PMID- 34219601
OWN - NLM
STAT- MEDLINE
DCOM- 20221230
LR  - 20230103
IS  - 1939-022X (Electronic)
IS  - 1939-0211 (Linking)
VI  - 20
IP  - 1
DP  - 2023
TI  - Effectiveness of Tinnitan Duo(R) in Subjective Tinnitus with Emotional Affectation: 
      A Prospective, Interventional Study.
PG  - 1-14
LID - 10.1080/19390211.2021.1944947 [doi]
AB  - To assess the effectiveness of a food supplement (Tinnitan Duo(R)) containing 
      5-hydroxytryptophan, Ginkgo biloba, magnesium, melatonin, vitamin B5 and B6, and 
      zinc at improving tinnitus response and intensity. Prospective, single-center 
      interventional study including patients with subjective tinnitus and emotional 
      affectation. The primary endpoint was the change in the Tinnitus Handicap 
      Inventory (THI) total score and the emotional subscale after 3 months of 
      treatment. Secondary endpoints were the change from baseline to month 3 in (1) 
      the Tinnitus Distress Rating (TDR) scale, and (2) in hearing status, and the 
      safety profile of patients throughout the study. Sixty-one patients were 
      included, and 29 completed the study. The THI total score was significantly 
      reduced after 3 months of treatment in the per-protocol (PP, all the patients 
      with no major protocol deviations) and intention-to-treat (ITT) populations 
      (-15.7 and -7.5, respectively; p = 0.001). The emotional subscale score 
      significantly decreased after 3 months of treatment by -5.6 in the PP (p = 0.001) 
      and by -2.6 in the ITT populations (p = 0.001). Perceived tinnitus loudness 
      significantly decreased after 3 months of treatment (p = 0.001). The audiogram 
      showed no significant changes in hearing status after 3 months of treatment. Of 
      the five adverse events (AEs) reported, all were mild or moderate, and three were 
      related to the study treatment (two headaches and one dizziness). This new food 
      supplement was associated with an improved tinnitus-related emotional affectation 
      and with a good safety profile.
FAU - Knapper, Jennifer
AU  - Knapper J
AD  - Centro Medico Teknon (Quiron Salud), Barcelona, Spain.
FAU - Girauta, M Victoria
AU  - Girauta MV
AD  - Centro Medico Teknon (Quiron Salud), Barcelona, Spain.
FAU - Coromina, Jordi
AU  - Coromina J
AD  - Centro Medico Teknon (Quiron Salud), Barcelona, Spain.
LA  - eng
PT  - Journal Article
DEP - 20210705
PL  - England
TA  - J Diet Suppl
JT  - Journal of dietary supplements
JID - 101249830
RN  - I38ZP9992A (Magnesium)
RN  - J41CSQ7QDS (Zinc)
SB  - IM
MH  - Humans
MH  - *Tinnitus/drug therapy/complications/psychology
MH  - Prospective Studies
MH  - Magnesium
MH  - Dietary Supplements
MH  - Zinc
OTO - NOTNLM
OT  - emotional affectation
OT  - food supplement
OT  - tinnitus
OT  - tinnitus loudness
EDAT- 2021/07/06 06:00
MHDA- 2022/12/31 06:00
CRDT- 2021/07/05 08:57
PHST- 2021/07/06 06:00 [pubmed]
PHST- 2022/12/31 06:00 [medline]
PHST- 2021/07/05 08:57 [entrez]
AID - 10.1080/19390211.2021.1944947 [doi]
PST - ppublish
SO  - J Diet Suppl. 2023;20(1):1-14. doi: 10.1080/19390211.2021.1944947. Epub 2021 Jul 
      5.