Zhu 2004.
| Methods |
RANDOMISED CONTROLLED CLINICAL TRIAL (RCT): yes, parallel RCT RANDOMISATION RATIO: equal ratio assumed (not stated in manuscript) NON‐INFERIORITY DESIGN: no EQUIVALENCE DESIGN: no ETHICS APPROVAL OBTAINED: unknown PATIENT CONSENT OBTAINED: unknown BLINDING OF PATIENT (P), EDUCATOR (E), RESEARCHER (R): P = no, E = no, R = no ANALYSIS BY INTENTION TO TREAT: No POWER CALCULATION: no |
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| Participants |
WHO PARTCIPATED: SEX (female% / male%): Insulin group 45% F(15/33), 54% M 18/33, Insulin + Chinese medicine 51% F (16/31), 49% M (15/31), SU group 45% F (9/20), 55% M (11/20). AGE (mean years (SD)): Insulin group (39.8), Insulin+ Chinese medicine (40.5), SU group (41.6) ETHNIC GROUPS (%): not stated DURATION OF DISEASE (mean months (SD)): Insulin 20.3 (3.6), Insulin + Chinese medicine 19.5 (3.9), SU group 19.8 (4.3) INCLUSION CRITERIA: (1) Adult (32 years +) (2) type 2 diabetes with GADA+ and ICA + . EXCLUSION CRITERIA: none given DIAGNOSTIC CRITERIA: type 2 diabetes with GADA+ and ICA+ CO‐MORBIDITIES:Not given CO‐MEDICATIONS: Not given NUMBER: Insulin 33, IInsulin+ Chinese medicine 31, SU 20. LOSS TO FOLLOW‐UP: 0% |
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| Interventions |
NUMBER OF STUDY CENTRES:2 COUNTRY/ LOCATION: China SETTING: out‐patient INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY): Insulin or insulin plus Chinese medicine CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY): Sulphonylurea TREATMENT BEFORE STUDY:None TITRATION PERIOD: None |
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| Outcomes |
PRIMARY OUTCOME(S) (as stated in the publication):Not stated but abstract states "to study the effect of integrated Chinese and Westerm medicine on improvement of islet beta cell function in treating patients with latent autoimmune diabetes in adults (LADA)" SECONDARY OUTCOMES (as stated in the publication):Not stated ADDITIONAL OUTCOMES: 1.HbA1c, 2. FBG, 3. Stimulated C‐peptide and changes in C‐peptide PRIMARY OUTCOME(S) (as stated in the publication): SECONDARY OUTCOMES (as stated in the publication): ADDITIONAL OUTCOMES: 1. HbA1c (%), 2. Fasting C‐peptide (nmol/L) |
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| Study details |
DURATION OF INTERVENTION: 12 months DURATION OF FOLLOW‐UP: 12 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): yes PUBLICATION STATUS (ABSTRACT): no |
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| Stated aim for study | Quote " To study the effect of integrated Chinese and Westerm medicine on improvement of the islet beta cell function in treating patients with latent autoimmune diabetes mellitus in adults (LADA)" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Low risk | Unblinded |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unblinded but not indication the analysis was blinded |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not described |
| Selective reporting (reporting bias) | Low risk | No problems identified |
| Other bias | Low risk | No problems identified |
CG: control group; IG = intervention group