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

Design Details

1. Trial Name


	NA

2. What kind of study is this?

3. Month/Year Study Included

Add the month and year the study was included in the review


	carried forward from prior Chronic Pain reports

4. Setting

List country or continent


	NR

5. Study Design


	RCT

6. Crossover Design

Is this a crossover trial?


	Yes No

7. Pain Population


	NPP

8. Pain Condition

Add specific condition here if specified


	Mixed

9. Prior Cannabis Exposure


	Prior cannabis use in the past year: 10%

10. Age Measure (Mean, Median)


	Mean

11. Age, Years

Input the mean or median age for the entire sample


	57

12. Female %

Input the whole number here for the entire study sample - no need to add %


	61

13. Race, White %

Add % White for entire sample and round to nearest whole number - no need to add %


	99

14. Race, Black %

Add % Black for entire sample and round to nearest whole number - no need to add %


	1

15. Race, Hispanic/Latino %

Add % Hispanic/Latino for entire sample and round to nearest whole number - no need to add %


	NR

16. Race, Asian %


	NR

17. Race, Other %

Add % Other Race for entire sample and round to nearest whole number - no need to add %


	<0.5

18. Pain Duration Measure (Mean, Median)


	Mean

19. Pain Duration, Months


	76

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"


	NR

21. Opioid Use at Baseline

Add information for opioid use at baseline.


	90% of overall patients continued to take analgesics during the study; 19% took natural opium alkaloids (such as dihydrocodeine) and 18% other opioids (mostly tramadol)

22. N Randomized


	240

23. N Analyzed


	240

24. Treatment Duration, weeks

25. Assessment Time Category

26. Funding Source

27. Companion Paper


	None

Arms

Arm Name	Arm Description
Dronabinol	started at 2.5 mg/d titrated by 2.5 mg/5d to dose between 7./5 mg and 15 mg after 4 weeks
Placebo	Placebo

Arm Details

1. Dose Received, mean

Dronabinol


	13 mg/d

Placebo


	NR

Outcomes

Type	Domain	Specific measurement (i.e., tool/definition/specific outcome)	Populations	Timepoints
Continuous	Pain Severity (change)	NRS	All Participants	Baseline 16 (weeks)
Continuous	Function / Disability (Change)	EDSS	All Participants	Baseline 16 (weeks)
Continuous	Quality of Life	SF-36	All Participants	Baseline 16 (weeks)
Categorical	Any Adverse Events		All Participants	Baseline 16 (weeks)
Categorical	Serious Adverse Events		All Participants	Baseline 16 (weeks)
Categorical	Withdrawal Due to Adverse Events		All Participants	Baseline 16 (weeks)
Categorical	Dizziness		All Participants	Baseline 16 (weeks)
Categorical	Nausea		All Participants	Baseline 16 (weeks)
Categorical	Sedation		All Participants	Baseline 16 (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


	NR

3. Notes

Results

Categorical

Any Adverse Events

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Dronabinol	Placebo
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
16 (weeks)
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
		Within Arm Comparisons			Net Comparisons
		Dronabinol	Placebo

Serious Adverse Events

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Dronabinol	Placebo
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
16 (weeks)
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
		Within Arm Comparisons			Net Comparisons
		Dronabinol	Placebo

Withdrawal Due to Adverse Events

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Dronabinol	Placebo
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
16 (weeks)
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
		Within Arm Comparisons			Net Comparisons
		Dronabinol	Placebo

Dizziness

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Dronabinol	Placebo
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
16 (weeks)
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
		Within Arm Comparisons			Net Comparisons
		Dronabinol	Placebo

Nausea

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Dronabinol	Placebo
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
16 (weeks)
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
		Within Arm Comparisons			Net Comparisons
		Dronabinol	Placebo

Sedation

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Dronabinol	Placebo
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
16 (weeks)
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
		Within Arm Comparisons			Net Comparisons
		Dronabinol	Placebo

Continuous

Pain Severity (change) (NRS)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Dronabinol	Placebo		Dronabinol (started at...) vs. Placebo (Placebo)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	SE			SD (MD)
	95% CI low			p value (MD)
	95% CI high
16 (weeks)
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	SE			SD (MD)
	95% CI low			p value (MD)
	95% CI high
		Within Arm Comparisons			Net Comparisons
		Dronabinol	Placebo		Dronabinol (started at...) vs. Placebo (Placebo)
16 weeks vs. Baseline
	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!	Saved!	95% CI high (NMD)	Saved!
	SD (MD)	Saved!	Saved!	SD (NMD)	Saved!
	p value (MD)	Saved!	Saved!	P value (NMD)	Saved!

