Hirsch 1994.
Methods | Design: cross‐over (randomization not explicitly described but likely) Allocation concealment: unclear Blinding: patients and evaluators Jadad score: 0‐2‐1 Duration: 5 weeks each phase, no washout | |
Participants | N = 39 randomised (15 female, 24 male), age range 5‐17 years, 32 analysed. Outpatients of an academic teaching hospital in Germany. Diagnosis ‐ children with mild to moderately severe asthma, according to ATS (American Thorarcic Society) criteria. 28 used inhaled beta‐agonist, 4 cromoglycate. Children taking oral or inhaled steroids excluded. | |
Interventions | Acupuncture group: Standardized laser acupuncture formula (N = 32) with 10 points (EX‐BW1, LU‐1, LU‐5, LU‐7, LI‐4, REN‐17, BL‐13, BL‐17, KID‐3, SP‐6), 20 sec per acupuncture point. Treatment with soft‐laser (50 mw output, 820 mm wave length produced by Reimer und Janssen, Herbolzheim, Germany). Control group: Sham laser acupuncture (N=32) at the same acupuncture points as experimental group, laser switched off. Treatment Duration 15 sessions, twice weekly. Acupuncturist: Therapist trained by a German acupuncture association. TCM‐Diagnosis done/applied to intervention: (‐/‐) |
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Outcomes | Peak flow, subjective symptoms and drug use recorded daily by the patient. Spiromety and provocation test before and after each treatment phase. | |
Notes | Overall no significant differences between the groups. Insufficient data presentation. Assertions that significant improvement was seen in placebo group unsupported by data reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | No information provided; randomisation not explicitly described, but likely |
Allocation concealment? | Unclear risk | No information available |
Blinding? All outcomes | Low risk | Acupuncture administered at the same site as sham |
Incomplete outcome data addressed? All outcomes | Unclear risk | Not clear if data from participants who withdrew included in data analysis |
Free of other bias? | Unclear risk | Therapist trained by national association in Germany |