KERATOCONJUNCTIVITIS SICCA, PRIMARY SJOGREN SYNDROME, SICCA SYNDROME, XEROSTOMIA
Conditions
Keywords
Sjogrens Syndrome, Syndrome, Sjogren's, Sjogren Syndrome, Sicca Syndrome, Syndrome, Sicca
Brief summary
This study was designed to test the efficacy and safety of low laser therapy to treat the xerostomia of patients with primary Sjogren's Syndrome.
Detailed description
The Sjogren's Syndrome is a disease that affects around 0,5% of the population and is mainly characterized for inflammatory involvement of salivary and lacrimal glands. The xerostomia leads to low quality of life caused by dry sensations that can disturb the taste, the speaking, the swallow and chewing functions in the affected patients. The absent saliva can cause increase of dental caries and decays. Until now, there is no effective treatment that increases the amount of saliva and the patients have low improvements with cholinergic drugs such as pilocarpine and cevimeline. These drugs can cause unpleasant collateral effects.
Interventions
DEVICELasertherapy
Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)
DEVICESham Lasertherapy
Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group).
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with primary Sjogren Syndrome according criteria american european 2002. * Salivary flux non stimulated \< 0,1 ml/min.
Exclusion criteria
* hepatitis B and/or C * radiotherapy in the glandular area (previous) * other connective diseases * thyroidopathy non compensated * GVHD graft-versus-host disease * HIV * Sarcoidosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Xerostomia Inventory | 6 weeks | The Xerostomia Inventory (XI) is an 11-item questionnaire (Thomson et al, 1999). Scores to the 11 items are summated, providing a single score (5-55) representing the subjective severity of xerostomia. In 2012, da Mata published a validated version in portuguese and we used this version. The better score is the lowest. The significant variation is defined as 6 or more. Bellow we describe all the 11 questions: 1. I sip liquids to aid in swallowing food 2. My mouth feels dry when eating a meal 3. I get up at night to drink 4. My mouth feels dry 5. I have difficulty in eating dry foods 6. I suck sweets or cough lollies to relieve dry mouth 7. I have difficulties swallowing certain foods 8. The skin of my face feels dry 9. My eyes feel dry 10. My lips feel dry 11. The inside of my nose feels dry \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Score: Never' (1), Hardly ever' (2), Occasionally' (3), Fairly often' (4), Very often' (5) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Biomarker Analysis. Beta 2 Microglobulin. | 6 weeks | The saliva in Sögren's syndrome patients has a high level of beta 2 microglobulin reflecting progression of the disease and inflammatory process at glandular epithelium. The saliva samples were collected at the baseline and end point. Beta 2 microglobulin was determined by Elisa human kit (ABCAM ab 108885). The normal levels are 1,2 +/- 0,7 microg/ml, and for primary Sjögren's syndrome 5,3 +/- 4,6 microg/ml. This measure was done in the samples of saliva before and after the lasertherapy for all patients. |
| Salivary Flux Measurement | 6 weeks | The salivary flux was measured at the same time, without previous meal or tooth brushing, drinking or eating, in a quiet room. Spilled saliva was collected in a graduated Falcon 15ml tube. The samples of saliva were frozen and stored at -20° C. Normal salivary stimulated flux is above 0,5 ml/min. Normal unstimulated salivary flux is above 0,2 ml/min. |
Countries
Brazil
Participant flow
Recruitment details
The study sample consisted of 66 patients who were selected from 84 patients referred from ophthalmology and rheumatology division of university hospital. The patients met primary Sjögren's criteria (2002).
Pre-assignment details
The exclusion criteria were: sarcoidosis, uncontrolled thyroidopathy, HIV and HCV infections and head or neck irradiation history. A computer-generated randomization list was used to allocate patients ramdomly into two groups: active laser therapy and sham laser therapy. Concealed randomization was performed with opaque sealed envelopes.
Participants by arm
| Arm | Count |
|---|---|
| Sham Comparator: Sham Lasertherapy Sham lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Sham Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group). | 33 |
| Active Comparator: Lasertherapy Low level lasertherapy in parotid, submandibular and sublingual glands for six weeks.
Lasertherapy: Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group) | 33 |
| Total | 66 |
Baseline characteristics
| Characteristic | Active Comparator: Lasertherapy | Total | Sham Comparator: Sham Lasertherapy |
|---|---|---|---|
| Age, Continuous | 54 years (SD) STANDARD_DEVIATION 11.3 | 57 years (SD) STANDARD_DEVIATION 11 | 58 years (SD) STANDARD_DEVIATION 11.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Brazil | 33 participants | 66 participants | 33 participants |
| Sex: Female, Male Female | 32 Participants | 64 Participants | 32 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
The Xerostomia Inventory
The Xerostomia Inventory (XI) is an 11-item questionnaire (Thomson et al, 1999). Scores to the 11 items are summated, providing a single score (5-55) representing the subjective severity of xerostomia. In 2012, da Mata published a validated version in portuguese and we used this version. The better score is the lowest. The significant variation is defined as 6 or more. Bellow we describe all the 11 questions: 1. I sip liquids to aid in swallowing food 2. My mouth feels dry when eating a meal 3. I get up at night to drink 4. My mouth feels dry 5. I have difficulty in eating dry foods 6. I suck sweets or cough lollies to relieve dry mouth 7. I have difficulties swallowing certain foods 8. The skin of my face feels dry 9. My eyes feel dry 10. My lips feel dry 11. The inside of my nose feels dry \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Score: Never' (1), Hardly ever' (2), Occasionally' (3), Fairly often' (4), Very often' (5)
Time frame: 6 weeks
Population: Intent to treat population. Last observation carried forward imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Comparator: Sham Lasertherapy | The Xerostomia Inventory | 40.2 units on a scale | Standard Deviation 8.3 |
| Active Comparator: Lasertherapy | The Xerostomia Inventory | 39.3 units on a scale | Standard Deviation 8.1 |
p-value: 0.05ANOVA
Secondary
Salivary Biomarker Analysis. Beta 2 Microglobulin.
The saliva in Sögren's syndrome patients has a high level of beta 2 microglobulin reflecting progression of the disease and inflammatory process at glandular epithelium. The saliva samples were collected at the baseline and end point. Beta 2 microglobulin was determined by Elisa human kit (ABCAM ab 108885). The normal levels are 1,2 +/- 0,7 microg/ml, and for primary Sjögren's syndrome 5,3 +/- 4,6 microg/ml. This measure was done in the samples of saliva before and after the lasertherapy for all patients.
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Sham Comparator: Sham Lasertherapy | Salivary Biomarker Analysis. Beta 2 Microglobulin. | 1.10 microg/ml | Standard Deviation 3.63 |
| Active Comparator: Lasertherapy | Salivary Biomarker Analysis. Beta 2 Microglobulin. | 0.84 microg/ml | Standard Deviation 4.93 |
Secondary
Salivary Flux Measurement
The salivary flux was measured at the same time, without previous meal or tooth brushing, drinking or eating, in a quiet room. Spilled saliva was collected in a graduated Falcon 15ml tube. The samples of saliva were frozen and stored at -20° C. Normal salivary stimulated flux is above 0,5 ml/min. Normal unstimulated salivary flux is above 0,2 ml/min.
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Sham Comparator: Sham Lasertherapy | Salivary Flux Measurement | 0.100 ml/min | Standard Deviation 0.164 |
| Active Comparator: Lasertherapy | Salivary Flux Measurement | 0.100 ml/min | Standard Deviation 0.114 |