Fibromyalgia is a chronic, disabling musculoskeletal pain disorder. Pregabalin is the sole pharmaceutical agent approved for the treatment of fibromyalgia in China. Tongluo Kaibi Tablet, an approved proprietary Chinese medicine with collaterals-dredging and blood-activating effects, has demonstrated potential therapeutic benefits for fibromyalgia in preliminary small-scale observational studies, yet high-quality large-sample clinical evidence remains lacking. This multicenter, randomized, double-blind, double-dummy parallel-controlled clinical trial was conducted to evaluate the clinical efficacy and safety of Tongluo Kaibi Tablet in patients with fibromyalgia syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Tongluo Kaibi Tablet is composed of eight Chinese herbal medicines: Nux Vomica Powder, Radix Cyathulae, Radix Angelicae Sinensis, Flos Carthami, Fructus Chaenomelis, Herba Schizonepetae, Radix Saposhnikoviae and Scorpio. It dispels wind and unblocks collaterals, activates blood circulation and dissipates stagnation. It is indicated for joint pain and swelling caused by intermingled cold-heat complicated with blood stasis obstructing collaterals. Since its launch, it has been widely used in the treatment of rheumatic diseases.
Pregabalin is one of the three medications (pregabalin, duloxetine, and milnacipran) that have been approved by the Food and Drug Administration (FDA) to treat fibromyalgia in US, and the only medicine that has been approved in China.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
The change of the Visual Analogue Scale (VAS) for pain from baseline.
Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe.
Time frame: Baseline, week 4, and week 8
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms.
Time frame: Baseline, week 4, and week 8.
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.
Time frame: Baseline, week 4, and week 8.
The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.
Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.
Time frame: Baseline, week 4, and week 8.
The Beck II Depression Inventory (BDI)
The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.
Time frame: Baseline, week 4, and week 8.
The change of the revised Widespread Pain Index(WPI)from baseline.
The total score of the Widespread Pain Index (WPI) ranges from 0 to 19, corresponding to 19 standard pain sites all over the body. One point is assigned if pain is present at a site within the past week, and zero point if no pain occurs. A higher total score indicates a wider distribution of pain across the body.
Time frame: Baseline, week 4, and week 8.
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