| Methods |
Design: three group parallel trial
Purpose: examine the effect of vitamin B6 on carpal tunnel syndrome |
| Participants |
Patients: out‐patients suffering from carpal tunnel syndrome
Baseline comparability: NS |
| Interventions |
Placebo: tablet without vitamin B6 (content: dextrose)
Untreated: no tablet
Experimental: tablet with vitamin B6
(Co‐intervention: NS) |
| Outcomes |
Number of patients who improved in symptoms
Improvement in median and ulnar nerve conduction latency |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'We undertook a randomized, double‐blind, placebo‐controlled study...' |
| 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? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
High risk |
N = 9 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
