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The results of a randomized controlled trial of hydrocortisone in acute exacerbation of COPD
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AMERICAN JOURNAL OF EMERGENCY MEDICINE • Volume 18, Number 1 • January 2000
is not clinically safe; however, they do not offer any hard evidence to support their contention. It is true that patients presenting with acute or hyperacute alcoholic intoxications may harbor a host of other conditions. Still, for the patient that was presented, a thorough evaluation had been completed before initiating therapy. It would be my opinion that any competent emergency physician would do the same without need of further prompting. Contrary to Drs Roberts and Greenberg's statement "aggressive monitoring of fluid administration" is not proscribed in the protocol. Rather, it was stated that in those patients that had been treated by us it was found not to be necessary. As for plasma expansion for the purposes of reducing the concentration of alcohol, Drs Roberts and Greenberg state that " . . . fluid administration has minimal e f f e c t s , . . " ; however, they fail to cite any sources and, in any case, the data reported in the publication show that it is indeed possible to reduce the concentration of alcohol through plasma expansion. One should note that when an isotonic/isoionic solution is infused, only one-fourth remains in the intravascular space. 1 Thus, for any infusion to have meaningful effects on the plasma volume one must accept that large volumes must be infused. As for double-blind placebo-controlled studies, it is a mantra of doubtful value. In this group of patients where (as Drs Roberts and Greenberg correctly point out) heterogenicity is the norm, the essentials for a homogeneous baseline cohort are missing. Further and historically important contributions have always come from astute and careful observations; the discovery that digitalis, quinidine, aspirin, penicillin, and colchicine all have therapeutic value being all cases in point. (Did Dr Harvey have double-blind controls when he proposed his scheme of the peripheral circulation?) ANTONIOBOB& MD
Neurological Associates Poughkeepsie, NY
exacerbation of COPD. We wish to call attention to several errors in the report. These errors are especially important because a recent systematic review of the effectiveness of corticosteroids in COPD that incorporated this trial may have reached erroneous conclusions.Z Table 2, p. 141 of that report describes improvement at three time points (15 minutes, 2 hours, and 6 hours) for each of two measures (peak expiratory flow rate [PEFR] and forced expiratory volume in 1 second [FEV1]). However, several of the data are erroneous. For the "nonsteroid" group, the mean values for PEFR at 0 to 2 hours and 0 to 6 hours and the means for FEV1 for 0 to 2 hours and 0 to 6 hours fall outside the reported 95% confidence intervals (CI). We suspect that the lower bound of each interval lacks a minus sign. This would result in reasonably symmetric confidence intervals around the mean values. However, once this error is corrected, the meaning of the 95% CI is still open to interpretation. Are these based on the standard error of the mean (ie, represent a 95% confidence bound for the mean) or based on standard deviation (ie, represent a 95% confidence bound for the individual data). We suspect the former, although WoodBaker and Walters 2 apparently assumed the latter. Please clarify the data reported. We urge you to print a corrected Table 2 and the primary data on which the results were based. DOUGLASC. McCRORY, MD, MHSc
Department of Medicine and the Centerfor Clinical Health Policy Research, Duke University Medical Center and Centerfor Health Services Research in Primary Care, Durham VeteransAffairs Medical Center, Durham, NC VIC HASSELBLAD,PHI) Department of Community and Family Medicine, Duke University Medical Center, Durham, NC Dr McCrory is supported by the Agency for Health Care Policy Research (Contract no. 290-97-0014).
Reference 1. Boba A: Responses to hemorrhage replaced with lactated Ringer solution. Acta Anaesthesiol Scand 1968; Supplementum XXXI:5-76
THE RESULTS OF A RANDOMIZEDCONTROLLED TRIAL OF HYDROCORTISONE IN ACUTE EXACERBATIONOF COPD To the Editor:--A previously published article z describes the results of a randomized controlled trial of hydrocortisone in acute
References 1. Bullard MJ, Liaw S, Tsai Y, Min HP: Early corticosteroid use in acute exacerbations of chronic airflow obstruction. Am J Emerg Med 1996;14:139-143 2. Wood-Baker R, Waiters EH: The role of corticosteroids in acute exacerbations of chronic obstructive pulmonary disease (Cochrane review). The Cochrane Library, Issue 4, 1998. Oxford, Update Software.
