Download Effective Treatment of Lyme Borreliosis with Pentacyclic Alkaloid

Effective Treatment of Lyme Borreliosis with Pentacyclic Alkaloid
Uncaria tomentosa (TOA-free Cat’s Claw)
Executive Summary
Introduction
In a six-month prospective cohort study designed to compare the effectiveness of an alternative method of
Lyme borreliosis treatment to conventional antibiotic treatment, patients receiving alternative treatment
showed greater improvement based on self-reported disease symptoms, physician evaluation and clinical
laboratory tests. The alternative treatment consisted of the use of Pentacyclic Alkaloid Chemotype Uncaria
tomentosa, or TOA-Free Cat’s Claw, dietary and lifestyle changes, enzymes, vitamins, minerals,
detoxification herbs and body pH-balancing. Conventional treatment included antibiotic treatment as
recommended by the American Medical Association.
Structure of Study
Twenty-eight patients with advanced Lyme borreliosis entered the study, one patient dropped out due to
hospitalization and surgery for an unrelated pelvic tumor, and twenty-seven patients completed the study.
The presence of the IgG and IgM antibodies to Borrelia burgdorferi and clinical evaluation confirmed each
patient’s diagnosis. Each person had had the disease for over 10 years, had experienced progressive
deterioration and had shown very little or no clinical improvement with long-term and/or repeated courses
of antibiotics.
Patients were divided into two groups, comparable in terms of symptoms, length and clinical course of the
illness, demographics, socio-economic status, and compliance with the treatment protocol. Over the study
period of six months, all patients were evaluated a minimum of three times: at the initiation of the study,
mid-study and at the study’s conclusion. Many were evaluated at additional visits (on as-needed basis)
throughout the study period.
Results of the study are based on three groups of data, collected over the period of six months: selfevaluation, clinical evaluation by the physician, and immunological tests. Self-evaluation consisted of two
data instruments: 1) a patient self-assessment form in which patients evaluated the severity of each of their
disease-related symptoms before the study treatment protocol and periodically thereafter, and 2) the
widely-used SF-8 survey which evaluated a person’s quality of life as it related to health on each visit.
Clinical evaluation included a physical examination, neurological assessment, kinesiological assessment,
comprehensive clinical blood test, and clinical urinalysis. Immunological tests included serological tests for
the presence of the IgG & IgM antibodies to Borrelia burgdorferi (the Western Blot test) and other
infectious agents, including Babesia microti, Ehrlichia, Mycoplasma, Chlamydia, Helicobacter pylori,
Cytomegalovirus, Epstein Barr Virus, Herpes Simplex Virus type 1 and 2, and Coxsackie Virus.
Treatment Protocol
Experimental Group
All prescription antibiotics were discontinued before the start of the study, and during the study most other
pharmaceuticals were dramatically reduced or discontinued. During the first two weeks of the study (weeks
1 and 2), treatment included general body detoxification through diet and supplements, but did not include
TOA-free Cat’s Claw. Patients began taking TOA-free Cat’s Claw in the third week at 600 mg 3 times a
day, continued to increase their daily dosage by 600 mg a day, and by the end of the fourth week all
patients were taking 1800 mg 3 times a day for a total of 5400 mg a day (weeks 3 and 4). This dose and
supportive remedies were continued for the next 4 weeks (weeks 5 through 8). During the following two
weeks (weeks 9 and 10) TOA-free Cat’s Claw was continued at 5400 mg a day, but supportive remedies
were used only minimally. After the tenth week, most of the supportive remedies were discontinued, and
TOA-free Cat’s Claw was continued at 3600 to 5400 mg a day for an additional 16 weeks (weeks 11 – 26).
Control Group
During the 26 weeks of the study, all patients in the control group continued treatment with antibiotics
and/or symptomatic medications in accordance with their treatment protocol.
Results
The following table summarizes the results of the patients’ self-reported symptoms at the first and last
visits for both the experimental and the control groups. Each patient rated their severity of symptoms based
on a scale of 0 to 10. The means for the first and last visits and the ratio of these two means are reported
for each group. For the experimental group, compared to the control group, the mean for each symptom
except joint pain and peripheral neuropathy was slightly higher at the beginning of the study, and
significantly (P<0.05) lower for all symptoms at the end of the study. Additionally, the percentage of
patients who improved was higher in the experimental group for each symptom, with statistically
significant difference (P<0.05) for all neurological symptoms and fatigue.
