By Mike Montemarano, Associate Editor 04.11.24
The U.S. Food and Drug Administration has approved of a study by Wake Forest University to explore the efficacy of supplement manufacturer Desert Harvest’s Super Strength Aloe Vera (SSAV) capsules in reducing symptoms associated with interstitial cystitis (IC). IC is characterized by chronic inflammation and irritation of the bladder wall, which can lead to scarring or stiffening of the bladder.
This would be the first double-blind, placebo-controlled study that specifically addresses safety and efficacy as primary endpoints in patients with IC, which is sometimes referred to as bladder pain syndrome (BPS), noted Stephen J. Walker, PhD, a urologist at Wake Forest University who will lead the study.
“Interstitial cystitis/bladder pain syndrome is a heterogeneous clinical syndrome that is perhaps 10 times more prevalent in women than in men. Although there are several compelling hypotheses, the underlying cause(s) for IC/BPS is largely unknown ... Due to the heterogeneous nature of symptoms, a personalized, multi-modal approach to therapy is recommended. These therapies may include everything from diet modification, stress management, and treatment of common co-occurring conditions (e.g., irritable bowel syndrome, fibromyalgia, panic, depression), to physical therapy and pain management, oral medications and/or bladder installations, neuromodulation, or surgical intervention for severe bladder-centric disease.”
“The dosage will be increased every 4 weeks for the first 3 months of the study followed by a decrease in the dosing regimen during the fourth month. Evaluation of all participants will include a review of their medical history, physical examination, whole blood collection for research purposes, and specific laboratory assessments. These procedures, along with a review and evaluation of all inclusion and exclusion criteria, concomitant medications, and any adverse events, will occur during every study visit,” said Walker.
In addition to the primary objective of determining the safety of the treatment, secondary objectives will include measuring changes in symptoms such as suprapubic pain, urinary frequency, urgency, nocturia, and dysuria, measured through McGill Quality of Life Questionnaire – Revised; O’Leary Sant Questionnaire; Genitourinary Pain Index; and the Male and Female Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction Brief Profile v2.0 after every study visit. 24-hour voiding diaries will also be used to capture pre-treatment symptoms and voiding frequency throughout the study.
For instance, a 2018 report by the Emory Eye Center found that long-term exposure might damage retinal tissue. A subsequent report by the American Academy of Ophthalmology found that patients who took Elmiron for about 15 years developed unusual changes in their macula. The rate of toxicity in patients who took the drug for at least 15 years rose with the amount of the drug consumed, and in the late stage, toxicity could “result in permanent vision loss,” the AAO reported.
As reported by Forbes, thousands of Elmiron users have filed lawsuits alleging that exposure to the drug has caused damage to the retina, affecting their vision.
“The length of time for receiving FDA approval is unknown,” Florio said. “We are in the first phase of the process, and FDA will determine how many phases are required. Super-Strength Aloe Vera (SSAV) would be classified as a supplement until the FDA wants to denote it as a drug. It will not be up to us to determine how many phases the FDA will need to conduct. The ultimate goal at the end of this process is that it would be classified and listed as a drug.”
In 1995, a phase I double-blind, placebo controlled study at the Urology Wellness Center in Rockville, Maryland found that SSAV treatment was associated with an 87.5% response rate in patients, ranging from some to complete relief of symptoms. In this study, 50% of all patients treated saw significant relief from all or most of their symptoms, and were able to return to a more normal lifestyle.
A 2016 consumer survey also found that, in 660 respondents, 92% of patients reported experiencing significant relief from at least some symptoms while taking SSAV supplements. After examining specific symptoms in more detail, between 63% and 68% of respondents reported either moderate or significant improvements in urgency/frequency, pelvic pain, and urethral burning, with only 12-13% of respondents reporting no improvement in each category.
“Most recently, our Italian study, which was completed last year and will be published later this year, took the worst patients — those who responded to no other treatments up to this point,” Florio said. “Our Super-Strength Aloe Vera showed a 78.78% response rate of some to complete relief of symptoms.”
Importantly, Desert Harvest developed a proprietary harvesting and production method that removes anthraquinones, which are toxic compounds known to cause bladder irritation.
“What most people don’t realize is that the minute you cut the aloe leaf off of the plant, malic acid starts to eat away at the nutrients. After 6-8 hours, all the nutrients in the Aloe vera are dead. Since Aloe vera is made up of 98.5% water, what is left is the water, fiber, and toxic anthraquinones. However, our patented process starts processing within only 20 minutes of cutting the leaf off to maximize the nutrients. We utilize a unique patented process to extract all the anthraquinones, remove all the insoluble fiber, and freeze dry it to remove the water, so what is left is simply a potent, pure, and safe product that supports the sensitive systems of those suffering with interstitial cystitis. We add a little calcium carbonate to make it as alkaline as possible for the bladder to help buffer acidity,” Florio said.
This would be the first double-blind, placebo-controlled study that specifically addresses safety and efficacy as primary endpoints in patients with IC, which is sometimes referred to as bladder pain syndrome (BPS), noted Stephen J. Walker, PhD, a urologist at Wake Forest University who will lead the study.
