Hospital recorded that only two patients had recurrent stones.' I would like to report my experience of a pilot study of 11 patients who had a modified cholecystolithotomy during 1983-4. After localisation of the gall bladder by ultrasonography a minilaparotomy was performed through a 5 0-7 6 cm incision. The gall bladder was cleared of stones through a fundal incision. Bile was sampled for culture and a baseline lithogenic index was determined by a simple ratio of cholesterol to dry weight. A biopsy specimen of the gall bladder fundus was examined for histological evidence of cholecystitis. Clearance of the gall bladder was checked using a choledochoscope and residual fragments were removed with stone grasping forceps. An operative cholangiogram was then taken with an 8 French gauge Foley catheter with a balloon inflated and impacted in the gall bladder. After negative results on cholangiography the gall bladder was sutured with catgut and then the gall bladder fundus was sutured to the abdominal wall incision using 3/0 Ethiflex. This rendered a small area of the gall baldder wall extraperitoneal to allow safe follow up sampling of bile directed by ultrasonography to determine if dietary manipulation influenced the lithogenicity of the bile and to permit safe percutaneous extraction of symptomatic recurrent stones. Only four of the 11 patients remained free of stones at follow up at a mean of 5-5 years. Stones recurred from seven months to five years postoperatively. There was no clear relation between recurrence and baseline lithogenic index or gall bladder histology, and a high fibre diet failed to protect against stone recurrence. I believe that until there is an effective method of preventing stones reforming percutaneous techniques should be reserved for patients in whom cholecystectomy carries a high risk. A E STUART Oldchurch Hospital, Essex RM7 OBE I Chiverton SG, Inglis JA, Hudd C, Kellett MJ, Russell RCG, Wickham JEA. Percutaneous cholecystolithotomy: the first 60 patients. BrMedj7 1990;300:1310-2. (19 May.)
The empty theatre SIR,-I was encouraged that Mr Anthony Young's editorial' supported our report on the management and use of operating departments.2 The report was the main item of consideration at the Healthcare Exhibition at the National Exhibition Centre (2224 May)-at the first of the three days nearly 700 doctors, nurses, operating department assistants, and theatre managers heard the main recommendations, and at the further two meetings discussion was lively and responsible. In view of the interest aroused I venture to reorientate some of the impressions in Mr Young's editorial. Although the courses of our report and that of the National Audit Office' were parallel, some of the findings were significantly different. The National Audit Office reported an alarming average of 52% of theatre sessions lost while we emphasised that this figure included spare theatre sessions never planned for use. The true figure of theatre sessions that were staffed, scheduled, and resourced averaged 70%. It was hoped that by good management this figure could be raised to 90% in many cases. Similarly, the National Audit Office gave the unacceptably high figure of £450 an hour as the cost of running an operating theatre, whereas our more careful and detailed study showed that the average figure is £151 For the first time the true facts and figures relating to the running of our operating theatres are supplied in our report. Mr Young rightly states that there is no reason why theatre managers should be drawn from the nursing hierarchy but neglects to say that there is VOLUME
PETER GILROY BEVAN
Birmingham B13 8RD 1 Young A. The empty theatre. Br Med J 1990;300:1288-9. (19
May.) 2 NHS Management Executive. The management and utilisation of operating departments. London: HMSO, 1989. (Chairman P G
Bevan.) 3 National Audit Office. The use of operating theatres in the National Health Service; report by the Comptroller and Auditor General. London: HMSO, 1987.
Romford,
BMJ
no reason why not. For the foreseeable future most theatre managers will probably be nurses with the required managerial skills. Support for the nurse manager by the consultants working in theatre is essential. Our report suggests that the chairman of the theatre users' committee (if a consultant, as is usually the case) or "a representative of the medical profession" should act in this way. This embraces Mr Young's point about a clinical director. The emphasis on interchangeability of support staff needs putting into context. Our steering group recommended that nurses and operating department assistants working in theatre should be trained in all relevant activities-for example, assisting the surgeon and anaesthetist, circulating duties, checking and adjusting equipment, and lifting and positioning the patient. Efficiency and best practice, however, are best achieved by surgeons and anaesthetists who have a regular team of assistants familiar with the requirements. The need for specialisation must be combined with sufficient breadth of experience to provide flexibility-for example, for emergency lists and holiday cover. Finally, our report does deal with the bed problem related to operating theatres, and I refute the allegation that this problem was not addressed. Paragraphs 3.2.4, 3.5.1, and 4.3. 1 clearly describe "a limited overall bed capacity in relation to the provision of theatres" and the curtailment of lists that results when emergency admissions fill the beds needed for elective surgical admissions.
301
14
JULY
1990
SIR,-In his editorial on the better use of operating theatres Mr A Young suggested that firm management is one way to solve the problems of underuse of scarce and expensive theatre resources.' He suggested that a clinical director who is a clinician, either surgeon or anaesthetist, might provide the most direct and effective support. This suggestion has been made previously in the report Efficiency of Theatre Services, published by the Association of Anaesthetists of Great Britain and Ireland in association with specialist surgical groups.2 The report made many suggestions to improve the use of theatres, the first being that a theatre services director (or equivalent) should be appointed to establish and implement guidelines for usage. This post could be part time and would normally be held by a consultant. The incumbent would have a role distinct from that of the theatre superintendent or theatre manager but would work closely with him or her, and with the theatre users' committee. It was recognised that adequate financial control and information systems, as well as appropriate secretarial and administrative support, would be necessary for effective management. Other recommendations included the need to match beds, patients, and theatre time, and the need for close collaboration between the surgical teams and the admission department was recognised as essential. It was suggested that waiting lists should be regularly reviewed and that lists of patients willing to attend at short notice should be established and maintained. Increased use of preadmission assessment clinics and day stay surgery were commended as methods of reducing the number of late cancellations and other avoidable expense. The report also discussed the problems created by work outside normal working hours and
strongly recommended the provision of a dedicated emergency theatre. The ability to recruit and retain trained nursing and support staff for all aspects of theatre work was thought to be vital for improved efficiency. Every anaesthetist and s'urgeon has experienced frustration and delay occasioned by poor administrative arrangements, and in the complex series of interactions that are inherent in theatre usage there are many potential weak points that may break down because of false economies or insufficient planning. This report addresses many of these problems and offers practical solutions to many of the problems foreseen by Mr Young. M M BURROWS Association of Anaesthetists of Great Britain and Ireland, London WC1B 3RA I Young A. The empty theatre. Br MedJf 1990;300:1288-9. (19 May.) 2 Association of Anaesthetists of Great Britain and Ireland, Association of Surgeons of Great Britain and Ireland, British Orthopaedic Association. Efficiency of theatre services. London: Association of Anaesthetists of Great Britain and Ireland, 1989.
Out of hours workload in general practice SIR,-I question the assumption by Dr Andrew Orr and colleagues,' following on from the article by Drs John Pitts and Margaret Whitby,' that out of hours workload is simply related to expectation. I work in the same health centre in Hythe as Drs Pitts and Whitby and cover exactly the same population, but I am in a two man partnership with only 3000 patients between us. We do not have a trainee and cover all of our out of hours commitments on a straight one in two rota. Unfortunately I do not have figures for out of hours consultations for exactly the same period covered in their article, but I did keep records from 1 December 1989 for six months (table). Comparison of out of hours workload of two practices in Hythe. Figures are mean numbers of patient contactsl 1000 patients
Total contact rate (day and night) Contact rate with casualty department Contact rate excluding contacts with casualty department Contact rate at night Visiting rate at night
Drs Pitts and Whitby 19892
Drs Markby and Menin 1989-90
273
184
59
51
214 37 20
133 17 11
Our contact rate with the casualty department of Hythe Hospital was very similar to that of the larger practice, suggesting that the department was being used mainly for only accidents and emergencies. Our contact rate excluding contacts with the casualty department and our contact rate at night were only 133/1000 patients and 17/1000 patients respectively, compared with 214/1000 and 37/1000 in the larger practice. Our telephone advice rate to patients who contacted us was about the same as that reported by Drs Pitts and Whitby (40% compared with 44%), as was our hospital admission rate (7% compared with 4-9%). The difference in use of out of hours services between the practices requires further evaluation. Possible explanations include: patients in smaller practices know that they will be disturbing "their own doctor"; patients may be happier to wait overnight in the knowledge that they will see their own doctor the following morning; and patients not seeing their own doctor may have less faith in a surgery consultation, leading to a lower threshold for calling during the night hours, when anxiety is
121
increased. I would invite any further explanations to account for the difference in figures. As a final suggestion, it would be interesting to repeat the study over a further 12 months to see what effect, if any, Mr Clarke's impositions are having on general practice and whether the recent organisational changes within Dr Pitts's and Whitby's practice will alter the consultation rate. P T MENIN
Medical Centre, Hythe, Southampton 1 Orr A, MacNeill D, Griffith J, Begg A. Out of hours workload in general practice: deprivation or expectation? Br Mcd J 1990;300:1527. (9 June.) 2 Pitts J, Whitbv M. Out of hours workload of a suburban general practice: deprivation or expectation? Br Med J 1990;300: 1113-5. (28 April.)
Policies on drugs in the new Europe SIR,-The editorial by Dr Tony Smith' reviews the European Commission document III/8267/89 but not the commission's proposals (111/3603/90EN) of February 1990. These sweeping proposals should alert doctors and their patients to the powerful centralised bureaucracy which, it is proposed, should be established for the approval of new medicines in the European Community. Document III/3603/90-EN proposes a centralised procedure for approving products from biotechnology (and other important new drugs if the producers wish) and a decentralised machinery for other drugs. Thus the centralised procedure will handle the new drugs for which the risk of unexpected adverse effects is greatest. In both procedures if member states "are unable to reach a bilateral agreement, the matter will be referred for binding arbitration at Community level." Thus the proposal is for absolute power overriding national sovereignty in a sensitive aspect of public health. With respect to monitoring adverse drug reactions quite impractical timetables are proposed with a requirement that all information should be passed to companies. This would break the confidentiality of the yellow card scheme and seriously damage our only fully national method of postmarketing surveillance. It is important that these proposals should not be agreed and that doctors alert themselves to this issue. RONALD D MANN
Royal Societv of Medicine, London WIM 8AE 1 Smith T. Policies on drugs in the new Europe Br Med J7 1990;300: 1476-7. (9 June.) 2 Mann RD. EEC supranational drug regulatory authority by 1992? Lancet 1988;ii:324-6.
Fibre in.the management of diabetes SIR,-In their articles on the role of fibre in the management of diabetes Dr T D R Hockaday and Drs Robert Tattersall and Peter Mansell conclude that the gel forming fibre guar gum does not improve glycaemic control when it is sprinkled on food or taken before a meal.' We have carried out several controlled studies with guar gum in our department during the past 10 years.24 We gave guar gum before meals with juice, water, or milk products or sprinkled it on food-for example, on salads. During the long term fasting blood glucose concentration was reduced by 1-2 mmol/l with guar gum granules at doses of 15-21 g daily. The reduction in blood glucose concentration was accompanied by a considerable decline in glucosuria,"3but in some studies no significant reduction
122
of the mean fasting blood glucose concentration was observed.4 The lowering effect of guar gum on serum total cholesterol concentration is even more consistent than its glucose lowering effect, and controlled studies have shown that both serum total cholesterol and low density lipoprotein cholesterol concentrations are reduced by 1015% with guar gum granules as compared with placebo.2 The effect is similar in diabetic and nondiabetic subjects. Furthermore, our unpublished data show that guar gum is almost as effective as (but less expensive than) cholestyramine when combined with lovastatin in reducing raised cholesterol and apolipoprotein B concentrations in patients with non-familial hypercholesterolaemia. Formerly, guargum had also been used successfully with gemfibrozil in hyperlipidaemic patients.6 So far there is no conclusive evidence concerning the long term benefit of any hypoglycaemic drug treatment for non-insulin dependent diabetes as far as macrovascular diseases are concerned, but controlling weight and normalising raised blood pressures and abnormalities in serum lipid concentration by diet and, if necessary, drugs may be as important as frequently unsuccessful lowering of raised blood glucose concentration by oral hypoglycaemic drugs or insulin. Guar gum offers a possibility to lower raised low density lipoprotein cholesterol concentrations in diabetic subjects without harmful effects on high density lipoprotein cholesterol or serum triglyceride concentrations, and its beneficial effect on fasting blood glucose concentration may have clinical importance in a certain proportion of patients. Long term compliance with guar gum can be considerably improved by giving proper advice on its use. MATTI I J UUSITUPA
Department of Clinical Nutrition, Universitv of Kuopio, PO Box 6, 70211 Kuopio, Finland
Comparison of results of cytology with histological state. Figures are numbers (percentages) ofpatients Cytological appearance
Histological appearance CINI CINII CIN III Invasive carcinoma Koilocytosis Benign CIN
=
Mild Moderate Severe dyskaryosis dyskaryosis dyskaryosis 104(23-0) 82(18-2) 72 (15 9)
37 (9-5) 115(29-8) 154 (39-6)
113 (25-0) 81(17 9)
38 (9-8) 44(11-3)
4 (1-3) 17 (5-5) 280 (88 0) 9 (2 8) 4 (1-3) 4 (1-3)
Cervical intraepithelial neoplasia.
Unfortunately, our recent experience does not bear out this precise concordance (table). Dr Hudson points out that part of the problem lies in the confusion between the cytological appearances induced by mild dysplasia, inflammation, and human papillomavirus infection. We' and others4 have shown that experienced consultant histopathologists are consistent in diagnosing CIN III and squamous carcinoma, but they are very much less consistent for lower grades of CIN. It is therefore difficult to understand how a range of cytological appearances can correlate closely with a histological terminology that cannot be applied consistently by experienced histopathologists. We believe that any terminology for reporting histopathology or cytology that is proposed for use in the NHS should be evaluated for robustness before promotion for general use. We agree with Dr Hudson that the Bethesda system has little to commend it. A J ROBERTSON KUDAIR HUSSEIN J SWANSON BECK
Pathology Departments, Ninewells Hospital, Dundee Perth Royal Infirmary, Perth 1 Hudson E. Cervical cytology. Br Med J 1990;300:1353-4.
(26 May.) 1 Hockaday TDR, Tattersall R, Mansell P. Fibre in the management of diabetes. Br MedJ7 1990;300:1334-7. (19 May.) 2 Aro A, Uusitupa M, Voutilainen E, Hersio K, Korhonen T, Siitonen 0. Improved diabetic control and hypocholesterolaemic effect induced by long-term dietary supplementation with guar gum in type 2 (insulin-dependent) diabetes.
Diabetologia 1981;21:29-33. 3 Uusitupa M, Tuomilehto J, Karttunen P, Wolf E. Long term effects of guar gum on metabolic control, serum cholesterol and blood pressure levels in type 2 (non-insulin-dependent) diabetic patients with high blood pressure. Ann Clin Res 1984;16(suppl 43):126-3 1. 4 Uusitupa M, Siitonen 0, Savolainen K, Silvasti M, Penttila I, Parviainen M. Metabolic and nutritional effects of long-term use of guar gum in the treatment of noninsulin-dependent diabetes of poor metabolic control. Am J Clin Nutr 1989;49: 345-51.
5 Tuomilehto J, Silvasti M, Aro A, et al. Long term treatment of severe hvpercholesterolaemia with guar gum. Atherosclerosis 1988;72: 157-62. 6 Tuomilehto J, Silvasti M, Manninen V, Uusitupa M, Aro A. Guar gum and gemfibrozil-an effective combination in the treatment of hypercholesterolaemia. Atherosclerosis 1989;76: 71-7. 7 Ebeling P, Yki-Jarvinen H, Aro A, Helve E, Sinisalo M, Koivisto VA. Glucose and lipid metabolism and insulin sensitivity in type I diabetes: the effect of guar gum. Am 7 Clin Nutr
1988;48:98-103.
Cervical cytology SIR,-The editorial by Dr Elizabeth Hudson on terminology in cervical cytology is timely.' All agree with her that the report on a smear should be accurate pathologically, unambiguous in presentation, and relevant to the subsequent management of the patient. She clearly advocates the use of the terminology of the British Society for Clinical Cytology,2 which relates the severity of dyskaryosis in exfoliated cells to the likely grade of cervical intraepithelial neoplasia (CIN I, CIN II, and CIN III) in the ectocervix. She claims that the value of the smear test result lies in its remarkably true reflection of the histological state of the section.
2 Evans DMD, Hudson EA, Brown CL, et al. Terminology in gynaecological cytopathology: report of the working party of
the British Societv for Clinical Cytology. J Clin Pathol 1986;39:933-44. 3 Robertson AJ, Anderson JM, Beck JS, et al. Observer variability in histopathological reporting of cervical biopsy specimens. 7 Clin Pathol 1989;42:23 1-8. 4 Ismail SM, Colclough AB, Dinnen JS, et al. Observer variation in histopathological diagnosis and grading of cervical intraepithelial neoplasia. Br Medj' 1989;298:707- 10.
Shy-Drager syndrome presenting as isolated paralysis of vocal cord abductors SIR, -Dr John Kew and colleagues reported on a woman with Shy-Drager syndrome presenting with isolated paralysis of the abductor muscles of the larynx.' Vocal cord paralysis is possibly the commonest form of presentation of the syndrome to the otolaryngologist but usually occurs late in the disease.2 We describe a less common otological symptom. A 59 year old woman presented in 1983 with the first of recurrent acute episodes of true rotatory vertigo and vomiting associated with tinnitus and a feeling of pressure in the right ear and was treated with cinnarizine and betahistine, initially to good effect. By 1988 her vertigo had recurred and she had developed a fluctuating low frequency sensorineural hearing loss in her right ear. A transtympanic electrocochleogram showed an abnormally wide action potential in the eighth nerve, of the pattern commonly associated with endolymphatic hydrops.' At about the same time she was found to have developed appreciable postural hypotension and a degree of truncal ataxia, and she later began to experience problems with
BMJ VOLUME 301
14 JULY 1990
The empty theatre SIR,-I was encouraged that Mr Anthony Young's editorial' supported our report on the management and use of operating departments.2 The report was the main item of consideration at the Healthcare Exhibition at the National Exhibition Centre (2224 May)-at the first of the three days nearly 700 doctors, nurses, operating department assistants, and theatre managers heard the main recommendations, and at the further two meetings discussion was lively and responsible. In view of the interest aroused I venture to reorientate some of the impressions in Mr Young's editorial. Although the courses of our report and that of the National Audit Office' were parallel, some of the findings were significantly different. The National Audit Office reported an alarming average of 52% of theatre sessions lost while we emphasised that this figure included spare theatre sessions never planned for use. The true figure of theatre sessions that were staffed, scheduled, and resourced averaged 70%. It was hoped that by good management this figure could be raised to 90% in many cases. Similarly, the National Audit Office gave the unacceptably high figure of £450 an hour as the cost of running an operating theatre, whereas our more careful and detailed study showed that the average figure is £151 For the first time the true facts and figures relating to the running of our operating theatres are supplied in our report. Mr Young rightly states that there is no reason why theatre managers should be drawn from the nursing hierarchy but neglects to say that there is VOLUME
PETER GILROY BEVAN
Birmingham B13 8RD 1 Young A. The empty theatre. Br Med J 1990;300:1288-9. (19
May.) 2 NHS Management Executive. The management and utilisation of operating departments. London: HMSO, 1989. (Chairman P G
Bevan.) 3 National Audit Office. The use of operating theatres in the National Health Service; report by the Comptroller and Auditor General. London: HMSO, 1987.
Romford,
BMJ
no reason why not. For the foreseeable future most theatre managers will probably be nurses with the required managerial skills. Support for the nurse manager by the consultants working in theatre is essential. Our report suggests that the chairman of the theatre users' committee (if a consultant, as is usually the case) or "a representative of the medical profession" should act in this way. This embraces Mr Young's point about a clinical director. The emphasis on interchangeability of support staff needs putting into context. Our steering group recommended that nurses and operating department assistants working in theatre should be trained in all relevant activities-for example, assisting the surgeon and anaesthetist, circulating duties, checking and adjusting equipment, and lifting and positioning the patient. Efficiency and best practice, however, are best achieved by surgeons and anaesthetists who have a regular team of assistants familiar with the requirements. The need for specialisation must be combined with sufficient breadth of experience to provide flexibility-for example, for emergency lists and holiday cover. Finally, our report does deal with the bed problem related to operating theatres, and I refute the allegation that this problem was not addressed. Paragraphs 3.2.4, 3.5.1, and 4.3. 1 clearly describe "a limited overall bed capacity in relation to the provision of theatres" and the curtailment of lists that results when emergency admissions fill the beds needed for elective surgical admissions.
301
14
JULY
1990
SIR,-In his editorial on the better use of operating theatres Mr A Young suggested that firm management is one way to solve the problems of underuse of scarce and expensive theatre resources.' He suggested that a clinical director who is a clinician, either surgeon or anaesthetist, might provide the most direct and effective support. This suggestion has been made previously in the report Efficiency of Theatre Services, published by the Association of Anaesthetists of Great Britain and Ireland in association with specialist surgical groups.2 The report made many suggestions to improve the use of theatres, the first being that a theatre services director (or equivalent) should be appointed to establish and implement guidelines for usage. This post could be part time and would normally be held by a consultant. The incumbent would have a role distinct from that of the theatre superintendent or theatre manager but would work closely with him or her, and with the theatre users' committee. It was recognised that adequate financial control and information systems, as well as appropriate secretarial and administrative support, would be necessary for effective management. Other recommendations included the need to match beds, patients, and theatre time, and the need for close collaboration between the surgical teams and the admission department was recognised as essential. It was suggested that waiting lists should be regularly reviewed and that lists of patients willing to attend at short notice should be established and maintained. Increased use of preadmission assessment clinics and day stay surgery were commended as methods of reducing the number of late cancellations and other avoidable expense. The report also discussed the problems created by work outside normal working hours and
strongly recommended the provision of a dedicated emergency theatre. The ability to recruit and retain trained nursing and support staff for all aspects of theatre work was thought to be vital for improved efficiency. Every anaesthetist and s'urgeon has experienced frustration and delay occasioned by poor administrative arrangements, and in the complex series of interactions that are inherent in theatre usage there are many potential weak points that may break down because of false economies or insufficient planning. This report addresses many of these problems and offers practical solutions to many of the problems foreseen by Mr Young. M M BURROWS Association of Anaesthetists of Great Britain and Ireland, London WC1B 3RA I Young A. The empty theatre. Br MedJf 1990;300:1288-9. (19 May.) 2 Association of Anaesthetists of Great Britain and Ireland, Association of Surgeons of Great Britain and Ireland, British Orthopaedic Association. Efficiency of theatre services. London: Association of Anaesthetists of Great Britain and Ireland, 1989.
Out of hours workload in general practice SIR,-I question the assumption by Dr Andrew Orr and colleagues,' following on from the article by Drs John Pitts and Margaret Whitby,' that out of hours workload is simply related to expectation. I work in the same health centre in Hythe as Drs Pitts and Whitby and cover exactly the same population, but I am in a two man partnership with only 3000 patients between us. We do not have a trainee and cover all of our out of hours commitments on a straight one in two rota. Unfortunately I do not have figures for out of hours consultations for exactly the same period covered in their article, but I did keep records from 1 December 1989 for six months (table). Comparison of out of hours workload of two practices in Hythe. Figures are mean numbers of patient contactsl 1000 patients
Total contact rate (day and night) Contact rate with casualty department Contact rate excluding contacts with casualty department Contact rate at night Visiting rate at night
Drs Pitts and Whitby 19892
Drs Markby and Menin 1989-90
273
184
59
51
214 37 20
133 17 11
Our contact rate with the casualty department of Hythe Hospital was very similar to that of the larger practice, suggesting that the department was being used mainly for only accidents and emergencies. Our contact rate excluding contacts with the casualty department and our contact rate at night were only 133/1000 patients and 17/1000 patients respectively, compared with 214/1000 and 37/1000 in the larger practice. Our telephone advice rate to patients who contacted us was about the same as that reported by Drs Pitts and Whitby (40% compared with 44%), as was our hospital admission rate (7% compared with 4-9%). The difference in use of out of hours services between the practices requires further evaluation. Possible explanations include: patients in smaller practices know that they will be disturbing "their own doctor"; patients may be happier to wait overnight in the knowledge that they will see their own doctor the following morning; and patients not seeing their own doctor may have less faith in a surgery consultation, leading to a lower threshold for calling during the night hours, when anxiety is
121
increased. I would invite any further explanations to account for the difference in figures. As a final suggestion, it would be interesting to repeat the study over a further 12 months to see what effect, if any, Mr Clarke's impositions are having on general practice and whether the recent organisational changes within Dr Pitts's and Whitby's practice will alter the consultation rate. P T MENIN
Medical Centre, Hythe, Southampton 1 Orr A, MacNeill D, Griffith J, Begg A. Out of hours workload in general practice: deprivation or expectation? Br Mcd J 1990;300:1527. (9 June.) 2 Pitts J, Whitbv M. Out of hours workload of a suburban general practice: deprivation or expectation? Br Med J 1990;300: 1113-5. (28 April.)
Policies on drugs in the new Europe SIR,-The editorial by Dr Tony Smith' reviews the European Commission document III/8267/89 but not the commission's proposals (111/3603/90EN) of February 1990. These sweeping proposals should alert doctors and their patients to the powerful centralised bureaucracy which, it is proposed, should be established for the approval of new medicines in the European Community. Document III/3603/90-EN proposes a centralised procedure for approving products from biotechnology (and other important new drugs if the producers wish) and a decentralised machinery for other drugs. Thus the centralised procedure will handle the new drugs for which the risk of unexpected adverse effects is greatest. In both procedures if member states "are unable to reach a bilateral agreement, the matter will be referred for binding arbitration at Community level." Thus the proposal is for absolute power overriding national sovereignty in a sensitive aspect of public health. With respect to monitoring adverse drug reactions quite impractical timetables are proposed with a requirement that all information should be passed to companies. This would break the confidentiality of the yellow card scheme and seriously damage our only fully national method of postmarketing surveillance. It is important that these proposals should not be agreed and that doctors alert themselves to this issue. RONALD D MANN
Royal Societv of Medicine, London WIM 8AE 1 Smith T. Policies on drugs in the new Europe Br Med J7 1990;300: 1476-7. (9 June.) 2 Mann RD. EEC supranational drug regulatory authority by 1992? Lancet 1988;ii:324-6.
Fibre in.the management of diabetes SIR,-In their articles on the role of fibre in the management of diabetes Dr T D R Hockaday and Drs Robert Tattersall and Peter Mansell conclude that the gel forming fibre guar gum does not improve glycaemic control when it is sprinkled on food or taken before a meal.' We have carried out several controlled studies with guar gum in our department during the past 10 years.24 We gave guar gum before meals with juice, water, or milk products or sprinkled it on food-for example, on salads. During the long term fasting blood glucose concentration was reduced by 1-2 mmol/l with guar gum granules at doses of 15-21 g daily. The reduction in blood glucose concentration was accompanied by a considerable decline in glucosuria,"3but in some studies no significant reduction
122
of the mean fasting blood glucose concentration was observed.4 The lowering effect of guar gum on serum total cholesterol concentration is even more consistent than its glucose lowering effect, and controlled studies have shown that both serum total cholesterol and low density lipoprotein cholesterol concentrations are reduced by 1015% with guar gum granules as compared with placebo.2 The effect is similar in diabetic and nondiabetic subjects. Furthermore, our unpublished data show that guar gum is almost as effective as (but less expensive than) cholestyramine when combined with lovastatin in reducing raised cholesterol and apolipoprotein B concentrations in patients with non-familial hypercholesterolaemia. Formerly, guargum had also been used successfully with gemfibrozil in hyperlipidaemic patients.6 So far there is no conclusive evidence concerning the long term benefit of any hypoglycaemic drug treatment for non-insulin dependent diabetes as far as macrovascular diseases are concerned, but controlling weight and normalising raised blood pressures and abnormalities in serum lipid concentration by diet and, if necessary, drugs may be as important as frequently unsuccessful lowering of raised blood glucose concentration by oral hypoglycaemic drugs or insulin. Guar gum offers a possibility to lower raised low density lipoprotein cholesterol concentrations in diabetic subjects without harmful effects on high density lipoprotein cholesterol or serum triglyceride concentrations, and its beneficial effect on fasting blood glucose concentration may have clinical importance in a certain proportion of patients. Long term compliance with guar gum can be considerably improved by giving proper advice on its use. MATTI I J UUSITUPA
Department of Clinical Nutrition, Universitv of Kuopio, PO Box 6, 70211 Kuopio, Finland
Comparison of results of cytology with histological state. Figures are numbers (percentages) ofpatients Cytological appearance
Histological appearance CINI CINII CIN III Invasive carcinoma Koilocytosis Benign CIN
=
Mild Moderate Severe dyskaryosis dyskaryosis dyskaryosis 104(23-0) 82(18-2) 72 (15 9)
37 (9-5) 115(29-8) 154 (39-6)
113 (25-0) 81(17 9)
38 (9-8) 44(11-3)
4 (1-3) 17 (5-5) 280 (88 0) 9 (2 8) 4 (1-3) 4 (1-3)
Cervical intraepithelial neoplasia.
Unfortunately, our recent experience does not bear out this precise concordance (table). Dr Hudson points out that part of the problem lies in the confusion between the cytological appearances induced by mild dysplasia, inflammation, and human papillomavirus infection. We' and others4 have shown that experienced consultant histopathologists are consistent in diagnosing CIN III and squamous carcinoma, but they are very much less consistent for lower grades of CIN. It is therefore difficult to understand how a range of cytological appearances can correlate closely with a histological terminology that cannot be applied consistently by experienced histopathologists. We believe that any terminology for reporting histopathology or cytology that is proposed for use in the NHS should be evaluated for robustness before promotion for general use. We agree with Dr Hudson that the Bethesda system has little to commend it. A J ROBERTSON KUDAIR HUSSEIN J SWANSON BECK
Pathology Departments, Ninewells Hospital, Dundee Perth Royal Infirmary, Perth 1 Hudson E. Cervical cytology. Br Med J 1990;300:1353-4.
(26 May.) 1 Hockaday TDR, Tattersall R, Mansell P. Fibre in the management of diabetes. Br MedJ7 1990;300:1334-7. (19 May.) 2 Aro A, Uusitupa M, Voutilainen E, Hersio K, Korhonen T, Siitonen 0. Improved diabetic control and hypocholesterolaemic effect induced by long-term dietary supplementation with guar gum in type 2 (insulin-dependent) diabetes.
Diabetologia 1981;21:29-33. 3 Uusitupa M, Tuomilehto J, Karttunen P, Wolf E. Long term effects of guar gum on metabolic control, serum cholesterol and blood pressure levels in type 2 (non-insulin-dependent) diabetic patients with high blood pressure. Ann Clin Res 1984;16(suppl 43):126-3 1. 4 Uusitupa M, Siitonen 0, Savolainen K, Silvasti M, Penttila I, Parviainen M. Metabolic and nutritional effects of long-term use of guar gum in the treatment of noninsulin-dependent diabetes of poor metabolic control. Am J Clin Nutr 1989;49: 345-51.
5 Tuomilehto J, Silvasti M, Aro A, et al. Long term treatment of severe hvpercholesterolaemia with guar gum. Atherosclerosis 1988;72: 157-62. 6 Tuomilehto J, Silvasti M, Manninen V, Uusitupa M, Aro A. Guar gum and gemfibrozil-an effective combination in the treatment of hypercholesterolaemia. Atherosclerosis 1989;76: 71-7. 7 Ebeling P, Yki-Jarvinen H, Aro A, Helve E, Sinisalo M, Koivisto VA. Glucose and lipid metabolism and insulin sensitivity in type I diabetes: the effect of guar gum. Am 7 Clin Nutr
1988;48:98-103.
Cervical cytology SIR,-The editorial by Dr Elizabeth Hudson on terminology in cervical cytology is timely.' All agree with her that the report on a smear should be accurate pathologically, unambiguous in presentation, and relevant to the subsequent management of the patient. She clearly advocates the use of the terminology of the British Society for Clinical Cytology,2 which relates the severity of dyskaryosis in exfoliated cells to the likely grade of cervical intraepithelial neoplasia (CIN I, CIN II, and CIN III) in the ectocervix. She claims that the value of the smear test result lies in its remarkably true reflection of the histological state of the section.
2 Evans DMD, Hudson EA, Brown CL, et al. Terminology in gynaecological cytopathology: report of the working party of
the British Societv for Clinical Cytology. J Clin Pathol 1986;39:933-44. 3 Robertson AJ, Anderson JM, Beck JS, et al. Observer variability in histopathological reporting of cervical biopsy specimens. 7 Clin Pathol 1989;42:23 1-8. 4 Ismail SM, Colclough AB, Dinnen JS, et al. Observer variation in histopathological diagnosis and grading of cervical intraepithelial neoplasia. Br Medj' 1989;298:707- 10.
Shy-Drager syndrome presenting as isolated paralysis of vocal cord abductors SIR, -Dr John Kew and colleagues reported on a woman with Shy-Drager syndrome presenting with isolated paralysis of the abductor muscles of the larynx.' Vocal cord paralysis is possibly the commonest form of presentation of the syndrome to the otolaryngologist but usually occurs late in the disease.2 We describe a less common otological symptom. A 59 year old woman presented in 1983 with the first of recurrent acute episodes of true rotatory vertigo and vomiting associated with tinnitus and a feeling of pressure in the right ear and was treated with cinnarizine and betahistine, initially to good effect. By 1988 her vertigo had recurred and she had developed a fluctuating low frequency sensorineural hearing loss in her right ear. A transtympanic electrocochleogram showed an abnormally wide action potential in the eighth nerve, of the pattern commonly associated with endolymphatic hydrops.' At about the same time she was found to have developed appreciable postural hypotension and a degree of truncal ataxia, and she later began to experience problems with
BMJ VOLUME 301
14 JULY 1990
