(a) Renal Stones: Out of 4 cases, after 2 months of Cystone therapy to each of them, the decrease in size of the stone was significant in 3 of them where the stone was reduced to ½ to 1/3rd of the original radiological size. The 4th patient showed no progress and Cystone administration was stopped. When 2 months of Cystone administration did not show any further decrease in stone size for reasons still unexplainable, the therapy was abandoned after the 4th month.
(b) Ureteric Stones: Out of 26 cases of ureteric stones there were 20 males and 6 females, all ranging in the age group of 21 to 45 years. The sizes of the stones varied from 0.2 cm to 0.9 cm in different cases. Table 1 shows the number of cases in relation to size of the stone and the time taken to expel these stones.
The expulsion of ureteric stones in 24 out of 26 carefully selected cases following Cystone therapy is a highly significant observation in the present series. Besides this Cystone helped in clearance of
crystalluria in 13 out of 14 cases of calcium oxalate crystalluria cases. These observations assume still more significance in the light of the fact that the modern system of medicine has yet not been able to provide a safe and effective therapy of these day-to-day problems. Therefore, Cystone, an indigenous drug, deserves a clinical trial in all cases as described above
The modus operandi of Cystone in urolithiasis has yet not been conclusively elucidated. However, Phukhan et al., (1977) have found in experimental studies that Cystone has a diuretic activity in doses >400 mg/100 g of body weight in rats. The second mode of action may be due to its spasmolytic effect on the ureteric smooth muscle as reported by Phukhan et al. (1977) in their studies on rabbits and guinea pigs. Thirdly, it might be acting by correcting the crystalloid and colloid balance, as suggested by Sengupta and Gupta (1978). Fourthly, the action of disintegration of the calculi, especially the renal ones, may be due to its action on mucin which binds particles together in a calculus (Misgar and Kariholu, 1981). Fifthly, the crystalluria clearance may be due to flushing out of the particles with the flow of urine (increased by the diuretic and antispasmolytic actions of the drug). Last but not the least, Cystone might be helping in alteration of the electrical conductivity of the urine, thus preventing further accumulation of particles over a nucleus which is already formed, and stopping further growth of the stone, in addition to dissolving the already formed stone (author’s hypothesis). It would be important here to add that a significant difference in the electrical conductivity of urine has been noticed in stone formers and non-stone formers (Satyavir and Chhabra 1983 – Personal communication). If the above hypothesis is proved by experimental studies, then Cystone might prove a wonder drug, not only useful in treating stones but as a prophylactic for prevention of recurrences also.
Cystone has been tried in 26 selected cases of ureteric calculi, 4 of renal calculi and 17 of crystalluria. It has been found to be an effective and safe drug in a highly significant number of cases. It avoids undue surgical intervention. However, case selection must be done carefully after thorough investigations and periodic monitoring under adequate medical supervision.
Effect of Cystone on pediatric urolithiasis with special reference to urinary excretion of calculogenesis inhibitors
Veereshwar Bhatnagar, MS, MCh., Additional Professor, Department of Pediatric Surgery,
Agarwal, S., Assistant Professor, Department of Pediatric Surgery
Gupta, S.K., Professor and Head, Department of Phamacology, All India Institute of Medical Sciences, New Delhi, India.
Kolhapure, S.A., M.D., Senior Medical Advisor,
R&D Center, The Himalaya Drug Company, Bangalore, India
The incidence of urolithiasis is high in developing countries; and the northern and north-western regions of India. These regions can be termed an endemic stone-forming belt, due to a dietary pattern rich in cereals and pulses. Urolithiasis is a consequence of complex physio-chemical processes and the major contributory factors are urinary super saturation, crystallization, calculogenesis and matrix formation.
This study was aimed to evaluate the efficacy and safety of Cystone in children with urolithiasis below 12 years of age, with special reference to urinary excretion of calculogenesis inhibitors. This study was a randomized, placebo-controlled, double blind clinical trial. Eighty-seven children below 12 years of age were included in this study. Children with complications, stones secondary to other developmental abnormalities, presenting with pyonephrosis, and those whose parents refused to give informed consent, were excluded from the study. All included patients were stratified by diagnosis and from each strata, patients were randomized to receive Cystone or placebo. All children were investigated for routine hemogram and blood urea, serum creatinine, sodium, potassium, calcium and phosphorus, and uric acid levels. For all children, routine and microscopic urine examination, were done, followed by urine culture for three consecutive days. Furthermore, all children were monitored for 24-hours urinary excretion of albumin, creatinine, calcium, phosphorus, citric acid and magnesium levels. All children underwent abdominal radio imaging and ultrasound examination. DTPA was done to rule out renal malfunction. Investigations were repeated at 4 months.
