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demonstrating effectiveness of. OTC cold remedies in preschool- ers.3 A systematic review of ran- domized controlled trials did not show any effectiveness on ...
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The Attitude of Physicians Toward Cold Remedies for Upper Respiratory Infection in Infants and Children: A Questionnaire Survey Raanan Cohen-Kerem, Savithiri Ratnapalan, Josephine Djulus, Xu Duan, Rahul V. Chandra and Shinya Ito Clin Pediatr (Phila) 2006; 45; 828 DOI: 10.1177/0009922806295281 The online version of this article can be found at: http://cpj.sagepub.com/cgi/content/abstract/45/9/828

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The Attitude of Physicians Toward Cold Remedies for Upper Respiratory Infection in Infants and Children: A Questionnaire Survey Raanan Cohen-Kerem, MD Savithiri Ratnapalan, MBBS Josephine Djulus, MD Xu Duan Rahul V. Chandra Shinya Ito, MD

Summary: Over-the-counter cold remedies are widely used for symptomatic relief of upper respiratory tract infections. The safety of these drugs is not well established in infants and their efficacy is questionable. Our aim was to study the attitude of family physicians and pediatricians toward the use of cold remedies in infants and children. A questionnaire was sent to 400 family physicians and 100 pediatricians randomly selected across Ontario. The overall response rate was 53.2%. Sixteen percent of family physicians recommended cold remedies for infants 0 to 6 months of age compared to 4% of the pediatricians (P = 0.01). For infants 6 to 12 months of age, the difference between pediatricians and family physicians persisted (14% and 38% of, respectively; P < 0.001). Despite that cold remedies are not proven to be effective and some safety issues are associated with their use in the pediatric age group, physicians still recommend them. Continuing medical education programs should address the issue. Clin Pediatr. 2006;45:828-834

Introduction

C

old remedies are available as over-the-counter (OTC) drugs for all age groups including children. Despite the lack of eff icacy in the young

age group, cold remedies are widely used for symptomatic relief of upper respiratory tract infections.1-4 A critical review of clinical trials that were performed in 1951 to 1991 did not find any evidence

Division of Clinical Pharmacology and Toxicology, Department of Pediatrics, and the University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada. This study was presented at the Pediatric Academic Societies Annual Meeting, Seattle, Washington, May 3–6, 2003. Reprint requests and correspondence to: Shinya Ito, MD, Division of Clinical Pharmacology and Toxicology, Department of Paediatrics, Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, Canada M5G 1X8. DOI: 10.1177/0009922806295281 © 2006 Sage Publications Please visit the Journal at http://cpj.sagepub.com.

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demonstrating effectiveness of OTC cold remedies in preschoolers.3 A systematic review of randomized controlled trials did not show any effectiveness on coughrelieving of OTC cold remedies over placebo. 5 Another systematic review concluded that combinations of antihistamines with decongestants are not effective in small children, but they do have a beneficial effect on general recover y in older children and adults.6 A double-blind, randomized controlled trial of 59 patients with upper respiratory infection showed that there was no symptom relief between cold remedies.7

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Cold Remedies for Upper Respirator y Infection Oral preparations used for colds usually contain a mixture of sympathomimetics and antihistamines; nasal drops contain mainly sympathomimetics. The safety of these two groups of drugs is not well established in infants and their effectiveness is questionable. Some of these drugs are not recommended for children less than 6 years of age (e.g., diphenhydramine HCl) and less than 2 years of age (e.g., pseudoephedrine HCl).8 However, manufacturers of oral cold medications suggest that a drug can be used for children below the indicated age on physician’s recommendations. Alpha-adrenoreceptor agonists produce adverse effects such as hypertension, tachycardia, and cardiac arrythmias that can cause serious harm in young infants.9 An appetite suppressant, phenylpropanolamine, also used as decongestant, was removed from the market since it was associated with sudden death. 10-12 Others, such as imidazoline derivatives, were associated with significant morbidity.9,10 Although the American Academy of Pediatrics issued in 1997 a policy statement on cough medications discouraging their use,13 no clear recommendations for treating the common cold are available from the American Academy of Pediatrics or the Canadian Pediatric Society. A 1993 questionnaire survey, conducted in Maryland (United States), analyzed management options chosen by pediatricians to treat a 12-month-old infant with an uncomplicated common cold. Of the responders, 47% stated that they recommended the use of cold remedies sometimes and 13% said they have usually recommended them.14 Since then, some data 1,4 on lack of efficacy of OTC cold remedies have been accumulated.

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However, there are no other published studies for the last 10 years regarding physicians’ attitude toward the use of cold remedies in children. Therefore, we hypothesized that OTC cold remedies are used quite frequently in infancy and in young children. In this study, we aimed to elucidate the current clinical practice of family physicians and pediatricians in Ontario with regard to the use of OTC cold remedies in children. Both groups of physicians take care of children but with different background training; hence we also aimed to look for differences in the attitude of pediatricians compared to family physicians.

Methods Four hundred family physicians (~4% of all family physicians) and 100 pediatricians (~10% of all pediatricians) across the Province of Ontario, Canada, were randomly selected (computer-generated random numbers) from the most recent Canadian Medical Directory to form the survey target. This survey was conducted in 2002. The structured questionnaire was pilot tested on 10 pediatricians from our institute for clarity and validity, and modified accordingly. The revised questionnaire (Figure 1) and a self-addressed stamped envelope were coded and sent to the selected physicians. To increase the response rate, a reminder was sent to nonresponders in 1 month. Available data on nonresponding physicians (according to the Canadian Medical Directory database, e.g., gender, hospital affiliation, and number of years in practice) were compared to responders to validate the results to the whole group.

Data collected from the questionnaire included the following: physician’s specialty, gender, proportion of young patients under the age of 12 years in the physician’s practice, university and/or hospital affiliation, number of years in practice, whether he would recommend oral or nasal cold remedies in five different age groups (0–6 months, 6–12 months, 1–3 years, 3–6 years, and 6–12 years), and the physician’s general concern on his patient’s use of OTC cold remedies. This study was approved by the research ethics board of the Hospital for Sick Children. Descriptive statistics was used to delineate demographics and sur vey results. χ 2 was used for comparison of nominal variables.

Results Pediatricians Versus Family Physicians The overall response rate was 53.2% (73% of pediatricians and 46% of family physicians). The characteristics of the responding and nonresponding physicians are shown in Table 1. A significant proportion of responding physicians was willing to recommend cold remedies in the young age groups (12.7% for 0–6 months, 30.1% for 6–12 months, and 50.6% for 1–3 years). Pediatricians compared to family physicians were less likely to recommend cold remedies in all pediatric age groups (Figure 2). Proportion of Young Patients in Physicians’ Practices Twenty-six percent of physicians had more than 50% pediatric patients younger than 12 years of age in their practice, 43% had 10% to 50%, and 31% had less than 10%. The proportion of patients younger than 12 years of age was not a factor in the pediatricians’

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Figure 1. The study questionnaire.

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Table 1

CHARACTERISTICS OF RESPONDING AND NON-RESPONDING PHYSICIANS Responders

Nonresponders

Number

%

Number

%

Male

154

57.9

130

72.2

Female

101

38.0

50

27.8

Not specified

11

4.1





Yes

88

33.1





No

151

56.8





Not specified

27

10.2





Yes

207

77.8

96

46.7

No

43

16.2

84

53.3

Not specified

16

6.0





10 yr

187

70.3

143

79.4

Not specified

10

3.8





Gender

University affiliation

Hospital affiliation

Years in practice

and family physicians’ preference of whether or not to recommend cold remedies. However, physicians with more than 50% children in their practice were more reluctant to recommend cold remedies to children 3 to 6 years and 6 to 12 years of age compared to those with less than 50% children in their practice (51% vs. 29% and 31%, P = 0.023; and 47% vs. 23% and 23%, P = 0.004, respectively). No statistically significant difference was noted in younger children.

Affiliation with an Academic Institution Pediatricians and family physicians who are affiliated with an

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academic institution were more reluctant to recommend cold remedies to children in all age groups compared to those who are not affiliated to such an institution (Figure 3).

Hospital Affiliation Pediatricians and family physicians who are aff iliated with a hospital were more reluctant to recommend cold remedies to children in most age groups. In the 6- to 12-months, 3to 6-years, and 6- to 12-years groups the difference was not statistically significant, although a trend was evident (Figure 4).

Years in Practice and Physician Concern of Patients’ Use of OTC Cold Remedies Seventy-three percent of the responding physicians have more than 10 years in practice, whereas the rest have less than 10. Physicians’ recommendations for the use of cold remedies were not influenced by the number of years in practice. Ninety-two percent of the physicians were always or sometimes concerned with their patients’ use of cold remedies. However, no significant difference was found in a physician’s recommendation among those who were concerned with their patients’ use of cold remedies versus those who were not.

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Figure 2. Proportion of pediatricians and family physicians recommending cold remedies for children of different age groups.

Figure 3. Physicians reluctant to recommend cold remedies based on affiliation to an academic institution affiliation.

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Figure 4. Physicians reluctant to recommend cold remedies (based on hospital affiliation).

Most physicians (94.6% for 0–6 months, 92.2% for 6–12 months, and 91.1% for 1–3 years of age) were reluctant to recommend topical nasal decongestants in all age groups; however, a small proportion was willing to recommend nasal decongestants for infants younger than 1 year of age. No difference was obser ved in that matter when we compared pediatricians to family physicians. Some of the physicians designated a specific drug they would have recommended although they were not asked to. Those drugs or drug combinations are outlined on Table 2. Data on nonresponders were available for 180 subjects. Nonresponders were different from the responders group in gender (male > females; P = 0.011) and in whether subjects were hospital-affiliated or not (nonaffiliated > affiliated; P = 0.0001). The two groups were not different in physicians’ years in practice.

