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Upper respiratory tract infections and otitis media
Complementary Therapiesin Medicine (1997)5, 9%101
© PearsonProfessionalLtd 1997
Upper respiratory tract infections and otitis media G.T. L e w i t h University of Southampton, Southampton, UK
SUMMARY. This article examines the evidence for the use of homoeopathy and dietary exclusion in the management of upper respiratory tract infections and otitis media. The evidence for homoeopathy is largely anecdotal, but substantively supported by a few good clinical trials. The evidence for dietary exclusion is more limited, but again of interest, particularly in relation to milk-exclusion.
INTRODUCTION
the field of upper respiratory tract disease. All showed a positive effect, indicating that homoeopathy was superior to placebo in the treatment of these conditions. Four of these 19 studies were in the top 8 as scored by Kleijnen et al. It is also interesting to note that, in the majority of these studies, a form of polypharmacy was used. Many homoeopaths, particularly in France and Germany, use mixtures or complexes in order to treat certain specific conditions, rather than the single remedies commonly used in the UK. These are often constructed so that they are targeted or 'balanced' at the likely problems which may occur in someone suffering from a polysymptomatic complaint such as 'flu or menopausal symptoms. The prescription of complexes directly contradicts the approach that is used by single homoeopaths, who often attempt to prescribe a single constitutional remedy. Homoeopaths will prescribe a fairly low-potency remedy for simple acute conditions, usually a C6, but this is invariably a single remedy. Most complexes are also low-potency, frequently being C6 and below. The review on upper respiratory tract disease would implicitly, therefore, support the value of homoeopathic complexes in the management of these simple and common conditions. The study that scored the highest mark as far as scientific competence was concerned was that carried out by Ferley et al. 2 This study represents one of the first attempts at a randomized controlled trial to evaluate the real clinical effects of one of France's best-selling common-cold remedies, the homoeopathic preparation Oscillocoecinum. The patients were entered if they presented with increased temperature, headache, stiffness, lumbar and articular pain, and 'the shivers', i.e. a clinical diagnosis of influenza. No immunological tests were used, which in many ways reduplicates the clinical situation in general
Claims are frequently made by homoeopaths that homoeopathic remedies are superior to antibiotics in the treatment of upper respiratory tract infections (URTIs) and acute otitis media. If such approaches can be used to manage acute episodes of illness in childhood, they represent a valuable, simple and safe approach to a whole group of common complaints. It is possible that homoeopathy may offer the general practitioner an important alternative to the repeated prescription of antibiotics. This article will examine the use of both homoeopathy and environmental medicine in the treatment of URTIs and otitis media.
HOMOEOPATHY Kleijnen et al, in their 1991 review of clinical trials within homoeopathy, were able to identify 19 studies in which homoeopathy was used for a variety of different upper respiratory tract problems. 1These included influenza, pharyngitis, the common cold, whooping cough, and otitis media. Of these 19 studies, 12 gave a positive result with respect to homoeopathic treatment. Kleijnen et al also scored the studies on methodological grounds, looking at whether the trials involved proper randomization, adequate patient numbers, and good blind outcome assessment. A rank order of studies was then constructed, and it was quite clear from this that four of the most competent evaluations of homoeopathy had been carried out within
George T. Lewith MA, DM, MRCP, MRCGP, Honorary Visiting Clinical Senior Lecturer, University Medicine, Level D, Centre Block, Southampton General Hospital, Tremona Road, Southampton SO16 6YD, UK. 99
100
Complementary Therapies in Medicine
