| Methods |
Design: three group parallel trial
Purpose: examine the prophylactic effect of acupuncture on recurrent lower urinary tract infection (UTI) |
| Participants |
Patients: female out‐patients with recurrent UTI
Baseline comparability: yes (age, number of UTI last 5 years) |
| Interventions |
Placebo: needling in areas that are not known acupuncture sites
Untreated: no needling
Experimental: needling in areas that are known acupuncture sites
(Co‐intervention: NS) |
| Outcomes |
Number of patients who had infections during 6 months
Number of infections during 6 months |
| Notes |
Patients were randomised to placebo and no treatment in a 2:1 ratio |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'computer based schedule' |
| Allocation concealment? |
Low risk |
'sealed envelopes' |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/acupuncture) |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome. (Urine was tested when patients reported UTI symptoms) |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
High risk |
N = 40 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
