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 gastrooesophageal 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 (LPRHRQL)

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 23 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.