Bray, C.A.

Hole, D.J.

Mackie, R.M.

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and Lynettte Yaxley for help in initial development of the studyand Michael Grande for statistical advice. RCT is guarantor forthe study.Funding: None.Competing interests: None declared.1 Casson IF, Clarke CA, Howard CV, McKendrick O, Pennycook S, PharoahPOD, et al. Outcomes of pregnancy in insulin dependent women: resultsof a five year cohort study. BMJ 1997;315:275›8.2 Hawthorne G, Robson S, Ryall EA, Sen D, Roberts SH, Ward Platt MP.Prospective population based survey of outcome of pregnancy in diabeticwomen: results of the northern diabetic pregnancy audit, 1994. BMJ1997;315:279›81.3 Hanson U, Persson B, Thurnell S. Relationship between haemoglobinA1c in early type 1 (insulin›dependent) diabetic pregnancy and theoccurrence of spontaneous abortion and fetal malformation in Sweden.Diabetologia 1990;33:100›4.4 Nielson GL, Sorensen PH, Nielson PH, Sabroe S, Olsen J. Glycosylatedhemoglobin as predictor of adverse fetal outcome in type 1 diabeticpregnancies. Acta Diabetol 1997;34:217›22.5 Rosenn B, Miodovnik M, Combs CA, Khoury J, Siddiqi TA. Glycaemicthresholds for spontaneous abortions and congenital malformations ininsulin›dependent diabetes mellitus. Obstet Gynecol 1994;84:515›20.(Accepted 22 April 2002)Observational study of type of surgical trainingand outcome of definitive surgery for primarymalignant melanomaRona M MacKie, Caroline A Bray, David J HoleThe incidence of primary cutaneous malignantmelanoma continues to rise,1 coinciding with narrowerexcision margins of normal skin being recommendedaround primary melanomas.2 3 The bulk of surgery forprimary melanoma is now done on an outpatient basisunder local anaesthesia. This change has occurred at atime when training in dermatological surgery hasdeveloped, leading to a much higher proportion ofexcisions of primary melanoma being done by derma›tologists. In 1979 in the west of Scotland only 3% of allprimary melanomas were removed by dermatologists.By 1998 this figure had risen to 40%. Plastic surgeonsnow excise 26% of primary melanomas compared with65% 20 years ago, and general surgeons excise 34%compared with 32%.We aimed to establish if the change in type of sur›geon removing primary cutaneous malignantmelanoma has affected the prognosis, and alsowhether any evidence exists for a specialist treatmenteffect such as has been observed for breast cancers,with better outcomes for surgeons carrying out breastcancer surgery regularly.4Participants, methods, and resultsWe identified 4159 melanoma patients from the files ofthe Scottish melanoma group. All patients had hadtheir primary melanoma removed between 1979 and1998. We divided the surgeons performing the defini›tive excision of the primary melanoma into dermato›logical, plastic surgery, or general surgery training. Werecorded age, sex, tumour thickness, presence ofulceration, and maximum diameter of the primarytumour and noted mortality and cause of death up to1998. We also looked at the effect within the three sur›gical groups of treating up to six or more than six pri›mary melanomas annually.An average of 10 years’ follow up information wasavailable for all patients. To test for an associationbetween tumour thickness and type of surgicalexperience we used the ÷2 statistic for trend, aggregatedover the period of diagnosis. We used the Coxproportional hazards model to compare the survival ofpatients in relation to surgical experience,5 withadjustment for thickness, ulceration, and maximumdiameter of tumour and sex, age, and deprivationcategory of patients.The table shows the division of patients by tumourthickness, ulceration, maximum diameter of primarymelanoma, and outcome by surgical training. Derma›tologists treated a significantly higher proportion ofthin melanomas (P < 0.001). The proportion ofulcerated melanomas was higher in the plastic surgerygroup than in the dermatological group (P < 0.001)and higher in the general surgical group than theplastic surgery group (P < 0.001).After adjustment for thickness, the best outcomewas in the dermatological surgeon treatment groupDetails of melanomas treated, by surgical groups adjusted for type of surgical training. Values are numbers (percentages) unless stated otherwiseCharacteristics of melanomas Dermatologist surgeon (n=1076) Plastic surgeon (n=1691) General surgeon (n=1392) Total (n=4159)Primary tumours <1.5 mm thick 739 (69)* 809 (48) 589 (42) 2137 (51)Primary tumours 1.5›3.49 mm thick 217 (20) 447 (26) 342 (25) 1006 (24)Primary tumours >3.5 mm thick 120 (11) 435 (26) 461 (33) 1016 (24)No of primary tumours ulcerated 129 (12)* 432 (26)* 499 (36) 1060 (25)Relative hazard ratios† (95% CI) (risk of death)Adjusted for thickness‡ 1.0 1.33 (1.07 to 1.65) 1.41 (1.14 to 1.75) P=0.008Adjusted for thickness and ulceration 1.0 1.22 (0.97 to 1.54) 1.23 (0.97 to 1.55) P=0.19Adjusted for thickness, ulceration, and maximum diameter 1.0 1.14 (0.88 to 1.48) 1.18 (0.90 to 1.54) P=0.48*P<0.001 for comparison of proportion of thin melanomas treated by dermatological surgeons compared with other surgeons; also for proportion of ulcerated melanomas both betweendermatological and plastic surgeons and between plastic and general surgeons.†Sex, age, deprivation category, and year of diagnosis were considered in the model but did not contribute any significant impact on surgical training differences.‡Thickness of primary tumour has been entered as a stratification variable owing to non›proportionality of the hazard functions.PapersDepartment ofPublic Health,University ofGlasgow, GlasgowG12 8RZRona M MacKieLeverhulmeprofessorial researchfellowCaroline A Braymedical statisticianDavid J Holeprofessor ofepidemiology andbiostatisticsCorrespondence toR M MacKieR.M.Mackie@clinmed.gla.ac.ukBMJ 2002;325:1276–71276 BMJ VOLUME 325 30 NOVEMBER 2002 bmj.com(P=0.008). Statistical significance was lost when adjust›ment was made for ulceration and then for maximumdiameter. We found no evidence that surgeons in anyof the three categories who performed more than sixprimary melanoma excisions annually had betteroutcomes than those who performed fewer excisions.CommentSurvival of melanoma patients does not depend on thesurgical background of the person removing theprimary tumour. The object of this study was toprovide an evidence base for primary care guidelineson appropriate specialist referral. The data show thatthe growth in dermatological surgeons excisingprimary melanomas has had no adverse affect onpatient outcome. We found no evidence that any typeof surgeon performing excisions of primary melano›mas regularly had a better outcome than those whocarried out fewer excisions, possibly because wide localexcision is a relatively simple procedure. We thereforeprovide an evidence base to recommend referral ofsuspected primary melanomas to the dermatological,plastic surgery, or general surgical service with theshortest surgical waiting time.Contributors: RMM collected the data, wrote the paper, and isthe guarantor for the study. CAB and DJH analysed the data.Funding: The Scottish Melanoma Group is funded by NHSScotland. RMM receives financial support from the LeverhulmeTrust.Conflicts of interest: None declared.1 MacKie RM, Hole DJ, Hunter JAA, Rankin R, Evans A, McLaren K, et al.Cutaneous malignant melanoma in Scotland: incidence, survival, andmortality 1979›94. BMJ 1997;315:1117›21.2 Veronesi U, Cascinelli N, Adamus J, Balch C, Bandiera D, Barchuk A, et al.Thin stage I primary cutaneous malignant melanoma: comparison ofexcision with margins of 1 or 3 cm. N Engl J Med 1988;318:1159›62.3 Balch CM, Urist MM, Karakousis CP, Smith TJ, Temple WJ, Drzewiecki K,et al. Efficacy of 2›cm surgical margins for intermediate thicknessmelanomas (1 to 4 mm): Results of a multi›institutional randomized sur›gical trial. Ann Surg 1993;218:262›8.4 Sainsbury R, Haward B, Rider L, Johnston C, Round C. Influence of clini›cian workload and patterns of treatment on survival from breast cancer.Lancet 1995;345:1265›70.5 Cox DR. Regression models and life tables. J R Stat Soc (B)1972;34:187›220.(Accepted 17 April 2002)Drug pointsDysgeusia and burning mouth syndrome byeprosartanXavier Castells, Isidre Rodoreda, Consuelo Pedrós, Gloria Cereza,Joan›Ramon LaporteEprosartan is an angiotensin II receptor antagonist.Dysgeusia and burning mouth syndrome attributed toangiotensin converting enzyme inhibitors have beenreported.1 Several case reports related to angiotensin IIreceptor antagonists have also been published. We reportthe case of a patient in whom oral eprosartan inducedreversible taste disturbance and burning mouth sensationon two occasions. This case was reported to the Catalanpharmacovigilance centre.A 48 year old woman with a 10 year history of essen›tial hypertension was being treated with valsartan 160 mgdaily. She had no other medical condition and was nottaking any other drugs. She started taking eprosartan600 mg daily because her blood pressure remaineduncontrolled with valsartan. Three weeks later shecomplained of a metallic taste and a burning sensation inher mouth. The oral cavity was normal and no underlyingmedical causes were identified. She stopped takingeprosartan and one week later her taste had returned tonormal. The dysgeusia was not attributed to eprosartanand she started taking the drug again. A few days later,dysgeusia and the burning sensation in her mouthreturned. She stopped taking eprosartan and her tasterecovered in two days.Taste disorders related to angiotensin II receptorantagonists had not been described in clinical trials,2 butseveral cases of dysgeusia have been reported in patientstreated with losartan3–5 and with valsartan.6 To our knowl›edge, this is the first reported case of dysgeusia induced byeprosartan and the first case of dysgeusia induced byangiotensin II receptor antagonists with positive rechal›lenge. Dysgeusia with losartan but not with angiotensinconverting enzyme inhibitors has been reported to occurin the same patient, suggesting that angiotensin convert›ing enzyme inhibitors or angiotensin II receptorantagonists produce this effect by acting through differentmechanisms.5 Because the incidence of dysgeusia inpatients treated with drugs from these two therapeuticgroups is low,1 2 it is possible that this adverse effectappears only in patients with some predisposingcondition.In our case report, the temporal sequence of events—and, in particular, positive rechallenge—and the lack ofunderlying concomitant diseases or other drugs stronglysuggest that the association between dysgeusia, burningmouth syndrome, and eprosartan was causal. Becausethese effects occurred with eprosartan but not with valsar›tan at equivalent doses, however, our observation does notfavour the theory of an effect due to the angiotensin IIreceptor antagonist class of drug. Factors predisposing tothis adverse effect remain to be identified and themechanism remains to be elucidated.Funding: Departament de Sanitat i Seguretat Social, Generalitatde Catalunya.Competing interests: None declared.1 Henkin RI. Drug›induced taste and smell disorders. Incidence,mechanisms and management related primarly to treatment of sensoryreceptor dysfunction. Drug Saf 1994;11:318›77.2 Mazzolai L, Burnier M. Comparative safety and tolerability of angiotensinII›receptor antagonists. Drug Saf 1999;21:23›33.3 Malnick SD, Becker S. Dysgeusia by losartan in a patient intolerant ofcaptopril. Med Gen Med 1999;4:E33.4 Schlienger RG, Saxer MS, Haefeli WE. Reversible dysgeusia associatedwith losartan. Lancet 1996;347:471›2.5 Heeringa M, van Puijenbroek EP. Reversible dysgeusia attributed tolosartan. Ann Intern Med 1998;129:72.6 Stroeder D, Zessig, I Heath R. Angiotensin›II antagonist cGP 48933 (Val›sartan). Ergebnisse einer doppelblinden, plazebo›kontroliertenMulticenter›studie. Nieren Hochdruckkrankheiten 1994;23:217›20.PapersFundació InstitutCatalà deFarmacologia,Servei deFarmacologiaClínica, HospitalUniversitari Valld’Hebron,08035›Barcelona,SpainXavier CastellsConsuelo PedrósGloria CerezaJoan›RamonLaporteÀrea Bàsica deSalut Pla d’Urgell,Mollerusa, Lleida,SpainIsidre RodoredaCorrespondence to:J›R Laportejrl@icf.uab.esBMJ 2002;325:12771277BMJ VOLUME 325 30 NOVEMBER 2002 bmj.com

Observational study of type of surgical training and outcome of definitive surgery for primary malignant melanoma

R. M MacKie

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Observational study of type of surgical training and outcome of definitive surgery for primary malignant melanoma

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