Wang 2004.
Methods | RCT Number Analyzed/Randomized: 217/240 Index treatment: N = 109/120 Comparison treatment: N = 108/120 Power Analysis: not reported Funding Source: Shanghai Developing Company of Modern TCM Technique |
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Participants | Chronic neck disorder with radicular signs or symptoms Patients recruitment: out‐patients from the Fujian Academy of Traditional Chinese Medicine, the First Hospital Affiliated to Guangxi College of Traditional Chinese Medicine, Zhejiang Hospital of Traditional Chinese Medicine, and the First Hospital Affiliated to Hunan College of Traditional Chinese Medicine Index treatment: the age range was 25 to 65 year old, mean age was 54.86±7.47 years old; 52 male, 68 female; duration of pain was 5.06±4.62 years. Comparison treatment: the age range was 27 to 65 year old, mean age was 54.65±8.90 years old; 45 male, 75 female; duration of pain was 4.94±4.16 years. DDD was verified by x‐ray |
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Interventions | INDEX TREATMENT: Compound Qishe Tablet 25 tablets twice a day for 4 weeks. COMPARISON TREATMENT: Placebo 25 tablets twice a day for 4 weeks. Treatment Schedule: for 4 weeks Duration of Follow‐up: 8 weeks after randomization |
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Outcomes | PAIN RELIEF: (Numerical Rating Scale, 0 to 3) with 0 indicated no pain, 1 mild, 2 moderate, and 3 severe. Definitions of recovery was defined as having no neck or radicular pain. Baseline: Compound Qishe Tablet group: 1 case without neck pain, 27 cases with mild neck pain, 65 cases with moderate neck pain, and 16 cases with severe neck pain, and 2 cases without radicular pain, 40 cases with mild radicular pain, 63 cases with moderate radicular pain, and 4 cases with severe radicular pain. Control group: 27 cases with mild neck pain, 67 cases with moderate neck pain, and 14 cases with severe neck pain, 1 case without radicular pain, 46 cases with mild radicular pain, 52 cases with moderate radicular pain, and 9 cases with severe radicular pain. End of study: Compound Qishe Tablet group: 42 cases without neck pain, 57 cases with mild neck pain, 10 cases with moderate neck pain, and 0 case with severe neck pain, and 60 cases without radicular pain, 46 cases with mild radicular pain, 3 cases with moderate radicular pain, and 0 case with severe radicular pain. Control group: 10 cases without neck pain, 50 cases with mild neck pain, 45 cases with moderate neck pain, and 3 cases with severe neck pain, and 17 case without radicular pain, 54 cases with mild radicular pain, 35 cases with moderate radicular pain, and 2 cases with severe radicular pain. Reported Results: Compound Qishe Tablet is more effective for pain relief than placebo for patients with chronic neck pain, measured at the end of the study (eight weeks of follow‐up after four weeks of treatment). Reason for Dropouts: withdrew, refused treatment, accident, lost to follow‐up Index treatment: 4 withdrew, 3 refused treatment, 1 accident, 3 lost to follow‐up Comparison treatment: 3 withdrew, 6 refused treatment, 1 accident, 2 lost to follow‐up Adverse Effects: Index treatment: 2 cases with diarrhea, 1 case with abdominal pain and diarrhea, and 1 case with stomachache. Comparison treatment: 1 case with diarrhea and abdominal pain. Cost of Care: not reported |
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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 in the article and we confirmed with the author through our survey that allocation concealment was not done |
Blinding? patients blinded ‐ All outcomes | Low risk | Described in the report |
Blinding? Careproviders blinded ‐ All outcomes | Low risk | Described in the report |
Blinding? Outcome assessor blinded ‐ All outcomes | Low risk | Described in the report |
Incomplete outcome data addressed? All outcomes ‐ ITT analysis? | High risk | Not reported |
Incomplete outcome data addressed? All outcomes ‐ drop‐outs? | Unclear risk | The number of drop‐outs could be calculated but the reasons were unclear. Index treatment: 11 drop‐outs Comparison treatment: 12 drop‐outs |
Free of selective reporting? | High risk | Information such as age range and duration of symptoms were 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 the 8 week follow‐up after 4 weeks of treatment |