To study the effectiveness of adenoidectomy and of the placement of tympanostomy tubes in the treatment of chronic otitis media with effusion, we randomly assigned 578 children, aged four through eight years, to receive bilateral myringotomy and no additional treatment (Group 1), placement of tympanostomy tubes (Group 2), adenoidectomy (Group 3), or adenoidectomy and placement of tympanostomy tubes (Group 4). The 491 children who underwent one of these treatments were examined at six-week intervals for up to two years. The mean time spent with effusion of any type in either ear over the two-year follow-up in the four groups was 51, 36, 31, and 27 weeks, respectively (P less than 0.0001), comparing Group 1 with each of the other groups. Hearing was equivalent in Groups 2, 3, and 4, and was significantly better than in Group 1. The most frequent sequela, purulent otorrhea, occurred one or more times in 22, 29, 11, and 24 percent of the subjects in Groups 1, 2, 3, and 4, respectively (P less than 0.001). Adenoidectomy plus bilateral myringotomy lowered the overall post-treatment morbidity (as measured by hearing acuity in the most severely affected ear [P = 0.0174] and the number of surgical retreatments required [P = 0.009]) more than did tympanostomy tubes alone and to the same degree as did adenoidectomy and tympanostomy tubes. We conclude that adenoidectomy should be considered when surgical therapy is indicated in children four to eight years old who are severely affected by chronic otitis media with effusion.

Otorrhea is the most common complication of surgical drainage of the tympanum for the treatment of chronic secretory otitis media. Otorrhea present at the first postoperative visit may be due to the operative procedure, the underlying disease process, or both. After analyzing data from 525 operations on 1045 ears of 396 children with chronic secretory otitis media, and finding an over-all incidence of immediate postoperative otorrhea of 3.4%, we conclude that preparations of the ear canal with povidone iodine and the postoperative prophylactic use of an antimicrobial-corticosteroid topical preparation provides optimal control of postoperative wound infection. Sporadic increases in the incidence of postoperative otorrhea may be due to extrinsic factors such as outbreaks of upper respiratory infection.

To investigate the mechanism whereby adenoidectomy influences the subsequent course of patients with chronic otitis media with effusion, we analyzed, on the basis of adenoid size, the outcomes of 476 children randomly assigned to receive, after paracentesis and aspiration of the middle ear, either no treatment, tympanostomy tubes, adenoidectomy, or both. The two groups receiving adenoidectomy did significantly better than those who did not, and the effect was independent of adenoid size. This suggests that reduction of the adenoidal bacterial reservoir may be the mechanism whereby adenoidectomy is effective.

To study the effectiveness of adenoidectomy and tympanostomy tubes in the treatment of chronic otitis media with effusion, we randomly assigned 578 4- to 8-year-old children to receive one of the following: Bilateral myringotomy and no additional treatment (group 1), tympanostomy tubes (group 2), adenoidectomy and myringotomy (group 3), or adenoidectomy and tympanostomy tubes (group 4). The 491 who accepted surgical treatment were evaluated at 6-week intervals for up to 2 years. Treatment effect was assessed by four main outcomes: Time with effusion, time with hearing loss, time to first recurrence of effusion, and number of surgical re-treatments. For the groups (in order), the mean percent of time with any effusion in either ear was 49, 35, 30, 26 (p < .0001); the mean percent of time with hearing thresholds 20 dB or greater was 19, 10, 8, and 7 (p < .0001) in the better ear; and 38, 30, 22 and 22 in the worse ear (p < .0001); the median number of days to first recurrence was 54, 222, 92, and 240 (p < .0001); and the number of surgical re-treatments was 66, 36, 17, and 17 (p < .0001). The most notable adverse sequela, purulent otorrhea, occurred in 22%, 29%, 11%, and 24% of the patients assigned to groups 1 through 4, respectively (p < .001). In severely affected children who have chronic otitis media with effusion resistant to medical therapy, adenoidectomy is an effective treatment. Adenoidectomy plus bilateral myringotomy lowered posttreatment morbidity more than tympanostomy tubes alone and to the same degree as did adenoidectomy and tympanostomy tubes. Adenoidectomy appears to modify the underlying pathophysiology of chronic otitis media with effusion. This effect is independent of the preoperative size of the adenoid. Tympanostomy tube drainage and ventilation of the middle ear provide adequate palliation so long as the tubes remain in place and functioning. We recommend that adenoidectomy be considered in the initial surgical management of 4- to 8-year-old children with hearing loss due to chronic secretory otitis media that is refractory to medical management and, further, that the size of the adenoid not be used as a criterion for adenoidectomy. Concomitant bilateral myringotomy with suction aspiration of the middle ear contents also should be done, with or without placement of tympanostomy tubes at the discretion of the surgeon.

The present study compares the occurrence of a dry, persistent cough with doses of 80 mg of valsartan, 10 mg of lisinopril, or 25 mg of hydrochlorothiazide in patients with a history of angiotensin-converting enzyme inhibitor-induced cough. This was a randomized, double-blind, active-controlled, parallel group, multicenter trial involving 129 adult outpatients with essential hypertension. After confirmation of angiotensin-converting enzyme inhibitor-induced cough during a 2 to 4 week challenge with lisinopril (followed by a washout period of 2 weeks), patients were randomized to receive 6 weeks of double-blind treatment once daily with 80 mg valsartan, 10 mg lisinopril, or 25 mg hydrochlorothiazide. Assessments were made at baseline and after 3 and 6 weeks of treatment. Comparability of response to treatment was assessed by mean sitting diastolic and systolic blood pressure at the end of treatment. The occurrence of a dry, persistent cough was significantly less (P < 0.001) at 3 and 6 weeks with valsartan (19.5%) than with lisinopril (68.9%), with no significant difference between valsartan and hydrochlorothiazide (19.0%). There were no statistically significant differences in reduction of blood pressure among the three treatment groups. The overall incidence of adverse experiences, whether or not treatment-related, was highest for lisinopril (86.7%) compared with valsartan (57.1%), and hydrochlorothiazide (61.9%). A dry cough in the lisinopril group accounted for this difference. There were no clinically significant changes in physical signs or in results of clinical laboratory evaluations during double-blind treatment, except for from metabolic changes in 3 patients receiving hydrochlorothiazide. In hypertensive patients with a history of angiotensin-converting enzyme inhibitor-induced cough, a single daily dose of 80 mg of valsartan produced therapeutic efficacy comparable to lisinopril but with significantly less cough.