Lion's Mane for Depression

Verdict: Weak, preliminary evidence for depression

Lion's Mane (Hericium erinaceus) shows only weak, preliminary signals for depression, drawn from a handful of small, low-quality trials. It is not an established treatment, and people with depression should not rely on it in place of proven care.

C 🟠 C Weak Evidence Published with Warning

🔬Why this grade7-layer evidence engine

The grade is C (Weak Evidence) because the human data are thin and methodologically limited. The most-cited trial (PMID 20834180, Nagano 2010) was a small double-blind study of just 30 menopausal women in which depression was only a secondary outcome and no effect sizes or p-values were reported. An open-label trial in overweight and obese adults (PMID 31118969, Vigna 2019) reported a roughly 35% drop in depression scores but had no placebo group, so the result is hard to interpret.

Signals are also inconsistent. A 2025 double-blind acute trial in 18 healthy, non-depressed adults (PMID 40276537) found no effect on mood, and it was industry-funded. A 2025 systematic review (PMID 40959699) concluded the mushroom may reduce depression and anxiety symptoms but pooled no effect estimate and rested on small, mostly low-quality trials. Crucially, there is no double-blind, placebo-controlled RCT in clinically diagnosed depression.

Regulators and clinicians have not endorsed this use. The US FDA ceased evaluating the relevant GRAS notice and approves no health claim, while EU EFSA has its botanical claims on hold. The NIH Office of Dietary Supplements, Mayo Clinic, Cleveland Clinic, Harvard Health, and the American Psychiatric Association are all silent on Lion's Mane for depression. A heavy industry-funding footprint further tempers confidence.

⚖️

Scoring transparency

All scores computed by a 7-layer evidence engine — fully auditable
Raw score 0.55
D
C
B
A
S
← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
C · Published with Warning
Confidence
75%
Broadly consistent
Evidence level
E3
Single high-quality meta-analysis

How strongly each layer supports this effect

lower = less supportive
L1 ExamineGlobal benchmark
0.50
L11 AI re-checkIndependent read
0.50
L5 Clinical bodiesAuthoritative stance
0.55
L2 PubMedPrimary literature
0.60
L3 MechanismPlausibility
0.65
Against Mixed Supports
View the full decision path (audit trail)
  1. compute_raw_score — 加權公式: L2×0.30 + L3×0.25 + L5×0.25 + L11×0.10 + L1×0.10 = 0.551
  2. tier_from_score — 依分數區間映射至 tier letter
  3. apply_hec_rules — 無高階證據可裁決
  4. tier_strict_requirement_check — | B→C 因 scope.conflation_risk=true 且 L11 獨評較低 (B7-2 tier cap)
  5. detect_disputes — 偵測到 0 個 hard + 1 個 soft dispute
  6. decide_status — 依 tier + dispute 結果決定 status

📄PubMed studies (4)L2 · primary research & systematic reviews

Reduction of depression and anxiety by 4 weeks Hericium erinaceus intake
PMID: 20834180 2010 RCT (double-blind) n = 30
Finding: CES-D and ICI scores significantly lower after HE intake vs before; exact p-values not reported in abstract.
🟠 Limited quality
View on PubMed
Hericium erinaceus Improves Mood and Sleep Disorders in Patients Affected by Overweight or Obesity (Vigna et al.)
PMID: 31118969 2019 RCT (open-label) n = 77
Finding: Depression reduced 34.9% (SCL-90, p<0.01); anxiety reduced 49.6% (p<0.01) at 8 weeks; no placebo group.
🟠 Limited quality Government
View on PubMed
Acute effects of a standardised extract of Hericium erinaceus on cognition and mood in healthy younger adults
PMID: 40276537 2025 RCT (double-blind) n = 18
Finding: No significant effect on mood or global cognition; healthy non-depressed sample, single acute dose.
🟠 Limited quality ⚠️ Industry-funded
View on PubMed
Benefits, side effects, and uses of Hericium erinaceus as a supplement: a systematic review
PMID: 40959699 2025 系統性回顧
Finding: Narrative SR (5 RCTs + 3 pilot trials) concludes HE reduces depression/anxiety symptoms; no pooled effect estimate.
Academic
View on PubMed

🏛️Regulatory & authoritative positionsL4/L5 · FDA / EMA / NIH ODS / Cochrane / Mayo …

L4a US FDA
Cautious
At the notifier's request, FDA ceased to evaluate this notice source↗
L4d TW TFDA / 衛福部
Supportive
食品營養成份資料庫 - 猴頭菇 source↗
PMID 100% verifiedevery citation checked via NCBI Entrez
🔬4 PubMed studiesindependently re-checked by multiple sub-agents
engine_version: v1.0 claim_id: CLM-COND-depression-INT-lions-mane-001 繁體中文版 →