Adverse events of herbal decoction: A systematic review and meta-analysis over past 10 years.

BACKGROUND: Herbal decoctions (HDs) are the oldest and most common herbal medicine formulations. Different HDs exist, and some consumers are concerned that they may become contaminated during manufacturing. Therefore, the need for a safety assessment of HDs has been raised. This study aimed to investigate the adverse events (AEs) associated with HDs by comprehensively analyzing randomized controlled trials (RCTs) using systematic reviews and meta-analyses. METHODS: A systematic search was conducted on PubMed, Embase, and the Cochrane Library for articles published up to November 2022. The included RCTs compared HDs with other treatments published between 2013 and 2022, and the risk of bias was assessed using RevMan 5.4. Meta-analyses of the number of AEs associated with HDs reported in the included RCTs were also performed. RESULTS: The systematic review included 26 RCTs, and the meta-analysis included 17 RCTs that reported AEs. The meta-analysis comparing HDs with active controls showed that both the number of AEs (14 studies; risk ratio (RR)= 0.50 cases, 95 % confidence interval (CI) [0.29, 0.88]; I2 = 42 %) and the number of patients who complained of AEs (seven studies; RR=0.51 patients, 95 % CI [0.28, 0.94]; I2 =9 %) were fewer in the HDs group than in the active control groups. CONCLUSION: This study showed that HDs are safer than other conventional medications based on the results of qualitative and quantitative syntheses of RCTs.

The Effects of Acupuncture on Crohn's Disease: a systematic review and meta-analysis.

Objectives: Crohn's disease is a chronic gastrointestinal disease that belongs to inflammatory bowel disease. This systematic review aims to assess the level of evidence in randomized controlled trials (RCTs) on the effects of acupuncture for Crohn's disease. Methods: We searched 12 databases from the date of the establishment of each database up to May, 2023 for relevant RCTs. The risk of bias of each study was assessed independently by three reviewers. The level of evidence of meta-analysis was assessed using GRADE (Grading of Recommendations, Assessment, Development, and Evaluation). Results: A total of 12 studies were included. The effective rate (odds ratio [OR] 3.23, 95% confidence interval [CI] 1.43, 7.30) for mild to moderate Crohn's disease patients showed a significant difference between the acupuncture with moxibustion group and the sham-acupuncture with sham-moxibustion group. CDAI change (mean difference [MD] -74.15, 95% CI -93.28, -55.01) for mild to moderate Crohn's disease showed a significant difference between the acupuncture with moxibustion group and the sham-acupuncture with sham-moxibustion group. Conclusion: Although acupuncture with moxibustion showed significant effects compared to sham-acupuncture with sham-moxibustion, the effect of acupuncture alone is inconclusive. Moreover, only the effect of acupuncture treatment on mild to moderate Crohn's disease patients was derived as a remarkable result. To confirm the effectiveness of acupuncture treatment for Crohn's disease, studies using only acupuncture for intervention or more RCTs targeting various Crohn's disease patients according to the CDAI are required.

Acupuncture Treatment for Hip Pain: A Systematic Review and Meta-Analysis.

Acupuncture treatment (AT) is an effective treatment for pain relief; however, there are few systematic reviews that have reported on the effectiveness of AT for hip pain. This systematic review aimed to evaluate the efficacy and safety of AT of hip pain. We searched eight databases for randomised controlled trials (RCTs) evaluating the effect of AT on hip pain until August 2022. Twelve RCTs (806 patients) were included: two reported a significant effect of AT compared with that of conventional medicine (CM) alone for hip pain; two reported significant effects of AT + CM compared with that of CM alone in terms of Visual Analogue Scale (VAS); two reported a significant effect of AT + CM compared with that of Sham AT + CM in terms of anaesthetic dosage; two reported a significant effect of AT + CM compared with that of Sham AT + CM in terms of the side effects associated with analgesic use; one study reported a significant effect of AT compared to that of no-treatment. No serious adverse events were reported. Our findings demonstrate the potential of AT in managing hip pain. Given the low quality and small sample sizes of the studies, the evidence supporting AT for hip pain management was weak. Further clinical trials and systematic reviews are required. The protocol of the current study was registered in the PROSPERO International prospective register of systematic reviews (CRD42017079586).

