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. 2010 Jan 20;2010(1):CD003974. doi: 10.1002/14651858.CD003974.pub3

Karst 2007.

Methods Design: four group parallel trial 
 Purpose: study the effect of auricular acupuncture on dental procedural anxiety
Participants Patients: outpatients undergoing dental extraction 
 Baseline comparability: yes
Interventions Placebo: needling with non penetrative needle at points not regarded having effect on anxiety (finger and liver points) 
 Untreated: no needling 
 Experimental:
‐needling at ' ... relaxation, tranquillizer, and master cerebral points in the external ear ...'.
‐midazolam, intranasal (average dose 4mg) 
 (Co‐intervention: NS)
Outcomes Spielberger state‐trait anxiety inventory 
 VAS 
 Sedation score 
 Quality of dental condition 
 Physiological status
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Low risk 'list of random numbers'
Allocation concealment? Unclear risk NS
Blinding? 
 Treatment provider High risk Not described as double‐blind (placebo/acupuncture)
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 = 29
Clearly concealed allocation + trial size > 49 + drop‐out max 15% High risk Trial size < 49