Black Seed for Asthma

Verdict: Promising add-on, but evidence is preliminary

Early trials suggest black seed (Nigella sativa) may modestly improve asthma control and lung function when added to standard inhaled medication, but the evidence is small and uncertain, and it should never replace prescribed controller inhalers.

B 🟡 B Preliminary Evidence Published with Warning

🔬Why this grade7-layer evidence engine

Two meta-analyses (PMID 34658694, pooling 4 RCTs and 187 patients; PMID 31892440) consistently found that Nigella sativa significantly improved Asthma Control Test scores (SMD ~0.50) and FEV1 (SMD 1.84), though it did nothing for peak expiratory flow. Supporting RCTs include a double-blind, MRC-funded trial (PMID 28093815) showing a ~1.5-point ACT gain and lower blood eosinophils, and a trial (PMID 28151459) where 2 g/day improved FEV1 and lowered airway inflammation markers (FeNO, IgE).

The grade stays at preliminary (Tier B) because the evidence base is genuinely thin: only about four RCTs, heterogeneous and often poorly characterized preparations (seed powder vs oil) at varying doses, and a very wide FEV1 confidence interval (0.07-3.60) signaling imprecision. Most trials were low quality with undisclosed funding, and there are too few studies to rule out publication bias.

Regulators and clinics add caution rather than endorsement. The US FDA treats black seed only as a GRAS culinary spice (21 CFR 182.10), not as a proven supplement, while EFSA, NHS and WHO have not addressed it. Among major clinics only Cleveland Clinic comments, and it is merely cautiously supportive, stressing it is not a substitute for controller medication. Critically, every trial used black seed as an add-on to maintenance inhalers, and GINA/ATS guidelines do not endorse it.

⚖️

Scoring transparency

All scores computed by a 7-layer evidence engine — fully auditable
Raw score 0.57
D
C
B
A
S
← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
B · Published with Warning
Confidence
80%
Broadly consistent
Evidence level
E2
Multiple high-quality MAs (≥2 independent, consistent)

How strongly each layer supports this effect

lower = less supportive
L5 Clinical bodiesAuthoritative stance
0.40
L1 ExamineGlobal benchmark
0.50
L11 AI re-checkIndependent read
0.50
L3 MechanismPlausibility
0.65
L2 PubMedPrimary literature
0.70
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 = 0.573
  2. tier_from_score — 依分數區間映射至 tier letter
  3. apply_hec_rules — 高品質 SR/MA 顯示 positive (1 篇 > 0 negative)
  4. tier_strict_requirement_check — Tier 條件達標,未降階
  5. detect_disputes — 偵測到 0 個 hard + 0 個 soft dispute
  6. decide_status — 依 tier + dispute 結果決定 status

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

The efficacy of Nigella sativa supplementation for asthma control: a meta-analysis of randomized controlled studies
PMID: 34658694 2021 統合分析 n = 187
Finding: Pooled across 4 RCTs (187 subjects), Nigella sativa significantly improved ACT scores (SMD 0.50, 95% CI 0.11 to 0.88, p=0.01) and FEV1 (SMD 1.84, 95% CI 0.07 to 3.60, p=0.04), but had no significant effect on PEF (SMD 3.11, 95% CI -1.30 to 7.52, p=0.17). All included studies scored Jadad 3-4.
🟠 Limited quality Effect size: SMD ACT +0.50; SMD FEV1 +1.84; PEF NS
View on PubMed
The influence of Nigella sativa for asthma control: A meta-analysis
PMID: 31892440 2020 統合分析
Finding: Across 4 RCTs, Nigella sativa supplementation was associated with increased ACT scores (SMD 0.50, 95% CI 0.11 to 0.88, p=0.01) and FEV1 (SMD 1.84, 95% CI 0.07 to 3.60, p=0.04), but no significant impact on PEF (SMD 3.11, 95% CI -1.30 to 7.52, p=0.17), IL-4, or IFN-gamma.
🟠 Limited quality Effect size: SMD ACT +0.50; SMD FEV1 +1.84; PEF/IL-4/IFN-gamma NS
View on PubMed
Nigella sativa Supplementation Improves Asthma Control and Biomarkers: A Randomized, Double-Blind, Placebo-Controlled Trial
PMID: 28093815 2017 RCT (double-blind) n = 80
Finding: After 4 weeks, the NSO group had higher mean ACT score (21.1, SD 2.6) than placebo (19.6, SD 3.7), p=0.044, and reduced blood eosinophils (-50 vs +15 cells/microL, p=0.013). FEV1 improvement (4% vs 1%) did not reach significance (p=0.170). 70 of 80 enrolled completed.
Effect size: ACT mean difference ~1.5 points (p=0.044); eosinophils p=0.013; FEV1 NS
View on PubMed
Effect of Nigella sativa supplementation on lung function and inflammatory mediators in partly controlled asthma: a randomized controlled trial
PMID: 28151459 2017 RCT (single-blind) n = 76
Finding: FEF25-75% and FEV1 increased significantly in the 2 g/day group (p<0.05). FeNO and serum IgE decreased significantly in both treatment groups by 12 weeks (p<0.05). ACT scores improved significantly at 6 and 12 weeks in both groups (p<0.001, p<0.01). Fewer exacerbations in the 1 g/day group (p<0.05).
🟠 Limited quality Effect size: FEV1 / FEF25-75 significant at 2 g/day; ACT significant both doses; FeNO and IgE reduced
View on PubMed

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

L4a US FDA
Cautious
black cumin (black caraway), Nigella sativa L. — listed as a spice and other natural seasoning and flavoring (21 CFR 182.10), GRAS source↗
L4b EU EFSA
Neutral
L4d TW TFDA / 衛福部
Neutral
黑種草能食用的部位是黑種草籽油,只要適量食用,不會有特別的風險。 source↗
L5a NIH Office of Dietary Supplements
Cautious
L5c Cleveland Clinic
Cautious
L5e Specialty Society (condition-mapped)
Not addressed
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-asthma-INT-black-seed-001 繁體中文版 →