Methods and Compositions for the Treatment of Symptoms of Complex Regional Pain Syndrome
A therapeutic composition for the treatment of the symptoms of complex regional pain syndrome and the method for preparing the therapeutic agents is disclosed. The therapeutic composition is a stable pharmaceutical composition comprising one or more digestive and/or pancreatic enzymes. The therapeutic composition may be manufactured by a variety of encapsulation technologies. Delivery of the therapeutic composition may be made orally, through injection, by adherence of a medicated patch or other method. Further, a method of using fecal chymotrypsin level as a biomarker for the presence of complex regional pain syndrome, or the likelihood of an individual to develop complex regional pain syndrome is disclosed.
1 . A method of treating an individual having a Complex Regional Pain Syndrome, comprising administering to the individual a therapeutically effective amount of a pharmaceutical composition comprising digestive enzymes.
2 . The method of claim 1 , wherein the digestive enzymes comprise one or more enzymes selected from the group consisting of a protease, an amylase, a cellulase, a sucrase, a maltase, a papaya, a papain, and a lipase.
3 . The method of claim 1 , wherein the digestive enzymes comprise one or more pancreatic enzymes.
4 . The method of claim 2 , wherein the pharmaceutical composition comprises multiple proteases that comprise chymotrypsin and trypsin.
5 . The method of claim 1 , wherein the digestive enzymes are, independently, animal enzymes, microbial enzymes, plant enzymes, or synthetic enzyme.
6 . The method of claim 5 , wherein the digestive enzymes are animal enzymes derived from a pig.
7 . The method of claim 1 , wherein the pharmaceutical composition comprises at least one amylase, a mixture of proteases comprising chymotrypsin and trypsin, at least one lipase, and papain.
8 . The method of claim 7 , wherein the pharmaceutical composition further comprises papaya.
9 . The method of claim 1 , wherein the pharmaceutical composition comprises an amylase in an amount of from about 10,000 to about 60,000 U.S.P. units/mg, a protease in an amount of from about 10,000 to about 70,000 U.S.P. units/mg, a lipase in an amount of from about 4,000 to about 30,000 U.S.P. units/mg, a chymotrypsin in an amount of from about 2 to about 5 mg, a trypsin in an amount of from about 60 to about 100 mg, a papain from about 3,000 to about 10,000 U.S.P. units/mg, and a papaya in an amount of from about 30 to about 60 mg.
10 . The method of claim 1 , wherein the pharmaceutical composition comprises at least one protease and at least one lipase, and wherein a ratio of total protease to total lipase in U.S.P. units in the pharmaceutical composition ranges from about 1:1 to about 20:1.
11 . The method of claim 10 , wherein the ratio of total protease to total lipase ranges from about 4:1 to about 10:1.
12 . The method of claim 1 , wherein one or more symptoms of the Complex Regional Pain Syndrome are selected from the group consisting of intense pain, a burning sensation, skin sensitivity, changes in skin temperature, color or texture, changes in hair and nail growth, joint stiffness, swelling and damage, muscle spasms, muscle weakness, muscle loss (atrophy), and decreased ability to move an affected body part.
13 . The method of claim 1 , wherein the pharmaceutical composition is a dosage formulation selected from the group consisting of a pill, a tablet, a capsule, a microcapsule, a mini-capsule, a time released capsule, a mini-tab, a sprinkle, and a combination thereof.
14 . A method of diagnosing an individual as having a Complex Regional Pain Syndrome, comprising:
obtaining a fecal sample from the individual;
measuring a level of fecal chymotrypsin present in the fecal sample; and
diagnosing the patient as having the Complex Regional Pain Syndrome if the level of fecal chymotrypsin is 8.4 U/gram or less and the individual exhibits at least one symptom associated with the Complex Regional Pain Syndrome.
15 . The method of claim 14 , wherein the fecal chymotrypsin level is between 8.4 and 4.2 U/gram.
16 - 46 . (canceled)
47 . A method of treating an individual having a Complex Regional Pain Syndrome 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 to the individual a therapeutically effective amount of a pharmaceutical composition that comprises digestive enzymes to the individual if the level of fecal chymotrypsin in the stool sample is less than the normal fecal chymotrypsin level.
48 . The method of claim 47 , wherein
administering the pharmaceutical composition promotes protein digestion; and
ameliorates a symptom of the Complex Regional Pain Syndrome.
49 . The method of claim 47 , wherein the level of fecal chymotrypsin in the stool sample is measured using a technique selected from the group consisting of enzymatic photospectrometry, colorimetry, treatment with substrates, and a combination thereof.
50 . The method of claim 1 , wherein the digestive enzymes comprise a protease, an amylase and a lipase.
51 . The method of claim 47 , wherein the digestive enzymes comprise a protease, an amylase and a lipase.