Drooling in Patient with Parkinson’s Disease Drooling,
Conditions
Interventions
The patients will be assessed pre and post-
treatment by objective and subjective measures. At baseline,
patients will be assessed with the MMSE,
and rated on the Hoehn and Yahr scale,
MDS-
UPDRS part II: item 2.2,
MDS part III,
their quality of life with the visual analogue scale including Drooling Severity and Frequency Scale(DSFS) which will be recorded by the patients at home 3 days preceding and collected as baseline bef
in the morning and in the on state for the trial. A quantitative measure of saliva production will be done in the subjects by having dental rolls placed into the mouth with these staying in place for
patients will receive 1 drop of atropine solution sublingually. Patients will be reassessed at 40 and 120 minutes intervals from medication administration with both the drooling scale and the quantita
taking 1 drop of the treatment solution twice daily (morning and evening). They will observe their drooling severity and recorded DSFS in the last 3 days,
returned 1 week later,
and will be reassessed with the same measures used at the baseline assessment.
,The patients will receive 1 drop of placebo solution sublingually which the color,
and taste of solution were relatively the same. Patients will administer it in the morning and in the evening for 1 week. The patients will be assessed pre and post-
treatment by objective and s
Experimental Drug,Placebo Comparator Drug
1% atropine group,Placebo group
Sponsors
None
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria included patients diagnosed with Parkinson’s disease(PD) according to United Kingdom Parkinson’s Disease Society Brain Bank (UKPDS-BB) criteria by neurologists, age more than 17 years, suffering from drooling which was evaluated by Movement Disorders Society - United Parkinson’s Disease Rating Scale (MDS-UPDRS) part II: item 2.2; salivation and drooling subscore more than 1 score. The patients have not been received 1% atropine solution before, had the stable regimen of PD medications or stable Deep Brain Stimulation(DBS) setting in case of having the device for the preceding 2 weeks, and no changes were to be made to other antiparkinsonian medication doses or DBS setting during this study
Exclusion criteria
Exclusion criteria: Exclusion criteria for the trial included the patients who had drooling from other causes such as dental problem, active hallucinations or psychosis, cardiovascular disease and, or cardiac arrhythmia, history of Botulinum toxin injection to salivary gland, active treatment with an anticholinergic drug. The patients getting pregnant or lactating women, diagnosed with Parkinson’s disease with dementia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of sublingual administration of atropine solution for drooling in PD patients 1 week Movement Disorders Society - United Parkinson’s Disease Rating Scale (MDS-UPDRS) part II: item 2.2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective measurement of volume of saliva 1 week weight of saliva in dental roll,Severity of drooling 1 week Drooling Severity and Frequency Scale (DSFS) ,Quality of life 1 week Visual analogue scale ,Adverse events 1 week History taking and questionnaire of adverse events | — |
Contacts
Public ContactPrachaya Srivanitchapoom
Faculty of Medicine, Siriraj Hospital, Mahidol University
Outcome results
None listed