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CLINICAL TRIAL
Effect of Fuzheng (Supporting
Vital Qi) Compound on Fatigue
John Pittman, et al
Abstract: A
60-day clinical case study on the therapeutic effect of Leucozepin® (LP), a natural Fuzheng (Supporting Vital Qi) compound, on
fatigue was evaluated in 30 patients. The results showed that the LP compound was able to alleviate fatigue
associated with cancer, anemia, leucopenia, HIV, MS, Lyme disease and other
chronic diseases. Among the thirty cases, a reduction of fatigue was reported in 28 patients after taking LP, representing
a significant effective rate of 93.4%. The therapeutic effect on the symptoms of poor appetite, nausea,
vomiting and insomnia was also assessed, resulting in a total effective rate of
92%, 87.5% and 76.9% respectively. Of the
30 patients, 28 patients reported a much better quality of life after LP treatment. The
results indicated that the LP compound had hematopoietic
as well as immune-modulating functions.
METHODS & MATERIALS
Introduction
This was a 60-day non-randomized clinical
study to assess the efficacy of LP on fatigue and patient’s quality of life via clinical observation
and questionnaires.
Supply
Leucozepin® (LP), a Fuzheng (Supporting Vital Qi) extract formula of
traditional Chinese medicine, was provided by LIFEnhance, Inc. LP is a natural proprietary
extract consisting of 15 carefully selected
herbs. Ingredients include: Huang Qi (Radix Astragali), Ji Xue Teng (Radix et
Caulis Jixueteng), Ling Zhi (Ganoderma Lucidum), Dang Shen (Radix Codonopsis
Pilosulae), Dang Gui (Radix Angelicae Sinensis), Shu Di Huang (Radix Rehmanniae
glutinosa Conquitae), Huang Jing (Rhizoma Polygonati), Bu Gu Zhi (Fructus
Psoralae Corylifoliae), Nu Zhen Zi (Fructus Ligustri Lucidi), Bai Zhu (Rhizoma
Atractylodis Macrocephalae), Fu Ling (Sclerotium Podiae Cocos), Gou Qi Zi
(Frutcus Lycii Chinensis), Chen Pi (Pericarpium Citri Reticulatae), Shi Hu
(Herba Dendrobi) and Gan Cao (Radix Glycyrrhizae Uralensis). The supply
included six boxes (10 packets/20 capsules per box) per patient for the duration of sixty days. Patients took two 500mg
capsules after breakfast and one 20-gram packet of the powder in the evening.
Subjects
Thirty patients were selected based
on the following criteria: Patients suffered from fatigue related with one or
more of the following: poor nutrition intake, anemia or leucopenia, GI Disorder,
and other severe diseases. Patients with the following situations were
excluded: bleeding, diabetes with infection, allergy to any of the ingredients
in the LP formula, pregnant or breast feeding.
Patient population
All 30 patients suffered from
fatigue of varying degrees: 11 patients
associated with cancer and/or cancer treatment, 5 patients associated with low
RBC and anemia, 5 patients associated with low WBC, 2 patients associated with
HIV and 3 patients associated with Lyme disease. The rest had fatigue related
with other diseases such as GI disturbance, immune deficiency, diabetes,
chronic sinusitis, multiple sclerosis, chronic bronchitis, yeast infection,
uterine fibromyoma and multiple myeloma.
Procedures
Patients had to complete three
mandatory office visits during the clinical study: initial (screen) visit,
second visit after 30 days and third visit after 60 days. Patients were instructed to fill out three
questionnaires, which constituted the partial efficacy analysis, during each
visit.
The supply of LP was prescribed to the patient
at the initial and 2nd visit.
The
tools used for the evaluation were the Questionnaires for the patients and the
Study Report Form recorded by the practitioners. The final evaluation was
primarily based on the practitioner’s records. The Questionnaire was comprised
of six statements in terms of fatigue, poor appetite, nausea/vomiting,
insomnia, and quality of life. On a scale from 0 to 4, with 0 being the least
true and 4 the most true, the patients were required to circle the number corresponding
to severity. The Study Report Form was
for the practitioner to record the patient’s progress based on his/her
diagnosis.
Criterion of analysis
Symptom
Improvement Analysis was based on the practitioner’s records on the Study
Report Form and the Questionnaire--pre and post comparison on energy level,
fatigue, poor appetite, nausea/vomiting, insomnia, overall quality of life,
and/or blood test results (if available).
RESULTS
Effects on fatigue
Reduction of fatigue can be seen
from Table 1. Compared to 63.4% of patients with severe and moderate severe
fatigue before taking LP, the percentage dropped to 20% in 30 days and 0% in 60
days, achieving a total response rate of 93.4% (see Tables 5.1 and 5.2). Figure
1 shows the shifting trend from the right “Severe fatigue” towards the left “No
fatigue”.
Table 1: Comparison
of Pre & Post LP Treatment in 30 Patients
* PT: Patients
Figure 1: Effect on Fatigue
Effects on poor appetite
Table 2 shows the improvement of
appetite in 36% of patients 30 days after taking LP. Significant improvement
can be seen after 60 days with a total response rate of 92% (see Table 5.2).
See Figure 2 for a visual representation of the change in patients’ conditions.
Before LP the majority of patients fell under Moderate Severe, shifting to Mild
and Good Appetite after 30 days. There was a greater shift towards Good
Appetite after 60 days.
Table 2: Comparison of Pre &
Post LP Treatment in 25 Patients
Figure 2: Effect on Poor Appetite
Effects on nausea and/or vomiting
Table
3 shows the detailed changes in the number of patients under each category.
Before LP treatment there were 6 people, representing 37.5%, classified as
having moderate severe and severe nausea and vomiting. 30 days afterwards the
percentage dropped to 6.2% with a total response rate of 75% after 30
days. The rate increased to 87.5% after
60 days (See Table 5.1 and Table 5.2). Figure 3 shows a slight shifting trend
after 30 days but a huge jump after 60 days towards the Y axis. The change
after 60 days is significant with 68.8% of patients reporting “No Nausea and/
or Vomiting”.
Table 3: Comparison of Pre & Post LP Treatment
in 16 Patients
Figure 3: Effect on Nausea/Vomiting
Effects on insomnia
Total response rate for insomnia
was 65.4% after 30 days and 76.9% after 60 days (See Tables 5.1 and 5.2). Table
4 shows that compared to 57.7% of patients with Severe and Moderate Severe
insomnia before taking LP, there were less than 8% remaining in that category
after 60 days. Figure 4 shows the shifting trend from the majority experiencing
Severe Insomnia to later experiencing No Insomnia.
Table 4: Comparison
of Pre & Post LP Treatment in 26 Patients
Figure 4: Effect on Insomnia
Recording the blood work depended
on availability of these reports. Blood work pre and post treatment was
collected from seven patients with low WBC and/or RBC induced by
chemo-radiation therapy. Almost all of
these patients reported that their quality of life improved after taking LP. LP
helped in the recovery of blood cell counts, the maintenance of an adequate
blood level and the reduction of the side effects from the treatment. The
following table is a summary of the blood cell counts of the seven patients.
Table 5 Comparison
of Blood Count Before & After Taking LP
Note: All seven patients were undergoing
chemotherapy at the time. RBC counts increased after LP. Four out of seven
patients had decreased WBC counts but three of them remained in the normal
range.
Effect on quality of life
28 out of the total 30 patients
expressed that their overall quality of life improved to varying degrees after
taking LP. This improvement was a result of the alleviation of fatigue reported
among 93.4% of the patients. It was also due to the reduction and/or
disappearance of other symptoms: poor appetite, nausea, vomiting and
insomnia.
Other effects
The immune modulating and
anti-bacteria effects were also reported. One patient with immune deficiency
did not suffer from any infections and her vaginal yeast infection disappeared
completely during the LP treatment period. Another case worth mentioning was
that of a patient who used to rely on antibiotics and was able to be off them
while taking LP.
Total Effectiveness
1. Complete Response (CR): Greater than 60% disappearance
of one or more targeted symptoms during treatment (changes in terms of
improvement on the scales of the Questionnaires, at least 3 levels).
2. Excellent Response (ER): Greater than 40% decrease
(changes in terms of improvement on the scales of the Questionnaires, at least
2 levels) in one or more targeted symptoms.
3. Good Response (GR): Greater than 20% decrease (changes
in terms of improvement on the scales of the Questionnaires, at least 1 level)
in one or more targeted symptoms.
4. No Response (NR): Either no changes or the changes
were smaller than 20% in terms of improvement in one or more targeted symptoms.
