Summary of findings van de geïncludeerde studies

Quality assessment

Summary of Findings

Participants

(studies)

Follow up

Risk of bias

Inconsis-tency

Indirectness

Imprecision

Publication bias

Overall quality of evidence

Study event rates (%)

Relative effect

(95% CI)

Anticipated absolute effects

Comments

With Control

With DPCP

Risk with Control

Risk difference with DPCP (95% CI)

Change in QoL (CRITICAL OUTCOME: not measured)

-

-

-

-

-

-

See comments

-

-

-

No study addressed this outcome

Participant assessed satisfaction at end of treatment (CRITICAL OUTCOME; measured with: Scores 0-10 (0 = failure and 10 excellent; range of scores: 0-10; Better indicated by higher values)

28

(1 study3)

19 months

serious1

no serious inconsistency

no serious indirectness

serious2

undetected

⊕⊝⊝⊝

VERY LOW1,2

due to risk of bias, imprecision

-

28

-

The mean participant assessed satisfaction

 at end of treatment in the intervention

groups was

7.7

Data on the 28 participants, that had a satisfactory result according to physicians, of which only 20 patients gave their response and these gave a score of 7.7

Proportion of participants in whom adverse events was a reason to stop (CRITICAL OUTCOME)

475

(10 studies5)

serious4

no serious inconsistency

no serious indirectness

no serious imprecision

undetected

⊕⊝⊝⊝

VERY LOW4

due to risk of bias

-

15/475 (3.2%)

-

-

15/475 participants dropped out due to adverse events. Might be an underestimation as reasons for drop-outs were not always provided and per protocol analysis was used.

Total number of reported adverse events (IMPORTANT OUTCOME)

419

(9 studies7)

serious6

no serious inconsis-tency

no serious indirectness

Serious6

undetected

⊕⊝⊝⊝

VERY LOW4,6

due to risk of bias, imprecision

-

213/419

(50.8%)

-

-

213/419 adverse events were reported (other than expected contact eczema). Van der Steen 1991 reported far more adverse events than the other studies. Most common adverse events were: severe eczema, headache, blistering, sleep disturbances, minor flu like symptoms, edema eyelids, urticaria. Vitiligo in two patients.

Duration of remission (IMPORTANT OUTCOME; Better indicated by higher values)

135

(4 studies8)

6-30 months

serious6

no serious inconsis-tency

no serious indirectness

Serious6

undetected

⊕⊝⊝⊝

VERY LOW4,6

due to risk of bias, imprecision

-

135

-

The mean duration of remission was

13.2 months

Of the 135 who had satisfactory regrowth 55 (41%) stayed in remission for 13.2 months (mean).

The effect shown might be an overestimation as in four studies the drop-out rate was high, combined with a per-protocol analysis. Additionally the follow-up was inadequately reported in most studies and we need to take into account that AA may improve and resolve spontaneously

Hair regrowth (> 50 %) (IMPORTANT OUTCOME; assessed with: MacDonald Hull and Norris (scale 1-4, with higher indicating better) or 3 point Likert scale)

303

(6 studies9)

serious6

no serious inconsis-tency

no serious indirectness

Serious6

undetected

⊕⊝⊝⊝

VERY LOW4,6

due to risk of bias, imprecision

-

147/303

(48.5%)

-

-

147/303 (48.5%) had partial hair regrowth, percentages ranged from 30-50%

Complete remission (LESS IMPORTANT OUTCOME; assessed with: MacDonald Hull and Norris (scale 1-4, with higher indicating better) or just in percentages)

338

(6 studies10)

serious6

no serious inconsis-tency

no serious indirectness

Serious6

-

111/338

(32.8%)

-

-

111/338 (32.8%) had a 100% hair regrowth

Regrowth of vellus hair (LESS IMPORTANT OUTCOME; assessed with: MacDonald Hull and Norris (scale 1-4, with higher indicating better) )

137

(4 studies11)

serious6

no serious inconsis-tency

no serious indirectness

Serious6

undetected

⊕⊝⊝⊝

VERY LOW4,6

due to risk of bias, imprecision

-

12/137

(8.8%)

-

-

12/137 had vellus hair regrowth (8.8%)

GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.