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

Design Details

1. Trial Name


	None

2. What kind of study is this?

3. Month/Year Study Included

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


	November 2020

4. Setting

List country or continent


	Europe

5. Study Design


	RCT

6. Crossover Design

Is this a crossover trial?


	Yes No

7. Pain Population


	Inflammatory arthritis

8. Pain Condition

Add specific condition here if specified


	Rheumatoid arthritis

9. Prior Cannabis Exposure


	Recreational: 3% Medical: 2%

10. Age Measure (Mean, Median)


	Mean

11. Age, Years

Input the mean or median age for the entire sample


	63

12. Female %

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


	79

13. Race, White %

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


	NR

14. Race, Black %

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


	NR

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 %


	NR

18. Pain Duration Measure (Mean, Median)


	NR

19. Pain Duration, Months


	NR

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.


	NR

22. N Randomized


	58

23. N Analyzed


	58

24. Treatment Duration, weeks

25. Assessment Time Category

26. Funding Source

27. Companion Paper


	None

Arms

Arm Name	Arm Description
Comparable THC/CBD ratio	THC 2.7 mg/CBD 2.5 mg per 100 mcl oromucosal spray (Sativex) titrated to max 6 doses with stable dosing for further 3 weeks
Placebo	Placebo spray

Arm Details

1. Dose Received, mean

Comparable THC/CBD ratio


	5.4 sprays/day

Placebo


	5.3 sprays/day

Outcomes

Type	Domain	Specific measurement (i.e., tool/definition/specific outcome)	Populations	Timepoints
Continuous	Pain Severity (Change)	NRS - morning pain at rest	All Participants	Baseline Followup
Continuous	Function / Disability (Change)	28-Joint Disease Activity Score	All Participants	Baseline Followup
Continuous	Sleep Quality/Interference	NRS	All Participants	Baseline Followup
Categorical	Serious Adverse Events		All Participants	Followup
Categorical	Withdrawal Due to Adverse Events		All Participants	Followup
Categorical	Dizziness		All Participants	Followup
Categorical	Nausea		All Participants	Followup
Categorical	Sedation		All Participants	Followup
Categorical	Psychosis	NRS	All Participants	Baseline
Categorical	A vs. B test	NRS morning pain	All Participants	Baseline

Outcome Details

1. Other Outcomes Reported (primary)

What other primary outcomes, besides: "Pain Response >= 30%", "Pain Severity (Change)", "Pain Interference (Change)", "Function/Disability (Change)".


	Morning pain on movement; morning stiffness; SF-MPQ total intensity of pain; SF-MPQ, pain at present; McGill Pain Questionnaire

2. Other AE Outcomes of Importance reported


	Lightheadedness

3. Notes

Results

Categorical

Serious Adverse Events

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Comparable THC/CBD ratio	Placebo
Followup
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Comparable THC/CBD ratio	Placebo

Withdrawal Due to Adverse Events

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Comparable THC/CBD ratio	Placebo
Followup
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Comparable THC/CBD ratio	Placebo

Dizziness

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Comparable THC/CBD ratio	Placebo
Followup
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Comparable THC/CBD ratio	Placebo

Nausea

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Comparable THC/CBD ratio	Placebo
Followup
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Comparable THC/CBD ratio	Placebo

Sedation

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Comparable THC/CBD ratio	Placebo
Followup
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Comparable THC/CBD ratio	Placebo

Psychosis (NRS)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Comparable THC/CBD ratio	Placebo
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Comparable THC/CBD ratio	Placebo

A vs. B test (NRS morning pain )

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Comparable THC/CBD ratio	Placebo
Baseline
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				p value
		Within Arm Comparisons			Net Comparisons
		Comparable THC/CBD ratio	Placebo

Continuous

Pain Severity (Change) (NRS - morning pain at rest)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Comparable THC/CBD ratio	Placebo		Comparable THC/CBD ratio (THC 2.7...) vs. Placebo (Placebo spray)
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
Followup
	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
		Comparable THC/CBD ratio	Placebo		Comparable THC/CBD ratio (THC 2.7...) vs. Placebo (Placebo spray)
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!	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) (28-Joint Disease Activity Score )

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Comparable THC/CBD ratio	Placebo		Comparable THC/CBD ratio (THC 2.7...) vs. Placebo (Placebo spray)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	95% CI low			SD (MD)
	95% CI high			p value (MD)
Followup
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	95% CI low			SD (MD)
	95% CI high			p value (MD)
		Within Arm Comparisons			Net Comparisons
		Comparable THC/CBD ratio	Placebo		Comparable THC/CBD ratio (THC 2.7...) vs. Placebo (Placebo spray)
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!	Saved!	95% CI high (NMD)	Saved!
	SD (MD)	Saved!	Saved!	SD (NMD)	Saved!
	p value (MD)	Saved!	Saved!	P value (NMD)	Saved!

Sleep Quality/Interference (NRS)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Comparable THC/CBD ratio	Placebo		Comparable THC/CBD ratio (THC 2.7...) vs. Placebo (Placebo spray)
Baseline
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	SD			SD (MD)
	SE			p value (MD)
	95% CI low
	95% CI high
Followup
	Total (N analyzed)			Mean Difference (MD)
	Mean			95% CI low (MD)
	SD			95% CI high (MD)
	SD			SD (MD)
	SE			p value (MD)
	95% CI low
	95% CI high
		Within Arm Comparisons			Net Comparisons
		Comparable THC/CBD ratio	Placebo		Comparable THC/CBD ratio (THC 2.7...) vs. Placebo (Placebo spray)
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!	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


	Unclear

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

4. Allocation Concealment Adequate?

Ottawa


	Unclear

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?


	Unclear

8. Care provider masked?


	Unclear

9. Outcome assessors masked?


	Unclear

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

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


	Yes

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

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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

Comparable THC/CBD ratio

Placebo

Outcomes

Outcome Details

1. Other Outcomes Reported (primary)

2. Other AE Outcomes of Importance reported

3. Notes

Results

Categorical

Serious Adverse Events

Withdrawal Due to Adverse Events

Dizziness

Nausea

Sedation

Psychosis (NRS)

A vs. B test (NRS morning pain )

Continuous

Pain Severity (Change) (NRS - morning pain at rest)

Function / Disability (Change) (28-Joint Disease Activity Score )

Sleep Quality/Interference (NRS)

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
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