Homeopathy (2014) -, 1e2 Ó 2014 The Faculty of Homeopathy http://dx.doi.org/10.1016/j.homp.2014.05.004, available online at http://www.sciencedirect.com
EDITORIAL
Malaria in pregnancy and irritable bowel syndrome This issue of Homeopathy features randomised, controlled clinical trials in two very different diseases, both of significant public health concern in different parts of the world: malaria in pregnancy and irritable bowel syndrome, and both evaluated homeopathy as an adjunct to conventional treatment. Homeopathy and malaria is a sensitive area: one of the first shots fired in the campaign against homeopathy was an expose broadcast on BBC TV showing unqualified practitioners of homeopathy giving highly irresponsible advice on malaria prophylaxis. The advice, not to take conventional malaria prophylaxis and to rely instead on homeopathy, was dangerous and indefensible.
Homeopathy toreduce adverse effects of quininein pregnancy Danno et al, in this issue of Homeopathy, report a randomised controlled trial which takes the opposite approach, looking at the potential of homeopathy to improve the tolerability of, and compliance with, conventional treatment of malaria in pregnant women. Malaria remains the greatest public health problem in Africa: in 2012 there were over 200 million cases and over 600,000 deaths from malaria, most of them in Africa. One child dies every minute from malaria in Africa, although there has been significant improvement in the last decade. Apart from children, pregnant women are at high risk, malaria causes high rates of miscarriage and can lead to maternal death.1 In Benin, West Africa, malaria is endemic and is the leading cause of mortality, accounting for 20% of all deaths.2 Danno et al conducted a randomised controlled trial of simple design looking at the impact of homeopathic China rubra 7CH in addition to standard quinine treatment in pregnant women in Benin.3 No attempt was at blinding and there was no placebo, control was simply standard treatment. The outcomes were adverse effects of treatment and compliance with conventional treatment. The randomisation scheme was simple: patients attending in the first half of the month received China rubra 7CH in addition to standard treatment, those attending in the second half of the month received standard treatment only. The decision on which half of the month received standard treatment only and in which half additional homeopathic treatment was made randomly and resulted in groups which were well matched in terms of size and demographic variables. The trial was commercially sponsored although the medication used is generic, and produced by many homeopathic manufacturers. Indeed it
is the original homeopathic medicine. Hahnemann’s seminal proving was of Cinchona bark, which is China rubra. The results show a highly significant reduction in the numbers of adverse treatment effects in the group receiving China rubra on intention-to-treat analysis. Of greater potential importance is the higher compliance in the treated group, presumably associated with the reduced adverse effects: of the 211 participants, 54% of the standard treatment group completed treatment, compared to 68% of the group which received homeopathic China rubra. There was virtually no loss to follow-up, the reasons for non completion are known in all but one case. There are weaknesses to this study which the authors acknowledge but these findings certainly deserve further investigation.
Homeopathyor supportivelisteningin addition to standard care forirritable bowelsyndrome Also in this issue Peckham et al report the preliminary findings of a randomised, controlled study conducted in the UK of irritable bowel syndrome. Irritable bowel syndrome is extremely common, with an estimated prevalence of in Europe and North America of 10e15% and in the UK 12% on the basis of the standard Rome criteria.4 Peckham at al recruited patients from a local cohort of patients suffering irritable bowel syndrome from primary and secondary care.5 Randomisation again was somewhat unusual, they used a 4:1:1 randomisation between standard care: homeopathic treatment in addition to standard care: an equivalent number of sessions of supportive listening in additional to standard care. Homeopathic treatment was given by two experienced Members of the Society of Homeopaths. Recruitment was disappointing, nevertheless 94 patients were randomised and there was little lost to follow-up. The study is underpowered (although the authors hope to recruit more patients) and no firm conclusions can be drawn. Nevertheless it is notable that the group which received Homeopathy in addition to standard care had the greatest improvement in the main outcome measure, the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) and was the only group in which no patients were lost to follow-up. Presumably the power of this study would have been increased if randomisation had been more balanced, with equal numbers assigned to the three treatments. The authors are seeking further funding to complete the study with adequate statistical power. I hope that they succeed in finding support.
Please cite this article in press as: Fisher P, Malaria in pregnancy and irritable bowel syndrome, Homeopathy (2014), http://dx.doi.org/10.1016/ j.homp.2014.05.004
Editorial P Fisher
2
References 1 www.who.int/mediacentre/factsheets/fs094/en (Accessed 17.05.2014). 2 www.cdc.gov/globalhealth/countries/benin (Accessed 17.05.2014). 3 Danno K, Rerolle F, De Sigalony S, Drouet A, Terzan L, Bordet M-F. Impact of China rubra 7CH on the side-effects of quinine: a prospective randomised study comparing China rubra plus quinine versus quinine only in pregnant women with malaria in Cotonou, Benin. Homeopathy 2014; 103: 164e170. 4 Quigley E, Fried M, Gwee KA, et al. Irritable bowel syndrome: a global perspective. World Gastroentereology Organisation, www.
worldgastroenterology.org/assets/downloads/en/pdf/guidelines/20_ irritable_bowel_syndrome.pdf; 2009 (Accessed 17.05.2014). 5 Peckham E, Relton C, Raw J, et al. Interim results of a randomised controlled trial of homeopathic treatment for irritable bowel syndrome. Homeopathy 2014; 103: 171e177.
Peter Fisher Editor-in-Chief E-mail: [email protected]
Homeopathy Please cite this article in press as: Fisher P, Malaria in pregnancy and irritable bowel syndrome, Homeopathy (2014), http://dx.doi.org/10.1016/ j.homp.2014.05.004
EDITORIAL
Malaria in pregnancy and irritable bowel syndrome This issue of Homeopathy features randomised, controlled clinical trials in two very different diseases, both of significant public health concern in different parts of the world: malaria in pregnancy and irritable bowel syndrome, and both evaluated homeopathy as an adjunct to conventional treatment. Homeopathy and malaria is a sensitive area: one of the first shots fired in the campaign against homeopathy was an expose broadcast on BBC TV showing unqualified practitioners of homeopathy giving highly irresponsible advice on malaria prophylaxis. The advice, not to take conventional malaria prophylaxis and to rely instead on homeopathy, was dangerous and indefensible.
Homeopathy toreduce adverse effects of quininein pregnancy Danno et al, in this issue of Homeopathy, report a randomised controlled trial which takes the opposite approach, looking at the potential of homeopathy to improve the tolerability of, and compliance with, conventional treatment of malaria in pregnant women. Malaria remains the greatest public health problem in Africa: in 2012 there were over 200 million cases and over 600,000 deaths from malaria, most of them in Africa. One child dies every minute from malaria in Africa, although there has been significant improvement in the last decade. Apart from children, pregnant women are at high risk, malaria causes high rates of miscarriage and can lead to maternal death.1 In Benin, West Africa, malaria is endemic and is the leading cause of mortality, accounting for 20% of all deaths.2 Danno et al conducted a randomised controlled trial of simple design looking at the impact of homeopathic China rubra 7CH in addition to standard quinine treatment in pregnant women in Benin.3 No attempt was at blinding and there was no placebo, control was simply standard treatment. The outcomes were adverse effects of treatment and compliance with conventional treatment. The randomisation scheme was simple: patients attending in the first half of the month received China rubra 7CH in addition to standard treatment, those attending in the second half of the month received standard treatment only. The decision on which half of the month received standard treatment only and in which half additional homeopathic treatment was made randomly and resulted in groups which were well matched in terms of size and demographic variables. The trial was commercially sponsored although the medication used is generic, and produced by many homeopathic manufacturers. Indeed it
is the original homeopathic medicine. Hahnemann’s seminal proving was of Cinchona bark, which is China rubra. The results show a highly significant reduction in the numbers of adverse treatment effects in the group receiving China rubra on intention-to-treat analysis. Of greater potential importance is the higher compliance in the treated group, presumably associated with the reduced adverse effects: of the 211 participants, 54% of the standard treatment group completed treatment, compared to 68% of the group which received homeopathic China rubra. There was virtually no loss to follow-up, the reasons for non completion are known in all but one case. There are weaknesses to this study which the authors acknowledge but these findings certainly deserve further investigation.
Homeopathyor supportivelisteningin addition to standard care forirritable bowelsyndrome Also in this issue Peckham et al report the preliminary findings of a randomised, controlled study conducted in the UK of irritable bowel syndrome. Irritable bowel syndrome is extremely common, with an estimated prevalence of in Europe and North America of 10e15% and in the UK 12% on the basis of the standard Rome criteria.4 Peckham at al recruited patients from a local cohort of patients suffering irritable bowel syndrome from primary and secondary care.5 Randomisation again was somewhat unusual, they used a 4:1:1 randomisation between standard care: homeopathic treatment in addition to standard care: an equivalent number of sessions of supportive listening in additional to standard care. Homeopathic treatment was given by two experienced Members of the Society of Homeopaths. Recruitment was disappointing, nevertheless 94 patients were randomised and there was little lost to follow-up. The study is underpowered (although the authors hope to recruit more patients) and no firm conclusions can be drawn. Nevertheless it is notable that the group which received Homeopathy in addition to standard care had the greatest improvement in the main outcome measure, the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) and was the only group in which no patients were lost to follow-up. Presumably the power of this study would have been increased if randomisation had been more balanced, with equal numbers assigned to the three treatments. The authors are seeking further funding to complete the study with adequate statistical power. I hope that they succeed in finding support.
Please cite this article in press as: Fisher P, Malaria in pregnancy and irritable bowel syndrome, Homeopathy (2014), http://dx.doi.org/10.1016/ j.homp.2014.05.004
Editorial P Fisher
2
References 1 www.who.int/mediacentre/factsheets/fs094/en (Accessed 17.05.2014). 2 www.cdc.gov/globalhealth/countries/benin (Accessed 17.05.2014). 3 Danno K, Rerolle F, De Sigalony S, Drouet A, Terzan L, Bordet M-F. Impact of China rubra 7CH on the side-effects of quinine: a prospective randomised study comparing China rubra plus quinine versus quinine only in pregnant women with malaria in Cotonou, Benin. Homeopathy 2014; 103: 164e170. 4 Quigley E, Fried M, Gwee KA, et al. Irritable bowel syndrome: a global perspective. World Gastroentereology Organisation, www.
worldgastroenterology.org/assets/downloads/en/pdf/guidelines/20_ irritable_bowel_syndrome.pdf; 2009 (Accessed 17.05.2014). 5 Peckham E, Relton C, Raw J, et al. Interim results of a randomised controlled trial of homeopathic treatment for irritable bowel syndrome. Homeopathy 2014; 103: 171e177.
Peter Fisher Editor-in-Chief E-mail: [email protected]
Homeopathy Please cite this article in press as: Fisher P, Malaria in pregnancy and irritable bowel syndrome, Homeopathy (2014), http://dx.doi.org/10.1016/ j.homp.2014.05.004
