432
Education of patients about chronic obstructive pulmonary disease SIR,-Dr Tougaard and colleagues’ (June 20, p 1517) finding that educating Danish patients with chronic obstructive pulmonary disease leads to a reduction in consumption of health services is interesting because it differs from the experience in the UK. Cockcroft et aP reported that 42 patients supervised by a respiratory health worker (RHW) in west London (whose function included patient education) stayed longer in hospital than 33 controls. Their explanation was that patients looked after by the RHW were more ill than were the controls on admission. Because fewer patients died in the group visited by a RHW they suggested that they might have survived longer because they sought help. In a randomised controlled trial of 152 patients in southwest Londonwe found that patients looked after by RHW were three times less likely to die in the first year. The odds ratio increased to 5 (95% confidence interval 1-2-24-5) when age and lung function were further controlled for. This rise in life expectation was not associated with an increase in hospital admission or length of stay, but was related to increased general practitioner consultations and a greater range of drugs being prescribed. There was improvement in some aspects of individual patient’s quality of life, but overall the quality of life of the experimental group was worse than that of controls, probably because of the survival of patients with more severe disease. In the UK, therefore, attempts to improve the quality of care offered to patients with chronic disease through education and supervision have led to an increase, not a decrease, in the use of health services. This probably results from a combination of increased longevity and a rise in patients’ and carers’ expectations. A striking finding in the Danish study was that pOz deteriorated significantly in the experimental group, to the point that patients should be considered for long-term domiciliary oxygen (table 11). This would substantially increase the health service costs in this group. In contrast, pOz in the controls improved significantly suggesting that the health of the controls improved whereas that of the experimental group deteriorated. Improving the quality of chronic disease care, while at the same time reducing health service costs, remains an enviable but elusive goal, whose achievement is still unproven. Relying on education alone to improve the health of patients with chronic disease is unlikely to provide the answer. In a review of 320 articles on patient education in chronic diseases, Mazzuca3 concluded that "efforts to improve health by increasing patient’s knowledge alone were rarely successful. Behavioral orientated programs often with special attention to changing the environment in which patients care for themselves were consistently more successful at improving the clinical course of chronic disease". We hope that in attempting to improve the health of the nation the government will heed this evidence when they come to tackle the major chronic disabling disorders such as chronic obstructive pulmonary disease.’ Public Health Sciences and Physiological Medicine, St George’s Hospital Medical School, London SW17 0RE, UK
PETER LITTLEJOHNS
PAUL JONES
Bagnell P, Heslop A, et al. Controlled trial of respiratory health worker visiting patients with chronic respiratory disability. BMJ 1987; 294: 225-28 2. Littlejohns P, Baveystock CM, Parnell H, Jones WJ. Randomised controlled trial of the effectiveness of a respiratory health worker in reducing impairment, disability, and handicap due to chronic airflow limitation Thorax 1991; 46: 559-64. 3. Mazzuca SA. Does patient education in chronic disease have therapeutic value? Chron Dis 1982; 35: 251-29. 4. Secretary of State for Health. The health of the nation: a strategy for health in England. London: HM Stationery Office, 1992. 1. Cockcroft A,
How Israel tackled homoeopathy SIR,-European Community countries have been given five years to formulate legislation for alternative medicine including homoeopathy (July 18, p 167). The problems posed by such thcrapies were addressed by the Israel Ministry of Health in the early 1970s. The multicultural nature of that country resulted in pressure to recognise alternative therapies. Drug registration and
import laws permitted the distribution of allopathic remedies only and were based mainly on UK and US regulations, requiring proof of efficacy and safety with preclinical and clinical data. The difficulty with homoeopathic remedies was that these regulations could not be applied to them. In my capacity as "imports authority" and, later as head of drug registration in Israel I was subject to pressure not only from "below" (the public and importers) but also "above" (members of Parliament and Ministers). There were political considerations because of the sensitive international relations and lucrative markets involved. Not least of the pressure groups were tourists returning from the newly opened Far East with tales of wondrous cures and herbal remedies. My investigations brought me to the Royal Homoeopathic Hospital, London, to see the late Dr Margaret Blackey. The major principle I learned from her lay in the title of her book The Patient Not the Cure. Any success of homoeopathy and other alternatives was in great measure due to a holistic approach, which involved changes in lifestyle and diet. This, however, could not help with official drugs policy. There was also a fear that recognition of one type of remedy without applying strict criteria of efficacy and safety would be a dangerous precedent for a flood of fringe therapies of no proven value. Unlike the UK, Israel did not adopt the "licences of right" idea as a solution. The Ministry of Health in Jerusalem decided to approach all physicians and importers (there are no local manufacturers of homoeopathic remedies). In the early 1980s, a period of almost three years was given to them to provide controlled evidence on the efficacy of such remedies. No such evidence was presented. One faction in the Ministry was inclined to allow a token recognition, based on the assumption that the cures were largely psychological and did little if any harm. The impossibility of detecting active ingredients in the huge dilutions of homoeopathic remedies did not allow the application of normal quality control procedures. However, at about that time the Ministry was cracking down on "nature stores" which were beginning to proliferate in Israel. Many of those stores had infested products and some preparations were adulterated with poisonous ingredients. A lack of official control measures and pharmacognostic identification threatened public safety and this reflected back onto homoeopathy. The Union of Private Pharmacies also began to pressurise the Ministry to ban products claiming medical efficacy from these stores, especially when presented as tablets, capsules, and the like. By the mid-1980s legislation on homoeopathy was added to the drug regulation reforms. Whereas registration (and detailed data) is required for all finished products, this does not apply to raw materials or materials in stages before the finished product stage. It was decided that homoeopathic mother liquors should be classified as raw materials. This allowed their import, providing that the manufacturers’ quality control certification was available and satisfactory. Finished products could not be imported. This compromise is not entirely satisfactory in that scientific assessment of efficacy cannot be applied. New criteria-which can, I maintain, be based only on controlled clinical trials-need to be formulated for finished products. Toxicological studies must be made available. Quality control "in-house" should be allowed only when the licensing authority is satisfied about the credibility of the manufacturer. The situation in Israel (which can be thought of as a "little Europe"), in which the public is not denied the right to homoeopathic remedies, could be the starting point for European
legislation. PJB Publications, Otterman House, 14 Petersham Road,
HAROLD FENTON
Richmond, TW10 6UW, UK
Zinc metabolism in hypothyroidism Y ourJuneL.Iecutonal
discusses the mtIuences ot zmc on
thyroid hormones. Although zinc deficiency causes some changes in thyroid hormone metabolism no published data are available to show how thyroid hormones affects zinc metabolism. We have studied 14 children (10 girls, 4 boys) aged 2 months to 10 years who had hypothyroidism (2 aplasia, 8 hypoplasia, 4 ectopia) diagnosed on
conventional clinical and biochemical
grounds. All were treated
433
thyroxine. Serum samples were collected before and after replacement therapy for 6 months, when all children were in good health and clinically and biochemically euthyroid. None was taking any medication known to interfere with the metabolism of thyroid BB1th
hormones. Zinc concentrations were measured with a PerkinElmer 503 double-beam atomic absorption spectrometer with a HGA-2100 graphite furnace and a model 56 recorder. 19 normal children of comparable ages served as controls. Mean serum zinc concentrations were 1-15 (SD 0-19) ug/ml and 0-70 (0-18) ug/ml for After thyroid controls and hypothyroid patients (p
Education of patients about chronic obstructive pulmonary disease SIR,-Dr Tougaard and colleagues’ (June 20, p 1517) finding that educating Danish patients with chronic obstructive pulmonary disease leads to a reduction in consumption of health services is interesting because it differs from the experience in the UK. Cockcroft et aP reported that 42 patients supervised by a respiratory health worker (RHW) in west London (whose function included patient education) stayed longer in hospital than 33 controls. Their explanation was that patients looked after by the RHW were more ill than were the controls on admission. Because fewer patients died in the group visited by a RHW they suggested that they might have survived longer because they sought help. In a randomised controlled trial of 152 patients in southwest Londonwe found that patients looked after by RHW were three times less likely to die in the first year. The odds ratio increased to 5 (95% confidence interval 1-2-24-5) when age and lung function were further controlled for. This rise in life expectation was not associated with an increase in hospital admission or length of stay, but was related to increased general practitioner consultations and a greater range of drugs being prescribed. There was improvement in some aspects of individual patient’s quality of life, but overall the quality of life of the experimental group was worse than that of controls, probably because of the survival of patients with more severe disease. In the UK, therefore, attempts to improve the quality of care offered to patients with chronic disease through education and supervision have led to an increase, not a decrease, in the use of health services. This probably results from a combination of increased longevity and a rise in patients’ and carers’ expectations. A striking finding in the Danish study was that pOz deteriorated significantly in the experimental group, to the point that patients should be considered for long-term domiciliary oxygen (table 11). This would substantially increase the health service costs in this group. In contrast, pOz in the controls improved significantly suggesting that the health of the controls improved whereas that of the experimental group deteriorated. Improving the quality of chronic disease care, while at the same time reducing health service costs, remains an enviable but elusive goal, whose achievement is still unproven. Relying on education alone to improve the health of patients with chronic disease is unlikely to provide the answer. In a review of 320 articles on patient education in chronic diseases, Mazzuca3 concluded that "efforts to improve health by increasing patient’s knowledge alone were rarely successful. Behavioral orientated programs often with special attention to changing the environment in which patients care for themselves were consistently more successful at improving the clinical course of chronic disease". We hope that in attempting to improve the health of the nation the government will heed this evidence when they come to tackle the major chronic disabling disorders such as chronic obstructive pulmonary disease.’ Public Health Sciences and Physiological Medicine, St George’s Hospital Medical School, London SW17 0RE, UK
PETER LITTLEJOHNS
PAUL JONES
Bagnell P, Heslop A, et al. Controlled trial of respiratory health worker visiting patients with chronic respiratory disability. BMJ 1987; 294: 225-28 2. Littlejohns P, Baveystock CM, Parnell H, Jones WJ. Randomised controlled trial of the effectiveness of a respiratory health worker in reducing impairment, disability, and handicap due to chronic airflow limitation Thorax 1991; 46: 559-64. 3. Mazzuca SA. Does patient education in chronic disease have therapeutic value? Chron Dis 1982; 35: 251-29. 4. Secretary of State for Health. The health of the nation: a strategy for health in England. London: HM Stationery Office, 1992. 1. Cockcroft A,
How Israel tackled homoeopathy SIR,-European Community countries have been given five years to formulate legislation for alternative medicine including homoeopathy (July 18, p 167). The problems posed by such thcrapies were addressed by the Israel Ministry of Health in the early 1970s. The multicultural nature of that country resulted in pressure to recognise alternative therapies. Drug registration and
import laws permitted the distribution of allopathic remedies only and were based mainly on UK and US regulations, requiring proof of efficacy and safety with preclinical and clinical data. The difficulty with homoeopathic remedies was that these regulations could not be applied to them. In my capacity as "imports authority" and, later as head of drug registration in Israel I was subject to pressure not only from "below" (the public and importers) but also "above" (members of Parliament and Ministers). There were political considerations because of the sensitive international relations and lucrative markets involved. Not least of the pressure groups were tourists returning from the newly opened Far East with tales of wondrous cures and herbal remedies. My investigations brought me to the Royal Homoeopathic Hospital, London, to see the late Dr Margaret Blackey. The major principle I learned from her lay in the title of her book The Patient Not the Cure. Any success of homoeopathy and other alternatives was in great measure due to a holistic approach, which involved changes in lifestyle and diet. This, however, could not help with official drugs policy. There was also a fear that recognition of one type of remedy without applying strict criteria of efficacy and safety would be a dangerous precedent for a flood of fringe therapies of no proven value. Unlike the UK, Israel did not adopt the "licences of right" idea as a solution. The Ministry of Health in Jerusalem decided to approach all physicians and importers (there are no local manufacturers of homoeopathic remedies). In the early 1980s, a period of almost three years was given to them to provide controlled evidence on the efficacy of such remedies. No such evidence was presented. One faction in the Ministry was inclined to allow a token recognition, based on the assumption that the cures were largely psychological and did little if any harm. The impossibility of detecting active ingredients in the huge dilutions of homoeopathic remedies did not allow the application of normal quality control procedures. However, at about that time the Ministry was cracking down on "nature stores" which were beginning to proliferate in Israel. Many of those stores had infested products and some preparations were adulterated with poisonous ingredients. A lack of official control measures and pharmacognostic identification threatened public safety and this reflected back onto homoeopathy. The Union of Private Pharmacies also began to pressurise the Ministry to ban products claiming medical efficacy from these stores, especially when presented as tablets, capsules, and the like. By the mid-1980s legislation on homoeopathy was added to the drug regulation reforms. Whereas registration (and detailed data) is required for all finished products, this does not apply to raw materials or materials in stages before the finished product stage. It was decided that homoeopathic mother liquors should be classified as raw materials. This allowed their import, providing that the manufacturers’ quality control certification was available and satisfactory. Finished products could not be imported. This compromise is not entirely satisfactory in that scientific assessment of efficacy cannot be applied. New criteria-which can, I maintain, be based only on controlled clinical trials-need to be formulated for finished products. Toxicological studies must be made available. Quality control "in-house" should be allowed only when the licensing authority is satisfied about the credibility of the manufacturer. The situation in Israel (which can be thought of as a "little Europe"), in which the public is not denied the right to homoeopathic remedies, could be the starting point for European
legislation. PJB Publications, Otterman House, 14 Petersham Road,
HAROLD FENTON
Richmond, TW10 6UW, UK
Zinc metabolism in hypothyroidism Y ourJuneL.Iecutonal
discusses the mtIuences ot zmc on
thyroid hormones. Although zinc deficiency causes some changes in thyroid hormone metabolism no published data are available to show how thyroid hormones affects zinc metabolism. We have studied 14 children (10 girls, 4 boys) aged 2 months to 10 years who had hypothyroidism (2 aplasia, 8 hypoplasia, 4 ectopia) diagnosed on
conventional clinical and biochemical
grounds. All were treated
433
thyroxine. Serum samples were collected before and after replacement therapy for 6 months, when all children were in good health and clinically and biochemically euthyroid. None was taking any medication known to interfere with the metabolism of thyroid BB1th
hormones. Zinc concentrations were measured with a PerkinElmer 503 double-beam atomic absorption spectrometer with a HGA-2100 graphite furnace and a model 56 recorder. 19 normal children of comparable ages served as controls. Mean serum zinc concentrations were 1-15 (SD 0-19) ug/ml and 0-70 (0-18) ug/ml for After thyroid controls and hypothyroid patients (p
