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Doi:10.1016/j.homp.2005.01.002

Homeopathy (]]]]) ], ]]]–]]]r 2004 The Faculty of Homeopathy doi:10.1016/j.homp.2005.01.002, available online at ORIGINAL PAPER
Adjunctive homeopathic treatment in patients
with severe sepsis: a randomized, double-blind,
placebo-controlled trial in an intensive care unit
M Frass1,Ã, M Linkesch2, S Banyai2,3, G Resch1, C Dielacher2, T Lo¨bl2, C Endler1, M Haidvogl1, 1Ludwig Boltzmann Institute for Homeopathy, Graz, Austria 2II Department of Internal Medicine, University of Vienna, Vienna, Austria 4Department of Medical Computer Sciences, University of Vienna, Vienna, Austria Background: Mortality in patients with severe sepsis remains high despite the
development of several therapeutic strategies. The aim of this randomized, double-

blind, placebo-controlled trial was to evaluate whether homeopathy is able to influence
long-term outcome in critically ill patients suffering from severe sepsis.

Methods: Sixty-seven patients with severe sepsis received homeopathic treatment
(n
¼ 33) or placebo (n ¼ 34). Five globules in a potency of 200c were given at 12 h
interval during the stay at the intensive care unit. Survival after a 30 and 180 days was
recorded.

Results: Baseline characteristics including age, sex, BMI, prior conditions, APACHE II
score, signs of sepsis, number of organ failures, need for mechanical ventilation, need

for vasopressors or veno-venous hemofiltration, and laboratory parameters were not
significantly different between groups. On day 30, there was non-statistically

significantly trend of survival in favour of homeopathy (verum 81.8%, placebo 67.7%,
P
¼ 0.19). On day 180, survival was statistically significantly higher with verum
homeopathy (75.8% vs 50.0%, P ¼ 0.043). No adverse effects were observed.
Conclusions: Our data suggest that homeopathic treatment may be an useful

additional therapeutic measure with a long-term benefit for severely septic patients
admitted to the intensive care unit. A constraint to wider application of this method is

