A randomized controlled clinical trial comparing the efficacy of dead sea mineral-enriched body lotion versus two types of placebo in the treatment of cutaneous dryness, itching, peeling and tightness in hemodialysis patients (EDIT).
OBJECTIVE
The present study was designed to investigate the short-term safety and efficacy of topical application with body lotion enriched with minerals from the Dead Sea versus 2 different placebo treatments in reducing symptoms of uremic pruritus.


METHODS
In this single-center, randomized, double placebo-controlled clinical trial, 78 hemodialysis patients with self-reported uremic pruritus were randomized to twice-daily topical treatment with body lotion enriched with minerals from the Dead Sea (DS) or to each of 2 types of placebo: (1) lotion with no Dead Sea minerals but otherwise identical to DS (P1) or (2) lotion with no active ingredients (P2). Symptoms of uremic pruritus (itching, dryness, peeling, tightness) were evaluated at baseline and 2 weeks (14 days) after treatment intervention using a 5-point Likert scale.


RESULTS
Following treatment, significant differences in symptom severity scores between DS and P1 and, separately, between group DS and P2, were not detected. Additionally, when DS was compared to the combined placebo groups (P1 and P2 together), significant post-treatment differences in symptom severity scores were not observed. Symptoms were less severe post-treatment regardless of treatment assignment.


CONCLUSIONS
DS was not superior to either of the placebo treatments in the symptomatic relief of uremic pruritus.
Boaz
Mona
M
Epidemiology and Research Unit, E. Wolfson Medical Center, Holon, Israel. mboaz8@yahoo.com
Shtendik
Larisa
L
Oron
Miriam
M
Portugal-Cohen
Meital
M
Kohen
Ron
R
Biro
Alexander
A
Cernes
Relu
R
Barnea
Zvi
Z
Maor
Zeevi
Z
Katzir
Ze'ev
Z
D000279:Administration, Cutaneous; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004643:Emollients / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008903:Minerals / Q000008:administration & dosage*; D011537:Pruritus / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D006435:Renal Dialysis / Q000009:adverse effects*; D012623:Seawater; D012871:Skin Diseases / Q000188:drug therapy / Q000209:etiology / Q000473:pathology; D016896:Treatment Outcome
D004643:Emollients; D008903:Minerals