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Table 8 Data extraction for respiratory studies

From: Manual therapy for the pediatric population: a systematic review

Condition

Author/year

Study objective

Study design sample size intervention

Patient description/ condition

Primary/main outcome(s)

Main results/conclusions

Adverse events

Asthma

Guiney P, et al. 2005 [40]

To demonstrate the therapeutic relevance of osteopathic manipulation in the pediatric asthma population.

RCT

n = 140

OMT

Children ages 5–17, diagnosed with asthma by guidelines from NIH

Peak Expiratory Flow Rates

There was statistically significant improvement of 7 L per minute to 9 L per minute for peak expiratory flow rates in the treatment group.

There was no mention of adverse events made in this study.

Bronfort G, et al. 2001 [41]

To determine if chiropractic manipulative therapy in addition to optimal medical management resulted in clinically important changes in asthma-related outcomes.

RCT

n = 34

CMT

Children ages 6–17, with persistent asthma

Pulmonary function tests, diary recording peak expiratory flow and inhaler use, questionnaires assessing quality of life, asthma severity and improvement

Little to no change in pulmonary function tests at 12 weeks and no change in patient, parent/guardian or pulmonologist rated improvement

There was no mention of adverse events made in this study.

Obstructive Apnea

Vandenplas Y, et al. 2008 [42]

To evaluate if osteopathy can influence the incidence of obstructive apnea during sleep in infants.

RCT

n = 34

OMT

Infants aged 1.5–4 months, with obstructive apnea as determined by a polysomnographic test

Decrease in the number of obstructive apneas as measured by polysomnography.

Infants aged 1.5–4 months, with obstructive apnea as determined by polysomnographic

There was no mention of adverse events made in this study.

Otitis Media

Steele D, et al.2014 [43]

To evaluate the efficacy of an osteopathic manipulative treatment protocol on middle ear effusion resolution following acute otitis media.

RCT

n = 52

OMT

Infant ages 6–24 months, with acute otitis media and abnormal tomogram

Tympanometer and acoustic reflectometer

Both tympanometer data and acoustic reflectometer analysis demonstrated significantly significant improvement in middle ear effusion at visit 3 in the standard care plus osteopathic treatment group.

There were no serious adverse events reported during the study.

Wahl R, et al. 2008 [44]

To assess the efficacy of Echinacea and osteopathic manipulative treatment for preventing acute otitis media.

RCT

n = 90

OMT

Children aged 12–60 months, with recurrent otitis media

Reduction in future episodes of OM

No interaction was found between Echinacea and osteopathic manipulation. 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. Osteopathic manipulation did not significantly affect risk compared to sham.

“One subject withdrew from the study following an adverse effect (vomiting after taking the Echinacea placebo). One additional subject reported adverse effects (vomiting and non-urticarial rash 2 days after starting Echinacea for a viral upper respiratory illness) but did not withdraw. Neither adverse effect was considered to have been caused by the study medication.

Degenhardt B & Kuchera M, 2006 [45]

Does osteopathic manipulation decrease the recurrence of otitis media?

Before-After

n = 8

OMT/CST

Infants ages 7–35 months, with recurrent otitis media

Decreased incidence of acute otitis media

5 participants had no recurrence after 1 year follow-up. 1 participant had 1 recurrence. 2 participants had a short-term of no recurrence only.

There is no mention of adverse events made in this study.

Zhang J & Snyder B, 2004 [46]

To study the effect of Toftness chiropractic adjustment for acute otitis media.

Before-After

n = 22

CMT

Children ages 9 months −9 years, with acute otitis media

Tympanic Membrane visualization via otoscopic exam and oral temperature

After Toftness chiropractic adjustment, red and bulging tympanic membrane returned to normal in 95% of children. A decrease in average oral temperature was noted.

“During the study protocol, no side effects or deterioration of clinical presentations were found among 21 children with otitis media.”

Mills M, et al. 2003 [47]

To evaluate the effect of usual care and osteopathic manipulation for children with acute otitis media.

RCT

n = 57

OMT

Children ages 6 months - 6 years, with recurrent otitis media

Decreased frequency of acute otitis media, antibiotic us, surgical interventions, and improved tympanometric and audiometric performance

Intervention group had fewer episodes of acute otitis media, fewer surgical procedures and an increased frequency of more normal tympanogram readings.

There were no adverse events reported during the study.