Lipo-Flavonoid is sold to treat tinnitus. The claims are misleading, and the evidence isn’t there.
The dietary supplement Lipo-Flavonoid is advertised as an effective treatment for tinnitus. They claim “More than 50 Years of Clinical Experience” and go on to explain:
Lipo-Flavonoid® Plus is a natural bioflavonoid product that has been used extensively for decades for the treatment of tinnitus. Lipo-Flavonoid has been used and evaluated in clinical settings for over 50 years, and continues to be the #1 recommendation of doctors for relief of ringing in the ears (Source: April 2018 survey).
With a little investigation, I soon learned that the “#1 recommendation” claim was bogus. The National Advertising Division (NAD) of the Better Business Bureau found the company’s claims unsubstantiated and found that the survey they cite did not ask ENTs the proper questions. The doctors surveyed did not recommend Lipo-Flavonoid for its effectiveness in treating tinnitus in general; they recommended it only as an adjunct therapy for tinnitus in patients with Meniere’s disease. The NAD recommended the company discontinue the advertising claims, but the claims continue unchanged.
I don’t know of any doctors who recommend it, and I know “used extensively” and “clinical experience” are no guarantee of effectiveness. I wanted to see the evidence.
What is tinnitus?
Tinnitus is a symptom, the perception of noise or ringing in the ears, usually a phantom noise that is not audible to an examining doctor. It can be a symptom of age-related hearing loss, exposure to loud noise, earwax blockage, otosclerosis, Meniere’s disease, TMJ disorders, head and neck injuries, acoustic neuroma, Eustachian tube dysfunction, muscle spasms, or blood vessel disorders. Various medications can cause tinnitus or worsen it, including certain antibiotics, aspirin, cancer medications, diuretics, and quinine. Underlying treatable causes must be ruled out, but in many cases an exact cause is never found. The good news is that it usually isn’t a sign of anything serious; it can be very annoying to some people but is otherwise harmless.
Up to 18% of people in industrialized societies are mildly affected by chronic tinnitus, and 0.5% report tinnitus having a severe effect on their daily life.
Tinnitus is the most frequent service-connected disability for U.S. military veterans, with nearly 1 million veterans receiving disability payments for tinnitus in 2012. I am one of them. I was exposed to flight line noise as a flight surgeon in the Air Force, and I am considered 10% disabled, so that 10% of my retirement pay comes from the VA and is tax-exempt.
Not all tinnitus is bothersome. I am a good example of that. When I think about it, my tinnitus is always there; but unless I happen to think about it, I am not aware of it – I tune it out, sometimes for days or weeks at a time. Normal brain mechanisms allow us to become habituated to a constant background noise and no longer notice it.
What are the ingredients in Lipo-Flavonoid?
- Lemon bioflavonoid complex 300 mg (This is a proprietary blend that includes eriodictyol glycoside, a phytonutrient found in lemon peels.)
- Ascorbic acid (Vitamin C) 300 mg
- Choline bitartrate 334 mg
- Inositol 334 mg
- Thiamine (Vitamin B-1) 1 mg
- Niacinamide (Vitamin B-3) 10 mg
- Pyridoxine (Vitamin B-6) 1 mg
- Cyanocobalamin (Vitamin B-12) 5 mcg
- Pantothenate 5 mg
- Riboflavin (Vitamin B-2) 1 mg
- And Lipo-Flavonoid Night also contains melatonin (3 mg immediate-release and 2 mg time-release).
It has been tested and was found lacking. A small randomized controlled trial in 2016 did not find Lipoflavonoid Plus effective for tinnitus.
As for melatonin, an article on Healthline said:
Randomized-controlled studies have shown that the supplement improves tinnitus symptoms, but many of the studies were poorly designed, so it’s hard to draw any conclusions…Melatonin may be most effective for helping people with this condition sleep more soundly.
Money back guarantee
To their credit, they acknowledge that “Lipo-Flavonoid may not work for everyone”. They offer a money-back guarantee: “Try it for 60 days, and if you don’t find relief, just submit your cash register receipt and UPC code, and we will refund your purchase”.
But please use it correctly:
In order for Lipo-Flavonoid caplet products to work effectively, the recommended dosage is two (2) caplets, three (3) times a day for 60 days (a total of 360 caplets) before seeing results. This exact dosage is based on clinical experience and is recommended to maintain blood levels over time and reduce stomach upset. Taking the correct dosage of Lipo-Flavonoid caplet products is necessary to maintain inner ear health and reduce the symptoms of tinnitus.
What does the evidence say?
Many treatments have been used for tinnitus, but how many of them actually work? What does the evidence show? What do the experts say?
Clinical practice guidelines published by the American Academy of Otolaryngology offer this advice:
- Clinicians should offer hearing aid evaluations, education, and counselling.
- Sound Therapy – Clinicians may offer sound therapy to patients with persistent, bothersome tinnitus.
- Cognitive Behavior Therapy – Clinicians should recommend cognitive behavior therapy to patients with persistent, bothersome tinnitus.
- Medical Therapy – Clinicians should NOT routinely prescribe antidepressants, anticonvulsants, anxiolytics, or intratympanic medications.
- Dietary Supplements – Clinicians should NOT recommend ginkgo biloba, melatonin, zinc, or other dietary supplements for treating patients with persistent, bothersome tinnitus.
- Acupuncture – No recommendation can be made.
- Transcranial Magnetic Stimulation – Clinicians should NOT recommend.
A Clinical Evidence Handbook published in American Family Physician reviewed the published evidence. They found insufficient evidence for most treatments including acupuncture, hypnosis, tinnitus masking devices, tinnitus retraining therapy, drugs, and dietary supplements. As for cognitive behavioral therapy, they said it “may be ineffective at reducing tinnitus loudness, but it may improve quality of life in persons with tinnitus.”
A review article in Audiology Online titled “Dietary Supplements for Tinnitus – Really? says “the promise of an easy fix for tinnitus is a false one.” There are over 50 products sold over the counter for tinnitus relief, but the ingredients:
are often selected based on folklore, anecdotes or traditional Chinese medicine, and routinely contain ingredients that have not been scientifically-evaluated for their efficacy or safety, or have been shown to be no better than a placebo.
ConsumerLab reported two studies of flavonoids and vitamin B6 for Meniere’s disease and vertigo and said:
Based on these reports, some have assumed that these ingredients would be beneficial for a variety of ear disorders including tinnitus and others. However, these reports are very preliminary. Neither Lipo-flavonoid Plus, nor its main ingredient, have been evaluated in reliable clinical studies for tinnitus or other ear-related conditions.
A survey of the effectiveness of dietary supplements to treat tinnituswas published in the American Journal of Audiology in 2016. 1,788 subjects in 53 different countries answered a questionnaire. 70.7% reported no effect, 19% reported improvement, and 10.3% reported worsening. 6% reported adverse effects including bleeding, diarrhea, headache, and others. The authors warned that the positive subjective reports should be interpreted with caution, since these subjects were committed to treatment and expected a benefit. They concluded:
The use of dietary supplements to treat tinnitus is common, particularly with Ginkgo biloba, lipoflavonoids, magnesium, melatonin, vitamin B12, and zinc. It is likely that some supplements will help with sleep for some patients. However, they are generally not effective, and many produced adverse effects. We concluded that dietary supplements should not be recommended to treat tinnitus but could have a positive outcome on tinnitus reactions in some people.
A review of over-the-counter tinnitus remedies was published in Laryngoscope in 2019. It found that all the remedies made unfounded claims, and some of them, including Lipo-Flavonoid, targeted otolaryngologists by advertising in their specialty journals, and featured supposed endorsements by ENT doctors in their marketing. They recommended that specialty organizations oppose such misrepresentations and that their journals not accept advertisements for dietary supplements that make unproven therapeutic claims.
Steven Novella wrote about alternative treatments for tinnitus in 2012, including gingko, the homeopathic remedy Quietus, and craniosacral therapy (CST, recommended by Andrew Weil). He pointed out that homeopathy and CST were both “rank pseudosciences” and that the best evidence showed gingko was ineffective. He concluded that alternative therapies had nothing to offer. Since he wrote that article, research has confirmed the gingko findings: a 2013 Cochrane review found that the limited evidence did not show that gingko biloba was effective for tinnitus, and a 2018 review of systematic reviews concluded that it didn’t work.
Conclusion: No cure, but distraction helps
Some people are bothered by tinnitus; some aren’t. I suspect there is a large psychological component. If you are worried that it could be a sign of something serious, it is likely to bother you more. If you think of it as only a harmless, minor annoyance, you are less likely to worry. There is no cure for tinnitus, but anything that helps distract attention from the noise is likely to reduce the suffering. It is unethical to prescribe untested treatments or placebos, but in this case, I’m almost tempted to recommend Lipo-Flavonoid, telling patients only “it may make you less aware of the tinnitus.” It probably won’t do any harm, and I think there’s a good chance it might serve as a distraction and elicit a placebo response.
They say laughter is the best medicine. It might help if patients could laugh about it; laughter can be a good distraction. There’s a website that features tinnitus cartoons. In one, the patient tells the doctor, “It’s a constant ringing in my ears. When I try to ignore it, they leave a message.” In another, the doctor tells the patient “Tinnitus? I think I can help”. The patient is a cow wearing a large cowbell.
This article was originally published in the Science-Based Medicine blog.