Quality assessmentNo of patientsEffectQuality
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsVitamin D or vitamin D analoguesCorticosteroid (potent)Relative (95% CI)Absolute
Investigator’s assessment (clear/nearly clear) – Calcipotriol OD/BD or calcitriol BD vs betamethasone dipropionate OD/BD or betamethasone valerate BD (follow-up 4–8 weeks)
6
Fleming 2010A
Kaufmann 2002
Douglas 2002
Papp 2003
Molin 1997
Camarasa 2003		randomised trialsseriousavery seriousbno serious indirectnessseriouscnone547/1565 (35%)730/1571 (46.5%)RR 0.76 (0.62 to 0.94)122 fewer per 1000 (from 28 fewer to 177 fewer)⊕○○○
VERY LOW
Patient’s assessment (clear/nearly clear) - Calcipotriol OD vs betamethasone dipropionate OD (follow-up 4 weeks)
1
Kaufmann 2002		randomised trialsseriousdno serious inconsistencyno serious indirectnessno serious imprecisionnone137/480 (28.5%)216/476 (45.4%)RR 0.63 (0.53 to 0.75)168 fewer per 1000 (from 113 fewer to 213 fewer)⊕⊕⊕○
MODERATE
Patient’s assessment (clear/nearly clear) - Calcipotriol BD vs betamethasone dipropionate BD (follow-up 4 weeks)
1
Douglas 2002		randomised trialsseriousdno serious inconsistencyno serious indirectnessseriouscnone140/365 (38.4%)183/363 (50.4%)RR 0.76 (0.64 to 0.9)121 fewer per 1000 (from 50 fewer to 181 fewer)⊕⊕○○
LOW
Patient’s assessment (clear/nearly clear) - Calcipotriol BD vs betamethasone valerate BD (follow-up 6 weeks)
2
Cunliffe 1992
Kragballe 1991		randomised trialsseriousdno serious inconsistencyno serious indirectnessseriouscnone403/543 (61.2%)338/542 (50.5%)RR 1.19 (1.10 to 1.29)118 more per 1000 (from 62 more to 181 more)⊕⊕○○
LOW
% change in PASI - Calcipotriol (BD) vs betamethasone valerate (BD) (follow-up 6–8 weeks; Better indicated by lower values)
2
Kragballe 1991
Molin 1997		randomised trialsseriouseno serious inconsistencyno serious indirectnessno serious imprecisionnone547549-MD 5.94 higher (2.29 to 9.60 higher)⊕⊕⊕○
MODERATE
Relapse rate (requiring re-treatment [not maintaining clear/nearly clear] within 8-weeks post Tx) - Calcitriol BD vs betamethasone dipropionate BD
1
Camarasa 2003		randomised trialsvery seriousfno serious inconsistencyseriousgserioushnone30/58 (51.7%)55/73 (75.3%)RR 0.69 (0.52 to 0.91)234 fewer per 1000 (from 68 fewer to 362 fewer)⊕○○○
VERY LOW
Mean time to relapse (requiring re-treatment [not maintaining clear/nearly clear] within 8-weeks post Tx) - Calcitriol BD vs betamethasone dipropionate BD
1
Camarasa 2003		randomised trialsvery seriousfno serious inconsistencyno serious indirectnessseriousinone5873-Vitamin D: 25.3 days

Corticosteroid: 23.4 days		⊕○○○
VERY LOW
Withdrawals due to adverse events – Calcipotriol OD/BD or calcitriol BD vs betamethasone dipropionate OD/BD, betamethasone valerate BD or fluocinonide BD (follow-up 4–8 weeks)
7
Douglas 2002
Kaufmann 2002
Cunliffe 1992
Kragballe 1991
Molin 1997
Bruce 1994
Camarasa 2003		randomised trialsseriousjno serious inconsistencykno serious indirectnessseriouscnone30/1709 (1.8%)14/1718 (0.81%)RR 2.10 (1.13 to 3.90)9 more per 1000 (from 1 more to 24 more)⊕⊕○○
LOW
Withdrawals due to lack of efficacy – Calcipotriol or calcitriol BD vs betamethasone dipropionate or valerate BD (follow-up 6 weeks)
3
Cunliffe 1992
Kragballe 1991
Camarasa 2003		randomised trialsseriouslno serious inconsistencymno serious indirectnessvery seriousnnone11/661 (1.7%)11/660 (1.7%)RR 1 (0.44 to 2.28)0 fewer per 1000 (from 9 fewer to 21 more)⊕○○○
VERY LOW
Skin atrophy – Calcipotriol BD vs betamethasone dipropionate or valerate BD (follow-up 4–8 weeks)
2
Papp 2003
Molin 1997		randomised trialsseriousono serious inconsistencyno serious indirectnessvery seriousnnone0/515 (0%)5/523 (0.96%)RR 0.17 (0.02 to 1.4)8 fewer per 1000 (from 9 fewer to 4 more)⊕○○○
VERY LOW
a

6/6 unclear allocation concealment; 2/6 (26.8% weighted) unclear blinding

b

Heterogeneity was present (I2 = 81%) that could not be explained by pre-defined subgroups (however, 5/6 studies showed the same direction of effect)

c

Serious imprecision according to GDG discussion (confidence interval ranges from clinically important benefit in favour of corticosteroid to no clinically important difference)

d

Unclear allocation concealment

e

2/2 unclear allocation concealment; 1/2 (26.2% weighted) unclear blinding and unclear baseline demographics

f

Unclear allocation concealment and blinding; 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 group

g

Surrogate outcome for duration of remission and definition of relapse = requiring re-treatment (not maintaining clear/nearly clear)

h

Serious imprecision according to GDG discussion (confidence interval ranges from clinically important benefit in favour of vitamin D or vitamin D analogue to no clinically important difference)

i

No SD given

j

7/7 unclear allocation concealment; 4/7 unclear blinding (55.5% weighted); 1/7 (22% weighted) unclear baseline demographics; 1/7 (11.2% weighted) dropout rate not stratified by group

k

No statistically significant heterogeneity but one study (Bruce) favours a different treatment

l

3/3 unclear allocation concealment; 2/3 (81.8% weighted) unclear blinding

m

No statistically significant heterogeneity but one study (Kragballe) favours a different treatment

n

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

o

2/2 unclear allocation concealment; 1/2 (58.4% weighted) unclear blinding and unclear baseline demographics

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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