Mattw77,
A good evening to you. There isn't a whole heap that I have come across in the past specifically directed to and focused on Gout in isolation and its associated Uric crystals. However, there is still some good peripheral evidence that has come up..
Take a look at this patent:
https://patents.google.com/patent/WO2019157560A1/en
In the above patent there is this paragraph that relates to the action of Pentosan, my red emphasis added:
Examples of pain and inflammation that can be treated in embodiments of the invention include but are not limited to pain and/or inflammation arising from a rheumatic disease or condition, bone joint pain, bursitis, bone joint inflammation, bone marrow edema, synovial inflammation, synovitis, inflammation of tendons (tendonitis), gout, neck and lower back pain arising from e.g., degenerative changes in the vertebral discs and adjacent spinal structures (e.g., including lumbago and sciatica), spondylosis, ankylosing spondylitis, musculoskeletal diseases and conditions, and musculoskeletal pain e.g., including soft tissue trauma and sprains.
...and further...
Rheumatic diseases and conditions that may be treated in accordance with the embodiments of the invention include, but are not limited to, arthritis, osteoarthritis, inflammatory arthritis, rheumatoid arthritis, idiopathic arthritis, juvenile rheumatoid arthritis, gout, gouty arthritis, pseudogout, and psoriatic arthritis.
Moreover, as has happened multiple times over the last 3 years, someone asks a question on this here forum and it leads to surprising uncovering of further research and examples of OUR miracle drug at work!
How about one example...actually wait, dang it, how about 6 examples?
See Appendix A below for the full text.
A couple of amazing highlights:
"JM reported that her joint pain, particularly of the hands had been substantially reduced, allowing her to undertake normal household and sporting activities. JM maintained this treatment regimen on an ongoing basis for 15 months with continued beneficial effects. She did not report any adverse side effects over this period".
Look at this evidence on blood pressure in example 4 (see below for full text) as a additional advantage:
"PG reported amelioration of arthritic symptoms, and reduction in daily use of hypertension medications while maintaining acceptable blood pressure. During the subsequent 12 months PG changed his protocol to a daily oral dose of the 350 mg".The above example clearly demonstrates the incredible off labelling potential we are going to have once we are allowed to sell...it will take some months but it will escalate rapidly in my view after we are allowed to sell. This is exciting.
Example 6:
"After following this regimen for 6 - 12 weeks LM reported total relief of pain emanating from both his right hip joint and lumbar spine. No adverse side effects attributable to the medications were reported by LM over this period".
Read that again, TOTAL RELIEF OF PAIN. What do we have here? What do we own?
As a group, example 6 resulted in these amazing measurements:
"The mean percentage changes from baseline of hand OA symptoms of pain (-58.9%), grip strength (+32.68%), joint stiffness (-45.55%) and duration of stiffness (-29.16%) for the group confirmed the overall significant improvement in the symptoms of hand OA without supplementary' use of commercially available non-opioid analgesises or NSAIDs".
Those percentages above are compelling.
And who filed this incredible patent involving oral PPS?
Our own late Dr Peter Ghosh.
Mate.
APPENDIX A
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EXAMPLE 1 JM: A fit and active 70-year-old female who had experienced symptoms of pain and joint stiffness in both hands and knees for 25 years. Radiological examination had confirmed some cartilage loss in peripheral joints as well as deterioration of disc space in cervical and lumbar spines. Physiotherapy and regular exercise (swimming and walking) and use ofNSAIDs and paracetamol had provided some relief of the pain associated with the neck and lower back. However, these modalities failed to mitigate the pain in the peripheral joints, particularly in the hands. Hand-splints and combinations of higher doses of analgesics (codeine and paracetamol (Panadol™; GlaxoSmithKline Australia, Ermington, NSW, Australia) and twice daily Celebrex™ (200mg) (Pfizer, Inc., USA) failed to provide lasting relief of pain and joint stiffness. Cortisone injections provided short-term relief but on the advice of her doctor they were terminated because of the known adverse side effects associated with the regular used of this class of drugs.
More recent radiological examination of JM’s hands and knees showed increased joint space narrowing in the joints of the hands, particularly at the base of the thumb and the left knee. Pseudo gout was diagnosed and local cortisone injections were again initiated to the hand joints but the relief of pain was fleeting. Her hand specialist recommended surgery as the only treatment option remaining. The knee specialist recommended additional physiotherapy and maintenance of regular exercise. These regimens just maintained for approximately 12 months but the arthritic pain associated with use of her hands for daily activities were described as being excruciating.
JM then commenced a treatment protocol which required cessation of daily use of analgesics and Celebrex™ or any corticosteroids. These medications were substituted by thrice weekly oral administration of a formulation comprising 250 mg NaPPS (obtained from Bene-PharmaChem GmbH & Co KG, Germany, as described above) and 250 mg celecoxib (commercially available generic preparation) (Pentabrex™, a formulation of NaPPS and celecoxib embodied by the invention of Proteobioactives Pty Ltd, Balgowlah, NSW, Australia). Within 2 -3 weeks of the commencement of this treatment JM reported that her joint pain, particularly of the hands had been substantially reduced, allowing her to undertake normal household and sporting activities. JM maintained this treatment regimen on an ongoing basis for 15 months with continued beneficial effects. She did not report any adverse side effects over this period.
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EXAMPLE 2
DA: A 74-year-old female diagnosed with idiopathic OA 5 years previously and prescribed 200 mg Celebrex™ daily with supplementation with analgesics such as paracetamol (Panadol™) when required by her doctor. The major sites of pain and stiffness were the ankles and hands but the pain emanating from these joints was not effectively attenuated by the Celebrex™ unless its daily use was supplemented with high doses of analgesics. DA discontinued use of analgesics and Celebrex™ and initiated oral use of only a formulation of comprising 250 mg NaPPS and 200 mg celecoxib (Pentabrex™;
Proteobiactives Pty Ltd) thrice weekly, which she has continued to follow for 4 months. Within 2 weeks of commencing the new treatment protocol, DA reported a positive response and reported that she did not require the use of any analgesics to support the pain relief provided by the PPS and celecoxib formulation. During the subsequent 8 months DA changed her protocol to a daily oral dose to the 350 mg Pentabrex™ formulation (175 mg celecoxib and 175 mg NaPPS) with the same clinical outcomes without any accompanying adverse side effects.
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EXAMPLE 3
NW: An active 66-year-old female with joint pain arising from an early traumatic injury to the left knee that resulted in a tom medial meniscus and medial compartment loss of articular cartilage. NW also experienced moderate pain from the posterior compartment of her right knee that was diagnosed as arising from bursitis. These symptoms were partially managed over a number of years with the use of a variety of NSAIDs. Within the previous 2 years NW was prescribed Celebrex™. However, the pain and joint stiffness were not satisfactorily resolved by this drug and symptoms were exacerbated by exercises such as heavy gardening, walking and playing golf. NW commenced treatment with a formulation comprising two 250 mg Pentabrex™ HPMC capsules each containing(l25 mg Celebrex and 125 mg NaPPS) taken orally thrice weekly, and reported therapeutic benefits with respect to amelioration of joint pain, improved joint function and wellbeing after 2 - 3 weeks of commencing this treatment protocol. NW maintained this regimen on an ongoing basis for a further 12 months. The protocol was then changed to oral daily dose of a single 250 mg Pentabrex™ (containing 125 mg Celebrex and 125 mg NaPPS). Using this new regimen symptomatic relief was maintained as before. During the period of these treatments NW did not observe any adverse side effects while using the daily 250 mg Pentabrex™ formulation or thrice weekly 500mg Pentabrex™ formulation.
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EXAMPLE 4
PG: An active 77 year old male with a history of sport induced post-traumatic osteoarthritis (PTOA) exacerbated by mild bilateral genu valgum leading to medial compartment cartilage loss and bone edema. PG had been a regular user of complementary medicines of putative therapeutic benefits together with regular use of Celebrex™. However, the symptoms of joint pain exacerbated by physical activity remained unresolved and he commenced treatment with a Pentabrex™ formulation comprising 250 mg NaPPS and 250 mg celecoxib (500 mg Pentabrex™, Proteobiactives Pty Ltd) taken orally on an ongoing thrice weekly basis. PG reported amelioration of arthritic symptoms, and reduction in daily use of hypertension medications while maintaining acceptable blood pressure. During the subsequent 12 months PG changed his protocol to a daily oral dose of the 350 mg
Pentabrex™ formulation (containg 175 mg Celecoxib and 175 mg NaPPS). This formulation provided the same positive clinical outcomes as initially experienced, again without any accompanying adverse side effects.
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EXAMPLE 5
LM: A generally fit 72 year old male experienced unacceptable pain at rest from his left hip joint that was exacerbated on walking. Radiological examination showed almost complete loss of joint articular cartilage corresponding to Kellgren and Lawrence grade 4 OA. Following hip replacement surgery and subsequent physiotherapy the pain was resolved. However, within 6 months of the operation he complained of pain arising from his contralateral hip joint and lumbar spine. Subsequent radiographic examination of his spine revealed loss of disc height and marginal osteophytes indicative of spinal OA. This pain was not ameliorated by oral analgesics or NSAIDs including daily consumption of Celebrex™ (200mg).
LM was then treated with Pentabrex™ composed of 250 mg NaPPS and 200 mg celecoxib (Proteobiactives Pty Ltd) taken orally thrice weekly. After following this regimen for 6 - 12 weeks LM reported total relief of pain emanating from both his right hip joint and lumbar spine. No adverse side effects attributable to the medications were reported by LM over this period.
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EXAMPLE 6
In this study, five female patients with established OA of the hands were enlisted in an open clinical trial to evaluate the efficacy and tolerability of a Pentabrex™ formulation (2 x 250 mg capsules, each capsule containing l25mg Celecoxib and 125 mg NaPPS) when taken orally 3 times a week for 6 weeks. These patients were referred to the Subiaco Rheumatology Clinic (Subiaco, Perth, WA, Australia) as their OA symptoms were not satisfactorily resolved by their current usage of analgesics or NSAIDs (including coxibs). To be included in the clinical trial, patients had to be 50 years of age or older and have an OA grade of 3 - 4 (Kellgren JH, Lawrence JS. Radiological assessment of osteoarthrosis. Annals Rheumatic Dis.1957; 16:494 - 502) that had been symptomatic for at least 6 months
Following their consent to participate in the study, patient’s details of the symptomatic hand joints affected and grade of OA were recorded and the level of hand pain and stiffness determined to provide baseline values using validated 10 cm visual analogue scale (VAS) scoring systems (Sokka T. Assessment of pain in patients with rheumatic diseases. Best Pract Res Clin Rheumatol, 2003; 17:427 - 49, Domenica A. Delgado, DA, Lambert B, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring with a Traditional Paper-based Visual Analog Scale in Adults. JAAOS Glob Res Rev 2018; 2:e088 DOI: 10.5434/ ). The duration of their early morning hand stiffness was recorded in minutes, and the grip strength of the symptomatic hand quantified (in kgs) using a Constant electronic hand dynamometer (model number 14192-709E). The use of a dynamometer to quantify grip strength in patients with hand OA has also been validated (Villafane JH, Valdes K, Vanti C, Pillastrini P, Borboni A. Reliability of handgrip strength test in elderly subjects with unilateral thumb carpometacarpal osteoarthritis HAND. 2015: 10:205-209. DO! 10.1007/sl 1552-014-9678-y). The patients w'ere then provided with six week supplies of Pentabrex™ contained in labelled containers. Over the 6 week study period, patients were requested to refrain from using additional analgesics or NSAIDs unless absolutely necessary' and return the container provide for the Pentabrex™ formulation to confirm compliance.
The 4 patients who completed the six week study were re-examined to determine the final values of the same medical parameters that w ere assessed at the commencement of the study. The net changes between the baseline values and the corresponding final values were calculated and the % change from baseline for each parameter determined. Patient’s blood was also collected for routine haematological analysis plus additional assessment of Activated Partial thromboplastin time (APTT) and Prothrombin times (PT) at the time of
commencement of the trial and immediately after its completion.
Table 1 summarises the results of the study. Apart from patient # 2, who dropped-out only after one week stating that the medication w as not affective, all of the remaining patients who completed the six week trial reported positive outcomes with no adverse side effects.
The mean percentage changes from baseline of hand OA symptoms of pain (-58.9%), grip strength (+32.68%), joint stiffness (-45.55%) and duration of stiffness (-29.16%) for the group confirmed the overall significant improvement in the symptoms of hand OA without supplementary'use of commercially available non-opioid analgesises or NSAIDs.
(20min delay)