Jalali S. et al., 2023: A Comparison of Boron Supplement and Tamsulosin as Medical Expulsive Therapy for Urinary Stones After Extracorporeal Shock Wave Lithotripsy: a Randomized Controlled Clinical Trial

Monday, 17 July 2023

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University of British Columbia, Vancouver, British Columbia, Canada.
Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, No. 103, Shahid Jafari (9Th Boostan) St., Pasdaran Ave, IR 1666663111, Tehran, Iran.
Baqiyatallah University of Medical Sciences, Tehran, Islamic Republic of Iran.
Department of Epidemiology and Biostatistics, Research Centre for Emerging and Reemerging Infectious Diseases, Pasteur Institute of Iran, Tehran, Iran.
Shahid Beheshti University of Medical Sciences, Tehran, IR, Iran.
Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, No. 103, Shahid Jafari (9Th Boostan) St., Pasdaran Ave, IR 1666663111, Tehran, Iran.

Abstract

Treatment with alpha-blockers has been used in many studies to facilitate stone clearance after extra-corporeal shock wave lithotripsy (ESWL), based on mediating ureteral wall relaxation. Ureteral wall edema is another barrier against the stone passage. We aimed to compare the effectiveness of boron supplement (due to its anti-inflammatory effect) and tamsulosin in the passage of stone fragments after ESWL. Eligible patients after ESWL were randomly assigned to two groups and were treated with boron supplement (10 mg/BD) or tamsulosin (0.4 mg per night) for 2 weeks. The primary outcome was the stone expulsion rate according to the remained fragmented stone burden. The secondary outcomes were the time of stone clearance, pain intensity, drug side effects, and the need for auxiliary procedures. In this randomized control trial, 200 eligible patients were treated with boron supplement or tamsulosin. Finally, 89 and 81 patients in the two groups completed the study, respectively. The expulsion rate was 46.6% in the boron and 38.7% in the tamsulosin group, which there was no statistically significant difference between the two groups (p = 0.003), as well as the time of stone clearance (7.47 ± 22.4 vs 6.52 ± 18.45, days, p = 0.648, respectively), after 2-week follow-up. Moreover, pain intensity was the same in both groups. No Significant side effects were reported in the two groups. Boron supplement could be effective as adjuvant medical expulsive therapy after ESWL with no significant side effects in short-term follow-up. Iranian Clinical Trial Registration number and date of registration: IRCT20191026045244N3, 07/29/2020.
Biol Trace Elem Res. 2023 Feb 21. doi: 10.1007/s12011-023-03597-0. Online ahead of print. PMID: 36808295

Comments 1

Peter Alken on Monday, 17 July 2023 10:30

In the introduction it says “According to available literature, boron can act as an anti-inflammatory agent with a significant decrease in plasma C-reactive protein, tumor necrosing factor-α, and interleukins 6, … B plays an important role in the health of humans and animals. It has beneficial effects on numerous processes including cell growth and proliferation, modulation of some enzymatic activities, calcium and magnesium metabolism, vitamin D and bone health, cardiovascular system, neurological function, cancer, and premature mortality …Additionally, cell-cultured studies showed that B can modulate the response to the condition of oxidative stress or inflammatory process.”

This is a typical description of a food supplement sold as a wonder drug. The available literature has low quality. How can you be sure about “premature death” when the time has come? Maybe Boron helps the soul to get a reduced fare by the ferryman Charon at the river Styx for transportation across the river into the Underworld (https://en.wikipedia.org/wiki/Styx).

Journey across the Styx (Gustave Doré, 1861)

Boron is not an essential element for humans and there are no relevant deficiency symptoms. However, money is an essential element and deficiencies could be cured by Boron:
Today in Germany you can buy 1 kg Boron as raw material for 3 - 6 € (https://www.google.com/search?q=bor+kgpreis).
If you turn this into tablets to swallow, you can sell this 1 kg Boron in tablets of 3mg as a food supplement for 80 – 180 €. A true wonder drug moneywise.

