Omega-3 Fatty Acids
| 證據等級: L5 | 預測適應症: 10 個 |
目錄
Omega-3 Fatty Acids: From Nutritional Supplementation to Tendinitis
One-Sentence Summary
Omega-3 fatty acids (DrugBank DB11133) are widely used as a nutritional/dietary supplement, with no specific original indication documented in this evidence pack. The TxGNN model predicts they may be effective for Tendinitis, with 0 clinical trials and 16 publications currently supporting this direction, including one relevant randomized controlled trial in rotator cuff–related shoulder pain.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not specified in the evidence pack (Omega-3 fatty acids are commonly used as a nutritional/dietary supplement) |
| Predicted New Indication | Tendinitis |
| TxGNN Prediction Score | 99.13% |
| Evidence Level | L2 |
| South Africa Market Status | Not Marketed |
| Number of SAHPRA Registrations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, Omega-3 fatty acids belong to the polyunsaturated fatty acid (PUFA) class, most commonly used as a nutritional/dietary supplement rather than a registered prescription indication, and mechanistically may be applicable to tendinitis through their known anti-inflammatory and pro-resolving lipid mediator activity (e.g., resolvins, lipoxins, maresins) demonstrated in tendon tissue.
The repurposing rationale generated for this candidate notes that Omega-3, and DHA in particular, has animal-study evidence of suppressing pro-inflammatory mediators (IL-1β, TNF-α) and improving tendon collagen repair, while human observational data show that degenerative rotator cuff tears are associated with a lower “Omega-3 Index.” This provides a biologically plausible, though still preliminary, link between the drug’s known anti-inflammatory pharmacology and the chronic inflammatory/degenerative process underlying tendinitis and tendinopathy.
Because Omega-3 fatty acids have no clearly documented original therapeutic indication in this pack (they are typically used as a general nutritional supplement), the strength of this prediction rests primarily on mechanistic plausibility and early-stage clinical/preclinical data rather than on an established indication-to-indication analogy.
Clinical Trial Evidence
Currently no related clinical trials registered for tendinitis.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 30364577 | 2018 | RCT | BMJ Open Sport & Exercise Medicine | Multicentre, double-blind, placebo-controlled RCT of long-chain omega-3 PUFA in the management of rotator cuff–related shoulder pain |
| 16215602 | 2005 | RCT (negative) | Tidsskrift for den Norske Laegeforening | Randomised trial found no effect of essential fatty acid supplementation on pain in lateral epicondylitis |
| 36458821 | 2023 | Animal study | Applied Physiology, Nutrition, and Metabolism | Omega-3 plus exercise reduced collagenase-induced Achilles tendinopathy severity in a rat model |
| 34612118 | 2022 | Animal study | Connective Tissue Research | DHA supplementation modulated cytokines and showed protective effect in a collagenase-induced Achilles tendinopathy rat model |
| 31492432 | 2019 | Cohort | Prostaglandins, Leukotrienes, and Essential Fatty Acids | Degenerative rotator cuff tears were associated with a lower Omega-3 Index compared with controls |
| 37146985 | 2023 | Review | Journal of Sport Rehabilitation | Scoping review of nutritional supplements, including omega-3, used in the clinical management of tendinopathy |
| 18950988 | 2009 | Review | Journal of Hand Therapy | Reviews the potential role of PUFAs and antioxidants in rotator cuff tendinopathy management |
| 40376939 | 2025 | Preclinical/mechanistic | The American Journal of Sports Medicine | Investigates effect of aerobic exercise combined with omega-3 supplementation on the tendon healing process |
| 31526772 | 2019 | Commentary | The American Journal of Pathology | Commentary on the role of bioactive lipids in resolution of inflammation in shoulder tendon tears |
| 28887458 | 2017 | Mechanistic study | Scientific Reports | Shows dysregulated pro-resolving lipid mediator responses (including omega-3–derived mediators) in stromal cells from chronic tendinopathy patients |
South Africa Market Information
Omega-3 fatty acids (DrugBank DB11133) currently have no SAHPRA registrations on record; market status is Not Marketed in South Africa.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale: Evidence for tendinitis is currently limited to one relevant RCT (rotator cuff shoulder pain, with a second negative RCT in lateral epicondylitis) plus supportive animal and mechanistic studies — no indication-specific interventional trials are registered, and the drug has no current SAHPRA market presence. The blocking data gap in SAHPRA-equivalent safety/PI information also prevents a formal safety review at this stage.
To proceed, the following is needed:
- SAHPRA-approved Professional Information (PI), including warnings, contraindications, and DDI data (currently a blocking gap)
- Confirmed mechanism of action data for Omega-3 fatty acids
- Adequately powered, tendinitis-specific randomized controlled trials
- A regulatory pathway/registration assessment, given the drug is currently not marketed in South Africa
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.