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

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.

Figure 1

Flow diagram of the Multicenter Osteopathic Pneumonia Study in the Elderly. ITT = intention-to-treat, PP = per-protocol, OMT = osteopathic manipulative treatment, LT = light-touch treatment, CCO = conventional care only. Data on each site are presented in the following order: Michigan, Missouri, New Jersey, Ohio, and Texas.

Figure 2

Comparison between intention-to-treat and per-protocol analyses on MOPSE subject comorbidities. ITT = intention-to-treat, PP = per-protocol, OMT = osteopathic manipulative treatment, LT = light-touch treatment, CCO = conventional care only, COPD = chronic obstructive pulmonary disease.

Figure 3

Comparison between intention-to-treat and per-protocol analyses on MOPSE subject pneumonia severity. ITT = intention-to-treat, PP = per-protocol, OMT = osteopathic manipulative treatment, LT = light-touch treatment, CCO = conventional care only.

Figure 4

Kaplan-Meier curves and hazard ratios for hospital length of stay comparing treatment groups. OMT = osteopathic manipulative treatment, LT = light-touch treatment, CCO = conventional care only. A, Kaplan-Meier curves - intention-to-treat analysis on subjects aged 50 and above. B, Kaplan-Meier curves - per-protocol analysis on subjects aged 50 and above. C, Kaplan-Meier curves - per-protocol analysis on subjects aged 60 and above. D, Hazard ratios comparing treatment groups. Hazard ratios >1 correspond to an earlier discharge from the hospital for the first treatment group compared to the second. Calculated using intention-to-treat analysis on subjects aged 50 and above (ITT50+, diamond), per-protocol analysis on subjects aged 50 and above (PP50+, square), and per-protocol analysis on subjects aged 60 and above (PP60+, triangle).

Figure 5

Analysis of adverse events comparing treatment groups. OMT = osteopathic manipulative treatment, LT = light-touch treatment, CCO = conventional care only. Subjects may be included in more than one category. For example, three subjects had respiratory failure as their treatment endpoint and subsequently died while still in the hospital. * Serious adverse event category excludes respiratory failure and death. A, Intention-to-treat analysis. † OMT significantly greater than LT and CCO, P < 0.05. B, Per-protocol analysis. ‡ OMT significantly less than CCO, P < 0.05.