Experimental Group
Control Group
Symptoms
First Visit
Mean
Last Visit
Mean
Ratio
First/ Last
% who
improved
First Visit
Mean
Last Visit
Mean
Ratio
First/ Last
% who
improved
Fatigue
Joint Pain
Muscle pain
Digestive Disturbances
Cognitive Dysfunction
Memory Impairment
Limbic Encephalopathy
Sleep Disturbances
Headache
Peripheral Neuropathy
7.92*
7.64*
7.43*
7.00*
7.50*
8.25*
6.80*
8.25
7.00
7.05*
4.17*
4.10*
4.29*
2.73*
3.75*†
3.25*
3.45*
4.25
4.25
3.60*†
1.9
1.9
1.7
2.6
2.0
2.5
2.0
1.9
1.6
2.0
83.3*
60.0
71.4
81.8
100*
87.5*
80.0*
75.0
66.7
83.3*
7.25*
7.88
7.24
6.06*
7.00
6.50
6.07
5.67
6.17
7.25
5.67*
6.13
5.63
4.06*
5.81†
5.20
4.97
4.00
6.17
7.25†
1.3
1.3
1.3
1.5
1.2
1.3
1.2
1.4
1.0
1.0
58.4*
55.6
62.5
62.5
70.0*
50.0*
57.1*
33.3
33.3
0.0*
*Statistically significant difference (p<0.05 by paired t-test) between first and last visits
†Statistically significant difference (p<0.05 by paired t-test) between Experimental and Control groups last visits
Physicians evaluating patients’ clinical status at the end of the study period found that the experimental
group showed significantly (p<0.05) higher overall improvement in clinical conditions than the control
group. Eighty-five percent of individuals in the experimental group showed marked improvement in their
overall clinical conditions, and nobody worsened. No patient in the control group demonstrated as much
improvement. One patient (7%) in the control group showed moderate improvement, while the rest showed
only slight improvement (43%), no change (29%), or a worsening of their condition (21%).
The dynamics of changes in clinical symptoms during the study period for the patients’ first, middle, and
last visits and the rate of their improvement (in percent) demonstrate earlier (within the first 10 weeks of
study) and greater improvement in the patients of the experimental group, than of the control group. Over
the entire study period, the rate of improvement in all clinical symptoms was much higher in the
experimental group (from 2.2 to 3.6 times), than in the control group, being the highest for all neurological
symptoms (memory impairment – 3.6 times; cognitive dysfunction - 2.7 times; limbic encephalopathy - 2.7
times) and digestive disturbances (2.7 times) (Figure 1). Within the first period of study (10 weeks), the
patients of the experimental group showed some improvement in clinical symptoms during the 2-week
detoxification period. Substantial improvement in patients’ clinical symptoms occurred with the use of
TOA-free Cat’s Claw, starting within the 2-week dose adjustment period, progressing during the 6-week
period of full dosage therapy, and progressing further or leveling during the 16-week period of using TOAfree Cat’s Claw in individualized dosage with no other supplements (Figure 2).
The SF8 Survey data for the patients’ first and last visits demonstrate substantial positive changes in the
patients’ quality of life in the experimental group, compared to the control group. In the experimental
group, there was lower impact of the patients’ physical and emotional health problems on their physical,
social and routine daily activities and social activities with family and friends, as well as decreased severity
of the patients’ emotional problems and bodily pain, and higher energy level (Figure 3). By the end of the
2
study, 85 percent of patients in the experimental group rated their overall health in general as “better” or
“much better “, compared to one year ago. The SF8 Survey data for the patients of the experimental group,
analyzed on a monthly basis during the study period, demonstrated progressive positive changes and steady
improvement in the patients’ quality of life concurrently with their clinical improvement (Figure 4).
During the entire study period, the majority of the patients’ routine clinical blood test indexes (including all
indexes of the comprehensive metabolic panel, CBC, WBC differential) did not demonstrate major
differences in their values and/or unusual patterns of their value distribution in the patients of the either
group. But there was some improvement in various indexes, more visible in the experimental group.
The most noticeable changes during the study period were in the lipid profile indexes: pre-study
Triglycerides, Cholesterol and LDL were significantly elevated beyond the normal range in the majority of
patients of the both groups. Over the study period, the positive changes in the lipid profile indexes
(decreased Triglycerides, Cholesterol and LDL, increased HDL, normalization of the HDL/LDL ratio) were
more substantial in the patients of the experimental group, than of the control group.
Isolated slight elevations in the Liver enzymes (SGOT and SGPT), possibly related to the Herxheimer
reaction, in three patients of the experimental group and in two patients of the control group, decreased to
the normal level faster (in 1-2 weeks) in the patients of the experimental group, than of the control group.
The serum Albumin level, while within the range (2.9 to 5.0 G/DL), had the value distribution pattern
within the upper half of the optimal range in all patients of the both groups during the entire study period.
Four patients in the experimental group and four patients in the control group were slightly anemic with
low RBC, Hemoglobin and Hematocrit at the beginning of the study. All four patients of the experimental
group had multiple co-infections with Mycoplasma, Chlamydia, Cytomegalovirus (CMV), Epstein Barr
Virus (EBV), Herpes Simplex Virus (HSV) type 1 and 2; all these patients improved progressively and
steadily in all indexes. Four patients with mild anemia in the control group had co-infections with Ehrlichia
(HME type), and one of them - additionally with Babesia Microti; all of these patients showed slight
improvement by the end of the study. About half of patients in the both groups had WBC elevated at the
upper limit of the range, mostly at the expense of relative or absolute Monocytosis and /or Lymphocytosis
in the experimental group, and a slightly higher percent of Neutrophils in the patients of the control group.
At the beginning of the study, in both the experimental and the control groups about half of patients (46%
and 43% respectively) had co-infections with Babesia microti, Ehrlichia (HME type), Mycoplasma (of
various types), Chlamydia pneumonia, Helicobacter pylori, CMV, EBV, HSV type 1and 2, and Coxsackie
virus, confirmed by the presence of the IgG & IgM antibodies to these infectious agents in the patients’
serum. The patients of the experimental group had a higher number of co-infections (mostly, with 4 to 7 of
these pathogens in each case), compared to the lower number of the same co-infections in the patients of
the control group (mostly with 1, and no more than 2 to 3 of these infectious pathogens in each case). This
fact undoubtedly contributed to more severe clinical symptoms and worse health conditions in the patients
of the experimental group at the beginning of the study.
Initially, all patients in both groups were seropositive to Borrelia burgdorferi (Bb) by the IgG and/or IgM
antibody in the Western Blot Test (by the CDC and/or ILADS criteria). At the end of the study, 85% of
patients in each group became seronegative to Bb by the IgG antibody in the Western Blot Test, with some
quantitative and qualitative differences between the groups in the patients’ Immune Response. The patients
of the experimental group demonstrated comparatively higher activity in the production and wider diversity
in the number of the bands to various Bb surface proteins than the patients of the control group. These
differences can possibly be considered as a result of the artificial activation of the patients’ immune
response (previously suppressed and/or modulated by chronic Bb infection) while using TOA-free Cat’s
Claw as a powerful immunomodulator and a strong natural herbal antibiotic.
The results of the study demonstrate that the Alternative method of treatment, including the use of
Pentacyclic Alkaloid Chemotype Uncaria tomentosa, is a safe and efficient method for improving the
health and quality of life in patients with Chronic borreliosis, and surpasses the effectiveness of standard
antibiotics for the treatment of this condition.
3
Figure I: Changes in Clinical Symptoms and Rate of Improvement
Experimental and Control Groups
Fatigue
Cognitive Dysfunction
Mean
First
Middle
Last
7.92
3.67
4.17
