Introduction: The aim of this study was to evaluate the efficacy and safety of botulinum toxin therapy (BT) in children with headaches. Chronic headaches and migraine resistant to standard medical treatment were observed in 15 pediatric patients. Botulinum toxin injections were administered off-label every 3-6 months. The Headache Impact Test–6 (HIT-6) is a brief six-item questionnaire designed to assess the impact of headaches on daily activities as well as social, occupational, and emotional aspects of life. It is widely used in clinical practice for patients with migraine and other types of headache. All patients completed the HIT-6 questionnaire independently before and after botulinum toxin administration.

Methods: Fifteen patients were included in the study (mean age 14.7 years), including 12 girls (80%) and 3 boys (20%). Comorbid conditions included visual impairment, sleep disturbances, postural abnormalities, flat feet, and depressive symptoms. All patients had previously received pharmacological therapy, including antiemetics (metoclopramide, ondansetron), nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, diclofenac), triptans (sumatriptan, rizatriptan), combination analgesics containing codeine, antidepressants (amitriptyline), muscle relaxants (tizanidine, baclofen) for pronounced muscle tension, and antiepileptic drugs (topiramate). Despite treatment, headache control remained insufficient. Patients responded to the HIT-6 questionnaire, indicating how often during the previous weeks headaches caused severe pain, interfered with daily activities, led to the desire to lie down, caused fatigue, irritability, and impaired concentration. Each response category (“never,” “rarely,” “sometimes,” “often,” “always”) was scored as 6, 8, 10, 11, or 13 points, respectively. The total score ranged from 36 to 78, with higher scores indicating a greater negative impact of headaches on quality of life.

Results: Baseline assessment prior to botulinum toxin therapy (BT) demonstrated varying degrees of headache impact according to the HIT-6 scale. Little or no impact (<49 points) was observed in 2 children (13%), with individual scores of 38 and 44. Moderate impact (50–55 points) was identified in 4 children (27%) with scores of 51, 53, 53, and 55. Substantial impact (56–59 points) was present in 3 children (20%) with scores of 57, 58, and 59. Severe impact (>60 points) was noted in 6 children (40%), with scores of 64, 65, 68, 70, 74, and 76. All 15 patients (100%) underwent botulinum toxin therapy with injections administered to predefined target muscles: facial muscles (m. frontalis, m. corrugator supercilii, m. - 2 - procerus, m. orbicularis oculi), the temporal region (m. temporalis), the occipital region (m. occipitalis), and the cervicothoracic region (m. trapezius). Repeat HIT-6 assessment was performed 3 weeks after BT. Little or no headache impact (<49 points) was observed in 5 children (33%) with scores of 37, 42, 44, 45, and 49. Moderate impact (50–55 points) was present in 5 children (33%) with scores of 51, 52, 52, 54, and 55. Substantial impact (56–59 points) was identified in 4 children (27%) with scores of 56, 57, 57, and 59. Severe impact (>60 points) persisted in only 1 child (7%), with a score of 74. All 15 patients (100%) completed HIT-6 assessments both before treatment and 3 weeks after BT.

Conclusion: The obtained results indicate the potential efficacy of botulinum toxin therapy in children with headaches resistant to pharmacological treatment. The reduction in HIT-6 scores reflects not only a decrease in headache intensity but also improvements in functional status, emotional well-being, and the ability to concentrate. Botulinum toxin type A is known to exert an analgesic effect by inhibiting the release of neuropeptides, including calcitonin gene-related peptide (CGRP) and substance P, as well as by modulating peripheral and central sensitization. These mechanisms are particularly relevant in chronic migraine and tension-type headache, in which central sensitization processes and involvement of the trigeminocervical complex play a key role. It should be noted that in pediatric practice, botulinum toxin therapy is used off-label, and published data on its use in children are limited to small case series. In this context, the present clinical experience with botulinum toxin therapy in the Russian Federation contributes additional evidence to the existing literature and demonstrates a favorable safety profile when an individualized approach to dose selection and target muscle choice is applied. The limitations of this study include a small sample size, the absence of a control group, and the use of a subjective self-report assessment scale. Nevertheless, the HIT-6 is a validated instrument widely used in both clinical practice and research, which enhances the clinical relevance of the obtained results. This study provides the first evidence from the Russian Federation supporting the use of botulinum toxin therapy in children with headaches refractory to pharmacological treatment.

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