Echinacea purpurea and osteopathic manipulative treatment in children with recurrent otitis media: a randomized controlled trial.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00010465.

Effectiveness of osteopathy in the cranial field and myofascial release versus acupuncture as complementary treatment for children with spastic cerebral palsy: a pilot study.

CONTEXT: Case reports and clinical trials have indicated that osteopathic manipulative treatment (OMT) may improve motor function and quality of life for children with cerebral palsy. OBJECTIVE: To assess the effectiveness of osteopathy in the cranial field, myofascial release, or both versus acupuncture in children with moderate to severe spastic cerebral palsy, as measured by several outcomes instruments in a randomized controlled trial. METHODS: Children between the ages of 20 months and 12 years with moderate to severe spastic cerebral palsy were enrolled in a single-blind, randomized wait-list control pilot study. There were three arms in the study: OMT (ie, osteopathy in the cranial field, myofascial release, or both, using direct or indirect methods), acupuncture, and control (ie, nontherapeutic attention). Children who were initially randomly assigned to the control arm were subsequently randomly reassigned to the intervention arms, increasing the sample size. Outcome measures included standard instruments used in the evaluation of children with cerebral palsy. Less traditional measures were also used, including serial evaluations by an independent blind osteopathic physician and visual analog scale assessments by an independent osteopathic physician and the parents or guardians. A total of 11 outcome variables were analyzed. RESULTS: Fifty-five patients were included in the study. Individual analyses of the 11 outcome variables revealed statistically significant improvement in two mobility measures for patients who received OMT--the total score of Gross Motor Function Measurement and the mobility domain of Functional Independence Measure for Children (P<.05). No statistically significant improvements were seen among patients in the acupuncture treatment arm. CONCLUSIONS: A series of treatments using osteopathy in the cranial field, myofascial release, or both improved motor function in children with moderate to severe spastic cerebral palsy. These results can be used to guide future research into the effectiveness of OMT or acupuncture in treating children with spastic cerebral palsy.

Confirmatory factor analysis in osteopathic medicine: fascial and spinal motion restrictions as correlates of muscle spasticity in children with cerebral palsy.

CONTEXT: While numerous measures are available to assist physicians in assessing patients with cerebral palsy, there is a paucity of instruments that capture data relevant to osteopathic assessment. The lack of such tools limits the reach of research in key osteopathic indicators. METHODS: A structured objective form designed to assist osteopathic physicians in the evaluation of fascial restriction, restriction of spinal motion, and muscle spasticity was developed for use during osteopathic musculoskeletal structural examinations. Data were collected as part of a larger study investigating the effects of osteopathic manipulative treatment versus acupuncture in children with cerebral palsy. In the present study, confirmatory factor analysis was used to examine the relationships between fascial and spinal motion restrictions in addition to spasticity. RESULTS: In 57 children with spastic cerebral palsy, latent factors for fascial restrictions and spinal motion restriction fit the data well and both factors were correlated with a visual analog scale rating of the child's muscle spasticity. CONCLUSIONS: These findings provide preliminary evidence for the factorial and concurrent validity of fascial and spinal motion restrictions, demonstrating the benefits of an instrument for assessing the results of osteopathic musculoskeletal structural examinations.