All patients received the same dosage of Cystone or placebo for 4-month period. The predefined primary outcome measures were the effect on urinary excretion of stone formation inhibitors, change in the number and size of stones, and spontaneous passage of stone. The predefined secondary outcome measures were symptomatic relief and incidence of recurrence. The relation of adverse events to study medication was predefined as “Unrelated”, “Possible”, and “Probable”. Non-compliance was not regarded as treatment failure, and reasons for non-compliance were noted.
A total of 87 patients were enrolled in the study, 4 patients were excluded from the study and 15 patients were lost to follow up. There was no statistical difference in the gender-wise distribution of patients in the drug and placebo groups. On starting Cystone, symptomatic relief was reported by 70.6% patients. The disappearance of stones was noted in 11 patients, as confirmed by X-ray KUB and ultrasound examination. In patients with “solitary stone”,
“multiple stones”, “calcium oxalate and magnesium-calcium phosphate stones” and “lower tract stones” there was no statistically significant difference in the 24-hour urinary excretion of calcium, phosphorus, citric acid and magnesium in the pre-treatment and post-treatment levels between the drug and placebo groups. In patients with “calcium oxalate and triple phosphate stones”, there was a statistically significant difference in the 24-hour urinary excretion of calcium and magnesium in pre-treatment and post-treatment levels between the drug and placebo groups. In patients with “upper tract stones”, there was a statistically significant difference in the 24-hour urinary excretion of phosphorus in pre-treatment and post-treatment levels between the drug and placebo groups. No recurrences were noted during the study period and no adverse events were reported during the study period.
This study indicates that in pediatric urolithiasis, Cystone appears to be an effective and safe treatment for long-term use. It also appears that Cystone has a favorable effect on inhibition of calculogenesis and it also seems to prevent recurrence in pediatric urolithiasis.
Role of Cystone Tablets in Ureteric Calculi and Urinary Tract Infections (E. Coli)
Dalbir Singh, M.B.,B.S., Consultant Physician Police Hospital, Rohtak (Haryana), India. Now: Registrar, Dept. of Forensic Medicine, Medical College, Rohtak, India.
Urolithiasis in developing countries like India is more amongst the population whose diets contain low amount of inferior quality proteins. It is also reported that high intake of animal protein like meat, fish and poultry products might augment the risk of stone formation. Dietary imbalance of minerals, namely calcium, phosphorus and magnesium are common causative factors of urinary calculi disease (Dr. Anasuya Das, National Institute of Nutrition, Hyderabad, Nutrition News (1982): 5, 1).
Urinary tract infection patients complain of burning micturition, pyrexia etc. Most of the patients were suffering from E. coli infections.
Cystone, a product of The Himalaya Drug Co., Mumbai has been extensively evaluated in ureteric calculi and U.T.I. cases with excellent results (Dandia-1975, Gupta-1976, Saronwala-1973, Trivedi-1974, Gohsal-1980).
Cystone is claimed to correct crystalloid-colloid imbalance and relieve the binding mucin of calculi. It acts as a urinary antiseptic, antispasmodic and diuretic. Cystone is known to relax the detrusor muscles and promote diuresis by virtue of its high content of natural mineral salts. The prolonged use of Cystone does not disturb the electrolyte balance.
MATERIAL AND METHODS
A clinical trial was undertaken on 10 patients of ureteric calculi with 1.5 cm calculi treated with Cystone tablets 2 t.i.d. for 3 months.
Twenty cases of U.T.I., having E. coli infection, were divided into three groups.
Group A : In this group 7 patients were given Cystone 2 t.i.d. for 10 to 12 days or till the infection cleared.
Group B : Seven patients in group B were given Cystone tablets 2 t.i.d. for 10 days and co-trimoxazole 2 b.i.d. for 5 days.
Group C : This group of 6 patients received nitrofurantoin 1 t.i.d. for 10 days with co-trimoxazole 2 b.i.d. for 5 days.
All the patients of ureteric calculi passed out calculi with Cystone. Six patients passed out calculi in 30 days and the remaining 4 cases passed out their calculi within 3 months of treatment. Out of 7 patients in Group A (U.T.I.) 6 recovered. In Group B all the patients recovered, i.e. 100% results, whereas in Group C out of 6 patients, 5 patients responded to this combination
In this series Cystone proved promising in 10 cases of ureteric calculi and in 20 cases of urinary tract infections. Cystone can be combined with co-trimoxazole or used in pregnancy where co-trimoxazole is contra-indicated. In such cases instead of giving an antibiotic we should recommend Cystone. None of the patients reported any toxic effects with Cystone therapy.
Hyperoxaluria in urolithiasis and Cystone Therapy
Deepak Verma, Assistant Professor, Surgery Medical College, Jodhpur, India, Pendse, A.K. Professor, Surgery, Medical College, Udaipur, India and Singh, P.P. Professor, Bio-chemistry, Medical College, Udaipur, India.
