Table 97Evidence profile comparing acitretin plus PUVA vs placebo plus PUVA

Quality assessmentNo of patientsEffectQuality
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsAcitretin plus PUVAPlacebo plus PUVARelative (95% CI)Absolute
Clear/nearly clear on IAGI (follow-up 8–12 weeks)
3
Saurat 1998
Sommerburg 1993
Tanew 1991
randomised trialsvery seriousano serious inconsistencyno serious indirectnessseriousbnone67/81 (82.7%)55/88 (62.5%)RR 1.33 (1.11 to 1.59)206 more per 1000 (from 69 more to 369 more)⊕○○○
VERY LOW
Time to remission (follow-up 12 weeks; Better indicated by lower values)
1
Saurat 1998
randomised trialsseriouscno serious inconsistencyno serious indirectnessno serious imprecisionnone2022-MD 17.60 lower (26.02 to 9.18 lower)⊕⊕⊕○
MODERATE
Mean number of UV treatments (all participants) (follow-up 8 weeks; Better indicated by lower values)
1
Sommerburg 1993
randomised trialsvery seriousdno serious inconsistencyno serious indirectnessno serious imprecisionnone4043-MD 0.2 higher (2.58 lower to 2.98 higher)⊕⊕○○
LOW
Mean number of UV treatments - Number of UVA treatments (among those who cleared) (follow-up 11–12 weeks; Better indicated by lower values)
2
Saurat 1998
Tanew 1991
randomised trialsseriouseno serious inconsistencyno serious indirectnessno serious imprecisionnone4145-MD 6.17 lower (9.2 to 3.14 lower)⊕⊕⊕○
MODERATE
Withdrawal due to toxicity (follow-up 8–12 weeks)
3
Saurat 1998
Sommerburg 1993
Tanew 1991
randomised trialsvery seriousano serious inconsistencyno serious indirectnessvery seriousfnone7/81 (8.6%)4/78 (5.1%)RR 1.58 (0.51 to 4.87)30 more per 1000 (from 25 fewer to 198 more)⊕○○○
VERY LOW
Severe adverse events (follow-up 12 weeks)
2
Saurat 1998
Sommerburg 1993
randomised trialsseriousgno serious inconsistencyno serious indirectnessno serious imprecisionnone15/60 (25%)4/65 (6.2%)RR 4.11 (1.55 to 10.92)191 more per 1000 (from 34 more to 610 more)⊕⊕⊕○
MODERATE
a

3/3 allocation concealment and method of randomisation; 2/3 (total 70% weighting) had a high drop out rate 20% TANEW and 23.9% SOMMERBURG.

b

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

c

Unclear allocation concealment. No information on the method of randomization, previous treatment history or the use of concurrent treatments during the trial.

d

Unclear allocation concealment and randomisation method and high drop out rate (23.9%).

e

2/2 studies had unclear allocation concealment and method of randomisation; 1/2 had a 20% drop out rate.

f

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

g

2/2 unclear allocation concealment and method of randomization Drop out rate was 23.9% in one study (25% weighted)

From: 9, Phototherapy

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