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  • 1135THE LANCET

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    2. Bone RC, Fisher CJ Jr, Clemmer TP, et al. Sepsis syndrome: a validclinical entity. Crit Care Med 1989; 17: 389-93.

    3. Kaplan RL, Sahn SA, Petty TL. Incidence and outcome of therespiratory distress syndrome in gram-negative sepsis. Arch Intern Med1979; 139: 867-69.

    4. Fowler AA, Hamman RF, Good JT, et al. Adult respiratory distresssyndrome: risk with common predispositions. Ann Intern Med 1983;98: 593-97.

    5. Martin MA, Silverman HJ. Gram-negative sepsis and the adultrespiratory distress syndrome. Clin Infect Dis 1992; 14: 1213-28.

    6. Niederman MS, Fein AM. Sepsis syndrome, the adult respiratorydistress syndrome, and nosocomial pneumonia: a common clinicalsequence. Clin Chest Med 1990; 11: 633-56.

    7. Montgomery AB, Stager MA, Carrico CJ, Hudson LD. Causes ofmortality in patients with the adult respiratory distress syndrome.Am Rev Respir Dis 1985; 132: 485-89.

    8. Seidenfeld JJ, Pohl DF, Bell RC, Harris GD, Johanson WG Jr.Incidence, site and outcome of infections in patients with the adultrespiratory distress syndrome. Am Rev Respir Dis 1986; 134: 12-16.

    9. van Deventer SJH, Buller HR, ten Cate JW, Sturk A, Pauw W.Endotoxaemia: an early predictor of septicaemia in febrile patients.Lancet 1988; i: 605-09.

    10. Parsons PE, Worthen GS, Moore EE, Tate RM, Henson PM. Theassociation of circulating endotoxin with the development of the adultrespiratory distress syndrome. Am Rev Respir Dis 1989; 140: 294-301.

    11. Miyata T, Yokoyama I, Todo S, Tzakis A, Selby R, Starzl TE.Endotoxaemia, pulmonary complications, and thrombocytopenia inliver transplantation. Lancet 1989; ii: 189-91.

    12. Danner RL, Elin RJ, Hosseini JM, Wesley RA, Reilly JM, Parillo JE.Endotoxaemia in human septic shock. Chest 1991; 99: 169-75.

    13. Brandtzaeg P, Kierulf P, Gaustad P, et al. Plasma endotoxin as a predictorof multiple organ failure and death in systemic meningococcal disease. JInfect Dis 1989; 159: 195-204.

    14. Andersen BM, Solberg O. Endotoxin liberation and invasivity ofNeisseria meningitidis. Scand J Infect Dis 1984; 16: 247-54.

    15. Bell RC, Coalson JJ, Smith JD, Johanson WG Jr. Multiple organ systemfailure and infection in adult respiratory distress syndrome. Ann InternMed 1983; 99: 293-98.

    16. Boucek MM, Boerth RC, Artman M, Graham TP Jr, Boucek RJ.Myocardial dysfunction in children with acute meningococcemia.J Pediatr 1984; 105: 538-42.

    17. Vandenroucke-Grauls CMJE, Vandenbroucke JP. Effect of selectivedecontamination of the digestive tract on respiratory tract infectionsand mortality in the intensive care unit. Lancet 1991; 338: 859-62.

    18. Fein AM, Lippmann M, Holtzman H, Eliraz A, Goldberg SK. The riskfactors, incidence, and prognosis of ARDS following septicemia. Chest1983; 83: 40-42.

    19. Ognibene FP, Martin SE, Parker MM, et al. Adult respiratory distresssyndrome in patients with severe neutropenia. N Engl J Med 1986; 315:547-51.

    20. Wortel CH, von der Mohlen AM, van Deventer SJH, et al. Effectivenessof a human monoclonal anti-endotoxin antibody (HA-1A) in gram-negative sepsis: relationship to endotoxin and cytokine levels. J InfectDis 1992; 166: 1367-74.

    21. Parsons PE, Moore FA, Moore EE, Ilke DN, Henson PM, Worthen GS.Studies on the role of tumor necrosis factor in adult respiratory distresssyndrome. Am Rev Respir Dis 1992; 146: 694-700.

    22. Anon. A nasty shock from antibiotics? Lancet 1985; ii: 594.23. Hurley JC. Antibiotic action and endotoxin [PhD thesis]. Melbourne:

    University of Melbourne, 1991.24. Hurley JC. Antibiotic-induced release of endotoxin: a reappraisal. Clin

    Infect Dis 1992, 15: 840-54.25. Anon. Endotoxaemia or endotoxinaemia? Lancet 1992; 340: 1323.26. Brandtzaeg P, Bryn K. Kierulf P, et al. Meningococcal endotoxin in lethal

    septic shock plasma studied by gas chromatography, mass-spectrometry, ultracentrifugation, and electron microscopy. J ClinInvest 1992; 89: 816-23.

