| Methods |
Design: four group, four period cross‐over trial
Purpose: examine the prophylactic effect of acupuncture on exercise induced asthma |
| Participants |
Patients: female out‐patients suffering from exercise induced asthma
Baseline comparability: not relevant |
| Interventions |
Placebo: acupuncture with laser beam off
Untreated: no acupuncture
Experimental:
‐acupuncture with laser beam on
‐salbutamol inhalation
(Co‐intervention: corticosteroids in 3 participants) |
| Outcomes |
Forced expiratory volume after 1 second (FEV1) as % of pretreatment value
Proportion with bronchoconstriction (15% reduction in FEV1) |
| Notes |
The outcome data was treated as if coming from a parallel trial |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/acupuncture) |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| 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? |
Unclear risk |
The outcome data from this cross‐over trial was treated as if coming from a parallel trial |
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
| Trial size > 49? |
High risk |
N = 26 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
