Iodine for Fibrocystic Breast

Verdict: Published with Warning

Across 3 PubMed studies, the evidence for Iodine in Fibrocystic Breast grades Tier C — weak evidence. Effective, but with safety or population caveats.

C 🟠 C Weak Evidence Published with Warning

🔬Why this grade7-layer evidence engine

⚖️

Scoring transparency

All scores computed by a 7-layer evidence engine — fully auditable
Raw score 0.51
D
C
B
A
S
← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
C · Published with Warning
Confidence
87%
Highly consistent evidence
Evidence level
E6
Multiple smaller RCTs (n<500)

How strongly each layer supports this effect

lower = less supportive
L1 ExamineGlobal benchmark
0.50
L3 MechanismPlausibility
0.50
L11 AI re-checkIndependent read
0.50
L5 Clinical bodiesAuthoritative stance
0.52
L2 PubMedPrimary literature
0.60
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 = 0.508
  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 — Tier 條件達標,未降階
  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 (3)L2 · primary research & systematic reviews

The effect of supraphysiologic levels of iodine on patients with cyclic mastalgia
PMID: 15239792 2004 RCT (double-blind) n = 111
Finding: Molecular iodine produced a statistically significant dose-dependent reduction in the Lewin overall pain scale versus placebo (p<0.01), with >50% of the 6.0 mg/day group achieving a clinically significant pain reduction.
⚠️ Industry-funded Effect size: Dose-dependent improvement, p<0.01; >50% of 6.0 mg/day arm with clinically significant pain reduction
View on PubMed
A Randomized Controlled Multicenter Trial of an Investigational Liquid Nutritional Formula in Women with Cyclic Breast Pain Associated with Fibrocystic Breast Changes
PMID: 29237134 2018 RCT (double-blind) n = 188
Finding: Breast pain fell almost identically in the treatment and control arms (-32.2% vs -33.1%, p=0.64), with significance only on secondary endpoints nodularity (p=0.03) and pain-medication use (p=0.02), and the combined formula prevents attributing any effect to iodine alone.
⚠️ Industry-funded Effect size: Pain -32.2% vs -33.1% (p=0.64, NS); nodularity p=0.03; pain-med use p=0.02
View on PubMed
Iodine replacement in fibrocystic disease of the breast
PMID: 8221402 1993 RCT (double-blind) n = 56
Finding: In the embedded double-blind RCT (n=56), molecular iodine yielded ~65% subjective and objective improvement versus a 33% placebo response, but no p-value was reported and the doses (1.5-6 mg/day) far exceed the safe upper intake limit.
🟠 Limited quality Academic Effect size: ~65% improvement (treatment) vs ~33% (placebo); no p-value reported
View on PubMed

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

L4a US FDA
Supportive
Iodized salt or iodized table salt is the article of commerce, salt for human food use, to which has been added cuprous iodide or potassium iodide. The label shall bear the statement 'This salt supplies iodide, a necessary nutrient'. Cuprous iodide and potassium iodide may be added to table salt as a source of dietary iodine in an amount not greater than 0.01 percent. source↗
L4b EU EFSA
Supportive
Iodine contributes to normal cognitive function, normal functioning of the nervous system, the maintenance of normal skin, normal production of thyroid hormones and normal thyroid function, and contributes to normal growth of children source↗
L4c UK NHS
Cautious
Adults need 140 micrograms (μg) of iodine a day. Most people should be able to get all the iodine they need by eating a varied and balanced diet. Taking high doses of iodine for long periods of time could change the way your thyroid gland works. This can lead to a wide range of different symptoms, such as weight gain. Taking 0.5mg or less a day of iodine supplements is unlikely to cause any harm. source↗
L4d TW TFDA / 衛福部
Supportive
孕婦碘的每日建議攝取量為225微克,較一般成人140微克高出許多;衛生福利部建議孕婦及哺乳婦使用加碘鹽,並可適量攝取含碘量豐富的食物,如海帶、海藻類等。 source↗
L4e WHO
Supportive
All food-grade salt, used in household and food processing should be fortified with iodine as a safe and effective strategy for the prevention and control of iodine deficiency disorders in populations living in stable and emergency settings. source↗
L5a NIH Office of Dietary Supplements
Supportive
Iodine is a mineral found in some foods. The body needs iodine to make thyroid hormones. These hormones control the body's metabolism and many other important functions. The body also needs thyroid hormones for proper bone and brain development during pregnancy and infancy. source↗
L5c Cleveland Clinic
Cautious
Experts recognize iodine deficiency as a possible factor causing fibrocystic breasts. One older study reported that iodine therapy can help relieve the symptoms of fibrocystic breast changes. source↗
PMID 100% verifiedevery citation checked via NCBI Entrez
🔬3 PubMed studiesindependently re-checked by multiple sub-agents
engine_version: v1.0 claim_id: CLM-COND-fibrocystic-breast-INT-iodine-001 繁體中文版 →