Hao 2010.
| Methods | RCT No estimation of sample size |
|
| Participants | 112 participants were randomised into intervention group (n = 60, M/F 38/22, mean age 51.6 ± 3.7 years), and control group (n = 52, M/F 30/22, mean age 50.4 ± 7.1 years). Type of DM: not reported Study location: China Study setting: outpatients Diagnostic criteria: World Health Organization 1999 criteria Inclusion criteria: meeting DM diagnosis criteria; having DPN symptoms; peripheral nerve damage Exclusion criteria: with other diabetic complications; DPN due to other diseases. |
|
| Interventions | (1) Intervention: Xuesaitong tablet and mecobalamin. The main components of Xuesaitong capsule were total saponins of panax notoginseng (the exact amount was not reported). Xuesaitong 50 mg, taken 3 times a day and 0.5 mg mecobalamin orally 3 times per day. Treatment lasted for 3 months (2) Control: 0.5 mg mecobalamin orally 3 times per day. Treatment lasted for 3 months Participants in both the intervention group and control group received hypoglycaemic therapy, which included oral hypoglycaemic drug, insulin, exercise |
|
| Outcomes | Global symptom improvement Change of motor nerve conduction velocity in tibial nerve (m/s) Change of sensory nerve conduction velocity in tibial nerve (m/s) Change of motor nerve conduction velocity in common peroneal nerve (m/s) Change of sensory nerve conduction velocity in common peroneal nerve (m/s) Adverse events: not reported |
|
| Notes | Sources of funding not stated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Random number table was used to generate the allocation sequence, but insufficient information was provided to judge whether or not it was conducted properly |
| Allocation concealment (selection bias) | High risk | Not mentioned in the report |
| Blinding (performance bias and detection bias) All outcomes | High risk | No blinding of participants or investigators |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Not mentioned in the report |
| Selective reporting (reporting bias) | Unclear risk | Unclear as the trial protocol was not accessible |
| Other bias | Low risk | No evidence of other bias |