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Table 1 Characteristics of studies included in the systematic review

From: The efficacy and safety of high-dose nonsedating antihistamines in chronic spontaneous urticaria: a systematic review and meta-analysis of randomized clinical trials

Study

Sample Size (female,%)

Age

Course of the disease (week)

Outcome measurement

Intervention

TD

Definition of response

Response ratea, no. (%)

Adverse events, no. (%)

Somnolence (%)

Main outcome

Gimenez-Arnau et al. (2007) [23]

329 (68.39%)

12–65

≥ 6

5-point rating score b (MPS, MNW, MTSS);

5-point rating score c (Global efficacy);

DLQI

Rupatadine 10 mg

Rupatadine 20 mg

Placebo

6 weeks

pruritus symptoms reduction higher than 50%

72 (65.5%)

79 (73.15%)

51 (45.9%)

13 (11.6%)

18 (16.5%)

13 (11.5%)

3 (2.7%)

9 (8.3%)

6 (5.3%)

Rupatadine 10 mg has an overall better AE profile than rupatadine 20 mg. Rupatadine 10 mg is the preferred dose of choice for patients with CIU

Finn et al. (1999) [24]

439 (74.26%)

12–65

≥ 6

5-point rating score b (MPS, MNW, MTSS),

Sleep and daily activitiesd

Fexofenadine HCl 20 mg bid

Fexofenadine HCl 60 mg bid

Fexofenadine HCl 120 mg bid

Fexofenadine HCl 240 mg bid

Placebo

4 weeks

NA

NA

67 (71%)

51 (57%)

60 (65%)

50 (59%)

61 (66%)

NA

Fexofenadine 60 mg bid had a larger treatment effect than fexofenadine 20 mg bid. All doses were well tolerated, with safety profiles similar to that of placebo

Gibson et al. (1984) [25]

20 (60%)

19–74

≥ 4

5-point rating scoreb (pruritus, wheals,

Discomfort VASe

Acrivastine 4 mg tid

Acrivastine 8 mg tid

Placebo tid

5 days

NA

NA

4 (20%)

8 (40%)

6 (30%)

2 (10%)

7 (35%)

3 (15%)

Acrivastine 8 mg was significantly better than Acrivastine 4 mg in improving itching and whealing

Nelson et al. (2000) [29]

418 (70.10%)

12–65

≥ 6

5-point rating score b (MPS, MNW)

sleep and daily activitiesd

fexofenadine HCl 20 mg bid

fexofenadine HCl 60 mg bid

fexofenadine HCl 120 mg bid

fexofenadine HCl 240 mg bid

Placebo

4 weeks

NA

NA

NA

NA

Fexofenadine HCl significantly reduced pruritus severity, number of wheals, and twice-daily doses of 60 mg or greater were most effective

Paul et al. (1998) [22]

208 (57.69%)

≥ 18

≥ 6

4-point rating scoref(MPS);

5-point rating scoreb (MNW);

TSS;

Sleep and daily activitiesd;

Medication effectivenessi

Fexofenadine HCI 60 mg

Fexofenadine HCI 120 mg

Fexofenadine HCI 180 mg

Fexofenadine HCI 240 mg

Placebo

6 weeks

rated the effectiveness of the medication as good, very good or excellent

25 (63%)

18 (50%)

30 (64%)

21 (55%)

19 (41%)

7 (18%)

9 (26%)

13 (28%)

10 (26%)

15 (33%)

0 (0%)

0 (0%)

0 (0%)

0 (0%)

0 (0%)

There was no significant difference between the 180 mg/day and the 240 mg/day doses. The authors recommend fexofenadine HCI 180 mg/day as the optimal dose for the treatment of CSU

Dubertret et al. (2007) [33]

277 (72.92%)

12–65

≥ 6

5-point rating scoreb (MPS, MNS, MTSS);

sleep and daily activitiesd;

Global efficacyc

Rupatadine 5 mg

Rupatadine 10 mg

Rupatadine 20 mg

Placebo

4 weeks

0: worse

1: unchanged

2:slight improvement

3:good improvement

37 (54.24%)

42 (57.04%)

49 (72.80%)

17 (25.04%)

NA

3 (4.29%)

4 (5.41%)

14 (21.43%)

2 (2.90%)

Rupatadine 10 mg and 20 mg provides rapid and long-lasting relief from pruritus, in CSU

Weller et al. 2013 [26]

29 (55.17%)

21–65

NA

UAS7;

Discomfort VASe;

Area size of wheals;

Desloratadine 5 mg (on demand)

Desloratadine 20 mg (on demand)

21 days

NA

NA

0 (0%)

0 (0%)

0 (0%)

0 (0%)

The beneficial effects of desloratadine on existing wheals (on-demand treatment) seem to be low

Sánchez et al. (2016) [30]

180 (55.17%)

12–50

≥ 6

UAS, DLQI

First 4 weeks:

cetirizine 10 mg

Fexofenadine 180 mg

bilastine 20 mg

Desloratadine 5 mg

Ebastine 20 mg

Placebo

Second 4 weeks:

2 ~ fourfold dose based on the original drug

8 weeks

Controlled: (DLQI ≤ 5)

Moderate:

(DLQI 6–9)

Uncontrolled: (DLQI ≥ 10)

onefold: 88 (58.7%)

