Effects
of Vital Cell in the Treatment of Hyperlipidemia
Yang
Ming-Jun and Li Chao-Min
The Affiliated Hospital of Chengdu University of Chinese Medicine
and Pharmacology
We describe the results of
a study conducted on the traditional Chinese formula Vital
Cell in the treatment of hyperlipidemia. The research was
carried out from September 1996 through December 1996.
Patient
Selection and Criteria
Patients were considered for
the study if they met the traditional Chinese syndrome pattern
of Qi/blood stasis accompanied by either Spleen and Kidney
Yang deficiency or Liver and Kidney Yin deficiency, and by
the biomedical diagnosis of primary hyperlipidemia with the
following serum cholesterol and triglyceride levels (normal
diet, 2 fasting appraisals completed at least 2 weeks apart):
total serum cholesterol level (TCL) >6.5 mmol/L, triglyceride
levels >1.58mmol/L, and/or high density lipoproteins (HDL)
<1.04mmol/L (males) and <1.17 mmol/L (females).
Patients who presented the
following were not accepted into the study: age <45 and
>80 years; severe primary cardiovascular, liver, kidney,
and/or endocrine disease; hypersensitivity to Vital Cell;
pregnant or breastfeeding; and hyperlipidemia due to nephrotic
syndrome, hypothyroidism, diabetes mellitus, acute or chronic
liver and/or gallbladder disease, or to certain pharmacologic
agents.
Methods
Sixty patients were enrolled
in the study. Forty-four were inpatients and 16 were outpatients.
There were 31 males and 29 females; age range was 45-65 years;
and duration of condition ranged between 1 and 10+ years.
The 60 patients were randomly divided into 2 groups of 30
each.
The following evaluations were
each conducted once, prior to start of the study: total serum
cholesterol, triglyceride levels, high density lipoprotein
(HDL), and levels of the aging biomarkers, superoxide dismutase
(SOD) and lipid peroxidase (LPO). Subjects also underwent
a general physical examination, which included analyses of
the blood, urine, and stool; an electrocardiogram; evaluations
of liver and kidney functions.
The two groups each received
the following regimen over the course of 3 months:
Treatment group:
Oral administration of Vital Cell in tablet form, 3 pills,
twice daily.
Control group:
Oral administration of Chun Bao (CB; a traditional Chinese
herbal formula), 3 pills twice daily.
Subjects were told to not take
any other herbal or pharmaceutical medications during the
3-month study period.
Results
At the conclusion of the study
period, all subjects in both groups again underwent laboratory
evaluations to determine any changes in the biofactors associated
with hyperlipidemia.
Total Cholesterol Levels
Total cholesterol levels in both the treatment and
control groups were reduced (Table 1). However, Vital Cell
was found to reduce total cholesterol levels more significantly
than CB (t = 6.77; p < 0.01). Moreover, within the Vital
Cell group, total cholesterol levels were found to be markedly
reduced when the before and after treatment levels were compared
(t = 11.14; p <0.01).
Triglyceride Levels
Triglyceride levels in both the Vital Cell and CB groups were
reduced (Table 2). Again, as with total cholesterol levels,
Vital Cell reduced triglyceride levels more significantly
than CB (t = 4.07; p < 0.01). Within the Vital Cell group,
the triglyceride levels were markedly reduced when the before
and after treatment levels were compared (t = 10.80; p <
0.01).
High Density Lipoprotein
Levels
HDL levels rose in both the Vital Cell and CB groups (Table
3). Vital Cell raised HDL levels more significantly than CB
(t = 2.27; p < 0.05), and within the Vital Cell group,
the HDL levels rose markedly following treatment (t = 4.45;
p < 0.01).
Lipid Peroxidase and
Superoxide Dismutase Levels
The aging biomarkers LPO and SOD were altered as well (Tables
4, 5). In comparing the decrease in LPO levels of the Vital
Cell and CB groups, the difference between the two groups
was not significant (t = 1.64; p < 0.05). However, the
decrease within the Vital Cell group was markedly significant
(t = 8.91; p < 0.01) (Table 4).
Comparison of the SOD levels
between the Vital Cell and CB groups found that the difference
in increase between the two groups was not significant (t
= 1; p < 0.05). The increase was, however, markedly significant
when the before and after treatment SOD levels were compared
within the Vital Cell group (t = 10.44; p < 0.01) (Table
5).
Discussion
and Conclusions
The study demonstrated that
Vital Cell is capable of reducing serum cholesterol and triglyceride
levels and of elevating HDL levels. Of interest is that this
formula appears to have modulating effects on the aging biomarkers
of superoxide dismutase and lipid peroxidase, a phenomenon
that warrants further research.
All subjects in this study
were over 45 years of age and were experiencing symptoms related
to aging such as decreased libido and sexual function, overactive
bladder, aversion to cold, forgetfulness, hair loss, and low
back pain. At the conclusion of the study period, all subjects
in the Vital Cell group indicated that such symptoms were
either greatly improved or completely relieved.
No untoward side effects were
reported by any of the participants in the Vital Cell group. |
