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Review

Clinical Studies of Bee Venom Acupuncture for Lower Back Pain in the Korean Literature

by
Soo-Hyun Sung
1,
Ji-Eun Han
1,
Hee-Jung Lee
1,
Minjung Park
2,
Ji-Yeon Lee
3,
Soobin Jang
4,
Jang-Kyung Park
5 and
Gihyun Lee
6,*
1
Department of Policy Development, National Institute of Korean Medicine Development, Seoul 04554, Korea
2
Center for Development of Innovative Technologies in Korean Medicine, National Institute of Korean Medicine Development, Seoul 04554, Korea
3
Department of Obstetrics & Gynecology, Daejeon Korean Medicine Hospital of Daejeon University, Daejeon 35235, Korea
4
Department of Preventive Medicine, College of Korean Medicine, Daegu Haany University, Gyeongsangbuk-do, Gyeongsan 38609, Korea
5
Department of Korean Medicine Obstetrics and Gynecology, School of Korean Medicine, Pusan National University, Yangsan 50612, Korea
6
College of Korean Medicine, Dongshin University, Naju 58245, Korea
*
Author to whom correspondence should be addressed.
Toxins 2022, 14(8), 524; https://doi.org/10.3390/toxins14080524
Submission received: 5 July 2022 / Revised: 23 July 2022 / Accepted: 27 July 2022 / Published: 30 July 2022
(This article belongs to the Special Issue The Frontiers of Toxin in Pharmacology)
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Abstract

:
This study aimed to identify all of the characteristics of bee venom acupuncture (BVA) for the treatment of lower back pain (LBP) that are described in the Korean literature, and to provide English-speaking researchers with bibliometrics. Six Korean electronic databases and sixteen Korean journals on BVA treatment for back pain were searched up to February 2022. This report included and analyzed 64 clinical studies on BVA interventions for back pain and 1297 patients with LBP. The most common disease in patients with back pain was lumbar herniated intervertebral discs (HIVD) of the lumbar spine (L-spine). All studies used bee venom (BV) diluted with distilled water. The concentration of BVA for HIVD of L-spine patients with LBP ranged from 0.01 to 5.0 mg/mL; the dosage per treatment was 0.02–2.0 mL, and for a total session was 0.3–40.0 mL. The most used outcome measure was the visual analogue scale for back pain (n = 45, 70.3%), and most of the papers reported that each outcome measure had a positive effect. Korean clinical studies were typically omitted from the review research, resulting in potential language bias. This study provides clinical cases in Korea for future development and standardization of BVA treatment for back pain.
Keywords:
bee venom; bee venom acupuncture; lower back pain; clinical studies; complementary and alternative medicine
Key Contribution: Korean-language clinical trials are typically omitted from systematic reviews, resulting in potential language bias. This study provides information (e.g., study design, sample size, medical conditions, bee venom concentration, treatment sessions, and dosage) to readers who have difficulty accessing the results of studies on bee venom acupuncture for lower back pain published in Korean journals owing to language problems.

