Abstract
Dear Editor:
Nephrolithiasis is a global problem from ancient times and many remedies have been used over the ages. Its incidence varies in different parts of world, and many factors are contributory, such as high intake of animal proteins, wheat diets, and hot and dry climate, which might augment the risk of stone formation. 1 In industrialized nations, it affects about 10% of the population with an annual incidence of 0.5%–1.9%. 2 In India, the incidence of renal stone is still high (30 of 1000 population). It is more common in Northern India compared to the southern state. 3,4 Calcium oxalate urolithiasis accounts for approximately 75% of urinary stone disease in the United States. 5
In Ayurvedic literature, a number of drugs have been described that are very effective against nephrolithiasis. Kulattha, Sitivaraka, Varun, and Sighru are among them. We conducted a study to compare the efficacy of herbal medicine, Sitivaraka (Celosia argental) with potassium citrate as litholytic agent in urinary stone diseases. The ethical committee of the university had approved the study.
In this randomized, controlled, open-label trial, we selected 44 patients with renal stones and randomly divided them into two groups to receive the drugs. Group I received Sitivaraka seed preparation (dose: 10 mg/kg body weight 3 times daily) and group II received potassium citrate (dose: 0.25 mL/kg body weight every 6 hours). A total of 21 cases were in group I and 23 cases were in group II.
Inclusion criteria were the following: 1. Patient with renal calculus as evident from X-ray film, ultrasonography (USG), or computed tomography scan 2. Serum creatinine <2 mg/100 mL 3. Patients who were not receiving any litholytic therapy 4. Stone size ≤8 mm
Patients with serum creatinine of >2 mg/100 mL, radiological evidence of hydronephrotic change, and history of previous drug hypersensitivity were excluded from the study. A detailed history taking and physical examination were performed. Baseline urine, hematological, biochemical, and radiological investigations had been done.
Patients were reassessed for any improvement or deterioration of symptoms after 1 month of enrollment and were followed up for a period of 6 months. USG was done at the initial visit and then at the 3rd and 6th month while other the investigations were done once a month. Clinical improvement with radiological evidence of reduction in size of calculus or history of passage of stone in urine were used as criteria for improvement. At the end of the 6th month, data were analyzed using appropriate statistical methods.
It was found that after 6 months of Sitivaraka therapy, there was a statistically significant difference in the value of serum Ca2+ and Po42- in both of the groups when the 6-month visit was compared with the initial visit (p<0.05), though that was not significant when group I was compared with group II at the 6th month (p>0.05) (Table 1). A statistically significant result was observed when mean serum creatinine at the 3-month visit was compared with the initial visit in group I, but in group II that was not significant during the entire of study period (Table 1). Mean serum urea levels at the start of therapy were 28.5±16.05 and 30.6±19.7 mg/100 mL in group I and II, respectively, and there was no significant change in either of the groups during the study (p<0.05) (Table 1). However, the serum parathyroid hormone (PTH) level was reduced significantly (p<0.05) from 40.33±9.65 to 36±7.19 ng/L at the end of the 6th month only in group I (Table 1). When the urinary calcium, oxalate, and uric acid levels in group I at the 6-month visit were compared with those of the initial visit, there was a significant difference in both of the groups. However, the urinary calcium level in group II was not significantly changed (Table 1).
Statistically significant when 0 month was compared to 3rd month by using paired t-test: p<0.05.
Statistically significant when 0 month was compared to 6th month by using paired t-test: p<0.05.
SD, standard deviation; PTH, parathyroid hormone; excr., excretion; cal., calcium.
In intragroup comparison, the mean size of the stone in group I was reduced from 6.47±3.9 mm at the initial visit to 3.9±2.54 mm at the 6th month, which was statistically significant (p<0.05). However, in group II the stone size was reduced from 6.46±3.08 mm at the initial visit to 4.04±1.04 mm at the 6th month, which was statistically insignificant (p>0.05) (Table 2). When stone size in the two groups was compared at the 6th month, there was a significant difference (p<0.05). However, it was found that a significant reduction in stone size was appreciated only at the 6th month of the study.
SD, standard deviation.
To conclude, our study has shown that Sitivaraka is a useful herbal drug in reducing stone size and serum PTH level. Thus, the present study shows a need for an additional prolonged prospective study on a larger study sample on the role of the litholytic property of this herbal drug, especially in small stones and as a complementary approach to the management and prevention of recurrence of larger ones.
Footnotes
Disclosure Statement
No competing financial interests exist.