Quality assessmentNo of patientsEffectQuality
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsVitamin D and corticosteroid combinationVitamin D or vitamin D analogueRelative (95% CI)Absolute
Investigator’s assessment (clear/nearly clear) – combination OD vs calcipotriol OD/BD (follow-up 8 weeks)
3
Kragballe2009
Jemec 2008
van de Kerkhof 2009		randomised trialsvery seriousaseriousbno serious indirectnessno serious imprecisionnone915/1315 (69.6%)257/663 (38.8%)RR 1.83 (1.52 to 2.20)322 more per 1000 (from 202 more to 465 more)⊕○○○
VERY LOW
Patient’s assessment (clear/nearly clear) - combination OD gel vs calcipotriol OD gel (follow-up 8 weeks)
2
Jemec 2008
van de Kerkhof 2009		randomised trialsvery seriouscno serious inconsistencyno serious indirectnessno serious imprecisionnone766/1108 (69.1%)232/558 (41.6%)RR 1.66 (1.5 to 1.85)274 more per 1000 (from 208 more to 353 more)⊕⊕○○
LOW
Patient’s assessment (clear/nearly clear) - combination OD gel vs calcipotriol BD solution (follow-up 8 weeks)
1
Kragballe2009		randomised trialsvery seriousdno serious inconsistencyno serious indirectnessno serious imprecisionnone170/207 (82.1%)36/105 (34.3%)RR 2.4 (1.82 to 3.15)480 more per 1000 (from 281 more to 737 more)⊕⊕○○
LOW
Skin atrophy - combination OD vs calcipotriol BD (follow-up 8 weeks)
1
Kragballe2009		randomised trialsvery seriousdno serious inconsistencyno serious indirectnessno serious imprecisionnone0/207 (0%)0/105 (0%)not poolednot pooled⊕⊕○○
LOW
Skin atrophy - combination OD vs calcipotriol OD (follow-up 52 weeks)
1
Luger 2008		randomised trialsseriouseno serious inconsistencyno serious indirectnessno serious imprecisionnone0/429 (0%)0/440 (0%)not poolednot pooled⊕⊕⊕○
MODERATE
Relapse rate - combination OD vs calcipotriol BD (follow-up 8 weeks)
1
Kragballe2009		randomised trialsvery seriousfno serious inconsistencyseriousgserioushnone73/135 (54.1%)10/29 (34.5%)RR 1.57 (0.93 to 2.65)197 more per 1000 (from 24 fewer to 569 more)⊕○○○
VERY LOW
Median time to relapse - combination OD vs calcipotriol BD
1
Kragballe2009		randomised trialsvery seriousfno serious inconsistencyno serious indirectnessseriousinone13529Combination: 35 days

Vitamin D analogue: 58 days		⊕○○○
VERY LOW
Withdrawals due to adverse events - combination OD vs calcipotriol OD/BD (follow-up 8 weeks)
3
Kragballe2009
Jemec 2008
van de Kerkhof 2009		randomised trialsvery seriousano serious inconsistencyno serious indirectnessno serious imprecisionnone14/1204 (1.2%)37/582 (6.4%)RR 0.18 (0.1 to 0.33)52 fewer per 1000 (from 43 fewer to 57 fewer)⊕⊕○○
LOW
Withdrawals due to lack of efficacy - combination OD vs calcipotriol OD (follow-up 8 weeks)
2
Jemec 2008
van de Kerkhof 2009		randomised trialsvery seriousjvery seriouskno serious indirectnessvery seriousjnone9/1009 (0.89%)27/490 (5.5%)RR 0.16 (0.02 to 1.35)46 fewer per 1000 (from 54 fewer to 19 more)⊕○○○
VERY LOW
Withdrawals due to adverse events - combination OD vs calcipotriol OD (follow-up 52 weeks)
1
Luger 2008		randomised trialsseriouseno serious inconsistencyno serious indirectnessno serious imprecisionnone9/346 (2.6%)44/309 (14.2%)RR 0.18 (0.09 to 0.37)117 fewer per 1000 (from 90 fewer to 130 fewer)⊕⊕⊕○
MODERATE
Withdrawals due to lack of efficacy - combination OD vs calcipotriol OD (follow-up 52 weeks)
1
Luger 2008		randomised trialsseriouseno serious inconsistencyno serious indirectnessno serious imprecisionnone14/351 (4%)51/316 (16.1%)RR 0.25 (0.14 to 0.44)121 fewer per 1000 (from 90 fewer to 139 fewer)⊕⊕⊕○
MODERATE
a

3/3 unclear allocation concealment; 1/3 (48.2% weighted) unclear blinding; 1/3 single blind (investigator); 2/3 higher dropout with vitamin D or vitamin D analogue

b

Heterogeneity was present (I2 = 64%) that could not be explained by pre-defined subgroups (however, all studies showed the same direction of effect and the p-value for chi squared was >0.05)

c

2/2 unclear allocation concealment; 1/2 single blind (investigator); 1/2 higher dropout rate in vitamin D or vitamin D analogue group (22.1% vs 11.3% in combination group)

d

Unclear allocation concealment; single blind (investigator); higher dropout in vitamin D or vitamin D analogue group (21.9% vs 8.2% in combination group)

e

Unclear allocation concealment

f

Unclear allocation concealment; single blind (investigator); higher dropout in vitamin D or vitamin D analogue group (21.9% vs 8.2% in combination group); also, unclear baseline comparability as only includes those in each group who achieved remission; therefore, there are also fewer participants in the vitamin D or vitamin D analogue group

g

Surrogate outcome for duration of remission

h

Confidence interval ranges from clinically important effect to no effect

i

No range given

j

2/2 unclear allocation concealment; 1/2 unclear blinding; 1/2 higher dropout rate in vitamin D or vitamin D analogue group (22.1% vs 11.3% in combination group)

k

Heterogeneity was present (I2 = 80%) that could not be explained by pre-defined subgroups (however, all studies showed the same direction of effect)

l

Confidence interval crosses the boundary for clinical significance in favour of both treatments, as well as line of no effect

From: 8, Topical therapy

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Psoriasis: Assessment and Management of Psoriasis.
NICE Clinical Guidelines, No. 153.
National Clinical Guideline Centre (UK).
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