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Table of Contents
ORIGINAL ARTICLE
Year : 2022  |  Volume : 24  |  Issue : 4  |  Page : 151-156

Effects of combination therapy in reduction of tinnitus functional index score for tinnitus patients in a Tertiary Hospital in Malaysia: A randomized pilot trial


1 Department of Otorhinolaryngology and Head and Neck Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Malaysia
2 Audiology Program, Centre of Healthy Ageing and Wellness (H-CARE), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Malaysia
3 Research Centre for Quran and Sunnah, Faculty of Islamic Studies, Universiti Kebangsaan Malaysia, Malaysia
4 Department of Community Health, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Malaysia

Date of Submission11-Sep-2022
Date of Decision25-Oct-2022
Date of Acceptance28-Oct-2022
Date of Web Publication30-Dec-2022

Correspondence Address:
Dr. Asma Abdullah
Department of Otorhinolaryngology and Head and Neck Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, Cheras 56000, Kuala Lumpur
Malaysia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/sjoh.sjoh_43_22

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  Abstract 


Background: This trial aimed to study the effect of combination therapy and compare it with tinnitus counseling alone in the reduction of tinnitus functional index (TFI) score. Materials and Methods: This work is a two-arm pilot-controlled trial where Muslims aged more than 18 years and with primary chronic bothersome tinnitus and a TFI score of more than 24 were recruited. The exclusion criteria were subjects with pulsatile or objective tinnitus or those with poor cognitive functions and Meniere's disease. They were randomized into two groups by using block randomization. The first treatment group received a combination of Al Quran sound therapy and tinnitus counseling, and the second treatment group received tinnitus counseling only. The results of the TFI score before intervention and 1-month postintervention were recorded and analyzed. Results: A total of 25 patients were recruited and randomized. Among them, 10 received combination therapy and 15 received counseling treatment. Overall, 68% of the patients (17/25) had reduced global TFI scores. The mean decline in total TFI score in the combination group was higher (12.4, standard deviation [SD]: 18.5) than that in the counseling group (4.9, SD: 18.8). Clinically relevant improvement was also higher in the combination group (40%) than in the counseling group (26.7%). Both comparisons were not statistically significant. Among the TFI subscales, the mean scores of intrusiveness, sense of control, and emotion decreased significantly after the intervention within the combination group, with values of P = 0.036, 0.026, and 0.036, respectively. Conclusion: This study was unable to determine if combination therapy is better than counseling due to the small sample size. However, combination therapy improved the emotion, sense of control, and degree of intrusiveness of tinnitus.

Keywords: Al-Quran, sound therapy, tinnitus


How to cite this article:
Kamarudin NA, Ishak WS, Nazri MA, Tamil AM, Abdullah A. Effects of combination therapy in reduction of tinnitus functional index score for tinnitus patients in a Tertiary Hospital in Malaysia: A randomized pilot trial. Saudi J Otorhinolaryngol Head Neck Surg 2022;24:151-6

How to cite this URL:
Kamarudin NA, Ishak WS, Nazri MA, Tamil AM, Abdullah A. Effects of combination therapy in reduction of tinnitus functional index score for tinnitus patients in a Tertiary Hospital in Malaysia: A randomized pilot trial. Saudi J Otorhinolaryngol Head Neck Surg [serial online] 2022 [cited 2023 Jan 31];24:151-6. Available from: https://www.sjohns.org/text.asp?2022/24/4/151/366335




  Introduction Top


Tinnitus is a phantom auditory perception without an actual external sound. The characteristics of tinnitus could be described as buzzing, hissing, tonal, ringing, pulsatile, or nonpulsatile, and in some patients, more than one sound could be heard. Tinnitus could also be constant or intermittent throughout the day, and it could be a quiet background noise or loud. It could be audible either unilaterally, bilaterally, or inside the head. Tinnitus is commonly divided into two categories: objective tinnitus, where the sound could be audible to another person, and subjective tinnitus, in which the sound could only be heard by the patient. Tinnitus is considered acute if tinnitus occurs for <3 months, subacute if 3–6 months, or chronic if it persists for more than 6 months. Majority of patients are affected by subacute or chronic idiopathic tinnitus.[1]

The prevalence of tinnitus worldwide ranged from 11.9% to 30.3%, and it increased with age.[2] Bothersome tinnitus constitutes 3%–6% of these populations.[1] Even though this condition is very common, patients find this disorder life-changing. Chronic bothersome tinnitus may lead to worsened cognitive performance,[3] anxiety, and depression.[4],[5] Various scoring systems have been developed, such as the tinnitus functional index (TFI), Tinnitus Handicap Inventory, Tinnitus Questionnaire, and Tinnitus Reaction Questionnaire, to quantify the burden of tinnitus. TFI is superior to other questionnaires in measuring treatment-related change. It consists of 25 questions, with a total score of 100. A higher score indicates that tinnitus is more bothersome. A score of more than 24 indicates bothersome tinnitus that requires intervention. A reduction in the total TFI score of 13 indicates meaningful clinical reduction.[6]

