Ruzicka 1998.

Methods	Study design: randomised controlled trial Study grouping: parallel group
Participants	Baseline characteristics Overall Number of participants randomised: 159/160 Losses to follow‐up: 28 (numbers do not add up, as there is a discrepancy between number lost to follow up and reported number of participants completing the study (n =138)) Age: mean age in groups ranged from 36.0 to 39.2 years (age range 18 to 65 years) Duration of condition: group means ranged between 7.0 and 14.1 years (total range 1 month to 51 years) Duration of current episodes ranged between 2 days and 72 months Severity of condition: pruritus on VAS moderate (4 to 7) (10‐cm VAS) at baseline; EASI: subtotal score A ≥ 18 and ≤ 40, and B ≥ 2 and ≤ 10 Male/Female: 51/98 Inclusion criteria: (1) diagnostic AD according to Hanifin and Rajka, age 18 to 65 years; (2) severity of condition: pruritus score 4 to 7 (VAS), moderate severity of condition according to EASI score (Eczema Area and Severity Index) subtotal score A ≥ 18 and ≤ 40, and B ≥ 2 and ≤ 10; (3) duration of condition: not reported; (4) site evaluated (e.g. face/back): not reported Exclusion criteria: cardiovascular disease; neurological and other systemic diseases; administration of depot corticosteroids within previous 3 months, systemic corticosteroids within previous 28 days, or topical corticosteroids within previous 7 days Group differences: no baseline comparisons were provided; however, study authors report that baseline pruritus was not equally distributed among groups
Interventions	Intervention characteristics Loratadine 5 mg Presentation: oral Dose and frequency: 5 mg 1×/d Total dose: 5 mg/d Duration given for: 2 weeks Supplier and trade name if relevant: not reported Loratadine 10 mg Presentation: oral Dose and frequency: 10 mg 1×/d Total dose: 10 mg/d Duration given for: 2 weeks Supplier and trade name if relevant: not reported Loratadine 20 mg Presentation: oral Dose and frequency: 20 mg 1×/d Total dose: 20 mg/d Duration given for: 2 weeks Supplier and trade name if relevant: not reported Placebo Presentation: oral Dose and frequency: not reported Total dose: n/a Duration given for: 2 weeks Supplier and trade name if relevant: not reported
Outcomes	Primary outcome 1: mean change in patient‐assessed symptoms: VAS pruritus (0 to 10 cm) (difference in pruritus sum between day 0 and day 13) Outcome type: continuous outcome Direction: lower is better Notes: VAS on a scale from 0 to 10 cm; from Table 2, it appears as if the absolute difference between VAS pruritus day 0 and day 13 was calculated (i.e. not a difference in pruritus sums but difference in VAS 0 to 10, day 0 and day 13 Patient‐assessed symptoms: VAS pruritus: sum of days 7 to 13 Outcome type: continuous outcome Direction: lower is better Notes: respective VAS pruritus values were summed over days 7 to 13. Study authors did not provide possible minimum and maximum values for this outcome, but it seems as if they could range from 0 to 70. Significant differences between groups (Jonckheer‐Terpstra Test) in Table 4, and all post‐hoc comparisons with placebo significant, but baseline not considered (i.e. should have been done with differences between t0 and t2) Primary outcome 2: adverse events Outcome type: adverse event Data value: endpoint Notes: 16.2% of 160 randomised participants reported adverse events. However, study authors failed to describe or analyse, respectively, the number of AE across groups. Secondary outcome 1: physician‐assessed clinical signs: no. for whom treatment success was judged as good or very good Outcome type: dichotomous outcome Notes: again, comparisons not considering baseline differences, as only days 7 and 13; significance in Table 5 (not sure whether based on therapy success or global efficacy evaluation, or whether study authors meant they are the same)
Identification	Sponsorship source: not reported Country: Germany Setting: secondary Comments: 8 centres Author's name: T. Ruzicka Institution: Klinik und Poliklinik für Dermatologie und Allergologie, Frauenlobstraße 9–11, 80337 München Email: Marion.Michl@med.uni‐muenchen.de Address: Klinik und Poliklinik für Dermatologie und Allergologie, Frauenlobstraße 9–11, 80337 MünchenKlinikum München Thalkirchner Straße, Thalkirchner Straße 48, 80337 München
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Information about the sequence generation process insufficient to permit judgement of low risk or high risk
Allocation concealment (selection bias)	Unclear risk	Information insufficient to permit judgement of low risk or high risk
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Information insufficient to permit judgement of low risk or high risk Comment: whether medication was identical in appearance to placebo remains unclear
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Information insufficient to permit judgement of low risk or high risk
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: of 160 participants randomised, only 138 were assessed at the end of the study (i.e. attrition rate was 13.7%). Study authors did not provide reasons for these dropouts and did not describe the missing data ‐ but the risk of attrition bias was considered low based on the attrition rate
Selective reporting (reporting bias)	Unclear risk	Information insufficient to permit judgement of low risk or high risk Comment: no comparison with protocol possible, as a study protocol is not available
Other bias	Unclear risk	Further risk of bias is possible, but information is insufficient to judge whether additional bias exists (e.g. no conflict of interest statement provided, no provision of information regarding origin of drugs, Was study initiated by pharmacological company? Did study authors receive funding from any source?)