Methods |
Design: three group parallel trial
Purpose: study the feasibility of running a randomised trial aimed at evaluating specific and non‐specific effects in homeopathy |
Participants |
Out‐patients with dermatitis
Baseline comparability: yes (age, gender) |
Interventions |
Placebo: lactose pills
Untreated: no pills
Experimental: homeopathic pills
(Co‐intervention: NS) |
Outcomes |
Overall symptoms
Skin symptoms
Itching
Sleep
DLQI (dermatology life quality index)
Use of steroids |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
'randomisation list' |
Allocation concealment? |
Unclear risk |
NS |
Blinding?
Treatment provider |
Low risk |
'double‐blind placebo' |
Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
Free of selective reporting? |
Unclear risk |
No protocol available |
Free of other bias? |
Low risk |
|
No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
Trial size > 49? |
High risk |
N = 27 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |