A scientist is conducting a study to determine how well a new medication treats ear infections. The scientist tells the participants to put 10 drops in their infected ear each day. After two weeks, all participants' ear infections had healed. Which of the following changes to the design of this study would most improve the ability to test if the new medication effectively treats ear infections? (a) Have participants use ear drops for only one week (b)Create a second group of participants with ear infections who use 15 drops a day (c)Have participants put ear drops in both their infected ear and healthy ear (d)Create a second group of participants with ear infections who do not use any ear drops
Answers
Objective. To determine if use of a homeopathic ear drop preparation reduces antibiotic use in children diagnosed with acute otitis media (AOM). Methods. Children 6 months to 11 years old, diagnosed with AOM and managed with a delayed antibiotic approach, were randomized to standard therapy alone or standard therapy plus a homeopathic ear drop preparation. The primary outcome was whether or not the antibiotic prescription given at the index visit was filled during a 12- to 15-day follow-up period. Results. Among 210 enrolled children, follow-up antibiotic data were collected on 206. During the 12- to 15-day follow-up period, fewer parents of children randomized to the homeopathic ear drops group filled the antibiotic prescription compared with those of children receiving standard therapy alone (26.9% and 41.2%, respectively, P = .032). Conclusion. Homeopathic ear drops may be effective in reducing the use of antibiotics in children with AOM managed with a delayed antibiotic approach.