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

Donald R Noll, Brian F Degenhardt, Thomas F Morley, Francis X Blais, Kari A Hortos, Kendi Hensel, Jane C Johnson, David J Pasta, Scott T Stoll, Donald R Noll, Brian F Degenhardt, Thomas F Morley, Francis X Blais, Kari A Hortos, Kendi Hensel, Jane C Johnson, David J Pasta, Scott T Stoll

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.

Figures

Figure 1
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
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
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
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
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.

References

    1. DeFrances CJ, Lucas CA, Buie VC, Golosinskiy A. 2006 National Hospital Discharge Survey. Natl Health Stat Report. 2008. p. 5. 2 October 2008.
    1. DeFrances CJ, Podgornik MN. 2004 National Hospital Discharge Survey. Adv Data. 2006. p. 371. 15 August 2007.
    1. Fry AM, Shay DK, Holman RC, Curns AT, Anderson LJ. Trends in hospitalizations for pneumonia among persons aged 65 or older in the United States, 1988-2002. JAMA. 2005;294:2712–2719. doi: 10.1001/jama.294.21.2712.
    1. Kaplan V, Angus DC, Griffin MF, Clermont G, Watson RS, Linde-Zwirble WT. Hospitalized community-acquired pneumonia in the elderly: age- and sex-related patterns of care and outcomes in the United States. Am J Respir Crit Care Med. 2002;165:766–772.
    1. Kaplan V, Clermont G, Griffin MF, Kasal J, Watson RS, Linde-Zwirble WT, Angus DC. Pneumonia: still the old man's friend? Arch Intern Med. 2003;163:317–323. doi: 10.1001/archinte.163.3.317.
    1. Britton S, Bejstedt M, Vedin L. Chest physiotherapy inprimary pneumonia. Br Med J. 1985;290:1703–1704. doi: 10.1136/bmj.290.6483.1703.
    1. Graham WG, Bradley DA. Efficacy of chest physiotherapy and intermittent positive-pressure breathing in the resolution of pneumonia. N Engl J Med. 1978;299:624–627.
    1. Kirschenbaum L, Azzi E, Sfeir T, Tietjen P, Astiz M. Effect of continuous lateral rotational therapy on the prevalence of ventilator-associated pneumonia in patients requiring long-term ventilatory care. Crit Care Med. 2002;30:1983–1986. doi: 10.1097/00003246-200209000-00006.
    1. Mundy LM, Leet TL, Darst K, Schnitzler MA, Dunagan WC. Early mobilization of patients hospitalized with community-acquired pneumonia. Chest. 2003;124:883–889. doi: 10.1378/chest.124.3.883.
    1. Ntoumenopoulos G, Presneill JJ, McElholum M, Cade FJ. Chest physiotherapy for the prevention of ventilator-associated pneumonia. Intensive Care Med. 2002;28:850–856. doi: 10.1007/s00134-002-1342-2.
    1. Whiteman K, Nachtmann L, Kramer D, Sereika S, Bierman M. Effects of continuous lateral rotation therapy on pulmonary complications in liver transplant patients. Am J Crit Care. 1995;4:133–139.
    1. Chila AG. Pneumonia: helping our bodies help themselves. Consultant. 1982;Mar:174–188.
    1. Facto LL. The osteopathic treatment for lobar pneumonia. J Am Osteopath Assoc. 1947;46:385–392.
    1. Kimberly PE. Formulating a prescription for osteopathic manipulative treatment. J Am Osteopath Assoc. 1980;79:506–513.
    1. Noll DR, Degenhardt BF, Fossum C, Hensel K. Clinical and research protocol for osteopathic manipulative treatment of elderly patients with pneumonia. J Am Osteopath Assoc. 2008;108:508–516.
    1. Tuttle LK, Rogers RW. Influenza and pneumonia treatment. J Am Osteopath Assoc. 1919;18:211–214.
    1. Noll DR, Shores J, Bryman PN, Masterson EV. Adjunctive osteopathic manipulative treatment in the elderly hospitalized with pneumonia: a pilot study. J Am Osteopath Assoc. 1999;99:143–146.
    1. Noll DR, Shores JH, Gamber RG, Herron KM, Swift J Jr. Benefits of osteopathic manipulative treatment for hospitalized elderly patients with pneumonia. J Am Osteopath Assoc. 2000;100:776–782.
    1. Halm EA, Fine MJ, Marrie TJ, Coley CM, Kapoor WN, Obrosky DS, Singer DE. Time to clinical stability in patients hospitalized with community-acquired pneumonia: implications for practice guidelines. JAMA. 1998;279:1452–1457. doi: 10.1001/jama.279.18.1452.