practice almost exactly. However, it would have been more convincing, from an academic point of view, to have some immunological evidence of viral infection. The study itself was well thought through and there were clear outcome criteria for monitoring the patients. There were also clear criteria for evaluating and defining recovery in relation to the clinical signs and symptoms used for entry. A total of 480 patients were entered into the study and randomly allocated to those receiving placebo or homoeopathic treatment. The proportion of cases who recovered within 48 h of treatment was far greater amongst the active drug group (those receiving the real homoeopathic remedy) than those in the placebo group. In all, 17.1% recovered within 48 h in the homoeopathic group, and 10.3% in the placebo group; this is a statistically significant result. The authors appear almost apologetic about their results; they emphasize the fact that there is no underlying mechanism to explain homoeopathy, in spite of the clear result obtained. We do not understand the exact mechanism of general anaesthesia, but that does not appear to have stopped anaesthetists using these medicaments both frequently and safely! Why should we be apologetic about an effect that is obvious clinically, but lacks an underlying mechanism? As with many of the complementary therapies, the authors are not claiming that the homoeopathic medication cures the common cold - rather that it speeds recovery. Their method of statistical analysis is of particular interest and involves looking very closely at the speed of recovery after entry into the study. Time is used as the end-point variable. Others working within the field of complementary medicine would be well advised to consider this statistical method carefully, since if this 'survival curve technique' had not been used, an important and significant result could have been missed. After two weeks, both groups would have had exactly the same rate of recovery if measurements had been taken only at entry and two weeks subsequent to entry. The study itself is a very competent piece of clinical research, which demonstrates the clinical effectiveness of a simple, cheap, homoeopathic remedy in the context of a common condition. A second study of interest is that of Mossinger? Mossinger looked in a double-blind controlled manner at the use of a single remedy, Pulsatilla, in the treatment of otitis media. Thirty-eight patients were entered, and a double-blind randomized control model was used. Again, patients were evaluated both on the basis of descriptive symptoms and repeated ear examination. It was quite clear from this study that young children could benefit from the use of a single homoeopathic remedy in otitis media. While there are a number of other studies mentioned by Kleijnen et al with respect to the treatment of generalized URTIs this is the only study which specifically looks at the value of homoeopathic
prescriptions in otitis media. There are no negative studies mentioned within the field of otitis media; while there are some negative studies in the fields of coughs, colds and URTIs, they are outweighed by the positive evidence available. The negative studies would appear to be poorly constructed, involve fewer patients, much more limited outcome measures and, therefore, on balance, should be seen as having less value than the majority view which implies that homoeopathy has a beneficial effect on the management of these minor ailments. A study by De Lang 4 took place in Holland between 1987 and 1992. The aim was to study the effects of individually prescribed homoeopathic remedies in children with recurrent URTI. The aim of the research was to define to what degree the remedies affected the frequency, duration and severity of respiratory tract infections in children who suffer from recurrent problems in this area. The study involved 175 children and data was analyzed from 170 of the children; five were excluded because they moved away from the area during the study. The treatments resulted in a small but consistent difference between the two treatment groups in favour of the true homoeopathic remedy. The study was of a double-blind, placebo-controlled nature, and in each instance the general practitioner recommended a prescription for homoeopathic remedies but was unaware whether the child was consistently given a true medicine or a placebo. Antibiotics were used as an escape remedy if this was indicated by the child's clinical presentation. Antibiotic use was far less frequent in the children given true homoeopathic preparations over a prolonged period of time. Minor adverse reactions were seen in both placebo and real treatment groups, in equal numbers. It is therefore reasonable to claim the homoeopathic remedies do not present the patient with a serious risk of adverse reactions. A significantly different situation exists in trials which involve conventional medicine.
