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European Journal of Heart Failure 2004 6(4):517-518; doi:10.1016/j.ejheart.2004.04.005
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© 2004 European Society of Cardiology

Response from editor to letter to the editor—Alternative approaches to the management of heart failure: Editors response

John G.F. Cleland*

Cottingham, Kingston-upon-Hull, UK E-mail address: a.p.coletta{at}hull.ac.uk

One of the cardinal sins of science is a closed mind. The Journal received a large amount of correspondence criticising the publication of an article by Schroder et al. on Cralonin, a treatment that can either be used as a ‘herbal’ or homeopathic treatment for patients with ‘mild’ heart failure [1–6]. I was not surprised to receive this criticism. The paper probably would have been rejected had the subject of enquiry been of a ‘conventional’ pharmacological agent. However, I believe it is wrong, currently, to apply the same rigorous standards to all branches of health care, although it should be a long-term goal of scientific research to raise the quality of all research. The question is how best to achieve that goal. Scientific research methods did not suddenly appear in ‘conventional’ medicine, they evolved over centuries and continue to do so. Engaging and encouraging disciplines that have not yet evolved to a rigorous level is an important role for scientific journals. Moreover, the fresh perspectives that alternative disciplines can bring should be welcomed by an open-minded scientific community. The article by Schroder et al. is an important step in this direction. The authors should be congratulated for having the courage and desire to make an effort when scientists practicing ‘conventional’ medicine have shown little interest in ‘alternative’ medicine, suggesting that their minds are ‘closed’. Interested scepticism on the part of ‘conventional’ medicine would have developed good trials to show whether the scepticism is warranted rather than leaving this matter to others. Why have the ‘conventional’ scientists failed so badly?

The goals of treating heart failure are to improve how patients feel (this can ONLY be assessed subjectively), reduce morbidity (semi-objective) and delay mortality (objective). The suggestion that relevant, subjective patient assessments are in some way inferior to objective surrogate markers for the evaluation of treatments for heart failure is clearly nonsense. Making or keeping patients feeling well is one of our major tasks as doctors. Many patients seek homeopathic practitioners. Are they wrong to do so? If they feel better as a result, then surely we need to have objective evidence that it could have been done more effectively, more efficiently or more safely by other means before we reject the patient's experience out of hand. I have no doubt whatsoever that many patients benefit and that some patients are harmed by homeopathic care, just as they are with ‘conventional’ medicine. We need to engage our colleagues in alternative medicine to find out why patients seek their help, why they are usually happy with the care they receive and whether their treatments alter clinically relevant measures of disease, not surrogate markers such as exercise capacity, cardiac function or hospitalisation. The Journal has already published the design paper for the first adequately-powered, randomised, placebo-controlled mortality trial of an ‘alternative’ medicine for heart failure [2]. It is important that this momentum and direction are maintained.

‘Conventional’ medicine should examine its own practices with care. Where is the randomised controlled trial showing that revascularisation is of benefit in patients with heart failure and ischaemic heart disease [7]. Huge amounts of health care resources are poured into such procedures, cause much suffering to patients and yet we do not know if they are safe or effective? Indeed, the largest trial of angioplasty for chronic angina (there are none in heart failure) suggests that this procedure causes objective harm and it is only the patients subjective experience of angina reduction that provides a basis for providing this therapy [8]. There is no trial showing a substantial benefit from long-term aspirin therapy and considerable evidence to suggest harm but the ‘herd’ instinct compels most ‘conventional’ practitioners to prescribe it [9]. I am far less concerned about any potential harm from alternative medicine than I am about the harm from unproven ‘conventional’ medicine.

Some correspondents suggested that it was unethical to withhold ACE inhibitors for a few weeks and yet several large ‘conventional’ trials of patients with heart failure or major post-infarction left ventricular systolic dysfunction have done precisely that without any great outcry about ethics [10–13]. Does ‘conventional’ medicine have ‘double-standards’ when judging other disciplines? ‘Conventional’ medicine has improved the care of patients with heart failure but not to the extent that some believe. Many patients have severe persisting symptoms despite (and sometimes because of) conventional medicine and patients continue to die prematurely with monotonous regularity. The impact of ACE inhibitors in mild heart failure is useful but probably not dramatic. The HOPE study [14] suggested that 98.2% of patients did not benefit over 5 years from the introduction of an ACE inhibitor in terms of death (12.2% died on placebo vs. 10.4% on ramipril) and 96.2% (17.8% on placebo reduced to 14.0% on ramipril) did not benefit in terms of death, infarction or stroke. Likewise, in the SOLVD-treatment study [15], over 3 years, 95% of patients did not benefit in terms of death and 90% did not benefit in terms of death or hospitalisation for heart failure. Getting rid of the hype and looking at the reality of ‘conventional’ heart failure medicine is sobering. Even with the best available conventional treatment one in every four patients with heart failure and left ventricular systolic dysfunction recruited to a randomised controlled trial will die within 3.5 years [16]. It is likely that patients in the ‘real’ world do much worse. Heart failure has yet to find something as effective as penicillin, histamine-2-antagonists or proton-pump inhibitors that radically change patients’ lives. Indeed, one of the most effective groups of agents used for heart failure symptoms, loop diuretics, has not been subjected to robust clinical trials.

Let's celebrate the success of bringing different medical cultures together to focus on patients’ unmet needs. Stifling alternative opinions, even if you do not like them, is unhealthy and should not be condoned by the scientific community. The study design of the paper by Schroder et al was not robust and the authors readily admit this. The final conclusion of the authors was absolutely sound and yet seems to have been over-looked by the correspondents. The authors called for precisely the sort of study, as an add-on to conventional therapy, that the correspondents criticised them for not doing. As a result of the publication of this paper, I think it is far more likely that such a trial will happen than if it had been rejected.


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* Tel.: +44-1482-624086; fax: +44-1482-624085 Back


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  1. Schroder D, Weiser M, Klein P. Efficacy of a homeopathic Crataegus preparation compared with usual therapy for mild (NYHA II) cardiac insufficiency: result of an observational cohort study. Eur J Heart Fail (2003) 5:319–326.[Abstract/Free Full Text]
  2. Holubarsch C.J, Colucci W.S, Meinertz T, Gaus W, Tendera M. Survival and prognosis: investigation of Crataegus extract WS 1442 in congestive heart failure (SPICE)—rationale, study design and study protocol. Eur J Heart Fail (2000) 2:431–437.[Abstract/Free Full Text]
  3. Zanolla L. Letter to the Editor. Eur J Heart Fail 2004; this issue.
  4. Clark AL, Morice A. Letter to the Editor. Eur J Heart Fail 2004; this issue.
  5. Niebauer J. Letter to the Editor. Eur J Heart Fail 2004; this issue.
  6. Anker S. Letter to the Editor. Eur J Heart Fail 2004; this issue.
  7. Cleland J.G.F, Freemantle N, Ball S.G, et al. The heart failure revascularisation trial (HEART): rationale, design and methodology. Eur J Heart Fail (2003) 5(3):295–303.[Abstract/Free Full Text]
  8. RITA-2 trial participants. Coronary angioplasty vs. medical therapy for angina: the second randomised intervention treatment of angina (RITA-2) trial. Lancet 1997;350:461–468.
  9. Cleland JGF, Ghosh J, Freemantle N, et al. Clinical trials update and cumulative meta-analyses from the American College of Cardiology: WATCH, SCD-HeFT, DINAMIT, CASINO, INSPIRE, STRATUS-US, RIO-LIPIDS and cardiac resynchronisation therapy in heart failure. Eur J Heart Fail 2004; in this issue.
  10. Komajda M, Lutiger B, Madeira H, et al. Tolerability of carvedilol and ACE-Inhibition in mild heart failure Results of CARMEN (Carvedilol ACE-Inhibitor Remodelling Mild CHF EvaluatioN). Eur J Heart Fail 2004; in this issue.
  11. Pfeffer M.A, McMurray J.V, Velazquez E.J, et al. Valsartan, Captopril, or Both in Myocardial Infarction Complicated by Heart Failure, Left Ventricular Dysfunction, or Both. N Engl J Med (2003) 349:1893–1906.[Abstract/Free Full Text]
  12. Dickstein K, Kjekshus J. OPTIMAAL Steering Committee of the OPTIMAAL Study Group. Effects of losartan and captopril on mortality and morbidity in high-risk patients after acute myocardial infarction: the OPTIMAAL randomised trial. Optimal Trial in Myocardial Infarction with Angiotensin II Antagonist Losartan. Lancet (2002) 360(9335):752–760.[CrossRef][Web of Science][Medline]
  13. Pitt B, Poole-Wilson P.A, Segal R, et al. Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure: randomised trial--the Losartan Heart Failure Survival Study ELITE II. Lancet (2000) 355(9215):1582–1587.[CrossRef][Web of Science][Medline]
  14. The Heart Outcomes Prevention Evaluation Study Investigators. Effects of an angiotensin converting enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Eng J Med 2000;342:145–153.
  15. The SOLVD Investigators. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Eng J Med 1991;325:293–302.
  16. Pfeffer M.A, Swedberg K, Granger C.B, et al. for the CHARM investigators and committees. Effects of candesartan on mortality and morbidity in patients with chronic heart failure: the CHARM-Overall programmem. Lancet (2003) 362(9386):759–766.[CrossRef][Web of Science][Medline]

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This Article
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