Extraction form for project: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain

Design Details

1. Trial Name
2. What kind of study is this?
3. Month/Year Study Included
Add the month and year the study was included in the review
4. Setting
List country or continent
5. Study Design
6. Crossover Design
Is this a crossover trial?
7. Pain Population
8. Pain Condition
Add specific condition here if specified
9. Prior Cannabis Exposure
10. Age Measure (Mean, Median)
11. Age, Years
Input the mean or median age for the entire sample
12. Female %
Input the whole number here for the entire study sample - no need to add %
13. Race, White %
Add % White for entire sample and round to nearest whole number - no need to add %
14. Race, Black %
Add % Black for entire sample and round to nearest whole number - no need to add %
15. Race, Hispanic/Latino %
Add % Hispanic/Latino for entire sample and round to nearest whole number - no need to add %
16. Race, Asian %
17. Race, Other %
Add % Other Race for entire sample and round to nearest whole number - no need to add %
18. Pain Duration Measure (Mean, Median)
19. Pain Duration, Months
20. Psychiatric Comorbidity %
Add % psychiatric comorbidity for entire sample and round to nearest whole number - no need to add %. If excluded from inclusion criteria, say "Excluded"
21. Opioid Use at Baseline
Add information for opioid use at baseline.
22. N Randomized
23. N Analyzed
24. Treatment Duration, weeks
25. Assessment Time Category
26. Funding Source
27. Companion Paper

Arms

Arm NameArm Description
Nabiximols2.7 mg THC/2.5mg CBD oral spray
DronabinolOral capsule (strength NR)

Arm Details

1. Dose Received, mean
Nabiximols
Dronabinol

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalPainPain intensity index (VAS 0-100 scale) mean relative change (improvement) rates at week 24
  • All Participants
  • 24 weeks
CategoricalFunctionPain-related disabilities (VAS 0-100 scale) mean relative change (improvement) rates at week 24
  • All Participants
  • 24 weeks
CategoricalQuality of LifePhysical quality of life (VR12-PCS; NRS 100 scale) mean relative change (improvement) rates at week 24
  • All Participants
  • 24 weeks
CategoricalDepression (Change)Depression (DASS-D; NRS21) mean relative change (improvement) rates at week 24
  • All Participants
  • 24 weeks
CategoricalOpioid UseBetween-cohort differences in discontinuation of strong opioid analgesics:
  • All Participants
  • 24 weeks
CategoricalQuality of Life- MentalMental quality of life (VR12-MCS; NRS 100 scale) mean relative change (improvement) rates at week 24
  • All Participants
  • 24 weeks
CategoricalAnxietyAnxiety (DASS-A; NRS21) mean relative change (improvement) rates at week 24
  • All Participants
  • 24 weeks
CategoricalOpioid UseBetween-cohort differences in stopping of mild opioids
  • All Participants
  • 24 weeks
CategoricalOpioid UseBetween-cohort differences in stopping of strong opioids
  • All Participants
  • 24 weeks
CategoricalOpioid UseDiscontinuation of all rescue analgesics
  • All Participants
  • 24 weeks
CategoricalOpioid UseDiscontinuation of at least one rescue analgesic
  • All Participants
  • 24 weeks
CategoricalAdverse EventsTotal patients reporting treatment related adverse event
  • All Participants
  • 24 weeks
CategoricalAdverse EventsCardiac disorders
  • All Participants
  • 24 weeks
CategoricalAdverse EventsGastrointestinal disorders
  • All Participants
  • 24 weeks
CategoricalAdverse EventsMusculoskeletal and connective tissue disorders
  • All Participants
  • 24 weeks
CategoricalAdverse EventsNervous system disorders
  • All Participants
  • 24 weeks
CategoricalAdverse EventsPsychiatric disorders
  • All Participants
  • 24 weeks
CategoricalAdverse EventsVascular disorders
  • All Participants
  • 24 weeks

Outcome Details

1. Other Outcomes Reported (primary)
What other primary outcomes, besides: "Pain Response >= 30%", "Pain Severity (Change)", "Pain Interference (Change)", "Function/Disability (Change)".
2. Other AE Outcomes of Importance reported
3. Notes

Results

Categorical


Pain (Pain intensity index (VAS 0-100 scale) mean relative change (improvement) rates at week 24)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)
24 weeks
Total (N analyzed)
Mean Difference (MD)
Percentage
95% CI low (MD)
95% CI high (MD)
Odds Ratio (OR)
Risk Ratio (RR)
95% CI low (RR)
95% CI high (RR)
p value
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)

Function (Pain-related disabilities (VAS 0-100 scale) mean relative change (improvement) rates at week 24)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
24 weeks
Total (N analyzed)
Mean Difference (MD)
Percentage
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
Risk Ratio (RR)
95% CI low (RR)
95% CI high (RR)
p value
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol

Quality of Life (Physical quality of life (VR12-PCS; NRS 100 scale) mean relative change (improvement) rates at week 24)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
24 weeks
Total (N analyzed)
Mean Difference (MD)
Percentage
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
Risk Ratio (RR)
95% CI low (RR)
95% CI high (RR)
p value
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol

Depression (Change) (Depression (DASS-D; NRS21) mean relative change (improvement) rates at week 24)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
24 weeks
Total (N analyzed)
Mean Difference (MD)
Percentage
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
Risk Ratio (RR)
95% CI low (RR)
95% CI high (RR)
p value
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol

Opioid Use (Between-cohort differences in discontinuation of strong opioid analgesics:)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
24 weeks
Total (N analyzed)
Mean Difference (MD)
Percentage
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
Risk Ratio (RR)
95% CI low (RR)
95% CI high (RR)
p value
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol

Quality of Life- Mental (Mental quality of life (VR12-MCS; NRS 100 scale) mean relative change (improvement) rates at week 24)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
24 weeks
Total (N analyzed)
Mean Difference (MD)
Percentage
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
Risk Ratio (RR)
95% CI low (RR)
95% CI high (RR)
p value
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol

Anxiety (Anxiety (DASS-A; NRS21) mean relative change (improvement) rates at week 24)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
24 weeks
Total (N analyzed)
Mean Difference (MD)
Percentage
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
Risk Ratio (RR)
95% CI low (RR)
95% CI high (RR)
p value
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol

Opioid Use (Between-cohort differences in stopping of mild opioids)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
24 weeks
Total (N analyzed)
Mean Difference (MD)
Percentage
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
Risk Ratio (RR)
95% CI low (RR)
95% CI high (RR)
p value
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol

Opioid Use (Between-cohort differences in stopping of strong opioids)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
24 weeks
Total (N analyzed)
Mean Difference (MD)
Percentage
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
Risk Ratio (RR)
95% CI low (RR)
95% CI high (RR)
p value
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol

Opioid Use (Discontinuation of all rescue analgesics)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
Dronabinol (Oral capsule...)
vs.
24 weeks
Total (N analyzed)
Odds Ratio (OR)
Percentage
Risk Ratio (RR)
95% CI low (RR)
95% CI high (RR)
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
Dronabinol (Oral capsule...)
vs.

Opioid Use (Discontinuation of at least one rescue analgesic)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
Dronabinol (Oral capsule...)
vs.
24 weeks
Total (N analyzed)
Odds Ratio (OR)
Percentage
Risk Ratio (RR)
95% CI low (RR)
95% CI high (RR)
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
Dronabinol (Oral capsule...)
vs.

Adverse Events (Total patients reporting treatment related adverse event)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)
24 weeks
Total (N analyzed)
Risk Ratio (RR)
Events
95% CI low (RR)
Percentage
95% CI high (RR)
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)

Adverse Events (Cardiac disorders)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)
24 weeks
Total (N analyzed)
Risk Ratio (RR)
Events
95% CI low (RR)
Percentage
95% CI high (RR)
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)

Adverse Events (Gastrointestinal disorders)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)
24 weeks
Total (N analyzed)
Risk Ratio (RR)
Events
95% CI low (RR)
Percentage
95% CI high (RR)
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)

Adverse Events (Musculoskeletal and connective tissue disorders)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)
24 weeks
Total (N analyzed)
Risk Ratio (RR)
Events
95% CI low (RR)
Percentage
95% CI high (RR)
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)

Adverse Events (Nervous system disorders)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)
24 weeks
Total (N analyzed)
Risk Ratio (RR)
Events
95% CI low (RR)
Percentage
95% CI high (RR)
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)

Adverse Events (Psychiatric disorders)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)
24 weeks
Total (N analyzed)
Risk Ratio (RR)
Events
95% CI low (RR)
Percentage
95% CI high (RR)
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)

Adverse Events (Vascular disorders)

All Participants
Descriptive StatisticsBetween Arm Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)
24 weeks
Total (N analyzed)
Risk Ratio (RR)
Events
95% CI low (RR)
Percentage
95% CI high (RR)
Within Arm ComparisonsNet Comparisons
NabiximolsDronabinol
Nabiximols (2.7 mg...)
vs.
Dronabinol (Oral capsule...)

Risk of Bias Assessment

1. What kind of study is this?
Choose whether this is an RCT or an Observational Study
2. Randomization Adequate?
ROB2.0
3. Did the study attempt to enroll all (or a random sample of) patients meeting inclusion criteria (inception cohort)?
4. Allocation Concealment Adequate?
Ottawa
5. Groups similar at baseline?
6. Did the study use accurate methods for ascertaining exposures and potential confounders (i.e., age, sex, other medications)?
7. Patients masked?
8. Care provider masked?
9. Outcome assessors masked?
10. Were outcome assessors and/or data analysts blinded to the exposure being studied?
11. Intention-to-treat (ITT) analysis?
12. Did the study perform appropriate statistical analyses on potential confounders (i.e. age, sex, other medications)?
13. Acceptable levels of overall attrition?
14. Acceptable levels of differential attrition?
15. Did the article report attrition or missing data?
16. Is there important differential loss to followup or overall high loss to followup or missing data?
17. Were outcomes prespecified and defined, and ascertained using accurate methods?
18. Assessment of Bias