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The effects of Cystone therapy were studied in this comparative trial
on 297 patients complaining principally of burning micturition and
frequency of micturition. Twenty two cases had some complications
like kidney and bladder stones.
The study was in 2 phases : in the first the efficacy of therapy and
in the second the efficacy of therapy on the rate of recurrence of
infection. In the former it was observed that when Cystone was added
to the usual alkalizer + specific antibiotic regimen, relief from
symptoms was quicker than with alkalizer + specific antibiotic.
In the second phase the incidence of recurrence of infection and side-effects
was much less with the addition of Cystone to the usual regimen than
with alkalizer + specific antibiotic. It took longer for the urine
to return to normal with the latter regimen.
Urinary tract infections
are quite frequent and are difficult to eradicate (Freedman 1971,
Stanley 1972, Brumfitt et al. 1973). Some workers impressed
by the frequency with which chronic, symptomless urinary tract infections
may present after an acute infection with serious and even fatal
consequences, would advise maintenance therapy of antibacterial
agents at low dose for as long as 3 months (Laurence, 1973, Bailey
1971). Gut bacteria being the principal cause of urinary tract infection,
if antimicrobials are used for long periods, the result is disturbed
bacterial flora in the colon and drug resistance (Freedman and Epstein
1977).
In the present study we
have explored the role of Cystone as :
|
1.
|
An adjuvant to
antimicrobial therapy in urinary tract infection (UTI).
|
|
2.
|
Maintenance
therapy once the acute phase of urinary tract infection has
subsided, and
|
|
3.
|
Chemoprophylaxis
of urinary tract infection.
|
Cystone was chosen
because it has proven its efficacy in burning micturition and acute
urinary tract infection (Garg and Singh 1985, Prasad 1980) and been
used for long-term therapy (for four to six months and even longer)
in urolithiasis and various other urinary disorders (Chaudhury 1982,
Chatterji 1982) without significant side-effects.
The present study was
done in 297 patients of either sex over a period of about 2 years,
complaining of burning and frequency of micturition. Before starting
therapy a urine sample was collected under strict sterile conditions.
Immediately a portion of the sample was used for microscopic examination.
If this showed presence of pus cells in increased number, then the
sample was sent for culture and sensitivity report. The specific
antimicrobial drug was used depending upon the test report.
A study of the clinical
characteristics of the patients with UTI revealed the following
:
| a) |
Burning
micturition alone |
80 cases |
| b) |
Frequency
of micturition alone |
67 cases |
| c) |
Fever
alone |
32 cases |
| d) |
Burning
micturition plus frequency of micturition |
63 cases |
| e) |
Burning
micturition plus frequency of micturition plus fever |
55 cases |
| |
Total
: |
297 cases |
Further, 22 cases of UTI were complicated
as follows :
| a) |
Urethral
dilatation for stricture urethra |
2 cases |
| b) |
Nephrolithiasis |
5 cases |
| c) |
Ureteric
stone |
1 case |
| d) |
Cystolithiasis |
2 cases |
| e) |
Catheterisation
following surgery |
6 cases |
| f) |
Catheterisation
following neurovascular accident |
1 case |
| g) |
Associated
with diabetes mellitus |
5 cases |
| |
Total
: |
22 cases |
The remaining 275 cases
of UTI were without complications. Of the 297 UTI cases, 251 reported
for the first time, while the remaining 46 were having recurrent
infection.
The study was carried
out in two parts : in the first the efficacy of therapy, and in
the second its efficacy on the rate of recurrence of infection and
side-effects, if any, were assessed.
Part 1
Out of 297 patients, 91 patients who showed increase
of only epithelial cells in their urine were classified in group
A. The remaining 206 who had increased number of pus cells were
divided into Group B and C with 103 in each group.
Group A was given Cystone, 2 tabs. t.d.s. plus
an alkalizer, 2 tsp. t.d.s. for 10 days. Pending culture and sensitivity
reports, patients of Groups B and C, received Cystone 2 tablets
t.d.s. plus alkalizer, 2 tsp. t.d.s. and alkalizer only, 2 tsp.
t.d.s. respectively, for the same duration (10 days). On receiving
the culture and sensitivity reports, the appropriate antibiotic
was added to patients of Group B (Cystone and alkalizer) and Group
C (alkalizer only), till such time as the pus cells decreased to
normal limits. Microscopic examination of the urine was repeated
after every 3 days and the duration of antimicrobial therapy recorded.
Part-2
To check recurrence of infection, if any, maintenance
therapy for 3 months was administered to the 206 patients who had
shown positive urine culture. They were divided into 3 subgroups
viz. Group I, II and III. Group I (68 patients) received only antimicrobial
therapy in low doses. Group II (69 patients) received Cystone with
an antimicrobial drug, while Group III (69 patients) received only
Cystone as maintenance therapy. Any recurrence of urinary symptoms
was recorded and in that event microscopic examination of the urine
was repeated.
