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
Low THC/CBD ratioSynthetic CBD 10 mg tablet once daily, with dose increased to 10 mg twice daily after two weeks. After four weeks, patients not experiencing pain reduction of more than 20 mm on the VAS increased to 10 mg thrice daily
PlaceboPlacebo tablet

Arm Details

1. Dose Received, mean
Low THC/CBD ratio
Placebo

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalPain Response ≥30%VAS
  • All Participants
  • Followup
ContinuousPain Severity (change)VAS
  • All Participants
  • Baseline
  • Followup
ContinuousFunction/Disability (change)HAQ-DI
  • All Participants
  • Baseline
  • Followup
ContinuousDepression (change)HADS-D
  • All Participants
  • Baseline
  • Followup
ContinuousAnxiety (change)HADS-D HADS-D
  • All Participants
  • Baseline
  • Followup
ContinuousSleep Quality/Interference (change)PSQI
  • All Participants
  • Baseline
  • Followup
CategoricalAny Adverse Event
  • All Participants
  • Followup
CategoricalSerious Adverse Events
  • All Participants
  • Followup
CategoricalWithdrawals Due to Adverse Events
  • All Participants
  • Followup

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 Response ≥30% (VAS)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Low THC/CBD ratioPlacebo
Followup
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Low THC/CBD ratioPlacebo

Any Adverse Event

All Participants
Descriptive StatisticsBetween Arm Comparisons
Low THC/CBD ratioPlacebo
Followup
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Low THC/CBD ratioPlacebo

Serious Adverse Events

All Participants
Descriptive StatisticsBetween Arm Comparisons
Low THC/CBD ratioPlacebo
Followup
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Low THC/CBD ratioPlacebo

Withdrawals Due to Adverse Events

All Participants
Descriptive StatisticsBetween Arm Comparisons
Low THC/CBD ratioPlacebo
Followup
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Low THC/CBD ratioPlacebo

Continuous


Pain Severity (change) (VAS)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Low THC/CBD ratioPlacebo
Low THC/CBD ratio (Synthetic CBD...)
vs.
Placebo (Placebo tablet)
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
Median
p value (MD)
25th percentile
75th percentile
Followup
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
Median
p value (MD)
25th percentile
75th percentile
Within Arm ComparisonsNet Comparisons
Low THC/CBD ratioPlacebo
Low THC/CBD ratio (Synthetic CBD...)
vs.
Placebo (Placebo tablet)
Baseline
vs.
Followup
Mean Difference (MD)
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Net Mean Difference (NMD)
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95% CI low (MD)
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95% CI low (NMD)
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95% CI high (MD)
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95% CI high (NMD)
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SD (MD)
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SD (NMD)
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p value (MD)
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P value (NMD)
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Function/Disability (change) (HAQ-DI)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Low THC/CBD ratioPlacebo
Low THC/CBD ratio (Synthetic CBD...)
vs.
Placebo (Placebo tablet)
Baseline
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Followup
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Low THC/CBD ratioPlacebo
Low THC/CBD ratio (Synthetic CBD...)
vs.
Placebo (Placebo tablet)
Baseline
vs.
Followup
Mean Difference (MD)
Saved!
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Net Mean Difference (NMD)
Saved!
95% CI low (MD)
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95% CI low (NMD)
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95% CI high (MD)
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95% CI high (NMD)
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SD (MD)
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SD (NMD)
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p value (MD)
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P value (NMD)
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Depression (change) (HADS-D)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Low THC/CBD ratioPlacebo
Low THC/CBD ratio (Synthetic CBD...)
vs.
Placebo (Placebo tablet)
Baseline
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Followup
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Low THC/CBD ratioPlacebo
Low THC/CBD ratio (Synthetic CBD...)
vs.
Placebo (Placebo tablet)
Baseline
vs.
Followup
Mean Difference (MD)
Saved!
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Net Mean Difference (NMD)
Saved!
95% CI low (MD)
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95% CI low (NMD)
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95% CI high (MD)
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95% CI high (NMD)
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SD (MD)
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SD (NMD)
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p value (MD)
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P value (NMD)
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Anxiety (change) (HADS-D HADS-D)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Low THC/CBD ratioPlacebo
Low THC/CBD ratio (Synthetic CBD...)
vs.
Placebo (Placebo tablet)
Baseline
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Followup
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Low THC/CBD ratioPlacebo
Low THC/CBD ratio (Synthetic CBD...)
vs.
Placebo (Placebo tablet)
Baseline
vs.
Followup
Mean Difference (MD)
Saved!
Saved!
Net Mean Difference (NMD)
Saved!
95% CI low (MD)
Saved!
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95% CI low (NMD)
Saved!
95% CI high (MD)
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95% CI high (NMD)
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SD (MD)
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SD (NMD)
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p value (MD)
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P value (NMD)
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Sleep Quality/Interference (change) (PSQI)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Low THC/CBD ratioPlacebo
Low THC/CBD ratio (Synthetic CBD...)
vs.
Placebo (Placebo tablet)
Baseline
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Followup
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Low THC/CBD ratioPlacebo
Low THC/CBD ratio (Synthetic CBD...)
vs.
Placebo (Placebo tablet)
Baseline
vs.
Followup
Mean Difference (MD)
Saved!
Saved!
Net Mean Difference (NMD)
Saved!
95% CI low (MD)
Saved!
Saved!
95% CI low (NMD)
Saved!
95% CI high (MD)
Saved!
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95% CI high (NMD)
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SD (MD)
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SD (NMD)
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p value (MD)
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P value (NMD)
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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