Background Degenerative knee osteoarthritis is a leading cause of disability in the elderly. If patients do not respond to pharmacological or nonpharmacological intervention, total knee replacement surgery is recommended. However, owing to the contraindications and adverse effects of surgery, the need for a new treatment strategy is emerging. Traditional herbal medicine is a widely used intervention in east Asia to treat knee osteoarthritis. Gyejigachulbutang is one of the frequently prescribed herbal formulae. The aim of our study is to evaluate the efficacy and safety of gyejigachulbutang for knee osteoarthritis. Methods This study is a randomized, placebo-controlled, patient and assessor blinded, superiority clinical trial. A total of 80 patients with knee osteoarthritis will be enrolled. The participants will be randomly assigned to the gyejigachulbutang or placebo group in a 1:1 ratio in two Korean medical hospitals. Every participant will take gyejigachulbutang or placebo at a dose of 2.5 g three times a day for 4 weeks. Additional follow-up will be conducted 4 weeks after treatment completion. Any concomitant treatment to relive knee pain will not be allowed except for rescue medicine (acetaminophen). The primary outcome will be a comparison of the change in the visual analogue scale score for knee pain from baseline to visit 3 (week 4) for both the treatment and placebo groups. Secondary outcomes include clinical relevance, minimal clinically important difference, disability, quality of life, and safety. Discussion This protocol presents a research methodology for clinical trials of gyejigachulbutang for knee osteoarthritis. Various secondary outcomes make this trial more informative. Our trial will provide fundamental evidence for knee osteoarthritis management via herbal medicine treatment. Trial registration Clinical Research Information Service (CRIS), KCT0003024 . Registered on 25 July 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3234-6) contains supplementary material, which is available to authorized users.
Background: This study examined the characteristics and prognosis of patients admitted to the Dunsan Korean medicine hospital for treatment of herniated intervertebral disc (HIVD) or spinal stenosis with Miniscalpel needle therapy (MSN). Methods: Patients were admitted to the Dunsan Korean medicine hospital from January 01, 2016 to September 30, 2017 for the treatment of HIVD or spinal stenosis with MSN. Crossover analysis, Independent sample t test, one-way ANOVA, multiple linear regression analysis, and binary logistic regression analysis were performed. Results: Crossover analysis showed statistically significant differences in treatment methods according to gender, current pain according to the disease duration, satisfaction of MSN according to disease duration, treatment methods, and intention of re-treatment with MSN according to treatment methods. Independent t test and one-way ANOVA showed that there was a difference in current Numeric Rating Scale (NRS) according to disease duration, and difference between discharge and current NRS, and number of MSN according to disease. Multiple linear regression analysis showed that age, disease duration, and number of MSN affect discharge NRS, disease duration, and number of MSN affect current NRS, and Western medical treatment after MSN, discharge NRS, and current NRS affect satisfaction of MSN. Binary logistic regression analysis showed that discharge NRS affects current pain, and gender, discharge NRS, and treatment methods affect intention of re-treatment with MSN. Conclusion: Characteristics, prognosis, satisfaction and variables affecting prognosis of MSN were statistically significant, indicating that more systematic studies are required to further examine the effects of MSN on HIVD or spinal stenosis.
Background. Gyejigachulbutang (GUI-ZHI-JIA-SHU-FU-TANG, GCB) is an herbal formula widely prescribed in traditional East Asian medicine practice for arthritis and muscle pain. We evaluated the efficacy and safety of GCB for degenerative knee osteoarthritis (KOA). Methods. Eighty patients with KOA were randomly assigned to the GCB group or the placebo group in a 1 : 1 ratio in two Korean medicine hospitals. Patients took GCB or placebo three times a day for 4 weeks. Primary outcome was the change in the visual analogue scale (VAS) score for knee pain from baseline to 4th week. Secondary outcomes were the change in the VAS score from baseline to 2nd week and 8th week, Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC), European Quality of Life Five Dimensions questionnaire (EQ-5D), and safety. Results. There was no significant difference between the compared indicators of the GCB and placebo groups. However, in subgroup analysis, GCB was effective for subjects with a BMI lower than 25 kg/m2. The dose of pain medication was significantly lower in the GCB group than in the placebo group after four weeks ( p = 0.016 ). There were no serious adverse events in the GCB group. Conclusions. GCB was not effective in primary outcome analysis. In exploratory subgroup analysis, GCB might be effective for individuals with BMI lower than 25 kg/m2 for the treatment of degenerative KOA. GCB may also help reduce the consumption of pain medication. Furthermore, research is required for our hypothesis. This trial is registered with KCT0003024.
The aim of this report is to describe improved symptom changes in eye movement disorders and dizziness of a patient with Miller Fisher syndrome after receiving combined Korean medicine treatment (CKMT). A 24-year-old male was diagnosed with MFS accompanied by eye movement disorder, diplopia, and dizziness. For 6 weeks, the patient received acupuncture, electro-acupuncture, pharmacopuncture, herbal medicine, and physical therapy treatment. Visual analogue scale were checked and other outcomes (the range of eye movement, the distance that diplopia appears, diplopia questionnaire) were measured. Following CKMT, the movement of both eyes improved in both the horizontal and vertical direction. Also for diplopia and dizziness, there was a decrease in the visual analogue scale and the distance that diplopia appeared. The present case report suggests that CKMT may have a role in treating eye movement disorders and dizziness in patient diagnosed with MFS.
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