    1. Metlay JP, Fine MJ, Schulz R, Marrie TJ, Coley CM, Kapoor WN, Singer DE. Measuring symptomatic and functional recovery in patients with community-acquired pneumonia. J Gen Intern Med. 1997;12:423–430. doi: 10.1046/j.1525-1497.1997.00074.x.
    1. Fine MJ, Auble TE, Yealy DM, Hanusa BH, Weissfeld LA, Singer DE, Coley CM, Marrie TJ, Kapoor WN. A prediction rule to identify low-risk patients with community-acquired pneumonia. N Engl J Med. 1997;336:243–250. doi: 10.1056/NEJM199701233360402.
    1. Mandell LA, Bartlett JG, Dowell SF, File TM Jr, Musher DM, Whitney C. Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. Clin Infect Dis. 2003;37:1405–1433. doi: 10.1086/380488.
    1. Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, Dowell SF, File TM Jr, Musher DM, Niederman MS, Torres A, Whitney CG. Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007;44(Suppl 2):S27–72. doi: 10.1086/511159.
    1. Kahn KL, Keeler EB, Sherwood MJ, Rogers WH, Draper D, Bentow SS, Reinisch EJ, Rubenstein LV, Kosecoff J, Brook RH. Comparing outcomes of care before and after implementation of the DRG-based prospective payment system. JAMA. 1990;264:1984–1988. doi: 10.1001/jama.264.15.1984.
    1. Kozak LJ, Hall MJ, Owings MF. National Hospital Discharge Survey. 2000 Annual Summary with detailed diagnosis and procedure data. Vital Health Stat. 2002;13(153):1–194. 2 October 2008.
    1. Menendez R, Torres A, Rodriguez de Castro F, Zalacain R, Aspa J, Martin Villasclaras JJ, orderías L, Benítez Moya JM, Ruiz-Manzano J, Blanquer J, Pérez D, Puzo C, Sánchez-Gascón F, Gallardo J, Alvarez CJ, Molinos L. Neumofail Group. Reaching stability in community-acquired pneumonia: the effects of the severity of disease, treatment, and the characteristics of patients. Clin Infect Dis. 2004;39:1783–1790. doi: 10.1086/426028.
    1. Heritier SR, Gebski VJ, Keech AC. Inclusion of patients in clinical trial analysis: the intention-to-treat principle. Med J Aust. 2003;179:438–440.
    1. Montori VM, Guyatt GH. Intention-to-treat principle. CMAJ. 2001;165:1339–1341.
    1. Dery MA, Yonuschot G, Winterson BJ. The effects of manually applied intermittent pulsation pressure to rat ventral thorax on lymphtransport. Lymphology. 2000;33:58–61.
    1. Knott EM, Tune JD, Stoll ST, Downey HF. Increased lymphatic flow in the thoracic duct during manipulative intervention. J Am Osteopath Assoc. 2005;105:447–456.
    1. Hodge LM, King HH, Williams AG, Reder SJ, Belavadi T, Simecka JW, Stoll ST, Downey HF. Abdominal lymphatic pump treatment increases leukocyte count and flux in thoracic duct lymph. Lymphat Res Biol. 2007;5:127–134. doi: 10.1089/lrb.2007.1001.
    1. Measel JW Jr. The effect of the lymphatic pump on the immune response: I. preliminary studies on the antibody response to pneumococcal polysaccharide assayed by bacterial agglutination and passive hemagglutination. J Am Osteopath Assoc. 1982;82:28–31.
    1. Breithaupt T, Harris K, Ellis J, Purcell E, Weir J, Clothier M, Boesler D. Thoracic lymphatic pumping and the efficacy of influenza vaccination in healthy young and elderly populations. J Am Osteopath Assoc. 2001;101:21–25.
    1. Noll DR, Degenhardt BF, Stuart MK, Werden S, McGovern RJ, Johnson JC. The effect of osteopathic manipulative treatment on immune response to the influenza vaccine in nursing homes residents: a pilot study. Altern Ther Health Med. 2004;10:74–76.
    1. Wawruch M, Krcmery S, Bozekova L, Wsolova L, Lassan S, Slobodova Z, Kriska M. Factors influencing prognosis of pneumonia in elderly patients. Aging Clin Exp Res. 2004;16:467–471.
    1. Hruby RJ, Hoffman KN. Avian influenza: an osteopathic component to treatment. Osteopath Med Prim Care. 2007;1:10. doi: 10.1186/1750-4732-1-10. 19 November 2007.
    1. McFee RB. Global infections--avian influenza and other significant emerging pathogens: an overview. Dis Mon. 2007;53:343–347. doi: 10.1016/j.disamonth.2007.05.005.
    1. Yoshikawa TT. Antimicrobial resistance and aging: beginning of the end of the antibiotic era? J Am Geriatr Soc. 2002;50(Suppl):S226–229. doi: 10.1046/j.1532-5415.50.7s.2.x.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit