Tonsillectomy and adenotonsillectomy for recurrent throat infection in moderately affected children. Tonsillectomy versus watchful waiting in recurrent streptococcal pharyngitis in adults: randomised controlled trial. Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial. Efficacy of tonsillectomy for recurrent throat infection in severely affected children. Results of parallel randomized and nonrandomized clinical trials.
In previous clinical trials involving children severely affected with recurrent throat infection (7 or more well-documented, clinically important, adequately treated episodes of throat infection in the preceding year, or 5 or more such episodes in each of the 2 preceding years, or 3 or more such episodes in each of the 3 preceding years), we found tonsillectomy efficacious in reducing the number and severity of subsequent episodes of throat infection for at least 2 years. The results seemed to warrant the election of tonsillectomy in children meeting the trials' stringent eligibility criteria but also provided support for nonsurgical management. We undertook the present trials to determine 1) whether tonsillectomy would afford equivalent benefit in children who were less severely affected than those in our earlier trials but who nonetheless had indications for tonsillectomy comparable to those in general use, and 2) whether, in such children, the addition of adenoidectomy would confer additional benefit.
                We conducted 2 parallel randomized, controlled trials in the Ambulatory Care Center of Children's Hospital of Pittsburgh. To be eligible, children were required to have had a history of recurrent episodes of throat infection that met standards slightly less stringent than the standards used in our earlier trials regarding either the frequency of previous episodes or their clinical features or their degree of documentation, but not regarding >1 of those parameters. These reduced standards were nonetheless more stringent than those in current official guidelines, which list "3 or more infections of tonsils and/or adenoids per year despite adequate medical therapy" as an indication for tonsillectomy or adenotonsillectomy. Of 2174 children referred by physicians or parents, 373 met the current trials' eligibility criteria and 328 were enrolled. Of these, 177 children without obstructing adenoids or recurrent or persistent otitis media were randomized to either a tonsillectomy group, an adenotonsillectomy group, or a control group (the 3-way trial), and 151 children who had 1 or more such conditions were randomized to either an adenotonsillectomy group or a control group (the 2-way trial). Outcome measures were the occurrence of episodes of throat infection during the 3 years of follow-up; other, indirect measures of morbidity; and complications of surgery.
                By various measures, the incidence of throat infection was significantly lower in surgical groups than in corresponding control groups during each of the 3 follow-up years. However, even among control children, mean rates of moderate or severe episodes were low, ranging from 0.16 to 0.43 per year. Adenotonsillectomy was no more efficacious than tonsillectomy alone. Of 203 children treated with surgery, 16 (7.9%) had surgery-related complications of varying types and severity.
                The modest benefit conferred by tonsillectomy or adenotonsillectomy in children moderately affected with recurrent throat infection seems not to justify the inherent risks, morbidity, and cost of the operations. We conclude that, under ordinary circumstances, neither eligibility criteria such as those used for the present trials nor the criterion for surgery in current official guidelines are sufficiently stringent for use in clinical practice. To determine the short term efficacy and safety of tonsillectomy for recurrent streptococcal pharyngitis in adults. Design Randomised controlled trial.
                Academic referral centre in Finland.
                70 adults with documented recurrent episodes of streptococcal group A pharyngitis.
                Instant tonsillectomy (n=36) or remaining on waiting list as control (n=34).
                Percentage change in the risk of an episode of streptococcal pharyngitis at 90 days. Rates of all episodes of pharyngitis and days with symptoms and adverse effects.
                The mean (SD) follow-up was 164 (63) days in the control group and 170 (12) days in the tonsillectomy group. At 90 days, streptococcal pharyngitis had recurred in 24% (8/34) in the control group and 3% (1/36) in the tonsillectomy group (difference 21%; 95% confidence interval 6% to 36%). The number needed to undergo tonsillectomy to prevent one recurrence was 5 (3 to 16). During the whole follow-up, the rates of other episodes of pharyngitis and days with throat pain and fever were significantly lower in the tonsillectomy group than in the control group. The most common morbidity related to tonsillectomy was postoperative throat pain (mean length 13 days, SD 4).
                Adults with a history of documented recurrent episodes of streptococcal pharyngitis were less likely to have further streptococcal or other throat infections or days with throat pain if they had their tonsils removed.
                Clinical Trials NCT00136877. To assess the effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy.
                Open, randomised controlled trial.
                21 general hospitals and three academic centres in the Netherlands.
                300 children aged 2-8 years requiring adenotonsillectomy.
                Adenotonsillectomy compared with watchful waiting.
                Episodes of fever, throat infections, upper respiratory tract infections, and health related quality of life.
                During the median follow up period of 22 months, children in the adenotonsillectomy group had 2.97 episodes of fever per person year compared with 3.18 in the watchful waiting group (difference -0.21, 95% confidence interval -0.54 to 0.12), 0.56 throat infections per person year compared with 0.77 (-0.21, -0.36 to -0.06), and 5.47 upper respiratory tract infections per person year compared with 6.00 (-0.53, -0.97 to -0.08). No clinically relevant differences were found for health related quality of life. Adenotonsillectomy was more effective in children with a history of three to six throat infections than in those with none to two. 12 children had complications related to surgery.
                Adenotonsillectomy has no major clinical benefits over watchful waiting in children with mild symptoms of throat infections or adenotonsillar hypertrophy. 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 less than or equal to 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.
Adeno-/tonsillectomy is effective in reducing the number of episodes of sore throat and days with sore throats in children, the gain being more marked in those most severely affected. The size of the effect is modest, but there may be a benefit to knowing the precise timing of one episode of pain lasting several days - it occurs immediately after surgery as a direct consequence of it.
It is clear that some children get better without any surgery, and that whilst removing the tonsils will always prevent 'tonsillitis', the impact of the procedure on 'sore throats' due to pharyngitis is much less predictable.