the limited number of trained homeopaths.
Homeopathy (]]]]) ], ]]]–]]].
Keywords: APACHE II; homeopathy; critically ill patients; intensive care unit; sepsis;
survival; double-blind; randomized prospective; placebo-controlled study
during the last decades. Recent guidelinesrecommend use of goal directed therapy, low-tidal ventilation, The incidence of severe sepsis is 70,000 to 300,000 administration of recombinant Protein C (aPC), close UNCORRECTED PROOF
monitoring of blood glucose with a target value of associated with mortality rates ranging from 40% to 80–100 mg/dl, and administration of hydrocortisone.
90%.Several new therapeutic approaches have failed Despite these therapeutic strategies, mortality hasremained almost unchanged during the last few years.
Homeopathic medicine has been used for about two ÃCorrespondence: M Frass, Ludwig Boltzmann Institute for centuries. Several studies describe its superiority above Homeopathy, Duerergasse 4, A 8010 Graz, Austria.
placebo.Experimental studies demonstrate the E-mail: michael.frass@kabsi.atReceived 3 August 2004; revised 11 January 2005; accepted 26 effect of high dilutionseven beyond Avogadro’s number.There are several case reports on the and after administration of the globules, no oral fluid or food intake or oral hygiene was allowed to avoid patients.We initiated this study to investigate the any potential interference with the globules. The effect of homeopathy on the outcome of critically ill homeopathic doctors were free to decide which patients. The aim of this prospective, randomized, homeopathic medicine should be applied. All medi- double-blind, placebo-controlled trial was to evaluate cines were prepared as a 200c (Rote Krebs Apotheke, at two time points (30 and 180 days) whether homeopathy can influence outcome in patients suffer- Patients were followed for 180 days after the start of treatment unless death occurred earlier. Base-line characteristics including demographic information and information on pre-existing conditions, organ The Ethical Committee of the University of Vienna function, markers of disease severity (APACHE II), approved the study. Seventy patients admitted to a and infection were assessed within the 24 h before Medical Intensive Care Unit (MICU) of the University starting treatment. Adverse effects were recorded of Vienna were assessed for eligibility, all were included in the study. All were randomized and treated, threehad to be excluded because of incomplete data, all of the latter survived. Written informed consent was obtained from all participants or their authorized representatives. The criteria for severe sepsis of Bone et The evaluated end point was death within 180 days.
al. were used.Patients with a known or suspected Statistical analysis was done at the Department of infection on the basis of clinical data at the time of Medical Computer Sciences, University of Vienna, screening and three or more signs of systemic using the SAS software package (Statistical Analysis System, SAS Institute Inc., Cary, NC). All statistical analyses were done before breaking the randomization code. Statistical analysis of the data was performed X12 G/L) and sepsis-induced dysfunction of at least two organ systems that lasted no longer than 48 h using Kruskal–Wallis Test for comparing the two were included. Treatment with homeopathy or placebo started within 48 h after the patients met the inclusion Within 24 h after meeting the criteria for sepsis, all No adverse effects were observed in either group.
eligible patients were sequentially randomized into two Baseline demographic characteristics including age, groups, receiving either the homeopathic medicine or sex, weight, height, and body mass index (BMI) as well placebo, according to a computer-generated code. An as prior conditions were similar between the two independent physician not involved into the study held groups (). Baseline clinical indices including the code. A person not involved in the decision and/or APACHE II score and signs of inflammation, the 101 application process for the study prepared the medica- number of organ failures, the need for mechanical ventilation, vasopressor support, veno-venous pump- 103 driven haemofiltration and positive blood cultures Start of therapy and sublingual administration of the were not significantly different between groups. Only 105 heart rate exceeding 90 beats/min differed significantly, Within 12 h after meeting the criteria for sepsis, occurring more frequently in the placebo group 107 homeopathic treatment started. A person not involved in the randomization process poured five globules into On day 30, survival showed a non-statistically 109 UNCORRECTED PROOF
the tube containing the globules, then the significant trend in favour of homeopathy (verum globules were poured from the lid directly underneath 81.8%, placebo 67.7%, P ¼ 0.19; ). On day the patient’s tongue. In patients with endotracheal 180, survival was statistically significantly higher in the tubes, the globules were administered just aside the verum group 1 (verum 75.8%, placebo 50.0%, 112 endotracheal tube. Globules were given twice daily at P ¼ 0.043; ). The most frequently prescribed an interval of 12 h until sepsis was resolved or until homeopathic medicines were Apis mellifica, Arsenicum 113 death. Patients were treated for the duration of their album, Baptisia, Bryonia, Carbo vegetabilis, Crotalus stay in the intensive care unit. Treatment stopped on horridus, Lachesis muta, Lycopodium clavatum, Phos- 114 transfer to the general ward. Fifteen minutes before ill patients. Short-time survival showed a non-statisti-cally significant trend in favour of homeopathy; Our data suggest that adjunctive homeopathic however, this may be due to the relatively small sample treatment may be beneficial for the survival of critically size. The lack of adverse effects is an important advantage of homeopathic treatment. As a furtheradvantage, there is no interference with traditional treatment. Dosing via the oral route is easy and possible also in intubated patients orally and patients with oral or nasal feeding tubes. Furthermore,homeopathic medicines are low cost. One constraint is the small number of trained homeopathic doctors Confounding factors include that placebo patients were more seriously affected in terms of heart rate and leukocyte count. However, there was no significant difference in the means of these variables. All patients The mortality of severe sepsis, defined as sepsis with at least one organ failure, and septic shock, defined as hypotension not reversible by fluid resuscitation and associated with organ dysfunction or hypoperfusion abnormalities, remains very high despite increased Guidelines have been developed in an endeavour to improve outcome.Resuscitation of a patient in severe sepsis or sepsis-induced tissue hypoperfusion should begin as soon as the syndrome is recognized and should not be delayed pending ICU admission. During UNCORRECTED PROOF
the first 6 h, the goals should include all of the promptly. Intravenous antibiotic therapy should be following: central venous pressure 8–12 mmHg; mean started within the first hour of recognition of severe arterial pressure 465 mmHg; urine output 40.5 ml/ sepsis, after appropriate cultures have been obtained.