1. Introduction

Lower back pain (LBP) is a highly uncomfortable and often chronic sensation in the back below the lower rib cage and above the gluteal fold [1]. LBP is the most common musculoskeletal condition affecting the adult population, with a worldwide prevalence of 7.5% in 2017 [2,3,4]. It is a major condition leading to disability, affecting work performance and the overall wellbeing of individuals [5,6].
For the treatment of patients with acute LBP, the guidelines recommend reassurance on the favorable prognosis and advice on returning to normal activities, avoiding bedrest, as well as the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and weak opioids for short periods [7]. For the treatment of patients with chronic LBP, the guidelines recommend the use of NSAIDs and antidepressants, exercise therapy, and psychosocial interventions [7]. NSAIDs are the most frequently prescribed medications worldwide, and are widely used in patients with LBP [8]. However, NSAIDs may cause gastrointestinal ulcers, serious cardiovascular events, hypertension, acute renal failure, and worsening of pre-existing heart failure [9]. The most commonly used complementary and alternative medicine (CAM) treatments for LBP are acupuncture, herbal therapies, chiropractic manipulation, massage, yoga, tai chi, and qigong [10].
Bee venom acupuncture (BVA) involves injecting purified and diluted bee venom (BV) into acupuncture points [11]. BVA is commonly used in Asia, Eastern Europe, and South America [12]. BV is mainly used in East Asian countries, including Korea, for pharmacopuncture, which is a traditional medical treatment that combines acupuncture and herbal medicine, unlike traditional acupuncture [13]. According to the National Survey for Traditional Korean Medicine (TKM), pharmacopuncture is used in 22.4% of TKM clinic patients, and BVA is the second most used treatment in pharmacopuncture [14,15].
Two clinical trials in Western databases (e.g., PubMed, Embase, or the Cochrane Central Register of Controlled Trials) investigated the treatment effect of BVA on LBP. In one randomized controlled trial (RCT), the BVA plus NSAIDs group showed a more significant effect on LBP than that of the control group (saline injection plus NSAIDs) [16]. In another study [17], BVA injection showed a more significant effect than that of the normal saline group. A systematic review on BVA for LBP has not yet been published, and one RCT involving LBP was included in a systematic review on musculoskeletal disorders [18]. Korean trials of TKM interventions have usually been published in TKM journals rather than in Western CAM or conventional medicine journals [19]. Thus, identifying Korean clinical studies for inclusion in English-language reviews is difficult [19]. The language barrier increases the risk of language bias [20]. Therefore, we aimed to identify Korean clinical studies on BVA for LBP, and to provide comprehensive information on BV toxins while developing LBP treatment.

2. Results

2.1. Study Description

As shown in Figure 1, our search identified 64 full-text articles that met our inclusion criteria [21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84]. The first BVA-related clinical study published in Korea was published in 1999. From 1999 to 2020, such studies were published yearly, with a maximum of seven papers published in 2008 (Figure 2). The study design is summarized in Table 1. This report includes 37 (57.8%) case studies, 5 (7.8%) case–control trials (CCTs), 6 (9.3%) RCTs, and 16 (25.0%) retrospective studies.

2.2. Medical Conditions

Of the 64 included trials, 18 types of single medical conditions were reported in 61 papers, and complex medical conditions were reported in the remaining 3 papers. Six medical conditions—HIVD of L-spine patients with back pain, back pain, failed back surgery syndrome patients with back pain, lumbar spinal stenosis patients with back pain, car accident patients with lower back pain, and back sprain patients with back pain—were mentioned in more than two papers. The numbers of papers and patients by disease are shown in Table 2.

2.3. Sample Size

In total, 1295 participants from the 64 clinical studies were included in this review. The sample size per trial ranged from 1 to 208 (20.2 ± 33.1).

2.4. BVA Intervention

The intervention used in all included studies was in injection form, using a syringe through which BV was dispensed and injected into the body. The BVA concentration range was 0.01–5.0 mg/mL, and the dosage per treatment and for the total sessions was 0.02–2.0 mL and 0.3–40.0 mL, respectively, for herniated intervertebral disc (HIVD) in lumbar-spine (L-spine) patients with back pain. The BV concentration was 0.05–0.5 mg/mL and the dosage per treatment and the total sessions were 0.03–1.0 mL and 0.51–5.1 mL, respectively, in patients with back pain. The concentration and dosage of BVA according to the participant’s medical condition (e.g., failed back surgery syndrome patients with back pain, lumbar spinal stenosis patients with back pain, car accident patients with LBP, and back sprain patients with back pain) are shown in Table 3. Six papers did not report BV concentration, eight papers did not report the dosage of one session, and eighteen papers did not report the dosage of the total sessions.

2.5. Outcome Measures

A total of 22 types of outcome measures were reported in the 64 included papers. Figure 3 shows the results of classifying the main results of 11 outcome measures used in four or more papers into three categories, including “statistically improved,” “improved”, and “not improved”. The most commonly used outcome measure was the visual analogue scale (VAS) for back pain (n = 45, 70.3%), and most of the papers reported that each evaluation tool had a positive effect.

