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Evaluation of Smell and Taste in Fibromyalgia
trial testing Sniffin' Sticks test and Taste strips in Fibromyalgia in 50 participants. Completed in 10 June 2019.
| Lead sponsor | Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 2 January 2019 |
| Primary completion | 2 June 2019 |
| Estimated completion | 10 June 2019 |
| Sites | 1 location across Turkey (Türkiye) |
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Adults 18 to 70, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
total smell test score minimum score: 0 maximum score: 48 Higher scores reflect better smell function.
| Group | Value | 95% CI |
|---|---|---|
| Fibromyalgia | 25.96 | ± 6.50 |
| Control | 36.40 | ± 4.50 |
total taste score minimum score: 0 maximum score: 16 Higher scores indicate better taste function.
| Group | Value | 95% CI |
|---|---|---|
| Fibromyalgia | 9.93 | ± 2.65 |
| Control | 13.55 | ± 1.76 |
A EQ-5D-3L is a standardized instrument for measuring generic health status. minimum score: -0.59 maximum score: 1 Higher scores indicate better health status.
| Group | Value | 95% CI |
|---|---|---|
| Fibromyalgia | 0.452 | ± 0.288 |
| Control | 0.916 | ± 0.109 |
Hamilton anxiety scale: Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
| Group | Value | 95% CI |
|---|---|---|
| Fibromyalgia | 21.23 | ± 9.22 |
| Control | 5.45 | ± 4.24 |
Toronto alexithymia scale minimum score: 20 maximum score: 100 Cut-off scores: ≤50=no alexithymia, 51-60=borderline alexithymia, and ≥61=alexithymia
| Group | Value | 95% CI |
|---|---|---|
| Fibromyalgia | 57.20 | ± 13.12 |
| Control | 46.80 | ± 11.30 |
Hamilton depression scale is designed to rate the severity of depression in patients. Although it contains 21 areas, calculate the patient's score on the first 17 answers. Minimum score:0 Maximum score: 53 Higher scores reflect more severe depression.
| Group | Value | 95% CI |
|---|---|---|
| Fibromyalgia | 18.03 | ± 7.75 |
| Control | 5.70 | ± 5.98 |
Patients diagnosed with fibromyalgia syndrome according to 2016 ACR criteria and 18-70 years old healthy subjects will be included in the study. Their smell and taste will be assessed with sniffin sticks and taste strips. Besides they will be evaluated for quality of life, anxiety, depression, and alexithymia.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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