A randomized prospective study on the treatment of nontuberculous mycobacterial head and neck infections in children: preliminary results of surgery versus medical therapy

Abstract

Introduction: Considerable controversy remains with regard to the treatment of nontuberculous head and neck infections in children. Surgery is still widely regarded as the treatment of choice, but in recent years several authors have reported successful medical treatment. The objective of the current study was to assess the success rate of medical (antibiotic) treatment in comparison with surgical excision in a prospective cohort of children with cervicofacial lymphadenitis. Materials and Methods: Sixty-five children between the ages of 1 and 12 years with a persistent cervicofacial lymph node swelling were subjected to a diagnostic protocol. Inclusion criteria for the study were 1) a cervicofacial lymph node swelling; 2) a positive mycobacterial skin test, or positive stain, positive culture for mycobacteria or positive PCR for mycobacteria; and 3) a negative PCR for Mycobacterium tuberculosis. Exclusion criteria were immunocompromised patients, use of immunosuppressive drugs, patients older than 15 years, and refusal to participate in the study of the patient, parent, or legal representative. Forty children were included and were randomized to either surgical excision of the affected lymph nodes or medical therapy consisting of claritromycin and rifabutin during 3 months. Primary outcome was complete closure of the wound or resolution of the lymphadenitis after 6 months with medical therapy or surgical intervention. Successes were defined as complete regression of the lymphadenitis or complete healing of the wound. Failure was defined as an open wound or a persistent enlargement of lymph nodes, a fistula, or a sinus tract. Secondary outcome parameters were microbiologic eradication measured after 3 months, visibility and aesthetic assessment of the scar after both medical and surgical therapy, adverse effects of surgery, and side effects of medical therapy. Statistical Analysis: Based on data in literature, surgical excision is successful in about 90% of the patients. In order to justify medical treatment of the condition, we anticipated a success rate difference of no more than 15%, that is, a success rate of at least 75% for the medicinal treatment option. Statistical analyses were performed with a one-sided test and a type I and type II error rate of 5% and 10%, respectively. Results: In the surgical treatment group, 90% of the patients were completely cured after therapy, whereas in the medical therapy group, 65% of the patients were cured with antibiotics alone. Two patients in the surgical group developed a temporary paresis of the marginal branch of the facial nerve. One patient in the medical group experienced severe side effects of the medication, whereas 12 patients had temporary side effects. Conclusions: Surgical excision seems to be the most effective treatment, and medical therapy should mainly be reserved for cases with limited lymph node involvement or in cases where the anatomic location of the infected lymph node implicates a major risk factor for the facial nerve branches.