Li 2007.
| Methods | RCT Number Analyzed/Randomized: 360/360 Index treatment: N =185 Comparison treatment: N =175 Power Analysis: not reported Funding Source: not reported |
|
| Participants | Chronic neck pain with radicular signs or symptoms Patients recruitment: out‐patients from the Traditional Chinese Medicine Hospital of Shenzhen Index treatment: 50.8±9.3 year old; 96 male, 89 female; Duration of pain: 18.4±5.1 months. Comparison treatment: 48.6±10.2 year old; 90 male, 85 female; Duration of pain: 17.8±5.9 months. DDD confirmed by X‐ray |
|
| Interventions | INDEX TREATMENT: Compound Extractum Nucis Vomicae made in the Shenzhen Hospital of Traditional Chinese Medicine, composed of Maqianzi(Semen Strychni), Chanshu(Venenum Bufonis), Honghua(Flos Carthami), Chuanwu(Radix Aconiti), and Tiannanxing(Rhizoma Pinelliae seu Arisaematis). Extractum Nucis Vomicae ointment was applied to the painful area of the neck, 3 times daily, for 4 weeks. (Dose not reported) COMPARISON TREATMENT: Diclofenac Diethylamine Emulgel 3 times a day for 4 weeks (Dose and composition not reported) Treatment Schedule: for 4 weeks Duration of Follow‐up: 4 weeks after randomization |
|
| Outcomes | PAIN RELIEF: (Numerical Rating Scale, 0 to 3) Baseline mean: Compound Extractum Nucis Vomicae 2.73±0.52 for neck pain, and 2.42±0.60 for radicular pain; control 2.58±0.62 for neck pain, and 2.50±0.57 for radicular pain End of study mean: Compound Extractum Nucis Vomicae 0.59±0.14 for neck pain, and 0.61±0.17 for radicular pain; control 0.86±0.21 for neck pain, and 0.88±0.23 for radicular pain Absolute Benefit: Compound Extractum Nucis Vomicae 2.14 for neck pain, and 1.81 for radicular pain; control 1.72 for neck pain, and 1.62 for radicular pain Reported Results: Compound Extractum Nucis Vomicae treatment was significantly better than Diclofenac Diethylamine Emulgel at 4 weeks. Reason for Dropouts: No drop‐outs Adverse Effects: Herbal treatment, 14 cases had pruritus, 9 cases had reddish skin, and among them 2 cases had small blister on the skin. Diclofenac Diethylamine Emulgel, 10 cases had pruritus, and 6 cases had reddish skin. Cost of Care: not reported |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | Sequence was generated from a random table. This was confirmed in the author's reply to our survey about their allocation concealment |
| Allocation concealment? | High risk | This was not described and we verified with the author through our survey that this was not done. |
| Blinding? patients blinded ‐ All outcomes | High risk | Not reported |
| Blinding? Careproviders blinded ‐ All outcomes | High risk | Not reported |
| Blinding? Outcome assessor blinded ‐ All outcomes | High risk | Not reported |
| Incomplete outcome data addressed? All outcomes ‐ ITT analysis? | High risk | Not reported |
| Incomplete outcome data addressed? All outcomes ‐ drop‐outs? | Low risk | No drop‐outs |
| Free of selective reporting? | Unclear risk | Information such as age range and duration of symptoms missing |
| Similarity of baseline characteristics? | Low risk | reported to be similar |
| Co‐interventions avoided or similar? | Unclear risk | Unclear whether co‐interventions were avoided from the description in the article |
| Compliance acceptable? | Unclear risk | Not assessed |
| Timing outcome assessments similar? | Low risk | all at 4 weeks after randomization |