Wang 2005.
Methods | RCT Number Analyzed/Randomized: 416/440 Index treatment: 311/330 Comparison treatment: 105/110 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, Affiliated Hospital of Jiangxi College of Traditional Chinese Medicine, Hubei Academy of Traditional Chinese Medicine Index treatment: the age range was 30 to 62 year old; mean age was 49.71±11.07 years old; 121 male, 219 female; duration of pain was 4.77±5.42 years. Comparison treatment: the age range was 29 to 63 year old; mean age was 50.45±10.78 years old; 32 male, 78 female; duration of pain was 4.89±5.26 years. |
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Interventions | INDEX TREATMENT: Compound Qishe Tablet 1 bag (25 tablets) twice a day for 4 weeks with placebo Jingfukang 1 bag (granules) twice a day for 4 weeks COMPARISON TREATMENT: Placebo Qishe Tablet 1 bag (25 tablets) twice a day for 4 weeks with Jingfukang 1 bag (granules) twice a day for 4 weeks CO‐INTERVENTION: unclear 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. Baseline: Compound Qishe Tablet group: 0 cases without neck pain, 38 cases with mild neck pain, 229 cases with moderate neck pain, and 44 cases with severe neck pain; and 18 cases without radicular pain, 88 cases with mild radicular pain, 189 cases with moderate radicular pain, and 16 cases with severe radicular pain. Control group:, 0 cases without neck pain, 14 cases with mild neck pain, 83 cases with moderate neck pain, and 8 cases with severe neck pain; and 1 case without radicular pain, 28 cases with mild radicular pain, 74 cases with moderate radicular pain, and 2 cases with severe radicular pain. End of study: Compound Qishe Tablet group: 84 cases without neck pain, 202 cases with mild neck pain, 24 cases with moderate neck pain, and 1 case with severe neck pain; and 166 cases without radicular pain, 128 cases with mild radicular pain, 17 cases with moderate radicular pain, and 0 cases with severe radicular pain. Control group: 28 cases without neck pain, 61 cases with mild neck pain, 16 cases with moderate neck pain, and 0 cases with severe neck pain; and 51 case without radicular pain, 42 cases with mild radicular pain, 12 cases with moderate radicular pain, and 0 cases with severe radicular pain. Reported Results: Compound Qishe Tablet treatment was significantly better than Jingfukang at eight weeks after completing the four weeks of treatment. Reason for Dropouts: withdrew, refused treatment, accident, lost to follow‐up Index treatment: 19 cases Comparison treatment: 5 cases Adverse Effects: Index treatment, 11 cases with diarrhea, 9 cases with abdominal pain, and 2 cases with stomachache. Comparison treatment, 1 case with diarrhea, 1 case with stomachache. 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 | Reasons for drop‐outs were mentioned but the number of drop‐outs associated with each reason was not given Index treatment: 19 cases Comparison treatment: 5 cases |
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 described. |
Timing outcome assessments similar? | Low risk | All assessed at the end of the 8 weeks after end of treatment |