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Discussion The lack of proven effectiveness of OTC cold remedies combined with some safety issues put in question the vast use of those medications, especially in children.3,5,7 Schroeder and Fahey,5 in a systematic review, concluded that the number of trials addressing cold remedies in children is small and their results should be interpreted with caution. However, based on the available evidence, we expected physicians to avoid recommending oral cold remedies or nasal decongestants for the pediatric population. Our study shows that up to 30% of the responders would recommend the use of oral cold remedies in children younger than 1 year of age. Several factors can be identified as potential determinants of physicians’ attitude toward OTC cold remedies. Pediatricians are more reluctant to recommend

the use of cold remedies. It is unknown what aspect(s) of their training and/or practice is a determining factor. The universityaffiliated physicians were more reluctant to recommend cold remedies for the pediatric age group, and so were hospital-affiliated physicians. This may indicate an increased likelihood of university-/hospital-affiliated physicians to access evidence-based updated knowledge in the field. Physicians who do recommend the use of cold remedies for the young age groups argue that “sometimes there is a need to give something because of an anxious parent” or “I am treating the parent rather than the child; the parents would have got it anyway.” Given the role of the physician as an expert and advocate, this approach cannot be justified. In this era of evidence-based medicine, we need to take this matter more seriously. Some limitations can be identified in our study. The sample

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Table 2

PHYSICIANS’ SPECIFIC ORAL-DECONGESTANT PREFERENCES BRAND NAMES CONTAINING THOSE DRUGS ARE IN PARENTHESES Decongestants

Decongestant/Antihistamine Combined

Antihistamines

• Pseudoephedrine HCl (CoActifed®, • Robitussin®, Sudafed®, Triaminic®)

• Brompheniramine maleate• phenylephrine HCl (Dimetapp® Cold)

• Diphenhydamine HCl • (Benadryl®)

• Phenylephrine HCl (Novahistine®)

• Chlorpheniramine maleate-pseudoephedrine • HCl (Triaminic® Cold, Tylenol® Cold)

size may not be sufficient to reflect the way most pediatricians and family physicians practice with respect to cold remedies and an increased response rate would probably reflect a more reliable answer to this issue. However, the results of this survey cannot be overlooked.

2.

3.

Conclusions Despite that cold remedies are not proven to be effective and some safety issues are associated with their use, physicians still recommend their use. For some reason, family physicians tend to do it more than pediatricians. Practice guidelines and policy statements must be implemented to prevent the use of cold remedies in infants. Continued medical education programs should focus on physicians who are not affiliated to an academic institution.

REFERENCES 1. Flynn CA, Griffin G, Tudiver F. Decongestants and antihistamines for

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4.

5.

6.

7.

acute otitis media in children. Cochrane Database Syst Rev. 2002; CD001727. Hutton N, Wilson MH, Mellits ED, Baumgardner R, Wissow LS, Bonuccelli C, et al. Effectiveness of an antihistamine-decongestant combination for young children with the common cold: a randomized, controlled clinical trial. J Pediatr. 1991;118:125-130. Smith MB, Feldman W. Over-thecounter cold medications. A critical review of clinical trials between 1950 and 1991. JAMA. 1993;269:2258-2263. Taylor JA, Novack AH, Almquist JR, Rogers JE. Efficacy of cough suppressants in children. J Pediatr. 1993; 122:799-802. Schroeder K, Fahey T. Should we advise parents to administer over the counter cough medicines for acute cough? Systematic review of randomised controlled trials. Arch Dis Child. 2002;86:170-175. Sutter AI, Lemiengre M, Campbell H, Mackinnon HF. Antihistamines for the common cold. Cochrane Database Syst Rev. 2003;CD001267. Clemens CJ, Taylor JA, Almquist JR, Quinn HC, Mehta A, Naylor GS. Is an antihistamine-decongestant combination effective in temporarily relieving symptoms of the common cold in preschool children? J Pediatr. 1997;130:463-466.

8. Canadian Pharmacists Association. The Canadian Drug Reference for Health Professionals. Compendium of Pharmaceuticals and Specialists (CPS). 2002. 9. Stamer UM, Buderus S, Wetegrove S, Lentze MJ, Stuber F. Prolonged awakening and pulmonar y edema after general anesthesia and naphazoline application in an infant. Anesth Analg. 2001;93:1162-1164. 10. Gunn VL, Taha SH, Liebelt EL, Serwint JR. Toxicity of over-the-counter cough and cold medications. Pediatrics. 2001;108:E52. 11. Joseph MM, King WD. Dystonic reaction following recommended use of a cold syr up. Ann Emerg Med. 1995;26:749-751. 12. Kernan WN, Viscoli CM, Brass LM, Broderick JP, Brott T, Feldmann E, et al. Phenylpropanolamine and the risk of hemorrhagic stroke. N Engl J Med. 2000;343:1826-1832. 13. Use of codeine- and dextromethorphan-containing cough remedies in children. American Academy of Pediatrics. Committee on Drugs. Pediatrics. 1997;99:918-920. 14. Gadomski AM, Rubin JD. Cough and cold medicine use in young children: a survey of Maryland pediatricians. Md Med J. 1993;42:647-650.

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