Clinical Evaluation of Spirudio for Children With ADHD and Behavioral Disorders

Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most common neurodevelopmental disorders in children. The hallmarks are hyperactivity, impulsivity, and inattention that are beyond reasonable developmental expectations for a child’s age. The diagnosis of ADHD is made frequently in children with behavioral problems or academic underachievement. It is usually first diagnosed in childhood and often lasts into adolescence and adulthood. Children with ADHD typically have trouble paying attention, controlling impulsive behaviors (may act without thinking about what the result will be), or be overly active. Although the use of a standardized approach ensures the reliability of the diagnosis, concerns regarding the validity of the diagnosis often arise. At present, there is no biologic marker that identifies children with ADHD. Furthermore, whether ADHD is a unique disorder or merely one end of the continuum of age-appropriate behavior is not clear.

ADHD incidence rates are 5 to 10 times higher in the United States compared with other countries. There is significant regional variability in the diagnosis and treatment of ADHD across the United States, as well. For example, 8% to 10% of 30,000 children in second to fifth grade were diagnosed with ADHD in 1 Virginia school system, whereas the NIH reports a lower 3% to 5% incidence. Underdiagnosis and suboptimal treatment of children with ADHD is also a well-documented public health issue. One study of treatment services for ADHD nationwide found that only 50% of children with identified ADHD in real-world practice settings receive care that corresponds to guidelines of the American Academy of Child and Adolescent Psychiatry. Barriers to appropriate service provision include a lack of pediatric specialists.

Disorders in behavior and attention are quite common among the pediatric population (Zavadenko, 2006). The core symptoms include inattention, hyperactivity, and impulsivity. The incidence of Attention-Deficit/Hyperactivity Disorder (ADHD) children is up to 3-7%. Approximately 30-80% of children with ADHD (ADD) have the disorder as adults. Most experts believe that the rate is well above 50%.

The science behind Spirudio is based on a new way to combine homeopathy and antibody science. This product has been used for almost ten years in Europe (under a different brand name but with the same formulation) and has shown excellent results for children who have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD), or who are dealing with anxiety and hyperactivity issues. Spirudio is found both safe and impactful and is widely accepted as a safe alternative to prescription pharmaceuticals that have harmful side effects. Spirudio can help reduce the symptoms of anxiety and hyperactivity, consequently helping improve attention and focus. It also helps in lowering temper tantrums, obsessive behavior, and defiant behavior [1-10].

Drug therapy of anxiety disorders is also a challenge and should be combined with effective psychotherapy. The first-line drugs for the treatment of childhood anxiety disorders are selective serotonin reuptake inhibitors (SSRIs) with broad-spectrum activity but have delayed the onset of action. Benzodiazepines are usually not used as first-line therapy in children and adolescents, as they were shown to cause behavioral disinhibition in younger children and their addictive potential. However, despite the variety of drugs for the treatment of anxiety disorders, their administration is limited by frequent and severe adverse events (Arena, Rozenbaum, 2004; Khodarev, 2002). Spirudio is useful in childhood anxiety disorders, unlike other ADHD drugs, which is an additional benefit.

The active ingredient of Spirudio is produced using antibodies to the brain-specific S-100 protein (S-100B). This protein is an essential regulator of many different intracellular and extracellular brain processes, e.g., various enzyme activities, calcium homeostasis, communication between neurons, etc. Since almost all mental and neurological diseases, as well as temporal stress-induced conditions, are accompanied by disturbance of the processes as mentioned above, especially communication between neurons, the normalization of these processes is considered to be a prospective way to treat people with such undesirable conditions.

Behavioral Interventions: The effectiveness of behavioral interventions was compared with methylphenidate therapy in the Multimodal Treatment Study of Children With Attention-Deficit/Hyperactivity Disorder (MTA). This landmark study included 579 children aged 7-10 years with DSM-IV ADHD combined type. There were 3 active treatments (methylphenidate, behavioral therapy, and combination methylphenidate and behavioral treatment), which were compared with community care or “naturalistic” treatment. This controlled multicenter study was continued for 14 months. All active treatments received ongoing monitoring and coordination with parents, teachers, and clinicians. Community care included stimulant therapy in two-thirds of cases, but there was no systematic coordination of care. Parent training was an integral part of behavioral interventions. Parent training included education on ADHD, counseling for parents, training in contingency management techniques, and development of realistic expectations of treatment.

Mechanism of Action: S-100 protein is involved in multiple neurotransmitter networks of the body. Through its effects on these networks, the product helps improve the concentration of attention, reduce hyperactivity, and mitigate anxiety. Spirudio for Children exhibits a neuroprotective effect that restricts the area of damage and improves cognitive function (learning achievement and memory). Also, the drug modifies the activity of S-100 protein that integrates synaptic and metabolic processes in the brain. Brain-specific S-100 is expressed in different cell types, including astrocytes and specific neuronal populations. It stimulates cell proliferation and migration and inhibits apoptosis and differentiation in nanomolar concentrations. Extracellular brain-specific S-100 protein regulates synaptic plasticity, although the molecular mechanism of this activity is unknown.