More to the paper on ‘Homeopathy in Sepsis in ICU’ than meets the eye

Frass et al are to be congratulated on an excellent piece of work on the role of homeopathy in critically ill patients.[ ¹ ] It is a pleasant surprise to read the use of homeopathy in severe, acute illness. Homeopathy is more often associated with chronic illness and with intractable conditions where other treatments are limited by side effects and/or poor efficacy. Of course, earlier in its history (perhaps as late as mid-20th century) homeopathy had numerous examples of benefit in life-threatening illnesses. Could this paper mark a revival of homeopathy in this area?

I admire the authors for taking a bold step, also for persuading the ICU medical staff and the ethics committee to support a trial of homeopathy in adult septic shock. I am intrigued by (and a little jealous of) this achievement! Like all important papers, this one sparks many thoughts, including:

• The role of randomised control trial in homeopathy (the issue of simplicity vs complexity).

• The nature of information provided by the results of a randomised controlled trial, and not just in relation to homeopathy.

• Attempting to quantify treatment effects—and their importance.

• The apparent lack of antidoting and interference by potent drugs on homeopathy.

Classical homeopathy is a complex intervention involving multiple components. It has therefore been argued that the double-blind randomised control trial (DBRCT) method poses several methodological difficulties when applied to homeopathic practice.[ ² ] The complexity arises from the inherent nature of homeopathic history taking, individual practitioners, knowledge and experience, accuracy of prescription and often the need for several medicines in sequence to effect a successful outcome. In this study, however, the homeopathic intervention was simplified, apparently to a single homeopathic review within 48 h of enrolment in the study and the same medicine repeated every 12 h.

Where a therapeutic intervention has been simplified to essentially one step or task, the DBRCT method of assessing efficacy is a powerful tool. One of its main strength is that the conclusions drawn from trials using such methodology can be robust. But mainstream practitioners have rightly been reluctant to accept the limitations of DBRCTs when applied to complex interventions. A good example was the reporting of a multi-centre trial of caesarean section vs vaginal delivery for the management of breech presentation, which concluded that vaginal delivery was not as safe as caesarean section.[ ³ ]

A subsequent review published in the BMJ criticised the conclusion because the complexity of ‘safe vaginal delivery’ was studied as if it were a simple one-step intervention.[ ⁴ ] Whereas in reality the intervention is determined by the experience of the clinical team, the number of vaginal breech deliveries performed in each participating unit, the method and style of foetal monitoring and the confidence in managing breech delivery, to name but a few. The sweeping conclusion that caesarean section is safer than vaginal delivery was criticised as an over simplification. The challenge remains to find the most appropriate tool for studying ‘complex’ homeopathy. But for ‘simple’ homeopathy the DBRCT has its uses. Note that here ‘complex’ refers to the nature of the intervention, not the homeopathic medicine.

• References

• [1] Frass M, Linkesch M, Banyai S, et al. Adjunctive homeopathic treatment in patients with severe sepsis: a randomized, double-blind, placebo-controlled trial in an intensive care unit.
• [2] Van Haselen R. Randomised placebo controlled trials of classical homeopathy: is there a problem?. Brit Hom J 1998; 87: 1288-1300.
• [3] Hannah M.E, Hannah W.J, Hewson S.A, Hodnett E.D, Saigal S, Willan A.R. Planned cesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial Term Breech Trial Collaborative Group.. Lancet 2000; 356: 1375-1383.
• [4] Kotaska A. Inappropriate use of randomised trials to evaluate complex phenomena: case study of vaginal breech delivery. BMJ 2004; 329: 1039-1042.
• [5] Bernard G.R, Vincent J.L, Laterre P.F. et al. Recombinant human protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 2001; 344 (10) 699-709.
• [6] Paediatric Intensive Care Audit Network National Report 2003–2004 (published May 2005): Universities of Leeds, Leicester and Sheffield, ISBN 0 85316 2549.