Function / Disability (Change) (EDSS)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Dronabinol	Placebo		Dronabinol (started at...) vs. Placebo (Placebo)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	SE			SD (MD)
	95% CI low			p value (MD)
	95% CI high
16 (weeks)
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	SE			SD (MD)
	95% CI low			p value (MD)
	95% CI high
		Within Arm Comparisons			Net Comparisons
		Dronabinol	Placebo		Dronabinol (started at...) vs. Placebo (Placebo)
16 weeks vs. Baseline
	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!	Saved!	95% CI high (NMD)	Saved!
	SD (MD)	Saved!	Saved!	SD (NMD)	Saved!
	p value (MD)	Saved!	Saved!	P value (NMD)	Saved!

Quality of Life (SF-36)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Dronabinol	Placebo		Dronabinol (started at...) vs. Placebo (Placebo)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	SE			SD (MD)
	95% CI low			p value (MD)
	95% CI high
16 (weeks)
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	SE			SD (MD)
	95% CI low			p value (MD)
	95% CI high
		Within Arm Comparisons			Net Comparisons
		Dronabinol	Placebo		Dronabinol (started at...) vs. Placebo (Placebo)
16 weeks vs. Baseline
	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!	Saved!	95% CI high (NMD)	Saved!
	SD (MD)	Saved!	Saved!	SD (NMD)	Saved!
	p value (MD)	Saved!	Saved!	P value (NMD)	Saved!

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


	Yes

3. Did the study attempt to enroll all (or a random sample of) patients meeting inclusion criteria (inception cohort)?

4. Allocation Concealment Adequate?

Ottawa


	Yes

5. Groups similar at baseline?


	Yes

6. Did the study use accurate methods for ascertaining exposures and potential confounders (i.e., age, sex, other medications)?

7. Patients masked?


	Yes

8. Care provider masked?


	Yes

9. Outcome assessors masked?


	Yes

10. Were outcome assessors and/or data analysts blinded to the exposure being studied?

11. Intention-to-treat (ITT) analysis?


	Unclear

12. Did the study perform appropriate statistical analyses on potential confounders (i.e. age, sex, other medications)?

13. Acceptable levels of overall attrition?


	Yes

14. Acceptable levels of differential attrition?


	Yes

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

ResourcesCiteUsage

ContactAboutContact

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

4. Setting

5. Study Design

6. Crossover Design

7. Pain Population

8. Pain Condition

9. Prior Cannabis Exposure

10. Age Measure (Mean, Median)

11. Age, Years

12. Female %

13. Race, White %

14. Race, Black %

15. Race, Hispanic/Latino %

16. Race, Asian %

17. Race, Other %

18. Pain Duration Measure (Mean, Median)

19. Pain Duration, Months

20. Psychiatric Comorbidity %

21. 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 Details

1. Dose Received, mean

Dronabinol

Placebo

Outcomes

Outcome Details

1. Other Outcomes Reported (primary)

2. Other AE Outcomes of Importance reported

3. Notes

Results

Categorical

Any Adverse Events

Serious Adverse Events

Withdrawal Due to Adverse Events

Dizziness

Nausea

Sedation

Continuous

Pain Severity (change) (NRS)

Function / Disability (Change) (EDSS)

Quality of Life (SF-36)

Risk of Bias Assessment

1. What kind of study is this?

2. Randomization Adequate?

3. Did the study attempt to enroll all (or a random sample of) patients meeting inclusion criteria (inception cohort)?

4. Allocation Concealment Adequate?

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

Resources
Cite
Usage

Contact
About
Contact