Quality assessmentNo of patientsEffectQuality
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsCombined productVitamin D or vitamin D analogueRelative (95% CI)Absolute
Investigator’s assessment (clear/nearly clear) – Combination OD vs. vitamin D or vitamin D analogue (calcipotriol or tacalcitol) OD (follow-up 4–8 weeks)
4
Fleming 2010A
Kaufmann 2002
Langley 2011 A
Ortonne 2004		randomised trialsseriousano serious inconsistencyno serious indirectnessno serious imprecisionNone536/1084 (49.4%)192/995 (19.3%)RR 2.65 (2.3 to 3.05)318 more per 1000 (from 251 more to 396 more)⊕⊕⊕○
MODERATE
Investigator’s assessment (clear/nearly clear) - Combination OD vs. vitamin D or vitamin D analogue (calcipotriol) BD (follow-up 4–8 weeks)
2
Guenther 2002
Kragballe 2004		randomised trialsseriousbno serious inconsistencyno serious indirectnessno serious imprecisionNone273/472 (57.8%)248/554 (44.8%)RR 1.31 (1.16 to 1.48)139 more per 1000 (from 72 more to 215 more)⊕⊕⊕○
MODERATE
Patient’s assessment (clear/nearly clear) - Combination OD vs. vitamin D or vitamin D analogue (calcipotriol or tacalcitol) OD or BD (follow-up 4–8 weeks)
4
Kaufmann 2002
Guenther 2002
Langley 2011 A
Ortonne 2004		randomised trialsseriouscvery seriousdno serious indirectnessno serious imprecisionNone628/1060 (59.2%)333/1122 (29.7%)RR 2.05 (1.35 to 3.11)312 more per 1000 (from 104 more to 626 more)⊕○○○
VERY LOW
% change in PASI – Combination OD vs. vitamin D or vitamin D analogue (calcipotriol or tacalcitol) OD or BD (follow-up 4–8 weeks; Better indicated by lower values)
5
Fleming 2010A
Kaufmann 2002
Kragballe 2004
Guenther 2002
Langley 2011 A		randomised trialsseriouseno serious inconsistencyno serious indirectnessno serious imprecisionNone10371297-MD 11.62 lower (14.87 to 8.37 lower)⊕⊕⊕○
MODERATE
Relapse rate at 8 weeks post-treatment - Combination OD vs. tacalcitol OD (follow-up 8 weeks + 8 weeks post-treatment)
1
Langley 2011 A		randomised trialsvery seriousfno serious inconsistencyseriousgserioushNone28/67 (41.8%)7/31 (22.6%)RR 1.85 (0.91 to 3.77)192 more per 1000 (from 20 fewer to 625 more)⊕○○○
VERY LOW
Median time to relapse – Combination OD vs. tacalcitol OD (follow-up 8 weeks + 8 weeks post-treatment)
1
Langley 2011 A		randomised trialsvery seriousfno serious inconsistencyno serious indirectnessseriousiNone6731-Combination: 63 days Vitamin D: 61 days⊕○○○
VERY LOW
Withdrawals due to adverse events – Combination OD vs. vitamin D or vitamin D analogue (calcipotriol or tacalcitol) OD or BD (follow-up 4–8 weeks)
3
Kaufmann 2002
Guenther 2002
Langley 2011 A		randomised trialsseriousjno serious inconsistencyno serious indirectnessno serious imprecisionNone6/797 (0.75%)23/839 (2.7%)RR 0.28 (0.12 to 0.67)20 fewer per 1000 (from 9 fewer to 24 fewer)⊕⊕⊕○
MODERATE
Withdrawals due to lack of efficacy - Combination OD vs. calcipotriol BD (follow-up 4 weeks)
1
Guenther 2002		randomised trialsseriouskno serious inconsistencyno serious indirectnessvery seriouslNone0/151 (0%)2/227 (0.9%)RR 0.3 (0.01 to 6.21)6 fewer per 1000 (from 9 fewer to 46 more)⊕○○○
VERY LOW
Skin atrophy - Combination OD vs. calcipotriol BD (follow-up 4–12 weeks)
2
Kragballe 2004
Guenther 2002		randomised trialsseriousmno serious inconsistencyseriousnvery seriouslNone2/473 (0.42%)1/554 (0.18%)RR 2.09 (0.27 to 16.53)2 more per 1000 (from 1 fewer to 28 more)⊕○○○
VERY LOW
a

4/4 unclear allocation concealment; 1/4 single blind; 4/4 differential dropout (higher with vitamin D or vitamin D analogue, but acceptable level in all but 1 study)

b

2/2 unclear allocation concealment; 1/2 (59.1% weighted) double blind in combination arm but single blind (investigator) in vitamin D or vitamin D analogue group

c

4/4 unclear allocation concealment; 1/4 single blind (investigator); 3/4 differential dropout rate (but only >20% in one study)

d

Heterogeneity was present (I2 = 93%) that could not be explained by pre-defined subgroups (however, all studies showed the same direction of effect)

e

5/5 unclear allocation concealment; 1/5 (13.8% weighted) single blind (investigator); 1/5 (35.2% weighted) double blind in combination arm but single blind (investigator) in vitamin D or vitamin D analogue group; 3/5 differential dropout (but none >20%)

f

Unclear allocation concealment and differential dropout rate (higher in vitamin D or vitamin D analogue group but not >20%); also, unclear baseline comparability as only includes those in each group who achieved remission; therefore, there are fewer participants in the vitamin D or vitamin D analogue alone group

g

Surrogate outcome for duration of remission

h

Confidence interval ranges from clinically significant effect to no effect

i

No range given

j

3/3 unclear allocation concealment; 1/3 (17.7% weighted) single blind (investigator); 2/3 differential dropout rate (but not >20%)

k

Unclear allocation concealment

l

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

m

2/2 unclear allocation concealment; 1/2 (38.3% weighted) double blind in combination arm but single blind (investigator) in vitamin D or vitamin D analogue group and differential dropout (but not >20%)

n

Data are for full study period (so combination group received vitamin D or vitamin D analogue only for the final 4 of 12 weeks)

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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