Xu 2008.
| Methods |
RANDOMISED CONTROLLED CLINICAL TRIAL (RCT): yes, parallel RCT RANDOMISATION RATIO: Equal numbers assumed (not stated in publication) NON‐INFERIORITY DESIGN: no EQUIVALENCE DESIGN: no ETHICS APPROVAL OBTAINED: not clear PATIENT CONSENT OBTAINED: yes BLINDING OF PATIENT (P), EDUCATOR (E), RESEARCHER (R): P = no, E = no, R = no ANALYSIS BY INTENTION TO TREAT: no, not reported POWER CALCULATION: no |
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| Participants |
WHO PARTCIPATED: SEX (female% / male%): TYK and insulin group 38% F(14/37), 62% M(23/37), insulin group 35% F(13/37), 64% M (24/37) AGE (mean years (SD)): TYK and insulin group = 39.51 ± 10.6, Insulin group = 38.7 ± 8.1 ETHNIC GROUPS (%): not stated DURATION OF DISEASE (median months (range)):unclear INCLUSION CRITERIA: unclear EXCLUSION CRITERIA:unclear DIAGNOSTIC CRITERIA: unclear CO‐MORBIDITIES:Not given CO‐MEDICATIONS: Not given NUMBER: TYK + insulin 37, Insulin 37 LOSS TO FOLLOW‐UP: not clear |
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| Interventions |
NUMBER OF STUDY CENTRES:1 COUNTRY/ LOCATION: China SETTING: out‐patient INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY): subcutaneous insulin therapy and oral TKY. Insulin injection 0.5 u/kg daily 2/3 of the amount injected 30 min before breakfast 1/3 of the amount injected 30min before supper, adjusted according to blood sugar level. TKY consisted of red ginseng 10g, milkvetch root 30g, lilyturf root 15g, wild weed 10g, coptis root 15g, cape‐jasmine fruit 10g, giant knotweed rhizome 10g, safflower 10g, and moutain bark 10g. CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY): subcutaneous insulin therapy (as described above) TREATMENT BEFORE STUDY:None TITRATION PERIOD: None. |
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| Outcomes |
PRIMARY OUTCOME(S) (as stated in the publication):Not stated but objectives states "to investigate the effect and mechanism of TKY for improving pancreatic islet beta cell function in patients with LADA" SECONDARY OUTCOMES (as stated in the publication):Not stated ADDITIONAL OUTCOMES: 1.HbA1c, 2. Stimulated C‐peptide and changes in C‐peptide were measured 3. Inflammatory markers (IFN‐y and IL‐4) |
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| Study details |
DURATION OF INTERVENTION: 3 months DURATION OF FOLLOW‐UP: 3 months RUN‐IN PERIOD: none |
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| Publication details |
LANGUAGE OF PUBLICATION: Chinese COMMERCIAL FUNDING: no NON‐COMMERCIAL FUNDING: yes PUBLICATION STATUS (PEER REVIEW JOURNAL): yes PUBLICATION STATUS (JOURNAL SUPPLEMENT): no PUBLICATION STATUS (ABSTRACT): Full paper |
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| Stated aim for study | Quote " To investigate the effect and mechanism of TYK for improving pancreatic islet ß cell function in patients with LADA " | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number table |
| Allocation concealment (selection bias) | Low risk | Unblinded |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | No evidence the analyst was blinded |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear if there were losses to follow‐up |
| Selective reporting (reporting bias) | Low risk | No problems identified |
| Other bias | Low risk | No problems identified |