18
Clinical insight
P R O B E
• V o l . L I I I • N o . 3 • A p r – J u n 2 0 1 4
of medical therapy for thousands
of years, especially in Eastern
civilizations.
55
Use of medicinal plants
as a source of relief and cure from
various illness is as old as humankind
itself. Even today, medicinal plants
provide a cheap source of drugs for
majority of the world’s population.
Plants have provided and will
continue to provide not only directly
usable drugs, but also a great variety
of chemical compounds that can
be used as starting points for the
synthesis of new drugs with improved
pharmacological properties.
57
World Health Organization has
also emphasized development and
utilization of herbal drugs and
traditional medicines for the benefit
of the world population, in terms
of cost effectiveness and side effects
of the drugs. The organization has
also estimated that about 80% of the
population living in the developing
countries relies on traditional
medicine for their healthcare needs.
58
In India, such systems offer excellent
remedies for gastrointestinal,
cardiovascular and nervous disorders,
tested through many centuries.
59,60
Analysis of natural medical substances
in use in the medieval Levant showed
81.8% predominance of plant-
based substances.
61
Although the
complete mechanism of action of each
remedy is lacking, again plant-based
phytotherapeutic agents represent the
majority used in medicine and most
of these plant-based substances have
been shown to be effective at different
stages of stone pathophysiology.
Currently, known extracts exert their
antilithogenic properties by altering
the ionic composition of urine, for
example, decreasing the calcium
ion concentration or increasing
magnesium and citrate excretion.
These remedies can also express
diuretic activity or they contain
saponins that can disaggregate
suspensions of mucoproteins,
which are actually promoters of the
crystallization process.
55
Cystone is a herbomineral
formulation, designed and developed
for the management of urolithiasis
or renal calculi. This product came
into existence in 1943 and since
then this product has been in use all
over the world for the management
of urolithiasis and UTI. In studies
conducted till date, Cystone has
proven to be significantly effective
(80%) in patients of urolithiasis.
In the present study, clinical trials
and their details were tabulated and
analyzed statistically. In case of all
or none phenomenon (resolved and
unresolved), Fisher exact test has
been utilized. In case of within the
group comparison (before and after
drug therapy in the same patients),
Student
t
test has been employed. In
case of comparison between different
intervals, repeated measures of
ANOVA test has been employed for
meta-analysis. Statistical significance
or statistical difference depends upon
a number of factors including the
population size. Some of the clinical
trials of Cystone have a population
size, which helps to make clear
differentiation. On the other hand,
there are some trials where study
population of patients could have been
more so that the statistical significance
would have been achieved. None of
the clinical trials were conducted to
evaluate the relationship between
Cystone’s efficacy, dosage, and
dosage regime.
The various studies of Cystone in
urolithiasis can be broadly categorized
into controlled and uncontrolled
studies. The number of uncontrolled
studies is definitely more as compared
to controlled studies, especially the
studies carried out before 1995.
Nonrandomized studies (controlled,
uncontrolled, case reports, and cross-
sectional surveys) confirm the finding
of a systematic review of randomized
trials. They also provide information
on long-term effects, prognostic
factors, and adverse effects. While
these may not be conclusive, they can
provide useful summaries of the state
of knowledge.
62,63
However, efforts
were made to document the efficacy
of Cystone by averaging different
clinical trials.
64
Even in controlled
studies, comparisons have been made
with respect to different modalities
like forced diuresis, antispasmodics,
etc. The number of uncontrolled
(open trial) and controlled trials of
Cystone in urolithiasis was 23 and 8,
in burning micturition it was 2 and
1, and in bacteriuria/pus cells it was
6 and 5, respectively. The placebo-
controlled clinical trials are very few.
Nevertheless, an overview of these
clinical trials indicates that Cystone
is efficacious in the management of
urolithiasis, especially when the site of
urinary stone is ureter.
The results obtained in urolithiasis are
better as compared to nephrolithiasis.
Few of the studies have evaluated
the efficacy of Cystone in pediatric
population and stone formers. A study
on pediatric urolithiasis, which was a
double-blind placebo controlled study,
involved 87 patients, the duration of
treatment being 4 months. This study
indicated significant symptomatic
relief in patients of Cystone group
along with significant reduction in
24-hour urinary excretion of calcium,
magnesium, phosphorus, etc.
This analysis also indicates safety
profile of Cystone. The adverse effects
have been dyspepsia, flatulence and
gastric irritation, which did not
necessitate withdrawal of the drug.
None of the studies have aimed to
describe the mechanism of activity
of Cystone.
Karamakar D, et al.
Meta-analysis of Efficacy and Safety Studies of Cystone
