1
77 results in torsion.9 Although the peak incidence of torsion is in boys between 13 and 16 years the condition may be seen at almost any age, and unless there is clear evidence of some other diagnosis the tender swollen scrotum must be explored just as soon as possible in any patient. Only in this way will the next decade show a testicular survival rate better than the present 50%. PILES AND THEIR P-VALUES WHEN investigators lOcite significance levels ofp<0’01 in relation to the symptoms produced by haemorrhoids and when othersl’claim that injection of haemorrhoids is after all as good as banding, then perhaps as well as questioning our concepts of haemorrhoids’2 we should look carefully at the manner in which they have been investigated in the past. By the early 1970s most of today’s techniques of treatment had been developed and tested. At this stage two things happened. Firstly, the assumption was made (seldom overtly but often implicitly) that piles, rather than the symptoms they produced, could by one technique or another be cured-i.e., a rivalry between techniques was established. Secondly, because of the variety of techniques and the vogue for clinical trials, a large number of such trials and surveys were, and still are being, reported. In some of these the claims of success were limited to specific symptoms such as pain and bleeding,13 3 in others, however, the claims approached panacea level’4In this headlong rush to compare everything with everything, nearly all techniques from diet to cryosurgery were studied with hope of finding a clear favourite.1O,11,IS-17 One of the latest papers" compares rubber banding with injections and it clearly underlines the difficulties of investigating such a wide variety of symptoms with such wide scope for observer error. As in many previous trials, efforts to’ avoid the bias inherent in such subjective research are not always made obvious-for instance, there is no mention of an independent assessor of the symptoms. Without evidence of impartiality, even conclusions which are bolstered by significance levels of p<O . 00 must be suspect, particularly when, as in this study, at one-year follow-up, about a third of the patients in each treatment group of 40 patients had either been withdrawn from the trial or been lost. Despite these reservations, however, there are many who would still find it refreshing to read the conclusion, which is essentially that "good old-fashioned injection" of the piles is still as effective as banding (which, if you believe the other trials, is as good as haemorrhoidectomy, which is as good as, if not better than, 8 Stage KH, Schoenvogel R, Lewis S. Testicular scanning: Clinical experience with 72 patients J Urol 1981, 125: 334-37 9 Nasrallah PF, Manzone D, King LR. Falsely negative doppler examinations in testicular torsion J Urol 1977, 118: 194-95. 10. Murie JA, Sim AJW, Mackenzie I. The importance of pain, pruritus and soiling as symptoms of haemorrhoids and their response to haemorrhoidectomy or rubber band ligation. Br J Surg 1981; 68: 247-49. 11 Greca F, Hares MM, Nevah E, Alexander-Williams JA, Keighley MRB. A randomized trial to compare rubber band ligation with phenol injection for treatment of haemorrhoids Br J Surg 1981; 68: 250-52. 12 Thomson WHF. The nature of haemorrhoids. Br J Surg 1975; 62: 542-52. 13 Chant ADB, May A, Wilken BJ. Haemorrhoidectomy versus manual dilatation ofthe anus. Lancet 1972; ii: 398-399 14 Lord PH A day-care procedure for the care of third-degree haemorrhoids Br J Surg 1969; 56: 747-49. 15 Ruffin Hood T, Alexander-Williams J. Prospective trials of minor surgical procedures and high fibre diet for hemorrhoids Am J Surg 1971; 122: 545-48. 16 Keighley MRB, Buchmann P, Minervini S, Arabi Y, Alexander-Williams J. Prospective trials of minor surgical procedures and high-fibre diet for haemorrhoids. Br Med J 1979; ii: 967-69. 17 Lloyd Williams K, Haq IO, Elem B. Cryodestruction of haemorrhoids. Br Med J 1973; i 666-68. manual dilation of the anus, which is worse than ... and so on). Obviously no single method of treating piles, not even haemorrhoidectomy, can guarantee to rid the patient of all symptoms, and this fact seems to have been overlooked. In retrospect we can now see that the role of the clinical trial in this type of investigation has been distorted, often because the investigators have lost sight of the original problem. This is not "Which technique is best at destroying piles?"; it is, or should be, "How may the clinician safely improve those symptoms which either he or the patient have ascribed to the piles?" For example, having weeded out the fissures, the Crohn’s disease, and so on, the clinician, in his surgery or outpatients, should be able by injections or banding to improve many of the symptoms of pain, prolapse, and bleeding. If these outpatient manoeuvres fail and the patient wants further treatment, then a more radical approach is possibly indicated. For those whose symptoms are predominantly pain and bleeding or whose rectal pressures are greater than 100 mm Hg., then manual dilatation seems the logical treatment.16 The remainder, whose troubles are usually prolapse, irritation, or skin tags, a haemor- rhoidectomy, cryosurgical or otherwise, is probably indicated. 1 Future trials therefore should investigate treatment sequences such as this rather than techniques of pile destruction per se, all of which are beginning to look much of a muchness. NEW JOURNAL OF TROPICAL PAEDIATRICS AN international forum for papers dealing with paediatrics in the tropics, major health hazards in children, new approaches to old problems, and clinical and epidemiological research in tropical medicine should be welcome. This is the aim of Annals of Tropical Paediatrl’cs, to be published under the eye of the Liverpool School of Tropical Medicine.1 The first issue includes an article about 179 cases of acute renal failure (ARF) in South Indian. 50% children needed dialysis (peritoneal) compared with 62% in a previous report from Guy’s Hospital. Haemolytic uraemic syndrome, mainly complicating bacillary dysentery, caused 41% of the 179 cases, but only 18% of ARF was caused by renal hypoperfusion. In a report from the U.S.A. the proportions were comparable4 but in the Guy’s series2,3 the ratio was reserved with 43% of cases caused by hypoperfusion (one-third from the nephrotic syndrome) and 16% from HUS. The Indian mortality of 51% was higher than that in haemodialysed patients treated (40%)4 in Minneapolis and also greater than that at Guy’s (20%). However, the last figure is low because of facilities for long-term treatment of irreversible renal failure. The Indian workers give no details of long-term follow-up, but with HUS and glomerulonephritis comprising 70% of the causes of ARF it is likely that a substantial number will eventually have died. 1. Annals of Tropical Paediatrics published for the Liverpool School of Tropical Medicine, by Academic Press (24 - 28 Oval Road, London NW 17DX or 111 Fifth Avenue, New York, N.Y 10003) and edited by Prof. R G Hendricksc. Quarterly Personal subscriptions &pound;15, U.K , $U.S 35 elsewhere; otherwise &pound;35 and $98. 2. Raghupathy P, Date A, Shastry JC, Jadhav M, Peveira SM, Acute renal failure in South Indian Children a ten year experience Annals of Tropical Paediatrics 1981,1: 39-44. 3. Counahan R, Cameron JS, Ogg CS, Spurgeon P, Williams DG, Winder E, Chantler C, Presentation, management, complications and outcome of acute renal failure in children: five years’ experience 1977, i: 599-602 4 Lieberman E. Hemolytic-uremic syndrome. Nephron 1973; 11: 193-208. 5 Hodson EM, Kjellstrand CM. Mauer SM, Acute renal failure in infants and children- outcome of 53 patients requiring haemodialysis treatment. J Pediatr 1978; 93: 756-61.

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Page 1: PILES AND THEIR P-VALUES

77

results in torsion.9 Although the peak incidence of torsion isin boys between 13 and 16 years the condition may be seen atalmost any age, and unless there is clear evidence of someother diagnosis the tender swollen scrotum must be exploredjust as soon as possible in any patient. Only in this way willthe next decade show a testicular survival rate better than the

present 50%.

PILES AND THEIR P-VALUES

WHEN investigators lOcite significance levels ofp<0’01 inrelation to the symptoms produced by haemorrhoids andwhen othersl’claim that injection of haemorrhoids is after allas good as banding, then perhaps as well as questioning ourconcepts of haemorrhoids’2 we should look carefully at themanner in which they have been investigated in the past. Bythe early 1970s most of today’s techniques of treatment hadbeen developed and tested. At this stage two things happened.Firstly, the assumption was made (seldom overtly but oftenimplicitly) that piles, rather than the symptoms theyproduced, could by one technique or another be cured-i.e., arivalry between techniques was established. Secondly,because of the variety of techniques and the vogue for clinicaltrials, a large number of such trials and surveys were, and stillare being, reported. In some of these the claims of successwere limited to specific symptoms such as pain and bleeding,13 3in others, however, the claims approached panacea level’4Inthis headlong rush to compare everything with everything,nearly all techniques from diet to cryosurgery were studiedwith hope of finding a clear favourite.1O,11,IS-17One of the latest papers" compares rubber banding with

injections and it clearly underlines the difficulties of

investigating such a wide variety of symptoms with such widescope for observer error. As in many previous trials, efforts to’avoid the bias inherent in such subjective research are notalways made obvious-for instance, there is no mention of anindependent assessor of the symptoms. Without evidence ofimpartiality, even conclusions which are bolstered bysignificance levels of p<O . 00 must be suspect, particularlywhen, as in this study, at one-year follow-up, about a third ofthe patients in each treatment group of 40 patients had eitherbeen withdrawn from the trial or been lost. Despite thesereservations, however, there are many who would still find itrefreshing to read the conclusion, which is essentially that"good old-fashioned injection" of the piles is still as effectiveas banding (which, if you believe the other trials, is as good ashaemorrhoidectomy, which is as good as, if not better than,

8 Stage KH, Schoenvogel R, Lewis S. Testicular scanning: Clinical experience with 72patients J Urol 1981, 125: 334-37

9 Nasrallah PF, Manzone D, King LR. Falsely negative doppler examinations in

testicular torsion J Urol 1977, 118: 194-95.10. Murie JA, Sim AJW, Mackenzie I. The importance of pain, pruritus and soiling as

symptoms of haemorrhoids and their response to haemorrhoidectomy or rubberband ligation. Br J Surg 1981; 68: 247-49.

11 Greca F, Hares MM, Nevah E, Alexander-Williams JA, Keighley MRB. A randomizedtrial to compare rubber band ligation with phenol injection for treatment ofhaemorrhoids Br J Surg 1981; 68: 250-52.

12 Thomson WHF. The nature of haemorrhoids. Br J Surg 1975; 62: 542-52.13 Chant ADB, May A, Wilken BJ. Haemorrhoidectomy versus manual dilatation ofthe

anus. Lancet 1972; ii: 398-39914 Lord PH A day-care procedure for the care of third-degree haemorrhoids Br J Surg

1969; 56: 747-49.15 Ruffin Hood T, Alexander-Williams J. Prospective trials of minor surgical procedures

and high fibre diet for hemorrhoids Am J Surg 1971; 122: 545-48.16 Keighley MRB, Buchmann P, Minervini S, Arabi Y, Alexander-Williams J.

Prospective trials of minor surgical procedures and high-fibre diet forhaemorrhoids. Br Med J 1979; ii: 967-69.

17 Lloyd Williams K, Haq IO, Elem B. Cryodestruction of haemorrhoids. Br Med J 1973;i 666-68.

manual dilation of the anus, which is worse than ... and so

on). Obviously no single method of treating piles, not evenhaemorrhoidectomy, can guarantee to rid the patient of allsymptoms, and this fact seems to have been overlooked.

In retrospect we can now see that the role of the clinical trialin this type of investigation has been distorted, often becausethe investigators have lost sight of the original problem. Thisis not "Which technique is best at destroying piles?"; it is, orshould be, "How may the clinician safely improve thosesymptoms which either he or the patient have ascribed to thepiles?" For example, having weeded out the fissures, theCrohn’s disease, and so on, the clinician, in his surgery oroutpatients, should be able by injections or banding toimprove many of the symptoms of pain, prolapse, andbleeding. If these outpatient manoeuvres fail and the patientwants further treatment, then a more radical approach ispossibly indicated. For those whose symptoms are

predominantly pain and bleeding or whose rectal pressuresare greater than 100 mm Hg., then manual dilatation seemsthe logical treatment.16 The remainder, whose troubles areusually prolapse, irritation, or skin tags, a haemor-

rhoidectomy, cryosurgical or otherwise, is probablyindicated. 1 Future trials therefore should investigatetreatment sequences such as this rather than techniques ofpile destruction per se, all of which are beginning to lookmuch of a muchness.

NEW JOURNAL OF TROPICAL PAEDIATRICS

AN international forum for papers dealing with paediatricsin the tropics, major health hazards in children, newapproaches to old problems, and clinical and epidemiologicalresearch in tropical medicine should be welcome. This is theaim of Annals of Tropical Paediatrl’cs, to be published underthe eye of the Liverpool School of Tropical Medicine.1 Thefirst issue includes an article about 179 cases of acute renalfailure (ARF) in South Indian. 50% children needed dialysis(peritoneal) compared with 62% in a previous report fromGuy’s Hospital. Haemolytic uraemic syndrome, mainlycomplicating bacillary dysentery, caused 41% of the 179 cases,but only 18% of ARF was caused by renal hypoperfusion. In areport from the U.S.A. the proportions were comparable4 butin the Guy’s series2,3 the ratio was reserved with 43% of casescaused by hypoperfusion (one-third from the nephroticsyndrome) and 16% from HUS. The Indian mortality of 51%was higher than that in haemodialysed patients treated

(40%)4 in Minneapolis and also greater than that at Guy’s(20%). However, the last figure is low because of facilities forlong-term treatment of irreversible renal failure. The Indianworkers give no details of long-term follow-up, but with HUSand glomerulonephritis comprising 70% of the causes ofARF it is likely that a substantial number will eventually havedied.

1. Annals of Tropical Paediatrics published for the Liverpool School of Tropical Medicine,by Academic Press (24 - 28 Oval Road, London NW 17DX or 111 Fifth Avenue,New York, N.Y 10003) and edited by Prof. R G Hendricksc. Quarterly Personalsubscriptions &pound;15, U.K , $U.S 35 elsewhere; otherwise &pound;35 and $98.

2. Raghupathy P, Date A, Shastry JC, Jadhav M, Peveira SM, Acute renal failure inSouth Indian Children a ten year experience Annals of Tropical Paediatrics 1981,1:39-44.

3. Counahan R, Cameron JS, Ogg CS, Spurgeon P, Williams DG, Winder E, Chantler C,Presentation, management, complications and outcome of acute renal failure inchildren: five years’ experience 1977, i: 599-602

4 Lieberman E. Hemolytic-uremic syndrome. Nephron 1973; 11: 193-208.5 Hodson EM, Kjellstrand CM. Mauer SM, Acute renal failure in infants and children-

outcome of 53 patients requiring haemodialysis treatment. J Pediatr 1978; 93:756-61.