Grade table 14, [Question: Should theophylline versus placebo or doing nothing be used in COPD patients?]. - Prevention and Control of Noncommunicable Diseases

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Grade table 14

Question: Should theophylline versus placebo or doing nothing be used in COPD patients?

Settings: LMICs

Bibliography: Ram FSF et al. (11)

Quality assessment							Summary of findings					Importance
Quality assessment							No of patients		Effects		Quality
No of studies	Design	Limitations	Inconsistency	Indirectness	Imprecision	Other considerations	Theophylline	Placebo or doing nothing	Relative (95% CI)	Absolute	Quality
Mortality (follow-up 0.13–8 months; assessed with: number of patients died)
20	randomised trials¹					none	–	–	–	–	–	IMPORTANT
20	randomised trials¹					none	-	0%	–	–	–	IMPORTANT
QoL (assessed with: not reported in the review)
0	no evidence available					none	–	–	–	–	–	IMPORTANT
0	no evidence available					none	–	0%	–	–	–	IMPORTANT
Breathlessness (follow-up 1–2 months; measured with: visual analogue scale (0=extremely breathless, 100=not at all breathless; range of scores: 0–100; better indicated by higher values)
2	randomised trials²	serious²^,³	no serious inconsistency	serious⁴	no serious imprecision	reporting bias⁵	32	32²	–	MD 3.61 higher (4.62 lower to 11.84 higher)	⊕○○○ VERY LOW	IMPORTANT
Wheezing (follow-up 110–114 days; measured with: simple graded scale (absent=0, mild=1, moderate=2, severe=3); range of scores: 0–4; better indicated by lower values)
2	randomised trials²	serious²^,³^,⁶	no serious inconsistency	serious⁴	no serious imprecision	reporting bias⁵	21	21²	–	MD 0.19 lower (0.58 lower to 0.19 higher)	⊕○○○ VERY LOW	–
Cough
0	no evidence available					none	–	–	–	–	–	IMPORTANT⁷
0	no evidence available					none	–	0%	–	–	–	IMPORTANT⁷
Sputum production
0	no evidence available					none	–	–	–	–	–	IMPORTANT
0	no evidence available					none	–	0%	–	–	–	IMPORTANT
Distance walked (follow-up 2–8 weeks²; measured with: metres⁸; better indicated by lower values)
4	randomised trials²	serious²^,³^,⁸	serious⁹	serious⁴	no serious imprecision	reporting bias⁵	79	80	–	MD 0.30 higher (0.01 lower to 0.62 higher)	⊕○○○ VERY LOW	IMPORTANT
Drop-out (follow-up 8–30 days; assessed with: number of patients)
3	randomised trials²	serious²^,³^,⁹	serious⁹	serious⁴	no serious imprecision	reporting bias⁵	4/74 (5.4%)²	5/74 (6.8%)²	RR 0.8 (0.23 to 2.76)	14 fewer per 1000 (from 52 fewer to 119 more)	⊕○○○ VERY LOW	IMPORTANT
3	randomised trials²	serious²^,³^,⁹	serious⁹	serious⁴	no serious imprecision	reporting bias⁵		7%	RR 0.8 (0.23 to 2.76)	14 fewer per 1000 (from 54 fewer to 123 more)	⊕○○○ VERY LOW	IMPORTANT
Serious adverse events (assessed with: number of patients)
0	no evidence available					none	–	–	–	–	–	–
0	no evidence available					none	–	0%	–	–	–	–
Incidence of exacerbation (follow-up 2–4 weeks; assessed with: number of patients with one or more acute exacerbations)
2	randomised trials²	serious²^,³^,⁹	serious⁹^,¹⁰	serious⁴	serious¹¹	none⁵	3/45 (6.7%)	9/45 (20%)	RR 0.33 (0.1 to 1.14)	134 fewer per 1000 (from 180 fewer to 28 more)	⊕○○○ VERY LOW	IMPORTANT
							–	–		40 fewer per 1000 (from 54 fewer to 8 more)
							–	–		355 fewer per 1000 (from 477 fewer to 74 more)
PEFR (follow-up 1–8 weeks; measured with: litres per minute; better indicated by higher values)
5	randomised trials²	serious²^,³	serious⁹^,¹⁰	serious⁴	no serious imprecision	reporting bias⁵	98	98²	–	MD 14.82 higher (9.39 lower to 39.04 higher)	⊕○○○ VERY LOW	IMPORTANT
FEV1 (follow-up 8–90 days; measured with: litres; better indicated by higher values)
13	randomised trials²	serious²^,³^,⁹	serious⁹^,¹⁰	serious⁴	no serious imprecision	reporting bias⁵	244	244²	–	MD 0.10 higher (0.04 to 0.16 higher)	⊕○○○ VERY LOW	IMPORTANT
FVC (follow-up 8–90 days; measured with: litres; better indicated by higher values)
11	randomised trials²	serious²^,³^,⁹	serious⁹^,¹⁰	serious⁴	no serious imprecision	reporting bias⁵	196	196²	–	MD 0.21 higher (0.1 to 0.32 higher)	⊕○○○ VERY LOW	IMPORTANT

1: Mortality as an outcome is not reported in any study.
2: Cross-over design.
3: Trials are of different duration and different washout period, allocation concealment is unclear in trials.
4: Studies are not done exclusively in patient population of LMICs.
5: There is a possibility of having other studies with this outcome.
6: Scale of measuring outcome is not validated.
7: Not reported in the review.
8: Measured using 6-minute walking distance in two studies and 12-minute walking distance in two studies.
9: Different definition of COPD used for patient selection, other medications allowed in few studies.
10: Dosing of theophylline is done differently in different studies.
11: Effect size and CI around effect size varies considerably in two studies.

From: Annex 4, Grade tables

Cover of Prevention and Control of Noncommunicable Diseases

Prevention and Control of Noncommunicable Diseases: Guidelines for Primary Health Care in Low Resource Settings.

Geneva: World Health Organization; 2012.

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