Laryngopharyngeal reflux disease (LPR) is characterized by individuals who present to an otolaryngologist with signs of laryngeal inflammation or irritation associated with symptoms of hoarseness, reduced loudness, chronic cough, frequent throat clearing, sensation of a lump in the back of the throat, difficulty swallowing and sore throat.

LPR adalah suatu penyakit yang ditandai dengan adanya inflamasi dan iritasi laryng sehingga pada pasien akan timbul gejala suara serak, berkurangnya volume suara, batuk yang kronik, rasa tertekan pada tenggorok bagian belakang, kesulitan untuk bernafas dan nyeri tenggorok.

Research addressing effective management of LPR is of great interest because it has significant impact on communication, respiration and swallowing.

Penelitian menunjukan penatalaksanaan yang efektif untuk LPR lebih di minati karena berhubungan dengan fungsi komunikasi , respirasi dan proses menelan.

The currently recommended treatment of LPR is to pair dietary and lifestyle changes with pharmaceutical intervention using primarily proton pump inhibitors (PPIs).3,6,7 Initial studies addressing pharmaceutical management of LPR using PPIs demonstrated benefit from high-dose PPI use; however, these studies did not utilize a control arm

Pada Penelitian akhir2 ini menyarankan pengelolaan LPR adalah kombinasi perubahan gaya hidup dan pola makan dengan PPI dosis tinggi. Namun penelitian tersebut tidak menggunakan kelompok control dalam penelitiannya.

More recently, placebo-control trials have countered earlier findings regarding effectiveness of PPI use in LPR. Placebo-controlled trials have studied a variety of variables hypothesized to be sensitive to anticipated changes in LPR including quality of life ratings, endoscopic ratings of laryngeal tissues and gastro-oesophageal reflux disease (GORD) symptoms. However, none of these variables differentiated benefit from PPI management of LPR and placebo.

Placebo-controlled trials telah mempelajari variable untuk mengetahui perbaikan pada LPR seperti perbedaan tingkat kualitas hidup, perbedaan gambaran endoscopy dari laryng dan gejala-gejala pada GORD. Namun tidak satu pun dari variable tersebut memiliki perbedaan baik dalam kelompok PPI ataupun placebo untuk terapi LPR.

However, no prior placebo-controlled trials have directly investigated changes in voice production associated with the use of PPI management of LPR.

Tidak adanya perbedaan pada placebo-controlled trials yang telah diteliti dalam hal perubahan produksi suara yang berhubungan dengan penggunaan PPI untuk terapi LPR.

OBJECTIV

The aim of this study was to investigate the effectiveness of PPI twice daily vs placebo in treating

LPR by using a double-blind, placebo-controlled design

Metode

INKLUSI

Patients diagnosed with posterior laryngitis associated with hoarseness, cough, throat clearing, throat discomfort and globus sensation, and who were found to have GORD-related laryngeal mucosal changes were invited to participate in this study.

Pasien yang telah didiagnosa laryngitis posteror dengan tanda-tanda suara serak, batuk, rasa tidak nyaman pada tenggorok, dan perubahan mukosa laryng yang berhubungan dengan GORD. Semua pasein diperiksa oleh an otolaryngologist dan ditemukaannya tanda-tanda erutem, edem, ulserasi dan mukosa granulasi pada daerah interarytenoid atau posterior glottic. Pasien tidak mengkonsumsi obat-obat antireflux.

All patients were evaluated by an otolaryngologist and diagnosed with LPR subsequent to laryngeal inspection Laryngopharyngeal reflux was defined as the presence of erythema, oedema, ulceration, or granular mucosal appearance in the interarytenoid or posterior glottic areas. At the time of enrolment, none of the patients was consuming any type of antireflux medication.

Eksklusi

Patients were excluded from the study if they were currently on antireflux treatment, had prior antireflux or other oesophageal or gastric surgery, had undergone endotracheal intubation within the last 3 months, were diagnosed with oropharyngeal or laryngeal cancer, were pregnant, or had an allergy to a PPI. In addition, patients with severe comorbidity (cardiovascular, respiratory, renal, hepatic, hematologic, neurologic, or psychiatric), diabetes mellitus, scleroderma, gastroparesis, active peptic ulcer disease, taking prokinetic agents or narcotics were excluded from the study. Patients who were unable to sign an informed consent or complete all stages of the study were excluded as well

Memakai obat antireflux Pernah operasi pada esophagus atau pun gaster Pernah intubasi endotrakeal dalam 3 bulan sebelumnya Didiagnosa sebagai ca orofaringeal atau ca laryngeal Hamil Alergi PPI Memiliki penyakit yang berhubungan dengan kardiovaskuler , sitem pernafasan, ginjal,

hepar, kelainan darah, syaraf dan gangguan jiwa, diabetes mellitus, scleroderma, gastroparesis, peptic ulcer

Konsumsi obat prokinetic or narcotics Pasein yang tidak dapat menandatangani inform consent Pasein yang gugur pada tahap pemeriksaan.

evaluasi

evaluation of all participants was performed using the GORD Symptom Checklist, the Short Form 36 (SF-36), the Laryngopharyngeal Reflux Health-Related Quality of Life Questionnaire (LPR-HRQL), and the Demographics Questionnaire. Subsequently, patients underwent oesophagogastroduodenoscopy, ambulatory 24-h oesophageal pH monitoring, videostroboscopic recording of the larynx, and acoustic recordings of voice and speech tasks for analysis and perceptual ratings.

Pasien yang telah di evaluasi dengan checklist GORD Symptom, the Short Form 36 (SF-36), the Laryngopharyngeal Reflux Health-Related Quality of Life Questionnaire (LPR-HRQL), and the Demographics Questionnaire. Selanjutnya pasien diperiksa dengan oesophagogastroduodenoscopy, ambulatory 24-h oesophageal pH monitoring, videostroboscopic recording of the larynx serta pemeriksaan pada suara dan pengucapan untuk analisis

Patients completed a Daily Voice Use and Quality Diary for 1 week at baseline and during weeks 4, 8, and 12 of the treatment period. Patients also repeated a GORD symptom record diary for 7 days during week 12. On the last day of treatment, the SF-36 and LPR-HRQL were administered, and videostroboscopic recordings and acoustic recordings of voice and speech tasks were collected as well.

Demographical Questionnaire

The demographical questionnaire obtained information regarding participants_ age, gender, ethnicity, college education, income and other demographical parameters.

GORD Symptom Checklist

Patient_s symptom severity and frequency at baseline were selfreported using the validated GORD symptom questionnaire. This instrument assesses the occurrence and frequency of heartburn and acid regurgitation

Upper endoscopy

Upper endoscopy was performed to evaluate the distal oesophagus and to determine the presence of mucosal injury. The stomach and duodenum were evaluated for possible mucosal lesions as well.

Ambulatory 24-h oesophageal pH monitoring

Ambulatory 24-h oesophageal pH monitoring was performed using a VersaFlex_ pH catheter with lower oesophageal sphincter identifier (Alpine Biomed, Fountain Valley, CA, USA). The data

were stored on a portable digital recorder (Digitrapper MK III; Medtronic Functional Diagnostic Inc., Shoreview, MN, USA). Patients were instructed to keep a diary and record meal times, position changes, and the type and time of their symptoms. Patients were encouraged to pursue their everyday activities and usual diet.

Daily Voice Use and Quality Diary

Participants were instructed to complete a Daily Voice Use and Quality Diary for 1 week at baseline and again during the 4th, 8th, and 12th weeks of treatment. The Daily Voice Use and Quality

Diary required that patients rate four parameters on a visual analogue scale from 0 to 100: per cent of voice use, per cent of voice use during the day that felt fatigued, degree of effort to produce the voice when it was not fatigued, and gross rating of voice quality.

Laryngopharyngeal Reflux Health-related Quality of Life Questionnaire (LPR-HRQL)

The LPR-HRQL is a validated, disease-specific tool to assess patient reported outcomes and HRQL.12 It scores patient responses in four domains (Voice/Hoarse, Cough, Throat Clear, Swallow) and provides an overall assessment of the impact of LPR on a patient_s quality of life.

Short form 36 (SF-36)

The SF-36 is a generic HRQL tool that includes eight multi-item scales. The SF-36 evaluates the extent to which an individual_s health limits his or her physical, emotional or social functioning.

Videostroboscopy and voice and speech recordings

Patients underwent two different sessions of laryngeal imaging using rigid videostroboscopy and voice and speech recordings pretreatment to determine baseline appearance and function of the larynx for voice and speech production. The same procedures were repeated after 12 weeks of treatment. Laryngeal function and appearance were evaluated using the Kay Elemetrics Computer Integrated Laryngostroboscopic unit with a 70-degree rigid fiberoptic scope. Laryngeal recordings included the tasks of quiet breathing, sustained voicing of _ee_ at low and high pitches, pitch glide upwards and then downwards, and soft and loud voicing at a comfortable pitch. Still-frame images were digitized from all videostroboscopic recording sessions across participants to present optimal open and closed vocal fold positions for later rating using the Reflux Finding Score (RFS) system. The latter is a validated tool for diagnosing LPR.37 Open and closed vocal fold still images were paired

together and then randomly incorporated into a PowerPoint_ presentation for later perceptual rating analysis.

The acoustic parameters of fundamental frequency and intensity

were measured to determine changes in pitch and loudness

respectively. These two parameters of voice are both frequently

decreased in individuals with LPR due to increased vocal fold

mass related to swelling, resulting in reduced rate of vocal fold

vibration or lower pitch. Further, incomplete vocal fold approximation

can occur during phonation, resulting in air leakage and

reduced loudness. Vocal fold oedema also reduces the maximum

pitch range an individual can produce due to increased mass of the

vocal fold related to oedema and inflammation. Reduction in

oedema related to PPI treatment would be expected to result in

increased fundamental frequency, intensity and maximum pitch

range.

Acoustic recordings were obtained using the Kay Elemetrics

Computer Speech Lab system and an AKG head-mounted microphone

placed within two inches of the participant_s mouth at a

45-degree angle.

Fundamental frequency and intensity were determined from

the middle 2–3 s of the sustained phonation recordings and

from the second of three sentence repetition recordings. The

sentence stimuli repeated three times for each recording. The

maximum pitch range obtained across three trials was also

recorded.