Methods for Chronic Pain Management and Treatment using HCG

Abstract

A gonadotropin is administered within a surprisingly effective narrow range for the purpose of treating chronic pain or other central sensitization sequelae. In one aspect, a recipient is provided with at least one of human chorionic gonadotropin (uHCG and/or rHCG), a pharmaceutically active HCG analogue, and a pharmaceutically active metabolite of the HCG or analogue at a dosage selected to provide, or be equivalent to, a human subcutaneous dosage of between 120 IU/day and 170 IU/day of HCG, and more preferably between 140 IU/day and 160 IU/day of HCG. A kit is also described, which includes a supply of the HCG-related drug, a delivery device, and a label that identifies chronic pain or central sensitization as an indication of the drug.

1 . A method of interacting with a person, comprising:
 communicating with the person in a manner that aids in determining whether the person might suffer from chronic pain; and   facilitating the person discontinuously taking a drug at or equivalent to a subcutaneous dosage of human chorionic gonadotropin (HCG) between 120 IU/day and 170 IU/day, inclusive, with respect to chronic pain relief, for an express purpose of ameliorating the chronic pain, wherein the drug is selected from the group consisting of at least one of HCG (uHCG and/or rHCG), a pharmaceutically active HCG analogue, and a pharmaceutically active metabolite of the HCG or analogue.   
     
     
         2 . The method of  claim 1 , wherein the step of communicating comprises obtaining medical and diagnostic data of at least one of (a) procuring from the person a written and an oral symptom history, and a physical examination; and at least one of (b) conducting and referring for testing procedures. 
     
     
         3 . The method of  claim 2 , further comprising using the medical and diagnostic data to assist in determining whether the person has at least one of fibromyalgia and an irritable bowel syndrome. 
     
     
         4 . The method of  claim 2 , further comprising using the medical and diagnostic data to assist in determining whether the person has at least one of chronic arthropathy and an inflammatory pain. 
     
     
         5 . The method of  claim 2 , further comprising using the medical and diagnostic data to assist in determining whether the person has at least one of a post herpetic neuralgia, a trigeminal neuralgia, and a migraine. 
     
     
         6 . The method of  claim 2 , further comprising using the medical diagnostic data to assist in determining whether the person has at least one of chronic back pain and disc herniation. 
     
     
         7 . The method of  claim 2 , further comprising using the medical diagnostic data to assist in determining whether the person has at least one of neuropathic pain, traumatic nerve injury, post traumatic stress disorder pain syndrome, vulvodynia and chronic post-operative pain syndrome. 
     
     
         8 . The method of  claim 1 , wherein the step of communicating is performed synchronously between a health care professional and the person. 
     
     
         9 . The method of  claim 1 , wherein the step of communicating is performed asynchronously between a health care professional and the person, using at least one of physical mail and electronic communication. 
     
     
         10 . The method of  claim 1 , wherein the step of facilitating comprises issuing a prescription for use of the drug by the person. 
     
     
         11 . The method of  claim 1 , wherein the step of facilitating comprises providing the person with contact information from which the person can procure a supply of the drug. 
     
     
         12 . The method of  claim 1 , wherein the dosage is at or equivalent to a subcutaneous dosage of between 140 IU/day and 160 IU/day, inclusive, with respect to chronic pain relief. 
     
     
         13 . The method of  claim 1 , further comprising conducting a testing procedure that aids in distinguishing between nociceptive pain and central sensitization that the person may have. 
     
     
         14 . The method of  claim 1  further comprising assisting in procuring for the person an adjunct to the drug that facilitates coupling to the Gα, i/o, G-Protein Coupled Receptor (GPCR) subunits, facilitating and/or enhancing an analgesic effect. 
     
     
         15 . The method of  claim 1 , further comprising performing the step of facilitating after receiving information that HCG may have a peak effect on central sensitization between 120 IU/day and 170 IU/day, inclusive. 
     
     
         16 . A method of treating at least one of chronic pain and central sensitization, in a human user, comprising:
 providing a kit comprising a supply of a drug selected from the group consisting of at least one of HCG, a pharmaceutically active HCG analogue, and a pharmaceutically active metabolite of the HCG or analogue;   providing a delivery device and   providing a label that directs administration of the drug to the human in a dosage regimen to treat at least one of chronic pain and central sensitization, wherein the daily dosage regime is between 120 IU/day and 170 IU/day, inclusive.   
     
     
         17 . The kit of  claim 16 , wherein the dosage regimen provides a subcutaneous dosage of human chorionic gonadotropin (HCG) between 120 IU/day and 170 IU/day, inclusive. 
     
     
         18 . The method of  claim 16 , wherein the dosage regimen provides a daily dosage at or equivalent to a subcutaneous dosage of human chorionic gonadotropin (HCG) between 140 IU/day and 160 IU/day, inclusive. 
     
     
         19 . The method of  claim 16 , wherein the device comprises a vial or cartridge with chamber(s) that includes a lyophilized preparation of the drug that is suitable for injection when mixed with a diluent. 
     
     
         20 . The method of  claim 16 , wherein the device comprises a container that includes the drug in an orally available formulation. 
     
     
         21 . The method of  claim 16 , wherein the device includes the drug in a sub-dermal timed release pellet formulation. 
     
     
         22 . The method of  claim 16 , wherein the device includes the drug in an aerosolized formulation for intranasal administration. 
     
     
         23 . The method of  claim 19 , wherein the device is selected from one of an auto-inject pen and a dial up dosing pen. 
     
     
         24 . The method of  claim 23 , wherein the device has a cartridge with at least a first chamber containing a stabilized liquid form of the drug. 
     
     
         25 . A method of treating a subject, comprising:
 determining that the subject may suffer from a central sensitization disorder; and   providing the subject with a drug as a primary therapy for an express purpose of ameliorating the central sensitization, the drug selected from the group consisting of at least one of: human chorionic gonadotropin (uHCG and/or rHCG), a pharmaceutically active HCG analogue, and a pharmaceutically active metabolite of the HCG or analogue.   
     
     
         26 . The method of  claim 25 , wherein the step of determining comprises initiating a plurality of testing procedures that includes (a) at least one test selected from a first group consisting of dynamic tactile allodynia, secondary punctate/pressure hyperalgesia, temporal summation, and sensory after effects, and (b) at least one other test selected from a second group consisting of SMAC 25, fMRI, Neuro-Endocrine profile (neurotransmitters and hormones), CSF study (substance P, glutamate, NGF, BDNF), cytokines profile, genetic polymorphism profile, food allergy panel, and heavy metals analysis panel. 
     
     
         27 . The method of  claim 25 , wherein the step of determining comprises determining that the subject may suffer from central sensitization due to a trauma, and further comprising providing the subject with access to the drug peritraumatically. 
     
     
         28 . The method of  claim 27 , wherein the trauma comprises a surgery, and administering the drug perioperatively. 
     
     
         29 . The method of  claim 25 , wherein the step of providing comprises at least of one of suggesting and instructing the subject to self-administer an amount of the drug at or equivalent to a subcutaneous dosage of human chorionic gonadotropin (HCG) between 120 IU/day and 170 IU/day, inclusive, with respect to chronic pain relief. 
     
     
         30 . The method of  claim 29 , further comprising not concomitantly treating the subject with an opioid pain treatment. 
     
     
         31 . The method of  claim 16 , wherein the chronic pain is a result of central sensitization.