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
High THC/CBD ratioDronabinol 5 mg titrated by 5 mg every third day for a max dose of 20 mg/day (5 mg doses four times per day)
DiphenhydramineDiphenhydramine 25 mg titrated by 25 mg every fifth day to a max dose of 75 mg/day (25 mg doses three times per day)

Arm Details

1. Dose Received, mean
High THC/CBD ratio
Diphenhydramine

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPain Severity (change)BPI
  • All Participants
  • Baseline
  • Followup
CategoricalAny Adverse Event
  • All Participants
  • Followup
CategoricalSerious Adverse Events
  • All Participants
  • Followup
CategoricalWithdrawals Due to Adverse Events
  • All Participants
  • Followup
CategoricalDizziness
  • All Participants
  • Followup
CategoricalNausea
  • All Participants
  • Followup
CategoricalSedation
  • 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


Any Adverse Event

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

Serious Adverse Events

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

Withdrawals Due to Adverse Events

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

Dizziness

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

Nausea

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

Sedation

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

Continuous


Pain Severity (change) (BPI)

All Participants
Descriptive StatisticsBetween Arm Comparisons
High THC/CBD ratioDiphenhydramine
High THC/CBD ratio (Dronabinol 5...)
vs.
Diphenhydramine (Diphenhydrami...)
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Followup
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
High THC/CBD ratioDiphenhydramine
High THC/CBD ratio (Dronabinol 5...)
vs.
Diphenhydramine (Diphenhydrami...)
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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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