Plain English Summary
Background and study aims
Secretory otitis, commonly referred to as glue ear, is a childhood condition where fluid (mucus) builds up in the middle ear. This can cause hearing problems and affect the child’s social adaptation and academic performance. The mucus can just stay in the ear, can cause a hole to develop in the eardrum (perforated eardrum), or can cause an ear infection (acute otitis media), which would require treatment with antibiotics. The recent guidelines concluded that there is no single effective treatment for secretory otitis, and recommend a period of three months of monitoring during which the secretory otitis may improve spontaneously. If there is no improvement after 3 months, surgical treatment may be required to place tubes (grommets) in the ear to drain the mucus, with or without adenoidectomy (an operation to remove the adenoids). The aim of this study is to assess the effectiveness of homeopathy as an addition to the conventional treatment for children with secretory otitis.
Who can participate?
Children age 2 months to 12 years with secretory otitis
What does the study involve?
Participants are randomly allocated into two groups. One group receives homeopathic treatment and the other group receive a placebo (dummy drug). Both groups also receive conventional treatment (budesonide and ambroxol hydrochloride in an aerosol [spray]) for 20 days at a rate of one session per day.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Complejo Hospitalario de Toledo (Spain)
When is the study starting and how long is it expected to run for?
September 2012 to January 2014
Who is funding the study?
University of Zaragoza (Spain)
Who is the main contact?
María Fernanda Pedrero Escalas
mf.pedrero@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr María Fernanda Pedrero
ORCID ID
Contact details
Hospital Virgen de la Salud de Toledo
Otorrinilogy Service
Av. de Barber
30
Toledo
45071
Spain
+34 (0)687 468 806
mf.pedrero@gmail.com
Additional identifiers
EudraCT number
2011-006086-17
ClinicalTrials.gov number
Protocol/serial number
55005646
Study information
Scientific title
Effectiveness of homeopathic treatment (Agraphis nutans 5CH, Thuya occidentalis 5CH, Kalium muriaticum 9CH and Arsenicum iodatum 9CH), as an adjuvant in secretory otitis (SO) in childhood: a randomized parallel double-blind clinical trial
Acronym
Study hypothesis
The coadjuvancy with homeopathy, in patients aged 2 months to 12 years, can improve or resolve the SO, diagnosed through the Bilateral pneumatic otoscopy (OPN), the primary endpoint being a dichotomous one (positive or negative mobility of the tympanic membrane).
Ethics approval
RCREC of Toledo, Hospital of Toledo (RCREC of Toledo, Complejo Hospitalatio de Toledo), 16/01/2012
Study design
Controlled randomized (1:1) parallel double-blind clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact María Fernanda Pedrero Escalas [mf.pedrero@gmail.com] to request a patient information sheet
Condition
Secretory otitis in childhood
Intervention
Control arm receives
Aerosolot: 1 session / 24 hours / 20 days with: 1 vial of Ambroxol hydrochloride 7.5 mg/ml, 1 vial of budesonide 0.25 mg/ml suspension, and 2cc of physiological saline.
Intervention arm receives aerosol + A or B.
Aerosolot: 1 session / 24 hours / 20 days with: 1 vial of Ambroxol hydrochloride 7.5 mg/ml, 1 vial of budesonide 0.25 mg/ml suspension, and 2cc of physiological saline.
And
Homeopathic:
A: Agraphis nutans 5CH (granules) and Thuya occidentalis 5CH (granules) 5 granules once a day, preferably in the evening. Approximately 80 pellets are in each tube
or
B: Kalium muriaticum 9CH (granules) and Arsenicum iodatum 9CH (granules) 5 granules, twice a day. Approximately 80 pellets are in each tube.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The presence or absence of secretory otitis in childhood depending on the tympanic mobility measured with pneumatic otoscopy
Secondary outcome measures
1. Need for surgery (DTT + / - adenoidectomy) in any of the patient's ears with secretory otitis at the end of study to meet the surgical indications of the Spanish Society of Otolaryngology and cervico-facial
2. Number of Secretory Otitis Media, Secretory Otitis Media complicated and tympanic perforations in one of the two ears of patients with secretory otitis during the study period (3 months)
3. Number of days of absence from school or work, the patient or primary caregivers have been forced to make during the study period (3 months) for reasons related to hearing problems (Secretory Otitis Media, Complications of Secretory Otitis Media or perforated eardrum)
4. The proportion and type of intercurrent adverse events will be collected during the trial in both study groups
Overall trial start date
30/09/2012
Overall trial end date
31/01/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age: 2 months - 12 years
2. Informed consent from parents and / or tutors
3. SO diagnosed unilateral or bilateral diagnosed in otolaryngology consultations with pneumatic otoscopy, according to the presence or absence of tympanic mobility. Each ear counted as one unit of primary endpoint.
4. Do not be following any regular treatment, specifically especially corticosteroids, antihistamines and mucolytics
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
220 subjects
Participant exclusion criteria
1. Acute Otitis Media or complicated at the time of baseline
2. Have not passed the newborn hearing screenig (OAE)
3. Concomitant diseases
4. Permanent sensorineural hearing loss
5. Autism
6. Down Syndrome craneofaciales or other malformations
7. Malformations of the outer or middle ear
8. Acute Mastoiditis or Cholesteatoma
9. Recent vaccination (less than 30 days)
10. Cilial motility disorders (Kartagener syndrome)
11. Alterations prelingual speech or language
12. Obstructive sleep apnea (OSA)
13. Adenoidectomy
14. Persistence of Tubo-tympanic disease (TTD) or perforated eardrum
15. Lactose intolerance or diabetes (incompatible with placebo and homeopathy)
Recruitment start date
30/09/2012
Recruitment end date
31/01/2014
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Virgen de la Salud de Toledo
Toledo
45071
Spain
Sponsor information
Organisation
Individual sponsor (Spain)
Sponsor details
Dr. María Fernanda Pedrero Escalas
Hospital Virgen de la Salud de Toledo
Otorrinology Service
Av. de Barber
30
Toledo
45071
Spain
+34 (0)687 468 806
mf.pedrero@gmail.com
Sponsor type
Other
Website
Funders
Funder type
University/education
Funder name
Universidad de Zaragoza
Alternative name(s)
University of Zaragoza
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Spain
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary