A Pilot Study for Effectiveness and Safety of Adjunctive Pharmacopuncture to Acupuncture Treatment for Rotator Cuff Diseases: A Pragmatic Randomized Controlled Trial.

Purpose: Pharmacopuncture therapy has been used in the conservative treatment of rotator cuff disease adjuvant to acupuncture treatment. Despite the increasing utilization of pharmacopuncture therapy, there is still a lack of high-quality research to support its effectiveness. This pilot study aimed to assess the feasibility of pharmacopuncture therapy adjuvant to acupuncture treatment for rotator cuff disease. Patients and Methods: This was a parallel-grouped, pragmatic randomized controlled, pilot study. Forty patients were randomly allocated to either the experimental or the control group. All patients received acupuncture treatment for four weeks, and pharmacopuncture was additionally administered to the experimental group. After eight treatments were delivered over four weeks, follow-up assessments were performed. The primary outcome was the mean change in the visual analog scale (VAS) score for shoulder pain from baseline to visit 8. Secondary outcomes included shoulder pain and disability index (SPADI) at visits 4, 8, and 9, shoulder range of motion (ROM) at visits 4, 8, and 9, EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at visits 8 and 9, patient global impression of change (PGIC) at visits 8 and 9, and mean rescue medication consumption at visits 8 and 9. Results: Both groups showed that each treatment effectively improved rotator cuff disease in most assessments. Particularly, the group that received acupuncture plus pharmacopuncture required fewer rescue medications than the group that received acupuncture alone. However, there was little statistically significant difference between the two groups. There were no serious adverse events experienced by patients in this study. Conclusion: Although there was little statistical difference between the two groups, the combination of acupuncture and pharmacopuncture for rotator cuff disease was associated with a reduction in the rescue medicine dosage compared with acupuncture alone. Also, it confirmed the safety of pharmacopuncture therapy. This pilot study would help design future research on the effectiveness of pharmacopuncture in rotator cuff disease.

Efficacy and Safety of Acupoint Catgut Embedding for Knee Osteoarthritis: a Protocol for Systematic review and Meta-Analysis.

Background: Knee osteoarthritis causes physical dysfunction, and its prevalence increases with age. Although clinical studies examined acupoint catgut embedding in patients with knee osteoarthritis, no systematic reviews or meta-analyses have been conducted to date. We aim to comprehensively review the effects of acupoint catgut embedding on knee osteoarthritis. Methods: Eleven databases will be searched from inception to August 1, 2023, without language limitations. Additionally, two registration platforms-ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry-will be searched for ongoing trials. The primary outcomes will be assessed using the Visual Analog Scale and the Western Ontario and McMaster Universities Osteoarthritis Index. Secondary outcomes include the total effective rate, Lysholm Score, and adverse effects. Two reviewers will independently select the studies, extract data, and evaluate the risk of bias and the quality of evidence. Discussion: This systematic review will provide evidence regarding the safety and efficacy of acupoint catgut embedding in patients with knee osteoarthritis.

Pharmacopuncture Therapy as an Adjunctive Treatment for Patients with Lumbar Spinal Stenosis: A Pragmatic Randomized Controlled Pilot Trial.

Purpose: Pharmacopuncture therapy (PPT) combines medicinal extracts with acupuncture and is widely used as an adjunct in clinical practice. This study assessed the safety and feasibility of PPT in addition to conventional Korean Medicine treatment (CKMT), including electroacupuncture, cupping and infra-red, for lumbar spinal stenosis (LSS). Patients and Methods: Forty patients diagnosed with LSS were randomly assigned to undergo PPT with CKMT (experimental group) or CKMT alone (control group) at a 1:1 ratio, receiving 10 sessions of each intervention over five weeks. The primary clinical outcome was measured using the 100-mm Visual Analog Scale (VAS) for buttock and leg pain five weeks post-treatment. Secondary outcomes included clinically important difference (CID), Zurich Claudication Questionnaire, self-reported walking capacity, Modified-Modified Schober test, EuroQol 5-dimension 5-level questionnaire, and the patient's global impression of change. The adverse events were assessed at each visit. The analysis of covariance was conducted to compare between two groups. Results: Intervention completion rates were 95% and 100% in the experimental and control groups, respectively. No statistically significant differences were found between groups regarding the primary outcome (adjusted mean difference: 8.0; 95% confidence interval: -1.4-17.4). The mean difference in the 100-mm VAS for low back pain at week 5 (adjusted mean difference: 12.9; 95% confidence interval: 2.4-23.4) and the proportion of patients who reached the minimum CID was higher in the experimental group than in the control group. However, no significant differences were observed with other secondary outcomes. One patient in the experimental group experienced a systemic skin rash that resolved the same day, whereas the adverse events in the other group were mild and transient. Conclusion: This trial demonstrated the feasibility of add-on effects and the safety of pharmacopuncture in patients with LSS. Further studies are warranted to evaluate the add-on effects of PPT in treating LSS. Trial Registration: Clinical Research Information Service (CRIS), KCT0007229; registered on April 26, 2022.

Effect and Safety of Combining Pharmacopuncture Therapy and Acupotomy in the Treatment of Patients with Degenerative Lumbar Spinal Stenosis: a Study Protocol for a Pragmatic, Assessor-Blinded, Randomized, Controlled Trial.

Background: : Pharmacopuncture therapy and acupotomy are commonly used in combination for Conventional Korean Medicine Treatments (CKMT) for the treatment of patients with lumbar spinal stenosis (LSS). The aim of this study is to evaluate the effect and safety of combining pharmacopuncture therapy and acupotomy in the treatment of LSS. Methods: : This study is designed as a pragmatic, assessor-blinded, randomized controlled trial with two parallel arms in a 1:1 ratio. A total of 104 participants diagnosed with LSS will be randomly assigned to an experimental group (pharmacopuncture therapy and acupotomy in addition to CKMT) or a control group (only CKMT). Patients in both groups will receive treatment two times weekly for 6 weeks. The primary outcome will be the mean change on the 100-mm visual analog scale (VAS) from the baseline to the end of the treatment (week 6). The secondary outcomes will include the mean change in the 100-mm VAS from baseline to week 10 and week 14, respectively. Proportion of patients who achieve the clinically important difference, Zurich Claudication Questionnaire, Roland-Morris disability questionnaire, self-reported maxium walking distance, EuroQol 5-dimension 5-level, and Patients' Global Impression of Change will also be assessed. Adverse events will be assessed at each visit. The outcomes will be measured for a total of 14 weeks, including a treatment period of 6 weeks and follow-up of 4, 8 weeks. Discussion: : The results of this trial will confirm the effect and safety of combining pharmacopuncture therapy and acupotomy in the treatment of patients with LSS.