Solomon 1960.
Study characteristics | ||
Methods | Type: clinical Design: cross‐over Objective: to investigate psychologic and osteometabolic responses to sex hormones in elderly osteoporotic women Treatment duration: 6 weeks per cross‐over period Follow‐up duration (including treatment duration): 6 weeks per cross‐over period Washout between cross‐over periods: not stated explicitly, but probably none |
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Data | Country: USA Condition: women with postmenopausal osteoporosis or Paget's disease Number of people randomised: 12 randomised to a cross‐over sequence Number of people analysed: all 12 completed, but unclear if all 12 analysed for each placebo |
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Comparisons | Active placebo: dextroamphetamine and amobarbital (5 mg, twice daily) Standard placebo: lactose Experimental intervention: 2 groups: methallenestril (3 mg twice daily) and fluoxymesterone (5 mg twice a day) Administration: oral |
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Outcomes | Participant‐reported outcome: questionnaire covering 10 categories (household activities, social activities, resting, motor performance, sleeping, pain, psychological distress, well‐being, interest and participation in environment, and libidinal stimulation) Observer‐reported outcome: 24 hour urinary calcium excretion Harm outcome: none Co‐intervention outcome: none |
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Terminology for active placebo | "Active placebo" a priori | |
Scores and unpleasantness of the active placebo | Adequacy: 2
Risk of therapeutic effect: 4 Unpleasant/neutral/pleasant: unpleasant |
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Funding and conflicts of interest | Mixed; received drugs from companies. Conflicts of interest not reported. | |
Notes | ||
Risk of bias | ||
Item | Authors' judgement | Support for judgement |
Free from risk of bias arising from the randomisation process | Unclear | Completed Latin squares design. No other information. |
Free from risk of bias in selection of the reported result All outcomes | Unclear | No information. |