• Journal of Acupuncture Research
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• v.20 no.5
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• pp.151-158
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• 2003

Objective: There have not been so many study about the quality of acupuncture needle tip. In order to ensure safe acupuncture treatment, the quality of needle tip is essential. Therefore we investigated the current condition of the tip of the acupuncture needles in Korea. Methods: We have selected the needles that made by 8 companies in Korea, and selected 50 pieces from 1000 pieces each company by randomized methods. and observed the tip of each needle using a scanning electron microscope at ${\times}800$ magnification. Results & Discussion: We found that needles had several defects such as scratch marks on the surface, metallic scuff, lumps and irregularities of the needle tips, stubbed or malformed tips, tips of point off-center, peeled off coated tips. There was much difference on the quality of needle among the manufacturer, and some needles seem to need to do- thorough quality control. It is necessary to intensify quality management and a concentrated control on manufacturing process of acupuncture needles.

• Journal of Acupuncture Research
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• v.26 no.4
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• pp.11-18
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• 2009

Objectives : The objective of this review was to evaluate clinical trials of warming acupuncture for musculoskeletal pain diseases, to assess the methodologic quality of the trials and determine whether low-quality trials are associated with positive outcomes, to document adverse effects and to identify the effectiveness of the warming acupuncture. Methods : Seven databases and the Journal ZHONGGUO ZHENJIU(中國鍼灸) published between 2004－2008 were searched. Korean and Chinese randomized trials were evaluated for methodologic quality using the modified Jadad scale. Outcome measurements were pain, function and global improvement. The best-evidence synthesis was performed to determine the strength of evidence by control group. Results : Six clinical trials representing 564 patients with musculoskeletal pain diseases were identified. For pain and function, there was moderate evidence that warming acupuncture is more effective than manual acupuncture. For patient global assesment, there was limited evidence that warming acupuncture is more effective than manual acupuncture. However, for function, there was inconclusive evidence that warming acupuncture is more effective than acupuncture with TDP or western medicine or acupoint-injection treatment. Conclusions : The evidence suggests that warming acupuncture is more effective for musculoskeletal pain diseases than manual acupuncture, acupuncture with TDP, western medicine and acupoint-injection treatment. But the evidence is moderate to inclusive due to the low methodologic quality of the trials. Further clinical trials with high methodologic quality is required to investigate the effectiveness of warming acupuncture.

• Journal of Acupuncture Research
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• v.21 no.5
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• pp.149-162
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• 2004

Quality assurance with high safety profile is one of the most critical issues to medical device manufacturing. In general, this issue was not paid proper attention with respect to acupuncture needle and its related devices. Acupuncture needles are manufactured through various standards ranging from purely hand-made, partially hand-made and partially machine-made, to fully machine-made mainly in China, Korea, and Japan. There is a large difference in quality between needles from different manufacturers. In order to provide a standard manufacturing guideline, it seems necessary to make a Korean Industrial standard (KS). The authors review this topic from an historical view point, investigate the current situation of the standardization of acupuncture needles in other developed countries, and inspect the general procedure to establish a KS in Korea in order to suggest a KS for acupuncture needles.

• Journal of Biomedical Engineering Research
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• v.36 no.5
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• pp.191-197
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• 2015

Laser acupuncture is defined as the stimulation of traditional acupuncture points with low-intensity, nonthermal laser irradiation. Possible advantages in using laser acupuncture are the noninvasive, painless and low risks of infection treatment. The purpose of this study is to assess the effect of laser acupuncture on the quality and waveform of arterial pulses. Ten acupuncture points were stimulated repeatedly three times in 30 individuals by laser with emission in the near infrared spectral region (808 nm) using an out power and power density of 45 mW and $143W/cm^2$. The analysis of pulse quality and waveform was performed based on the measurement of arterial pressure of the left and right wrist, using a 3-dimensional blood pressure pulse analyzer. Excess-like pulse quality of subjects before laser acupuncture changed significantly to balanced pulse quality after 10, 20, and 30 minutes of laser acupuncture; coefficient of deficient or excess, $C_{DE}$, decreased significantly from 0.68 before acupuncture to 0.61, 0.55, and 0.55 after 10, 20, 30 minutes of laser acupuncture ($$p{\leq_-}0.006$$), respectively. Other pulse qualities, floating or sinking, slow or rapid, choppy or slippery did not change significantly by laser acupuncture (p > 0.05). Pulse waveform analysis showed that amplitude of main peak (systolic function or aortic compliance, $h_1$) of left and right artery pulse waves decreased significantly after 10, 20, and 30 minutes of laser acupuncture (p < 0.05). Other parameters, duration of one cardiac cycle (T), duration of rapid systolic ejection ($T_1$), duration of the systolic phase ($T_4$), and duration of the diastolic phase ($T_5$) of left and right artery pulses did not change significantly after laser acupuncture (p > 0.05).

• The Journal of Korean Medicine
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• v.27 no.3 s.67
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• pp.222-226
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• 2006

Objective: The aim of this study was to introduce newly developed cooperation group standards of acupuncture needles for single use and to make a contribution to the future development of Korean Industrial Standards (KS) of acupuncture needles for single use. Results and Conclusion: Quality assurance and quality control with high safety profile is one of the most critical issues in medical device manufacturing. Up to now, proper attention has not been paid to this issue with respect to acupuncture needles for single use and their related devices. We, therefore, organized a committee to make guidelines to produce an acupuncture needle with high quality and safety. In the committee, we reviewed the topic from an historical viewpoint, and investigated the current situation of the standardization of acupuncture needles in other developed countries. Finally, we developed the cooperation group standards in advance of development of KS on the acupuncture needles for single use. The standards are composed of 12 sections describing: Scope, Normative references, Definitions, Materials, Configuration, Appearance and Cleanliness, Quality, Sterilization and Safety, Processing of Surface and Coating Material, Test, Packaging, and Labeling. We hope that the standards would be useful guidelines to produce high quality acupuncture needles and play an important role in the development of KS in the future.

• Korean Journal of Acupuncture
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• v.21 no.4
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• pp.43-51
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• 2004

Objectives : In order to ensure safe acupuncture treatment, the quality of the needle tip is essential. But, there have not been so many studies about the quality of the acupuncture needle tip. For this reason we have been already reported about the quality of acupuncture needle tip in Korea using scanning electron microscope(SEM) in 2002, 2003. In order to compare than other society, we investigated the current condition of the tips of the acupuncture needles sold in Europe. Methods : We obtained the needles made by 7 companies, which are sold currently in Europe, and selected 50 pieces out of 100 pieces from each company by randomized methods. And then we observed the tip of each needle using a scanning electron microscope at ${\times}800$ magnification. Results and Discussion : We found that needles had several defects such as scratch marks on the surface, metallic scuff, lumps and irregularities of the needle tips, stubbed or malformed tips, tips of point off-center, peeled off coated tips, same as Korean needles. There was much difference on the quality of needles among the manufacturers, and some needles seem to need thorough quality control. Allowing for the high price, the quality of some needle in Europe generally are better than that of Korean needles. But some Korean needles hold a top position than European ones in quality. We want a good industrial standard to be made in acupuncture manufacturing fields in the near future, because the safety is not less valuable than the efficacy in medicine.

• Journal of Acupuncture Research
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• v.34 no.3
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• pp.59-69
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• 2017

Objectives : This study analyzed the current status of randomized controlled trials (RCTs) of miniscalpel acupuncture for lumbar spinal stenosis (LSS) in China. Methods : A literature search was performed using the China National Knowledge Infrastructure (CNKI) database. All studies up to June 7th, 2017 were searched. The quality of included RCTs was assessed with the Jadad scale. Results : Five RCTs were finally included in this review. The overall quality of the RCTs was assessed as low. All articles evaluated miniscalpel acupuncture as monotherapy or in combination with filiform needle therapy, drug injection therapy, Tuina treatment, thermal coagulation therapy, or spinal decompression. Miniscalpel acupuncture as monotherapy or adjunctive therapy showed greater therapeutic effect and fewer adverse effects. Conclusion : Miniscalpel acupuncture is a safe and effective nonpharmacological treatment for LSS. However, high-quality studies with consistent treatment protocols are needed to confirm these findings.

• Journal of Acupuncture Research
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• v.19 no.3
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• pp.138-155
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• 2002

Objective : The purpose of this study is to work on the problems and on the direction of the study regarding the evidence-based study of Acupuncture. Methods : We reviewed the PubMed electronic database. Eight articles of systematic review without meta-analysis and six articles without meta-analysis were selected. Results : In the study of eight articles of systematic review without meta-analysis, there were two articles on effectiveness of acupuncture and one on non-effectiveness of acupuncture. Four articles were about the changes according to the quality of randomized controlled trials. Also, one article was about the side-effect of acupuncture. In the study of six articles of systematic review with meta-analysis, there were two articles on Odds Ratio, two on Relative Risk, one on number-needed-to-treat, and two on 18 predefined methodological criteria. Conclusion : As the quality of RCTs was high, positive response decreased and as the quality of RCTs was low, positive response increased. For the study of evidence-based acupuncture, it is necessary that we conduct research on well-planned placebo acupuncture, large sample size, statistical method, method of searching and assessing literature and method of meta-analysis.

• Journal of Acupuncture Research
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• v.26 no.2
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• pp.125-145
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• 2009

Objectives : To analyze the inclusion criteria of participants, control group interventions, and the results of prior studies of acupuncture for OA. Also to identify aspects of the procedure that are associated with positive outcomes in order to establish ideal acupuncture treatment model. And to assess the methodological quality of the trials with modified Jadad score and FEAS in order to evaluate the quality of prior studies and find out whether or not acupuncture has a positive effect in treating OA. Methods : Articles up to the date of November 2008 were searched via computerized databases of PubMed, Journal of Korean Oriental Medicine, The Journal of Korean Acupuncture & Moxibustion Society and Journal of Oriental Rehabilitation Medicine. Bibliographies of reviewed papers were also searched and reviewed. Only randomized controlled trials (RCTs) and systematic reviews concerning the effects of acupuncture or electroacupuncture (EA) on symptoms of osteoarthritis of the human knee, published in English and Korean were included. The acupuncture treatment methods of the reviewed trials were assessed based on STRICTA. And the methodological quality of the trials was assessed by modified Jadad score and FEAS. Results : Twenty one trials of acupuncture for OA were analyzed. Based on the results of this review the following factors might contribute to optimal results from acupuncture treatment. 1) Usage of $ST_{35}$, $GB_{34$, $EX_{32}$, $ST_{36}$ and $SP_9$ acupuncture points. 2) More than four acupuncture points should be used. 3) More than 15 minutes of needle retention time. 4) Needle length-40mm and diameter-0.30mm 5) Usage of EA 6) more than 10 times treatment 7) Treatment frequency of more than once a week, 8) Treatment duration longer than 6 to 8 weeks. Conclusions : High quality clinical trials of Acupuncture for OA is still in lack. Future investigators must concentrate their attentions on the quality of acupuncture treatment itself used in the trials as well as the methodological quality of trials.

• Journal of Acupuncture Research
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• v.24 no.1
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• pp.209-216
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• 2007

Objectives : To review and summarize the existing evidence on acupuncture treatment for cancer and cancer related symptoms. Methods: Literature searches were made through domestic and international databases. Data were extracted according to pre-defined criteria. The methodological quality was assessed using the Modified Jadad scale. Results: Seven studies were included. Two of the studies were high in methodological quality. One study concerning acupuncture treatment for cancerous dyspnea reported insignificant differences between the treatment group and placebo group. The other study concerning auricular acupuncture for cancer related pain showed significant pain relief compared with the control group. All the other studies were non-blinded or uncontrolled trials. Conclusion : The hypothesis that acupuncture may be effective for the treatment of cancer is not supported by the data in recent clinical trials. More accurately designed randomized control trials (RCT) are needed.