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Table 1— Main characteristics of randomised controlled trials(RCTs) included in the meta-analysis

First author [Ref.]
Publication yr
Study design
Population^#
Regimen 1^¶
Regimen 2
Additional antibiotics allowed
Systemic corticosteroid before ABECB
Enrolled patients n
ITT patients n
Study quality score⁺

Macrolides versus quinolones

Martinez 24 2005 MC, DB, RCT Aged $≥$ 18 yrs with CB and type I or II ABECB Azithromycin 500 mg q24 h day 1 and 250 mg q24 h days 2–5 Levofloxacin 750 mg q24 h for 3 days None 15/151 (10) versus 16/143 (11) 394 202 versus 192 4

Lode 25 2004 MC, DB, RCT Aged >35 yrs with CB and type I or II ABECB Clarithromycin 250 mg q12 h for 10 days Levofloxacin 500 mg q24 h for 7 days None NA 511 254 versus 250 4

Amsden 26 2003 MC, DB, RCT Aged 35–75 yrs with CB and type I or II ABECB Azithromycin 500 mg q24 h day 1 and 250 mg q24 h days 2–5 Levofloxacin 500 mg q24 h for 7 days None NA 235 118 versus 117 3

Weiss 27 2002 MC, RCT Aged $≥$ 18 yrs with CB and type I or II ABECB Clarithromycin 500 mg q12 h for 10 days Levofloxacin 500 mg q24 h for 10 days None NA 191 97 versus 94 1

Wilson 28 2002 MC, DB, RCT Aged >40 yrs with CB and type I ABECB Clarithromycin 500 mg q12 h for 7 days Gemifloxacin 320 mg q24 h for 5 days None 76/358 (21) versus 74/351 (21) 712 358 versus 351 3

Chodosh 29 2000 MC, DB, RCT Aged $≥$ 18 yrs with CB or COPD with type I,II or III ABECB Clarithromycin 500 mg q12 h for 10 days Moxifloxacin 400 mg q24 h for 5 or 10 days None 74/312 (24) versus 134/614 (22) 936 312 versus 614 5

DeAbate 30 2000 MC, DB, RCT Aged $≥$ 18 yrs with CB or COPD with type I, II or III ABECB Azithromycin 500 mg q24 h day 1 then 250 mg q24 h for 4 days Moxifloxacin 400 mg q24 h for 5 days None NA 567 284 versus 283 5

Wilson 31 1999 MC, DB, RCT Aged $≥$ 18 yrs with CB and type I or II ABECB Clarithromycin 500 mg q12 h for 7 days Moxifloxacin 400 mg q24 h for 5 days None 128/327 (39) versus 160/322 (50)^## 750 371 versus 374 4

A/C versus quinolones

Martinez 24 2005 MC, RCT Aged $≥$ 18 yrs with CB and type I or II ABECB A/C 875/125 mg q12 h for 10 days Levofloxacin 750 mg q24 h for 5 days None 17/126 (14) versus 20/120 (17) 369 182 versus 187 2

Starakis 32 2004 RCT Aged $≥$ 18 yrs with CB and type II ABECB A/C 500/125 mg q8 h for 7 days Moxifloxacin 400 mg q24 h for 5 days None 32/74 (43) versus 38/79 (48) 162 79 versus 83 2

Schaberg 33 2001 MC, RCT Aged $≥$ 18 ys with CB and type I or II ABECB A/C 500/125 mg q12 h for 7 days Moxifloxacin 400 mg q24 h for 5 days None NA 577 283 versus 292 1

File 34 2000 MC, DB, RCT Aged $≥$ 40 yrs with CB and type I ABECB A/C 500/125 mg q8 h for 7 days Gemifloxacin 320 mg q24 h for 5 days None 0/296 (0) versus 0/304 (0)^¶¶ 600 296 versus 304 4

A/C versus macrolides

Anzueto 35 2001 MC, IB, RCT Aged $≥$ 40 yrs with COPD (FEV₁ $≤$ 70% pred) and type I ABECB A/C 875/125 mg q12 h for 10 days Clarithromycin 1000 mg q24 h for 7 days None Treatment groups with comparable steroid use⁺⁺ 287 143 versus 140 4

Martinot 36 2001 MC, IB, RCT Aged $≥$ 35 yrs with CB and type I or II ABECB A/C 500/125 mg q8 h for 7 days Clarithromycin 500 mg q24 h for 7 days None 0/123 (0) versus 0/127 (0)^¶¶ 250 123 versus 127 4

Hoepelman 37 1997 MC, DB, RCT Aged $≥$ 18 yrs with CB and type I ABECB A/C 500/125 mg q8 h for 10 days Azithromycin 500 mg q24 h for 3 days None NA 123 61 versus 62 4

Van Royen 38 1997 MC, RCT Aged $≥$ 18 yrs with CB and type I or II ABECB A/C 500/125 mg q8 h for 7 or 10 days Dirithromycin 500 mg q24 h for 5 days None NA 334 165 versus169 3

Biebuyck 39 1996 MC, RCT Aged $≥$ 18 yrs with CB and type I ABECB A/C 500/125 mg q8 h for 5 or 10 days Azithromycin 250 mg q12 h for 3 days None NA 139 45 versus 94 2

Gris 40 1996 MC, DB, RCT Aged $≥$ 18 yrs with CB and type I or II ABECB A/C 500/125 mg q8 h for 10 days Azithromycin 500 mg q24 h for 3 days None NA 61 28 versus 33 4

Beghi 41 1995 MC, RCT Aged $≥$ 18 yrs with CB and type I or II ABECB A/C 875/125 mg q12 h for 8 days Azithromycin 500 mg q24 h for 3 days None Allowed, $≤$ 25 mg·day^–1++ 142 73 versus 69 2

Dautzenberg 42 1992 MC, RCT Aged $≥$ 18 yrs with CB and type II ABECB A/C 500/125 mg q8 h for 14 days Roxithromycin 150 mg q12 h for 14 days None NA 65 33 versus 32 1

Data are presented as n (patients affected)/total number of patients in the study (%), unless otherwise stated. ABECB: acute bacterial exacerbation of chronic bronchitis (CB); ITT: intention-to-treat; A/C: amoxicillin/clavulanate; MC: multicentre; DB: double-blind; NA: not applicable; COPD: chronic obstructive pulmonary disease; IB: investigator blinded; FEV₁: forced expiratory volume in one second; % pred; % predicted. ^#: ABECB classified according to Anthonisen et al. 2; ^¶: all antibiotics were administered per os; ⁺: according to a modified Jadad score; : use of systemic corticosteroids at a dose of >10 mg prednisone or the equivalent was an exclusion criterion; : patients with COPD other than CB were excluded from this RCT; ^##: refers to clinically evaluable patients who received inhaled, oral or i.v. corticosteroids; ^¶¶: use of systemic corticosteroids at any dose was an exclusion criterion; ⁺⁺: according to the authors; : both hospitalised patients and outpatients were included. In the RCT by Martinez et al. 24 the quinolone levofloxacin was compared with both a macrolide (azithromycin) and A/C.

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