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 |
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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 |
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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 |
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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 |