What peer-reviewed clinical trials exist for supplements commonly marketed for tinnitus or hearing loss?
Executive summary
Peer-reviewed clinical trials for supplements marketed to treat tinnitus or hearing loss exist but are heterogeneous in quality and results: notable randomized trials and reviews have examined Ginkgo biloba, magnesium, lipoflavonoid/vitamins, various antioxidant combinations (including ACEMg/Soundbites), traditional herbal mixes such as Gushen Pian, and single‑ingredient trials (e.g., curcumin/boswellia), with many studies reporting conflicting or null results and some signal for sleep‑ or reaction‑related benefits rather than elimination of tinnitus [1] [2] [3] [4] [5].
1. Ginkgo biloba — the most studied, but inconsistent evidence
Ginkgo biloba is the dietary supplement with the largest body of tinnitus research: multiple randomized clinical trials and reviews have produced mixed outcomes, with some trials reporting improvement in tinnitus scores and others showing no effect, and clinical guidance warns of risks for people with seizures or bleeding disorders when using Ginkgo [1] [5] [6].
2. Lipoflavonoid and vitamin combinations — a negative randomized trial stands out
Commercial formulations built around flavonoids and vitamins (Lipoflavonoid Plus® and combinations with manganese) were tested in at least one randomized clinical trial and were not shown to reduce tinnitus compared with control, prompting major patient‑education groups to caution against expecting a “magic pill” from these products [1] [6].
3. Magnesium — phase 2 randomized testing with some premise but limited definitive benefit
A phase 2 randomized study examined magnesium supplementation (532 mg daily) for moderate to very severe tinnitus, grounding the trial in prior observational suggestions that magnesium might mitigate noise‑induced or idiopathic sensorineural hearing loss and associated tinnitus; the existence of that phase 2 trial is documented though its results require careful reading and replication before clinical endorsement [3].
4. Antioxidant combinations and ACEMg/Soundbites — industry‑backed trials and ongoing studies
Combination antioxidant regimens, including ACEMg marketed as Soundbites, have been the subject of real‑world data and are being validated in controlled trials such as the 24‑week OTIS study that aims to prospectively assess hearing stabilization or improvement and effects on tinnitus and hyperacusis; these are positioned as neuroprotective approaches but rely in part on company‑sponsored pipelines and need independent peer‑reviewed outcomes to be persuasive [4] [7].
5. Herbal mixtures and traditional formulas — small RCTs and exploratory findings
Herbal mixtures used in traditional medicine, notably Gushen Pian and Korean red ginseng, have appeared in double‑blind randomized trials and single‑center studies showing occasional statistically significant benefits, yet reviews stress limited sample sizes, variable standardization of extracts, and inconsistent replication across independent trials [5] [8].
6. Single‑ingredient and newcomer trials — curcumin/boswellia and other nutraceuticals
Recent trial listings include a study testing a pill combining curcumin and boswellia for severe tinnitus attributed to hearing loss; such trials are typically framed around anti‑inflammatory mechanisms but remain early and require peer‑reviewed publication of outcomes to alter practice [7].
7. Reviews, surveys and the bottom line — modest benefits, safety caveats, and research gaps
A 2016 survey of supplement users found most reported no effect from supplements (70.7%), with only a minority reporting improvement and some reporting worsened symptoms or adverse effects, while scoping reviews and patient‑education groups summarize the clinical trial landscape as conflicting and insufficient to recommend routine use of supplements for tinnitus; overall the literature more reliably shows occasional benefit for sleep or emotional reaction (e.g., melatonin, some flavonoid effects) than for tinnitus elimination itself [2] [9] [1] [6].
8. What the evidence does not yet show and where to watch next
Current gaps include standardized extract dosing, larger multicenter randomized trials with independent funding, and head‑to‑head comparisons with established behavioral therapies; several investigational agents and drug‑class compounds (e.g., ebselen/SPI‑1005) are advancing in clinical programs for hearing‑related indications, but these are pharmacologic candidates rather than over‑the‑counter supplements and highlight an evolving research pipeline distinct from traditional nutraceuticals [10].