Wahl Richard A, Aldous Michael B, Worden Katherine A, Grant Kathryn L
Department of Pediatrics, University of Arizona, Tucson, Arizona, USA.
BMC Complement Altern Med. 2008 Oct 2;8:56. doi: 10.1186/1472-6882-8-56.
Recurrent otitis media is a common problem in young children. Echinacea and osteopathic manipulative treatment have been proposed as preventive measures, but have been inadequately studied. This study was designed to assess the efficacy of Echinacea purpurea and/or osteopathic manipulative treatment (OMT) for prevention of acute otitis media in otitis-prone children.
A randomized, placebo-controlled, two-by-two factorial trial with 6-month follow-up, conducted 1999 - 2002 in Tucson, Arizona. Patients were aged 12-60 months with recurrent otitis media, defined as three or more separate episodes of acute otitis media within six months, or at least four episodes in one year. Ninety children (44% white non-Hispanic, 39% Hispanic, 57% male) were enrolled, of which 84 had follow-up for at least 3 months. Children were randomly assigned to one of four protocol groups: double placebo, echinacea plus sham OMT, true OMT (including cranial manipulation) plus placebo echinacea, or true echinacea plus OMT. An alcohol extract of Echinacea purpurea roots and seeds (or placebo) was administered for 10 days at the first sign of each common cold. Five OMT visits (or sham treatments) were offered over 3 months.
No interaction was found between echinacea and OMT. Echinacea was associated with a borderline increased risk of having at least one episode of acute otitis media during 6-month follow-up compared to placebo (65% versus 41%; relative risk, 1.59, 95% CI 1.04, 2.42). OMT did not significantly affect risk compared to sham (44% versus 61%; relative risk, 0.72, 95% CI 0.48, 1.10).
In otitis-prone young children, treating colds with this form of echinacea does not decrease the risk of acute otitis media, and may in fact increase risk. A regimen of up to five osteopathic manipulative treatments does not significantly decrease the risk of acute otitis media.
ClinicalTrials.gov Identifier: NCT00010465.
复发性中耳炎是幼儿常见问题。紫锥菊和整骨疗法已被提议作为预防措施，但研究尚不充分。本研究旨在评估紫锥菊和/或整骨疗法（OMT）对易患中耳炎儿童预防急性中耳炎的疗效。
1999年至2002年在亚利桑那州图森市进行了一项为期6个月随访的随机、安慰剂对照、二乘二析因试验。患者年龄为12至60个月，患有复发性中耳炎，定义为6个月内有三次或更多次单独的急性中耳炎发作，或一年内至少有四次发作。90名儿童（44%为非西班牙裔白人，39%为西班牙裔，57%为男性）入组，其中84名儿童进行了至少3个月的随访。儿童被随机分配到四个方案组之一：双安慰剂组、紫锥菊加假OMT组、真正的OMT（包括颅骨手法治疗）加安慰剂紫锥菊组或真正紫锥菊加OMT组。在每次感冒的最初症状出现时，给予紫锥菊根和种子的酒精提取物（或安慰剂）10天。在3个月内提供五次OMT就诊（或假治疗）。
未发现紫锥菊和OMT之间存在相互作用。与安慰剂相比，紫锥菊在6个月随访期间发生至少一次急性中耳炎发作的风险有临界性增加（65%对41%；相对风险，1.59，95%CI 1.04，2.42）。与假治疗相比，OMT对风险没有显著影响（44%对61%；相对风险，0.72，95%CI 0.48，1.10）。
在易患中耳炎的幼儿中，用这种形式的紫锥菊治疗感冒不会降低急性中耳炎的风险，实际上可能会增加风险。多达五次的整骨疗法治疗方案不会显著降低急性中耳炎的风险。
ClinicalTrials.gov标识符：NCT0001
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