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Diagnosis and Management of Infantile Hemangioma

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Table 37. Strength <strong>of</strong> evidence for harms <strong>of</strong> beta-blockers (continued)<br />

Intervention<br />

Timolol<br />

Outcome<br />

Study Design<br />

Quality <strong>and</strong> Number <strong>of</strong><br />

Studies (N Total)<br />

Lack <strong>of</strong> harms<br />

RCT: 1 good, 1 poor 14,104<br />

(71)<br />

Cohort studies: 1 good, 3<br />

poor 103,105,106,144 (287)<br />

Study<br />

Limitations<br />

Consistency Directness Precision<br />

Reporting<br />

Bias<br />

Finding<br />

Strength <strong>of</strong> Evidence<br />

Grade<br />

Medium Unknown Direct Imprecise Undetected No harms observed with<br />

timolol in 5 comparative<br />

studies <strong>and</strong> 1 case series.<br />

Shortness <strong>of</strong> breath <strong>and</strong><br />

insomnia observed in 1 <strong>of</strong><br />

30 children in one<br />

comparative study. 14<br />

Nadolol<br />

Case series: 1 poor 159 (25)<br />

Clinically important harms<br />

(hypotension, bradycardia,<br />

bronchospasm,<br />

hypoglycemia)<br />

Cohort studies: 1 poor 101<br />

(19)<br />

Minor harms (cold<br />

extremities, diarrhea, sleep<br />

changes)<br />

Cohort studies: 1 poor 101 (19)<br />

Low SOE for lack <strong>of</strong><br />

association <strong>of</strong> timolol with<br />

harms based on few<br />

studies.<br />

High Unknown Direct Imprecise NA Harms <strong>of</strong> nadolol reported<br />

in 10%-20% <strong>of</strong> children.<br />

Insufficient SOE for<br />

association with clinically<br />

important harms given<br />

single, small poor quality<br />

cohort study.<br />

High Unknown Direct Imprecise NA Harms <strong>of</strong> nadolol reported<br />

in 10%-50% <strong>of</strong> children.<br />

Insufficient SOE for<br />

association with minor<br />

harms given single, small<br />

poor quality study.<br />

91

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