS has
to be differentiated from peripheral neuropathy in which paresthesias are
constant and not relieved by activity.
The exact cause of RLS is unknown but uremic toxins have been implicated
in its pathogenesis, as well as iron deficiency anemia, vascular insufficiency,
chronic lung disease and caffeine abuse.
Studies in
dialysis patients have linked RLS to premature discontinuation of dialysis,
impairment in quality of life measures, and an increased risk of cardiovascular
events and mortality (2).
Pharmacological
treatment of RLS in dialysis patients is challenging as novel agents are often
not approved for use in this population. In a non-dialysis population,
pramipexole, a dopamine receptor agonist, has been associated with favorable
responses, and in dialysis patients, ropinirole, a dopamine receptor agonist,
has shown promising results.
The
FREEDOM Study is an ongoing prospective cohort study examining the clinical and
economic benefits of at-home short daily (6 times weekly) hemodialysis (SDHD).
In a recently published interim report (3), we examined the long-term effect of
SDHD on the prevalence and severity of RLS, as measured by the International
Restless Legs Syndrome (IRLS) Study Group Rating Scale, and on sleep
disturbances, as measured by the Medical Outcomes Study sleep survey.
235
participants were included in this analysis (intention-to-treat cohort), of
which 127 completed 12-month follow-up (per-protocol cohort). Mean age was 52
years, 55% had an arteriovenous fistula, and 40% suffered from RLS. In the
per-protocol analysis, among patients with RLS, the mean IRLS score improved significantly
by 7 points at month-12, after adjustment for use of RLS-related medications.
Among patients with moderate-to-severe RLS (IRLS score ≥15), there was an even
greater 10-point improvement in the IRLS score. The intention-to-treat analysis
yielded similar results. This impressive improvement in the IRLS score following
initiation of SDHD exceeds what is typically seen in efficacy trials of
RLS-related medications. Over the 12-month period, we also observed a decline
in the percentage of patients reporting RLS (35% vs. 26%) and those reporting
moderate-to-severe RLS (59% vs. 43%). There was a similar and sustained
12-month improvement in several scales of the sleep survey, after adjustment
for presence of RLS and use of anxiolytics and hypnotics.
This industry-sponsored
study has some important limitations including selection bias, which is evident
by the recruitment of a relatively young (although not necessarily healthier)
patient population. The absence of a control group is another important
limitation, although the observed improvements in RLS severity and sleep measures
were sustained over 12 months.
The
implications of these findings for clinicians and patients are that SDHD delivered
in the home setting appears to confer a benefit in term of improving these
quality of life measures. However, these perceived benefits might come at the
expense of a potential trade-off that is related to the burden of adopting
at-home self-care dialysis with the assistance of a family caregiver or helper.
In
conclusion, in this interim report of the FREEDOM study, at-home SDHD is
associated with long-term improvement in the prevalence and severity of RLS, as
well as sleep disturbances. These observations support previous findings from
the same study (4), demonstrating a benefit of SDHD on other quality of life
measures including, depressive symptoms and post-dialysis fatigue.
References
1. Unruh
ML, Levey AS, D'Ambrosio C, Fink NE, Powe NR, Meyer KB: Restless legs symptoms
among incident dialysis patients: association with lower quality of life and
shorter survival. Am J Kidney Dis 43:900-909, 2004
2. La Manna
G, Pizza F, Persici E, Baraldi O, Comai G, Cappuccilli ML, Centofanti F,
Carretta E, Plazzi G, Colì L, Montagna P, Stefoni S. Restless legs syndrome
enhances cardiovascular risk and mortality in patients with end-stage kidney
disease undergoing long-term haemodialysis treatment. Nephrol Dial Transplant.
2011 Jun;26(6):1976-83.
3. Jaber
BL, Schiller B, Burkart JM, Daoui R, Kraus MA, Lee Y, Miller BW, Teitelbaum I,
Williams AW, Finkelstein FO; FREEDOM Study Group. Impact of short daily
hemodialysis on restless legs symptoms and sleep disturbances. Clin J Am Soc
Nephrol. 2011 May;6(5):1049-56.
4. Jaber
BL, Lee Y, Collins AJ, Hull AR, Kraus MA, McCarthy J, Miller BW, Spry L,
Finkelstein FO; FREEDOM Study Group. Effect of daily hemodialysis on depressive
symptoms and postdialysis recovery time: interim report from the FREEDOM
(Following Rehabilitation, Economics and Everyday-Dialysis Outcome
Measurements) Study. Am J Kidney Dis. 2010 Sep;56(3):531-9.
