Abstract
Objective
To compare azithromycin (AZT) and benzathine penicillin (BP) in the treatment of recurrent tonsillitis in children.
Methods
The study comprised of 350 children with recurrent streptococcal tonsillitis, 284 of whom completed the study and 162 children received conventional surgical treatment. The rest of the children, 122, were divided randomly into two equal main groups. Group A children received a single intramuscular BP (600,000 IU for children ≤ 27 kg and 1,200,000 IU for ≥ 27 kg) every two weeks for six months. Group B children received single oral AZT (250 mg for children ≤ 25 kg and 500 mg for ≥ 25 kg) once weekly for six months.
Results
Both groups showed marked significant reduction in recurrent tonsillitis that is comparable to results of tonsillectomy. There were no statistical differences between group A and B regarding the recurrence of infections and drug safety after six-month follow-up. Group B showed better compliance.
Conclusion
AZT proved to be good alternative to BP in the management of recurrent tonsillitis with results similar to those obtained after tonsillectomy.
1
Introduction
In the present state of medical literature, tonsils are considered as assets to the immunological system and they are removed or partially excised only when there is a medical necessity caused by their size, recurrent bacterial infections or tumor . Recurrent tonsillitis has been defined as four or more confirmed infection episodes per year with streptococci A-infection diagnosed in one of them . Prevalence is from 11.0 to 12.3% with marked family burden and risk of man serious complication especially in developing countries . Recurrent tonsillitis is usually treated by either tonsillectomy or conservative medical treatment when tonsillectomy criteria are not fulfilled or there is a contraindication for tonsillectomy . A review by Burton et al. in 2014 found that children with recurrent acute tonsillitis have a small benefit from adeno-/tonsillectomy The procedure will avoid only 0.6 episodes of any type of sore throat in the first year after surgery compared to non-surgical treatment. The children who had surgery had three episodes of sore throat on average compared to 3.6 episodes experienced by the other children. One of the three episodes is the episode of pain caused by surgery. It seems that children with the more severe and frequent tonsillitis are the ones who benefit from surgery in comparison to the less severely affected children .
Sirimanna et al. reported the usefulness of long-acting penicillin in significant reduction of recurrent tonsillitis . However, long acting penicillin has multiple drawbacks such as hypersensitivity reactions, anaphylaxis and severe local pain .
Azithromycin (AZT) is an Azalide, a subclass of macrolide antibiotic which is widely distributed throughout the body, achieving higher concentrations in tonsillar tissues with adequate therapeutic levels during medication with minimal side effects .
Recurrent tonsillitis always present on a continuum rather than a dichotic representation. Children seem to suffer from different grades of recurrent tonsillitis. The possibility of having other treatment measures than tonsillectomy is tempting especially when the child has recurrent tonsillitis that falls little short of the criteria for tonsillectomy
The aim of the present study was to compare the efficacy of AZT and benzathine penicillin (BP)—both administered for six months in the management of recurrent tonsillitis—to conventional tonsillectomy.
2
Materials and methods
2.1
Design, setting and participants
A randomized controlled clinical trial study created in the otolaryngology department – Suez Canal University Hospital – Ismailia – Egypt and Alexandria University Children Hospital – Egypt from March 2005 to May 2012. The study protocol was approved by the local faculty ethics committee and written informed consent was obtained from all patients relevant.
2.2
Patient eligibility and enrolment
A total of 350 children with recurrent tonsillitis were included in the study. Recurrent tonsillitis was defined as four or more episodes of tonsillitis per year (for children of either gender) with two of the episodes confirmed to be group A streptococcal infection. The enrolled children were aged from five to 12. The 350 children enrolled fulfilled the inclusion criteria and did not have any significant co-morbidities. Significant morbidities included rheumatic heart disease, rheumatic fever, marked anesthetic risk, sensitivity to AZT or BP, the intake of drugs that might interfere with AZT or BP, hepatic impairment, or long QT syndrome (a prolonged QT interval of > 45 ms in ECG).
2.3
Study plan
Children were divided randomly and equally into two groups. Randomization was performed prior to study commencement as follows: Opaque envelopes were numbered sequentially from 1 to 350. A computer-generated table of random numbers was used for group assignment; if the last digit of the random number was from 0 to 4, assignment was to group 1 (received conventional tonsillectomy), and if the last digit was from 5 to 9, assignment was to group 2 (received BP or AZT). Group 2 was randomized again in similar manner in group A and group B. The assignments were then placed into the opaque envelopes and the envelopes sealed. As eligible participants were entered into the trial, these envelopes were opened in sequential order to give each patient his or her random group assignment. The envelopes were opened by the ORL specialist after patient consent and just prior to the treatment method; Group A received medical treatment with BP and group B received AZT. Subgroup A children received single intramuscular.
BP (600,000 IU for children ≤ 27 kg and 1,200,000 IU for children ≥ 27 kg) every two weeks for six months . Subgroup B children received single oral AZT (250 mg for children ≤ 25 kg and 500 mg for children ≥ 25 kg) once weekly for six months . Children in the AZT subgroup were subjected to ECG, calculation of the QT interval and liver enzymes before starting the treatment.
Out of the 350 children, only 284 managed to complete the study. The children had a mean age of 7.4 ± 1.6 years.
350 children randomly divided into tonsillectomy and medical treatment group with 175 in each. Drop out of 13 children in the tonsillectomy group and 53 children in the conservative medical treatment one. Tonsillectomy group was 162 children. Conservative medical treatment group was 122 children. 61 children in group A that received BP while 61 children in group B received AZT. More patients dropped out of the conservative medical treatment group. It is postulated that this may be due to some of them seeking conventional tonsillectomy in the private health care sector or due to poor compliance with the conservative medical treatment.
2.4
Objective and outcome measurement assessment
Data collected included complete medical histories with an emphasis on recurrent tonsillitis. Symptoms’ severity was assessed using a visual analog scale for symptoms’ severity (with 0 indicating no symptoms and 10 indicating the most severe symptoms). In addition, a complete ENT and general physical examination were carried out before the start of the study. CBC, ASOT, and ESR data were collected from all children at the beginning of the study and after six months.
The outcomes were assessed through the following measures: 1) Medical history and clinical evaluation by the end of the trial. 2) ASOT and ESR levels were taken before the start of the study and six months after it. 3) Symptoms’ severity was assessed using the visual analog scale for symptoms severity as described above. 4) The safety of drugs were assessed by the detection of adverse effects, which were classified as minor and accepted adverse effects (GIT upset, dizziness) or major, necessitating the exclusion of the child from the study (anaphylaxis, jaundice, a prolonged QT interval). 5) Satisfaction assessment was made by asking direct questions to the patients, their parents, and the medical staff. Patients’ satisfaction was classified as a) the patient is comfortable and accepts the regimen; b) the patient is not comfortable but accepts and continues the regimen; c) the patient is not comfortable and does not accept the regimen and discontinues it (whereupon they were excluded from the study).
2.5
Statistical analysis
Data collected were processed using SPSS version 18 (SPSS Inc., Chicago, IL, USA). Quantitative data were expressed as means ± SD while qualitative data were expressed as numbers and percentages. The Student’s t -test was used to compare the significance of difference for the quantitative variables that followed a normal distribution.
2.6
Ethical considerations
The study protocol was approved by the faculty’s ethical committee and written informed consent was obtained from the parents of the children enrolled in the study after an explanation of the study’s design, and the benefits and risks associated with the treatment regimen.
2
Materials and methods
2.1
Design, setting and participants
A randomized controlled clinical trial study created in the otolaryngology department – Suez Canal University Hospital – Ismailia – Egypt and Alexandria University Children Hospital – Egypt from March 2005 to May 2012. The study protocol was approved by the local faculty ethics committee and written informed consent was obtained from all patients relevant.
2.2
Patient eligibility and enrolment
A total of 350 children with recurrent tonsillitis were included in the study. Recurrent tonsillitis was defined as four or more episodes of tonsillitis per year (for children of either gender) with two of the episodes confirmed to be group A streptococcal infection. The enrolled children were aged from five to 12. The 350 children enrolled fulfilled the inclusion criteria and did not have any significant co-morbidities. Significant morbidities included rheumatic heart disease, rheumatic fever, marked anesthetic risk, sensitivity to AZT or BP, the intake of drugs that might interfere with AZT or BP, hepatic impairment, or long QT syndrome (a prolonged QT interval of > 45 ms in ECG).
2.3
Study plan
Children were divided randomly and equally into two groups. Randomization was performed prior to study commencement as follows: Opaque envelopes were numbered sequentially from 1 to 350. A computer-generated table of random numbers was used for group assignment; if the last digit of the random number was from 0 to 4, assignment was to group 1 (received conventional tonsillectomy), and if the last digit was from 5 to 9, assignment was to group 2 (received BP or AZT). Group 2 was randomized again in similar manner in group A and group B. The assignments were then placed into the opaque envelopes and the envelopes sealed. As eligible participants were entered into the trial, these envelopes were opened in sequential order to give each patient his or her random group assignment. The envelopes were opened by the ORL specialist after patient consent and just prior to the treatment method; Group A received medical treatment with BP and group B received AZT. Subgroup A children received single intramuscular.
BP (600,000 IU for children ≤ 27 kg and 1,200,000 IU for children ≥ 27 kg) every two weeks for six months . Subgroup B children received single oral AZT (250 mg for children ≤ 25 kg and 500 mg for children ≥ 25 kg) once weekly for six months . Children in the AZT subgroup were subjected to ECG, calculation of the QT interval and liver enzymes before starting the treatment.
Out of the 350 children, only 284 managed to complete the study. The children had a mean age of 7.4 ± 1.6 years.
350 children randomly divided into tonsillectomy and medical treatment group with 175 in each. Drop out of 13 children in the tonsillectomy group and 53 children in the conservative medical treatment one. Tonsillectomy group was 162 children. Conservative medical treatment group was 122 children. 61 children in group A that received BP while 61 children in group B received AZT. More patients dropped out of the conservative medical treatment group. It is postulated that this may be due to some of them seeking conventional tonsillectomy in the private health care sector or due to poor compliance with the conservative medical treatment.
2.4
Objective and outcome measurement assessment
Data collected included complete medical histories with an emphasis on recurrent tonsillitis. Symptoms’ severity was assessed using a visual analog scale for symptoms’ severity (with 0 indicating no symptoms and 10 indicating the most severe symptoms). In addition, a complete ENT and general physical examination were carried out before the start of the study. CBC, ASOT, and ESR data were collected from all children at the beginning of the study and after six months.
The outcomes were assessed through the following measures: 1) Medical history and clinical evaluation by the end of the trial. 2) ASOT and ESR levels were taken before the start of the study and six months after it. 3) Symptoms’ severity was assessed using the visual analog scale for symptoms severity as described above. 4) The safety of drugs were assessed by the detection of adverse effects, which were classified as minor and accepted adverse effects (GIT upset, dizziness) or major, necessitating the exclusion of the child from the study (anaphylaxis, jaundice, a prolonged QT interval). 5) Satisfaction assessment was made by asking direct questions to the patients, their parents, and the medical staff. Patients’ satisfaction was classified as a) the patient is comfortable and accepts the regimen; b) the patient is not comfortable but accepts and continues the regimen; c) the patient is not comfortable and does not accept the regimen and discontinues it (whereupon they were excluded from the study).
2.5
Statistical analysis
Data collected were processed using SPSS version 18 (SPSS Inc., Chicago, IL, USA). Quantitative data were expressed as means ± SD while qualitative data were expressed as numbers and percentages. The Student’s t -test was used to compare the significance of difference for the quantitative variables that followed a normal distribution.
2.6
Ethical considerations
The study protocol was approved by the faculty’s ethical committee and written informed consent was obtained from the parents of the children enrolled in the study after an explanation of the study’s design, and the benefits and risks associated with the treatment regimen.
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