Jacobs J, Springer D A, Crothers D
Department of Epidemiology, School of Public Health and Community Medicine, University of Washington, Seattle, USA.
Pediatr Infect Dis J. 2001 Feb;20(2):177-83. doi: 10.1097/00006454-200102000-00012.
The use of antibiotics in the initial treatment of acute otitis media is currently being questioned. Homeopathy has been used historically to treat this illness, but there have been no methodologically rigorous trials to determine whether there is a positive treatment effect.
A randomized double blind placebo control pilot study was conducted in a private pediatric practice in Seattle, WA. Seventy-five children ages 18 months to 6 years with middle ear effusion and ear pain and/or fever for no more than 36 h were entered into the study. Children received either an individualized homeopathic medicine or a placebo administered orally three times daily for 5 days, or until symptoms subsided, whichever occurred first. Outcome measures included the number of treatment failures after 5 days, 2 weeks and 6 weeks. Diary symptom scores during the first 3 days and middle ear effusion at 2 and 6 weeks after treatment were also evaluated.
There were fewer treatment failures in the group receiving homeopathy after 5 days, 2 weeks and 6 weeks, with differences of 11.4, 18.4 and 19.9%, respectively, but these differences were not statistically significant. Diary scores showed a significant decrease in symptoms at 24 and 64 h after treatment in favor of homeopathy (P < 0.05). Sample size calculations indicate that 243 children in each of 2 groups would be needed for significant results, based on 5-day failure rates.
These results suggest that a positive treatment effect of homeopathy when compared with placebo in acute otitis media cannot be excluded and that a larger study is justified.
目前，抗生素在急性中耳炎初始治疗中的应用受到质疑。顺势疗法在历史上一直被用于治疗这种疾病，但尚无方法学严谨的试验来确定是否存在积极的治疗效果。
在华盛顿州西雅图市的一家私人儿科诊所进行了一项随机双盲安慰剂对照试验性研究。75名年龄在18个月至6岁之间、中耳积液且耳痛和/或发热不超过36小时的儿童进入该研究。儿童接受个体化顺势疗法药物或安慰剂治疗，每天口服3次，共5天，或直至症状消退，以先出现者为准。观察指标包括5天、2周和6周后的治疗失败次数。还评估了治疗后头3天的症状日记评分以及治疗后2周和6周时的中耳积液情况。
接受顺势疗法治疗的组在5天、2周和6周后的治疗失败次数较少，差异分别为11.4%、18.4%和19.9%，但这些差异无统计学意义。症状日记评分显示，治疗后24小时和64小时症状显著减轻，支持顺势疗法（P<0.05）。样本量计算表明，根据5天的失败率，每组需要243名儿童才能得出显著结果。
这些结果表明，顺势疗法在急性中耳炎中与安慰剂相比具有积极治疗效果这一结论不能被排除，因此有必要开展更大规模的研究。
