Kidney Stones are one of the most frequent urological problems, encountered in ~10% of people worldwide [1]. Interestingly, this condition is 2-3 times more prevalent in women compared to men, with a peak incidence reported between 30 and 40 years of age [2]. The vast majority of kidney stones are composed of calcium oxalate, followed by uric acid and then struvite [3].

Even with adequate treatment, the recurrence rate of kidney stones varies between 22-51% with an average formation rate of between 2-7 years. Individuals with the following disorders have a higher incidence of recurrence:

• Hypercalciuria: excess calcium in the urine
• Hyperuricosuria: excess uric acid in the urine
• Hyperoxaluria: excessive urinary excretion of oxalate
• hypocitraturia: low citrate excretion in the urine (less than 320mg per day)

Phyllanthus niruri (commonly known as “stone-breaker” or “Chanca Piedra”) has documented usage dating back over 2000 years in treating kidney stones [6]. One of the primary drivers for this herb’s success is its triterpene content, which is considered to be the main anti-lithogenic (stone-preventing) factor. In particular, triterpenes can make kidney stones smoother and more fragile [7-9]. Thus, making kidney stones easier to pass and break apart.

Another noticeable effect is that calcium oxalate crystals remain equally dispersed in urine treated with Chanca Piedra extract [10]. Uniform dispersion lowers the likelihood of crystal formation significantly as crystals form in clusters and build upon each other. Given equal separation, the calcium oxalate crystals are more likely to bind with water and get flushed out of the system. 

Patient Selection

The study included 48 patients who received treatment or evaluation between September and December 2017 for nephrolithiasis (kidney stones). Participants were initially diagnosed by abdominal ultrasound and confirmed by non-contrast-enhanced computer tomography (CT scan). The maximum diameter for stones allowed in the study was 15mm. Additionally, any of the following conditions precluded individuals from participating in the research:

• Individuals with sensitivity to any of the active compounds
• Individuals who were pregnant/lactating
• Individuals with imaging evidence of ureterohydronephrosis (swollen kidneys due to poor urine drainage)
• Individuals with renal colic at admission to study period
• Individuals with impaired kidney/liver function
• Individuals using other anti-lithogenic substances
• Individuals with any other urological and/or non-urological malignant diseases

Out of 48 patients, 8 of them met one of the exclusion criteria before completing three months of treatment: 5 stopped before the established due date and three developed renal colic. Forty patients participated in the final study database.

Study Layout

All patients underwent a non-contrast-enhanced CT scan before beginning the treatment. The identified calculi (kidney stones) were classified according to their number, location in the kidney (superior, middle, inferior calyx), and size.

The treatment consisted of administration of capsules that combined three active principles, as follows: 

• 225mg dried Phyllanthus niruri leaf extract
• 152mg magnesium stearate
• 2mg pyridoxine hydrochloride (B6 vitamin).

Each patient followed the same therapeutic regimen: 1 capsule twice a day, for three months. After treatment, patients underwent another non-contrast-enhanced CT scan. This additional scan provided information on changes in the number, location, and size of the calculi (stones).

Results

Per Patient Analysis

The study included 40 patients, with the mean age of 48 years (range: 19-85 years), of whom 55% were men and 45% were female. The mean number of calculi was 1 (range: 1-4) and the mean dimension was 5.5mm (range: 2-14mm).

In 40% of cases, the calculi (kidney stones) were located in the right kidney, 45% of patients had left kidney lithiasis, whereas 15% of patients had bilateral (both kidneys) kidney lithiasis.

After treatment, 25% of the patients were entirely stone free. The stone-free status was not associated with the gender of the patients, with the side location, or the number of the calculi (kidney stones). A percentage of 13.8% of the patients with inferior calyx lithiasis achieved stone-free status after treatment, in comparison with 54.5% of the patients with calculi in the middle or superior calyx.

Per Stone Analysis

The study analyzed 60 calculi (kidney stones) in the 40 patients who participated. The mean dimension of the kidney stones before treatment was 4.93mm (range 2-14mm). Half of the calculi were located on the right side and half on the left side. The inferior calyx harbored 55% of the stones, whereas 36.7% were found in the middle and 8.3% in the superior calyx.

Upon analysis, 40% of calculi were absent on the post-treatment imaging, while 21.7% were shown with smaller dimensions. A total of 23 kidney stones (38.3%) had the same size as before the treatment.

The mean dimension of the remaining calculi after the treatment was 5.7mm (range: 2-14mm) and the mean reduction of the size was 1.7mm (range: 1-2mm).

The location of the kidney stone was significantly correlated with the response to treatment, as 68.18% of the kidney stones located in the middle calyx were absent on post-treatment imaging, in comparison with only 18% from the inferior calyx.

Conclusion

The Phyllanthus niruri (Chanca Piedra) standardized extract administered for three months had the highest efficacy in achieving stone-free status for patients with calculi less than or equal to 3mm, located in the middle or upper calyx. In patients with calculi between 3-6mm, a 1.7 mm reduction was shown after three months of treatment. Higher duration of the treatment might show improved results.

Read the full study here. 

References

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