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Table 1 Characteristics of included studies

From: Antihistamine effects and safety of fexofenadine: a systematic review and Meta-analysis of randomized controlled trials

First author, Years

Study design

Subject

Number

Experimental

Comparators

Study duration

Outcome measures

Barbanoj [25], 2003

RCT, crossover study

healthy

18

FEX 120 mg

n = 18

EBA 20 mg..

n = 18;

PL n = 18

5 days

Wheal, flare, AE, sedative effects

Boyle [36], 2005

RCT, crossover study

healthy

18

FEX 60 mg,

n = 18

LOR 10 mg,

n = 18;

PL n = 18

2 months

Wheal, flare, AE, sedative effects

Larbig [57], 2006

RCT, crossover study

healthy

30

FEX 120 mg,

n = 30

PL n = 30

24 h

Wheal, flare

Simons [55], 2002

RCT, parallel study

healthy

21

FEX 180 mg,

n = 7

CHL 8 mg,

n = 7;

LOR 10 mg,

n = 7

9 days

Wheal, flare

Simons [31], 2003

RCT, crossover study

healthy

15

FEX 30 mg,

n = 15

CET 10 mg,

n = 15

24 h

Wheal, flare, sedative effects

Takahashi [56], 2004

RCT, crossover study

healthy

7

FEX 120 mg,

n = 7

BEP 20 mg,

n = 7;

PL n = 7

24 h

Wheal, flare, VAS of drowsiness

Finn [11], 1999

RCT, parallel study

CIU

439

FEX 40 mg/ 120 mg/240 mg/480 mg,

n = 349

PL n = 90

4 weeks

AE, sedative effects

Berger [41], 2006

RCT, parallel study

AR

432

FEX 180 mg,

n = 288

PL n = 144

15 days

AE, sedative effects

Berkowitz [42], 2006

RCT, crossover study

AR

63

FEX 180 mg,

n = 63

PL n = 63

2 weeks

AE, sedative effects

Boyle [43], 2006

RCT, crossover study

healthy

18

FEX 120 mg,

n = 18

CHL 6 mg, n = 18;

PL n = 18

10 h

AE, sedative effects

Bronsky [10], 1998

RCT, parallel study

AR

548

FEX 80 mg/ 120 mg/ 240 mg,

n = 411

PL n = 137

14 days

AE, sedative effects

Casale [13], 1999

RCT, parallel study

AR

861

FEX 120 mg/ 180 mg,

n = 569

PL n = 292

3 weeks

AE, sedative effects

Van Cauwenberge [17], 2000

RCT, parallel study

AR

685

FEX 120 mg, n = 232

LOR 10 mg,

n = 228;

PL n = 225

14 days

AE, sedative effects

Day [33], 2004

RCT, parallel study

AR

575

FEX 180 mg, n = 239

CET 10 mg,

n = 240;

PL n = 96

24 h

AE, sedative effects

Ramesh [50], 2013

RCT, parallel study

AR

50

FEX 120 mg, n = 25

CHL 4 mg,

n = 25

14 days

AE, sedative effects

Grant [14], 1999

RCT, crossover study

healthy

14

FEX 60 mg,

n = 14

CET 10 mg,

n = 14;

EPI 20 mg,

n = 14;

TER 60 mg,

n = 14;

LOR 10 mg,

n = 14;

PL n = 14

24 h

AE, sedative effects

Grant [23], 2002

RCT, crossover study

healthy

18

FEX 180 mg, n = 18

EBA 10 mg,

n = 18;

LOR 10 mg,

n = 18;

MIZ 10 mg,

n = 18;

PL n = 18

24 h

AE, sedative effects

Hampel [26], 2003

RCT, parallel study

AR

495

FEX 180 mg, n = 248

CET 10 mg, n = 247

2 weeks

AE, sedative effects

Hampel [45], 2007

RCT, parallel study

AR

393

FEX 30 mg/ 60 mg,

n = 193

PL n = 200

8 days

AE, sedative effects

Hashiguchi [52], 2016

RCT, crossover study

healthy

126

FEX 120 mg, n = 126

BIL 10 mg/

20 mg,

n = 252;

PL n = 126

3 days

AE, sedative effects

Hindmarch [24], 2002

RCT, crossover study

healthy

15

FEX 360 mg, n = 15

PRO 30 mg n = 15,

PL n = 15

7 h

AE, sedative effects, CFF, CRT, LARS

Hindmarch [15], 1999

RCT, crossover study

healthy

24

FEX 120 mg, n = 24

PRO 30 mg,

n = 24;

LOR 10 mg,

n = 24;

PL n = 24

24 h

AE, sedative effects, CFF, CRT, LARS

Horak [20], 2001

RCT, crossover study

AR

40

FEX 120 mg, n = 40

CET 10 mg,

n = 40;

PL n = 40

2 days

AE, sedative effects

Horak [48], 2010

RCT, crossover study

allergic volunteers

75

FEX 120 mg, n = 70

CET 10 mg,

n = 68;

BIL 20 mg,

n = 74;

