What randomized clinical trials have been published testing multi‑ingredient tinnitus supplements (e.g., AUDISTIM) and what were their outcomes?

1. What the question really asks and what the evidence set covers

The user seeks randomized clinical trials specifically of multi‑ingredient tinnitus supplements (for example commercial combinations such as Lipoflavonoid products or named blends like AUDISTIM); the available literature in the supplied reporting includes RCTs of Lipoflavonoid (with and without manganese) and several herbal multi‑ingredient formulations reported in reviews, but the supplied sources do not document a published randomized trial of a product called “AUDISTIM,” so claims about that named product cannot be supported from these documents ^{[1] [2] [3] [4]}.

2. High‑profile negative trial: Lipoflavonoid ± manganese

A randomized trial that tested Lipoflavonoid Plus® alone or combined with manganese is repeatedly cited in reviews and summaries; that trial did not demonstrate effectiveness for reducing tinnitus, and subsequent expert summaries and patient‑facing guidance cite its null result as a key reason to caution against recommending such supplements ^{[1] [2] [5] [6]}.

3. Trials that reported positive signals: herbal formulas and a “food supplement” study

Systematic reviews highlight at least one randomized, double‑blind trial of a multi‑herb Chinese formula (Gushen Pian in Zhai et al., sometimes indexed as trial Z20080046) that reported very large differences versus placebo after four weeks (overall effective rate 89.2% vs 30.8% and relief rate 59.5% vs 5.1%), and a recent paper claims a food supplement reduced tinnitus and headache scores on THI, HIT‑6 and VAS measures ^{[3] [4] [7]}. These reports are the primary sources cited in favor of benefit for multi‑ingredient formulations ^{[3] [4] [7]}.

4. Why apparent positive trials do not settle the question: methodological caveats

Expert reviews and methodological analyses warn that many herbal and supplement RCTs in tinnitus suffer from small samples, unclear randomization or blinding, short follow‑up, and selective outcome reporting; systematic reviewers conclude overall evidence is low quality or conflicting and urge larger, better‑controlled trials before clinical recommendations—this critique applies to the positive herbal trials and the recent food supplement report alike ^{[3] [4] [8] [9]}.

5. Clinical‑guideline and consensus perspective

Major specialty guidance and tinnitus advocacy organizations summarize the evidence as unsupportive of routine use of dietary supplements for persistent bothersome tinnitus, noting inconsistent trial results and potential adverse effects; the American Academy of Otolaryngology and the American Tinnitus Association advise clinicians not to recommend ginkgo, melatonin, zinc, or other dietary supplements as proven treatments for tinnitus ^{[1] [6] [10]}.

6. Hidden agendas, marketing and what is still unknown

The supplement market and decades of marketing for products such as Lipoflavonoid create a perception of scientific backing that, on close inspection, rests on a handful of small or negative RCTs and non‑peer‑reviewed claims; given the absence of independent, high‑quality, replicated RCTs for most named commercial blends (and the lack of trial documentation for AUDISTIM in the provided sources), consumers and clinicians should treat positive single studies cautiously and demand rigorous replication before accepting efficacy claims ^{[5] [3] [4]}.

7. Bottom line

Randomized trials exist but give mixed and largely inconclusive evidence: the Lipoflavonoid ± manganese randomized trial failed to show benefit (null result), some herbal formula trials report large positive effects but carry important methodological limitations, and systematic reviews and guideline bodies conclude that evidence is insufficient to recommend multi‑ingredient supplements as effective tinnitus treatments until higher‑quality RCTs replicate positive findings ^{[2] [5] [3] [4] [10]}.