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Table 1 Baseline characteristics of study participants

From: Drug*placebo interaction effect may bias clinical trials interpretation: hybrid balanced placebo and randomized placebo-controlled design

Characteristics Hydroxyzine Group Placebo Group Blinded Hydroxyzine/Placebo Group
Age, mean (SD), yr. 31.5 (6.4) 30.8 (6.1) 31.8 (7.2)
Sex, no. (%)
 Female 50 (32) 56 (35) 58 (36)
 Male 106 (68) 102 (65) 101 (64)
Completed education, no. (%)
 High school 36 (23) 38 (24) 30 (19)
 College 85 (55) 72 (46) 88 (55)
 University 35 (22) 48 (30) 41 (26)
Occupational status, no. (%)
 Professional, technical, managerial 32 (22) 45 (29) 37 (24)
 Clerical, sales 1 (1) 0 (0) 2 (1)
 Service 107 (72) 99 (63) 101 (66)
 Agricultural, fishery, related 0 (0) 1 (1) 2 (1)
 House wife 0 (0) 1 (1) 2 (1)
 Student 5 (3) 6 (4) 7 (5)
 Unemployed 4 (3) 4 (3) 3 (2)
  Told hydroxyzine Told placebo Told placebo Told hydroxyzine Received hydroxyzine Received placebo
Drowsiness level, mean (SD), mma 4.5 (6.0) 6.3 (10.1) 4.7 (6.6) 5.1 (8.5) 4.9 (7.3) 4.6 (8.0)
Mouth-dryness level, mean (SD), mm a 5.9 (9.5) 8.5 (15.5) 6.2 (10.2) 6.1 (11.5) 5.5 (8.8) 5.7 (11.6)
Nausea level, mean (SD), mm a 2.8 (4.4) 3.0 (5.8) 2.9 (4.9) 3.5 (7.4) 2.3 (5.2) 3.0 (6.4)
Itchiness level, mean (SD), mm a 2.8 (3.8) 2.6 (4.3) 2.8 (4.5) 3.1 (5.3) 2.7 (4.5) 2.7 (4.4)
  1. Hydroxyzine group (group-1, n = 156): received 25 mg hydroxyzine twice and told its hydroxyzine on one time and placebo on the other, in a randomized crossover design. Placebo group (group-2, n = 158): received placebo twice and told its placebo on one time and 25 mg hydroxyzine on the other, in a randomized crossover design. Blinded hydroxyzine/placebo group (group-3, n = 159): received 25 mg hydroxyzine and placebo in a randomized single-blinded crossover design. Numbers may not sum up to group totals because of missing data and percentages may not add to 100% because of rounding
  2. a Measured on 100 mm visual analog scale