Research Article
Clinical Efficacy and Safety of Thai Herbal Formulation-6 in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized-Controlled Trial
Table 3
Safety outcome assessments.
| | Adverse events | THF-6 (n = 100) | Diclofenac (n = 100) | valuea |
| | Gastrointestinal system | | | | | Dyspepsia | 23 | 28 | 0.417 | | Nausea and vomiting | 3 | 4 | 1.000 | | Gastroesophageal reflux disease | 2 | 2 | 1.000 | | Loss of appetite | 4 | 1 | 0.369 | | Diarrhea | 3 | 1 | 0.621 | | Constipation | 5 | 5 | 1.000 | | Hematochezia | 1 | 0 | 1.000 |
| | Other systems | | | | | Peripheral edema | 4 | 5 | 1.000 | | Peripheral neuropathy | 2 | 1 | 1.000 | | Dizziness | 1 | 2 | 1.000 | | Headache | 1 | 0 | 1.000 | | Drowsiness | 1 | 0 | 1.000 | | Insomnia | 0 | 1 | 1.000 | | Dry mouth | 0 | 1 | 1.000 | | Blurred vision | 1 | 0 | 1.000 | | Low back pain | 2 | 2 | 1.000 | | Myalgia | 2 | 0 | 0.497 | | Cramp | 1 | 1 | 1.000 | | Rashes | 2 | 0 | 0.497 | | Itching | 2 | 0 | 0.497 | | AST elevation (>2.5–3.0 times from baseline) | 2 | 1 | 1.000 | | Creatinine rising (>1.5–2.0 times from baseline) | 0 | 3 | 0.246 |
|
|
aChi-square test or Fisher’s exact test. AST: aspartate aminotransferase.
|
