HOW WE CLASSIFY EVIDENCE.
HUMAN CLINICAL TRIALS
Randomized controlled trials or Phase 2/3 data in human subjects. The gold standard.
STRONG PRECLINICAL
Extensive animal surgical models with consistent results. Published in peer-reviewed journals. Considered investigational.
EARLY RESEARCH
Mechanistic rationale, limited clinical data, or non-Western trial evidence. Included only where mechanism is compelling and risk is low.
COMPOUND BY COMPOUND.
EVIDENCE BY PROTOCOL.
READY
Pre-Surgical OptimizationTirzepatide has Phase 3 FDA-approved data (SURMOUNT-1/2). Strongest evidence base of any protocol. GLP-1 receptor agonists are FDA-approved for chronic weight management.
RECOVER
Orthopedic RecoveryStrong preclinical evidence across multiple surgical tendon/ligament models. TB-500 adds Phase 2 wound data. Zero human RCTs in orthopedic populations specifically. BPC-157 considered investigational.
REBUILD
Muscle & Bone RecoveryTier 1 base: CJC-1295 + Ipamorelin (Growth Hormone Therapy). Human pharmacokinetic data confirms GH/IGF-1 elevation (Teichman 2006, Raun 1998). No bone-specific RCTs, but GH-axis support has adjacent rhGH human literature. Physiologic-dose growth hormone peptides with strict exclusions.
FOUNDATION
Daily Supplement SupportStandard-of-care vitamin and mineral supplementation. No investigational compounds. Evidence base is established nutritional science for bone health, lean mass, and metabolic function.
WHAT WE DON'T KNOW YET.
BPC-157's preclinical evidence is extraordinary in scope. It is also not human data. A plaintiff's expert asked under oath “how many randomized controlled trials in humans support post-surgical use of BPC-157?” will correctly answer “zero.”
Every publication in the BPC-157 space comes disproportionately from one research group (Sikiric et al., Zagreb). This is a known replicability concern — the 2025 Narrative Review explicitly flagged it as “possible publication bias toward positive findings.”
No human drug-interaction studies exist for BPC-157 with anticoagulants — and every post-surgical patient is on anticoagulation. The preclinical hemostatic interaction data (Stupnisek 2012/2015) shows effects, but whether those effects are beneficial or dangerous in humans is unknown.
We publish these gaps because the competitors who hide them are precisely what the FDA reclassification decision will be measured against. Being the operator that is obviously the safer, more transparent alternative is the strategic position worth claiming.
ADVISORY BOARD
Peer-reviewed by people whose names you can verify.
Truthe Ortho's clinical and scientific advisors review protocols, evaluate emerging evidence, and hold us accountable to the standards of academic medicine.
Name, MD / PhD
Credentials
Clinical Protocol ReviewerName, MD / PhD
Credentials
Scientific Evidence AdvisorName, MD / PhD
Credentials
Pharmacovigilance & SafetyAdvisor announcements coming Q3 2026
THE EVIDENCE INFORMS THE PROTOCOL.
See how we translate research into physician-designed recovery protocols.