Quality assessmentNo of patientsEffectQuality
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsVitamin D and vitamin D analoguesplaceboRelative (95% CI)Absolute
Investigator’s assessment (clear/nearly clear) - Calcipotriol OD (follow-up 4–8 weeks)
3
Barker1999
Fleming2010A
Kaufmann2002		randomised trialsseriousano serious inconsistencyno serious indirectnessno serious imprecisionNone129/587 (22%)17/223 (7.6%)RR 2.78 (1.75 to 4.41)136 more per 1000 (from 57 more to 260 more)⊕⊕⊕○
MODERATE
Investigator’s assessment (clear/nearly clear) - Calcipotriol BD (follow-up 4–8 weeks)
4
Dubertret 1992
Guenther 2002
Highton 1995
Papp 2003		randomised trialsseriousbno serious inconsistencyno serious indirectnessno serious imprecisionNone351/721 (48.7%)61/498 (12.2%)RR 4.48 (3.5 to 5.73)426 more per 1000 (from 306 more to 579 more)⊕⊕⊕○
MODERATE
Investigator’s assessment (clear/nearly clear) - Calcitriol OD (follow-up 10 weeks)
1
Perez 1996		randomised trialsseriouscno serious inconsistencyno serious indirectnessdno serious imprecisionNone37/84 (44%)0/84 (0%)RR 75 (4.68 to 1201.67)-⊕⊕⊕○
MODERATE
Investigator’s assessment (clear/nearly clear) - Calcitriol BD (follow-up 6 weeks)
2
Langner 1992
Langner 1993		randomised trialsseriouseno serious inconsistencyseriousfno serious imprecisionNone45/61 (73.8%)22/61 (36.1%)RR 2.05 (1.42 to 2.95)379 more per 1000 (from 151 more to 703 more)⊕⊕○○
LOW
Investigator’s assessment (clear/nearly clear) - Tacalcitol (OD) (follow-up 8 weeks)
1
Langley 2011A		randomised trialsvery seriousgno serious inconsistencyno serious indirectnessno serious imprecisionNone33/184 (17.9%)5/91 (5.5%)RR 3.26 (1.32 to 8.08)124 more per 1000 (from 18 more to 389 more)⊕⊕○○
LOW
Patient’s assessment (clear/nearly clear) - Calcipotriol OD or BD (follow-up 4–8 weeks)
3
Kaufmann 2002
Guenther 2002
Harrington 1996		randomised trialsserioushno serious inconsistencyno serious indirectnessno serious imprecisionNone402/988 (40.7%)54/434 (12.4%)RR 3.35 (2.58 to 4.34)292 more per 1000 (from 197 more to 416 more)⊕⊕⊕○
MODERATE
Patient’s assessment (clear/nearly clear) - Tacalcitol (OD) (follow-up 8 weeks)
1
Langley 2011A		randomised trialsvery seriousino serious inconsistencyno serious indirectnessvery seriousjNone35/163 (21.5%)14/64 (21.9%)RR 0.98 (0.57 to 1.7)4 fewer per 1000 (from 94 fewer to 153 more)⊕○○○
VERY LOW
% change in PASI - Calcipotriol BD (follow-up 4 weeks) (Better indicated by lower values)
1
Dubertret 1992		randomised trialsseriouscno serious inconsistencyno serious indirectnessno serious imprecisionNone6060-MD 23.2 lower (35.57 to 10.83 lower)⊕⊕⊕○
MODERATE
Withdrawals due to adverse events – Calcipotriol, calcitriol or tacalcitol OD or BD (follow-up 4–8 weeks)
11
Barker 1999
Kaufmann 2002
Guenther 2002
Harrington 1996
Highton 1995
Langner 1992
Langner 1993
Langley 2011A
Perez 1996
Scarpa 1997
van de Kerkhof 1996		randomised trialskseriouslno serious inconsistencyno serious indirectnessmseriousnData40/1736 (2.3%)31/1055 (2.9%)RR 0.62 (0.4 to 0.97)11 fewer per 1000 (from 1 fewer to 18 fewer)⊕⊕○○
LOW
Withdrawals due to lack of efficacy – Calcipotriol or calcitriol OD or BD (follow-up 4–8 weeks)
7
Barker 1999
Guenther 2002
Harrington 1996
Langner 1992
Langner 1993
Perez 1996
Scarpa 1997		randomised trialsoseriouspno serious inconsistencyno serious indirectnessno serious imprecisionNone3/893 (0.34%)22/644 (3.4%)RR 0.15 (0.05 to 0.42)29 fewer per 1000 (from 20 fewer to 32 fewer)⊕⊕⊕○
MODERATE
Skin atrophy – Calcipotriol BD (follow-up 4 weeks)
2
Guenther 2002
Papp 2003		randomised trialsseriousqno serious inconsistencyno serious indirectnessvery seriousjNone1/535 (0.19%)1/316 (0.32%)RR 0.92 (0.06 to 14.56)0 fewer per 1000 (from 3 fewer to 43 more)⊕○○○
VERY LOW
Relapse rate at 8 weeks post-treatment - Tacalcitol OD (follow-up 8 weeks)
1
Langley 2011A		randomised trialsvery seriousrno serious inconsistencyserioussseriousnNone7/31 (22.6%)3/5 (60%)RR 0.38 (0.14 to 0.99)372 fewer per 1000 (from 6 fewer to 516 fewer)⊕○○○
VERY LOW
Median time to relapse - Tacalcitol OD (follow-up 8 weeks post treatment)
1
Langley 2011A		randomised trialsvery seriousrno serious inconsistencyno serious indirectnessserioustNone315-61 days in both groups⊕○○○
VERY LOW
a

