Study register · detailKohortenstudie · Fibromyalgia · 2025
The effect of medical cannabis on gastrointestinal symptoms in fibromyalgia and disorders of gut-brain interaction: a patient‑centred real‑world observational study.
Santonicola et al.·Clinical and experimental rheumatologyImpact 1.2
Clear benefitGRADEVery low1 citations
Samplen = 60 Pat.
Duration6 months
EndpointFIQR
Blindingn.a.
DesignKohortenstudie
Cannabinoidvollspektrum
”Key finding
Significant improvement in fibromyalgia severity and several GI symptoms (epigastric pain, burning, abdominal pain, distension, bloating) over 6 months.
Summary
n=60 fibromyalgia patients, Bedrocan® cannabis treatment over 6 months; 76,6% met criteria for at least one disorder of gut-brain interaction (DGBI). FIQR severity score log-transformed significantly reduced (repeated-measures ANOVA, p<0.001). Among GI symptoms: log-transformed intensity-frequency scores of epigastric pain, epigastric burning, abdominal pain, abdominal distension and bloating significantly reduced (repeated-measures ANOVA, p<0.01). Open-label without control group.
P
PopulationFibromyalgia patients with gastrointestinal symptoms (including IBS, functional dyspepsia according to Rome IV criteria), n=60
I
InterventionBedrocan® medical cannabis oral/inhaled, 6 months
O
OutcomeFIQR severity score (log-transformed) significantly reduced over 6 months (p<0.001); GI symptoms (epigastric pain, epigastric burning, abdominal pain, bloating) also significantly reduced (p<0.01)
Confidence in the evidence
Very lowLowModerateHigh
Very low
The lowest GRADE level, the effect estimate remains uncertain.
Downgraded for
Imprecision
Quality profile
Sample size★★★★★
Blinding—
Effect sizeClear benefit
Citations / year★★★★★
Authors
Santonicola A, Moscato P, Soldaini C, Loi G, Merchionda A, D'Addieco P, Lauritano A, Pellegrino G, Sarzi-Puttini P, Iovino P
Objectives: Fibromyalgia (FM) is frequently associated with gastrointestinal (GI) disorders such as disorders of gut-brain interaction (DGBIs). Current treatments for FM offer limited relief, leading to the exploration of alternative therapies such as medical cannabis. This study evaluates in the impact of Bedrocan(R) medical cannabis in FM patients and GI symptoms over six months.
Methods: Sixty FM patients were enrolled, receiving a Bedrocan(R) cannabis treatment for 6 months. A standardised questionnaire evaluating upper and lower GI symptoms and the Revised Fibromyalgia Impact Questionnaire (FIQR) evaluating FM severity were administered at enrolment and 3 and 6-month follow-up evaluations. DGBIs, in particular, irritable bowel syndrome (IBS), and functional dyspepsia (FD) were diagnosed according to Rome IV criteria.
Results: Forty-six/60 (76.6%) FM patients fulfilled the diagnostic criteria for at least one DGBI; 10/60 (16.7%) FM patients fulfilled the diagnostic criteria for IBS, 17/60 (28.3%) for FD, and 19/60 (31.7%) for both IBS/FD. The FIQR severity score log-transformed significantly decreased during the months-by-month comparison period (repeated-measures ANOVA, p<0.001). Among GI symptoms, the log-transformed intensity-frequency score of epigastric pain, epigastric burning, abdominal pain, abdominal distension, and bloating significantly decreased during the month-by-month comparison period (repeated-measures ANOVA, p<0.01).
Conclusions: This study supports Bedrocan(R) medical cannabis as an alternative treatment for FM with a potential effect on FD and IBS symptoms. Despite positive outcomes, the study acknowledges limitations, such as the small sample size and absence of a control group. Further research is required to confirm the efficacy of medical cannabis in FM patients, particularly regarding its effects on GI symptoms.