Twenty-seven patients with urolithiasis and twenty-three normal subjects comprised this study. They were kept on an oxalate-free diet for 48 hr prior to and during urine collection to rule out any dietary influence on oxaluria. 24-hr urine samples were collected for oxalic acid estimation. After this all the patients received Cystone, 2 tabs. t.i.d. for 8 weeks. The above procedures were repeated at 4 and 8 weeks.
After Cystone therapy a marked reduction in oxaluria was noted in those with high initial values. This is of significance since it is known that hyperoxaluria is an important aetiological factor for urolithiasis.
Urolithaisis constitutes one of the commonest afflictions requiring surgical intervention in our country and by conservative estimates there are about 5-7 million patients suffering from urinary calculus disease in India. It is not only the high prevalence which requires early attention, but rather the more problematic, high rate of recurrence after surgical removal. It is for these reasons that the Indian Council of Medical Research has classified this disease as one of the refractory diseases and stressed that efficient efforts should be made to find out the cause/s of the disease and to search for suitable drug/s for its cure (Satyawati, 1982). High prevalence and recurrence rates in Rajasthan have been reported in past studies (Pendse et al, 1982 and Singh et al, 1983).
Finalyson (1974) has clearly stated that changes in urinary oxalate concentration are 15 times more potent than changes in calcium concentration in altering the saturation of urine with calcium oxalate. The role of hyperoxaluria in stone formation is further supported by the studies of Robertson et al (1979) and Thomas et al (1979).
Dandia et al (1975-76) concluded from their study on rats and dogs that Cystone provides some protection against the growth and recurrence of urinary stones. Therefore this study was carried out to compare the oxalic acid excretion of stone formers with those of normal subjects in the local population and to evaluate the effect of eight weeks’ Cystone therapy on oxaluria.
MATERIAL AND METHODS
Twenty-seven patients of urolithiasis and twenty-three normal subjects form the basis of this study. The normal subjects were selected from the medical students and staff members of the R.N.T. Medical College, Udaipur, while the stone formers were from the surgical wards of the General Hospital of the said Medical College. The latter were selected only after confirmation of their diagnosis by radiological examination. All the stone formers thus had a stone in their urinary tract.
Both the normal subjects and patients were put on a controlled diet avoiding oxalate-rich foods for 48 hours prior to and during urine collection, to rule out any dietary influence on oxaluria. 24-hour urine samples were collected (from 8.00 a.m. to 8.00 a.m.) in a 2.5 litre capacity bottle containing 10 ml of conc. HCl as preservative. Quantitative estimation of oxalic acid in urine was done by the method of Hodgkinson and Williams (1972). Following this, all the patients were put on Cystone, 2 tablets t.i.d. for eight weeks. After four weeks and eight weeks, the same procedures were repeated for collection and analysis of the urine samples.
OBSERVATIONS AND DISCUSSION
Oxalic acid excretion in stone formers is significantly higher as compared to the normal subjects. Therefore, hyperoxaluria is an important aetiological factor of urolithiasis in the local population of the Udaipur region.
In stone formers, oxaluria is gradually reduced after Cystone therapy, the mean values being similar to those of normal persons.
A marked decrease in oxaluria in six patients who had very high initial values was shown. After 8 weeks of treatment with Cystone, oxaluria was similar to that in normal persons
It can be concluded from the present study that hyperoxaluria is certainly an important aetiological factor for urolithiasis. Cystone therapy for eight weeks corrects this abnormality to a great extent - more so in severe hyperoxaluric patients. Patients subjected to surgical intervention for urolithiasis may also be treated with Cystone to lower the recurrence rate.
Effect of Cystone, a Herbal Formulation, on Glycolic Acid-induced Urolithiasis in Rats
Mitra, S.K., Gopumadhavan, S., Venkatarangannna, M.V. and Sundaram, R.
R&D Centre, The Himalaya Drug Co., Makali, Bangalore, India
The effect of Cystone, a herbal formulation, was studied on experimentally induced urolithiasis in rats. Oxalate urolithiasis was produced by the addition of 3% glycolic acid to the diet for a period for 42 days. Glycolic acid treatment resulted in a significant increase in the levels of calcium and oxalate in the kidney as well as in the total kidney weight. Also, the urinary levels of calcium, oxalate and inorganic phosphorus were increased. Cystone treatment at 250, 500 and 750 mg/kg b.wt. p. o . for 42 days revealed a dose-related effect in the reduction of lithogenic substances, following glycolic acid induced urolithiasis. Simultaneous oral treatment with Cystone at a dose of 500 and 750 mg/kg for 42 days, significantly reversed the glycolic acid-induced urolithiasis, presumably by preventing the urinary supersaturation of lithogenic substances, especially of oxalate and calcium. The reduction of urinary and kidney oxalate levels by Cystone may be due to its inhibitory action on oxalate synthesizing liver enzyme glycolate oxidase. These observations indicate that Cystone can play an important role in the prevention of disorders associated with kidney stone formation.
