Wong 2008.
Methods | Design: cross‐over study Randomization method: computer‐generated block randomisation table Method of allocation concealment: information not available Blinding: outcome assessors were blinded to group allocation; therapist and parents and patients were not blinded. Stratification: by age and severity of autism (according to Childhood Autism Rating Scale (CARS) score) |
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Participants | Inclusion criteria: age 3‐12 years, ASD diagnosed by DSM‐IV and ADI‐R and ADOS Exclusion criteria: children with epilepsy on antiepileptic drugs, or other neurological, psychiatric or genetic disorders, or had experienced acupuncture in the past one year. Parents who are unable to finish the questionnaire assessments were also excluded Number of participants (intervention:control): 18:18 Number of males (intervention:control): 17:17 Age: intervention group: mean 7.4 years (SD 2.215 years); control group: mean 7.62 years (SD 2.367 years). Specific diagnosis/diagnostic subtypes: information not available Comorbidities: information not available Duration of autism: information not available Previous treatment: information not available |
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Interventions | Intervention group: electroacupuncture + conventional education program Electroacupuncture: 5 acupoints were stimulated (GV20, EX‐HN3, bilateral HT7, bilateral SP6, and bilateral auricular brain points). Hwato sterile disposable single use acupuncture needles were used. Needles used for body acupuncture measured 0.25mm in diameter and 25mm in length, while that used for auricular acupuncture measured 0.25mm in diameter and 13mm in length. Needles were inserted transversely for 13‐25mm at GV20 and EX‐HN3, perpendicularly for 13‐25mm at HT7 and SP6, and perpendicularly for 5‐10mm at auricular points. The same acupuncturist provided acupuncture for all participants. The "De Qi" sensation was elicited as far as possible. The Hwato SDZ‐II electronic acupuncture treatment instrument was used for electrical stimulation. Continuous wave form was applied at amplitude tolerable to participants. The treatment provided was based on syndrome differentiation according to Traditional Chinese Medicine theory. Participants with deficiency syndrome, deficiency‐excess complex syndrome, and excess syndrome received electronic stimulation at frequencies of 25Hz, 50Hz, and 75 Hz respectively. The acupoints were stimulated for 30 minutes/session, daily for 3 days/week for 8 weeks (total 24 sessions) Control group: conventional education program alone 4 weeks after treatment, participants in intervention group received no electroacupuncture and participants in control group received 8 weeks of electroacupuncture |
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Outcomes | Aberrant Behavioral Checklist (ABC) Autism Treatment Evaluation Checklist (ATEC) Ritvo‐Freeman Real Life Rating Scale (RFRLRS) Autism Diagnostic Observation Scale (ADOS) Functional Independence Measure for children (WeeFIM) Symbolic Play Test (SPT) Clinical Global Impression Scale (CGIS) Side effects |
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Notes | Dropouts: Intervention group: 4 (1 unable to attend acupuncture sessions according to the allotted time slots, 1 withdrew after the 1st acupuncture session because parents found it too inconvenient to travel to the acupuncture clinic, both attended end‐of treatment assessment; 2 lost to follow‐up with unknown reasons and did not undergo final assessment); Control group: 2 (1 unable to attend acupuncture sessions according to the allotted time slots after cross over but attended final assessment, 1 lost to follow‐up with unknown reason and did not undergo final assessment) Duration of follow up: 20 weeks Acupuncture paradigm: Traditional Chinese Medicine paradigm Training or qualification of acupuncture therapist: PhD, professor of acupuncture in China, registered Chinese Medicine practitioner in Hong Kong, 20 years of experience in acupuncture |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation sequence is generated by computer block randomization |
Allocation concealment (selection bias) | Unclear risk | No information is available |
Blinding (performance bias and detection bias) All outcomes | High risk | Outcome assessors for most outcomes were blinded. However, parents were not blinded and they were involved in some outcome assessment which may potentially introduce bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Incomplete data were mostly explained and unrelated to outcome. Missing data constituted <30% of outcome data and similar in both groups |
Selective reporting (reporting bias) | Low risk | All outcomes were reported |
Other bias | Unclear risk | Conventional education program was variable for each patient and may introduce bias. Acupoints varied with syndromic diagnosis based on TCM theory and may introduce bias. No placebo or sham control was used and hence there might be placebo effect |