A Study on the Effectiveness of Antioxidant Supplementation in Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effectiveness of antioxidant supplementation in
      idiopathic tinnitus patients.

      To investigate this, a double-blind, randomized, and placebo-controlled clinical trial was
      conducted to assess the impact of a multivitamin-multimineral supplement with phytochemicals
      combined with a-lipoic acid supplements on serum oxidative stress, serum antioxidant capacity
      and tinnitus parameters in patients with idiopathic tinnitus.

      Subjective, idiopathic, non-pulsatile tinnitus ("tinnitus") is perception of sound without
      the presence of an external acoustic stimulus. Causes of idiopathic tinnitus remain unknown
      and the pathological mechanisms are not fully understood. Currently, effective therapies for
      tinnitus remain limited. Previous research has demonstrated that oxidative stress is possibly
      involved in the pathogenesis of idiopathic tinnitus and some studies have shown beneficial
      effects of antioxidant therapy in tinnitus patients. Moreover, many studies have shown the
      beneficial effect of antioxidant supplementation on the reduction of oxidative stress and the
      increase of endogenous antioxidant enzymes and antioxidant capacity.

      Seventy patients with idiopathic tinnitus were enrolled based on certain inclusion and
      exclusion criteria. Subsequently, they were informed regarding the aims, methods, anticipated
      benefits, and potential hazards of the study, and were provided with the information leaflet
      of the study. Each patient who agreed to take part in the study, signed an informed consent
      form, a copy of which was given to them.

      Participants were allocated to either antioxidant or placebo group. Randomisation was
      conducted by someone who was not involved in the study and blinding was strictly maintained
      to researchers and participants.

      The antioxidant group received one multivitamin and multimineral tablet with grape seed
      extract once a day together with one tablet of alpha-lipoic acid twice a day, whereas the
      placebo group received identical placebo tablets. Supplements were kindly donated by
      Lamberts. The intervention lasted 3 months. Both groups kept their usual medical treatment
      and their diet and exercise habits stable during the intervention.

      Patients were assessed after randomisation according to the following tools:

        -  Medical history

        -  Audiometric and Tinnitus assessment: Basic audiometric tests, pitch match, loudness
           match, minimum masking level (MML)

        -  Tinnitus questionnaires: Tinnitus Handicap Inventory (THI), Tinnitus Functional Index
           (TFI) and Visual Analogue Scale (VAS)

        -  anthropometrics: body weight , height, Body Mass Index, waist and hip circumferences

        -  Nutrition and physical activity evaluation

        -  Adherence to the Mediterranean dietary pattern (MedDietScore)

        -  Psychological assessment

        -  Biochemical measurements: Complete blood count, lipid profile, glucose, electrolytes,
           liver enzymes, thyroid hormones

        -  Vitamin laboratory tests

        -  Oxidative stress assessment in serum samples: Total Antioxidant Capacity (TAC),
           Superoxide Dismutase (SOD) activity and Oxidized LDL are quantified.

      Compliance and any side effects were checked with a weekly telephone contact with the
      patients. The consumption of tablets was checked with a diary completed by patients. At the
      end of the intervention, all baseline parameters were assessed.
    


Intervention name(s): Antioxidants; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): one multivitamin and multimineral tablet with 500 mg grape seed extract once a day and one tablet of alpha-lipoic acid (300 mg ALA) twice a day for 3 months.; one placebo tablet three times per day for 3 months.
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment