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Does increasing methylphenidate dose aid symptom control in ADHD?
Most children with attention deficit/hyperactivity disorder (ADHD) who are started on methylphenidate will respond favorably to a dose increase if the initial dose does not sufficiently reduce symptoms. Once titrated to an effective maintenance dose, frequent follow-up is necessary to monitor for side effects and recurring symptoms. The dose of methylphenidate can then be increased further for better symptom control, which may be warranted in most cases.
In some children, methylphenidate may not achieve response even at high doses or may cause intolerable side effects. For these children, start a different stimulant medication (strength of recommendation: B, based on extrapolation of 1 randomized controlled trial).
Evidence summary
Most studies of ADHD medication have lasted fewer than 4 months. The National Institute of Mental Health Collaborative Multisite Multimodal Treatment Study of Children with Attention Deficit/Hyperactivity Disorder (known as the MTA study) is the longest treatment study of children to date. This study—a 28-day, double-blind placebo-controlled trial—enrolled children aged 7 to 9 years with ADHD and compared 4 treatment strategies (including medication and behavioral interventions) over 14 months.1-3
Of particular interest was the dose-titration evaluation at the beginning of the study. Daily dose-switching titration of methylphenidate was used to identify the optimal starting dose for each child assigned to receive medication. In all, 289 children were randomized to receive methylphenidate, and 256 completed the titration (17 children refused to take medication, 1 moved, 4 had side effects, 4 had missing data, and 7 stopped mid-titration because of inability to follow the titration protocol).
Of the 256 children who completed titration, 198 (77%) responded favorably to 1 of the following doses: low (15 mg/day), intermediate (25 mg/day), or high (35 mg/day for children weighing less than 25 kg; or 50 mg/day for children weighing 25 kg or more). Of the remaining 23%, 32 children responded best to placebo and 26 were methylphenidate nonresponders and were subsequently placed on dextroamphetamine.
Children who responded to methylphenidate entered the 13-month maintenance phase on the optimal dose identified in the titration trial. They were monitored by monthly re-examination and review of information from parents and teachers regarding ADHD symptoms and potential drug side effects. The dose was changed if symptoms were not well controlled or if side effects were present. Subsequently, if no effective and well-tolerated dose of methylphenidate could be identified, the drug was deemed ineffective for that child and was replaced by another medication.
Of the children who responded to methylphenidate, 88% were still taking it at the end of the maintenance trial; 29% were still taking the titration-determined dose of methylphenidate, 18% took a lower dose, and 41% took a higher dose as their “optimal” dose, at which there were no clinically significant symptoms, or “no room for improvement.” The mean dose increased from 31 mg/day at the start to 34 mg/day at the end of the study. Of the 430 total changes in dose made during the maintenance period, 62% were dose increases.
While commendable for its design and large study population, the MTA study had several limitations. The titration trial’s complex method of determining each child’s “best dose” may not be feasible in clinical practice. Furthermore, the study enrolled only children aged 7 to 9 years, while ADHD affects a much broader age range. Finally, the chronic nature of ADHD limits the generalizability of this study beyond 14 months. Additional long-term studies are needed.
Recommendations from others
The most common strategy for managing children taking methylphenidate is to start with a low dose and gradually adjust upward, as required by residual symptoms and as allowed by side effects. This escalating-dose titration reflects typical practice in the United States, as described in several clinical guides.4,5 The Physician’s Desk Reference states that the maximum total daily dose is 60 mg for methylphenidate, and experts often limit the upper range to 25 mg for a single dose.6
The American Academy of Child and Adolescent Psychiatry suggests using a consistent titration schedule with weekly increases in increments of 5–10 mg per dose to achieve symptom control. Alternatively, a fixed-dose titration trial similar to that found in the MTA study may be employed, in which a full set of different doses is switched on a weekly basis. If the top recommended dose does not help, a change in drug or psychosocial intervention may be more beneficial than an increase in methylphenidate dose.6
John Hill, DO
University of Colorado Health Sciences Center, Denver
It is disheartening to watch a bright child receive D’s in school just because he or she cannot pay attention. Treating children with ADHD is one of the most clinically rewarding behavioral issues we can address as primary care physicians.
The escalating-dose titration and effective maintenance of methylphenidate can seem intimidating. We fear the side effects and are unsure if raising the dose of methylphenidate will have any benefits.
Clearly, it is shown that raising the methylphenidate dose brings further benefits for most children, but short-acting forms (such as Ritalin) frequently have intolerable side effects. Several long-acting forms of methylphenidate (Concerta, Metadate CD, Methylin ER, and Ritalin SR) are now on the market. This allows us to raise the dose as high as 54–60 mg/day with much less drug intolerance. For children who are benefiting from methylphenidate but cannot tolerate the side effects, consider the long-acting form.
1. Greenhill LL, Abikoff HB, Arnold LE, et al. Medication treatment strategies in the MTA Study: relevance to clinicians and researchers. J Am Acad Child Adolesc Psychiatry 1996;35:1304-1313.
2. Greenhill LL, Swanson JM, Vitiello B, et al. Impairment and deportment responses to different methylphenidate doses in children with ADHD: the MTA titration trial. J Am Acad Child Adolesc Psychiatry 2001;40:180-187.
3. Vitiello B, Severe JB, Greenhill LL, et al. Methylphenidate dosage for children with ADHD over time under controlled conditions: lessons from the MTA. J Am Acad Child Adolesc Psychiatry 2001;40:188-196.
4. Dulcan M. Using psychostimulants to treat behavior disorders of children and adolescents. J Child Adolesc Psychopharmacol. 1990;1:7-20.
5. Szymanski ML, Zolotor A. Attention-deficit/hyperactivity disorder: management. Am Fam Physician 2001;64:1355-1362.
6. Greenhill LL, Pliszka S, Dulcan MK, et al. Practice parameter for the use of stimulant medication in the treatment of children, adolescents, and adults. J Am Acad Child Adolesc Psychiatry 2002;41:26S-49S.
Most children with attention deficit/hyperactivity disorder (ADHD) who are started on methylphenidate will respond favorably to a dose increase if the initial dose does not sufficiently reduce symptoms. Once titrated to an effective maintenance dose, frequent follow-up is necessary to monitor for side effects and recurring symptoms. The dose of methylphenidate can then be increased further for better symptom control, which may be warranted in most cases.
In some children, methylphenidate may not achieve response even at high doses or may cause intolerable side effects. For these children, start a different stimulant medication (strength of recommendation: B, based on extrapolation of 1 randomized controlled trial).
Evidence summary
Most studies of ADHD medication have lasted fewer than 4 months. The National Institute of Mental Health Collaborative Multisite Multimodal Treatment Study of Children with Attention Deficit/Hyperactivity Disorder (known as the MTA study) is the longest treatment study of children to date. This study—a 28-day, double-blind placebo-controlled trial—enrolled children aged 7 to 9 years with ADHD and compared 4 treatment strategies (including medication and behavioral interventions) over 14 months.1-3
Of particular interest was the dose-titration evaluation at the beginning of the study. Daily dose-switching titration of methylphenidate was used to identify the optimal starting dose for each child assigned to receive medication. In all, 289 children were randomized to receive methylphenidate, and 256 completed the titration (17 children refused to take medication, 1 moved, 4 had side effects, 4 had missing data, and 7 stopped mid-titration because of inability to follow the titration protocol).
Of the 256 children who completed titration, 198 (77%) responded favorably to 1 of the following doses: low (15 mg/day), intermediate (25 mg/day), or high (35 mg/day for children weighing less than 25 kg; or 50 mg/day for children weighing 25 kg or more). Of the remaining 23%, 32 children responded best to placebo and 26 were methylphenidate nonresponders and were subsequently placed on dextroamphetamine.
Children who responded to methylphenidate entered the 13-month maintenance phase on the optimal dose identified in the titration trial. They were monitored by monthly re-examination and review of information from parents and teachers regarding ADHD symptoms and potential drug side effects. The dose was changed if symptoms were not well controlled or if side effects were present. Subsequently, if no effective and well-tolerated dose of methylphenidate could be identified, the drug was deemed ineffective for that child and was replaced by another medication.
Of the children who responded to methylphenidate, 88% were still taking it at the end of the maintenance trial; 29% were still taking the titration-determined dose of methylphenidate, 18% took a lower dose, and 41% took a higher dose as their “optimal” dose, at which there were no clinically significant symptoms, or “no room for improvement.” The mean dose increased from 31 mg/day at the start to 34 mg/day at the end of the study. Of the 430 total changes in dose made during the maintenance period, 62% were dose increases.
While commendable for its design and large study population, the MTA study had several limitations. The titration trial’s complex method of determining each child’s “best dose” may not be feasible in clinical practice. Furthermore, the study enrolled only children aged 7 to 9 years, while ADHD affects a much broader age range. Finally, the chronic nature of ADHD limits the generalizability of this study beyond 14 months. Additional long-term studies are needed.
Recommendations from others
The most common strategy for managing children taking methylphenidate is to start with a low dose and gradually adjust upward, as required by residual symptoms and as allowed by side effects. This escalating-dose titration reflects typical practice in the United States, as described in several clinical guides.4,5 The Physician’s Desk Reference states that the maximum total daily dose is 60 mg for methylphenidate, and experts often limit the upper range to 25 mg for a single dose.6
The American Academy of Child and Adolescent Psychiatry suggests using a consistent titration schedule with weekly increases in increments of 5–10 mg per dose to achieve symptom control. Alternatively, a fixed-dose titration trial similar to that found in the MTA study may be employed, in which a full set of different doses is switched on a weekly basis. If the top recommended dose does not help, a change in drug or psychosocial intervention may be more beneficial than an increase in methylphenidate dose.6
John Hill, DO
University of Colorado Health Sciences Center, Denver
It is disheartening to watch a bright child receive D’s in school just because he or she cannot pay attention. Treating children with ADHD is one of the most clinically rewarding behavioral issues we can address as primary care physicians.
The escalating-dose titration and effective maintenance of methylphenidate can seem intimidating. We fear the side effects and are unsure if raising the dose of methylphenidate will have any benefits.
Clearly, it is shown that raising the methylphenidate dose brings further benefits for most children, but short-acting forms (such as Ritalin) frequently have intolerable side effects. Several long-acting forms of methylphenidate (Concerta, Metadate CD, Methylin ER, and Ritalin SR) are now on the market. This allows us to raise the dose as high as 54–60 mg/day with much less drug intolerance. For children who are benefiting from methylphenidate but cannot tolerate the side effects, consider the long-acting form.
Most children with attention deficit/hyperactivity disorder (ADHD) who are started on methylphenidate will respond favorably to a dose increase if the initial dose does not sufficiently reduce symptoms. Once titrated to an effective maintenance dose, frequent follow-up is necessary to monitor for side effects and recurring symptoms. The dose of methylphenidate can then be increased further for better symptom control, which may be warranted in most cases.
In some children, methylphenidate may not achieve response even at high doses or may cause intolerable side effects. For these children, start a different stimulant medication (strength of recommendation: B, based on extrapolation of 1 randomized controlled trial).
Evidence summary
Most studies of ADHD medication have lasted fewer than 4 months. The National Institute of Mental Health Collaborative Multisite Multimodal Treatment Study of Children with Attention Deficit/Hyperactivity Disorder (known as the MTA study) is the longest treatment study of children to date. This study—a 28-day, double-blind placebo-controlled trial—enrolled children aged 7 to 9 years with ADHD and compared 4 treatment strategies (including medication and behavioral interventions) over 14 months.1-3
Of particular interest was the dose-titration evaluation at the beginning of the study. Daily dose-switching titration of methylphenidate was used to identify the optimal starting dose for each child assigned to receive medication. In all, 289 children were randomized to receive methylphenidate, and 256 completed the titration (17 children refused to take medication, 1 moved, 4 had side effects, 4 had missing data, and 7 stopped mid-titration because of inability to follow the titration protocol).
Of the 256 children who completed titration, 198 (77%) responded favorably to 1 of the following doses: low (15 mg/day), intermediate (25 mg/day), or high (35 mg/day for children weighing less than 25 kg; or 50 mg/day for children weighing 25 kg or more). Of the remaining 23%, 32 children responded best to placebo and 26 were methylphenidate nonresponders and were subsequently placed on dextroamphetamine.
Children who responded to methylphenidate entered the 13-month maintenance phase on the optimal dose identified in the titration trial. They were monitored by monthly re-examination and review of information from parents and teachers regarding ADHD symptoms and potential drug side effects. The dose was changed if symptoms were not well controlled or if side effects were present. Subsequently, if no effective and well-tolerated dose of methylphenidate could be identified, the drug was deemed ineffective for that child and was replaced by another medication.
Of the children who responded to methylphenidate, 88% were still taking it at the end of the maintenance trial; 29% were still taking the titration-determined dose of methylphenidate, 18% took a lower dose, and 41% took a higher dose as their “optimal” dose, at which there were no clinically significant symptoms, or “no room for improvement.” The mean dose increased from 31 mg/day at the start to 34 mg/day at the end of the study. Of the 430 total changes in dose made during the maintenance period, 62% were dose increases.
While commendable for its design and large study population, the MTA study had several limitations. The titration trial’s complex method of determining each child’s “best dose” may not be feasible in clinical practice. Furthermore, the study enrolled only children aged 7 to 9 years, while ADHD affects a much broader age range. Finally, the chronic nature of ADHD limits the generalizability of this study beyond 14 months. Additional long-term studies are needed.
Recommendations from others
The most common strategy for managing children taking methylphenidate is to start with a low dose and gradually adjust upward, as required by residual symptoms and as allowed by side effects. This escalating-dose titration reflects typical practice in the United States, as described in several clinical guides.4,5 The Physician’s Desk Reference states that the maximum total daily dose is 60 mg for methylphenidate, and experts often limit the upper range to 25 mg for a single dose.6
The American Academy of Child and Adolescent Psychiatry suggests using a consistent titration schedule with weekly increases in increments of 5–10 mg per dose to achieve symptom control. Alternatively, a fixed-dose titration trial similar to that found in the MTA study may be employed, in which a full set of different doses is switched on a weekly basis. If the top recommended dose does not help, a change in drug or psychosocial intervention may be more beneficial than an increase in methylphenidate dose.6
John Hill, DO
University of Colorado Health Sciences Center, Denver
It is disheartening to watch a bright child receive D’s in school just because he or she cannot pay attention. Treating children with ADHD is one of the most clinically rewarding behavioral issues we can address as primary care physicians.
The escalating-dose titration and effective maintenance of methylphenidate can seem intimidating. We fear the side effects and are unsure if raising the dose of methylphenidate will have any benefits.
Clearly, it is shown that raising the methylphenidate dose brings further benefits for most children, but short-acting forms (such as Ritalin) frequently have intolerable side effects. Several long-acting forms of methylphenidate (Concerta, Metadate CD, Methylin ER, and Ritalin SR) are now on the market. This allows us to raise the dose as high as 54–60 mg/day with much less drug intolerance. For children who are benefiting from methylphenidate but cannot tolerate the side effects, consider the long-acting form.
1. Greenhill LL, Abikoff HB, Arnold LE, et al. Medication treatment strategies in the MTA Study: relevance to clinicians and researchers. J Am Acad Child Adolesc Psychiatry 1996;35:1304-1313.
2. Greenhill LL, Swanson JM, Vitiello B, et al. Impairment and deportment responses to different methylphenidate doses in children with ADHD: the MTA titration trial. J Am Acad Child Adolesc Psychiatry 2001;40:180-187.
3. Vitiello B, Severe JB, Greenhill LL, et al. Methylphenidate dosage for children with ADHD over time under controlled conditions: lessons from the MTA. J Am Acad Child Adolesc Psychiatry 2001;40:188-196.
4. Dulcan M. Using psychostimulants to treat behavior disorders of children and adolescents. J Child Adolesc Psychopharmacol. 1990;1:7-20.
5. Szymanski ML, Zolotor A. Attention-deficit/hyperactivity disorder: management. Am Fam Physician 2001;64:1355-1362.
6. Greenhill LL, Pliszka S, Dulcan MK, et al. Practice parameter for the use of stimulant medication in the treatment of children, adolescents, and adults. J Am Acad Child Adolesc Psychiatry 2002;41:26S-49S.
1. Greenhill LL, Abikoff HB, Arnold LE, et al. Medication treatment strategies in the MTA Study: relevance to clinicians and researchers. J Am Acad Child Adolesc Psychiatry 1996;35:1304-1313.
2. Greenhill LL, Swanson JM, Vitiello B, et al. Impairment and deportment responses to different methylphenidate doses in children with ADHD: the MTA titration trial. J Am Acad Child Adolesc Psychiatry 2001;40:180-187.
3. Vitiello B, Severe JB, Greenhill LL, et al. Methylphenidate dosage for children with ADHD over time under controlled conditions: lessons from the MTA. J Am Acad Child Adolesc Psychiatry 2001;40:188-196.
4. Dulcan M. Using psychostimulants to treat behavior disorders of children and adolescents. J Child Adolesc Psychopharmacol. 1990;1:7-20.
5. Szymanski ML, Zolotor A. Attention-deficit/hyperactivity disorder: management. Am Fam Physician 2001;64:1355-1362.
6. Greenhill LL, Pliszka S, Dulcan MK, et al. Practice parameter for the use of stimulant medication in the treatment of children, adolescents, and adults. J Am Acad Child Adolesc Psychiatry 2002;41:26S-49S.
Evidence-based answers from the Family Physicians Inquiries Network
How does a “wait and see” approach to prescribing antibiotics for acute otitis media (AOM) compare with immediate antibiotic treatment?
BACKGROUND: Most patients who present with AOM receive antibiotics despite current controversy over whether antibiotics actually benefit patients. Health care providers have to balance concerns about antibiotic resistance with those regarding parental satisfaction.
POPULATION STUDIED: The study included 315 children aged 6 months to 10 years from general outpatient practices in southwest England who presented with acute ear pain with erythema, bulging, or perforation of the tympanic membrane on otoscopic examination. Children were excluded if they had pink tympanic membranes consistent with fever or crying alone, a history and examination consistent with otitis media with effusion and chronic suppurative otitis media, serious chronic disease, antibiotic use within the previous 2 weeks, previous complications of AOM, or if they appeared toxic.
STUDY DESIGN AND VALIDITY: This was a nonblinded controlled clinical trial with patients randomized to receive either immediate antibiotics (a prescription to be filled following the visit) or delayed antibiotics (instructions to return to clinic to pick up an prescription left at the reception desk in 3 days if the child was worse or not improving). When a patient was diagnosed with AOM, the physician opened an opaque envelope containing an advice sheet that allocated the patient to 1 of the 2 study groups. The advice sheet provided information on the benefits of the intervention, which the physician shared with the patient and parent to support the placebo effect of either intervention. The authors appropriately accounted for all study participants and used an intention-to-treat analysis.
OUTCOMES MEASURED: The authors measured duration and degree of pain, number of episodes of distress, amount of acetaminophen used, number of school days missed, and parental satisfaction scores as reported by parents in a daily diary.
