Table 2.
Characteristics of included studies: study procedures and outcome measures.
| Author, Year |
Treatment | Control Group Intervention | Randomization | Outcome Measures | Monitoring Duration | Power Analysis | Results | Is Treatment Effective? |
|---|---|---|---|---|---|---|---|---|
| Abtahi, 2018 [76] |
Anodal Stimulation, Cathodal Stimulation | Sham Stimulation | Unclear | Tinnitus Intensity Variations on A Scale Between −4 and +4. In This Scale, −4 Indicated Worsening Conditions, +4 Meant Full Recovery, And Zero Conveyed No Change in The Tinnitus Intensity. | 2 Months | No | Anodal Stimulation Was More Effective Than the Cathodal and Control Stimulation in Reducing the Intensity of Tinnitus in The Short Term | Yes, Between Two Versions of The Same Treatment |
| Albu, 2016 [50] |
Intratympanic (IT) Steroid and Melatonin | Melatonin | Unclear | THI, PSQI, BDI | 3 Months | No | Better Response in The Combined Group of Melatonine And IT In Acute Tinnitus Patients | Yes |
| Anders, 2010 [16] |
Active or Sham repetitive transcranial magnetic stimulation (rTMS) | Sham Rtms | Unclear | VAS, THI | 26 Weeks | No | 1 Hz Rtms Treatment Was Capable of Significantly Reducing the Total Baseline Score of Basic Scales That Measure Tinnitus Severity | No |
| Arif, 2017 [69] |
Relaxation Therapy or Mindfulness Meditation Treatment Over A Period Of 15 Weeks | Relaxation Procedure | Clear | Primary: TRQ Secondary VAS and A Health State Thermometer. |
15 Weeks | No | Changes in Tinnitus Loudness and THI (but not TRQ) with the Customized Sound Therapy Were Statistically Greater Than Those of The Broadband Noise Therapy | No |
| Beukes, 2017 [70] |
Internet-based cognitive behavioral treatment (iCBT) Intervention | ICBT After 8 Weeks | Algorithm Implemented by Independent Researcher | Primary: TFI, Secondary: ISI, GAD-7, PHQ-9, HHIA-S, HQ, CFQ, SWLS | 2 Months | 80% | Guided ICBT For Tinnitus Using Audiological Support Resulted in Statistically Significant Reductions in Tinnitus Distress and Comorbidities (Insomnia, Depression, Hyperacusis, Cognitive Failures) And Improved Quality of Life. | Yes |
| Beukes, 2018 [75] |
Internet- Based Intervention |
Face-To-Face Tinnitus Care | Unclear | THI, TFI | 2 Months | 90% | ICBT And F2F Interventions Are not Effective for Reducing Tinnitus Distress and Most Tinnitus-Related Difficulties. | No |
| Biesinger, 2010 [17] |
10 Qigong Training Sessions | No Treatment | Unclear | VAS, TBF-12 | 3 Months | No | No Statistically Significant Changes in Both Groups | No |
| Bilici, 2013 [44] |
rTMS | Paroxetine, Placebo | Unclear | THI, TSI, BAS, PSS | 6 Months | No | No Significant Improvement Neither for Rtms Groups nor For Controls | No |
| Choi, 2013 [31] |
IT Steroids | Placebo | Clear | THI. VAS | 1 Month | No | No Significant Difference Between IT Steroids and Placebo | No |
| Cima, 2012 [21] |
CBT | Usual Care | Clear | HUI, HADS, TFQ | 12 Months | No | Superiority Of CBT | Yes |
| Coelho, 2013 [32] |
Zinc | Placebo | Unclear | THQ | 4 Months | 90% | No Significant Differences Between Zinc and Placebo | No |
| Dehkordi, 2011 [18] |
Gabapentin | Placebo | Unclear | TSI | 26 Months | No | No Statistically Significant Difference Between the Two Groups In TSI. | No |
| Dehkordi, 2015 [43] |
Active Laser Treatment | Inactive Dummy Treatment | Unclear | TSI | 4 Weeks | No | No Statistically Significant Improvement Neither in Laser nor In Control Group | No |
| Doi, 2016 [51] |
Acupuncture | No Treatment | Randomization Was Carried Out with The Aid of Computerized Table of Random Numbers Created by A Microsoft Excel Spreadsheet. | VAS, THI | 5 Weeks | No | Treatment with Acupuncture Improves the Perception of Tinnitus, Decreases the Intensity Level, Hence There Is No Comparison Between Levels of Improvement | Yes, Against Placebo In 5 Weeks, However No Comparison of Decrease |
| Dos Santos, 2014 [38] | Hearing Aids + Sound Generator | Hearing Aids | Unclear | THI | 3 Months | 80,0% | No Superiority of The Combined Use of Amplification and Sound Generator Over Conventional Amplification Alone in Reducing the Discomfort of Tinnitus. Both Groups Presented Similar Responses in Both Reduction of Discomfort Caused by Tinnitus | No |
| El Beaino, 2018 [77] |
Sulodexide | Placebo | Unclear | THI, Mini TQ | Right After Treatment | 80% | Improvement in THI and Mini TQ Right After the End of Treatment with Sulodexide | Yes |
| Elzayat, 2018 [64] |
Group A Was Injected with Combined Lidocaine 2% And Dexamethasone 8 Mg/2 mL (ITLD). Group B Was Injected Only by Dexamethasone 8 Mg/2 ML. (ITD). | ITD As A Controlled Group | Clear | THI, VAS, ATQ | 6 Months | No | Both Treatments Were Effective but No Difference Between Groups Was Found | Yes |
| Folmer, 2015 [45] |
rTMS Daily For 2 Weeks | Sham Rtms With A Same Looking Coil | Unclear | TFI | 26 Months | No | Significant Improvement in Active Compared to Placebo Group | Yes |
| Godbehere, 2019 [79] | Theta Burst TMS | Placebo Arm | Unclear | TFI | 4 Weeks | No | No Significant Difference in Scores Between the Active Treatment Group and The Sham Control Group | No |
| Hall, 2019 [80] |
AUT00063 | Placebo | Clear | TFI, VAS | 28 Days | 90% | No Significant Improvement for Both Groups (Channel Blocker and Placebo) | No |
| Han, 2012 [22] |
Clonazepam | Ginkgo Biloba | Unclear | THI, VAS, Loudness Scale | No | Improvement with Use of Clonazepam and Not Gingko Biloba, but Right After Treatment | Yes | |
| Henry, 2016 [52] |
TM-TRT-TED | No Treatment | Clear | THI | 18 Months | 80% | No Statistically Significant Improvement In THI. By 6 Months, The TED Group Showed Significant Improvement from Baseline and Its Improvement Was Not Significantly Different from That Shown in TM Or TRT. | No |
| Hesser, 2012 [23] |
CBT Or ACT | Monitored Internet Discussion Forum | Clear | Primary: THI, Secondary: HADS | 1 Year | 80% | The Effect of ACT Compared with The Control Condition at Posttreatment on The Primary Outcome Was in The Moderate Range and Comparable to The Effect Observed Following CBT (D = 0.68 vs. D = 0.70). | No |
| Hoare, 2012 [24] |
Frequency Training | Different Frequency Training | THQ | 4 Weeks | 80% | Statistically and Clinically Meaningful Improvement in All Groups. No Difference Between Groups | Yes | |
| Hoare, 2014 [39] |
To Play A Tailored Video Game For 30 Minutes, 5 Days A Week For 4 Weeks | Another Type Of FDT | Clear | THQ | 4 Weeks | 80% | Statistically but Not Clinically Significant Changes in One of The Games Used | No |
| Hoekstra, 2013 [33] |
rTMS in 1000Hz | Placebo | Unclear | Primary: TQ. Secondary THI, VAS | 6 Months | 80% | No Significant Difference Between Groups | No |
| Hong, 2018 [78] |
40 Minutes Session of Nitrous Oxide Under General Anesthesia | Same Procedure Without Nitrous Oxide | Clear | TFI | 2 Weeks | 81% | No Significant Differences Between Intervention and Control Group. Neither Groups Had Clinical or Statistically Significant Improvement | No |
| Jasper, 2014 [40] |
GCBT, iCBT | Web-Based Discussion Forum (DF) | Unclear | THI, Mini-TQ, Secondary: HADS, ISI, TAQ | 6 Months | No | ICBT And Conventional GCBT Do Not Have Significant Differences Effects on Tinnitus Distress and Associated Problems. | No |
| Jeon, 2012 [25] |
Acupuncture | Sham | Unclear | THI, VAS | No | No Significant Differences Between Acupuncture and Sham | No | |
| Kallogjeri, 2017 [65] |
Brain fitness program tinnitus (BFP-T) | No Treatment | Unclear | THI, TFI, Global Bother Score | 8 Weeks | 85% | No Statistically Significant Changes Between Study Groups. | No |