So, back to the study. The paper is well written. However, there are some uncertainties:
Stones were defined as radiopaque, semi-opaque, or non-opaque (radiolucent). But these data are lacking for 90 of 170 patients.
“The primary outcome was the stone expulsion rate according to the remained fragmented stone burden. The secondary outcomes were the time of stone clearance ...”
It is not clear how the primary outcome could be evaluated with the methods described. “Due to the simultaneous presence of several stones in the kidneys of each patient, we used the “stone burden” for a better comparison before and after ESWL, which refers to sum of the multiple stone size” and
“The primary outcome was stone expulsion rate (SER) according to stone status after one session of ESWL in follow-up ultrasonography, whose SER has been defined as residual stone fragments 4 mm or less in size.” It is - in my experience – impossible to reliably determine a stone free rate or the size of remaining multiple or even one fragment after SWL with sonography, especially as fragments ≤ 4mm were regarded as stone free.
What stone expulsion time was measured if there are no data on how many patients were stone free? What do numbers like “Kidney stone burden before the study 16.11 mm and 9.57 after the study” mean and signalize?

So, back to Boron. Why would one do such a study? There seem to be constant Boron followers in Tehran since 30 years (1-3). So maybe it is a much-enjoyed habit to study this compound. However, it can also be a business as companies selling food supplements are eagerly waiting for scientific studies to quote and prove an effect to customers.

1 Naghii MR, Samman S. The role of boron in nutrition and metabolism. Prog Food Nutr Sci. 1993 Oct-Dec;17(4):331-49. PMID: 8140253.

2 Naghii MR. Significant pain alleviation, cease of hematuria, and renal stone removal after extracorporeal shock wave lithotripsy with adjuvant boron therapy - case report. Endocr Regul. 2013 Apr;47(2):101-4. doi: 10.4149/endo_2013_02_101. PMID: 23641791.

3 Bahadoran H, Naghii MR, Mofid M, Asadi MH, Ahmadi K, Sarveazad A. Protective effects of boron and vitamin E on ethylene glycol-induced renal crystal calcium deposition in rat. Endocr Regul. 2016 Oct 1;50(4):194-206. doi: 10.1515/enr-2016-0021. PMID: 27941176

Peter Alken

This is a typical description of a food supplement sold as a wonder drug. The available literature has low quality. How can you be sure about “premature death” when the time has come?  Maybe Boron helps the soul to get a reduced fare by the ferryman Charon at the river Styx for transportation across the river into the Underworld (https://en.wikipedia.org/wiki/Styx).

[img]https://www.storzmedical.com/images/blog/Jalali.png[/img]
Journey across the Styx (Gustave Doré, 1861)

Boron is not an essential element for humans and there are no relevant deficiency symptoms. However, money is an essential element and deficiencies could be cured by Boron:
 Today in Germany you can buy 1 kg Boron as raw material for 3 - 6  € (https://www.google.com/search?q=bor+kgpreis).
If you turn this into tablets to swallow, you can sell this 1 kg Boron in tablets of 3mg as a food supplement for 80 – 180 €. A true wonder drug moneywise.

So, back to the study. The paper is well written. However, there are some uncertainties: 
Stones were defined as radiopaque, semi-opaque, or non-opaque (radiolucent). But these data are lacking for 90 of 170 patients.
“The primary outcome was the stone expulsion rate according to the remained fragmented stone burden. The secondary outcomes were the time of stone clearance ...”
It is not clear how the primary outcome could be evaluated with the methods described. “Due to the simultaneous presence of several stones in the kidneys of each patient, we used the “stone burden” for a better comparison before and after ESWL, which refers to sum of the multiple stone size” and 
“The primary outcome was stone expulsion rate (SER) according to stone status after one session of ESWL in follow-up ultrasonography, whose SER has been defined as residual stone fragments 4 mm or less in size.” It is - in my experience – impossible to reliably determine a stone free rate or the size of remaining multiple or even one fragment after SWL with sonography, especially as fragments ≤ 4mm were regarded as stone free.
What stone expulsion time was measured if there are no data on how many patients were stone free? What do numbers like “Kidney stone burden before the study 16.11 mm and 9.57 after the study” mean and signalize?

So, back to Boron. Why would one do such a study? There seem to be constant Boron followers in Tehran since 30 years (1-3). So maybe it is a much-enjoyed habit to study this compound. However, it can also be a business as companies selling food supplements are eagerly waiting for scientific studies to quote and prove an effect to customers.

1 Naghii MR, Samman S. The role of boron in nutrition and metabolism. Prog Food Nutr Sci. 1993 Oct-Dec;17(4):331-49. PMID: 8140253.

2 Naghii MR. Significant pain alleviation, cease of hematuria, and renal stone removal after extracorporeal shock wave lithotripsy with adjuvant boron therapy - case report. Endocr Regul. 2013 Apr;47(2):101-4. doi: 10.4149/endo_2013_02_101. PMID: 23641791.

3 Bahadoran H, Naghii MR, Mofid M, Asadi MH, Ahmadi K, Sarveazad A. Protective effects of boron and vitamin E on ethylene glycol-induced renal crystal calcium deposition in rat. Endocr Regul. 2016 Oct 1;50(4):194-206. doi: 10.1515/enr-2016-0021. PMID: 27941176

Peter Alken

In the introduction it says “According to available literature, boron can act as an anti-inflammatory agent with a significant decrease in plasma C-reactive protein, tumor necrosing factor-α, and interleukins 6, … B plays an important role in the health of humans and animals. It has beneficial effects on numerous processes including cell growth and proliferation, modulation of some enzymatic activities, calcium and magnesium metabolism, vitamin D and bone health, cardiovascular system, neurological function, cancer, and premature mortality …Additionally, cell-cultured studies showed that B can modulate the response to the condition of oxidative stress or inflammatory process.” This is a typical description of a food supplement sold as a wonder drug. The available literature has low quality. How can you be sure about “premature death” when the time has come? Maybe Boron helps the soul to get a reduced fare by the ferryman Charon at the river Styx for transportation across the river into the Underworld (https://en.wikipedia.org/wiki/Styx). [img]https://www.storzmedical.com/images/blog/Jalali.png[/img] Journey across the Styx (Gustave Doré, 1861) Boron is not an essential element for humans and there are no relevant deficiency symptoms. However, money is an essential element and deficiencies could be cured by Boron: Today in Germany you can buy 1 kg Boron as raw material for 3 - 6 € (https://www.google.com/search?q=bor+kgpreis). If you turn this into tablets to swallow, you can sell this 1 kg Boron in tablets of 3mg as a food supplement for 80 – 180 €. A true wonder drug moneywise. So, back to the study. The paper is well written. However, there are some uncertainties: Stones were defined as radiopaque, semi-opaque, or non-opaque (radiolucent). But these data are lacking for 90 of 170 patients. “The primary outcome was the stone expulsion rate according to the remained fragmented stone burden. The secondary outcomes were the time of stone clearance ...” It is not clear how the primary outcome could be evaluated with the methods described. “Due to the simultaneous presence of several stones in the kidneys of each patient, we used the “stone burden” for a better comparison before and after ESWL, which refers to sum of the multiple stone size” and “The primary outcome was stone expulsion rate (SER) according to stone status after one session of ESWL in follow-up ultrasonography, whose SER has been defined as residual stone fragments 4 mm or less in size.” It is - in my experience – impossible to reliably determine a stone free rate or the size of remaining multiple or even one fragment after SWL with sonography, especially as fragments ≤ 4mm were regarded as stone free. What stone expulsion time was measured if there are no data on how many patients were stone free? What do numbers like “Kidney stone burden before the study 16.11 mm and 9.57 after the study” mean and signalize? So, back to Boron. Why would one do such a study? There seem to be constant Boron followers in Tehran since 30 years (1-3). So maybe it is a much-enjoyed habit to study this compound. However, it can also be a business as companies selling food supplements are eagerly waiting for scientific studies to quote and prove an effect to customers. 1 Naghii MR, Samman S. The role of boron in nutrition and metabolism. Prog Food Nutr Sci. 1993 Oct-Dec;17(4):331-49. PMID: 8140253. 2 Naghii MR. Significant pain alleviation, cease of hematuria, and renal stone removal after extracorporeal shock wave lithotripsy with adjuvant boron therapy - case report. Endocr Regul. 2013 Apr;47(2):101-4. doi: 10.4149/endo_2013_02_101. PMID: 23641791. 3 Bahadoran H, Naghii MR, Mofid M, Asadi MH, Ahmadi K, Sarveazad A. Protective effects of boron and vitamin E on ethylene glycol-induced renal crystal calcium deposition in rat. Endocr Regul. 2016 Oct 1;50(4):194-206. doi: 10.1515/enr-2016-0021. PMID: 27941176 Peter Alken

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