The New Bactericidal Patency of
ERVTHROCIN
(ERYTHROMYCIN STEARATE USP 500 mg)
.7.
7,
.7...7.
.,,
.7.7.,. ,.7,.....
..-. *,,..,
u.ibe.uur.dbvtke
..7.
t.DB.1 L.FL.f
ERYTHROCIN (erythromycin stearate, USP) 500 mg tablet tid. Should be taken immediately before meals. AVAILABILITY: Each Filmtab tablet contains: erythromycin (as the stearate) 500 mg buffered with sodium citrate. Available in bottles of 50 Filmtab tablets, and Erythrocin B.Bac* dispenser of 21 and 30 tablets. DOSAGE: 500 mg every 12 hours. For more severe infections (e.g., lower respiratory tract, sinusitis) 500 mg every 8 hours. Dosage may be increased up to 4 g per day, according to the severity of the infection. In the treatment of streptococcal infections, a therapeutic dosage of erythromycin should be administered for at least 10 days. In continuous prophylaxis of streptococcal infections in persons with a history of rheumatic heart disease, the dose is 250 mg twice a day. CONTRAINDICATIONS: Known hypersensitivity to erythromycin. ADVERSE EFFECTS: The most frequent adverse effects of oral erythromycin preparations are gastrointestinal, such as abdominal cramping and discomfort and are dose-related. Nausea, vomiting and diarrhea occur infrequently with the usual oral dose. During prolonged or repeated therapy there is a possibility of overgrowth of nonsusceptible bacteria or fungi. If such an infection occurs, the drug should be discontinued and appropriate therapy instituted. Mild allergic reactions, such as urticaria and other skin rashes, have occurred. Serious allergic reactions, including anaphylaxis, have been reported. Erythrocin is not clinically involved in transferable drug resistance. *RD TM .T M
B
PHARMACEUTICAL PRODUCTS DIVISION ABBOTT LABORATORIES, LIMITED MONTR.AL, CANADA
However, I had presumed, apparently in error, that Dr. Kershner had discussed the final conclusions with them and had received their approval to have their names appear as signatories of the letter. This obviously did not occur and the conclusions are primarily those of Dr. Kershner, based on his statistical analysis of the results of the study. Certainly if Grekin and Cutler were not consulted about the final conclusions and do not agree with them, they should not be considered as coauthors of the letter. Incidentally, I do not think the remarks on the relation of sugar to whatever problems we were studying (since they were extremely varied) are comical. Actually two alternatives were offered; one, to the best of my knowledge, favoured by the supporters of orthomolecular treatment, that effects were secondary to rebound hypoglycemia; and the other, which I believe to be more probable, that an increase in the intake of sugar means an increased intake of energy into the body. I have studied a few children who clearly showed increased activity after excessive intake of sugar but who did not, on formal tests, show any rebound hypoglycemia even after 6 hours. Almost all of us who have taken a drink containing sugar or candy during the late afternoon when we are tired are aware of the energy or drive that is produced, even for a short period, by the intake of that sugar. WILLIAM A. HAWKE, MD Hospital for Sick Children Toronto, Ont.
Home peritoneal dialysis To the editor: As a psychologist, with a friend who has been undergoing pentoneal dialysis in my home for 2½ years, I was most interested in the article by Dr. Karanicolas and colleagues (Can Med Assoc J 116: 266, 1977). I congratulate them on their success with this life support system but dispute their claim that 55% of patients returned to their predialysis lifestyle. Either Karanicolas and associates were not familiar with the lifestyles of the patients and their families before and after dialysis was instituted, or by the term lifestyle they meant employment. From my observations the lifestyles of both the patients and their families are changed greatly. Being tied to tubing several nights a week and able to move only a short distance results in the patient being completely dependent on others for hours at a time. Someone else has to attend to the doorbell, lights, heating, the dog, items out of reach, hazards of fire and other emergencies. There must
1370 CMA JOURNAL/DECEMBER 17, 1977/VOL. 117
be willing acceptance by the patient of partial dependency. The patient, with or without assistance, must spend an hour in setting up before, and cleaning up after, each dialysis. He or she is obliged to spend considerable time in filling out records, placing orders, taking samples, getting supplies and arranging for their storage. Time and effort are often necessary to attend to breakdown of equipment: faulty pumps, broken bags or tubing causing flooding and moppingup operations. Dietary restrictions and the "double boil" mean a change in menus and meal planning. The change in the patient's lifestyle can be gauged (a) by the number of hours per week spent on dialysis and activities associated with it; (b) by the amount of restriction of movement; (c) by the time spent in discussion of the problems connected with dialysis; and (d) by the number of tasks the patient previously carried out that are now delegated to other members of the household, and the number of actions for which assistance is needed. The functioning of the household is changed similarly. In our house more than half a ton of dialysis fluid must be received and stored each month without causing damage. (An architect informed us that on our upper floor no more than four boxes may be safely piled.) Arrangements must be made for the removal of the empty boxes and for the disposal of the quantities of garbage. Damage to carpets and floors from faulty equipment must be repaired; this is covered by neither household nor hospital insurance. The household schedule is changed. Some responsible person must always be in the house when the patient is undergoing dialysis. Nights out are limited. Parties and meetings at the house must be planned for nondialysis nights. Household tasks must be reassigned and arrangements for moving heavy objects must be made. Thus, the functioning of the household must be reorganized. The lifestyle of the patient with regard to travel is changed greatly. The two nights when he is not undergoing dialysis he can visit nearby places. For longer visits a special electric outlet and a raised bed are essential but are not available in all hotels. Fluid and supplies must be transported by station wagon or, in the case of a longer stay, by truck. Foreign travel is almost impossible; conveyance of dialysis supplies by air is expensive and difficult. In our household we have been left to work out solutions by ourselves. For example, after setting up dialysis in the patient's bedroom, with tubing going to the bathroom through the
hall, we experienced frequent breakdowns and flooding from the pumping system, so we turned a small guest room into a dialysis room with a direct drain to the plumbing. Supplies, fluid and accessories are stored here and there is heavy linoleum on the floor to protect it from spillage. This room is used exclusively by the patient for dialysis periods. It was set up with the approval of, but little assistance from, the hospital. It would be helpful if nephrologists were occasionally to visit homes where dialysis is undertaken to enable them to know how much life adjustment is required. There could be some exchange of ideas about methods for coping with the various problems, which would be of great value. If tremendous effort is being made at such great expense to keep patients alive, surely it is of importance to physicians, as it is to all of us, to see that life with this type of support system is made as pleasant and as comfortable as possible. The research and technical developments are justified only if the new lifestyle is as worthwhile as the old. MARY L. NORThWAY, PH D, FCPA The Brora Centre Toronto, Ont.
Treatment of obesity by exercise in the cold To the editor: The article describing the treatment of obesity by exercise in the cold by Dr. W.J. O'Hara, C. Allen and Dr. R.J. Shephard (Can Med Assoc 1 117: 773, 1977) raises questions related to both the significance of the findings and the ethics of the study. Rapid early weight loss can be induced by a variety of techniques that, like the regimen described, do not lend themselves to practical application. The preservation of lean mass in this study is said to distinguish this method from all previously reported diets and exercise fads: at least that is the implication. But the paucity of accurate data derived during other procedures makes it difficult to accept this conclusion. To ensure that the regimen described is unique a study would be needed in which the same measurements are taken by the same observers of subjects undergoing a variety of regimens. The practical significance of rapid early weight loss, as noted correctly, is mainly psychologic. In the view of at least one prominent researcher a study of behavioural change should include a 6-month follow-up to merit consideration as being likely applicable to longterm change.1 The 60-day follow-up reported is better than nothing but it is
short when one considers that an effective weight-control program must remain useful for decades. Therefore, the obscure significance of the findings leads to ethical questions. Specifically, was it proper to ask six men to expose themselves to such severe environmental conditions? Furthermore, the study took place in a quasimilitary setting and the subjects were employees of the military establishment. One is entitled to reassurance that the subjects' consent was given voluntarily and not influenced by the perception of possible negative consequences of noncompliance (even if none existed, which I trust was the case). After all, a military setting is a "total institution" in the same sense as a mental hospital;. the pitfalls of selecting "volunteers" from hospitalized psychiatric patients are well known.3 The ethical questions are important because the study relied heavily on the avoidance of aversive stimulation (i.e., punishment). The phrase "but the cold environment provided an incentive to vigorous activity" really means that if the subjects did not move around a lot they suffered pain. Similarly, the authors later observe: "The main function of the cold may... be to provide the motivation for sustained movement". However, we are not dealing with a "motivator" but with an aversive (painful) stimulus, to which the subjects must respond appropriately (i.e., as the investigators desire) to avoid pain. The significance of this would become obvious if the investigators had chosen a different aversive stimulus, such as electric stimulation. However, if they had done so, the aversive nature of the study would have been so apparent that it is an open question whether it would have been carried out. MORTON S. RAPP, MD
Associate professor Department of psychiatry University of Toronto Sunnybrook Medical Centre Toronto, Ont.
References 1. FRANKS CM, WILSON GT: Annual Review of Behavior Therapy, vol 3, New York, BrunnerMazel, 1975, p 66
2. GOFFMAN E: Asylums, Garden City, NY, Doubleday, 1961, p 5 3. LAKovics M: Voluntariness of hospitalization as an important research variable and legal implications of its omission from the psychiatric research literature, in Medical, Moral and Legal Issues in Mental Health Care, AYD FJ JR (ed), Don Mills, Burns & MacEachern, 1974
To the editor: In response to Dr. Rapp's comments, we were well aware that the findings from our preliminary study of exercise in the cold were sufficiently challenging to demand verification by a more extensive controlled study. The first phase of this additional work a crossover comparison of exercise in the cold versus exercise in a temperate
climate - has recently been completed. It fully substantiates the unique effect of the cold environment. We caution Dr. Rapp against thinking in terms of weight loss - a common error among clinicians. The need of the patient is to rid himself of fat rather than weight; strengthening of muscles without change of body weight is a more satisfactory result than loss of both fat and protein - as is the case when a dietary regimen alone is given. The point about the duration of "cure.. is obviously important, since most existing "remedies" are ineffective in the long term. The experiments were completed some 2½ years ago and provided a substantial incentive to change the lifestyle of the participants. Five of the six individuals have sustained or increased their fat loss, the one exception being a heavy drinker who has continued to consume some 6 to 7 L of beer per night. The ethics of the experiment are not a real issue. Unlike many clinical "treatments" of obesity, the project was considered and approved by a university committee on the ethics of human experimentation. This group was very careful to reassure itself that we exercised no pressure, direct or indirect, that would influence the decision of the subjects to begin and to continue their participation in the experiment. All men came forward of their own free will, their sole motivation being a personal wish to reduce their body fat. I should stress that although some of our subjects were military personnel, the majority of the employees at the Defence and Civil Institute of Environmental Medicine (DCIEM) are civilians, and the constraints of discipline are no greater than at Sunnybrook Medical Centre. None of our subjects experienced any pain, nor would they have done so if they had not exercised. Because of the complete absence of wind and the use of full arctic clothing the climate was much less severe than a casual reading of the environmental figures might suggest. It would have been too cool to sit in great comfort, but modest exercise was enough to keep the subjects quite warm. The mood of the participants was extremely thoughtful throughout the experiment, and to talk about an aversive stimulus is, frankly, nonsense. To paint further the caricature of the DCIEM as a "total institution" and to compare it with a mental hospital is to display a very limited understanding of the philosophy and modus operandi of a neighbouring research establishment. I hope Dr. Rapp will be able to correct his false impressions soon by
CMA JOURNAL/DECEMBER 17, 1977/VOL. 117
1371
ERVTHROCIN
(ERYTHROMYCIN STEARATE USP 500 mg)
.7.
7,
.7...7.
.,,
.7.7.,. ,.7,.....
..-. *,,..,
u.ibe.uur.dbvtke
..7.
t.DB.1 L.FL.f
ERYTHROCIN (erythromycin stearate, USP) 500 mg tablet tid. Should be taken immediately before meals. AVAILABILITY: Each Filmtab tablet contains: erythromycin (as the stearate) 500 mg buffered with sodium citrate. Available in bottles of 50 Filmtab tablets, and Erythrocin B.Bac* dispenser of 21 and 30 tablets. DOSAGE: 500 mg every 12 hours. For more severe infections (e.g., lower respiratory tract, sinusitis) 500 mg every 8 hours. Dosage may be increased up to 4 g per day, according to the severity of the infection. In the treatment of streptococcal infections, a therapeutic dosage of erythromycin should be administered for at least 10 days. In continuous prophylaxis of streptococcal infections in persons with a history of rheumatic heart disease, the dose is 250 mg twice a day. CONTRAINDICATIONS: Known hypersensitivity to erythromycin. ADVERSE EFFECTS: The most frequent adverse effects of oral erythromycin preparations are gastrointestinal, such as abdominal cramping and discomfort and are dose-related. Nausea, vomiting and diarrhea occur infrequently with the usual oral dose. During prolonged or repeated therapy there is a possibility of overgrowth of nonsusceptible bacteria or fungi. If such an infection occurs, the drug should be discontinued and appropriate therapy instituted. Mild allergic reactions, such as urticaria and other skin rashes, have occurred. Serious allergic reactions, including anaphylaxis, have been reported. Erythrocin is not clinically involved in transferable drug resistance. *RD TM .T M
B
PHARMACEUTICAL PRODUCTS DIVISION ABBOTT LABORATORIES, LIMITED MONTR.AL, CANADA
However, I had presumed, apparently in error, that Dr. Kershner had discussed the final conclusions with them and had received their approval to have their names appear as signatories of the letter. This obviously did not occur and the conclusions are primarily those of Dr. Kershner, based on his statistical analysis of the results of the study. Certainly if Grekin and Cutler were not consulted about the final conclusions and do not agree with them, they should not be considered as coauthors of the letter. Incidentally, I do not think the remarks on the relation of sugar to whatever problems we were studying (since they were extremely varied) are comical. Actually two alternatives were offered; one, to the best of my knowledge, favoured by the supporters of orthomolecular treatment, that effects were secondary to rebound hypoglycemia; and the other, which I believe to be more probable, that an increase in the intake of sugar means an increased intake of energy into the body. I have studied a few children who clearly showed increased activity after excessive intake of sugar but who did not, on formal tests, show any rebound hypoglycemia even after 6 hours. Almost all of us who have taken a drink containing sugar or candy during the late afternoon when we are tired are aware of the energy or drive that is produced, even for a short period, by the intake of that sugar. WILLIAM A. HAWKE, MD Hospital for Sick Children Toronto, Ont.
Home peritoneal dialysis To the editor: As a psychologist, with a friend who has been undergoing pentoneal dialysis in my home for 2½ years, I was most interested in the article by Dr. Karanicolas and colleagues (Can Med Assoc J 116: 266, 1977). I congratulate them on their success with this life support system but dispute their claim that 55% of patients returned to their predialysis lifestyle. Either Karanicolas and associates were not familiar with the lifestyles of the patients and their families before and after dialysis was instituted, or by the term lifestyle they meant employment. From my observations the lifestyles of both the patients and their families are changed greatly. Being tied to tubing several nights a week and able to move only a short distance results in the patient being completely dependent on others for hours at a time. Someone else has to attend to the doorbell, lights, heating, the dog, items out of reach, hazards of fire and other emergencies. There must
1370 CMA JOURNAL/DECEMBER 17, 1977/VOL. 117
be willing acceptance by the patient of partial dependency. The patient, with or without assistance, must spend an hour in setting up before, and cleaning up after, each dialysis. He or she is obliged to spend considerable time in filling out records, placing orders, taking samples, getting supplies and arranging for their storage. Time and effort are often necessary to attend to breakdown of equipment: faulty pumps, broken bags or tubing causing flooding and moppingup operations. Dietary restrictions and the "double boil" mean a change in menus and meal planning. The change in the patient's lifestyle can be gauged (a) by the number of hours per week spent on dialysis and activities associated with it; (b) by the amount of restriction of movement; (c) by the time spent in discussion of the problems connected with dialysis; and (d) by the number of tasks the patient previously carried out that are now delegated to other members of the household, and the number of actions for which assistance is needed. The functioning of the household is changed similarly. In our house more than half a ton of dialysis fluid must be received and stored each month without causing damage. (An architect informed us that on our upper floor no more than four boxes may be safely piled.) Arrangements must be made for the removal of the empty boxes and for the disposal of the quantities of garbage. Damage to carpets and floors from faulty equipment must be repaired; this is covered by neither household nor hospital insurance. The household schedule is changed. Some responsible person must always be in the house when the patient is undergoing dialysis. Nights out are limited. Parties and meetings at the house must be planned for nondialysis nights. Household tasks must be reassigned and arrangements for moving heavy objects must be made. Thus, the functioning of the household must be reorganized. The lifestyle of the patient with regard to travel is changed greatly. The two nights when he is not undergoing dialysis he can visit nearby places. For longer visits a special electric outlet and a raised bed are essential but are not available in all hotels. Fluid and supplies must be transported by station wagon or, in the case of a longer stay, by truck. Foreign travel is almost impossible; conveyance of dialysis supplies by air is expensive and difficult. In our household we have been left to work out solutions by ourselves. For example, after setting up dialysis in the patient's bedroom, with tubing going to the bathroom through the
hall, we experienced frequent breakdowns and flooding from the pumping system, so we turned a small guest room into a dialysis room with a direct drain to the plumbing. Supplies, fluid and accessories are stored here and there is heavy linoleum on the floor to protect it from spillage. This room is used exclusively by the patient for dialysis periods. It was set up with the approval of, but little assistance from, the hospital. It would be helpful if nephrologists were occasionally to visit homes where dialysis is undertaken to enable them to know how much life adjustment is required. There could be some exchange of ideas about methods for coping with the various problems, which would be of great value. If tremendous effort is being made at such great expense to keep patients alive, surely it is of importance to physicians, as it is to all of us, to see that life with this type of support system is made as pleasant and as comfortable as possible. The research and technical developments are justified only if the new lifestyle is as worthwhile as the old. MARY L. NORThWAY, PH D, FCPA The Brora Centre Toronto, Ont.
Treatment of obesity by exercise in the cold To the editor: The article describing the treatment of obesity by exercise in the cold by Dr. W.J. O'Hara, C. Allen and Dr. R.J. Shephard (Can Med Assoc 1 117: 773, 1977) raises questions related to both the significance of the findings and the ethics of the study. Rapid early weight loss can be induced by a variety of techniques that, like the regimen described, do not lend themselves to practical application. The preservation of lean mass in this study is said to distinguish this method from all previously reported diets and exercise fads: at least that is the implication. But the paucity of accurate data derived during other procedures makes it difficult to accept this conclusion. To ensure that the regimen described is unique a study would be needed in which the same measurements are taken by the same observers of subjects undergoing a variety of regimens. The practical significance of rapid early weight loss, as noted correctly, is mainly psychologic. In the view of at least one prominent researcher a study of behavioural change should include a 6-month follow-up to merit consideration as being likely applicable to longterm change.1 The 60-day follow-up reported is better than nothing but it is
short when one considers that an effective weight-control program must remain useful for decades. Therefore, the obscure significance of the findings leads to ethical questions. Specifically, was it proper to ask six men to expose themselves to such severe environmental conditions? Furthermore, the study took place in a quasimilitary setting and the subjects were employees of the military establishment. One is entitled to reassurance that the subjects' consent was given voluntarily and not influenced by the perception of possible negative consequences of noncompliance (even if none existed, which I trust was the case). After all, a military setting is a "total institution" in the same sense as a mental hospital;. the pitfalls of selecting "volunteers" from hospitalized psychiatric patients are well known.3 The ethical questions are important because the study relied heavily on the avoidance of aversive stimulation (i.e., punishment). The phrase "but the cold environment provided an incentive to vigorous activity" really means that if the subjects did not move around a lot they suffered pain. Similarly, the authors later observe: "The main function of the cold may... be to provide the motivation for sustained movement". However, we are not dealing with a "motivator" but with an aversive (painful) stimulus, to which the subjects must respond appropriately (i.e., as the investigators desire) to avoid pain. The significance of this would become obvious if the investigators had chosen a different aversive stimulus, such as electric stimulation. However, if they had done so, the aversive nature of the study would have been so apparent that it is an open question whether it would have been carried out. MORTON S. RAPP, MD
Associate professor Department of psychiatry University of Toronto Sunnybrook Medical Centre Toronto, Ont.
References 1. FRANKS CM, WILSON GT: Annual Review of Behavior Therapy, vol 3, New York, BrunnerMazel, 1975, p 66
2. GOFFMAN E: Asylums, Garden City, NY, Doubleday, 1961, p 5 3. LAKovics M: Voluntariness of hospitalization as an important research variable and legal implications of its omission from the psychiatric research literature, in Medical, Moral and Legal Issues in Mental Health Care, AYD FJ JR (ed), Don Mills, Burns & MacEachern, 1974
To the editor: In response to Dr. Rapp's comments, we were well aware that the findings from our preliminary study of exercise in the cold were sufficiently challenging to demand verification by a more extensive controlled study. The first phase of this additional work a crossover comparison of exercise in the cold versus exercise in a temperate
climate - has recently been completed. It fully substantiates the unique effect of the cold environment. We caution Dr. Rapp against thinking in terms of weight loss - a common error among clinicians. The need of the patient is to rid himself of fat rather than weight; strengthening of muscles without change of body weight is a more satisfactory result than loss of both fat and protein - as is the case when a dietary regimen alone is given. The point about the duration of "cure.. is obviously important, since most existing "remedies" are ineffective in the long term. The experiments were completed some 2½ years ago and provided a substantial incentive to change the lifestyle of the participants. Five of the six individuals have sustained or increased their fat loss, the one exception being a heavy drinker who has continued to consume some 6 to 7 L of beer per night. The ethics of the experiment are not a real issue. Unlike many clinical "treatments" of obesity, the project was considered and approved by a university committee on the ethics of human experimentation. This group was very careful to reassure itself that we exercised no pressure, direct or indirect, that would influence the decision of the subjects to begin and to continue their participation in the experiment. All men came forward of their own free will, their sole motivation being a personal wish to reduce their body fat. I should stress that although some of our subjects were military personnel, the majority of the employees at the Defence and Civil Institute of Environmental Medicine (DCIEM) are civilians, and the constraints of discipline are no greater than at Sunnybrook Medical Centre. None of our subjects experienced any pain, nor would they have done so if they had not exercised. Because of the complete absence of wind and the use of full arctic clothing the climate was much less severe than a casual reading of the environmental figures might suggest. It would have been too cool to sit in great comfort, but modest exercise was enough to keep the subjects quite warm. The mood of the participants was extremely thoughtful throughout the experiment, and to talk about an aversive stimulus is, frankly, nonsense. To paint further the caricature of the DCIEM as a "total institution" and to compare it with a mental hospital is to display a very limited understanding of the philosophy and modus operandi of a neighbouring research establishment. I hope Dr. Rapp will be able to correct his false impressions soon by
CMA JOURNAL/DECEMBER 17, 1977/VOL. 117
1371