| Kim, 2017 [66] |
Manual Acupuncture | Electroacupuncture | Unclear | THI, VAS | 80% | No Significant Improvement for Any Acupuncture Group In Regards To THI and Loudness | No | |
| Kreuzer, 2012 [26] |
Mindfulness and Body Group Therapy | Waiting List (Therapy After 24 Weeks) | Unclear | TQ | 24 Weeks | No | A Significant Reduction in The TQ Score (Baseline vs. Week 9) Compared to The Waiting List Control Group, However Difference Was Not Stable in Long Term F/U | No |
| Kreuzer, 2015 [46] |
Medial Frontal Stimulation with Double Cone Coil + Stimulation of The Left Temporo-Parietal Junction Area | Conventional Prefrontal Left DLPFC-Stimulation + Stimulation of The Left Temporo-Parietal Junction Area | Unclear | TQ, Secondary: THI, CGI-CHANGE, Whoqol-Bref-Questionnaire | 12 Weeks | No | ΤICDC-Stimulation Non-Superior to Standard Rtms Regarding Both Primary and Secondary Outcome Measures. | No |
| Landgrebe, 2017 [67] | 2 Week Treatment Real 1-Hz-Rtms vs. Sham Rtms | Sham Rtms | Clear | Primary: The Change of Tinnitus Severity Assessed by Means of The Change of The TQ Sum Score Between Baseline Score vs. Day 12. Secondary: Changes of The TQ Sum Score, The THI and TSS During the Treatment and The Follow-Up Period. Further: Changes of Overall Illness Severity, Changes in Depressive Symptoms, Changes in Quality of Life and Changes in Psychoacoustic Measures of Tinnitus. | 26 Weeks | No | Real 1-Hz-Rtms Applied to The Left Temporal Cortex Did Not Provide Any Therapeutic Benefit as Compared to Sham Treatment in Patients with Chronic Tinnitus. | No |
| Laureano, 2016 [53] |
True Acupuncture 99mTC-ECD SPECT |
Sham Acupuncture | Unclear | Primary: SPECT Measurements, Secondary: THI, VAS, HAS, BDI | 12 Weeks | 80% | No Significant Differences After Treatment Were Observed with Regard to the VAS, HAS or BDI Between the Treatment Groups. | No |
| Lee, 2018 [74] |
IT Steroids | Placebo (Saline) | Clear | THI, VAS | 1 Month | 80% | No Difference Between IT And Placebo Groups | No |
| Lehner, 2016 [54] |
High Frequency rTMS | Single Site Rtms | Clear | TQ, THI, | 6 Months | 80% | No Difference Between Groups | No |
| Li, 2016 [55] |
Music Altered by The Software to Treat Tinnitus | Unaltered Music | Unclear | THI, TFI, HADS | 12 Months | 80% | Statistically Significant and Clinically Meaningful Effects of The Therapy as Indicated by The Consistent Treatment-Control Group Difference in THI Score and The Significant Reduction in THI Score Within the Treatment Group During The 12-Month Period. | Yes |
| Li, 2019 [81] |
Masking Therapy+ Sound Treatment + CBT | Masking Therapy + Sound Treatment (Tinni Test) | Unclear | THI, SCL-90 | 6 Months | No | Effective Rate in Intervention Group Was Significantly Higher Than That in Control Group (P < 0.01) | Yes |
| Lim, 2016 [56] |
Oral 100 mg Cilostazol | Placebo | Unclear | VAS, THI, SF-36 | 4 Weeks | No | THI Failed to Show A Significant Drug Effect of Cilostazol | No |
| Malinvaud, 2015 [47] | Virtual reality (VR) | CBT | Clear | STSS, THI, THQ, VAS | No | Both VR And BT Groups Improved | Yes | |
| Mckenna, 2017 [68] |
RT Or MBCT Treatment vs. Waiting Period Without Treatment | RT Treatment Group | Clear | Primary: TQ, CORE-NR, Secondary: CORE-OM, VAS, TFI, HADS, TCS, T-FAS, TAQ, MAAS, WSAS | 6 Months | 80.0% | MBCT Is More Effective in Reducing Tinnitus Severity Than Both A Waiting Period and An Active Treatment of Equal Intensity (RT) | Yes |
| Mollasadeh, 2013 [34] | Low Laser Beam | Placebo | Unclear | THI, VAS, Loudness Scale | 3 Months | No | Larger Improvement in Low Beam Laser Compared to Placebo, Hence More Than 50% Of Intervention Group Without Improvement | Yes |
| Ngao, 2012 [27] |
TLLS | Sham | Unclear | THI, VAS | Right After Intervention | No | No Significant Difference Between TLLS And Sham | No |
| Noh, 2019 [82] |
Dual-Site Rtms Or Sham Rtms | Sham Rtms | Unclear | Primary: THI, Secondary: VAS | 8 Weeks | No | A Beneficial Effect of Rtms On Tinnitus Suppression Was Found in The Dual-Site Active Rtms Group, but Not in The Sham Rtms Group. | Yes |
| Nyenhuis, 2013 [35] |
Internet Training, Bibliotherapy, Group Treatment or An Information-Only Condition. | Information Only | Clear | Primary: TQ, Secondary: BL, PHQ-D | 9 Months | 80.0% | Improvement Rates Were Higher in The Active Training Conditions Than in The Control Condition, And Deterioration Rates Were Generally Lower in The Training Conditions In TQ. | Yes |
| Pal, 2015 [48] |
transcranial direct current stimulation (TDCS) | Unclear | Primary: THI, Secondary: STSS, HAD, VAS, CGI | 3 Months | 80.0% | This TDCS Protocol Did Not Show A Beneficial Effect on Tinnitus. | No | |
| Plewnia, 2012 [28] |
CTBS Over the Secondary Auditory Cortex (SAC), The Temporoparietal Association Cortex (TAC), Or Sham Stimulation [Placebo (PLC)]. | Placebo | Clear | TQ | 3 Months | 80% | No Difference Between Real and Sham Treatments nor Between Temporal and Temporoparietal Ctbs. | No |
| Prozchazkova, 2019 [83] |
Ginkgo Biloba | Pentoxifylline | Unclear | VAS, Mini TQ, HADS | 3 Months | No | Both Gingko Biloba and Pentoxifylline Improve Mini TQ. No Difference Between Groups | Yes |
| Radunz, 2019 [84] |
Gingko Biloba | HA | Unclear | THI, VAS | 6 Months | No | Both Gingko Biloba Improved Compared to Baseline, No Difference Between Groups Though, Apart from Long Lasting Tinnitus | Yes |
| Rocha, 2012 [29] |
10 Sessions of Myofascial Trigger Point Deactivation | 10 Sessions with Sham Deactivation | Unclear | THI | 3 Months | No | MTP Deactivation Through Digital Pressure Was Deemed Effective in Each and Every Tinnitus Variable Under Evaluation and In the Medium Run Responsiveness to Treatment Remained Stable In 75.8% Patients. | Yes |
| Rojas-Roncancio, 2016 [57] | Manganese and Lipoflavonoid Plus | Lipoflavonoid Plus | Unclear | THQ, TPFQ | 6 Months | No | No Significant Improvement in Both Groups | No |
| Roland, 2016 [58] |
Sham or Active Treatment rTMS to TPJ | Sham Rtms to TPJ | Clear | 2 or 4 Weeks | No | No Changes in Neural Connectivity Following Rtms Therapy. Results Suggest Instead That the TPJ May Not Be an Ideal Target for Tinnitus Treatment. | No | |
| Sahlsten, 2017 [71] |
rTMS | Placebo Rtms | Unclear | THI, VAS | 6 Months | 80% | Improvement for The VAS Scores (Intensity, Annoyance, Distress) And THI Scores Both in The Active Rtms Group and The Placebo Group. | No |
| Sahlsten, 2019 [85] | rTMS With and Without Neuronavigation for 2 Weeks In 2000 Hz | With and Without Neurostimulation | Unclear | THI, Global Impression of Change | 3 Months | No | No Significant Difference Between Groups, However Significant Improvement in Both | No |
| Scherer, 2019 [86] |
TRT, including tinnitus specific counseling (TC) and sound-therapy (ST) Implemented with Ear- Level sound generators (SGS); Partial TRT, Including TC and Placebo SGS; Or Standard of Care (SoC) | Placebo SGS Or Standard of Care (Soc) | Clear | Primary: TQ, Secondary: TFI, THI, VAS | 18 Months | 80.0% | No Meaningful Differences Between TRT And Soc (Our Primary Comparison) Or Between Partial TRT And Soc Or TRT (Our Secondary Comparisons). | No |
| Shekhawat, 2014 [41] | Transcranial direct current stimulation (TDCS) | Sham Stimulation | Clear | TFI, THI, THQ, MML | 7 Months | No | No Significant Differences for Any of The Questionnaires; Decrease in MML For the RTMS Group | No |
| Singh, 2016 [59] |
B12 | Placebo | Unclear | Matching, TSI | 1 Month | No | Improvement in Patients with B12 Insufficiency, Hence in A Very Small Sample | No |
| Sönmez, 2013 [36] |
Ozone | Betahistine | Unclear | THI, Loudness Scale | 6 Months | No | No Differences Between Ozone and Betahistine, Both Showed Improvement Compared to Baseline Though | Yes |
| Stein, 2016 [60] |
Fixed Notch-TMNMT | Placebo (Moving Notch) | Clear | THQ, VAS | 4 Months | 90.0% | Tinnitus Loudness and Other Measures of Tinnitus Distress Do Not Show Relevant Changes. | No |
| Sziklai, 2011 [19] |
Pramipexole | Placebo | Clear | THI | 4 Weeks | No | No Cumulative Analysis. Greater Proportion of Patients Reporting Tinnitus Disappearance in The Interventional Group. Results Not Confirmed by Electrocochleography. | Unclear |
| Taslimi, 2013 [37] |
Ondansedron | Placebo | Clear | THI, TSI, VAS, HADS | No | No Significant Differences Between Ondansedron And Placebo | No | |
| Tass, 2012 [30] |
CR | Placebo | VAS, TQ | 12 Weeks | No | Improvement Before and After Treatment and Also Compared to Placebo | Yes | |
| Teismann, 2014 [42] |
Anodal TDCS, Cathodal TDCS + TMNMT | Sham Stimulation + TMNMT | Unclear | THQ, THI, TQ | 31 Days | No | No Significant Modulating Effect of TDCS Polarity: Significant Main Effects or Interactions of TDCS Condition Were Neither Found in The Primary Outcome Measure nor In Any of The Secondary Outcome Measures (THI, TQ, Or Loudness VAS; | No |
| Thabit, 2015 [49] |
rTMS | RTMS | Unclear | THI, VAS | 1 Month | No | Combination Treatment Significantly Better | Yes |
| Theodoroff, 2017 [72] | LEVO System with A Tinnitus-Matched Stimulus (TM Group) vs. LEVO System with A Noise Stimulus (NS Group; White Noise And/or Band Noise) vs. Marsona 1288 Sound Conditioner/Tinnitus Masker (Bedside Sound Generator Device; BSG Group). | BSG And NS Groups, but Not in The Same Manner as A Placebo-Controlled Group | Unclear | TFI, NRS, And LM at 1 kHz | 3 Months | No | Greater Average Improvement in Reactions to Tinnitus with TM or NS Devices Compared to The BSG Device. | Yes |
| Tutar, 2020 [88] |
10 Sessions Of 30 Minutes in One Month | Placebo | Unclear | THI, DASS | 4 Weeks | No | Significant Improvement in Uni- And Bilateral Groups Compared to Placebo | Yes |
| Tyler, 2017 [73] |
VNS Implant-Paired | VNS Implant-Unpaired (Paired After 6 Weeks) | Clear | THI, TFI, THQ | 1 Year | No | No Significant Differences for Any of The Outcome Measures | No |
| Weise, 2016 [61] |
10-Week Guided Internet-Based Self-Help Program | DF | Unclear | Primary: THI, Mini-TQ, Secondary: HADS | 1 Year | No | ICBT Resulted to Significantly Better THI Scores Compared to Participation in An Online Forum | Yes |
| Westin, 2011 [20] |
ACT, TRT | Wait List Control | Unclear | Primary: THI, Secondary: ISI, QOLI, HADS, CGI-I | 18 Months | 80% | ACT Is More Effective in Reducing Tinnitus Impact Than Tinnitus Retraining Therapy or Being on A Wait List. | Yes |
| Wise, 2016 [62] |
Experimental Attention Training Game (“Terrain”) | A Control Game (“Tetris”) | Unclear | TFI, Secondary: THI, Tinnitus Severity Numeric Scales | 20 Days | 92% | TFI Scores Improved Following The 20-Day Use for the “Terrain” Program Compared with The Nonauditory “Tetris” Group. | Yes |
| Yakunina, 2019 [87] |
HAs With WDRC, HAs With FT, Or HAs With LFT | FL Techniques (LFT and FT) Group | Clear | Primary: THI, Secondary: VAS | 6 Months | 80.0% | No Significant Differences Were Found Between Conventional Has And FL-Type Has in Terms of Tinnitus Relief Among Patients With HFHL. | No |
| Zarenoe, 2016 [63] |
MI Group Received A Brief MI Program, Whereas Patients in The SP Group Underwent Conventional Hearing Aid Fitting. | Conventional Hearing Aid Fitting Group | Unclear | THI, IOI-HA | 3 Months | No | The MI Intervention Did Not Appear to Have Any Additional Effect on Hearing Aid Fitting Compared to Conventional Hearing Rehabilitation. | No |