Soybean Oil
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Soybean Oil: From Parenteral Nutrition (Lipid Source) to Amenorrhea
One-Sentence Summary
Soybean oil is a lipid source used in injectable lipid emulsions for nutrition, and it is currently marketed in Singapore as part of SMOFlipid 20%. The TxGNN model predicts it may be effective for amenorrhea (score 99.6%), but no clinical trials and no publications currently support this specific prediction. The evidence is model prediction only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the registration data (the product is an injectable lipid emulsion) |
| Predicted New Indication | Amenorrhea |
| TxGNN Prediction Score | 99.61% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, soybean oil is a lipid source (an omega-6 rich vegetable oil) used in injectable lipid emulsions. Its established role is as a source of calories and essential fatty acids, not as a treatment for a gynaecological condition.
Some soybean preparations contain phytoestrogen-related constituents, which could in theory touch on hormonal pathways. However, the data compiled for this report do not support a mechanism linking soybean oil to the treatment of amenorrhea. The high TxGNN score reflects a graph-based statistical association, not demonstrated biology. This prediction should be treated as a hypothesis only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available for amenorrhea.
For context, the other predicted indications also lack direct support. The only one with any publications is esophageal disease (rank 4, score 98.3%, evidence level L4). Its seven publications are indirect:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 10024108 | 1999 | Clinical study | Annals of Surgery | Soybean oil emulsion with EPA and its effects on stress response and immune function after surgery for esophageal cancer |
| 22457418 | 2013 | Clinical/ex vivo study | JPEN | Slow infusion of soybean oil emulsion and its effect on cytokines and T-cell proliferation after esophagectomy |
| 9646301 | 1998 | Review | Nutrition | n-3 versus n-6 polyunsaturated fatty acids in critical illness, including esophageal cancer patients |
| 17868414 | 2007 | Animal study | Cancer Science | High animal-fat intake altered bile-acid composition and promoted Barrett's esophagus and adenocarcinoma in rats |
| 27716366 | 2016 | Animal study | Lipids in Health and Disease | n-3/n-6 PUFAs and their effect on acute reflux esophagitis in rats |
| 31795982 | 2019 | Case report | BMC Pulmonary Medicine | Lipoid pneumonia linked to avocado/soybean unsaponifiables (off-topic, a harm report) |
| 105637 | 1979 | Case report | Am J Hosp Pharm | Essential fatty acid deficiency in fat-free parenteral nutrition (off-topic) |
None of these shows that soybean oil treats esophageal disease. They concern perioperative nutrition or animal models, and the n-6-rich oil may be pro-inflammatory rather than beneficial.
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN13246P | SMOFlipid 20% | Injection, emulsion | Not stated in the registration data |
Safety Considerations
Please refer to the package insert for safety information.
No drug-interaction records were found for this drug, and no disease contraindications were identified in the knowledge graph. This is not evidence that none exist.
Conclusion and Next Steps
Decision: Hold
Rationale: The amenorrhea prediction rests only on a model score, with no trials, no publications and no plausible mechanism in the available data. Other predicted indications, such as bone Paget disease, congenital malformations and several carcinomas, are also prediction-only (L5) and lack a credible biological link.
To proceed, the following is needed:
- Package insert warnings and contraindications from the HSA, which is a blocking gap for safety screening
- Mechanism of action data (for example from DrugBank)
- The approved indication text for SMOFlipid 20%
- A targeted literature search linking lipid or soybean-derived components to amenorrhea or menstrual function
- Confirmation of route compatibility, since the only available product is an intravenous emulsion
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.