Cystone Therapy in Urolithiasis
Kekade, S.R., M.S., General Surgeon and Urologist, Evangeline Booth Hospital, Ahmednagar, India.
Urinary calculi pose a universal problem. In some regions it is more prevalent than in the others. The incidence of urinary calculi is quite high in our country. But the number of patients registered in hospitals represents only a small fraction of the total.
The composition of urinary calculi varies in different cases. The stones may be located either in the kidney, pelvis, ureter, bladder or urethra. Surgical management is the recognised form of treatment but a large number of cases can be successfully treated on conservative lines.
Cystone (The Himalaya Drug Co.) corrects the crystalloid-colloid imbalance and possesses to a remarkable degree the property of disintegrating the gravel or calculi. Cystone also relaxes the smooth muscles and exerts a marked diuretic action. It is useful in urolithiasis, crystalluria, burning micturition and as follow-up treatment after surgical operations to prevent recurrence of calculi.
Our study was done to assess (I) Cystone postoperatively in prevention of further stone formation and (ii) its therapeutic effect when given alone in urinary calculi.
MATERIAL AND METHODS
There were 80 cases of stone formers. Of these 56 were males and 24 females.
Forty eight patients (60%) had ureteric stones, 28 (35%) kidney stones and 4 (5%) urinary bladder stones. The patients came with a history of pain in the abdomen (colic), vomiting, haematuria and increased frequency of micturition. Only in some patients were the calculi diagnosed coincidentally. Routine urine and blood examination, blood urea estimation, X-rays and intravenous pyelography were carried out in all the patients.
The patients were divided into 2 groups of 40 each. Group I patients underwent surgery and were put on Cystone post-operatively. Group II patients were on Cystone tablets only; only 4 patients in this category had to be operated on for stone removal for reasons explained later.
Fourteen patients were having big sized kidney stones with hydronephrotic changes in the kidney or non-functioning of the kidney on the same side with or without pain. There were 26 patients with ureteric stones with non-functioning of the kidney on the same side.
Fourteen were having small or big sized kidney stones with good functioning of the same kidney without any hydronephrotic changes. Then there were 22 patients with ureteric calculi with mild hydronephrosis or without hydronephrosis. Four cases presented with bladder stones of various sizes but with good bilateral kidney function without any hydronephrotic changes.
Both the groups were put on Cystone, 2 tablets t.i.d., for 6 months. Repeat check up X-rays were taken at the end of 3 and 6 months of Cystone therapy.
In the operated cases, Cystone was continued for 6 to 9 months in the post-operative period for prevention of further stone formation.
There has been no recurrence of stones in any of the operated patients for at least 6 months during which Cystone was administered.
Out of the 14 patients with small or big sized kidney stones, 10 expelled the stones. Of the remaining 4, in 2, the size of the stones was reduced remarkably and the other 2 patients underwent surgery later on.
The 22 patients with ureteric calculi were given large amounts of fluids along with Cystone therapy. Sixteen of them passed the stones per urethra. In 5 patients the stone size was decreased remarkably in 6 months. Only one patients had to be operated on as his stone got impacted at the vesico-ureteric junction.
Out of the 4 patients with bladder stones, 3 passed the stones per urethra after Cystone therapy. In one patient the stone was removed at the time of prostatectomy.
There were no short or long term toxic or other reactions on prolonged Cystone therapy.
1. A clinical trial of Cystone tablets, 2 t.i.d., was carried out on 80 cases of urolithiasis for 6 months.
2. The patients were divided into 2 groups of 40 each.
3. Group I patients (40) had disturbance of renal function or marked hydronephrosis on the same side and were operated on and given Cystone tablets, 2 t.i.d. for 6 months.
4. The other 40 patients in Group II were only put on Cystone tablets, 2 t.i.d. for 6 months.
5. All routine investigations, X-rays and I.V.P. were performed at the beginning and end of 3 months and 6 months in all cases.
6. In the operated group there was no recurrence of stones during the 6 months’ follow-up.
7. In the other group, only on Cystone therapy, 29 passed the stones in the urine. In 7, the stones were markedly reduced in size. Only in the remaining 4 the stones were surgically removed (in one case, during prostatectomy).
8. There were no toxic or untoward reactions on prolonged Cystone therapy.
9. Cystone prevents recurrence of urinary calculi and in a majority of cases can help avoid surgery.
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