Xiao 2008.
| Methods | Randomised, double‐blind, placebo‐controlled trial; qualifying participants were randomly assigned in a 1:1 manner using random numbers | |
| Participants | People with acute severe TBI and a GCS score ≤ 8 after resuscitation and stabilisation within 8 hours of injury Exclusion criteria: pregnant or lactating women; people who had taken other investigational drugs within 30 days; who had severe anoxic intracerebral damage or brain death; whose clinical condition was unstable (partial pressure of oxygen < 60 mmHg or a systolic blood pressure < 90 mmHg, or both); those for whom there was doubt about whether the neurological status resulted from head trauma or acute or chronic spinal cord injury | |
| Interventions | Intervention group: progesterone 1.0 mg/kg via intramuscular injection within 8 hours of the documented time of injury and repeated every 12 hours for 5 consecutive days Control group: placebo | |
| Outcomes | Mortality, GOS scores and Modified Functional Independence Measure scores at 3 and 6 months after injury ICP, and average body temperature during treatment Complications and adverse events | |
| Notes | The study was approved by the Institutional Review Board and the ethical committees and supported by the Scientific Research Fund of Zhejiang Provincial Education Department, China. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Qualifying patients were randomly assigned in a 1:1 manner to receive the matching treatment with random numbers". Comment: probably done |
| Allocation concealment (selection bias) | Low risk | Quote: "The appearance, packaging and administration of placebo and progesterone injections were the same for the two groups". Comment: probably done |
| Blinding (performance bias and detection bias) Subjective outcome | Low risk | "Double blind" "The appearance, packaging and administration of placebo and progesterone injections were the same for the two groups. All patients, treating physicians, nursing staff, and pharmacists were blinded throughout the study period". Comment: probably done |
| Blinding (performance bias and detection bias) Mortality | Low risk | Double blinded, and review authors judged that the outcome and the outcome measurement were not likely to be influenced. |
| Incomplete outcome data (attrition bias) Mortality | Low risk | Data were available for 154 participants (96%) at the 3‐month follow‐up and for 135 (85%) at the 6‐month follow‐up. At 2 months, 19 participants (12%) were lost to follow‐up, 3 (2%) refused follow‐up, and 2 (1%) withdrew from the trial. Missing outcome data were balanced in numbers between the progesterone group and placebo group, with similar reasons for missing data across the groups. |
| Incomplete outcome data (attrition bias) Favorable outcome | Low risk | Missing outcome data were balanced in numbers between the progesterone group and placebo group, with similar reasons for missing data across the groups. |
| Selective reporting (reporting bias) | High risk | The trial was registered retrospectively. The registration date was after the end of the trial. |
| Other bias | Low risk | ‐‐ |
Abbreviations
DRS: Disability Rating Score GCS: Glasgow Coma Scale GOS: Glasgow Outcome Scale GOS‐E: extended Glasgow Outcome Scale ICP: intracranial pressure ITT: intention‐to‐treat analysis RCT: randomised controlled trial TBI: traumatic brain injury