Different treatment modalities have been used in treating chronic bothersome tinnitus, including sound therapy, cognitive behavioral therapy (CBT), pharmacological treatment, and electromagnetic stimulation. However, according to the current treatment guidelines for tinnitus, CBT is the only modality that has a high level of evidence to treat tinnitus.[1],[7],[8] However, CBT is not suitable for all patients. Furthermore, ear, nose, and throat doctors and audiologists are not trained in CBT, and psychologists who are trained in CBT are not trained in tinnitus.

Previous studies have shown the effectiveness of using Al Quran sound therapy as a treatment option for other medical conditions. Jabbari et al. found that the voice of the Al Quran, with or without translation, was effective in decreasing stress, anxiety, and depression during pregnancy.[9] A study by Rafique et al. on the efficacy of surah Al-Rehman in managing depression in Muslim women found that women diagnosed with depression in the treatment group reported a reduced level of depression compared with the control group at the postassessment level.[10] A study by Frih et al. also showed the benefits of listening to Al Quran recitation in elderly patients undergoing hemodialysis on dialysis efficacy, physical condition, quality of life, and the large reduction in anxiety.[11]

At present, no study has evaluated the effect of listening to the Al Quran on patients with tinnitus. However, Al Quran recitation has been hypothesized to be a potential treatment for tinnitus. First, the psychological manifestations of patients with tinnitus are similar to those of patients with anxiety and depression. Al Quran has been shown to be effective in those patients; thus, listening to Al Quran may also reduce anxiety among patients with tinnitus. Islam encourages its believers to listen and read Al Quran regularly, and Quranic healing is not uncommon among its believers.


  Materials and Methods Top


This randomized single-blind controlled study was conducted from December 2020 to January 2022 in the otorhinolaryngology clinic of a tertiary hospital in Malaysia. This study received ethical approval from the University Research Ethics Committee (UKM PPI/111/8/JEP-2020-445). All subjects from the outpatient clinic and tinnitus sufferers who responded to public radio and social media announcements and fulfilled the inclusion and exclusion criteria were recruited. The inclusion criteria were Muslim subjects aged 18 years and older, who suffer from primary bothersome tinnitus with TFI more than 24, and who complained of tinnitus for 3 months or more. Subjects with pulsatile or objective tinnitus, poor cognitive functions, or Meniere's disease were excluded. The eligible subjects were randomized into two groups by using block randomization: combination (Al Quran sound therapy and tinnitus counseling) and counseling group. The block size was prepared by the other staff, and the investigator was blinded and could not predict the sequence of allocation for the subjects.

The Malay version of TFI was recorded before starting the treatment and 1 month after the intervention. Each of the 25 questions was assessed on an 11-point Likert scale, in which the sum of the score was divided by the number of questions answered and multiplied by 10 to give a total score between 0 and 100. A reduction in TFI score of at least 13 points was regarded as the minimum clinically important change.

All subjects who qualified in this study received intervention via online or direct meetings. The combination group received the same Al Quran sound therapy, which consisted of surah Al-Fatihah, Al-Ikhlas, Al Falaq, An Nas, Al-Baqarah, Ali-Imran, Ar-Rahman, Al-Fajr, and Yaasin recited by Sheikh Mahmud Khalil Al-Husari via the online platform. The counseling group did not receive any sound therapy. The subjects in the combination group were advised to listen to Al Quran verses for at least 2 h each day or when tinnitus was the most intrusive. They were also advised to adjust the sound volumes that allow for constant exposure to a very low level of tinnitus. The subjects were counseled via physical or online meetings on the basis of the Malaysian Tinnitus Management Module developed by the University Kebangsaan Malaysia in a single session with 1-h interactive discussion. The discussion was focused on patients' expectations, main concerns, detailed information on tinnitus, management plan, and how to change the negative perception and reaction to tinnitus toward positive thinking.

Statistical analysis

Statistical analysis was performed using SPSS 28.0 software (IBM Corporation, Armonk, NY, USA). Categorical variables were expressed as numbers or percentages. Continuous variables were presented as mean and standard deviation. Normal distribution was tested using the Shapiro–Wilk test. The baseline outcome was the TFI scores during screening or enrollment visits. The TFI scores after 1 month of intervention were taken as the final outcome measures. The change in TFI scores after the intervention compared with baseline was calculated for each subject, followed by the mean for each arm. An Independent t-test was used to analyze the mean between the two arms. Paired t-test was used to analyze the final outcome compared with the baseline. P < 0.05 was considered statistically significant.


  Results Top


A total of 25 subjects fulfilled the inclusion and exclusion criteria, and they were recruited in this study. After randomization was completed, 15 and 10 subjects were placed in the counseling and combination groups, respectively.

As shown in [Table 1], no statistically significant difference was found between the counseling and combination groups in terms of age, gender, and hearing (P > 0.05).
Table 1: Demographic data of subjects involved in the study according to age, gender, and hearing loss

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[Table 2] shows the mean decline and the percentage of subjects with clinically relevant reduction in TFI score within each group. In the combination therapy group, the percentage of subjects that had reduction in total TFI score was higher than those in the counseling therapy group. There is a larger mean decline in total TFI score as well as a higher percentage of subjects with a reduction of TFI score of more than 13 in the combination group, compared to counseling group.
Table 2: Comparison of total Tinnitus Functional Index score reduction, mean decline, and percentage of subjects with a clinically relevant reduction between combination and counseling groups

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[Table 3] shows that among the TFI subscales, the scores of intrusiveness, sense of control, and emotion decreased significantly after the intervention in the combination group (P < 0.05).
Table 3: Changes in Tinnitus Functional Index score before and after the intervention of combination therapy

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[Table 4] shows no statistically significant difference in the TFI subscale scores after intervention in all the domains in the counseling group (P > 0.05).
Table 4: Changes in Tinnitus Functional Index score before and after the intervention within tinnitus counseling therapy

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[Table 5] shows no statistically significant difference in the mean changes during pre-and post-intervention between the combination group and the counseling group for total TFI score and all domains (P > 0.05).
Table 5: Difference in TFI score during pre- and post-intervention between combination and counseling groups

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  Discussion Top


In this study, 68% of the subjects had a reduction in TFI score, with 70% in the combination group and 67% in the counseling group after 1 month of intervention. In the combination group, the mean decline was 12.4, compared with only 4.9 in the counseling group. This observation indicated that both therapeutic approaches are successful in reducing the negative effect of tinnitus. Within the combination group, a statistically significant reduction was found in the domains of emotion (P = 0.036), intrusiveness (0.036), and sense of control (0.026) postintervention. According to Hall et al., different domains may show better improvement with different types of intervention. The domains intrusiveness and sense of control were important parameters to measure the effectiveness of sound-based and psychological-based interventions, while the domain loudness was an important parameter in pharmacological-based intervention.[12] This finding explained the result of the present study, where patients who listened to Al Quran had reduced negative effects, mainly in the domains of emotion, sense of control, and intrusiveness.

Sound therapy has been widely used for the treatment of tinnitus, although evidence for its efficacy is limited.[8] In the present study, Al Quran was hypothesized as a sound therapy that could help patients with tinnitus through five mechanisms. The first mechanism is via masking, in which listening to Al Quran recitation at a certain volume may cover the intimidating sound of tinnitus and provide a sense of relief to the patient. In addition, patients may use a lower volume of sound therapy so that the sounds of Al Quran and tinnitus are audible in accordance with the patients' comfort level.[13] The second mechanism is distraction. Listening to the Al Quran sound passively diverts the attention away from tinnitus by reducing the contrast between tinnitus and the environment. Patients also had their attention focused on calming the Al Quran sound rather than annoying tinnitus.[14] The third mechanism is habituation, wherein the constant Al Quran sound heard by patients helps their brain to reclassify tinnitus as an unimportant sound that should be consciously ignored.[13] The fourth mechanism is neuromodulation, in which listening to Al Quran could desynchronize the neural hyperactivity that causes tinnitus.[15] The last mechanism is that Al Quran therapy could induce positive emotional association and decrease anxiety and depression experienced by patients with tinnitus.[16]

The entire Al Quran is a source of healing, and various sites in the Al Quran mention healing. For example, it is stated in Al-Quran.

And We sent down in the Quran such things that have healing and mercy for the believers (Al-Israr, 17:82).

Mankind there has come to you a guidance from your Lord and a healing for (the diseases) in your hearts, and for those who believe a guidance and a mercy (Yunus, 10:57).

A systematic review by Latuapo et al. and Nayef and Wahab supported that listening to Al Quran recitation has positive effects on human physiological processes and physical parameters, such as reduction in blood pressure, relaxation of muscle, and reduction in heart rate.[17],[18] All of these physical parameters are commonly abnormal in patients who experience stress, anxiety, and depression. The psychoacoustic principles found in the recitals of Al Quran provide relaxing music and calmness, improve mind clarity, and promote positive thinking. These properties help patients to be less focused on tinnitus and more aware of the surrounding environment, ultimately reducing the psychological complications observed in patients with tinnitus.[17],[19]

This study showed that when comparing both approaches, the combination group had a higher percentage of patients with minimal clinically important reduction. Furthermore, combination therapy had a greater reduction in the mean decline of total TFI score in all subdomains. However, the difference was not statistically significant. Although the effectiveness of sound therapy has been questioned by previous guidelines,[7],[8] recent systematic review and meta-analysis showed the efficacy of sound therapy in the treatment of tinnitus.[20] In contrast to the present study, previous studies that showed the effectiveness of sound therapy had a longer intervention time of 3–18 months,[21],[22] with the gradual reduction in tinnitus severity with a prolonged treatment period. Further studies with a longer period of intervention in treating patients with chronic tinnitus are recommended to observe clinically important improvement.

The current treatment for chronic bothersome tinnitus is to focus on acceptance and the alleviation of the negative effects of tinnitus. The basic principles of health and healing in Islam have similar concept. Therefore, healing by Al Quran sound therapy could be embraced by Muslim. “Iman” (faith) and ultimate submission to Allah is at the center of all principles and practices in Islam. Sickness is considered benediction for Muslim, and every disease has a cure. Those who have faith in the ultimate authority of Allah could accept any disease as a trial in this life for success in the life hereafter.[23] Thus, those who have tinnitus are encouraged to pray. As mentioned in Sahih Muslim 2725, “O Allah, direct me to the right path and make me adhere to the straight path.”

Limitation

This study was conducted during movement control order due to the COVID-19 pandemic, with strict inclusion criteria causing difficulty in recruiting a higher number of patients. Larger sample size and longer intervention period may yield and represent the effect of intervention to tinnitus better.


  Conclusion Top


Combination therapy and tinnitus counseling showed reduction in TFI score. Combination therapy using Al Quran and counseling improved the emotion, sense of control, and intrusiveness of tinnitus. However, no statistically significant difference was found between the combination and counseling groups in terms of total TFI score and subscales.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Cima RF, Mazurek B, Haider H, Kikidis D, Lapira A, Noreña A, et al. A multidisciplinary European guideline for tinnitus: Diagnostics, assessment, and treatment. HNO 2019;67:10-42.  Back to cited text no. 1
    
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McCormack A, Edmondson-Jones M, Somerset S, Hall D. A systematic review of the reporting of tinnitus prevalence and severity. Hear Res 2016;337:70-9.  Back to cited text no. 2
    
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Clarke NA, Henshaw H, Akeroyd MA, Adams B, Hoare DJ. Associations Between Subjective Tinnitus and Cognitive Performance: Systematic Review and Meta-Analyses. Trends Hear 2020;24:1-23.  Back to cited text no. 3
    
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Trevis KJ, McLachlan NM, Wilson SJ. A systematic review and meta-analysis of psychological functioning in chronic tinnitus. Clin Psychol Rev 2018;60:62-86.  Back to cited text no. 4
    
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Salazar JW, Meisel K, Smith ER, Quiggle A, McCoy DB, Amans MR. Depression in patients with tinnitus: A systematic review. Otolaryngol Head Neck Surg 2019;161:28-35.  Back to cited text no. 5
    
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Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, et al. The tinnitus functional index: Development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear 2012;33:153-76.  Back to cited text no. 6
    
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Jabbari B, Mirghafourvand M, Sehhatie F, Mohammad-Alizadeh-Charandabi S. The effect of holly Quran voice with and without translation on stress, anxiety and depression during pregnancy: A randomized controlled trial. J Relig Health 2020;59:544-54.  Back to cited text no. 9
    
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Frih B, Mkacher W, Bouzguenda A, Jaafar H, ALkandari SA, Ben Salah Z, et al. Effects of listening to Holy Qur'an recitation and physical training on dialysis efficacy, functional capacity, and psychosocial outcomes in elderly patients undergoing haemodialysis. Libyan J Med 2017;12:1372032.  Back to cited text no. 11
    
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Hall DA, Hibbert A, Smith H, Haider HF, Londero A, Mazurek B, et al. One Size Does Not Fit All: Developing Common Standards for Outcomes in Early-Phase Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults. Trends Hear. 2019;23:1–6.  Back to cited text no. 12
    
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Henry JA, Zaugg TL, Myers PJ, Schechter MA. Using therapeutic sound with progressive audiologic tinnitus management. Trends Amplif 2008;12:188-209.  Back to cited text no. 14
    
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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