2 ~ fourfold: 115 (76.7%)

87 (58%)

onefold: 43 (28.6%)

 ~ 2–fourfold: 34 (22.6%)

The safety and efficacy of the 5 antihistamines were similar. After updosing, rates of disease control increased from 58.7% to 76.7%

Hide et al. (2016) [27]

294 (73.81%)

18–74

≥ 4

4-point rating scoref (wheals);

5-point rating score b (pruritus);

TSS; DLQI;

Overall improvement scoreg

Bilastine 10 mg

Bilastine 20 mg

Placebo

2 weeks

1.markedly improved;

2.moderately improved;

3.mildly improved;

4.no change;

5.exacerbated

6.not evaluable

84 (84.8%)

74 (74.7%)

30 (31.6%)

24 (24.0%)

14 (13.9%)

20 (19.4%)

2 (2.0%)

0 (0.0%)

3 (2.9%)

Bilastine 20 and 10 mg once a day was effective and tolerable in Japanese patients with CSU.

Hide et al. (2019) [28]

276 (65.94%)

12–64

≥ 4

5-point rating score b (TPS, NWS, RDS); PWS, DLQI;

Overall improvement score h

Rupatadine 10 mg

Rupatadine 20 mg

Placebo

2 weeks

1.extremely improved

2.very improved

3.moderately improved

4.no change

5.worsened

68 (74.8%)

71 (78.1%)

29 (30.8%)

19 (20.9%)

16 (17.4%)

8 (8.5%)

10 (11.0%)

9 (9.8%)

0 (0%)

The optimal rupatadine dose was 10 mg once daily. The dose can be safely increased to 20 mg once daily,

Staevska et al.2010 [31]

80 (62.67%)

19–67

 ≥ 6

CU-Q2oL;

Discomfort VASe;

ASST

Levocetirizine (5 mg/1st wk, 10 mg/2nd wk, 20 mg/3rd wk)

Desloratadine (5 mg/1st wk, 10 mg/2nd wk, 20 mg/3rd wk)

levocetirizine 20 mg switch desloratadine 20 mg (4th wk)

4 weeks

Patients who had no urticarial lesions and no pruritus for the last 3 days of treatment were considered to be symptom-free

Levocetirizine/ Desloratadine:

1st wk 9/4

2nd wk 8/7

3rd wk 5/1

4th wk 7/0

6 (15%)

11 (27.5%)

No detailed data

Levocetirizine and desloratadine, to up to 4 times the conventionally prescribed doses increases the control of urticaria symptoms in approximately 75% of patients without compromising somnolence or safety. Levocetirizine was more effective drug in the course of treatment with 5-mg to 20-mg daily doses

Kalivas et al. 1990 [32]

215 (NA)

≥ 12

≥ 6

Four-point rating scoref (wheals, pruritus and number of episodes);

Global efficacyc

Cetirizine 5 mg ~ 20 mg;

Hydroxyzine 25 ~ 75 mg;

Placebo

4 weeks

NA

NA

No detailed data

15 (21.7%)

26 (36. 1%)

10 (13.5%)

cetirizine has a greater safety margin over the older parent drug hydroxyzine

NCT00536380 2013 [34]

314(66.56%)

≥ 18

≥ 6 weeks

UAS

desloratadine 5 mg

desloratadine 10 mg

desloratadine 20 mg

4 weeks

NA

NA

7(6.6%)

5(4.8%)

2(1.9%)

NA

There was no significant difference in UAS scores improvement between the 5 mg, 10 mg and 20 mg desloratadine groups

  1. Abbreviations: TD Treatment duration, DLQI Dermatology life quality index, VAS Visual analogue scale, MPS Mean pruritus score, MNW Mean number of wheals, MTSS Calculated as the sum of MPS and MNW, NA data were not available in the study, TSS The sum of the wheal and pruritus scores, TPS Total pruritus score, NWS Number of wheals score, RDS Rash duration score, PWS The sum of pruritus and number of wheals score, UAS Urticaria activity score, ASST Autologous serum skin test, CU-Q2oL Chronic urticaria quality of life questionnaire
  2. aResponse, pruritus symptoms reduction higher than 50%, or overall improvement rated at least moderately/very improved
  3. b Five-point rating score (0–4): 0 = no symptom to 4 = the worst symptom, the higher the score, the worse the symptoms
  4. c Global efficacy (0–4): 0 = worse to 4 = excellent improvement, the higher the score, the better the symptoms
  5. d sleep and daily activities: (0–3): 0 = none, 1 = mild, 2 = moderate, and 3 = severe
  6. eDiscomfort VAS: patients evaluated their drowsiness, itching and severity of symptoms by marking along a 0–100 mm long horizontal line (0 = min to 106 = max)
  7. fFour-point rating score (0–3): 0 = no symptom to 3 = the worst symptom, the higher the score, the worse the symptoms;
  8. g Five-point rating score (1–5): 1 = markedly improved to 5 = exacerbated, the higher the score, the worse the symptoms;
  9. h Overall improvement score (1–6): 1 = extremely improved, 2 = very improved, 3 = moderately improved, 4 = no change, 5 = worsened, and 6 = not evaluable
  10. i medication effectiveness (0–4, 0 = excellent to 4 = none)
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BMC Pharmacology and Toxicology

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