Skip to main content
. 2018 Mar 15;2018(3):CD011481. doi: 10.1002/14651858.CD011481.pub2

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
  1. Benzodiazepine taper schedule + progesterone minimum 1200 mg/d (up to 3600 mg as tolerated) (N = 30)

  2. Benzodiazepine taper schedule + placebo (N = 13)

Outcomes
  • Benzodiazepine withdrawal symptoms, Physician Withdrawal Checklist

  • Benzodiazepine cessation

  • Anxiety, HAM‐A

  • Non‐serious adverse events: sedation

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