“Interstitial cystitis/bladder pain syndrome is a heterogeneous clinical syndrome that is perhaps 10 times more prevalent in women than in men. Although there are several compelling hypotheses, the underlying cause(s) for IC/BPS is largely unknown ... Due to the heterogeneous nature of symptoms, a personalized, multi-modal approach to therapy is recommended. These therapies may include everything from diet modification, stress management, and treatment of common co-occurring conditions (e.g., irritable bowel syndrome, fibromyalgia, panic, depression), to physical therapy and pain management, oral medications and/or bladder installations, neuromodulation, or surgical intervention for severe bladder-centric disease.”
Study Details
The present study will be a randomized, double-blind, placebo-controlled clinical trial with a two-arm parallel group arrangement, specifically evaluating symptoms associated with IC. Participants will be randomized into study and control arms in a 4:1 ratio, favoring the active treatment, and all patients will self-administer the capsules over 16 weeks.“The dosage will be increased every 4 weeks for the first 3 months of the study followed by a decrease in the dosing regimen during the fourth month. Evaluation of all participants will include a review of their medical history, physical examination, whole blood collection for research purposes, and specific laboratory assessments. These procedures, along with a review and evaluation of all inclusion and exclusion criteria, concomitant medications, and any adverse events, will occur during every study visit,” said Walker.
In addition to the primary objective of determining the safety of the treatment, secondary objectives will include measuring changes in symptoms such as suprapubic pain, urinary frequency, urgency, nocturia, and dysuria, measured through McGill Quality of Life Questionnaire – Revised; O’Leary Sant Questionnaire; Genitourinary Pain Index; and the Male and Female Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction Brief Profile v2.0 after every study visit. 24-hour voiding diaries will also be used to capture pre-treatment symptoms and voiding frequency throughout the study.
Concern About Elmiron
Presently, the only FDA-approved treatment for IC is a drug called Elmiron, but emerging evidence suggests the possibility that vision damage may be an associated side effect.For instance, a 2018 report by the Emory Eye Center found that long-term exposure might damage retinal tissue. A subsequent report by the American Academy of Ophthalmology found that patients who took Elmiron for about 15 years developed unusual changes in their macula. The rate of toxicity in patients who took the drug for at least 15 years rose with the amount of the drug consumed, and in the late stage, toxicity could “result in permanent vision loss,” the AAO reported.
As reported by Forbes, thousands of Elmiron users have filed lawsuits alleging that exposure to the drug has caused damage to the retina, affecting their vision.
Decades of Research
Desert Harvest has supported research into the potential of aloe vera in alleviating interstitial cystitis for over 30 years, noted Heather Florio, CEO of Desert Harvest, and this study may be just one of several on the road to securing FDA approval of the company’s aloe ingredient for interstitial cystitis.“The length of time for receiving FDA approval is unknown,” Florio said. “We are in the first phase of the process, and FDA will determine how many phases are required. Super-Strength Aloe Vera (SSAV) would be classified as a supplement until the FDA wants to denote it as a drug. It will not be up to us to determine how many phases the FDA will need to conduct. The ultimate goal at the end of this process is that it would be classified and listed as a drug.”
In 1995, a phase I double-blind, placebo controlled study at the Urology Wellness Center in Rockville, Maryland found that SSAV treatment was associated with an 87.5% response rate in patients, ranging from some to complete relief of symptoms. In this study, 50% of all patients treated saw significant relief from all or most of their symptoms, and were able to return to a more normal lifestyle.
A 2016 consumer survey also found that, in 660 respondents, 92% of patients reported experiencing significant relief from at least some symptoms while taking SSAV supplements. After examining specific symptoms in more detail, between 63% and 68% of respondents reported either moderate or significant improvements in urgency/frequency, pelvic pain, and urethral burning, with only 12-13% of respondents reporting no improvement in each category.
“Most recently, our Italian study, which was completed last year and will be published later this year, took the worst patients — those who responded to no other treatments up to this point,” Florio said. “Our Super-Strength Aloe Vera showed a 78.78% response rate of some to complete relief of symptoms.”
Quality Controls
Florio noted that not all aloe products are subject to the same quality controls and processes.Importantly, Desert Harvest developed a proprietary harvesting and production method that removes anthraquinones, which are toxic compounds known to cause bladder irritation.
“What most people don’t realize is that the minute you cut the aloe leaf off of the plant, malic acid starts to eat away at the nutrients. After 6-8 hours, all the nutrients in the Aloe vera are dead. Since Aloe vera is made up of 98.5% water, what is left is the water, fiber, and toxic anthraquinones. However, our patented process starts processing within only 20 minutes of cutting the leaf off to maximize the nutrients. We utilize a unique patented process to extract all the anthraquinones, remove all the insoluble fiber, and freeze dry it to remove the water, so what is left is simply a potent, pure, and safe product that supports the sensitive systems of those suffering with interstitial cystitis. We add a little calcium carbonate to make it as alkaline as possible for the bladder to help buffer acidity,” Florio said.
