Fibromyalgia & musculoskeletal pain
Ramosetron as an add-on therapy for refractory fibromyalgia: a randomized, double-blind, placebo-controlled trial
Authors' conclusion
Intravenous administration of ramosetron provided safe and effective short-term relief of pain intensity in FM patients with inadequate response to standard treatments.
Study context
- Population
- Fibromyalgia (FM) patients unresponsive to conventional treatments
- Participants
- 80 participants
- Comparison
- IV ramosetron 0.3 mg/day for 5 consecutive days vs placebo, as add-on in refractory FM
- Ramosetronn = 40
- Placebon = 40reference
- Primary endpoint
- Reduction in pain intensity (VAS)
- Follow-up
- End of treatment period
Methodological detailsprospective, double-blind, placebo-controlled
- Prospective
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Reduction in VAS pain score · End of treatment phase
Ramosetron
1.18
± 1.60
Placebo
0.54
± 1.59
P < 0.05
Secondary outcomes
| Outcome | Ramosetron | Placebo | P value |
|---|---|---|---|
| BDI improvement · End of treatment phase | 4.42 ± 5.18 | 1.33 ± 4.87 | P < 0.05 |
| MDHAQ pain scale improvement · End of treatment phase | 0.37 ± 0.74 | 0.04 ± 0.52 | P < 0.05 |
Pain visual analogue scale (VAS) and Beck Depression Inventory (BDI) improvements · day 28
- Improvements not sustained through day 28
Original publication
Ramosetron as an add-on therapy for refractory fibromyalgia: a randomized, double-blind, placebo-controlled trial. Rheumatology (Oxford). Published 25 May 2024. doi:10.
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