CLINICAL ECOLOGY AND NUTRITIONAL MEDICINE While it is quite clear that there is good evidence for the effects of homoeopathy in URTIs, there is little such evidence for the value of food-exclusion. Empirically and clinically, many doctors find that using a milk-exclusion diet can be of real value in the management of chronic tonsillitis, but the evidence that exists in relation to dietary exclusion only really relates to the use of diet in secretory otitis media. Pelikan 5 has written an excellent review of the part allergy has to play in the development of secretory otitis media. He claims that there is good evidence to suggest that type 1 allergy is a major cause
URTIs and otitis media of secretory otitis media. There is also good evidence demonstrating significantly higher levels of immunoglobulin E (IgE) in middle-ear effusions and in the serum of patients with secretory otitis media. There are also higher levels than expected of IgA and IgG in middle-ear effusions and this suggests that a hypersensitivity or food intolerance mechanism may be involved. Clemis6 concludes that foods are regularly involved in secretory otitis media and believes that foods may, in some instances, be more important in allergic diseases of the upper airway than inhaled sensitivities. Pelikan has noted that in 80% of patients with secretory otitis media allergic rhinitis was also present; equally, 5% of patients with allergic rhinitis also have secretory otitis media. He also found that patients provoked with specific food allergens report sharp pains on challenge, usually as a result of measured increased ear pressure. Pelikan goes on to suggest that there are two possible mechanisms of food sensitivity in secretory otitis media. The first is that a middle-ear response can be produced by foods that are eaten and somehow pick the middle ear as their target organ. The second is through allergies that only involve the nasal mucosa. The theoretical basis for the use of food-exclusion in chronic otitis media is therefore at least partially substantiated. A limited number of clinical trials are available, one of which shows that food avoidance can definitely affect the normal progress of otitis media7 and the other which suggests that sodium cromoglycate will have a positive effect on the natural history of secretory otitis media, thereby implying an allergic origin? It is fair to conclude from this that food sensitivity, and in particular milk, judging by the specific IgE responses that have been recorded, is one of the factors that should be considered in patients with chronic secretory otitis media. The practical advice that one can give parents is that if their child is needing to have repeated grommets, or suffering from continued attacks of secretory otitis media, an approach based on food-exclusion which primarily involves milk products, is worthy of at least one month's triM. It may obviate the need for repeated operative intervention.
101
CONCLUSION There is good evidence for the use of homoeopathy in the treatment of URTIs, and some evidence for its use in secretory otitis media. Dietary intervention may well be of help in secretory otitis media. A number of other therapies have also been suggested with respect to these particular conditions. The flow of the academic debate surrounding nutritional supplements, particularly vitamin C and zinc, is fascinating. Some claim that 1-3 g of vitamin C per day represents a magical cure for their cold, while others quote apparently equally good evidence which would appear to dismiss this claim out of hand. Zinc also has been the subject of both positive and negative clinical trials so, while nutritional medicine is commonly used, the evidence for it is certainly equivocal at the present time. There is, however, some good clear evidence that homoeopathy may well be having an effect and therefore an understanding of some of the simpler homoeopathic remedies that can be used in primary care would certainly be of value to the general practitioner.
REFERENCES
1. Kleijnen J, Knipschild P, ter Riet (3. Clinical trials in homoeopathy. BMJ 1991; 302: 316-323. 2. Ferley J, Zimirou D, D'Adhemar D, Balducci E A controlled evaluation of homoeopathic preparations in the treatment of influenza-like syndromes. Lancet 1989; 1: 208-209. 3. Mossinger R Zur Behandlung der Otitis media mut Pulsatilla. Der Kinderarzi 1985; 16: 581-582. 4. de Lang D. Upper respiratory tract infection in children. Homoeopathy International R & D Newsletter 1993; 3(4): 4-5. 5. Pelikan Z. Rhinitis and secretory otitis media: a possible role of food allergy. In: Brostoff J, Challacombe S, eds. Food Allergy and Intolerance. London: Balli6re Tindall, 1987: pp 467486. 6. Clemis JD. Identification of allergic factors in middle ear effusions. Ann Otolar Rhin Laryng 1976; 23: 234-237. 7. Ruokonen J, Paganus A, Lehti H. Elimination diets in the treatment of secretory otitis media. Int J Ped Otorhinolaryn 1982; 4: 3946. 8. Shanon E, Englender M, Beizer M. A clinical pilot study of disodium cromoglycate in the treatment of secretory otitis media. In: Pepys J, Edwards AM, eds. The mast cell - its role in health and disease. Tunbridge Wells: Pitman Medical, 1979: pp 791-794.
