Fibromyalgia & musculoskeletal pain

Cannabidiol versus placebo in patients with fibromyalgia: a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial

Ann Rheum DisPublished Randomised controlled trial

Primary result · Mean change in pain intensity (NRS)Result — go to the resultBetween-group difference −0.7 points 95% CI −1.2 to −0.25

Authors' conclusion

The findings do not support CBD 50 mg daily as an analgesic supplement for patients with fibromyalgia.

Study context

Population
Patients with fibromyalgia from a specialised outpatient clinic in Denmark273 screened
Participants
200 patients
Comparison
Cannabidiol (CBD) 50 mg vs placebo tablets
  • CBDn = 100
  • Placebon = 100reference
Primary endpoint
Change in pain intensity (numeric rating scale (NRS) pain subitem of the revised Fibromyalgia Impact Questionnaire)
Follow-up
Week 24
Methodological detailsdouble-blind, placebo-controlled, parallel-group, single-centre, stratified by sex, age and pain level
  • Double-blind
  • Placebo-controlled
  • Parallel-group
  • Single-centre
  • Stratified by sex, age and pain level

Primary result

Mean change in pain intensity (NRS)

Between-group difference

−0.7 points

95% CI −1.2 to −0.25

P = 0.0028

Change by group

CBD

−0.4

mean · 95% CI −0.82–0.08 · points

Placebo

−1.1

mean · 95% CI −1.53–-0.63 · points

Placebovs CBD
between-group difference −0.7 points (95% CI −1.2 to −0.25); P = 0.0028

As reported in the abstract

Safety

Adverse events

Generally mild and evenly distributed between groups
  • Safety population

Original publication

Cannabidiol versus placebo in patients with fibromyalgia: a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial. Ann Rheum Dis. Published 22 August 2025. doi:10.1016/j.ard.2025.07.008

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