Efficacy of osteopathic manipulation as an adjunctive treatment for hospitalized patients with pneumonia: a randomized controlled trial
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Efficacy of osteopathic manipulation as an adjunctive treatment for hospitalized patients with pneumonia: a randomized controlled trial

Donald R Noll1, Brian F Degenhardt2, Thomas F Morley3, Francis X Blais4, Kari A Hortos5, Kendi Hensel6, Jane C Johnson2, David J Pasta7 and Scott T Stoll8

New Jersey Institute of Successful Aging, University of Medicine and Dentistry - School of Osteopathic Medicine, Stratford, New Jersey, USA

AT Still Research Institute, AT Still University, Kirksville, Missouri, USA

Department of Medicine, University of Medicine and Dentistry of New Jersey - School of Osteopathic Medicine, Stratford, New Jersey, USA

Department of Internal Medicine, Galion Community Hospital, Galion, Ohio, USA

Michigan State University - College of Osteopathic Medicine Macomb University Center, Clinton Township, Michigan, USA

Department of Osteopathic Manipulative Medicine, University of North Texas Health Science Center at Fort Worth - Texas College of Osteopathic Medicine, Fort Worth, Texas, USA

ICON Clinical Research, San Francisco, California, USA

Stoll Neurodiagnostics, PA, Fort Worth, Texas, USA

Osteopathic Medicine and Primary Care 2010, 4:2doi:10.1186/1750-4732-4-2

The electronic version of this article is the complete one and can be found online at: http://www.om-pc.com/content/4/1/2

Received: 11 September 2009
Accepted: 19 March 2010
Published: 19 March 2010

© 2010 Noll et al; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

The Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE) is a registered, double-blinded, randomized, controlled trial designed to assess the efficacy of osteopathic manipulative treatment (OMT) as an adjunctive treatment in elderly patients with pneumonia.

Methods

406 subjects aged ? 50 years hospitalized with pneumonia at 7 community hospitals were randomized using concealed allocation to conventional care only (CCO), light-touch treatment (LT), or OMT groups. All subjects received conventional treatment for pneumonia. OMT and LT groups received group-specific protocols for 15 minutes, twice daily until discharge, cessation of antibiotics, respiratory failure, death, or withdrawal from the study. The primary outcomes were hospital length of stay (LOS), time to clinical stability, and a symptomatic and functional recovery score.

Results

Intention-to-treat (ITT) analysis (n = 387) found no significant differences between groups. Per-protocol (PP) analysis (n = 318) found a significant difference between groups (P = 0.01) in LOS. Multiple comparisons indicated a reduction in median LOS (95% confidence interval) for the OMT group (3.5 [3.2-4.0] days) versus the CCO group (4.5 [3.9-4.9] days), but not versus the LT group (3.9 [3.5-4.8] days). Secondary outcomes of duration of intravenous antibiotics and treatment endpoint were also significantly different between groups (P = 0.05 and 0.006, respectively). Duration of intravenous antibiotics and death or respiratory failure were lower for the OMT group versus the CCO group, but not versus the LT group.

Conclusions

ITT analysis found no differences between groups. PP analysis found significant reductions in LOS, duration of intravenous antibiotics, and respiratory failure or death when OMT was compared to CCO. Given the prevalence of pneumonia, adjunctive OMT merits further study.

Background

Pneumonia is the fourth most common hospital discharge diagnosis in the US with a mean (SE) length of stay (LOS) of 5.1 (0.1) days [1]. The elderly are a vulnerable population: the majority of pneumonia-related hospital admissions occur in persons 60 years and older, and the elderly have a longer mean LOS, higher severity of illness, and greater mortality than younger age groups [2-5]. Adjunctive nonpharmacologic treatments for pneumonia may enhance conventional antibiotic therapy. Chest physiotherapy, early mobilization, and continuous lateral rotational therapy have been investigated with mixed results [6-11]. Osteopathic manipulative treatment (OMT) is a nonpharmacologic manual therapy developed in the late nineteenth century before the use of antibiotics. OMT includes a number of manipulative techniques intended to enhance host defenses and physiologic function [12-16]. Many of these techniques, such as rib raising, doming the diaphragm, and the thoracic lymphatic pump, were specifically developed to treat pneumonia [15]. Two small randomized controlled trials of OMT for pneumonia suggest OMT may reduce LOS in the elderly [17,18].

The Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE) was designed to further evaluate the efficacy of OMT. To better understand the potential therapeutic effect of the interaction between participants and providers, MOPSE included sham treatment and conventional care only control arms. The primary hypotheses were that OMT would reduce LOS, time to clinical stability [19], and a symptomatic and functional recovery score [20] in elderly patients hospitalized with pneumonia compared to light touch sham and conventional care only control groups. Analysis of secondary and safety-related outcomes was also performed.

Methods

MOPSE is a registered (http://www.clinicaltrials.gov/ webcite, NCT00258661), double-blinded, randomized, controlled trial conduct


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