Table 5.1 Rate of
Response After 30 Days
Note: Total Effectiveness Rate
(TER) =CR+ER+GR
Table 5.2 Rate of
Response After 60 Days
Note: Total Effectiveness Rate (TER)
= CR+ER+GR
DISCUSSION AND CONCLUSION
Fuzheng is one of the eight
commonly used therapies in Traditional Chinese Medicine (TCM) and has been used
widely in
For instance, Huang Qi (Astragalus membranaceus), traditionally used as a tonic, has been shown to restore a damaged immune
system. Specifically it is used for
recovery after surgery, chemotherapy and radiation. Evidence also shows administration
of Astragalus was associated with an obvious rise in white blood cell (WBC)
counts in 115 patients with leucopenia (5). Nu Zhen Zi (Ligustrum lucidum) is
a powerful immune enhancing herb as well. It is commonly used as the supportive treatment for patients with
neutropenia due to chemotherapy and radiation treatment (6). Ling
Zhi (Ganoderma lucidum), with
mushroom polysaccharide, has immunostimulating, modulating and
antitumor effects. Administration of Reishi mushroom has been reported to
increase monocytes, macrophages and T-cells as well as production of cytokine,
interleukin, tumor-necrosis-factor and interferon (7).
The primary purpose of this study was to evaluate the efficacy of LP in relieving
fatigue and fatigue-related symptoms. The 30 patients were all diagnosed with varying degrees (mild, moderate to severe) associated with cancer, leucopenia, low RBC, anemia, Lyme and/or
other chronic diseases. They received 60 days’ LP treatment at the six
clinics/centers. The results were recorded by comparing the pre and post LP
treatments. Compared to pre-LP, noticeable improvement of fatigue was shown
after 30 days of taking LP with a total response rate of 80% (refer to Table
5.1). The rate increased to 93.4% (refer to Table 5.2) after 60 days of
LP. The efficacy of LP on fatigue was also proven from
the changes in the blood cell counts among the cancer patients. These results suggest that LP may have
hematopoietic, immunostimulating and leukocytogenic functions and ability to
alleviate the suppression of bone marrow production as in the case of low WBC,
RBC and anemia. Similarly, Zhang XQ et al (8), in a clinical study on treatment of chemo-or radiotherapy induced
leucopenia with Fuzheng compound reported the normalization of white blood cell
count in 37 cases. The improvement of
the clinical symptoms such as poor appetite, nausea/vomiting and insomnia
proves that LP has a holistic effect in enhancing the patients’ quality of
life, which was similar to previous studies of Fuzheng therapy in Traditional
Chinese Medicine. In summary, LP compound
may naturally strengthen the immune system and
modulate the hematopoiesis level. It can be an
effective intervention for the side effects of cancer treatment such as
chemotherapy-induced fatigue, nausea, vomiting and insomnia. LP may also help improve cancer
treatment fulfillment rate. Despite the great results of the study, there are
some limitations. Many factors could have affected the accuracy of the results.
This was not a double blind clinical trial and the collection of blood work was
optional. Therefore the results were primarily based on the patients’ feelings
and the practitioners’ observations. Although seven cancer patients’ blood work
was collected, the sample size was too small to be conclusive. In addition, there could be other factors
that might have skewed the results, such as the kind of medications the
patients were taking while participating in the study. Initially the case study
enrolled 33 patients. Three patients dropped. One quit the project after 20
days due to complications with irritable bowel syndrome (IBS). One case with
Lyme disease quit due to complications with the treatment for Lyme disease. The
other one stopped the treatment with LP because of other complications and a
change of travel plans. The exact reasons are yet to be found.
To further assess the mechanism
and efficacy of LP in
a more controlled way, a collaboration between the manufacturer of LP and the
REFERENCES
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Shi-quan-da-bu-tan SQT. A potent Chinese biological response modifier in cancer
immunotherapy, potentiation and detoxification of anticancer drugs, Methods
Find Exp Clinic Pharmacol, 1992 Nov; 14(9);725-36
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Chinese and Western Medicine, 1995 Aug.; 15(8):462-4
6. Pharmacology and Applications
of Chinese Herbs (Chinese), People’s Publishing House, 1983
7. Sheng-Yuan
Wang, et al, The anti-tumor effect of Gandoderma
Lucidum is mediated by Cytokines released from activated macrophages and T
lymphocyte, International Journal of Cancer,
1997 Mar17;70(6):699-705
8. Zhang XQ, Liu SJ, Pan XY,
Clinical study on treatment of chemo-or radiotherapy induced leucopenia with
fuzheng compound. Chinese Journal of Integrated Traditional Medicine, 1996;
Jan; 16
About the Authors: The trial was completed by John Pittman, John Casey,
Cathy Liu, Kaixun Liu, Shouhua Xia and Chaohui Zhang. John Pittman, M.D., is from
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