Steele Karen M, Viola Judith, Burns Erin, Carreiro Jane E
WVSOM, 400 N Lee St, Lewisburg, WV 24901-1128, USA.
J Am Osteopath Assoc. 2010 May;110(5):278-84.
Osteopathic physicians have used osteopathic manipulative medicine (OMM) to treat patients with acute otitis media (AOM) and its sequelae (eg, middle ear effusion [MEE], conductive hearing loss) for more than a century. However, few clinical trials document the efficacy of OMM, perhaps because of various challenges related to OMM clinical trials.
To describe a research protocol studying the efficacy of OMM on MEE after an episode of AOM, comment on the feasibility of the protocol and statistical analysis, and report on lessons learned in the first 9 months of the study.
Dual-site, prospective, randomized, blinded, controlled clinical trial comparing OMM plus standard care to standard care only for MEE after an episode of AOM. Standard care comprised antibiotics and surgery. Patients were aged between 6 months and 24 months, were diagnosed as having AOM, were referred to the study by a participating pediatric provider, and had abnormal tympanogram results on entry into the study. All patients had 5 weekly study visits, and patients in the intervention group received OMM on visits 1 through 3. Patients received weekly tympanogram and acoustic reflectometer readings as well as daily at-home acoustic reflectometer readings for 30 days.
Fifty-six patients were screened, 34 subjects were enrolled, and 26 subjects completed the study protocol in the first 9 months of the study. This resulted in 22 "ears" in the standard card only group and 18 "ears" in the standard care plus OMM group, resulting in 40 cases of AOM studied in the first year of the trial. The OMM treatment protocol was easily administered without serious adverse events. Protocols for interpretation of tympanogram readings and conversion of data for statistical analysis resulted in analyzable data.
The OMM protocol can be administered with no serious adverse events. Subject recruitment is difficult, and a full-time research assistant at the referring site improves subject referral, enrollment and retention. Accepting only confirmed cases of AOM from trained pediatric providers reduces the patient pool but increases the reliability of the data. (ClinicalTrials.gov number NCT00520039).
一个多世纪以来，整骨疗法医生一直使用整骨手法医学（OMM）来治疗急性中耳炎（AOM）患者及其后遗症（如中耳积液[MEE]、传导性听力损失）。然而，很少有临床试验证明OMM的疗效，这可能是由于与OMM临床试验相关的各种挑战。
描述一项研究OMM对AOM发作后MEE疗效的研究方案，评论该方案的可行性和统计分析，并报告研究前9个月的经验教训。
双中心、前瞻性、随机、盲法、对照临床试验，比较OMM加标准治疗与仅标准治疗对AOM发作后MEE的疗效。标准治疗包括抗生素和手术。患者年龄在6个月至24个月之间，被诊断为患有AOM，由参与研究的儿科医生转诊至本研究，且在进入研究时鼓室图结果异常。所有患者每周进行5次研究访视，干预组患者在第1至3次访视时接受OMM治疗。患者每周接受鼓室图和声反射仪读数检查，并在30天内每天在家进行声反射仪读数检查。
在研究的前9个月，共筛查了56例患者，招募了34例受试者，26例受试者完成了研究方案。这导致仅标准治疗组有22只“耳”，标准治疗加OMM组有18只“耳”，在试验的第一年共研究了40例AOM病例。OMM治疗方案易于实施，无严重不良事件。鼓室图读数解释和数据转换用于统计分析的方案产生了可分析的数据。
OMM方案可以在不发生严重不良事件的情况下实施。受试者招募困难，在转诊地点配备一名全职研究助理可改善受试者转诊、入组和保留情况。仅接受来自训练有素的儿科医生确诊的AOM病例会减少患者群体，但会提高数据的可靠性。（ClinicalTrials.gov编号NCT00520039）