AMERICAN JOURNAL OF EMERGENCY MEDICINE • Volume 18, Number 1 • January 2000
is not clinically safe; however, they do not offer any hard evidence to support their contention. It is true that patients presenting with acute or hyperacute alcoholic intoxications may harbor a host of other conditions. Still, for the patient that was presented, a thorough evaluation had been completed before initiating therapy. It would be my opinion that any competent emergency physician would do the same without need of further prompting. Contrary to Drs Roberts and Greenberg's statement "aggressive monitoring of fluid administration" is not proscribed in the protocol. Rather, it was stated that in those patients that had been treated by us it was found not to be necessary. As for plasma expansion for the purposes of reducing the concentration of alcohol, Drs Roberts and Greenberg state that " . . . fluid administration has minimal e f f e c t s , . . " ; however, they fail to cite any sources and, in any case, the data reported in the publication show that it is indeed possible to reduce the concentration of alcohol through plasma expansion. One should note that when an isotonic/isoionic solution is infused, only one-fourth remains in the intravascular space. 1 Thus, for any infusion to have meaningful effects on the plasma volume one must accept that large volumes must be infused. As for double-blind placebo-controlled studies, it is a mantra of doubtful value. In this group of patients where (as Drs Roberts and Greenberg correctly point out) heterogenicity is the norm, the essentials for a homogeneous baseline cohort are missing. Further and historically important contributions have always come from astute and careful observations; the discovery that digitalis, quinidine, aspirin, penicillin, and colchicine all have therapeutic value being all cases in point. (Did Dr Harvey have double-blind controls when he proposed his scheme of the peripheral circulation?) ANTONIOBOB& MD
Neurological Associates Poughkeepsie, NY
exacerbation of COPD. We wish to call attention to several errors in the report. These errors are especially important because a recent systematic review of the effectiveness of corticosteroids in COPD that incorporated this trial may have reached erroneous conclusions.Z Table 2, p. 141 of that report describes improvement at three time points (15 minutes, 2 hours, and 6 hours) for each of two measures (peak expiratory flow rate [PEFR] and forced expiratory volume in 1 second [FEV1]). However, several of the data are erroneous. For the "nonsteroid" group, the mean values for PEFR at 0 to 2 hours and 0 to 6 hours and the means for FEV1 for 0 to 2 hours and 0 to 6 hours fall outside the reported 95% confidence intervals (CI). We suspect that the lower bound of each interval lacks a minus sign. This would result in reasonably symmetric confidence intervals around the mean values. However, once this error is corrected, the meaning of the 95% CI is still open to interpretation. Are these based on the standard error of the mean (ie, represent a 95% confidence bound for the mean) or based on standard deviation (ie, represent a 95% confidence bound for the individual data). We suspect the former, although WoodBaker and Walters 2 apparently assumed the latter. Please clarify the data reported. We urge you to print a corrected Table 2 and the primary data on which the results were based. DOUGLASC. McCRORY, MD, MHSc
Department of Medicine and the Centerfor Clinical Health Policy Research, Duke University Medical Center and Centerfor Health Services Research in Primary Care, Durham VeteransAffairs Medical Center, Durham, NC VIC HASSELBLAD,PHI) Department of Community and Family Medicine, Duke University Medical Center, Durham, NC Dr McCrory is supported by the Agency for Health Care Policy Research (Contract no. 290-97-0014).
Reference 1. Boba A: Responses to hemorrhage replaced with lactated Ringer solution. Acta Anaesthesiol Scand 1968; Supplementum XXXI:5-76
THE RESULTS OF A RANDOMIZEDCONTROLLED TRIAL OF HYDROCORTISONE IN ACUTE EXACERBATIONOF COPD To the Editor:--A previously published article z describes the results of a randomized controlled trial of hydrocortisone in acute
References 1. Bullard MJ, Liaw S, Tsai Y, Min HP: Early corticosteroid use in acute exacerbations of chronic airflow obstruction. Am J Emerg Med 1996;14:139-143 2. Wood-Baker R, Waiters EH: The role of corticosteroids in acute exacerbations of chronic obstructive pulmonary disease (Cochrane review). The Cochrane Library, Issue 4, 1998. Oxford, Update Software.