© PearsonProfessionalLtd 1997
Upper respiratory tract infections and otitis media G.T. L e w i t h University of Southampton, Southampton, UK
SUMMARY. This article examines the evidence for the use of homoeopathy and dietary exclusion in the management of upper respiratory tract infections and otitis media. The evidence for homoeopathy is largely anecdotal, but substantively supported by a few good clinical trials. The evidence for dietary exclusion is more limited, but again of interest, particularly in relation to milk-exclusion.
INTRODUCTION
the field of upper respiratory tract disease. All showed a positive effect, indicating that homoeopathy was superior to placebo in the treatment of these conditions. Four of these 19 studies were in the top 8 as scored by Kleijnen et al. It is also interesting to note that, in the majority of these studies, a form of polypharmacy was used. Many homoeopaths, particularly in France and Germany, use mixtures or complexes in order to treat certain specific conditions, rather than the single remedies commonly used in the UK. These are often constructed so that they are targeted or 'balanced' at the likely problems which may occur in someone suffering from a polysymptomatic complaint such as 'flu or menopausal symptoms. The prescription of complexes directly contradicts the approach that is used by single homoeopaths, who often attempt to prescribe a single constitutional remedy. Homoeopaths will prescribe a fairly low-potency remedy for simple acute conditions, usually a C6, but this is invariably a single remedy. Most complexes are also low-potency, frequently being C6 and below. The review on upper respiratory tract disease would implicitly, therefore, support the value of homoeopathic complexes in the management of these simple and common conditions. The study that scored the highest mark as far as scientific competence was concerned was that carried out by Ferley et al. 2 This study represents one of the first attempts at a randomized controlled trial to evaluate the real clinical effects of one of France's best-selling common-cold remedies, the homoeopathic preparation Oscillocoecinum. The patients were entered if they presented with increased temperature, headache, stiffness, lumbar and articular pain, and 'the shivers', i.e. a clinical diagnosis of influenza. No immunological tests were used, which in many ways reduplicates the clinical situation in general
Claims are frequently made by homoeopaths that homoeopathic remedies are superior to antibiotics in the treatment of upper respiratory tract infections (URTIs) and acute otitis media. If such approaches can be used to manage acute episodes of illness in childhood, they represent a valuable, simple and safe approach to a whole group of common complaints. It is possible that homoeopathy may offer the general practitioner an important alternative to the repeated prescription of antibiotics. This article will examine the use of both homoeopathy and environmental medicine in the treatment of URTIs and otitis media.
HOMOEOPATHY Kleijnen et al, in their 1991 review of clinical trials within homoeopathy, were able to identify 19 studies in which homoeopathy was used for a variety of different upper respiratory tract problems. 1These included influenza, pharyngitis, the common cold, whooping cough, and otitis media. Of these 19 studies, 12 gave a positive result with respect to homoeopathic treatment. Kleijnen et al also scored the studies on methodological grounds, looking at whether the trials involved proper randomization, adequate patient numbers, and good blind outcome assessment. A rank order of studies was then constructed, and it was quite clear from this that four of the most competent evaluations of homoeopathy had been carried out within
George T. Lewith MA, DM, MRCP, MRCGP, Honorary Visiting Clinical Senior Lecturer, University Medicine, Level D, Centre Block, Southampton General Hospital, Tremona Road, Southampton SO16 6YD, UK. 99
100
Complementary Therapies in Medicine
practice almost exactly. However, it would have been more convincing, from an academic point of view, to have some immunological evidence of viral infection. The study itself was well thought through and there were clear outcome criteria for monitoring the patients. There were also clear criteria for evaluating and defining recovery in relation to the clinical signs and symptoms used for entry. A total of 480 patients were entered into the study and randomly allocated to those receiving placebo or homoeopathic treatment. The proportion of cases who recovered within 48 h of treatment was far greater amongst the active drug group (those receiving the real homoeopathic remedy) than those in the placebo group. In all, 17.1% recovered within 48 h in the homoeopathic group, and 10.3% in the placebo group; this is a statistically significant result. The authors appear almost apologetic about their results; they emphasize the fact that there is no underlying mechanism to explain homoeopathy, in spite of the clear result obtained. We do not understand the exact mechanism of general anaesthesia, but that does not appear to have stopped anaesthetists using these medicaments both frequently and safely! Why should we be apologetic about an effect that is obvious clinically, but lacks an underlying mechanism? As with many of the complementary therapies, the authors are not claiming that the homoeopathic medication cures the common cold - rather that it speeds recovery. Their method of statistical analysis is of particular interest and involves looking very closely at the speed of recovery after entry into the study. Time is used as the end-point variable. Others working within the field of complementary medicine would be well advised to consider this statistical method carefully, since if this 'survival curve technique' had not been used, an important and significant result could have been missed. After two weeks, both groups would have had exactly the same rate of recovery if measurements had been taken only at entry and two weeks subsequent to entry. The study itself is a very competent piece of clinical research, which demonstrates the clinical effectiveness of a simple, cheap, homoeopathic remedy in the context of a common condition. A second study of interest is that of Mossinger? Mossinger looked in a double-blind controlled manner at the use of a single remedy, Pulsatilla, in the treatment of otitis media. Thirty-eight patients were entered, and a double-blind randomized control model was used. Again, patients were evaluated both on the basis of descriptive symptoms and repeated ear examination. It was quite clear from this study that young children could benefit from the use of a single homoeopathic remedy in otitis media. While there are a number of other studies mentioned by Kleijnen et al with respect to the treatment of generalized URTIs this is the only study which specifically looks at the value of homoeopathic
prescriptions in otitis media. There are no negative studies mentioned within the field of otitis media; while there are some negative studies in the fields of coughs, colds and URTIs, they are outweighed by the positive evidence available. The negative studies would appear to be poorly constructed, involve fewer patients, much more limited outcome measures and, therefore, on balance, should be seen as having less value than the majority view which implies that homoeopathy has a beneficial effect on the management of these minor ailments. A study by De Lang 4 took place in Holland between 1987 and 1992. The aim was to study the effects of individually prescribed homoeopathic remedies in children with recurrent URTI. The aim of the research was to define to what degree the remedies affected the frequency, duration and severity of respiratory tract infections in children who suffer from recurrent problems in this area. The study involved 175 children and data was analyzed from 170 of the children; five were excluded because they moved away from the area during the study. The treatments resulted in a small but consistent difference between the two treatment groups in favour of the true homoeopathic remedy. The study was of a double-blind, placebo-controlled nature, and in each instance the general practitioner recommended a prescription for homoeopathic remedies but was unaware whether the child was consistently given a true medicine or a placebo. Antibiotics were used as an escape remedy if this was indicated by the child's clinical presentation. Antibiotic use was far less frequent in the children given true homoeopathic preparations over a prolonged period of time. Minor adverse reactions were seen in both placebo and real treatment groups, in equal numbers. It is therefore reasonable to claim the homoeopathic remedies do not present the patient with a serious risk of adverse reactions. A significantly different situation exists in trials which involve conventional medicine.
CLINICAL ECOLOGY AND NUTRITIONAL MEDICINE While it is quite clear that there is good evidence for the effects of homoeopathy in URTIs, there is little such evidence for the value of food-exclusion. Empirically and clinically, many doctors find that using a milk-exclusion diet can be of real value in the management of chronic tonsillitis, but the evidence that exists in relation to dietary exclusion only really relates to the use of diet in secretory otitis media. Pelikan 5 has written an excellent review of the part allergy has to play in the development of secretory otitis media. He claims that there is good evidence to suggest that type 1 allergy is a major cause
URTIs and otitis media of secretory otitis media. There is also good evidence demonstrating significantly higher levels of immunoglobulin E (IgE) in middle-ear effusions and in the serum of patients with secretory otitis media. There are also higher levels than expected of IgA and IgG in middle-ear effusions and this suggests that a hypersensitivity or food intolerance mechanism may be involved. Clemis6 concludes that foods are regularly involved in secretory otitis media and believes that foods may, in some instances, be more important in allergic diseases of the upper airway than inhaled sensitivities. Pelikan has noted that in 80% of patients with secretory otitis media allergic rhinitis was also present; equally, 5% of patients with allergic rhinitis also have secretory otitis media. He also found that patients provoked with specific food allergens report sharp pains on challenge, usually as a result of measured increased ear pressure. Pelikan goes on to suggest that there are two possible mechanisms of food sensitivity in secretory otitis media. The first is that a middle-ear response can be produced by foods that are eaten and somehow pick the middle ear as their target organ. The second is through allergies that only involve the nasal mucosa. The theoretical basis for the use of food-exclusion in chronic otitis media is therefore at least partially substantiated. A limited number of clinical trials are available, one of which shows that food avoidance can definitely affect the normal progress of otitis media7 and the other which suggests that sodium cromoglycate will have a positive effect on the natural history of secretory otitis media, thereby implying an allergic origin? It is fair to conclude from this that food sensitivity, and in particular milk, judging by the specific IgE responses that have been recorded, is one of the factors that should be considered in patients with chronic secretory otitis media. The practical advice that one can give parents is that if their child is needing to have repeated grommets, or suffering from continued attacks of secretory otitis media, an approach based on food-exclusion which primarily involves milk products, is worthy of at least one month's triM. It may obviate the need for repeated operative intervention.
101
CONCLUSION There is good evidence for the use of homoeopathy in the treatment of URTIs, and some evidence for its use in secretory otitis media. Dietary intervention may well be of help in secretory otitis media. A number of other therapies have also been suggested with respect to these particular conditions. The flow of the academic debate surrounding nutritional supplements, particularly vitamin C and zinc, is fascinating. Some claim that 1-3 g of vitamin C per day represents a magical cure for their cold, while others quote apparently equally good evidence which would appear to dismiss this claim out of hand. Zinc also has been the subject of both positive and negative clinical trials so, while nutritional medicine is commonly used, the evidence for it is certainly equivocal at the present time. There is, however, some good clear evidence that homoeopathy may well be having an effect and therefore an understanding of some of the simpler homoeopathic remedies that can be used in primary care would certainly be of value to the general practitioner.
REFERENCES
1. Kleijnen J, Knipschild P, ter Riet (3. Clinical trials in homoeopathy. BMJ 1991; 302: 316-323. 2. Ferley J, Zimirou D, D'Adhemar D, Balducci E A controlled evaluation of homoeopathic preparations in the treatment of influenza-like syndromes. Lancet 1989; 1: 208-209. 3. Mossinger R Zur Behandlung der Otitis media mut Pulsatilla. Der Kinderarzi 1985; 16: 581-582. 4. de Lang D. Upper respiratory tract infection in children. Homoeopathy International R & D Newsletter 1993; 3(4): 4-5. 5. Pelikan Z. Rhinitis and secretory otitis media: a possible role of food allergy. In: Brostoff J, Challacombe S, eds. Food Allergy and Intolerance. London: Balli6re Tindall, 1987: pp 467486. 6. Clemis JD. Identification of allergic factors in middle ear effusions. Ann Otolar Rhin Laryng 1976; 23: 234-237. 7. Ruokonen J, Paganus A, Lehti H. Elimination diets in the treatment of secretory otitis media. Int J Ped Otorhinolaryn 1982; 4: 3946. 8. Shanon E, Englender M, Beizer M. A clinical pilot study of disodium cromoglycate in the treatment of secretory otitis media. In: Pepys J, Edwards AM, eds. The mast cell - its role in health and disease. Tunbridge Wells: Pitman Medical, 1979: pp 791-794.