Mang 2006.
| Methods | Design: randomised, double‐blind, placebo‐controlled, parallel group, single‐centre clinical trial Randomisation ratio: not stated |
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| Participants | Participants: 79 participants recruited, 65 analysed (cinnamon = 33, placebo = 32). Mean age (cinnamon = 62.8 ± 8.37 years, placebo = 63.7 ± 7.17 years). Sex (male/female) (cinnamon = 21/12, placebo = 23/9). Duration of diabetes (cinnamon = 7.1 ± 6.2 years, placebo = 6.8 ± 4.7 years) Inclusion criteria: type 2 diabetes mellitus Exclusion criteria: not stated Diagnostic criteria: not stated Co‐morbidities: not stated Co‐medications: oral hypoglycaemic agents (metformin, sulphonylureas, glinides, glitazones, or combination therapy) | |
| Interventions | Number of study centres: 1 Country/location: Hannover, Germany Setting: university research centre Intervention (route, total dose/day, frequency): oral, cinnamon (aqueous extract of C. cassia) 1000 mg capsule, 3 times a day Control (route, total dose/day, frequency): oral, 1 microcrystalline cellulose (placebo) capsule, 3 times a day Treatment before study: not stated Titration period: not applicable | |
| Outcomes | Primary outcome(s) (as stated in the publication): not stated Secondary outcomes (as stated in the publication): not stated Additional/other outcomes: HbA1c; FBGL; total cholesterol; low‐density lipoprotein cholesterol; high‐density lipoprotein cholesterol; triacylglycerol | |
| Study details | Duration of intervention: 4 months (16 weeks) Duration of follow‐up: not applicable Run‐in period: not applicable | |
| Publication details | Language of publication: English Commercial funding Publication status: peer‐reviewed journal |
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| Stated aim of study | To investigate the effects of aqueous cinnamon extract on HbA1c, fasting plasma glucose and serum lipids in type 2 diabetes | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomised"; "patients...[were] randomly assigned to take either cinnamon...or...placebo" (method not described) Comment: probably done |
| Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not described Comment: probably not done |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "double‐blind"; "placebo capsules looked identical [to cinnamon capsules]" Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | High risk | ITT not mentioned; withdrawn participants were excluded from the analysis |
| Selective reporting (reporting bias) | Unclear risk | All primary outcomes listed were reported, though no study protocol was published or lodged |
| Other bias | Unclear risk | The number and reasons for withdrawals were not given for each group separately |