Trial Outcomes & Findings for Acupuncture Therapy for COVID-Related Olfactory Loss (NCT NCT04952389)
NCT ID: NCT04952389
Last Updated: 2024-03-12
Results Overview
The 40-item UPSIT is a measurement of the ability to detect odors where microencapsulated odorants on a strip are released by scratching. Each item is scored from 0 (did not correctly detect the odor) to 1 (correctly detected the odor). Total scores range from 0-40 with higher scores indicating better smell and lower scores indicating worse smell.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Baseline, post-treatment approximately 12 weeks
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
Acupuncture Therapy Group
Subjects underwent ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care.
Acupuncture Therapy: Consisted of two treatments per week for five weeks
Budesonide: Twice daily nasal rinses with steroid medication (budesonide)
Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
|
Standard of Care
Subjects were treated with two times daily budesonide rinses and olfactory (sense of smell) training. This is considered the current standard of care in the treatment of olfactory dysfunction.
Budesonide: Twice daily nasal rinses with steroid medication (budesonide)
Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
7
|
11
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
| Measure |
Acupuncture Therapy Group
Subjects underwent ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care.
Acupuncture Therapy: Consisted of two treatments per week for five weeks
Budesonide: Twice daily nasal rinses with steroid medication (budesonide)
Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
|
Standard of Care
Subjects were treated with two times daily budesonide rinses and olfactory (sense of smell) training. This is considered the current standard of care in the treatment of olfactory dysfunction.
Budesonide: Twice daily nasal rinses with steroid medication (budesonide)
Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
4
|
Baseline Characteristics
Acupuncture Therapy for COVID-Related Olfactory Loss
Baseline characteristics by cohort
| Measure |
Acupuncture Therapy Group
n=15 Participants
Subjects underwent ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care.
Acupuncture Therapy: Consisted of two treatments per week for five weeks
Budesonide: Twice daily nasal rinses with steroid medication (budesonide)
Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
|
Standard of Care
n=15 Participants
Subjects were treated with two times daily budesonide rinses and olfactory (sense of smell) training. This is considered the current standard of care in the treatment of olfactory dysfunction.
Budesonide: Twice daily nasal rinses with steroid medication (budesonide)
Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
15 participants
n=4 Participants
|
30 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, post-treatment approximately 12 weeksPopulation: Data not collected nor analyzed for eight subjects in the Acupuncture arm and four subjects in the Standard of Care arm
The 40-item UPSIT is a measurement of the ability to detect odors where microencapsulated odorants on a strip are released by scratching. Each item is scored from 0 (did not correctly detect the odor) to 1 (correctly detected the odor). Total scores range from 0-40 with higher scores indicating better smell and lower scores indicating worse smell.
Outcome measures
| Measure |
Acupuncture Therapy Group
n=7 Participants
Subjects underwent ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care.
Acupuncture Therapy: Consisted of two treatments per week for five weeks
Budesonide: Twice daily nasal rinses with steroid medication (budesonide)
Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
|
Standard of Care
n=11 Participants
Subjects were treated with two times daily budesonide rinses and olfactory (sense of smell) training. This is considered the current standard of care in the treatment of olfactory dysfunction.
Budesonide: Twice daily nasal rinses with steroid medication (budesonide)
Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
|
|---|---|---|
|
Change in University of Pennsylvania Smell Identification Test (UPSIT) Scores
|
2.571 score on a scale
Standard Deviation 5.997
|
3.182 score on a scale
Standard Deviation 5.306
|
SECONDARY outcome
Timeframe: Baseline, post-treatment approximately 12 weeksPopulation: Data not collected nor analyzed for eight subjects in the Acupuncture arm and four subjects in the Standard of Care arm
Patient-reported subjective olfactory loss measured by a 10-point visual analog scale with 10 representing no sense of smell and 1 representing normal smell.
Outcome measures
| Measure |
Acupuncture Therapy Group
n=7 Participants
Subjects underwent ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care.
Acupuncture Therapy: Consisted of two treatments per week for five weeks
Budesonide: Twice daily nasal rinses with steroid medication (budesonide)
Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
|
Standard of Care
n=11 Participants
Subjects were treated with two times daily budesonide rinses and olfactory (sense of smell) training. This is considered the current standard of care in the treatment of olfactory dysfunction.
Budesonide: Twice daily nasal rinses with steroid medication (budesonide)
Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
|
|---|---|---|
|
Change in Patient-reported Subjective Olfactory Loss
|
1.857 score on a scale
Standard Deviation 2.167
|
1.727 score on a scale
Standard Deviation 2.125
|
SECONDARY outcome
Timeframe: Baseline, post-treatment approximately 12 weeksPopulation: Data not collected nor analyzed for eight subjects in the Acupuncture arm and four subjects in the Standard of Care arm
Patient-reported subjective olfactory loss measured by SNOT-22 questionnaire, rating symptoms experiences from 0 = no problem, 5 = problem as bad as it can be, with a total score ranging of 0-110, lower scores indicate no problem and higher scores indicate more problem.
Outcome measures
| Measure |
Acupuncture Therapy Group
n=7 Participants
Subjects underwent ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care.
Acupuncture Therapy: Consisted of two treatments per week for five weeks
Budesonide: Twice daily nasal rinses with steroid medication (budesonide)
Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
|
Standard of Care
n=11 Participants
Subjects were treated with two times daily budesonide rinses and olfactory (sense of smell) training. This is considered the current standard of care in the treatment of olfactory dysfunction.
Budesonide: Twice daily nasal rinses with steroid medication (budesonide)
Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
|
|---|---|---|
|
Change in Sino-Nasal Outcome Test (SNOT-22)
|
7.143 score on a scale
Standard Deviation 9.746
|
3.455 score on a scale
Standard Deviation 15.035
|
Adverse Events
Acupuncture Therapy Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acupuncture Therapy Group
n=15 participants at risk
Subjects underwent ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care.
Acupuncture Therapy: Consisted of two treatments per week for five weeks
Budesonide: Twice daily nasal rinses with steroid medication (budesonide)
Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
|
Standard of Care
n=15 participants at risk
Subjects were treated with two times daily budesonide rinses and olfactory (sense of smell) training. This is considered the current standard of care in the treatment of olfactory dysfunction.
Budesonide: Twice daily nasal rinses with steroid medication (budesonide)
Olfactory Training: involved smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • Adverse Events were collected from baseline until end of study, approximately 3 months
|
0.00%
0/15 • Adverse Events were collected from baseline until end of study, approximately 3 months
|
|
Nervous system disorders
Brain fog
|
0.00%
0/15 • Adverse Events were collected from baseline until end of study, approximately 3 months
|
6.7%
1/15 • Adverse Events were collected from baseline until end of study, approximately 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place