kg/h; and central venous or mixed venous oxygen Establishing vascular access and initiating aggressive saturation 470%. Early therapy directed towards fluid resuscitation is the first priority when managing patients with severe sepsis or septic shock. The Appropriate cultures should always be obtained antimicrobial regimen should always be reassessed before antimicrobial therapy is initiatedand tests after 48–72 h on the basis of microbiological and should be done as soon as possible to determine the clinical data with the aim of using a narrow-spectrum source of the infection and the causative organism.
antibiotic to prevent the development of resistance, to Imaging studies such as ultrasound and/or bedside reduce toxicity, and to reduce costs. Fluid challenge in computer tomography should be performed. Sources patients with suspected hypovolemia (suspected inade- of infection requiring drainage should be identified quate arterial circulation) may be given over 30 minand repeated based on response (increase in blood pressure and urine output) and tolerance (evidence of intravascular volume overload). If appropriate fluid challenge fails to restore adequate blood pressure and organ perfusion, administration with vasopressor Intravenous corticosteroids are recommended in patients with septic shock who, despite adequate fluid replacement, require vasopressor therapy to maintain Most often used homeopathic medicines and indications Anxiety, restlessnessCachectic appearance UNCORRECTED PROOF
adequate blood pressure.Recombinant activated 8 Frass M. Durch A¨hnliches Heilen—Homo¨opathie in O¨ster- protein C (rhAPC) is recommended in patients at high reich, 2nd edn. Peter Ko¨nig, Orac Verlag, Austria, in press.
risk of death (APACHE II 425, sepsis-induced 9 Bone RC, Fisher CJ, Clemmer TP, et al. A controlled clinical multiple organ failure, septic shock, or sepsis-induced trial of high-dose methylprednisolone in the treatment of severe sepsis and septic shock. N Engl J Med 1987; 317: ARDS) and no absolute contraindication that out- weighs the potential benefit of rhAPC. The inflamma- 10 Knaus WA, Draper EA, Wagner DP, et al. APACHE II: a tory response in sepsis is pro-coagulant in the early severity of disease classification system. Crit Care Med 1985; stages. rhAPC, an endogenous anti-coagulant with anti-inflammatory properties, has been shown, to 11 Dellinger RP. Cardiovascular management of septic shock.
improve survival in patients with sepsis-induced organ 12 Friedman G, Silva E, Vincent JL. Has the mortality of septic shock changed with time? Crit Care Med 1998; 26: 2078–2086.
Mechanical ventilation in sepsis-induced acute lung 13 Rivers E, Nguyen B, Havstad S, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N (ARDS) should be adjusted to a ‘‘low’’ tidal in conjunction with the goal of maintaining end-inspira- 14 Weinstein MP, Reller LP, Murphy JR, et al. The clinical significance of positive blood cultures: a comprehensive spontaneous breathing trials reduce the duration of analysis of 500 episodes of bacteremia and fungemia in adults.
mechanical ventilationMechanically ventilated I. Laboratory and epidemiologic observations. Rev Infect Dis patients receiving continuous sedation may have a 15 Annane D, Sebille V, Charpentier C, et al. Effect of treatment significantly longer duration of mechanical ventilation, with low doses of hydrocortisone and fludrocortisone on ICU and hospital length of stay.Daily interruption mortality in patients with septic shock. JAMA 2002; 288: or lightening of sedation may reduce the duration of mechanical ventilation and ICU stay.Following 16 Briegel J, Forst H, Haller M, et al. Stress doses of initial stabilization, blood glucose should be kept hydrocortisone reverse hyperdynamic septic shock: a prospec- below 8.3 mmol/l using continuous infusion insulin if tive, randomized, double-blind, single-center study. Crit CareMed 1999; 27: 723–732.
17 Bollaert PE, Charpentier C, Levy B, et al. Reversal of late septic shock with supraphysiologic doses of hydrocortisone.
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18 Bernard GR, Vincent JL, Laterre PF, et al. Recombinant Human Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group. Efficacy and safety of recombinant Our data suggest that homeopathic treatment has a human activated protein C for severe sepsis. N Engl J Med beneficial effect on the long-term survival of patients with sever sepsis, further research is required before 19 Amato MB, Barbas CS, Medeiros DM, et al. Effect of a protective-ventilation strategy on mortality in the acute making firm recommendations. The lack of trained respiratory distress syndrome. N Engl J Med 1998; 338: homeopaths available to advise on treatment on ICUs is an important constraint to further research and 20 Stewart TE, Meade MO, Cook DJ, et al. Evaluation of a ventilation strategy to prevent barotrauma in patients at high risk for acute respiratory distress syndrome Pressure- and Volume-Limited Ventilation Strategy Group. N Engl J Med 21 Brochard L, Roudat-Thoraval F, et al. Tidal volume reduction for prevention of ventilator-induced lung injury in acute 101 1 Dellinger RP, Carlet JM, Masur H, et al. Surviving sepsis respiratory distress syndrome. The Multicenter Trial Group campaign guidelines for management of severe sepsis and on Tidal Volume reduction in ARDS. Am J Respir Crit Care 103 septic shock. Intensive Care Med 2004; 30: 536–555.
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3 Reilly DT, Taylor MA, Beattie NGM, et al. Is evidence for 23 Esteban A, Alia I, Tobin MJ, et al. Effect of spontaneous 109 UNCORRECTED PROOF
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4 Linde K, Clausius N, Ramirez G, et al. Are the clinical effects breathing trial duration on outcome of attempts to discontinue of homoeopathy placebo effects? A meta-analysis of placebo- mechanical ventilation. Spanish Lung Failure Collaborative controlled trials. The Lancet 1997; 350: 834–843.
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5 Jacobs J, Jime´nez LM, Gloyd SS, et al. Treatment of acute 24 Ely EW, Baker AM, Dunagan DP, et al. Effect on the duration 112 childhood diarrhea with homeopathic medicine: a randomized of mechanical ventilation of identifying patients capable of clinical trial in Nicaragua. Pediatrics 1994; 93: 719–725.
breathing spontaneously. N Engl J Med 1996; 335: 1864–1869. 113 6 Samal S, Geckeler KE. Unexpected solute aggregation in water 25 Esteban A, Alia I, Gordo F, et al. Extubation outcome after on dilution. Chem Commun 2001; 2224–2225.
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26 Kollef MH, Levy NT, Ahrens TS, et al. The use of continuous 28 Berghe G van den, Wouters P, Weekers F, et al. Intensive IV sedation is associated with prolongation of mechanical insulin therapy in the critically ill patients. N Engl J Med 2001; ventilation. Chest 1998; 114: 541–548.
27 Kress JP, Pohlman AS, O’Connor MF, et al. Daily interrup- tion of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med 2000; 342: 1471–1477.
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