Evaluation of Smell and Taste in Patients With Fibromyalgia
Conditions: Fibromyalgia
Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Evaluation of Smell and Taste in Fibromyalgia- NCT03823937 
06/01/2019 
Study Protocol: 
Participants 
18-70 years old consecutive FM patients diagnosed according to ACR criteria 2016 revision and age, sex-matched 
healthy controls were included in the study. Neurologic disorders, rheumatologic and endocrine diseases, diabetes 
mellitus, traumatic brain injury, psychiatric disorders, chronic rhinitis/sinusitis/rhinosinusitis, history of head 
trauma or operation, malignancies, and pregnancy were defined as exclusion criteria. Besides, patients taking any 
antidepressants, pregabalin or gabapentin were excluded from the study. 
According to ACR criteria 2016 revision criteria widespread pain index (WPI), symptom severity scale (SSS) 
score and fibromyalgia severity scale (FSS) score which is the sum of WPI and SSS was calculated. Fibromyalgia 
impact questionnaire (FIQ) which measures patient status was applied to FM patients. EuroQol Questionnaire 5-
Dimensions (EQ-5D) was applied to all participants to assess QoL. Hamilton anxiety and depression scale were 
administered by the psychiatrist who is unaware of the diagnosis. Toronto Alexithymia Scale (TAS-20) was used 
for measurement of alexithymia which refers to trouble in identifying and describing emotions. 
Sniffin' Sticks test which consists of odor threshold (T), discrimination (D) and identification (I) subtests was 
used. Taste strips taste (Brughart Medical Technology, Wedel, Germany) which consists of 16 filter paper taste 
strips was used. 
Statistical Analysis: 
The IBM SPSS Statistics 22 (SPSS IBM, Turkey) program was used for statistical analysis. The normality of the 
parameters was assessed with the Shapiro-Wilk test. Mean, median, standard deviation, and frequency was used 
as descriptive statistical methods. The Student's t-test was used to make comparisons between the parameters in 
each group that showed normal distribution, and the Mann-Whitney U test was used to make comparisons between 
the parameters in each group that lacked normal distribution. The chi-square test, Fisher's exact test, and Yates 
continuity correction were used to compare the qualitative data. For the analysis of the correlation between the 
parameters, Spearman test was performed. Significance was assessed at p<0.05 level, 95% confidence interval.