Importance: Migraine headache is an extremely debilitating disorder with a poor response to traditional allopathic treatment methods. A new approach to the understanding of the physiology of chronic migraine and craniofacial neuralgia may provide long term and possibly curative treatment in the context of current multi drug therapies.
Objective: The purpose of the study was to measure the safety and long-term efficacy of simultaneous bilateral administration of the Di Novo algorithm which utilizes a composition of Dexamethasone, Lidocaine, and Thiamine into the trigeminal nerve branches as well as the greater/lesser occipital nerves.
Design, setting, and participants: The study has a quantitative descriptive design. This was a pilot study testing feasibility and facilitating a future full-scale study which is now in progress. Patients were recruited using nonprobability consecutive sampling. Study participants were current patients or referrals from other primary health care providers who were enrolled at the Corona Doctors Medical Clinics in Southern California. Patients met the inclusion criteria and participated in the study. All patients were previously diagnosed with chronic craniofacial headache and migraine and had received previous medical interventions and treatment modalities with no signs of any improvement. Patient 12-87 years of age were randomly included into the study as well.
Main outcome and measures: The main outcome were the relief of the neuralgia and other migraine associated symptoms as measured by the Wong-Baker face pain validated scale. Patients were followed up with questionnaires at week 1, week 4, month 6, and the year 1 point after the initial intervention. Migraine associated symptoms and variables were measured.
Results: Our data showed approximately 96% of the observed patients responded with complete relief after being treated initially with Dexamethasone, Lidocaine, and Thiamine (Di- Novo composition). 4% of patients experienced major relief in the frequency and intensity of their migraine attacks for a brief period of time and later experienced a relapse in migraine headache.
Safety Evaluation: Safety was assessed by observation of any adverse reaction in the clinical setting. Follow up examinations inquired and assessed the occurrence of physical and neurological symptoms at month 1, month 3, month 6, month 9, and the one-year point with no reports of adverse reaction.
Conclusion and relevance:
Our analysis indicates that the peripheral nerve system is nourished by vasa nervorum of the arterial and venous system. Vasa nervorum per se is controlled by the autonomic nerves embedding into tunica adventia and tunica muscularis, which genetically equilibrates its function toward the physical world by modifying bio signals, which play a major role in the synthesis of pro and neuroinflammatory cytokines as the initiator of pain signals. Primarily, pain signals initiated peripherally by sensory organs, as warning toward the hazardous effect of introduced outside physical elements. Pain signals precepted by CNS by release of modulatory proteins, analyzed and responded with consequent action for survival. The brain as the calculator and manager of the human body bioactivities, takes action to prevent further biophysical damage to sensory receptors. It should be noted that CNS without its combined sensory organs is a non-programmed Bio-computer with unlimited Gigabyte capacities. The brain per se does not carry any pain receptors. However, presence of cytokines such as TNFs in the CNS environment may block certain activities of the centers if not interrupted or eliminated.
Among the patients with chronic craniofacial neuralgia and chronic migraine headaches, introduction of simultaneous bilateral administration of dexamethasone, lidocaine and thiamine shows significantly improved symptoms compared to the current traditional abortive or preventative measures. In our trial, patients tolerated the treatment well without incident of any major adverse event. Long term, it eliminated abortive and preventive medications as well as behavioral lifestyle modifications. Chronic migraine and sub types received the same treatment and responded in the same manner.
Key words: migraine headache, trigeminal neuralgia, migraine treatment, Di Novo algorithm