Acupuncture Therapy for COVID-Related Olfactory Loss

• Acupuncture Therapy (Device): Consists of two treatments per week for five weeks
• Budesonide (Drug): Twice daily nasal rinses with steroid medication (budesonide)
• Olfactory Training (Other): involves smelling 4 different essential oils (e.g. rose, lemon, clove, and eucalyptus) twice a day for 20 seconds each (after the nasal rinse)

Primary outcomes

• Change in University of Pennsylvania Smell Identification Test (UPSIT) Scores [Baseline, post-treatment approximately 12 weeks]: 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.

Secondary outcomes

• Change in Patient-reported Subjective Olfactory Loss [Baseline, post-treatment approximately 12 weeks]: 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.
• Change in Sino-Nasal Outcome Test (SNOT-22) [Baseline, post-treatment approximately 12 weeks]: 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.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 18 years or older.
* Patients with post-viral olfactory dysfunction > 4 weeks.
* History of positive COVID-19 PCR.

Exclusion Criteria:

* Less than 18 years of age.
* Active sinus infection.
* New diagnosis of untreated CRS.
* Prior diagnosis of dementia or Parkinson's disease.
* Prior head trauma or neurosurgical procedure resulting in olfactory loss.
* Patients who do not speak or read English.
* Patients unable to understand and sign the study consent.

Participant flow

Outcome results

• Change in University of Pennsylvania Smell Identification Test (UPSIT) Scores (Primary), Mean, score on a scale: Acupuncture Therapy Group 2.571 +/- 5.997; Standard of Care 3.182 +/- 5.306
• Change in Patient-reported Subjective Olfactory Loss (Secondary), Mean, score on a scale: Acupuncture Therapy Group 1.857 +/- 2.167; Standard of Care 1.727 +/- 2.125
• Change in Sino-Nasal Outcome Test (SNOT-22) (Secondary), Mean, score on a scale: Acupuncture Therapy Group 7.143 +/- 9.746; Standard of Care 3.455 +/- 15.035

Adverse events

Time frame: Adverse Events were collected from baseline until end of study, approximately 3 months

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2021-03-23)

• Janalee Stokken, MD, Principal investigator, Mayo Clinic