Improvement rate = 47.4%
Mean
First
Middle
Last
7.25
7.00
5.67
Improvement rate = 21.8%
10
9
8
7
6
5
4
3
2
1
0
Mean
First
Middle
Last
7.50
4.75
3.75
Improvement rate = 50.0%
Muscle Pain
Mean
First
Middle
Last
7.43
3.79
4.29
Improvement rate = 42.3%
Mean
First
Middle
Last
7.24
6.62
5.63
Improvement rate = 25.9%
10
9
8
7
6
5
4
3
2
1
0
Mean
First
Middle
Last
8.25
4.25
3.25
Improvement rate = 60.6%
Joint Pain
First
Middle
Last
7.64
3.82
4.10
Improvement rate = 46.3%
Mean
First
Middle
Last
7.88
7.00
6.13
Improvement rate = 25.0%
10
9
8
7
6
5
4
3
2
1
0
Mean
First
Middle
Last
6.80
3.55
3.45
Improvement rate = 49.3%
Digestive Disturbances
8
Scale (0-10)
4
3
7
6
5
4
3
2
2
1
1
0
Mean
0
First
Middle
Last
7.00
2.00
2.73
Improvement rate = 61.0%
Mean
First
Middle
Last
6.06
5.64
4.06
Improvement rate = 22.5%
10
9
8
7
6
5
4
3
2
1
0
Mean
First
Middle
Last
7.05
3.88
3.60
Improvement rate = 49.0%
Headache
Mean
First
Middle
Last
7.00
2.33
5.33
Improvement rate = 23.8%
Mean
5.20
First
Middle
Last
6.07
5.1
4.97
Improvement rate = 18.6%
Control Group
10
9
8
7
6
5
4
3
2
1
0
Mean
First
Middle
Last
7.25
7.25
7.25
Improvement rate = 0.0%
First
Middle
Last
6.17
6.00
6.17
Improvement rate = 0%
10
9
8
7
6
5
4
3
2
1
0
Mean
Control Group
Scale (0-10)
10
9
8
7
6
5
4
3
2
1
0
Mean
10
9
8
7
6
5
4
3
2
1
0
Experimental Group
Scale (0-10)
10
9
8
7
6
5
4
3
2
1
0
Last
5.40
Sleep Disturbances
Control Group
Scale (0-10)
Scale (0-10)
Experimental Group
Middle
6.50
Control Group
Experimental Group
Scale (0-10)
5
First
Improvement rate = 16.9%
Scale (0-10)
9
8
Scale (0-10)
10
9
6
5.81
Peripheral Neuropathy
Control Group
10
7
10
9
8
7
6
5
4
3
2
1
0
Mean
Scale (0-10)
10
9
8
7
6
5
4
3
2
1
0
Experimental Group
Last
6.17
Control Group
Experimental Group
Scale (0-10)
Scale (0-10)
Scale (0-10)
Mean
Middle
7.00
Limbic Encephalopathy
Control Group
Experimental Group
10
9
8
7
6
5
4
3
2
1
0
First
Improvement rate = 18.2%
Scale (0-10)
10
9
8
7
6
5
4
3
2
1
0
Mean
Experimental Group
Scale (0-10)
Scale (0-10)
10
9
8
7
6
5
4
3
2
1
0
10
9
8
7
6
5
4
3
2
1
0
Memory Impairment
Control Group
Scale (0-10)
Experimental Group
Control Group
Scale (0-10)
10
9
8
7
6
5
4
3
2
1
0
Experimental Group
Scale (0-10)
Scale (0-10)
10
9
8
7
6
5
4
3
2
1
0
Control Group
Scale (0-10)
Experimental Group
First
Middle
Last
8.25
2.25
4.25
Improvement rate = 48.5%
10
9
8
7
6
5
4
3
2
1
0
Mean
First
Middle
Last
5.67
1.50
4.00
Improvement rate = 29.4%
Figure 2: Dynamic of Improvement in Clinical Symptoms
Experimental Group
Cognitive Dysfunction
10
9
9
8
8
7
7
Scale (0-10)
Scale (0-10)
Fatigue
10
6
5
4
3
2
Mean
5
4
3
2
1
0
6
1
1
2
3
4
5
6
7
8
7.92
5.5
5.25
4.75
3.67
3.89
4.36
4.17
0
Mean
1
2
3
4
5
6
7
8
7.5
6.57
5.38
5.88
4.75
2.33
4.69
3.75
Mean
Memory Impairment
Scale (0-10)
Scale (0-10)
Muscle Pain
10
9
8
7
6
5
4
3
2
1
0
1
2
3
4
5
6
7
8
7.43
5.5
5.36
3.93
3.79
4
4.07
4.29
10
9
8
7
6
5
4
3
2
1
0
Mean
1
2
3
4
5
6
7
8
8.25
7.25
6.25
6
4.25
3.33
4.5
3.25
Mean
Limbic Encephalopathy
Scale (0-10)
Scale (0-10)
Joint Pain
10
9
8
7
6
5
4
3
2
1
0
1
2
3
4
5
6
7
8
7.64
5.3
4
4.36
3.82
4.71
4.8
4.1
10
9
8
7
6
5
4
3
2
1
0
Mean
1
2
3
4
5
6
7
8
6.8
4.22
4.7
4.75
3.55
3.13
3.5
3.45
Mean
Peripheral Neuropathy
Scale (0-10)
Scale (0-10)
Digestive Disturbances
10
9
8
7
6
5
4
3
2
1
0
1
2
3
4
5
6
7
8
7
3.45
3.27
3.09
2
3.22
3.45
2.73
10
9
8
7
6
5
4
3
2
1
0
Mean
1
2
3
4
5
6
7
8
7.05
6.08
5.8
3.6
3.88
4
3.97
3.6
Sleep Disturbances
Mean
Scale (0-10)
Scale (0-10)
Headache
10
9
8
7
6
5
4
3
2
1
0
1
2
3
4
5
6
7
8
7
4
5.67
2.67
2.33
3.67
4.5
5.33
