Method for diagnosing and treating dysautonomia and other dysautonomic conditions

Abstract

A method for treating a Parkinson's patient with digestive/pancreatic enzymes involves administering an effective amount of digestive/pancreatic enzymes to an individual having the disorder in order to improve a symptom of the disorder. In addition, a method is provided for determining whether an individual has, or may develop, Parkinson's disease or related dysautonomic disorders and for determining whether an individual will benefit from the administration of pancreatic/digestive enzymes to treat the dysautonomic disorder.

1 . A pharmaceutical preparation to treat a dysautonomic disorder in an individual comprising a therapeutically effective amount of digestive enzymes. 
     
     
         2 . The pharmaceutical preparation of  claim 1 , wherein the dysautonomic disorder is Parkinson's disease. 
     
     
         3 . The pharmaceutical preparation of  claim 1 , wherein the digestive enzyme is selected from the group consisting of: amylase, lipase, protease, and a combination thereof. 
     
     
         4 . The pharmaceutical preparation of  claim 1 , wherein the digestive enzyme is further selected from the group consisting of: chymotrypsin, trypsin, pancreatin, papaya, papain, and a combination thereof. 
     
     
         5 . The pharmaceutical preparation of  claim 1 , wherein the enzymes are derived from a source selected from the group consisting of animal enzymes, plant enzymes, synthetic enzymes, and a combination thereof. 
     
     
         6 . The pharmaceutical preparation of  claim 1  wherein the preparation is manufactured using a technology selected from the group consisting of PROSOLV® technology, enteric coating, lipid encapsulation, direct compression, dry granulation, wet granulation, and a combination thereof. 
     
     
         7 . The pharmaceutical preparation of  claim 1 , wherein the preparation is administered orally via a dosage formulation selected from the group consisting of pills, tablets, capsules, microcapsules, mini-capsules, time-released capsules, mini-tabs, sprinkles, and a combination thereof. 
     
     
         8 . The pharmaceutical preparation of  claim 3 , wherein the amount of amylase ranges from 10,000 to 70,000 U.S. Pharmacopeia (U.S.P.) units/mg. 
     
     
         9 . The pharmaceutical preparation of  claim 3 , wherein the amount of protease ranges from 10,000 to 80,000 U.S.P. units/mg. 
     
     
         10 . The pharmaceutical preparation of  claim 3 , wherein the amount of lipase ranges from 4,000 to 80,000 USP units/mg. 
     
     
         11 . The pharmaceutical preparation of  claim 4 , wherein the amount of pancreatin ranges from 2,000 to 6,000 U.S.P. units/mg. 
     
     
         12 . The pharmaceutical preparation of  claim 4 , wherein the amount of chymotrypsin ranges from 2 to 7 mg. 
     
     
         13 . The pharmaceutical preparation of  claim 4 , wherein the amount of papain ranges from 3,000 to 30,000 U.S.P. units/mg. 
     
     
         14 . The pharmaceutical preparation of  claim 4 , wherein the amount of papaya ranges from 30 to 500 mg. 
     
     
         15 . The pharmaceutical preparation of  claim 4 , wherein the amount of trypsin ranges from 60 to 100 mg. 
     
     
         16 . The pharmaceutical preparation of  claim 1 , wherein a symptom of the dysautonomic disorder is ameliorated. 
     
     
         17 . The pharmaceutical preparation of  claim 1  wherein the symptom of the dysautonomic disorder is selected from the group consisting of constipation, tremors, falls, difficulty in ambulation, and a combination thereof. 
     
     
         18 . A method of treating an individual having a dysautonomic disorder with a therapeutically effective amount of digestive enzymes comprising the steps of:
 measuring a level of fecal chymotrypsin in a stool sample of the individual;   comparing the level of fecal chymotrypsin with a normal fecal chymotrypsin level; and   administering the digestive enzymes to the individual if the level of fecal chymotrypsin in the individual is less than the normal fecal chymotrypsin level.   
     
     
         19 . The method of  claim 18 , further comprising the steps of: administering the digestive enzymes to the individual in order to promote protein digestion; and administering the digestive enzymes to the individual in order to ameliorate a symptom of the dysautonomic disorder. 
     
     
         20 . The method of  claim 18 , wherein the stool sample is measured using a technique selected from the group consisting of enzymatic photospectrometry, colorimetry, treatment with substrates, assays, and a combination thereof. 
     
     
         21 . The method of  claim 18 , wherein the normal fecal chymotrypsin level is approximately 8.4 U/gram.