RESULTS: Of 384 children eligible for the study, 315 were randomized, and 285 completed the study. A total of 132 of the 135 patients allocated to receive immediate antibiotics actually used them; 36 of the 150 children (24%) allocated to delayed prescription used antibiotics. Symptoms resolved in both groups in an average of 3 days. The children who received immediate antibiotics had significantly fewer days of earache (mean difference = -1.10 days; 95% confidence interval [CI], -0.54 to -1.48) and used fewer teaspoons of acetaminophen (mean difference = -0.52 tsp; 95% CI, -0.79 to -0.26). There was no difference between the 2 groups in mean pain scores, number of episodes of distress, or absence from school. Any effect of antibiotics seemed to occur only after the first 24 hours of illness. Diarrhea occurred in 19% of children who received antibiotics immediately, compared with 9% in the delayed group. Ninety-one percent of the parents in the immediate antibiotics group and 77% of those in the delayed antibiotics group were very satisfied with the treatment approach. Eighty-three percent of the parents whose children received antibiotics immediately believed that they would need to see the physician for future episodes, compared with 63% in the delayed antibiotics group; 76% versus 46% of parents in the immediate and delayed antibiotic groups, respectively, believed that antibiotics were very effective for AOM.
Giving the parent of a child with AOM a prescription for antibiotics with instructions to not fill that prescription unless the child seems to be getting sicker or has not improved over 3 days will result in the majority of these children riding out the episode without receiving an antibiotic and without experiencing a clinically significant increase in distress. Clinicians who wish to reduce the exposure of children to antibiotics in their practices will find this approach helpful. These findings are similar to a study of adults in the United States that found high patient satisfaction and reduced antibiotic usage when delayed backup antibiotic prescribing was used for respiratory symptoms (J Fam Pract 2000; 49:907-13).
BACKGROUND: Most patients who present with AOM receive antibiotics despite current controversy over whether antibiotics actually benefit patients. Health care providers have to balance concerns about antibiotic resistance with those regarding parental satisfaction.
POPULATION STUDIED: The study included 315 children aged 6 months to 10 years from general outpatient practices in southwest England who presented with acute ear pain with erythema, bulging, or perforation of the tympanic membrane on otoscopic examination. Children were excluded if they had pink tympanic membranes consistent with fever or crying alone, a history and examination consistent with otitis media with effusion and chronic suppurative otitis media, serious chronic disease, antibiotic use within the previous 2 weeks, previous complications of AOM, or if they appeared toxic.
STUDY DESIGN AND VALIDITY: This was a nonblinded controlled clinical trial with patients randomized to receive either immediate antibiotics (a prescription to be filled following the visit) or delayed antibiotics (instructions to return to clinic to pick up an prescription left at the reception desk in 3 days if the child was worse or not improving). When a patient was diagnosed with AOM, the physician opened an opaque envelope containing an advice sheet that allocated the patient to 1 of the 2 study groups. The advice sheet provided information on the benefits of the intervention, which the physician shared with the patient and parent to support the placebo effect of either intervention. The authors appropriately accounted for all study participants and used an intention-to-treat analysis.
OUTCOMES MEASURED: The authors measured duration and degree of pain, number of episodes of distress, amount of acetaminophen used, number of school days missed, and parental satisfaction scores as reported by parents in a daily diary.
RESULTS: Of 384 children eligible for the study, 315 were randomized, and 285 completed the study. A total of 132 of the 135 patients allocated to receive immediate antibiotics actually used them; 36 of the 150 children (24%) allocated to delayed prescription used antibiotics. Symptoms resolved in both groups in an average of 3 days. The children who received immediate antibiotics had significantly fewer days of earache (mean difference = -1.10 days; 95% confidence interval [CI], -0.54 to -1.48) and used fewer teaspoons of acetaminophen (mean difference = -0.52 tsp; 95% CI, -0.79 to -0.26). There was no difference between the 2 groups in mean pain scores, number of episodes of distress, or absence from school. Any effect of antibiotics seemed to occur only after the first 24 hours of illness. Diarrhea occurred in 19% of children who received antibiotics immediately, compared with 9% in the delayed group. Ninety-one percent of the parents in the immediate antibiotics group and 77% of those in the delayed antibiotics group were very satisfied with the treatment approach. Eighty-three percent of the parents whose children received antibiotics immediately believed that they would need to see the physician for future episodes, compared with 63% in the delayed antibiotics group; 76% versus 46% of parents in the immediate and delayed antibiotic groups, respectively, believed that antibiotics were very effective for AOM.
Giving the parent of a child with AOM a prescription for antibiotics with instructions to not fill that prescription unless the child seems to be getting sicker or has not improved over 3 days will result in the majority of these children riding out the episode without receiving an antibiotic and without experiencing a clinically significant increase in distress. Clinicians who wish to reduce the exposure of children to antibiotics in their practices will find this approach helpful. These findings are similar to a study of adults in the United States that found high patient satisfaction and reduced antibiotic usage when delayed backup antibiotic prescribing was used for respiratory symptoms (J Fam Pract 2000; 49:907-13).
BACKGROUND: Most patients who present with AOM receive antibiotics despite current controversy over whether antibiotics actually benefit patients. Health care providers have to balance concerns about antibiotic resistance with those regarding parental satisfaction.
POPULATION STUDIED: The study included 315 children aged 6 months to 10 years from general outpatient practices in southwest England who presented with acute ear pain with erythema, bulging, or perforation of the tympanic membrane on otoscopic examination. Children were excluded if they had pink tympanic membranes consistent with fever or crying alone, a history and examination consistent with otitis media with effusion and chronic suppurative otitis media, serious chronic disease, antibiotic use within the previous 2 weeks, previous complications of AOM, or if they appeared toxic.
STUDY DESIGN AND VALIDITY: This was a nonblinded controlled clinical trial with patients randomized to receive either immediate antibiotics (a prescription to be filled following the visit) or delayed antibiotics (instructions to return to clinic to pick up an prescription left at the reception desk in 3 days if the child was worse or not improving). When a patient was diagnosed with AOM, the physician opened an opaque envelope containing an advice sheet that allocated the patient to 1 of the 2 study groups. The advice sheet provided information on the benefits of the intervention, which the physician shared with the patient and parent to support the placebo effect of either intervention. The authors appropriately accounted for all study participants and used an intention-to-treat analysis.
OUTCOMES MEASURED: The authors measured duration and degree of pain, number of episodes of distress, amount of acetaminophen used, number of school days missed, and parental satisfaction scores as reported by parents in a daily diary.
RESULTS: Of 384 children eligible for the study, 315 were randomized, and 285 completed the study. A total of 132 of the 135 patients allocated to receive immediate antibiotics actually used them; 36 of the 150 children (24%) allocated to delayed prescription used antibiotics. Symptoms resolved in both groups in an average of 3 days. The children who received immediate antibiotics had significantly fewer days of earache (mean difference = -1.10 days; 95% confidence interval [CI], -0.54 to -1.48) and used fewer teaspoons of acetaminophen (mean difference = -0.52 tsp; 95% CI, -0.79 to -0.26). There was no difference between the 2 groups in mean pain scores, number of episodes of distress, or absence from school. Any effect of antibiotics seemed to occur only after the first 24 hours of illness. Diarrhea occurred in 19% of children who received antibiotics immediately, compared with 9% in the delayed group. Ninety-one percent of the parents in the immediate antibiotics group and 77% of those in the delayed antibiotics group were very satisfied with the treatment approach. Eighty-three percent of the parents whose children received antibiotics immediately believed that they would need to see the physician for future episodes, compared with 63% in the delayed antibiotics group; 76% versus 46% of parents in the immediate and delayed antibiotic groups, respectively, believed that antibiotics were very effective for AOM.
Giving the parent of a child with AOM a prescription for antibiotics with instructions to not fill that prescription unless the child seems to be getting sicker or has not improved over 3 days will result in the majority of these children riding out the episode without receiving an antibiotic and without experiencing a clinically significant increase in distress. Clinicians who wish to reduce the exposure of children to antibiotics in their practices will find this approach helpful. These findings are similar to a study of adults in the United States that found high patient satisfaction and reduced antibiotic usage when delayed backup antibiotic prescribing was used for respiratory symptoms (J Fam Pract 2000; 49:907-13).