    27. Feingold DS. Biology and pathogenicity of microbial spheroplasts andL-forms. N Engl J Med 1969; 281: 1159-70.

    28. Madoff S, ed. The bacterial L-forms. New York: Marcel Dekker, 1986.29. Yamamoto A, Homma JY. Isolation of unstable L-forms from clinical

    specimens with Pseudomonas infection during antibiotic therapy. Jpn JExp Med 1979; 49: 361-64.

    30. Gutman LT, Turck M, Petersdorf RG, Wedgwood RJ. Significance ofbacterial variants in urine of patients with chronic bacteriuria. J ClinInvest 1965; 44: 1945-52.

    31. McKay KA, Abelseth MK, Vandreumel AA. Production of anenzootic-like pneumonia in pigs with "protoplasts" of Haemophilusparainfluenzae. Nature 1966; 212: 359-60.

    32. Cassell GH, Waites KB, Crouse DT, et al. Association of Ureaplasmaurealyticum infection of the lower respiratory tract with chronic lungdisease and death in very-low-birth-weight infants. Lancet 1988; ii:240-45.

    33. Cassell GH, Waites KB, Watson HL, Crouse DT, Harasawa R.Ureaplasma urealyticum intrauterine infection: role of prematurity anddisease in newborns. Clin Microbiol Rev 1993; 6: 69-87.

    34. Kreger BE, Craven DE, McCabe WR. Gram-negative bacteraemia: IV.Re-evaluation of clinical features and treatment in 612 patients. Am JMed 1980; 68: 344-55.

    35. Moore RD, Lietman PS, Smith CR. Clinical response to aminoglycosidetherapy: importance of the ratio of peak concentration to minimalinhibitory concentration. J Infect Dis 1987; 155: 93-99.

    36. Hurley JC. Bacteremia, endotoxemia and mortality in gram negativesepsis. J Infect Dis (in press).

    37. Korvick JA, Peacock JE Jr, Muder RR, Wheeler RR, Yu VL. Addition ofrifampicin to combination antibiotic therapy for Pseudomonasaeruginosa bacteraemia: prospective trial using the Zelen protocol.Antimicrob Agents Chemother 1992; 36: 620-25.

    38. Tanimoto H. A review of the recent progress in treatment of patients withdiffuse panbrochiolitis associated with Pseudomonas aeruginosainfection in Japan. Antibiot Chemother 1991; 44: 94-98.

    VIEWPOINT

    Searching for alternatives:loser pays

    Some conventional doctors have made it their mission tofight alternative medicine. To them, what is taught in theivory university tower is the only truth, almost by definition."Listen", they argue, "you may feel better after seeing yourfavourite charlatan, but the benefit of his interventions, ifany, is non-specific." At best, they say, alternativepractitioners can be considered masters of placebo therapy.Few patients, however, care about the scientificclassification of their improvement (spontaneous, placebo,or biomedical). They continue to choose the treatment thatthey expect to give them the best overall benefit.

    It is always important to optimise placebo effects, in anykind of medicine. But has mainstream medicine somethingextra to offer over alternative medicine? The answer to thatquestion must come mainly from clinical research.

    Searching the literatureThe method with the greatest impact for showing clinical

    efficacy is the controlled trial. To the surprise of people whoprefer the debate to study of what has been published, thereare many reports of controlled trials of alternative therapies.Sometimes these publications are difficult to trace.Computer databases are biased towards conventionalmedicine because many established journals are reluctant toprint the evidence--especially when it is positive. On theother hand, we also get a biased overview if research initiatedby supporters of alternative medicine is not published whenthe results are disappointing.My experience with alternative researchers is that many

    are honest people and welcome any effort to dig up the greyliterature. Sometimes one finds promising data. Theliterature on ginseng, for instance, which cannot be found on

    ADDRESSES- Department of Epidemiology, University ofLimburg, PO Box 616, 6200 MD Maastricht, Netherlands(Prof P. Knipschild, MD).

  • 1136 THE LANCET

    Medline, shows that it is a helpful tonic for elderly patientswho lack vitality.l Ginkgo biloba has been extensivelystudied in many trials in Germany and France; it seems towork against what the Germans call a TK/eMM.otM(cerebral insufficiency).2 But how many in theAngloamerican rampart of science read foreign languages?

    HomoeopathyLet me give one illustration of how exhaustive an

    alternative literature search can be. People from mydepartment rolled up their sleeves to look for researchpapers on the effectiveness of homoeopathy. The DutchMinistry of Public Health funded the enterprise.A Medline/Embase search (till 1991) gives 18 published

    reports of controlled trials on homoeopathy. Stepwisechecking the references in these publications yields 28 more.If you stop here, you miss more than half of all studies.3We continued browsing through many alternative

    journals, including homoeopathic journals. Our rummagein congress reports and doctoral theses in specialisedlibraries in Paris, Hamburg, London, and Glasgow was veryrewarding. Many homoeopathic companies offered help.We wrote to well-known investigators working on thissubject and sometimes paid them a visit. It was importantthat they felt comfortable discussing homoeopathy with us,so our meetings were often held in good restaurants! Weheard details of their studies that were not published andreceived other reports that were still confidential. Ourjourney into homoeopathy produced a pile of more than 100controlled studies. Our subsequent meta-analysis showed,to our astonishment, beneficial effects for homoeopathy inmany (but not all) well-performed trials."

