| Internal validity | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Author Year | Randomization adequate? | Allocation concealment adequate? | Groups similar at baseline? | Eligibility criteria specified? | Outcome assessors masked? | Care provider masked? | Patient masked? | Reporting of attrition, crossovers, adherence, and contamination | Loss to follow-up: differential/high | Intention-to-treat (ITT) analysis | Post-randomization exclusions | Funding | Quality rating |
| Head-to-head trials | |||||||||||||
| Garg 2007 | NA | NA | Yes (because crossover, so same patients) | Yes | Open label | Open label | Open label | Attrition reported, but reasons NR; cross-overs, adherence, and contamination NR | Yes 20/50 (40%) dropped | NR | NR | NR | Fair |
| Guerra 1994 | Yes, method not reported | NR | Yes | Yes | NR | NR | Yes | NR | Yes | Yes | NR | NR | Fair |
| Handa 2004 | Method not reported | Method not reported | NR | Yes | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | Attrition reported, but reasons NR; cross-overs, adherence, and contamination NR | No; 19/116 left the study (16%) | No, analyzed completers only 97/116 (84%) | NR | NR | Fair |
| Thomas 1998 | Method not reported | NR | Yes, though no data presented in a table | Yes | NR; study reported as ‘double blind’ | NR; study reported as ‘double blind’ | NR; study reported as ‘double blind’ | Attrition reported, but reasons NR; cross-overs, adherence, and contamination NR | No; 8/210 (4%) dropped | NR | NR | NR | Fair |
| Placebo-controlled trials | |||||||||||||
| Kapp 2006 | Method not reported | NR | Yes | Yes | NR; study reported as “double blind” | NR; study reported as “double blind” | NR; study reported as “double blind” | Attrition reported, but reasons NR; cross-overs, adherence, and contamination NR | 74.7% completed | Yes | NR | UCB (Farchim, Bulle, Switzerland) | Fair |
| Kaplan 2005 | Method not reported | Method not reported | Yes (for 255/259 in ITT population) | Yes | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | Yes (‘patients received double- blind study medication packages” | None were explicitly reported. It appears that 4 patients dropped out of study. | No (attrition 29/259) | No- excluded 4 patients from ITT analysis; imputed through LOCF for other dropouts. | NR | Study sponsored by Sanofi-Aventis Pharma, Bridgewater, NJ. Four of the authors were affiliated with Sanofi-Aventis Pharma | Fair |
| Nettis 2006 (Levocetrizine) | Method not reported | Method not reported | No | Yes (but not adequately) | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | Attrition 6/106; cross-overs, adherence, and contamination NR | No Loss twice as high in placebo but small N | No - excluded 6/106 (6%) | No | NR | Fair |
| Nettis 2006 (Desloratadine) | Method not reported | Method not reported | No | Yes | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | Yes | Attrition 2/36; cross-overs, adherence, and contamination NR | No | No - excluded 2/36 (6%) | No | NR | Fair |
| Ortonne 2007 | Yes | Method not reported | Yes | Yes | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | Attrition 57/142; cross-overs, adherence, and contamination NR | Yes 16/65 (25%) of drug discontinued: 36/77 (47%) of placebo discontinued | No - excluded 5/142 (3.5%) | Yes | Schering-Plough, Levallois Perret, France | Fair |
| Potter 2009 | Yes | Method not reported | Yes | Yes | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | Yes | NR | NR | No Incomplete report of data. Not clear if all randomized were in ITT | NR | UCB Farchim Chemin de Croix blanche, Bulle, Switzerland. | Fair |
| Grob 2008 | Yes | Yes | Yes | Yes | NR; study reported as “double blind” | NR; study reported as “double blind” | Yes | Attrition reported, but reasons NR; cross-overs, adherence, and contamination NR | No; 5/77 (6.5%) dropped from placebo group | Yes | Yes; 3 excluded because they lacked baseline data | Schering-Plough Research Group | Fair |
| Active-controlled trials | |||||||||||||
| Breneman 1996 | Method not reported | NR | Yes | Yes | Yes | NR | Yes | NR | No, 5% | Yes | NR, NR | NR | Fair |
| Di Lorenzo 2004 | Method not reported | Method not reported | Yes | Yes | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | Yes | Attrition reported, but reasons NR; cross-overs, adherence, and contamination NR | Yes; 62/160 discontinued study, all from groups B and D | No; attrition 39%, unclear if cross-overs | NR | Grants from the Ministero Italiano Universitya e Ricerca; no support from the pharmaceutical industry | Poor; very high attrition for unclear reasons; patients ‘selected’ into study |
| Juhlin 1988 | Not described as randomized; no details on how groups selected, although is cross- over study | NA | NR | Yes | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | Attrition 19/30; crossovers, adherence, and contamination NR | High-17/30 | No, high attrition | NR | NR; second author from UCB Braine-l’Alleud, Belgium | Poor; unclear if randomized, no information on how groups assigned; no wash-out between cross-over; attrition 19/30 |
| Kontou-Fili 1990 | Method not reported | Method not reported | NR | Yes | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | Attrition 1/11; others NR | No, 1/11 | No, attrition=1, crossovers NR | NR | NR | Poor: baseline comparability NR; attrition 1/11 |
| Monroe 2003 | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Attrition and adherence yes; others NR | No (3/226) | Yes | NR | Schering-Plough Research Group | Good |
| Sharpe 1993 | Method not reported | Method not reported | NR | Yes | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | NR; study reported as ‘double blind” | Attrition 2/21; others NR | No, 2/21 | No, attrition=2 | NR | NR | Poor: baseline comparability NR; attrition 2/21 |
| Zuberbier 1995 Cholinergic urticaria | Method not reported | Method not reported | NR | Yes | NR; study reported as ‘double blind” during treatment period (A or B) and single-blind when C delivered | NR; study reported as ‘double blind” during treatment period (A or B) and single-blind when C delivered | NR; study reported as ‘double blind” during treatment period (A or B) and single-blind when C delivered | Yes (1/25); others NR | No, 1/25 | No, attrition=1 ; crossovers NR | Yes, 1/25 as did not fit inclusion criteria | NR; one author from UCB Braine-l’Alleud, Belgium | Poor; treatment with placebo was single- blind, no baseline characteristics reported, randomization and allocation concealment methods NR |
| Zuberbier 1996 Cholinergic urticaria | Unclear “randomization list” | Method not reported | NR | Yes | NR; study reported as ‘double blind” | NR; study reported as “double blind” | NR; study reported as “double blind” | None were explicitly reported; 2 patients were excluded for lack of compliance with B (placebo) | Yes (2/11) | No; attrition=2 | Yes: 2 patients were excluded for lack of compliance, both in B | NR; one author from UCB Braine-l’Alleud, Belgium | Poor: high attrition (15%), no ITT, baseline characteristics not reported by group (unable to determine if groups by order of administration were similar) |
From: Evidence Tables
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