3/3 unclear allocation concealment; 1/3 (93.4% weighted) differential dropout (8.1%: calcipotriol; 15.9%: vehicle); 1/3 (4% weighted) baseline clinical characteristics not reported

b

4/4 unclear allocation concealment; 2/4 unclear blinding; 1/4 (35% weighted) unclear if dropout rate was evenly distributed between study arms

c

Unclear allocation concealment and blinding

d

Study used Vaseline as the placebo (not vehicle)

e

2/2 unclear allocation concealment and blinding; 1/2 studies (40.9% weighted) treatment stopped if at least one side cleared; therefore, lesion on contra lateral side may have clear if treated for the full study period

f

1/2 studies used high concentration of calcitriol (15 μg/g, licensed at 3 μg/g)

g

Unclear allocation concealment and blinding; high differential dropout rate: 11.4% tacalcitol; 29.7% placebo

h

3/3 unclear allocation concealment; 2/3 studies (61.4% weighted) higher but acceptable dropout in vehicle group

i

Unclear allocation concealment and single blinded (investigator); high dropout rate in placebo group (tacalcitol: 11.4%; placebo: 29.7%

j

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

k

For 3/9 (Barker, Scarpa and van de Kerkhof) studies data were taken from a published Cochrane Review

l

10/11 unclear allocation concealment; 3/11 unclear blinding (20.6% weighted); 3/11 higher dropout rate in placebo group; 1/11 (3.4% weighted) unclear baseline clinical characteristics

m

In one study (weighted 1.1%) 24.6% of patients test lesions were localised on the face or face and other parts of the body; one study used a very high concentration of calcitriol (weighted 1.1%)

n

Serious imprecision according to GDG discussion (confidence interval ranges from clinically important benefit to no clinically important benefit)

o

For 1/4 studies (Barker) data were taken from a published Cochrane Review

p

7/7 unclear allocation concealment; 1/7 (6.1% weighted) unclear baseline clinical characteristics; 1/7 (9.7% weighted) higher dropout in placebo group

q

2/2 unclear allocation concealment

r

Unclear allocation concealment and single blinded (investigator); high dropout rate in placebo group (tacalcitol: 11.4%; placebo: 29.7%); also, unclear baseline comparability as only includes those in each group who achieved remission; therefore, there are fewer participants in the placebo group

s

Surrogate outcome for duration of remission

t

No range provided

From: 8, Topical therapy

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Psoriasis: Assessment and Management of Psoriasis.
NICE Clinical Guidelines, No. 153.
National Clinical Guideline Centre (UK).
Copyright © National Clinical Guideline Centre - October 2012.

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