3. Discussion

This study is an analysis of Korean clinical trials published in Korean journals, and we found several clinical studies on BVA for back pain in the Korean literature. The first study on BVA for the treatment of LBP was published in 1999. Since then, such studies have been published yearly until 2020. In Korea, the Ministry of Food and Drug Safety introduced the Good Clinical Practice Guidelines for clinical trials in the late 1990s, and these guidelines seem to have significantly impacted the progress of clinical research, including research on bee venom [19]. In addition, acupuncture for LBP patients in Korea has been reported to reduce the frequency of back surgery, and BVA has been widely used for musculoskeletal disorders (e.g., HIVD, arthritis, back pain, shoulder pain, knee pain, and sprain) [85,86]. Thus, a certain number of BVA clinical trials seem to have been conducted.
Although most studies have reported that BVA is effective for LBP, six studies reported side effects including fever [36], itching [51,52,59,82], local redness [59], edema [59], skin hypersensitivity [73], mild chilling [82], and local rash [82]. BV contains active substances such as peptides, enzymes, and amines, which can exert anti-inflammatory, anti-nociceptive, and anticancer effects, but can also induce neurotoxic symptoms (e.g., redness, swelling, dizziness, nausea, and vomiting) or severe symptoms, such as anaphylaxis [87,88]. Kim et al. [89] suggest that the following are necessary for the safe use of BVA: (1) a qualified or licensed practitioner to treat the patient, and (2) a skin test and post-injection observation in the clinic to manage potential adverse events. Additionally, to develop a treatment using BV for patients with back pain, information on the dosage and concentration is essential to maximize the therapeutic effect while minimizing side effects. Future clinical studies with information on the side effects are necessary.
All 64 Korean clinical trials reported that BV was diluted with saline at a certain ratio and injected into the patients. The BV concentration used for each study was found to cover a wide range, from 0.01 mg/mL to 5.0 mg/mL. In particular, in the case of HIVD in L-spine patients with back pain, the concentration deviation was the largest. When a survey was conducted with 468 TKM doctors, it was reported that the BV concentration used without considering the disease was 0.1–0.3 mg/mL [89]. As such, it can be seen that the deviation of the BV concentration is very large even when compared with the previous study [89]. Based on these basic data, a clinical trial should be established to find the optimal BVA treatment concentration, dose, and frequency for lower back pain.
Pain is mainly evaluated subjectively in patients. Inflammation-related biomarkers, such as interleukin-6, C-reactive protein, and tumor necrosis factor α, along with range of motion (ROM), are also used to measure pain. However, self-reported outcomes, including the VAS, numerical rating scale (NRS), and Oswestry disability index (ODI), are more appropriate to show the clinical effectiveness and patient satisfaction with therapies. Quality of life is also used as an indicator, because LBP lowers the overall physical and psychological health. Although symptom changes in patients confirmed whether the subjectively felt pain of the patient improved, it was not quantified in the same way as when using the VAS. To develop a therapeutic agent, clinical trials that evaluate the effectiveness of the commonly used evaluation tools are necessary.
This study has several limitations. First, this review mostly included case or retrospective studies with low levels of clinical evidence and a relatively small sample size. A higher level of evidence from large-scale clinical studies is needed. Second, the VAS, ODI, and EQ-5D are validated questionnaires, although a meta-analysis was not performed considering the heterogeneity of the included RCTs and the individual variation of the study participants. Third, since this review searched only domestic Korean databases, clinical studies conducted in Korea but published in international journals might have been missing. Finally, the 64 included studies were conducted at university hospitals, and may differ from real-world data obtained at TKM clinics. Therefore, whether this study is representative of the use of BVA for LBP treatment in Korea is difficult to confirm. Nonetheless, many cases of BVA application for the treatment of back pain in Korea exist; the details of BVA summarized in this review could provide information to help in planning clinical trials for new drug development.

4. Conclusions

This study showed the clinical research trend for BVA’s use in LBP treatment as published in Korean journals. BV was diluted to an appropriate concentration for clinical purposes, and was confirmed to be an effective treatment for patients with LBP. However, no side effects were reported in most studies, and large variations in the concentration, dose, and number of BVA treatments were noted. This study provides clinical evidence for the future drug development and standardization of LBP treatment using BVA.

5. Materials and Methods

5.1. Data Sources and Searches

We searched six Korean bibliographic databases (the Korea Institute of Science and Technology Information, the Korean Traditional Knowledge Portal, KoreaMed, OASIS, RISS, and the National Library of Korea) up to February 2022. The Korean trials indexed in non-Korean databases such as PubMed and Embase were not considered.
The search terms were as follows: “bee venom OR bee toxin OR apitherapy OR bee venom therapy OR bee venom acupuncture” AND “back pain” AND “clinical studies OR clinical trial”.

5.2. Study Selection

We included all clinical studies (e.g., case studies, case series, CCTs, and RCTs) that evaluated the effects of BVA on back pain. All patients with back pain and without age- or sex-based restrictions were included. We included all types of BVA and all outcome measures (e.g., pain score, symptom change, quality of life, ROM, and adverse events) used for treating back pain. Non-clinical trials—including animal studies, experimental studies, surveys, and reviews—were excluded.

5.3. Data Extraction

Three authors (J.-E.H, H.-J.L., and J.-Y.L.) independently extracted data using a predefined data extraction form. Two independent reviewers (S.-H.S. and M.P.) collected data regarding author information, study design, sample size, medical conditions, interventions (i.e., form, concentration, treatment sessions, and dosage), adverse events, outcome measures, and main results. In cases of insufficient outcome data, the corresponding authors were contacted whenever possible. Any disagreements were resolved through discussions with G.L.

Author Contributions

Conceptualization, S.-H.S. and G.L.; methodology, S.-H.S., J.-E.H., H.-J.L., M.P., and J.-Y.L.; software, J.-E.H., H.-J.L., and J.-Y.L.; validation, J.-E.H., H.-J.L., and J.-Y.L.; formal analysis, S.-H.S.; investigation, S.-H.S.; resources, J.-E.H., H.-J.L., and J.-Y.L.; data curation, J.-E.H., H.-J.L., and J.-Y.L.; writing—original draft preparation, S.-H.S., S.J., and J.-K.P.; writing—review and editing, M.P. and G.L.; visualization, S.J. and J.-K.P.; supervision, G.L.; project administration, S.-H.S.; funding acquisition, S.-H.S. All authors have read and agreed to the published version of the manuscript.

Funding

This research was supported by the National Research Foundation of Korea (NRF) grant funded by the Korean government (MSIT; No. NRF 2022R1I1A3068255), and by a grant from the Project of National Development Institute of Korean Medicine, Accreditation of External Herbal Dispensaries of Traditional Korean Medicine Clinics, funded by the Korean Ministry of Health and Welfare.

Institutional Review Board Statement

Not applicable.

Informed Consent Statement

Not applicable.

Data Availability Statement

The datasets (Korean clinical studies) used and/or analyzed during this study are available from the corresponding author upon reasonable request.

Conflicts of Interest

The authors declare no conflict of interest.

References

  1. Kim, D.H.; Han, S.R.; Choi, C.Y.; Sohn, M.J.; Lee, C.H. Efficacy of pulsed radiofrequency medial branch treatment in low back pain patients. J. Back Musculoskelet Rehabil. 2016, 29, 361–366. [Google Scholar] [CrossRef]
  2. Balagué, F.; Mannion, A.F.; Pellisé, F.; Cedraschi, C. Non-specific low back pain. Lancet 2012, 379, 482–491. [Google Scholar] [CrossRef] [Green Version]
  3. Maher, C.; Underwood, M.; Buchbinder, R. Non-specific low back pain. Lancet 2017, 389, 736–747. [Google Scholar] [CrossRef] [Green Version]
  4. Wu, A.; March, L.; Zheng, X.; Huang, J.; Wang, X.; Zhao, J.; Blyth, F.M.; Smith, E.; Buchbinder, R.; Hoy, D. Global low back pain prevalence and years lived with disability from 1990 to 2017: Estimates from the Global Burden of Disease Study 2017. Ann. Transl. Med. 2020, 8, 299. [Google Scholar] [CrossRef] [PubMed]
  5. Ehrlich, G.E. Low back pain. Bull. World Health Organ. 2003, 81, 671–676. [Google Scholar] [PubMed]
  6. Manchikanti, L.; Singh, V.; Falco, F.J.; Benyamin, R.M.; Hirsch, J.A. Epidemiology of low back pain in adults. Neuromodulation 2014, 17 (Suppl. 2), 3–10. [Google Scholar] [CrossRef] [PubMed]
  7. Oliveira, C.B.; Maher, C.G.; Pinto, R.Z.; Traeger, A.C.; Lin, C.C.; Chenot, J.F.; van Tulder, M.; Koes, B.W. Clinical practice guidelines for the management of non-specific low back pain in primary care: An updated overview. Eur. Spine J. 2018, 27, 2791–2803. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  8. Roelofs, P.D.; Deyo, R.A.; Koes, B.W.; Scholten, R.J.; van Tulder, M.W. Nonsteroidal anti-inflammatory drugs for low back pain: An updated Cochrane review. Spine 2008, 33, 1766–1774. [Google Scholar] [CrossRef] [PubMed]
  9. Vonkeman, H.E.; van de Laar, M.A. Nonsteroidal anti-inflammatory drugs: Adverse effects and their prevention. Semin. Arthritis Rheum. 2010, 39, 294–312. [Google Scholar] [CrossRef]
  10. Ghildayal, N.; Johnson, P.J.; Evans, R.L.; Kreitzer, M.J. Complementary and alternative medicine use in the US adult low back pain population. Glob. Adv. Health Med. 2016, 5, 69–78. [Google Scholar] [CrossRef] [Green Version]
  11. Kim, Y.S.; Jun, H.; Chae, Y.; Park, H.J.; Kim, B.H.; Chang, I.M.; Kang, S.K.; Lee, H.J. The practice of Korean medicine: An overview of clinical trials in acupuncture. Evid. Based Complement. Alternat. Med. 2005, 2, 325–352. [Google Scholar] [CrossRef] [Green Version]
  12. Son, D.; Lee, J.; Lee, Y.; Song, H.; Lee, C.; Hong, J. Therapeutic application of anti-arthritis, pain-releasing, and anti-cancer effects of bee venom and its constituent compounds. Pharmacol. Ther. 2007, 115, 246–270. [Google Scholar] [CrossRef] [PubMed]
  13. Korea Pharmacopuncture Institute. Pharmacopuncturology, 3rd ed.; Hanmi Medical Publishing Co.: Seoul, Korea, 2019. [Google Scholar]
  14. Ministry of Health and Welfare; National Development Institute of Korean Medicine; Gallup Korea. 2020 Years National Survey for Traditional Korean Medicine (TKM) Usage; National Development Institute of Korean Medicine: Seoul, Korea, 2021; Available online: https://www.koms.or.kr/board/researchReport/view.do?post_no=185&menu_no=21 (accessed on 20 July 2022).
  15. Yook, T.H.; Kim, K.H.; Kim, S.H.; Jang, B.H.; Park, J.E.; Yoon, J.M. Institutionalization of Pharmacopuncture; Korea Pharmacopuncture Institute: Seoul, Korea, 2018. [Google Scholar]
  16. Seo, B.K.; Han, K.; Kwon, O.; Jo, D.J.; Lee, J.H. Efficacy of bee venom acupuncture for chronic low back pain: A randomized, double-blinded, sham-controlled trial. Toxins 2017, 9, 361. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  17. Shin, B.-C.; Kong., J.C.; Park, T.-Y.; Yang, C.-Y.; Kang, K.-W.; Choi, S.-M. Bee venom acupuncture for chronic low back pain: A randomised, sham-controlled, triple-blind clinical trial. Eur. J. Integr. Med. 2012, 4, e271–e280. [Google Scholar] [CrossRef]
  18. Lee, M.S.; Pittler, M.H.; Shin, B.C.; Kong, J.C.; Ernst, E. Bee venom acupuncture for musculoskeletal pain: A review. J. Pain 2008, 9, 289–297. [Google Scholar] [CrossRef] [PubMed]
  19. Kim, C.K.; Kim, D.H.; Lee, M.S.; Kim, J.I.; Wieland, L.S.; Shin, B.C. Randomized controlled trials on complementary and traditional medicine in the Korean literature. Evid. Based Complement. Alternat. Med. 2014, 2014, 194047. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  20. Egger, M.; Zellweger-Zähner, T.; Schneider, M.; Junker, C.; Lengeler, C.; Antes, G. Language bias in randomised controlled trials published in English and German. Lancet 1997, 350, 326–329. [Google Scholar] [CrossRef]
  21. Lee, B.C. Clinical study of Oriental medicine treatment with bee venom therapy of the extrusion type of herniated disc patient. J. Korea Acupunct. Moxibution Soc. 1999, 16, 285–293. [Google Scholar]
  22. Kim, J.H.; Lee, J.D. Assessment of bee-venom acupuncture effect on herniated disc patients by rating scale. J. Korean Med. 1999, 20, 200–207. [Google Scholar]
  23. Park, S.J.; Cho, M.R.; Kim, C.S. Clinical study on 100 patients of low back pain. J. Korea Acupunct. Moxibution Soc. 1999, 16, 119–135. [Google Scholar]
  24. Lee, B.C.; Cheon, M.N.; Yang, M.B. An experimental studies on the LFT, RFT of patients in Bee-venom Acupuncture. J. Korea Acupunct. Moxibution Soc. 2000, 17, 11–18. [Google Scholar]
  25. Yun, H.S.; Park, D.S. A case of the bee venom herbal acupuncture for the patients with severe pain and sciatica due to HIVD of L-spine. J. Orient. Chr. Dis. 2000, 6, 144–149. [Google Scholar]
  26. Kim, Y.I.; Lee, H.; Lee, B.C. Clinical studies on 20 cases of patient with bee venom acupuncture treatment. J. Heahwa Med. 2001, 10, 7–16. [Google Scholar]
  27. Lee, B.H.; Kim, C.H.; Seo, J.C.; Youn, H.M.; Jang, K.J.; Song, C.H.; Ahn, C.B. A case of the reduction of symptoms but no change on the CT scanning in HNP by Oriental Medical Treatment added Mori cortex-bee venom Acupuncture. J. Pharmacopunct. 2001, 4, 17–25. [Google Scholar]
  28. Lim, J.K.; Cho, G.C.; Park, Y.N.; Wang, W.H.; Jang, H.S. A clinical study on the patient of sequestrated disc treated by bee venom therapy-according to radiological change. J. Korean Acupunct. Moxibustion Soc. 2002, 19, 256–263. [Google Scholar]
  29. Yoo, C.K.; An, C.S.; Kang, K.S.; Cho, A.R.; Kwon, K.R.; Kim, B.W. Clinical study on 1 case of Klippel-Trenaunay-Weber syndrome. J. Pharmacopunct. 2002, 5, 109–115. [Google Scholar]
  30. Bae, E.J.; Cho, H.Y.; Jin, J.D.; Shin, M.K.; Han, S.G.; Yang, G.Y.; Hwang, K.J.; Shin, Y.I.; Lee, S.H.; Lee, B.R. A Clinical study carried out common acupuncture therapy and Bee-Venom Acupuncture on HNP of L-spine. J. Korean Acupunct. Moxibustion Soc. 2002, 19, 54–64. [Google Scholar]
  31. Moon, I.R.; Choi, S.G.; Lim, H.J.; Seo, W.H. A clinical study on the case of diffuse idiopathic skeletal hyperostosis(DISH) treated with traditional Korean Medicine, especially Korean bee-venom therapy. J. Korean Acupunct. Moxibustion Soc. 2002, 19, 225–233. [Google Scholar]
  32. Jun, H.J.; Hwang, O.; Kim, J.S.; Nam, S.S.; Kim, Y.S. Clinical evaluation of herniation of nucleus purposus patients treated by bee venom therapy. J. Korean Acupunct. Moxibustion Soc. 2003, 20, 36–72. [Google Scholar]
  33. Chung, W.S.; Lee, J.S.; Chung, S.H.; Kim, S.S. The effect of bee venom acupuncture on patient with herniation of nucleus pulposus of lumbar spine. J. Oriental. Rehab. Med. 2003, 13, 87–101. [Google Scholar]
  34. Hwang, O.; Kim, J.S.; Jun, H.J.; Nam, S.S.; Kim, Y.S. Case report of spinal meningeal cyst patient treated with by bee venom therapy. J. Korean Acupunct. Moxibustion Soc. 2003, 20, 213–228. [Google Scholar]
  35. Cha, J.D.; Jung, S.M.; Kim, K.O.; Kim, K.S.; Kim, N.O. The comparision of effectiveness between acupuncture and its cotreatment with bee venom acua-acupuncture therapy on the treatment of herniation of nucleus pulpous. J. Korean Acupunct. Moxibustion Soc. 2004, 21, 149–158. [Google Scholar]
  36. Lee, G.M.; Lee, K.S.; Yeom, S.C.; Jang, J.H.; Yun, J.Y.; Hwang, B.C.; Kug, Y.S.; Jang, J.Y.; Choi, J.S.; Kim, Y.J.; et al. A clinical study of bee-venom acupuncture treatment on protrusion disc patients. J. Korean Acupunct. Moxibustion Soc. 2004, 20, 13–26. [Google Scholar]
  37. Lee, J.H.; Kim, Y.; Park, J.M.; Park, S.G.; Sim, W.J.; Kim, S.Y.; Shin, J.S. The effect of conservative treatment on Failed Back Surgery Syndrome. J. Oriental. Rehab. Med. 2004, 14, 149–159. [Google Scholar]
  38. Lee, J.H.; So, K.S.; Choi, H.G.; Yeom, S.R.; Song, Y.S.; Kwon, Y.D. A case report on causalgia after lumbar partial laminectomy. J. Oriental. Rehab. Med. 2004, 14, 199–208. [Google Scholar]
  39. Yoo, J.R.; Song, H.S. A clinical case study of the effect of bee-venom acupuncture on HNP. J. Korean Skelet. Jt. Med. 2004, 1, 19–23. [Google Scholar]
  40. Kim, S.N.; Lim, J.A.; Lee, S.Y.; Yun, J.M.; Choi, S.Y.; Kim, H.H.; Kim, S.C.; Moon, H.C. A case of neurogenic bladder patient with lumbar disc herniation. J. Korean Acupunct. Moxibustion Soc. 2005, 4, 155–163. [Google Scholar]
  41. Kim, K.U.; Seo, B.M.; Yun, J.S.; Lee, Y.K.; Choi, S.H.; Lee, K.M.; Lim, S.C.; Seo, J.S.; Jung, T.Y.; Han, S.W. The comparison of bee venom herbal-acupuncture therapy between neighboring acupuncture points and neighboring-remote acupuncture points on the treatment of lumbar spine herniation of nucleus pulpous. J. Korean Acupunct. Moxibustion Soc. 2005, 22, 181–187. [Google Scholar]
  42. Kim, K.T.; Song, H.S. The effectiveness of bee venom acupuncture therapy on the treatment of sprain of L-Spine(a randomized controlled trial; double binding). J. Korean Acupunct. Moxibustion Soc. 2006, 22, 113–120. [Google Scholar]
  43. Rhee, S.H.; Cho, T.Y.; Jin, S.S.; Park, J.S.; Yeo, H.S.; Lim, H.H. The case report about herniation of inter-vertebral disc treated with bee venom acupuncture therapy. J. Korean Chuna Man. Med. Spine Nerves 2006, 1, 73–81. [Google Scholar]
  44. Cha, J.H.; Chang, S.Y.; Lee, T.H.; Owi, J.S.; Lee, E.U. The comparison of effectiveness between acupuncture and bee venom acupuncture on the treatment of acute lumbar herniation of intervertebral disc. J. Korean Acupunct. Moxibustion Soc. 2006, 9, 67–71. [Google Scholar]
  45. Yu, S.M.; Lee, J.Y.; Kwon, K.R.; Lee, H.S. Comparative study of acupuncture, bee venom acupuncture, and bee venom pharmacopuncture on the treatment of herniation of nucleus pulpous. J. Korean Acupunct. Moxibustion Soc. 2006, 23, 39–54. [Google Scholar]
  46. Kang, M.H.; Kim, S.Y.; Lee, J.H.; Koh, D.H.; Song, W.S. The clinical report on 1 case of low back pain and radiational pain patient treated by Chuna traction and consevative treatment. J. Korean Chuna Man. Med. Spine Nerves 2006, 1, 1–10. [Google Scholar]
  47. Lee, G.J.; Lee, G.Y.; Jang, G.; Song, Y.K.; Lim, H.H. The case report of lumbar spinal stenosis treated with bee venom acupuncture therapy. J. Korean Chuna Man. Med. Spine Nerves 2007, 2, 49–57. [Google Scholar]
  48. Lee, T.H.; Chang, S.Y.; Chang, S.Y.; Cha, J.H.; Jung, K.H.; Lee, E.Y.; Roh, J.D. The comparison of effectiveness between bee venom and sweet bee venom therapy on low back pain with radiating pain. J. Pharmacopunct. 2007, 10, 85–89. [Google Scholar] [CrossRef]
  49. Seo, Y.S.; Hong, K.E. Clinical study on 3 cases of HIVD patients treated by the Oriental medical conservative treatment. J. Korean Chuna Man. Med. Spine Nerves 2007, 2, 11–22. [Google Scholar]
  50. Lee, S.H.; Kang, M.W.; Lee, S.Y. Effectiveness of bee-venom acupuncture and Ouhyul herbal acupuncture in herniation of nucleus pulposus-comparison with acupuncture therapy only. J. Korean Acupunct. Moxibustion Soc. 2007, 24, 197–205. [Google Scholar]
  51. Kim, J.H.; Jang, S.H.; Yoon, H.M.; Jang, K.J.; Ahn, C.B.; Kim, C.H.; Song, C.H.; Choi, H.N. The comparison of effectiveness between bee venom and sweet bee venom therapy on chronic lower back pain. J. Pharm. 2008, 11, 15–24. [Google Scholar]
  52. Kwon, Y.D. Electrical acupuncture combined bee venom therapy for pain and disability induced intervertebral herniated disc of L-spine: A pilot study. Korean J. Orient. Physiol. Pathol. 2008, 22, 703–707. [Google Scholar]
  53. Youn, Y.S.; Park, W.S.; Ha, I.H.; Kim, J.W.; Kwon, H.J. A clinical study on the effect of Korean medical treatment for patients with lumbar disc herniation. J. Oriental. Rehab. Med. 2008, 18, 153–161. [Google Scholar]
  54. Youn, Y.S.; Lee, J.S.; Ha, I.H.; Kim, J.W.; Kwon, H.J. A comparative study with lumbar disc herniation under conservative treatment according to the duration. J. Oriental. Rehab. Med. 2008, 18, 135–145. [Google Scholar]
  55. Cho, H.C.; Lee, B.Y.; Lee, G.J.; Lim, H.H. The case report about Baastrup’s disease treated with conservative treatment. J. Oriental. Rehab. