The modifier of digestive behaviour
Classification: MAXERAN® (metoclopramide monohyd rochloride) is a modifier of upper gastrointestinal tract motility. Indications: Sub-acute gastritis, chronic gastritis, gastric sequellae of surgical procedures such as vagotomy and py/oroplasty. Under these conditions, when gastric emptying is delayed, Maxeran may relieve such symptoms as nausea, vomiting, epigastric distress, bloating, etc. Small bowel intubat,on: Maxeran may facilitate and accelerate small bowel intubation. Side-effects: Drowsiness and, more rarely, insomnia, fatigue, headaches, dizziness and bowel disturbances have been reported. Parkinsonism and other extra-pyramidal syndromes have been reported infrequently. An increase in the frequency and severity of seizures has been reported in conjunction with the administration of Maxeran to epileptic patients. Precautions: Drugs with atropine-like action should not be used simultaneously with Maxeran since they have a tendency to antagonize effect of this drug on gastrointestinal motility. Maxeran should not be used in conjunction with potent ganglioplegic or neuroleptic drugs since potentiation of effects might occur. Maxeran should not be used in patients with epilepsy and extrapyramidal syndromes, unless its expected benefits outweigh the risk of aggravating these symptoms. In view of the risk of extrapyramidal manifestations, metoclopramide should not be used in children unless a clear indication has been established. The recommended dosage of Maxeran should not be exceeded since a further increase in dosage will not produce a corresponding increase in the clinical response. The dosage recommended for children should not be exceeded. Contraindications: Maxeran should not be administered to patients in combination with MAO inhibitors, tricyclic antidepressants, sympathomimetics and foods with high tyramine content, since safety of such an association has not yet been established. As a safety measure, a twoweek period should elapse between using Maxeran and administration of any of these drugs. The safety of use of Maxeran in pregnancy has not been established. Therefore Maxeran should not be used in pregnant women, unless in the opinion of the physician the expected benefits to the patient outweigh the potential risks to the fetus.
Dosage and administration: For delayed gastric emptying Adults Tablets: ½ to 1 tablet (5 - 10 mg) three or four times a day before meals. Liquid: Injectable:
Children: Uquid:
5- 10 ml (5- 10mg) three or four times a day before meals. When parenteral administration is required, 1 ampoule (10 mg) tM. or IV. (slowly) to be repeated 2 or 3 times a day if necessary. (5 to 14 years): 2.5 to 5 ml (2.5 -5 mg)
For small bowel intubation: Adults: One ampoule (fO mg) IV. - 15 minutes before intubation. Other routes (oral or IM.) may be used but with a greater period of latency. Children: (Sf0 14 years): 2.5 to 5 ml (2.5 - 5 mg) Availability: Tablets: Each white scored compressed tablet contains 10 mg of Meto.lopramide Monohydrochloride. Bottles of 50 & 500 tablets. Liquid: Each ml contains 1 mg of Metoclopramide Monohydrochloride. Available in bottles of 110 ml and 450 ml. Injectable: Each 2 ml ampoule contains 10 mg of Metoclopramide Monohydrochloride in a clear colourless solution. Keep away from light and heat. Available in boxes of 5 and 50 ampoules. Product monograph available upon request.
.
rNfl/.. PHARMACEUTIQUES LT.E
t. .9) . IDnluxxP HARMACEUTICALS LTD LavaiQue.
Canada.
Statistical methodology in medicine Using statistical methodology and computers to aid in the analysis and interpretation of medical data is laudable. It is unlikely that anyone would quarrel with the application of methods that permit a more intelligent study of phenomenologic processes. Some people, however, attribute panacean powers to statistics and computers. Unfortunately the statistical methods of today are limited in their power to answer what may appear to the physician to be the simplest of questions. Also, statistical tests require that the data meet certain assumptions that are often ignored (albeit the assumptions themselves are often unrealistic). A regard for the limitations and rules makes the application of statistics difficult even for what may appear to be a trivial problem. A disregard for the facts makes misapplication easy, and one does not have to look far to find misapplications of statistics. Statistical promiscuity appears to be pandemic. If statistical methods are to become an effective tool in medicine, then much greater care must be taken in their use. Assessing results from a statistical analysis can be a deceptive process, even when the amount of data is small. How much more is this true of the masses of data now being churned through computers? Take for example a hypothetical study to test the effectiveness of a soporific drug on a sample of people. For this sample it was found that the drug increased the sleeping time of subjects by an average of 1 hour. Subjecting this information to a common statistical test (the paired t-test) it was discovered that the difference of 1 hour was "highly statistically significant" (P K 0.01). (The use of terms like "significant" when P K 0.05 and "highly significant" when P K 0.01 seems to be in vogue. It should be no.ed. however, that the use of these terms is quite arbitrary.) Suppose the information is changed for just one subject so that the soporific drug increases the average sleeping time by 2 hours instead of 1. How much "more significant" would this new difference be when analysed by the same test? The fact is, this new difference does not even approach statistical significance. This may appear contradictory and in one sense it is. Depending on your frame of reference this paradox may or may not be explained. What is unfortunate is that problems of this nature are not uncommon in medical data. These problems are subtle and the results from the statistical tests
may be more misleading than if no analysis had been done at all. The use of statistical methodology in medicine has been accelerated by the development of the computer. The computer's power to organize, tabulate and manipulate vast quantities of data has encouraged the development of large-scale projects and surveys. The computer's ability to make decisions and mathematical calculations quickly and accurately has permitted exploration into electrocardiograph analysis or even the diagnostic process (for example, given a list of certain symptoms, what is the probability of various diseases being the cause?). Information on the more direct role of computers in medicine was presented in the editorial "Limitations of computers in medicine" (Can Med Assoc J 104: 234, 1971) and is still up to date. There is unlikely to be any diminution, at least in the near future, of the present blizzard of statistics and statistical tests. The young science of statistics is based on a rigorous mathematical foundation but its application is an art. Its usefulness lies in the acknowledgement and understanding of both areas. Statistical methodology, along with the computer, is at least making some people think and others rethink about how to collect, store and analyse data. The physician who is familiar with many of the more common methodologies and tests is fortunate; he does not have to rely solely on his intuition. Common sense and intuition, however, are vital in the analysis and interpretation of data. The statistical tests should, in most cases, validate the physician's intuitive processes, provided he has closely scrutinized the raw or semiraw data; usually, that is, but not always. For example, how likely is it that of the next 35 patients who enter your office at least 2 will have the same birthday? Not very likely? Test it out. This will occur in 8 out of 10 such groups. ROBERT I. ROLLWAOEN
Computer department for health sciences Faculty of medicine University of Manitoba Winnipeg, Man.
CMA JOURNAL/MARCH 22, 1975/VOL. 112 677
Classification: MAXERAN® (metoclopramide monohyd rochloride) is a modifier of upper gastrointestinal tract motility. Indications: Sub-acute gastritis, chronic gastritis, gastric sequellae of surgical procedures such as vagotomy and py/oroplasty. Under these conditions, when gastric emptying is delayed, Maxeran may relieve such symptoms as nausea, vomiting, epigastric distress, bloating, etc. Small bowel intubat,on: Maxeran may facilitate and accelerate small bowel intubation. Side-effects: Drowsiness and, more rarely, insomnia, fatigue, headaches, dizziness and bowel disturbances have been reported. Parkinsonism and other extra-pyramidal syndromes have been reported infrequently. An increase in the frequency and severity of seizures has been reported in conjunction with the administration of Maxeran to epileptic patients. Precautions: Drugs with atropine-like action should not be used simultaneously with Maxeran since they have a tendency to antagonize effect of this drug on gastrointestinal motility. Maxeran should not be used in conjunction with potent ganglioplegic or neuroleptic drugs since potentiation of effects might occur. Maxeran should not be used in patients with epilepsy and extrapyramidal syndromes, unless its expected benefits outweigh the risk of aggravating these symptoms. In view of the risk of extrapyramidal manifestations, metoclopramide should not be used in children unless a clear indication has been established. The recommended dosage of Maxeran should not be exceeded since a further increase in dosage will not produce a corresponding increase in the clinical response. The dosage recommended for children should not be exceeded. Contraindications: Maxeran should not be administered to patients in combination with MAO inhibitors, tricyclic antidepressants, sympathomimetics and foods with high tyramine content, since safety of such an association has not yet been established. As a safety measure, a twoweek period should elapse between using Maxeran and administration of any of these drugs. The safety of use of Maxeran in pregnancy has not been established. Therefore Maxeran should not be used in pregnant women, unless in the opinion of the physician the expected benefits to the patient outweigh the potential risks to the fetus.
Dosage and administration: For delayed gastric emptying Adults Tablets: ½ to 1 tablet (5 - 10 mg) three or four times a day before meals. Liquid: Injectable:
Children: Uquid:
5- 10 ml (5- 10mg) three or four times a day before meals. When parenteral administration is required, 1 ampoule (10 mg) tM. or IV. (slowly) to be repeated 2 or 3 times a day if necessary. (5 to 14 years): 2.5 to 5 ml (2.5 -5 mg)
For small bowel intubation: Adults: One ampoule (fO mg) IV. - 15 minutes before intubation. Other routes (oral or IM.) may be used but with a greater period of latency. Children: (Sf0 14 years): 2.5 to 5 ml (2.5 - 5 mg) Availability: Tablets: Each white scored compressed tablet contains 10 mg of Meto.lopramide Monohydrochloride. Bottles of 50 & 500 tablets. Liquid: Each ml contains 1 mg of Metoclopramide Monohydrochloride. Available in bottles of 110 ml and 450 ml. Injectable: Each 2 ml ampoule contains 10 mg of Metoclopramide Monohydrochloride in a clear colourless solution. Keep away from light and heat. Available in boxes of 5 and 50 ampoules. Product monograph available upon request.
.
rNfl/.. PHARMACEUTIQUES LT.E
t. .9) . IDnluxxP HARMACEUTICALS LTD LavaiQue.
Canada.
Statistical methodology in medicine Using statistical methodology and computers to aid in the analysis and interpretation of medical data is laudable. It is unlikely that anyone would quarrel with the application of methods that permit a more intelligent study of phenomenologic processes. Some people, however, attribute panacean powers to statistics and computers. Unfortunately the statistical methods of today are limited in their power to answer what may appear to the physician to be the simplest of questions. Also, statistical tests require that the data meet certain assumptions that are often ignored (albeit the assumptions themselves are often unrealistic). A regard for the limitations and rules makes the application of statistics difficult even for what may appear to be a trivial problem. A disregard for the facts makes misapplication easy, and one does not have to look far to find misapplications of statistics. Statistical promiscuity appears to be pandemic. If statistical methods are to become an effective tool in medicine, then much greater care must be taken in their use. Assessing results from a statistical analysis can be a deceptive process, even when the amount of data is small. How much more is this true of the masses of data now being churned through computers? Take for example a hypothetical study to test the effectiveness of a soporific drug on a sample of people. For this sample it was found that the drug increased the sleeping time of subjects by an average of 1 hour. Subjecting this information to a common statistical test (the paired t-test) it was discovered that the difference of 1 hour was "highly statistically significant" (P K 0.01). (The use of terms like "significant" when P K 0.05 and "highly significant" when P K 0.01 seems to be in vogue. It should be no.ed. however, that the use of these terms is quite arbitrary.) Suppose the information is changed for just one subject so that the soporific drug increases the average sleeping time by 2 hours instead of 1. How much "more significant" would this new difference be when analysed by the same test? The fact is, this new difference does not even approach statistical significance. This may appear contradictory and in one sense it is. Depending on your frame of reference this paradox may or may not be explained. What is unfortunate is that problems of this nature are not uncommon in medical data. These problems are subtle and the results from the statistical tests
may be more misleading than if no analysis had been done at all. The use of statistical methodology in medicine has been accelerated by the development of the computer. The computer's power to organize, tabulate and manipulate vast quantities of data has encouraged the development of large-scale projects and surveys. The computer's ability to make decisions and mathematical calculations quickly and accurately has permitted exploration into electrocardiograph analysis or even the diagnostic process (for example, given a list of certain symptoms, what is the probability of various diseases being the cause?). Information on the more direct role of computers in medicine was presented in the editorial "Limitations of computers in medicine" (Can Med Assoc J 104: 234, 1971) and is still up to date. There is unlikely to be any diminution, at least in the near future, of the present blizzard of statistics and statistical tests. The young science of statistics is based on a rigorous mathematical foundation but its application is an art. Its usefulness lies in the acknowledgement and understanding of both areas. Statistical methodology, along with the computer, is at least making some people think and others rethink about how to collect, store and analyse data. The physician who is familiar with many of the more common methodologies and tests is fortunate; he does not have to rely solely on his intuition. Common sense and intuition, however, are vital in the analysis and interpretation of data. The statistical tests should, in most cases, validate the physician's intuitive processes, provided he has closely scrutinized the raw or semiraw data; usually, that is, but not always. For example, how likely is it that of the next 35 patients who enter your office at least 2 will have the same birthday? Not very likely? Test it out. This will occur in 8 out of 10 such groups. ROBERT I. ROLLWAOEN
Computer department for health sciences Faculty of medicine University of Manitoba Winnipeg, Man.
CMA JOURNAL/MARCH 22, 1975/VOL. 112 677