Part 1
It is evident from Table 1 that Group A (91) patients,
with increased frequency and burning micturition but non-infective,
showing only an increase in number of epithelial cells, did not
require any antimicrobial therapy and were relieved of their symptoms
by Cystone plus an alkalizer.
|
Table 1 : Group distribution
of patients
|
|
Group
|
No. of patients
|
Microscopic
examination of urine
|
Drugs given
|
Results
|
Side effects
|
A
(Cystone + alkalizer) |
91
|
Increased
epithelial cells |
Cystone
2 tabs. t.d.s. for 10 days + alkalizer 2 tsp. t.d.s. |
Relieved
of symptoms |
Nil |
B
(Cystone + alkalizer + antibiotic) |
103
|
Incrased
pus cells |
Cystone
2 tabs. t.d.s. + alkalizer 2 tsp. t.d.s. + antimicrobial for
6-9 days |
Relieved
of symptoms |
Occasional
dyspepsia diarrhoea flatulence |
C
(Alkalizer + antibiotic) |
103
|
Increased
pus cells |
Alkalizer
2 tsp. t.d.s. + antimicrobial for 9-12 days |
Relieved
for symptoms |
Occasional
dyspepsia diarrhoea flatulence |
Group B patients (Cystone
+ alkalizer + specific antimicrobial) were relieved of their symptoms
and acute infection in 6-9 days, while Group C patients (alkalizer
+ specific antimicrobial) took 9-12 days. Thus, the addition of
Cystone to the usual antimicrobial plus alkalizer regimen for urinary
tract infection, reduces the duration of the acute phase of infection
and symptoms, and the cost of antimicrobial therapy by about 25%.
From Table 2 it can
be seen that most of the patients (53 out of 103) of Group B (Cystone
+ alkalizer + specific antimicrobial) were relieved of their infection
in 6 days, while only 39 out of 103 Group C patients (alkalizer+specific
antimicrobial) took 9 days.
The total duration
of antimicrobial therapy for curing the infection was more (12 days)
in Group C patients (alkalizer + specific antimicrobial), while
it was only 9 days. In Group B patients (Cystone + alkalizer + specific
antimicrobial). So the addition of Cystone to the usual regimen
for urinary tract infections (antimicrobial + alkalizer) reduces
the duration and cost of therapy.
|
Table 2 : Showing the number
of urine examinations and days needed for the pus cells to
drop within normal limits
|
| Group
B (Cystone + alkalizer + antimicrobial) |
|
No. of examinations
|
Days needed
|
No. of patients
|
|
One
|
3
|
21
|
|
Two
|
6
|
53
|
|
Three
|
9
|
29
|
| |
Total
|
103
|
| Group
C (alkalizer + antimicrobial) |
|
No. of examinations
|
Days needed
|
No. of patients
|
|
One
|
3
|
16
|
|
Two
|
6
|
24
|
|
Three
|
9
|
39
|
|
Four
|
12
|
24
|
| |
Total
|
103
|
Part 2
As far as maintenance
therapy is concerned, Table 3 reveals that Cystone alone proved
superior (with recurrence in only 5 patients and side effects in
7), than both low-dose antimicrobial therapy (recurrence in 16 patients
and side-effects in the majority) and antimicrobial plus Cystone
therapy (recurrence in 2 patients and side-effects in the majority).
|
Table 3 : Results of various
regimens in maintenance therapy
|
|
Group
|
No. of patients
|
Drug regimen
|
Results
|
|
I
|
68
|
Antimicrobial |
Recurrence
of symptoms in 16 patients
Dyspepsia in 26 patients
Flatulence in 39 patients
Diarrhoea in 13 patients |
|
II
|
69
|
Cystone
+ antimicrobial |
Recurrence
of symptoms in 2 patients
Dyspepsia in 24 patients
Flatulence in 43 patients
Diarrhoea in 12 patients |
|
III
|
69
|
Cystone |
Recurrence
of symptoms in 5 patients
Dyspepsia in 3 patients
Flatulence in 4 patients. |
The addition of Cystone
to the usual regimen for urinary tract infection (antimicrobial
+ alkalizer) reduces both the duration and cost of therapy.
For maintenance therapy,
Cystone appears ideal as chances of recurrence of symptoms are very
few, with least side-effects. At the same time the cost of maintenance
therapy is much lower when compared to low-dose antimicrobial therapy.
- Bailey, R.R.: Prevention of urinary tract infection with low
dose nitrofurantoin. Lancet (1971): 2, 1112.
- Brumfitt, W. and Asscher, A.W.: Urinary tract infection. In:
Harrisons Principles of Internal Medicine, International
Student Ed., 8th Edn. McGraw-Hill Kogakusha Ltd. A Blakiston Publication,
Tokyo.
- Chatterjee, B.N.: Role of Cystone
in various urinary disorders. Probe (1982): 1, 27.
- Freedman, L.R.: Urinary tract infection,
pyelonephritis and other forms of chronic interstitial nephritis.
In: Diseases of Kidney, 2nd Ed. MB Strauss and LG Wett, Boston:
Little Brown (1971).
- Freedman, L.R. and Epstein, F.H.:
Urinary tract infection: Pyelonephritis and related conditions.
In : Harrisons Principles of Internal Medicine, Int. Stud.
Ed. 8th Ed. McGraw Hill Kogakusha Ltd., A Blakiston Pub Tokyo.
- Garg, S.K. and Singh, R.C.: Role
of Cystone in burning micturition. Probe (1985): 2, 119.
- Khan, Chaudhury: Efficacy of Cystone
in urolithiasis. Capsule (1983): 2, 37.
- Laurence, D.R.: Chemotherapy of
individual diseases. In Clinical Pharmacology, 4th Ed., pp. 8-12,
(1973), ELBL and Churchill, Edinburg, London and New York.
- Prasad, R.R.: The role of Cystone
in urinary tract infections. Ind. Practit. (1980): 12,
685.
- Standy, T.A.: Urinary infections,
Williams and Wilkins, Baltimore (1972).
- Symposium on urinary infections
(1975), Int. Suppl. 4. In Harrisons Principles of Internal
Medicine Int. Stud. Ed. 8th Ed. McGraw Hill Kogakusha Ltd. A Blakiston
Pub Tokyo.
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