Skip to main content
. 2016 Nov 16;2016(11):CD008320. doi: 10.1002/14651858.CD008320.pub3

Feily 2012.

Methods RCT
Vehicle‐controlled
Parallel‐group design
Participants Pruritus: UP
Description: participants with ESRD who were treated with haemodialysis
Number of participants randomised: 60
Number of participants evaluable: 60
  • CS 4% group : 30

  • Placebo group: 30


Withdrawals/dropouts: 0
Reason for dropout: NA
Age (mean ± SD): 53 years ± 11.4
Sex (male/female): 38 (63%)/22 (37%)
Underlying disease(s): ESRD
Participant pool: single‐centre
Setting: inpatient
Haemodialysis: 3 times per week
Baseline pruritus assessment: yes
Duration/severity of pruritus: for at least 6 weeks without any systemic or topical treatment for the pruritus
Baseline parameters: mean VAS ± SD:
  • Cromolyn sodium (CS 4%): 2.5 ± 1.1

  • Vehicle group: 2.7 ± 1.3

Interventions
  • Intervention 1: topical CS 4% 2 times a day starting immediately after dialysis

  • Intervention 2: vehicle 2 times a day immediately after dialysis


Additional medication: all other anti‐pruritus treatments were prohibited during the study; other routine medications were allowed
Route of administration: topical
Duration of treatment: 4 weeks
Follow‐up: no information
Outcomes Pruritus assessment: VAS (0‐5, 0: no pruritus and 5: the worst pruritus)
Adverse events
Notes Results in abstract and full text (e.g. Table 1) are conflicting; we worked with results stated in the abstract.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "[S]imple random table"
Allocation concealment (selection bias) Unclear risk "[P]atients were randomly allocated to one of the two arms of the study"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "The medications used were not revealed to their physicians"
"A similar tube was used to store CS 4% to make both creams to look physically identical"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "The placebo was formulated by a pharmacist to have a similar base with the drug but not containing the active ingredient and stored in a tube without any labelling. A similar tube was used to store CS 4% to make both creams to look physically identical"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropouts; unclear if intention‐to‐treat analysis was used
Selective reporting (reporting bias) Unclear risk No indication of selective reporting; no protocol or registration number
Size of study (possible biases confounded by small size) High risk Number of participants randomised: 60
Other bias High risk Results in abstract and full text (e.g. Table 1) are conflicting