PL n = 70

2 days

AE, sedative effects

Horak [34], 2005

RCT, crossover study

allergic volunteers

94

FEX 120 mg, n = 94

PL n = 94

2 days

AE, sedative effects

Howarth [16], 1999

RCT, parallel study

AR

722

FEX 120 mg/ 180 mg, n = 421

CET 10 mg,

n = 209;

PL n = 209

2 weeks

AE, sedative effects

Inami [53], 2016

RCT, crossover study

healthy

20

FEX 60 mg,

n = 20

DIP 50 mg,

n = 20;

PL n = 20

6 h

AE, sedative effects, LARS

Kaiser [47], 2008

RCT, parallel study

AR

835

FEX 120 mg, n = 359

LOR 10 mg,

n = 357;

PL n = 119

7 days

AE, sedative effects

Kaiser [21], 2001

RCT, parallel study

AR

836

FEX 120 mg, n = 360

LOR 10 mg,

n = 357;

PL n = 119

7 days

AE, sedative effects

Kamei [49], 2012

RCT, crossover study

healthy

24

FEX 60 mg,

n = 24

PRO 25 mg,

n = 24;

OLO 5 mg,

n = 24;

PL n = 24

8 h

AE, sedative effects, CFF, CRT, LARS

Kamei [28], 2003

RCT, crossover study

healthy

11

FEX 120 mg, n = 11

d-CHL 4 mg,

n = 11;

OLO 10 mg,

n = 11;

PL n = 11

8 h

AE, sedative effects, CFF, CRT, CTT, LARS

Mansfield [29], 2003

RCT, crossover study

healthy

42

FEX 180 mg, n = 42

DIP 50 mg,

n = 42;

PL n = 42

2 h

AE, sedative effects

Milgrom [46], 2007

RCT, parallel study

AR

453

FEX 60 mg,

n = 222

PL n = 231

2 weeks

AE, sedative effects

Okubo [44], 2006

RCT, crossover study

healthy

9

FEX 60 mg, n = 9

EPI 20 mg,

n = 9;

PL n = 9

5 h

AE, sedative effects

Okubo [54], 2016

RCT, parallel study

AR

747

FEX 120 mg, n = 247

BIL 20 mg,

n = 249;

PL n = 251

2 weeks

AE, sedative effects

Prenner [18], 2000

RCT, crossover study

AR

929

FEX 120 mg, n = 457

LOR 10 mg,

n = 472

14 days

AE, sedative effects

Purohit [22], 2001

RCT, crossover study

healthy

26

FEX 120 mg/ 180 mg, n = 52

CET 10 mg,

n = 26;

PL n = 26

24 h

AE, sedative effects

Purohit [35], 2004

RCT, crossover study

healthy

42

FEX 180 mg, n = 42

CET 10 mg,

n = 42

4 h

AE, sedative effects

Ridout [30], 2003

RCT, crossover study

healthy

18

FEX 180 mg, n = 18

HYD 50 mg,

n = 18;

PL n = 18

5 h

AE, sedative effects, CFF, CRT, LARS

Schapowal [39], 2005

RCT, parallel study

AR

220

FEX 180 mg, n = 113

PL n = 107

14 days

AE, sedative effects

Schoepke [51], 2013

RCT, crossover study

healthy

18

FEX 120 mg, n = 18

PL n = 18

24 h

AE, sedative effects

Simons [9], 1997

RCT, crossover study

healthy

20

FEX 120 mg, n = 40

LOR 10 mg,

n = 20

PL n = 20

24 h

AE, sedative effects

Tsuda [40], 2005

RCT, crossover study

healthy

10

FEX 120 mg, n = 10

CET 5 mg/10 mg,

n = 20;

LOR 10 mg,

n = 10;

PL n = 10

24 h

AE, sedative effects

Wahn [32], 2003

RCT, parallel study

AR

935

FEX 30 mg,

n = 464

PL n = 471

14 days

AE, sedative effects

Weiler [19], 2000

RCT, crossover study

healthy

40

FEX 60 mg,

n = 40

DIP 50 mg,

n = 40;

PL n = 40

5 h

AE, sedative effects, VAS of drowsiness

Ballmer-Weber [12], 1999

RCT, crossover study

healthy

20

FEX 180 mg, n = 20

CET 10 mg,

n = 40;

ACR 8 mg,

n = 20

1 h

sedative effects

Day [37], 2005

RCT, parallel study

AR

599

FEX 180 mg, n = 250

CET 10 mg,

n = 249;

PL n = 100

7 h

sedative effects

Handa [27], 2004

RCT, parallel study

CIU

97

FEX 180 mg, n = 45

CET 10 mg,

n = 52

28 days

sedative effects

Hyo [38], 2005

RCT, parallel study

healthy

113

FEX 120 mg, n = 28

CET 10 mg,

n = 30;

LOR 10 mg,

n = 28;

PL n = 27

2 days

sedative effects

Ridout [58], 2002

RCT, crossover study

healthy

24

FEX 120 mg, n = 24

PRO 25 mg,

n = 24;

PL n = 24

8 h

CFF, CRT, CTT, LARS

Naicker [59], 2013

RCT, crossover study

healthy

11

FEX 180 mg, n = 11

PRO 25 mg, n = 11; LOR 10 mg,

n = 11;

PL n = 11

3 h

CRT, CTT, VAS of drowsiness