Chromatographic Method for Monitoring of Pesticide Residues and Risk Assessment for Herbal Decoctions Used in Traditional Korean Medicine Clinics.

The presence of pesticide residues in herbs and the herbal products derived from them raises serious health concerns. This study was conducted to investigate the residual pesticide concentrations and assess potential human health risks from herbal medicines used in traditional Korean medicine clinics. A total of 40 samples of herbal decoctions were collected from 10 external herbal dispensaries. The pesticide residues were analyzed by the multiresidue method for 320 different pesticides using liquid chromatography tandem mass spectrometry (LC-MS/MS) and gas chromatography tandem mass spectrometry (GC-MS/MS). As a result of the monitoring, carbendazim was detected at 0.01 and 0.03 µg/g in eight samples and no pesticide was detected in the other herbal decoctions. Carbendazim was set for each individual item as less than 0.05 µg/g in Paeoniae radix, less than 0.05 µg/g in Cassiae semen, less than 2.0 µg/g in Lycii fructus, and less than 10 µg/g in Schisandrae fructus (dried). Therefore, the results of this study suggested that the detected pesticide residues in herbal decoctions could not be considered as posing a serious health risk.

Case Study of a Patient with Trigger Finger after Conducting Pharmacopuncture according to the Progress.

Our study purpose was to report the clinical application of five different pharmacopunctures (Sweet BV, Scolopendrae Corpus, Chukyu, Cervi Parvum Cornu, and Hominis Placenta) for trigger finger. A patient was admitted to Ba-reun-mom S Korean Medicine Clinic and diagnosed with trigger finger. Because the effects of each pharmacopuncture have been confirmed in various acute to chronic cases, we treated a patient diagnosed with trigger finger using pharmacopunctures Sweet BV and Scolopendrae Corpus at the acute phase, Chukyu pharmacopuncture at the acute to chronic phase, and pharmacopunctures Cervi Parvum Cornu and Hominis Placenta at the chronic phase. This case was measured and assessed by Quinnell's classification of triggering and visual analogue scale (VAS) scores. After treatment, the patient's fifth finger pain and function were improved. The VAS score decreased from 5 to 0. The Quinnell's classification of triggering score decreased from 2 to 0. This case indicated that a patient with trigger finger could be treated by five pharmacopuncture treatments according to the treatment regimen and disease progress.

Development of a Korean Medicine Online Program on Mental Health.

Objectives: The coronavirus disease 2019 has deteriorated mental health, particularly in mothers with elementary school children. Although the country has developed several health promotion programs to preserve mental health, no program has incorporated Korean medicine. Thus, this study focuses on developing vital Korean medicine mental health care programs. Methods: The program follows the Korean medicine health promotion program principles. Guidelines, reports, research, and previous programs were analyzed to form interventions and lecture content. Results: Pellets, hot packs, meditation, lavender oil, and green tea were selected as final intervention strategies. Mental health-related guidelines were analyzed to produce stress management lecture materials. In addition, an operational methods and evaluation tool manual was created. Conclusion: We designed a health promotion program capitalizing on Korean medicine to improve mental health. This program will be assessed and accordingly improved through practical applications.

Home Healthcare Service Awareness Survey for Korean Medicine Doctors: a survey study.

Objectives: Discussions regarding "medical blind spots" in Korea's "aging society" are continuously rising. In addition, the demand for medical attention and care for the elderly and vulnerable populations continues to increase. Given this, the government is promoting the "home healthcare service" project. This study aims to lay the foundation for promoting this project by investigating the perception of clinical Korean Medicine (KM) doctors in the "community health care" project. Methods: With the cooperation of the Association of Korean Medicine, we sent a questionnaire to all KM doctors through e-mail. The survey included personal information, awareness, appropriate disease and intervention, proper visit location, and pros and cons. Results: A total of 602 responses were collected and analyzed. Approximately 20% of the doctors answered that they were well aware of the service, while 55% responded that they did not know about it. For a visit, a KM doctor selected the appropriate diseases in the order of stroke, dementia and Parkinson's disease, osteoarthritis, and chronic diseases. Among treatments, acupuncture, moxibustion, and herbal medicine exhibited similar results. The most common opinion was that KM doctors should schedule their visits once a week for 6-12 months, which was the most prolonged period among the given options. More than 80% (84.1%) of the doctors replied that care projects were highly essential, and about 63.8% expressed their willingness to participate in these projects. Conclusion: To provide appropriate home health care, we must raise awareness among Korean medicine doctors. In addition, the healthcare budget must be increased to provide the required support.

Effectiveness of electroacupuncture on anxiety: a systematic review and meta-analysis of randomized controlled trials.

This systematic review and meta-analysis aimed to comprehensively evaluate the effectiveness of electroacupuncture (EA) for patients with anxiety. Randomized controlled trials (RCTs) on the treatment of anxiety by EA up to November 2022 were searched and collected from nine databases. Hamilton Anxiety Rating Scale (HAMA), self-rating anxiety scale (SAS), and adverse reactions were used as outcome indicators. The quality of relevant articles was evaluated using the Cochrane Collaboration's risk of bias tool. The quality of evidence for each outcome was classified as "low risk," "unclear risk," or "high risk." RevMan 5.0 was used for data analysis. A total of 633 articles were identified from nine electronic databases; 37 RCTs were included, which measured anxiety changes by using EA alone compared to the control group. For the main outcome, EA significantly reduced the HAMA score [Mean difference (MD):-1.13 (95% CI:-2.55-0.29), I2:80%], and the quality of evidence was moderate. EA significantly reduced the SAS score (MD:-3.47 (95% CI,-6.57--0.36), I2:88%), and the quality of evidence was moderate. Our meta-analysis shows that EA reduces HAMA and SAS. This study suggests that EA can relieve anxiety. For various uses, additional research is needed on its effect when combined with other treatments. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=345658, identifier (CRD42022345658).

Comparison of Effectiveness of Manual Therapy for Infant Crying: systematic review and meta-analysis of randomized controlled trials.

Objectives: The aim of this systematic review and meta-analysis is to assess and compare the effectiveness of manual therapy in alleviating infant crying, a common symptom of nocturnal crying (NC) and infantile colic (IC). Methods: Total effective rate, crying time and adverse events were used as outcome indicators. To assess the quality, the risk of bias was determined for each study by two authors, using the Cochrane Collaboration's risk of bias tool. RevMan 5.0 was used for data analysis. A total of 98 articles were identified from 6 electronic databases. Results: Among them, twenty-seven studies which included 13 NC and 14 IC were included. Meta-analysis showed favorable effects tuina therapy on total effective rate (TER) of NC (RR 1.20 [95% CI 1.05 to 1.37], p = 0.007), chiropractic therapy on crying time change of IC (SMD -0.83 [95% CI -1.61 to -0.06], p = 0.04) and massage on total crying time of IC (SMD -0.86 [95% CI -1.09 to -0.63], p < 0.00001). This systematic review compares different manual therapies for the treatment of NC and IC. While tuina, chiropractic, and massage show results in alleviating symptoms, the overall evidence remains limited due to the low quality and heterogeneity of the included studies. Conclusion: Therefore, further high-quality research with unified control groups is needed to establish manual therapy as a recommended treatment option for NC and IC. Protocol registration number is CRD42022348143 01/08/2022.

Herbal Decoctions for the Levels of Sulfur Dioxide, Benzopyrene, and Mycotoxin from Traditional Korean Medicine Clinics: A Preliminary Study.

In this study, we investigated whether the levels of sulfur dioxide (SO2), benzopyrene, and mycotoxins in herbal decoctions in Korea in 2019 were within normal limits. In total, 30 decoctions composed of multi-ingredient traditional herbs were sampled from traditional Korean medicine (TKM) clinics, TKM hospitals, and external herbal dispensaries in 2019. The decoctions were analyzed for SO2, benzopyrene, and mycotoxins using 10 samples. SO2 and benzopyrene were not detected in any of the herbal decoctions. With regard to mycotoxins, aflatoxin B1 was not detected, but B2 was detected in 7 cases (0.00~0.04 ppb), G1 in 13 cases (0.03~0.29 ppb), and G2 in 9 cases (0.02~0.93 ppb). None of these values exceeded the restrictions in prior studies. Thus, we confirm that the amounts of SO2, benzopyrene, and mycotoxins in herbal decoctions are at safe levels and provides the basis of establishing safety management criteria for herbal decoctions.

Warm needle acupuncture for osteoarthritis: A systematic review and meta-analysis.

BACKGROUND: Warm needle acupuncture (WA) is considered a potential intervention in the treatment of osteoarthritis (OA). PURPOSE: To systematically evaluate the clinical efficacy and safety of WA in the treatment of OA. STUDY DESIGN: Systematic review and meta-analysis METHODS: Fourteen databases were searched from their inception until May 2022. Randomized controlled trials (RCTs) of WA for treating OA were identified. Study selection and data extraction were performed by two independent reviewers. The Cochrane risk of bias tool and the Grading of Recommendations Assessment, Development and Evaluation program were used to assess all included RCTs. RESULTS: A total of 66 RCTs met the inclusion criteria for this review. Most of the included studies had an unclear risk of bias, and the certainty of the evidence was very low. Twenty-four RCTs compared the effects of WA with those of oral drug therapies. Meta-analysis showed superior effects of WA for the total effective rate (risk ratio (RR): 1.22, 95% confidence interval (CI): 1.17 to 1.27, I2 = 26%, p < 0.001, 24 studies, n = 2278), pain, and function. Eight RCTs compared the effects of WA+drug therapy, and meta-analysis showed favorable effects for the total effective rate (RR: 1.27, 95% CI: 1.18 to 1.35, I2 =0%, p < 0.001, 8 studies, n = 646). Eight RCTs compared the effects of WA and intra-articular sodium hyaluronate (IASH) injection on OA and found equivalent effects of WA on the symptoms of OA. Twenty-eight RCTs compared the effects of WA+IASH injection with those of IASH injection, and meta-analysis showed superior effects of WA+IASH in terms of the total effective rate (RR: 1.15, 95% CI: 1.11 to 1.19, I2 =27.3%, p < 0.001, 25 studies, n = 2208), pain, and function. None of the RCTs reported serious adverse events. CONCLUSIONS: WA may have some distinct advantages in the treatment of OA. However, well-designed RCTs with larger sample sizes are needed.

Monitoring of Heavy Metals and Pesticide Residues of Herbal Decoctions in Traditional Korean Medicine Clinics in Korea.

In this study, we investigated whether the levels of heavy metal and pesticide residues in herbal decoctions in Korea in 2019 were within normal limits. In total, 30 decoctions composed of multi-ingredient traditional herbs were sampled from traditional Korean medicine (TKM) clinics, TKM hospitals, and external herbal dispensaries in 2019. The decoctions were analyzed for heavy metal content such as lead, arsenic, and cadmium using inductively coupled plasma optical emission spectrometry. For mercury, an automatic mercury analyzer based on the gold amalgamation process was used. For pesticide residues, gas chromatography with electron capture detection and gas chromatography with mass selective detection were used for the analyses. Based on the testing, heavy metals were identified in most of the decoctions (Cd: 0.000-0.003 ppm, Pb: 0.003-0.023 ppm, As: 0.000-0.016 ppm, Hg: 0.000-0.002 ppm). Pesticide residues (e.g., total DDT, total BHC, aldrin, endrin, dieldrin) were not detected at all. All of these were no more than the limit values in preceding studies. Therefore, this study confirms that the contents of heavy metals and pesticides in herbal decoctions are within safe levels based on a previous study and provides evidence for establishing safety management standards for herbal decoctions in Korea.

Acupoint herbal patching for bronchitis: A systematic review and meta-analysis.

BACKGROUND: Acupoint herbal patching (AHP) has long been used to treat patients with bronchitis in East Asia. This review assessed the efficacy and safety of AHP as a treatment for bronchitis. METHODS: We performed a literature search using the 9 databases and included randomized controlled trials (RCTs) or quasi-RCTs that used AHP for bronchitis. The methodological quality of each RCT was assessed using the Cochrane Handbook version 5.3, the risk of bias tool, and Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: Seven RCTs were included based on the inclusion criteria. All RCTs were published in China and had a high risk of bias. Three RCTs compared AHP with conventional drug therapy for the treatment of bronchitis. The meta-analysis also showed a significant improvement in treatment effectiveness (relative risk [RR] 1.28, 95% confidence interval [CI] 1.15, 1.42; P < .00001; I2 = 0%). Two RCTs investigated AHP combined with conventional drug therapy versus conventional drug therapy. The meta-analysis showed that AHP was significantly more effective than conventional therapy in terms of treatment effective rate (RR 1.16, 95% CI 1.03, 1.29; P = .01; I2 = 0%). Three RCTs reported adverse events, and none reported severe adverse events. CONCLUSIONS: AHP appears to be more effective than conventional drug therapy alone or a placebo. Furthermore, the AHP appears to be a safe treatment option. However, due to the small number of included trials and their poor methodological quality, future studies should include larger sample sizes and well-designed RCTs. TRIAL REGISTRATION NUMBER: PROSPERO: CRD 42018110380.

Morus alba L. for Blood Sugar Management: A Systematic Review and Meta-Analysis.

Introduction: Morus alba L. is used for blood sugar management in patients with diabetes mellitus. This review aimed to evaluate the effect of Morus alba on blood sugar management. Methods: This review was conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). We searched PubMed, EMBASE, and four Korean medical databases (RISS, OASIS, NDSL, and KISS) using relevant keywords. Randomized controlled trials with any type of control intervention were included. The selection of studies, data extraction, and quality assessment were performed independently by two researchers. Results: Our results showed that Morus alba can reduce postprandial glucose and insulin levels. However, it is insufficient to conclude that Morus alba is an effective intervention for lowering blood glucose levels. Therefore, more rigorous studies are needed to reveal the effect of MA on blood glucose levels. Conclusion: The conclusion of this review provides evidence that Morus alba can control blood sugar level. This systematic review was registered with the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42021255940).

A Study on the Development of a Model for Providing Traditional Korean Medicine and Welfare Services for Community Care.

Objectives: This study aims to develop a community care model in traditional Korean medicine (TKM) by developing a community care participation model for the health of the elderly and deriving tasks to implement it. Methods: This study implemented a group interview with experts. A fact-finding survey was conducted targeting 16 local governments that are implementing a leading project to identify the status of TKM service provision and welfare service linkage in all regions. An expert group interview (FGI) targeted public and private sector experts for each job role, the former represented by those in charge of the central government's health care policy and administrative delivery system, and the latter by professors majoring in social welfare, professors majoring in health, and local TKM societies. After forming the expert groups, three expert group interviews were conducted. Results: Through collective interviews with experts, a model for providing TKM and welfare services in community integrated care was derived by dividing it into local and central government levels. The strategies and tasks for promoting TKM-oriented health welfare services were derived from 3 strategies, 8 tasks, and 20 detailed tasks. Conclusion: The core direction of the TKM health care model is the region-centered provision of TKM and welfare services. To this end, policy support for the use and linkage of health care service resources is required at the central government level, and linkage and provision of health welfare services centered on TKM are necessary through linkage and convergence between service subjects and between government health care projects.

Traditional Korean Medicine Usage and Perception: a comparative study between the general population and the disabilities.

Objectives: This study is a comparative analysis of the satisfaction and recognition characteristics for traditional Korean medicine (TKM) in people with disabilities and the general population of Korea. Methods: Here, 5,000 subjects were categorized into two groups based on a disability rating using the data from the 2017 National Survey for the Usage of Korean Medicine. The relationships among the sociodemographic characteristics, TKM usage status, recognition of TKM usage, and recognition of the effectiveness of the TKM treatment were analyzed based on the disease. The response reliability was verified using the chi-square test analysis method. Results: Disabilities corresponded with low rates of high school or higher education (44%, 83.5%) and no jobs (56.9%, 33.5%), mostly the status of the low-income class with a monthly household income of < 1,500 USD (50.9%, 10.5%), poor health conditions (55.2%, 9.8%), high chronic disease prevalence rate (69.0%, 19.9%), high medical care rate (11.2%, 0.5%), and low commercial health insurance subscription rate (44%, 74.2%). Furthermore, people with disabilities visited TKM institutions more often (88.8%, 74.1%) with a high frequency TKM usage rate of ≥ 1-2 times a month (26.2%, 15.3%). They also reported that the cost of using the TKM was very high (14.7%, 8.8%) and that primarily the application of insurance benefits should be improved (52.6%, 47.5%). The treatment effectiveness for diseases was high for musculoskeletal disorders for both people with disabilities and the general population. Conclusion: Preferential application of insurance benefits for musculoskeletal diseases must be extended to the TKM treatment as well, as people with disabilities have a high recognition for these conditions with TKM. It is difficult to perform randomized controlled trials on people with disability. Therefore, large-scale observational and cohort studies should be conducted. We hope this study will help establish a suitable TKM policy for people with disabilities.

Hair Growth Promotion with Black Soybean Extracts: case series.

Black soybean (BS) is widely thought to prevent or alleviate hair loss, which has been demonstrated by in vitro experiments. However, few clinical studies have directly assessed the effect of BS on hair growth. To assess the safety and efficacy of BS, we administered BS extract to 10 adult patients for 3 months without any other hair products and treatments. The number and diameter of hair lost from washing were examined every 4 weeks. In addition, the participants' satisfaction with their hair condition was also measured using the VAS (1 to 10) before and after treatment. The mean number of lost hair was 140.7 (SD 59.4) at baseline and 38.8 (SD 54.4) after 12 weeks, and the diameter of lost hair was 72.4 µm (SD 11.9) at baseline and 80.4 µm (SD 8.8) after 12 weeks, which indicated a statistically significant improvement (p = 0.002, p = 0.022, paired t-test). The satisfaction score was significantly increased from 6.10 (SD 1.2) to 8.2 (SD 1.1) after 12 weeks. These results suggest that BS extract may promote hair growth and prevent hair loss.

Literature Review on Korean Medicine Treatment for Alopecia.

This study aimed to analyze the use of Korean medicine treatments for alopecia in among clinical studies. We identified and analyzed 22 studies from Korean databases; Oriental Medicine Advanced Searching Integrated System (OASIS), Science ON, Korean Studies Information Service System (KISS), and Research Information Sharing Service (RISS) and international database; PubMed. We analyzed the Korean medical treatment in each case and determined the tendency to use each intervention. We analyzed 1,464 patients from 22 selected studies. Herbal medicine, acupuncture, external medicine or products, pharmacopuncture, and phototherapy were used for alopecia treatment. The herbal medicines mainly used to treat alopecia were Gagam Cheongyoung-tang, Gagam Hwajung-hwan, and Yukmijihwang-tang·hwan. The acupoints primarily used were GV20, EX-HN1, GB5, KI3, PC6, ST36, GV22, and A-shi. The most commonly used pharmacopuncture therapies were Hwangryunhaedoktang (HH), Carthami Fructus (CF), Bee Venom (BV), and Hominis placenta (HP). The Korean medical treatment for alopecia improved the condition of patients. However, seven studies reported the occurrence of side effects such as pruritus, dazed, drowsiness, headache, pain, and diarrhea. This study shows the potential of Korean medicine for the treatment of alopecia. Further studies with a large sample size and long-term follow-up are warranted to establish the primary treatment guidelines and objective outcome measures for alopecia.

Utilization Trends and Concentration Ratio of Korean Medicine: Based on the National Health Insurance Data.

OBJECTIVES: Although Korean Medicine (KM) subsidized by the National Health Insurance (NHI) has been used for a long time, there has been no active analysis using claims data . Therefore, the purpose of this study was to examine the NHI KM utilization trend using NHI statistics and to measure the level of market concentration by year. METHODS: By restructuring the contents of NHI Statistics for Pharmaceuticals for 2010-2019, the claim cases, costs, and annual growth rates of KM were demonstrated by year, sex, age group, region, therapeutic group, and KM treatment. The proportion of highly used k treatments in cost was calculated as the concentration ratio (CR) k and its trend by year was investigated. RESULTS: In 2019, the NHI cost on KM amounted to ₩38.2 billion KRW, increasing by 11.6% per year on average in 2010-2019. Notably, KM was used more frequently among women and patients aged ≥ 65 years, and the mixed formulation accounted for 95% of the total cost of KM. The CR of the simple formulation increased rapidly, whereas that of the mixed formulation remained constant. In 2019, three simple formulation treatments-peony, licorice, and ginseng- accounted for 93.8% of the total cost for KM (CR3 = 93.8%). CONCLUSION: NHI KM is rapidly increasing. Investigating the CR of KM confirmed that KM prescriptions have been concentrated in small numbers over the past 10 years.

Quality Control of Pharmacopuncture: A Comparative Study of Good Manufacturing Practice and External Herbal Dispensary Standards.

OBJECTIVES: We aimed to compare the external herbal dispensary (EHD) evaluation criteria for pharmacopuncture and the Korea Good Manufacturing Practice (KGMP) sterile medicine standards to contribute to the establishment of quality control criteria for pharmacopuncture. METHODS: We obtained the KGMP standards from the Ministry of Food and Drug Safety and the pharmacopuncture certification criteria from the Ministry of Health and Welfare of South Korea. The EHD evaluation items were classified into three categories facilities, quality control, and validation. The evaluation items were compared with the KGMP sterile medicine criteria to determine their conformance with each other, followed by a discussion among the committee of six experts and their consensus to suggest the items to complement the EHD evaluation criteria. RESULTS: Among the KGMP sterile medicine criteria, 44 were related to the management of the facilities, and 32 pharmacopuncture evaluation items corresponded to these KGMP items (66.7%). Fifty-eight KGMP criteria were related to quality management, and 42 pharmacopuncture evaluation items corresponded to these KGMP items (72.4%). Twenty-five KGMP sterile medicine criteria were related to validation, and 11 pharmacopuncture evaluation items corresponded to these KGMP items (44.0%). Sixteen items under the pharmacopuncture EHD criteria corresponded to the KGMP sterile medicine criteria based on the consent of the experts. Among these, 4 were related to facility management, 6 were related to quality control, and 6 were related to validation. CONCLUSION: For the safety and quality control of pharmacopuncture, there is a need to select the criteria for the mandatory items among the proposed pharmacopuncture-EHD criteria laws and systems to ensure that the pharmacopuncture materials are produced under the pharmacopuncture-EHD in compliance with the relevant requirements. More studies are needed to secure the safety level of pharmacopuncture materials corresponding to that of conventional medicine.