10
9
8
7
6
5
4
3
2
1
0
Mean
1
2
3
4
5
6
7
8
8.25
4
3.25
3.5
2.25
2
3.5
4.25
Figure 3: SF8 Survey Data, First and Last Visits
Experimental and Control Groups
Patients' Health in General Compared to
1 Year Ago
100
100
80
80
80
40
20
60
40
20
Percent of Patients
60
Control Group
100
Percent of Patients
80
Experimental Group
Control Group
Percent of Patients
60
40
60
40
20
20
0
0
0
Visit
First
Last
Somewhat Worse
Visit
First
Last
Somewhat Worse
About the Same
About the Same
0
Visit
Quite a Lot
Better Now
Better Now
First
Patients' Bodily Pain in the Past 4 Weeks
Experimental Group
Last
Somewhat
First
Visit
Quite a Lot
Very Little
Experimental Group
80
80
80
40
20
40
20
60
40
20
0
0
Visit
First
Severe
Last
Moderate
First
Severe
Moderate
Last
Mild
Low
Moderate
Low
High
Experimental Group
80
80
40
20
40
20
0
First
Extreme
Last
Moderate
Visit
Slight
First
Extreme
Moderate
Last
60
40
20
0
Visit
First
Slight
Severe
Control Group
80
80
80
20
Percent of Patients
100
Percent of Patients
100
40
60
40
20
First
Quite a lot
Some
Last
A little
Visit
Moderate
40
20
0
Visit
First
Quite a lot
Some
First
Low
Last
Severe
Moderate
Low
Control Group
100
60
40
Last
A little
Visit
80
60
40
20
20
0
0
0
0
Last
60
Experimental Group
100
60
High
Impact of Patients' Emotional or Physical Health
Problems on Their Social Activities
Difficulty Doing Daily Work
Experimental Group
Percent of Patients
100
Percent of Patients
100
80
60
Last
Moderate
Control Group
100
60
First
Visit
80
Percent of Patients
Percent of Patients
Last
Impact of Patients' Emotional Problems on
Their Daily Living
Control Group
0
Percent of Patients
20
100
Visit
Visit
40
0
First
Visit
Severity of Patients' Emotional Problems
in the past 4 Weeks
Experimental Group
60
0
Visit
Mild
Percent of Patients
80
Percent of Patients
100
Percent of Patients
100
Percent of Patients
100
60
Very Little
Control Group
100
60
Last
Somewhat
Patients' Energy Level in the Past 4 Weeks
Control Group
Percent of Patients
Percent of Patients
Experimental Group
100
Physical Activities Limited by Physical
Health Problems
First
Severe
Last
Moderate
A little
Visit
First
Severe
Moderate
Last
A little
Figure 4: SF-8 Survey of Quality of Life Indicators
Experimental Group
Patients' Health in General Compared to
1 Year Ago
100
Physical
Activities Limited by
100
90
90
80
80
Percent of Patients
Percent of Patients
Physical Activities Limited by Physical
Health Problems
70
60
50
40
30
70
60
50
40
30
20
20
10
10
0
0
1
Visit
2
3
Somewhat Worse
4
5
6
About the Same
7
8
1
Visit
Better Now
80
Percent of Patients
90
80
Percent of Patients
100
90
70
60
50
40
30
Somewhat
7
8
Very Little
50
40
30
20
10
10
0
2
3
Severe
4
5
Moderate
6
7
8
1
Visit
2
Mild
3
Low
Severity of Patients' Emotional Problems
in the Past 4 Weeks
90
80
80
Percent of Patients
100
90
70
60
50
40
30
4
5
Moderate
6
7
8
High
Impact of Patients' Emotional Problems on
Their Daily Activities
100
Percent of Patients
6
60
20
1
70
60
50
40
30
20
20
10
10
0
0
1
2
3
Extreme
4
5
Moderate
6
7
8
1
Visit
2
3
Severe
Slight
4
5
Moderate
6
7
8
Low
Impact of Patients' Emotional or Physical
Health Problems on Their Social Activities
Difficulty Doing Daily Work
100
90
90
80
80
Percent of Patients
100
Percent of Patients
5
70
0
70
60
50
40
30
70
60
50
40
30
20
20
10
10
0
Visit
4
Patients' Energy Level in the Past 4 Weeks
100
Visit
3
Quite a Lot
Patients' Bodily Pain in the Past 4 Weeks
Visit
2
0
1
2
3
Quite a lot
4
Some
5
6
A little
7
8
Visit
1
2
3
Severe
4
Moderate
5
6
A little
7
8