Unsaponifiable avocado/soybean ingredients

Unsaponifiable avocado/soybean ingredients

Unsaponifiable avocado/soybean ingredients

Clinical overview

Use

dosage

For the treatment of osteoarthritis, doses of 300 or 600 mg ASU/day (typical duration 6 months) have been investigated.

Contraindications

Contraindications have not been identified.

Pregnancy/breastfeeding

There is a lack of information regarding the effectiveness and safety of ASU during pregnancy and breastfeeding. Avocado fruits and soybeans are both generally recognized as safe (GRAS) when used as food.

Interactions

None are well documented.

Side effects

No clinically significant side effects were reported. Mild gastrointestinal complaints were rarely documented in reviews, just as often as with the comparison drug or placebo.

toxicology

No data.

Scientific family

• Fabaceae (Bohne)
• Lorbeergewächse

botany

ASU is obtained from avocado (Laurus persea L. or Persea americana Mill.) and soybean (Glycine max L. Merr.) plants (see individual avocado and soy monographs).

Story

Clinical studies evaluating ASU, conducted primarily by French researchers, first appeared in the literature in the 1970s. The published results were limited to a few research groups. Interest in veterinary applications has increased. Henrotin 2005, Henrotin 1998, Kawcak 2007 ASU has been studied in in vitro and in vivo animal models of experimental osteoarthritis. A commercial ASU product (Piascledine) is widely used for osteoarthritis in Europe (e.g. France) and has been evaluated as an alternative or adjunctive therapy to standard nonsteroidal anti-inflammatory drugs (NSAIDs). Frondoza 2018, Gluszko 2016, Henroitin 2017

Chemistry

ASU consists of unsaponifiable portions of avocado and soybean extracts. Gluszko 2016 Portions of avocado and soybean oils (approximately 1%) are unsaponifiable (i.e. cannot be hydrolyzed or made into soap) and are generally used in a combination to form ASU in a ratio of 1:2 (one third avocado and two thirds unsaponifiable soybean).Christiansen 2015, Gluszko 2016, Henrotin 1998, Lippiello 2008. Other avocado:unsaponifiable soybean ratios have been evaluated.Henrotin 1998

The main components of ASU are the phytosterols beta-sitosterol, campesterol and stigmasterol, as well as saturated hydrocarbons, squalene, tocopherols and alcohols. Henrotin 1998, Lippiello 2008

Use and Pharmacology

Anti-inflammatory effect

Animal and in vitro data

Anti-inflammatory effects have been demonstrated in vitro and in animal studies. (Al-Afify 2018, Christensen 2008, Goudarzi 2018, Henrotin 1998, Kawcak 2007, Lippiello 2008, Oliveira 2016) Several possible mechanisms of action have been described. (Frondoza 2018, Gluszko 2016, Henrotin 2017)

In a mouse model of knee osteoarthritis, oral administration of ASU 27.5 mg/kg daily for 3 weeks attenuated synovial, cartilage, and subchondral bone degeneration and reduced the expression of inflammatory mediators such as tumor necrosis factor alpha and matrix metalloproteinase-13, contributing to beneficial structure-modifying effects indicates osteoarthritis. (Al-Afify 2018, Ernst 2003) Furthermore, administration of ASU in a rat model of arthritis improved osseointegration as measured by bone-implant contact and bone area between sutures.(dePaula 2018)

In a small study of horses (N=16) with induced osteoarthritis, ASU supplementation did not improve outcomes of pain or lameness; However, researchers reported a reduction in the severity of articular cartilage erosion and synovial hemorrhage, as well as increased glycosaminoglycan synthesis in articular cartilage. (Kawcak 2007)

Clinical data

Clinical studies largely support the role of ASU in the treatment of osteoarthritis due to its anti-inflammatory effects; However, there are methodological limitations and sponsorship bias in the studies. (Christiansen 2015, Cornblatt 2016, Ernst 2003) Pain reduction has been reported; However, the effectiveness of ASU on structural disease-modifying properties has not been confirmed by radiological evidence in independent studies.

In a meta-analysis of 4 industry-funded clinical trials conducted before 2002 (664 patients with knee and/or hip osteoarthritis), the addition of ASU resulted in improvements in pain scores and functional indices, particularly in patients with knee osteoarthritis. (Christiansen 2008, Ernst 2003)

Other studies also report improvements in pain and function. A 6-month multicenter clinical trial comparing ASU (i.e., Piascledine) to chondroitin in patients with osteoarthritis of the knee (N=364) suggested equivalent efficacy, with reductions in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne Index scores noted for both groups. No adverse effects were documented in the study. (Pavelka 2010)

A three-year, industry-sponsored clinical trial in patients with hip osteoarthritis (N=399) who received 300 mg ASU/day or placebo suggested a protective effect of ASU therapy on the joint, as measured by the change in joint space width along the length of the process. A lower rate of progression (worsening) was noted in the ASU group (40% vs. 50%; P = 0.04), but no difference in mean joint space width loss was noted. No differences were noted for secondary outcomes of Lequesne index score, WOMAC pain score, or use of analgesics or NSAIDs. (Maheu 2014)

An open study of 4,822 patients with knee osteoarthritis examined the effects of 300 mg ASU daily for 6 months. The proportion of patients taking NSAIDs or other analgesics decreased from 58.8% at baseline to 24.9% after 6 months of therapy (P < 0.001). In addition, functional impairment, as measured by the Lequesne index, improved significantly from baseline to the last visit (mean score decrease from 8 to 4 points). [P<0.001]). ASU was also associated with a significant improvement in pain intensity from baseline (P < 0.001). (Gluszko 2016)

In a 6-month clinical trial evaluating ASU 300 mg daily compared to placebo in patients with osteoarthritis of the temporomandibular joint (N=14), reductions in pain and rescue analgesic use were reported in those receiving ASU. (Catunda 2016)

The European League Against Rheumatism's updated recommendations for the treatment of hand osteoarthritis (2018) indicate that there is no evidence for the clinical effectiveness of the use of avocado-soybean unsaponificents. (Kloppenburg 2018)

Antimicrobial effect

Animal data

Co-administration of ASU with praziquantel increased the elimination of Schistosoma mansoni in mice. (Soliman 2012)

Metabolic syndrome

Clinical data

ASU did not alter insulin sensitivity in a small clinical trial in obese adults (N=7). (Martinez-Abundis 2013)

wound healing

Animal data

A study in rats suggests that the anti-inflammatory effects of ASU may be responsible for the observed increased collagen synthesis and reduced inflammation during wound healing. (de Oliveira 2013, Oryan 2015)

dosage

ASU dosages (e.g., piascledine) of 300 or 600 mg/day (typical duration 6 months) have been studied for the treatment of osteoarthritis (e.g., osteoarthritis of the knee, hip, or temporomandibular joint). Catunda 2016, Gluszko 2016, Maheu 2014, Pavelka 2010

Pregnancy/breastfeeding

There is a lack of information regarding the use of ASU during pregnancy and breastfeeding. Avocado fruits and soybeans are both considered GRASS when used as food.

Interactions

None are well documented.

Side effects

No clinically significant side effects were reported in clinical studies.Catunda 2016, Pavelka 2010 In reviews, mild gastrointestinal complaints were rarely documented, with a similar frequency to that of the comparator product or placebo.Christensen 2008, Ernst 2003 In a safety meta-analysis, the side effect profile of ASU was similar to that of placebo.Honvo 2019

toxicology

The information is limited. Lack of short-term toxicity has been reported in in vitro studies with unsaponifiable mixtures. Henrotin 1998 See individual avocado and soy monographs.

References

Disclaimer

This information relates to an herbal, vitamin, mineral or other dietary supplement. This product has not been evaluated for safety or effectiveness by the FDA and is not subject to the quality and safety information collection standards that apply to most prescription drugs. This information should not be used to decide whether or not to take this product. This information does not confirm that this product is safe, effective, or approved to treat any patient or medical condition. This is just a brief summary of general information about this product. It does NOT contain all information about the possible uses, instructions, warnings, precautions, interactions, side effects or risks that may apply to this product. This information does not constitute specific medical advice and does not replace the information you receive from your healthcare provider. You should speak to your doctor to get complete information about the risks and benefits of using this product.

This product may interact negatively with certain health and medical conditions, other prescription and over-the-counter medications, foods or other dietary supplements. This product may be unsafe if used before surgery or other medical procedures. It is important to fully inform your doctor about the herbs, vitamins, minerals, or other supplements you are taking before any surgery or medical procedure. With the exception of certain products generally considered safe in normal amounts, including the use of folic acid and prenatal vitamins during pregnancy, this product has not been adequately studied to determine whether it is safe for use during pregnancy, breastfeeding, or in those younger than 2 years of age.

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Cartilage. 2018;9(3):304-312.29156944Głuszko P, Stasiek M. Symptom-modifying effect of oral unsaponifiable avocado/soybean in routine treatment of knee osteoarthritis in Poland. An open-label, prospective, observational study of patients who adhered to 6 months of treatment. Reumatology. 2016;54(5):217-226.27994265Goudarzi R, Reid A, McDougall JJ. Evaluation of the novel unsaponifiable avocado/soybean oil arthrocene to alter joint pain and inflammation in a rat model of osteoarthritis. Plus one. 2018;13(2):e0191906.29489828Henrotin Y, Sanchez C, Balligand M. Pharmaceutical and nutraceutical treatment of osteoarthritis in dogs: current and future perspectives. Vet J. 2005;170(1):113-123.15993795Henrotin YE. Unsaponifiable substances from avocado/soybeans (Piacledine 300) show a positive effect on the metabolism of osteoarthritic cartilage, synovium and subchondral bone: an overview of the mechanisms. AIMS Medical Science. 2017;5(1):33-52.Henrotin YE, Labasse AH, Jaspar JM, et al. Effects of three unsaponifiable mixtures of avocado and soybean on metalloproteinases, cytokines and prostaglandin E2 production by human articular chondrocytes. Rheumatol Clinic. 1998;17(1):31-39.9586676Honvo G, Reginster JY, Rabenda V, et al. Safety of symptomatic, slow-acting medications for osteoarthritis: results of a systematic review and meta-analysis. Drug aging 2019;36(suppl 1):S65-S99.31073924Kawcak CE, Frisbie DD, McIlwraith CW, Werpy NM, Park RD. Evaluation of unsaponifiable avocado and soybean extracts for the treatment of horses with experimentally induced osteoarthritis. Bin J Vet Res. 2007;68(6):598-604.17542691Kloppenburg M, Kroon FP, Blanco FJ, et al. 2018 update of the EULAR recommendations for the treatment of hand osteoarthritis. Ann Rheum Dis. 2019;78(1):16-24. doi:10.1136/annrheumdis-2018-21382630154087Lippiello L, Nardo JV, Harlan R, Chiou T. Metabolic effects of avocado/soy unsaponifiables on articular chondrocytes. 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