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
Nabilone monotherapy
Gabapentin
Gabapentin + Nabilone

Arm Details

1. Dose Received, mean
Nabilone monotherapy
Gabapentin
Gabapentin + Nabilone

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPain intensity VAS, 0 to 100 scale
  • All Participants
  • 3 months
ContinuousAbsolute improvement in VAS since initiationVAS
  • All Participants
  • 6 months
  • Initiation
ContinuousBrief Pain Index Pain Interference 0 to 10 scale
  • All Participants
  • 3 months
  • 6 months
ContinuousFunctional OutcomesSF-36 Physical Functioning,0 to 100 scale at 6 months
  • All Participants
  • 6 months
Continuous Quality of Life OutcomesEQ-5D, VAS 0 to 100 at 6 months
  • All Participants
  • 6 months
ContinuousAnxiety and Depression OutcomesHospital Anxiety and Depression Scale total score, scale unclear
  • All Participants
  • 6 months
ContinuousSleep OutcomesMedical Outcomes Study Sleep Scale, 12 to 71 scale
  • All Participants
  • 6 months
CategoricalAdverse EventsAny adverse event
  • All Participants
  • 3 months
  • 6 months
CategoricalAdverse EventsSedation
  • All Participants
  • 3 months
  • 6 months
CategoricalAdverse EventsDizziness
  • All Participants
  • 3 months
  • 6 months
CategoricalAdverse EventsWithdrawals due to adverse events
  • All Participants
  • 6 months
CategoricalAdverse eventSerious adverse events
  • All Participants
  • 6 months

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


Adverse Events (Any adverse event )

All Participants
Descriptive StatisticsBetween Arm Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
3 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
6 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone

Adverse Events (Sedation)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
3 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
6 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone

Adverse Events (Dizziness )

All Participants
Descriptive StatisticsBetween Arm Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
3 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
6 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone

Adverse Events (Withdrawals due to adverse events)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
6 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone

Adverse event (Serious adverse events)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
6 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone

Continuous


Brief Pain Index (Pain Interference 0 to 10 scale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
Nabilone monotherapy
vs.
Gabapentin

Nabilone monotherapy
vs.
Gabapentin + Nabilone
3 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
6 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
Within Arm ComparisonsNet Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
Nabilone monotherapy
vs.
Gabapentin
Nabilone monotherapy
vs.
Gabapentin + Nabilone

Functional Outcomes (SF-36 Physical Functioning,0 to 100 scale at 6 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
Nabilone monotherapy
vs.
Gabapentin

Nabilone monotherapy
vs.
Gabapentin + Nabilone
6 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
Within Arm ComparisonsNet Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
Nabilone monotherapy
vs.
Gabapentin
Nabilone monotherapy
vs.
Gabapentin + Nabilone

Quality of Life Outcomes (EQ-5D, VAS 0 to 100 at 6 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
Nabilone monotherapy
vs.
Gabapentin

Nabilone monotherapy
vs.
Gabapentin + Nabilone
6 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
Within Arm ComparisonsNet Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
Nabilone monotherapy
vs.
Gabapentin
Nabilone monotherapy
vs.
Gabapentin + Nabilone

Anxiety and Depression Outcomes (Hospital Anxiety and Depression Scale total score, scale unclear )

All Participants
Descriptive StatisticsBetween Arm Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
Nabilone monotherapy
vs.
Gabapentin

Nabilone monotherapy
vs.
Gabapentin + Nabilone
6 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
Within Arm ComparisonsNet Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
Nabilone monotherapy
vs.
Gabapentin
Nabilone monotherapy
vs.
Gabapentin + Nabilone

Sleep Outcomes (Medical Outcomes Study Sleep Scale, 12 to 71 scale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
Nabilone monotherapy
vs.
Gabapentin

Nabilone monotherapy
vs.
Gabapentin + Nabilone
6 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
Within Arm ComparisonsNet Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
Nabilone monotherapy
vs.
Gabapentin
Nabilone monotherapy
vs.
Gabapentin + Nabilone

Pain intensity ( VAS, 0 to 100 scale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
Nabilone monotherapy
vs.
Gabapentin

Nabilone monotherapy
vs.
Gabapentin + Nabilone
3 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
Within Arm ComparisonsNet Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
Nabilone monotherapy
vs.
Gabapentin
Nabilone monotherapy
vs.
Gabapentin + Nabilone

Absolute improvement in VAS since initiation (VAS)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
Nabilone monotherapy
vs.
Gabapentin

Nabilone monotherapy
vs.
Gabapentin + Nabilone
6 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
Initiation
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
Within Arm ComparisonsNet Comparisons
Nabilone monotherapyGabapentin Gabapentin + Nabilone
Nabilone monotherapy
vs.
Gabapentin
Nabilone monotherapy
vs.
Gabapentin + Nabilone

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