Efficacy of Tonsillectomy for Recurrent Throat Infection in Severely Affected Children Results of Parallel Randomized and Nonrandomized Clinical Trials

• Published in: The New England journal of medicine Vol. 310; no. 11; pp. 674 - 683
• Main Authors: Paradise, Jack L, Bluestone, Charles D, Bachman, Ruth Z, Colborn, D. Kathleen, Bernard, Beverly S, Taylor, Floyd H, Rogers, Kenneth D, Schwarzbach, Robert H, Stool, Sylvan E, Friday, Gilbert A, Smith, Ida H, Saez, Carol A
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 15.03.1984
• Subjects: Adenoidectomy - adverse effects; Adolescent; Ambulatory care; Child; Child, Preschool; Children; Children & youth; Clinical trials; Consent; Documentation; Evaluation Studies as Topic; Female; Follow-Up Studies; Hospitals; Humans; Infections; Male; Parents & parenting; Pharyngitis - epidemiology; Pharyngitis - prevention & control; Pharyngitis - therapy; Pharynx; Random Allocation; Recurrence; Recurrent infection; Research Design; Surgery; Throat surgery; Time Factors; Tonsillectomy - adverse effects
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJM198403153101102

We studied the efficacy of tonsillectomy, or tonsillectomy with adenoidectomy, in 187 children severely affected with recurrent throat infection. Ninety-one of the children were assigned randomly to either surgical or nonsurgical treatment groups, and 96 were assigned according to parental preference. In both the randomized and nonrandomized trials, the effects of tonsillectomy and of tonsillectomy with adenoidectomy were similar. By various measures, the incidence of throat infection during the first two years of follow-up was significantly lower (P≤0.05) in the surgical groups than in the corresponding nonsurgical groups. Third-year differences, although in most cases not significant, also consistently favored the surgical groups. On the other hand, in each follow-up year many subjects in the nonsurgical groups had fewer than three episodes of infection, and most episodes among subjects in the nonsurgical groups were mild. Of the 95 subjects treated with surgery, 13 (14 per cent) had surgery-related complications, all of which were readily managed or self-limited. These results warrant the election of tonsillectomy for children meeting the trials' stringent eligibility criteria, but also provide support for nonsurgical management. Treatment for such children must therefore be individualized. (N Engl J Med 1984; 310:674–83.) TONSILLECTOMY has long been the most common major operation performed on children in the United States, 1 , 2 yet indications remain uncertain and controversial, 3 4 5 and regional tonsillectomy rates vary widely. 6 Among currently sanctioned indications for tonsillectomy, 7 8 9 10 recurrent throat infection is at once the most frequently invoked 11 , 12 and the most problematic. Not only do opinions differ over how many episodes, of what character, and over what period constitute grounds for tonsillectomy, 5 , 11 , 13 but one standard pediatric textbook rejects recurrent throat infection altogether as a valid indication. 14 To some extent, these differences of opinion reflect differences in physicians' training, experience, and personal attitudes and values, . . .