    Lately, we have collected many efficacy studies on alltypes of alternative treatments. Many of these studies are notvery convincing because of faults with the methods. Ifacademia does not help, alternative practitioners may notsucceed in doing sound clinical research. Still, many are veryresearch-minded, and would welcome the chance to workwith honest, conventional practitioners on new projects.

    IridologyOur study of iridology is a good example of such

    cooperation. Medical students challenged me to show thatiridology is not a useful diagnostic aid. I began reading aboutthe method and soon found a dozen studies of varyingquality, mostly done and published in Germany. Theevidence in favour of iridology seemed thin. When Idiscussed its usefulness with leading Dutch iridologists,many turned out to be very willing to do a new study.We agreed to concentrate on cholecystitis ("Gallstones in

    your eye") and the iridologists readily accepted my writtenprotocol. Without receiving any payment, five of the bestwere anxious to stand the test. One even promised me thathe would ban iridology from his alternative practicealtogether if the new study also showed disappointingresults. Unfortunately, iridology was completely useless fordiscriminating between patients and healthy controls.5 I amtold that the iridologist who promised to abandon themethod later took up computerised medical astrology as adiagnostic aid instead.A later survey showed the impact of the iridology study.

    Many doctors who were not sure about the methodbeforehand could be persuaded of its lack of usefulnesswhen I showed them the empirical evidence.6 Isnt this whatmedical research is all about?

    BettingAs long as enough doctors and patients are interested in its

    results, additional research of high quality makes sense. Ibelieve the burden of proof lies mainly with the alternativepractitioners, who make a living out of it. But it is fair to lendthem a hand.Who should fund the research? It is too easy to point to

    government only. To make future research in this field evenmore fun than it already is, I propose to apply Hofsteesbetting model. Prestige will be at stake, but also for a realbetting game we need two parties who want the other to payfor a new study.As it is, there are two distinguished camps. Lets take

    acupuncture for patients with chronic pain as an example. Inone corner is the Union Against Quackery, a noisyorganisation of very conventional doctors. They completelydespise alternative medicine and look forward to shuttingdown every acupuncture practice with the help of the police.In the other corner we find the Platform of ClassicalAcupuncturists. They believe so strongly in what the yellowemperor advocated in the Nei Ching that they believe thenon-application of needles is negligence.

    I would like both parties to get together for a bettinggame. First we supply them with the existing, clinicalevidence.8 If they still want to do a new study to clean out theother, they are invited to design and perform, in fullcooperation, the ultimate trial to prove or disprove theirclaim. After the study, we strike the balance, not only foracupuncture but also financially. The loser pays for thestudy.

    REFERENCES

    1. Knipschild P. Ginseng: pep of nep?. Pharm Wkly 1988; 123: 4-11.2. Kleijnen J, Knipschild P. Ginkgo biloba for cerebral insufficiency. Br J

    Clin Pharmacol 1992; 34: 352-58.3. Kleijnen J, Knipschild P. The comprehensiveness of Medline and

    Embase computer searches. Pharm Wkly (Sci) 1992; 14: 316-20.4. Kleijnen J, Knipschild P, Ter Riet G. Clinical trials of homoeopathy.

    BMJ 1991; 302: 316-23.5. Knipschild P. Looking for gall bladder disease in the patients iris. BMJ

    1988; 297: 1578-81.6. Knipschild P. Changing belief in iridology after an empirical study. BMJ

    1989; 299: 491-92.7. Hofstee WKB. De empirische discussie. Meppel: Boom, 1980.8. Ter Riet G, Kleijnen J, Knipschild P. Acupuncture and chronic pain: a

    criteria-based meta-analysis. J Clin Epidemiol 1990; 43: 1191-99.

    From The Lancet

    Swollen bladders

    As a general practitioner of 30 years standing I am writingthrough you to those in authority in order to point out a very realphysical grievance to which our women motor-drivers are exposed.There have been under my care lately cases of women driverssuffering from atony of the bladder and cystitis due to over-distension in the performance of their duties. They tell me that veryrarely is any provision for their relief afforded, and though they takeno fluid all day they frequently suffer badly from distension due tothe absence of the smallest forethought on the part of those driven.One lady told me she often had to drive officers from London to acamp and back, a journey of many miles. On her arrival she wasalways asked to lunch in mess, previously being invited to wash herhands, no provision for a less literal interpretation being provided,with the usual result of all but intolerable distension. The worstoffenders are too young to remember that a bladder is an essentialpart of a womans physical equipment. The older officers, fathers offamilies, are the most considerate.

    (March 30, 1918)

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