Wong 2010a.
Methods | Design: parallel groups Randomization method: Computer random generation of group assignment for each patient Method of allocation concealment: computerized allocation of groups Blinding: outcome assessors and parents and patients were blinded to group allocation; therapist was not blinded. Stratification: not used |
|
Participants | Inclusion criteria: age 3‐11 years, ASD diagnosed by DSM‐IV and ADI‐R, Childhood Autism Rating Scale (CARS) score>30 Exclusion criteria: children with associated neurological disorders or epilepsy Number of participants (Intervention:control): 25:25 Number of males (Intervention:control): 21:23 Age: intervention group: mean 6.23 years (SD 1.87 years); control group: mean 6 years (SD 1.99 years). Specific diagnosis/diagnostic subtypes: information not available Comorbidities: information not available Duration of autism: information not available Previous treatment: information not available |
|
Interventions | Intervention group: tongue acupuncture + conventional educational and behavioral program Tongue acupuncture: needle acupuncture was applied using Hwato acupuncture needles (made in China) with diameter 0.3 mm and length 40 mm to 5 points on the tongue (Run Ze (1cm from the tongue tip, needle inserted to 1cm deep obliquely), Guan Zhu (0.5cm from tongue tip, needle to 0.3cm deep obliquely), Tian Men (center of tongue base, needle to 0.5‐1cm deep perpendicularly), Di You (0.5 cm from tongue base on both sides, needle to 0.5cm deep perpendicularly)). The child sat on the mother's lap with the head tilted around 45 degrees upwards. Sterile gauze was used to pick up and station the tongue with the examiner's left hand. The child was encouraged to open up his/her mouth, which was the usual mouth posture of those with persistent drooling. Quick and accurate needle insertion into 5 acupoints was performed with the examiner's right hand. The acupuncture procedure lasted for <15 seconds/session, daily for 5 days/week for 8 weeks (total 40 sessions) Control group: sham acupuncture + conventional educational and behavioral program Sham acupuncture: same procedure as tongue acupuncture in intervention group, except that the rough end of the acupuncture needle was used to touch the 5 acupoints instead of puncturing by the sharp end of the needle |
|
Outcomes | Griffiths Mental Developmental Scale (GMDS) Ritvo‐Freeman Real Life Rating Scale (RFRLRS) Reynell Language Developmental Scale (RLDS) Symbolic Play Test (SPT) Functional Independence Measure for children (WeeFIM) Side effects |
|
Notes | Dropouts: none Duration of follow‐up: 8 weeks Acupuncture paradigm: Traditional Chinese Medicine paradigm Training or qualification of acupuncture therapist: Bachelor degree in medicine and Chinese medicine, professor of acupuncture in China, 20 years of experience in acupuncture |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Group allocation was done by random computerized assignment for each case |
Allocation concealment (selection bias) | Low risk | Group allocation was concealed because of random computerized group allocation for each case |
Blinding (performance bias and detection bias) All outcomes | Low risk | Outcome assessors and parents and patients were blinded. Although acupuncture therapist was not blinded, he was not involved in the care of participants otherwise or in outcome assessment. Therefore this is unlikely to introduce bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data were complete |
Selective reporting (reporting bias) | Low risk | All outcomes were reported |
Other bias | Unclear risk | Conventional educational and behavioral program was variable for each patient and may introduce bias |