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. 2016 Nov 17;2016(11):CD004870. doi: 10.1002/14651858.CD004870.pub5
Methods RCT Number Analysed/randomised: 112/117 Intention‐to‐treat: NR Power analysis: NR Funding source: State Ministry of Science and Technology
Participants Chronic cervical spondylosis
Participant recruitment: Acupuncture Department of Guangdong Provincial Traditional Chinese Medicine Hospital, China
Interventions INDEX TREATMENT
Acupuncture group Acupuncture points ‐ Du14, ExHN15, SI15 needles inserted to muscle layer manipulated for Deqi, then remained inserted for 20 minutes; infrared radiation
COMPARISON TREATMENT
Sham
Superficial insertion 1 cm apart laterally from acupuncture points. Remained for 20 minutes, no manipulation; infrared radiation
CO‐INTERVENTION
NR
Treatment schedule: once every other day for 9 sessions over 18 days Duration of follow‐up: immediate post treatment, 4 weeks, 3 months
Outcomes PAIN INTENSITY (0 to 10 VAS scale) Baseline mean: acupuncture 5.14, sham 5.58 End of study mean: acupuncture 2.89, sham 3.28 at 3 month follow‐up Absolute benefit: acupuncture 2.25, sham 2.30 Reported results: significant immediate post treatment favouring acupuncture but not over long term
SMD ‐0.53 (95% CI random ‐0.91 to ‐0.16) immediate post treatment
SMD ‐0.59 (95% CI random ‐0.97 to ‐0.21) at 4 weeks
SMD ‐0.23 (95% CI random ‐0.61 to 0.14) at 3 months
Northwick Park Pain Questionnaire (NPQ) (0 to 100)
Baseline mean: acupuncture 33.63, sham 33.21 End of study mean: acupuncture 20.55, sham 25.77 Absolute benefit: acupuncture 13.08, sham 7.44
Reported results: significant immediate post treatment favouring acupuncture but not over long term SMD ‐0.41 (95% CI random ‐0.79 to ‐0.04) immediate post treatment
SMD ‐0.50 (95% CI random ‐0.88 to ‐0.12) at 4 weeks
SMD ‐0.40 (95% CI random ‐0.78 to ‐0.03) at 3 months Reasons for drop‐out: 2 fainted, 3 inconvenient (rate 4.27%) Adverse effects: 1 in each group fainted Costs of care: NR
Notes ‐‐
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computerised sequence number and grouping address on a randomising card
Allocation concealment (selection bias) Low risk Use of sealed opaque envelopes
Blinding (performance bias and detection bias) All outcomes ‐ patient? Low risk Described adequately in the report
Blinding (performance bias and detection bias) All outcomes ‐ care provider? High risk Not possible
Blinding (performance bias and detection bias) All outcomes ‐ outcome assessor? Low risk Participant as outcome assessor
Incomplete outcome data (attrition bias) All outcomes ‐ Drop out rate acceptable? Low risk Described and acceptable 4.27%
Incomplete outcome data (attrition bias) All outcomes ‐ Analyzed in the group to which they were allocated? High risk Not all randomised participants were analysed
Selective reporting (reporting bias) Unclear risk No protocol
Similarity of baseline characteristics Low risk Reported to be similar
Co‐interventions avoided or similar? Unclear risk Not reported
Compliance acceptable? Unclear risk Not reported
Similar timing of outcome assessment? Low risk Post, 4 weeks, 12 weeks
Fatal Flaw High risk No sample size justifications; multiple comparisons should have been done; analysis should have been stratified by syndrome type; time lines between points on graph are distorted