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.

Add-on Effect and Safety of Pharmacopuncture Therapy in the Treatment of Patients with Lumbar Spinal Stenosis.

Background: Recently, Korean Medicine treatment with pharmacopuncture therapy (PPT) has been increasingly used in clinical practice to improve symptoms in patients with lumbar spinal stenosis (LSS). The aim of this study is to evaluate the effectiveness and safety of PPT in addition to conventional Korean Medicine treatment (CKMT) for the treatment of patients with LSS, compared with CKMT alone. Methods: This study is designed as a pragmatic, randomized, two-armed, parallel, stratified (by sex), controlled pilot trial. Forty patients diagnosed with LSS will be randomly allocated to the PPT + CKMT group or the CKMT group. Patients in the two groups will receive treatment two times weekly for 5 weeks. The primary outcome will be the mean change in the 100-mm visual analog scale score from the baseline to the end of treatment (week 5). The secondary outcomes will include the clinically important difference, Zurich Claudication Questionnaire score, self-reported walking capacity, Modified-Modified Schober test, EuroQol 5-dimension 5-level questionnaire, and Patients' Global Impression of Change. Adverse events will be assessed at each visit. Discussion: The results of this study will provide meaningful data to evaluate the add-on effect and safety of PPT in the medical care of patients with LSS.

Treatment of Lumbosacral Radiculopathy with Acupuncture and Medical Herbs: Four Case Reports.

Lumbosacral radiculopathy (LR) is a musculoskeletal disorder or pain syndrome that is generally linked to the compression or irritation of the nerve root. There is a growing interest in the development of efficient acupuncture-based treatments for LR comparable to western medicine. Structured traditional Korean medical treatments including intensified acupuncture stimulus on the EX-B2 point using the G-shaped posture modified from the sitting posture were applied to four LR patients, and the outcomes were evaluated based on objective clinical endpoints including a numeric rating scale (NRS), the Oswestry disability index (ODI), the manual muscle test (MMT), neurological symptoms, and plantar photography. Patients showed improvements in NRS, ODI, MMT, and neurological symptoms without adverse effects during hospitalization and follow-up visits. Moreover, we observed substantial dissolvement of hyperkeratinization and parchedness of the soles of the feet, which was not reported previously. These four cases demonstrate the clinical usefulness of traditional medicine and the diagnostic applicability of plantar photography. However, further randomized controlled trials are required to confirm our findings.

Acupuncture as analgesia for non-emergent acute non-specific neck pain, ankle sprain and primary headache in an emergency department setting: a protocol for a parallel group, randomised, controlled pilot trial.

INTRODUCTION: This study aims to assess the feasibility of acupuncture as an add-on intervention for patients with non-emergent acute musculoskeletal pain and primary headache in an emergency department (ED) setting. METHODS AND ANALYSIS: A total of 40 patients who present to the ED and are diagnosed to have acute non-specific neck pain, ankle sprain or primary headache will be recruited by ED physicians. An intravenous or intramuscular injection of analgesics will be provided as the initial standard pain control intervention for all patients. Patients who still have moderate to severe pain after the 30 min of initial standard ED management will be considered eligible. These patients will be allocated in equal proportions to acupuncture plus standard ED management or to standard ED management alone based on computer-generated random numbers concealed in opaque, sealed, sequentially numbered envelopes. A 30 min session of acupuncture treatment with manual and/or electrical stimulation will be provided by qualified Korean medicine doctors. All patients will receive additional ED management at the ED physician's discretion and based on each patient's response to the allocated intervention. The primary outcome will be pain reduction measured at discharge from the ED by an unblinded assessor. Adverse events in both groups will be documented. Other outcomes will include the patient-reported overall improvement, disability due to neck pain (only for neck-pain patients), the treatment response rate, the use of other healthcare resources and the patients' perceived effectiveness of the acupuncture treatment. A follow-up telephone interview will be conducted by a blinded assessor 72±12 h after ED discharge. ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants. The study has been approved by the Institutional Review Boards (IRBs). The results of this study will guide a full-scale randomised trial of acupuncture in an ED context. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02013908.

Single and triple moxibustion with large, indirect moxa induced differential effects on skin temperature and blood perfusion in healthy human subjects: Counterevidence to a previous report.

OBJECTIVES: This study aims to investigate the possible differences in skin temperature and blood perfusion changes between single and triple moxibustion. DESIGN AND SETTING: Thirty healthy volunteers were randomly divided into two groups: a triple moxibustion group (n=15) received indirect moxibustion on CV12 for 30min and a single moxibustion group (n=15) for 10min. After 10min of bed rest, skin temperature and blood perfusion were measured by digital infrared thermal imaging and laser Doppler perfusion imaging eight times in total, pre-moxibustion and 0, 5, 10, 15, 20, 25 and 30min post moxibustion. MAIN OUTCOME MEASUREMENT: The changes in the skin temperature and blood perfusion in an area 5cm in diameter around CV12 at 0min post treatment compared to baseline was the main outcome measurement. RESULTS: The difference of changes in skin temperature and blood perfusion on CV12 between the two groups remained statistically significant for 30min in an area 5cm in diameter around CV12 and for 25min in a 15-cm-diameter area. No adverse events were reported. CONCLUSION: Triple moxibustion with large, indirect moxa appeared to induce greater increases in skin temperature and blood perfusion than single moxibustion.

Acupuncture for lumbar spinal stenosis: a systematic review and meta-analysis.

OBJECTIVES: Lumbar spinal stenosis (LSS) negatively affects patients' quality of life. No systematic review evaluating the effects and safety of acupuncture for this population is available. We aimed to evaluate evidence indicating the effectiveness and safety of acupuncture for LSS. METHODS: We searched five English-language databases (EMBASE, MEDLINE, CENTRAL, CINAHL, and AMED) and one Chinese database (CAJ) for randomised controlled trials (RCTs) and non-randomised controlled clinical trials (CCTs) of needle acupuncture for LSS. CCTs were analyzed only in terms of safety and intervention-related information. RESULTS: Six RCTs (n=582) and six CCTs, which were all from China and reported in Chinese, were included. High or uncertain risk of bias and clinical heterogeneity due to different acupuncture techniques were observed. All RCTs compared different combinations or techniques of acupuncture. None of the included studies mentioned safety issues. Acupuncture combined with other interventions and/or with additional stimulation increased the number of improved patients compared with acupuncture alone or relatively simpler stimulation (n=582; relative risk, 1.16; 95% confidence interval 1.08-1.25). Pain intensity, overall symptoms, and functional outcomes related to LSS and quality of life showed significantly favourable improvement in the treatment group compared with the control group, which lasted for up to 6 months post-treatment. CONCLUSIONS: We found no conclusive evidence of the effectiveness and safety of acupuncture for LSS because of high or uncertain risk of bias and the limited generalisability of the included studies. Future trials using rigorous methodology, appropriate comparisons and clinically relevant outcomes should be conducted.

Use of acupuncture for pain management in an academic Korean medicine hospital: a retrospective review of electronic medical records.

OBJECTIVE: This study aimed to identify the descriptive characteristics of patients with pain conditions who visited an academic medical centre for traditional Korean medicine (TKM). METHODS: This work was a retrospective review of the electronic medical records of patients who received at least one session of acupuncture for pain management from March 2010 to February 2012 in the Korean medical hospital of Pusan National University. Demographic characteristics and data on patient conditions, treatment interventions received and costs associated with acupuncture treatments were analysed. RESULTS: We identified a total of 2167 patients, including 2105 outpatients and 237 inpatients. The mean age (SD) of the patients was 52.0 (15.3) years, and approximately two-thirds of the patients were women (64.0%). The average number of acupuncture treatment sessions was 8.0 (6.6 for outpatients and 14.5 for inpatients). The most treated conditions were low back pain (30.5%), neck pain (23.9%) and shoulder pain (17.5%). Interventions included needle acupuncture with manual (52.6%) or electrical (47.4%) stimulation, herbal medicine (44.2%), cupping (21.2%) and moxibustion (3.5%). Over one-third of outpatients (33.5%) received at least six sessions of acupuncture. The median total cost of each outpatient and inpatient care per person was 169 604 and 1 001 707 Korean Won (approximately £98 and £577), respectively. CONCLUSIONS: Acupuncture was primarily used for the treatment of low back, neck and shoulder pain with a wide range of related interventions at an academic medical centre for traditional Korean medicine. These data reflect real clinical practice and should inform the design of future prospective clinical research of acupuncture.

Acupuncture for management of balance impairment in a patient with bipolar disorder.

A case is reported of unexplained unilateral thigh muscle atrophy and frequent falling with poor response to conventional conservative treatments in a patient with bipolar disorder who self-selected acupuncture treatment as a last resort. The patient experienced gradual improvements in lower extremity weakness and fewer falls during the 8-month treatment. No adverse event or aggravation of the bipolar disorder was observed. These outcomes suggest that acupuncture may be a feasible adjunct for reducing falling and restoring postural balances in patients with bipolar disorder.

The role of acupuncture in emergency department settings: a systematic review.

OBJECTIVES: Patients with non-emergent and non-life threatening conditions often present to the emergency department (ED), which hinders the efficient utilisation of healthcare resources. Acupuncture has frequently been used for such common conditions, although not in the ED context. This study aimed to evaluate the current evidence for acupuncture treatment in the ED and to inform future randomised controlled trials (RCTs) for acupuncture in ED settings. METHODS: Four English databases (MEDLINE, EMBASE, CENTRAL and AMED) were systematically searched to identify studies that tested the effects of acupuncture in ED settings using the search terms of "acupuncture" and "emergency". Data extraction and the risk of bias assessments were performed by two independent reviewers. RESULTS: Of the 102 screened studies, two RCTs and two uncontrolled observational studies were deemed eligible. Sample sizes ranged from 42 to 100. The conditions treated included various musculoskeletal and non-musculoskeletal symptoms and showed substantial clinical heterogeneity. Acupuncture was delivered in conjunction with standard medical care with the goal of immediate pain alleviation; in one RCT, acupuncture resulted in a positive outcome, but it did not in the other. The risk of bias was generally high or unclear. Uncontrolled studies reported beneficial effects for acupuncture, although these studies were prone to bias. Two studies reported mild and transient adverse events associated with acupuncture. CONCLUSIONS: The current evidence is insufficient to make any recommendations concerning the use of acupuncture in the ED. The effectiveness and safety as well as the feasibility of acupuncture should be tested in future RCTs.

Electro-acupuncture at acupoint ST36 reduces inflammation and regulates immune activity in Collagen-Induced Arthritic Mice.

This study aimed to investigate the anti-inflammatory, anti-arthritic and immuno-regulatory effects of electro-acupuncture (EA) at ST36 on Collagen-induced arthritis (CIA) in mice. Male DBA/1J mice were divided into five groups: Normal, Control, NR (needle retention), EAI and EAII. All mice except those in the normal group were immunized with Collagen II for arthritis induction. Acupuncture needles were inserted into mice ST36 and electrical currents at a frequency of 2 Hz in a continuous rectangular wave form were conducted through the needles for 15 min, 3 times a week. EA treatments were administered for 5 weeks in the EAI group and for 9 weeks in the EAII group. The mice in the NR group were acupunctured in the same manner as the EA groups and the needles were retained for 15 min without electrical stimulation. CIA incidence analysis, ELISA, histological analysis and FACS analysis were performed to evaluate the effect of EA on CIA. EA at ST36 significantly reduced CIA incidence, IL-6, TNF-a, INF-gamma, collagen II antibody, IgG and IgM levels in CIA mice serum and prevented knee joint destruction. EA at ST36 also reduced CD69+/CD3e+ cells and CD11a+/CD19+ cells in CIA mice lymph nodes, and CD11b+/Gr1+ cells in CIA mice knee joints. The ratios of CD3e+ cells to CD19+ cells, and CD8+ cells to CD4+ cells were maintained closer to the normal range in the EA groups as compared with the control group or the NR group. EAII was more effective than EAI throughout all the measurements. The NR was effective as well, though less effective than EA. EA at ST36 may have an anti-inflammatory, anti-arthritic and immuno-regulatory effects on CIA in mice. The effectiveness is stronger when EA starts earlier and is applied longer. Needle retention without electrical stimulation may be effective on CIA as well, however less effective than EA. Electrical stimulation and acupoint ST36 may have synergistic effects on CIA.

Hepatoprotective effect of manual acupuncture at acupoint GB34 against CCl4-induced chronic liver damage in rats.

AIM: To investigate the hepatoprotective effect of manual acupuncture at Yanglingquan (GB34) on CCl4-induced chronic liver damage in rats. METHODS: Rats were injected intraperitoneally with CCl4 (1 mL/kg) and treated with manual acupuncture using reinforcing manipulation techniques at left GB34 (Yanglingquan) 3 times a week for 10 wk. A non-acupoint in left gluteal area was selected as a sham point. To estimate the hepatoprotective effect of manual acupuncture at GB34, measurement of liver index, biochemical assays including serum ALT, AST, ALP and total cholesterol, histological analysis and blood cell counts were conducted. RESULTS: Manual acupuncture at GB34 reduced the liver index, serum ALT, AST, ALP and total cholesterol levels as compared with the control group and the sham acupuncture group. It also increased and normalized the populations of WBC and lymphocytes. CONCLUSION: Manual acupuncture with reinforcing manipulation techniques at left GB34 reduces liver toxicity, protects liver function and liver tissue, and normalizes immune activity in CCl4-intoxicated rats.