Meta-analysis of placebo-arm dropouts in osteoporosis randomized-controlled trials and implications for nocebo-associated discontinuation of anti-osteoporotic drugs in clinical practice
Authors' conclusion
Almost 1 in 10 osteoporosis patients receiving placebo in trials of bisphosphonates and SERMs experiences AEs leading to dropout, implying that nocebo contributes to treatment-discontinuation in clinical practice.
Study context
- Population
- Placebo-treated patients in double-blind trials of anti-osteoporotic drugs published January 1993–March 2022
- Participants
- 16,460 patients44 trials
- Comparison
- Placebo arms of bisphosphonate vs SERM trials
- Outcome
- Nocebo dropouts: dropouts due to reported adverse events in the placebo arms
Methodological detailsdouble-blind, placebo-controlled
- Double-blind
- Placebo-controlled
Pooled result
As reported in the abstract
Pooled nocebo-dropout
| Group | Value | Range |
|---|---|---|
| Bisphosphonates | average 0.08 (95% CI 0.06–0.10) | 0.01-0.27 |
| Selective estrogen receptor modulators (SERMs) | average 0.08 (95% CI 0.05–0.13) | 0.03-0.15 |
Value
Bisphosphonatesaverage 0.08 (95% CI 0.06–0.10)
Selective estrogen receptor modulators (SERMs)average 0.08 (95% CI 0.05–0.13)
Range
Bisphosphonates0.01-0.27
Selective estrogen receptor modulators (SERMs)0.03-0.15
Further pooled results
| Outcome | ≥ 65 years | Younger | P value |
|---|---|---|---|
| Nocebo-dropout in bisphosphonate trials by age (subgroup)Higher in trials enrolling ≥ 65 years · average | 0.11 (95% CI 0.08–0.13) | 0.06 (95% CI 0.05–0.08) | P = 0.001 |
| Trials (n) | 18 | 18 |
Other moderators
- Participants' sex, dosing-intervals, publication year, or severity of osteoporosis had no impact on the nocebo-dropouts
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Meta-analysis of placebo-arm dropouts in osteoporosis randomized-controlled trials and implications for nocebo-associated discontinuation of anti-osteoporotic drugs in clinical practice. Osteoporos Int. Published 4 January 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →