Schweizer 1995.
Methods |
Study design: Randomised controlled trial Study grouping: Parallel group Blinding: Double Duration: 10 weeks Single‐centre |
|
Participants |
Baseline characteristics Not reported Inclusion criteria: At least 18 years of age and taking diazepam, lorazepam, or alprazolam on a continuous daily basis for at least 1 year Exclusion criteria: Individuals were excluded from the study if they had a history of alcohol or substance abuse or dependence in the past year, or if they had any acute or unstable medical condition. Men could be of any age, while women had to be at least 2 years' postmenopause, or to have undergone an ovariectomy. Pretreatment: Unknown |
|
Interventions |
Intervention characteristics Benzodiazepine taper schedule: 2 to 3 weeks pretreatment with experimental drug, taper at the rate of 25% per week, after completion of taper experimental drug was continued for 4 weeks, then abruptly discontinued
|
|
Outcomes |
|
|
Identification |
Sponsorship source: This study was supported by USPHS Research Grant MHO‐8957. Country: USA Setting: Outpatients Declarations of interest: Not mentioned Author's name: Edward Schweizer Institution: University Science Center, Suite 803, 3600 Market Street, Philadelphia, PA 19104‐2649, USA Email: Address: University Science Center, Suite 803, 3600 Market Street, Philadelphia, PA 19104‐2649, USA |
|
Notes | Benzodiazepine withdrawal symptoms and anxiety not reported appropriately. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: Not described |
Allocation concealment (selection bias) | Unclear risk | Comment: Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "under random, double‐blind conditions", "either micronized oral progesterone in 300 mg capsules or matched placebo" Comment: Described as double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: 8 (27%) participants in progesterone group versus 1 (8%) participant in placebo group dropped out during the pretreatment phase (due to sedation as side effect). |
Selective reporting (reporting bias) | Low risk | Comment: No apparent selective outcome reporting |
Other bias | Low risk | Comment: No apparent other bias |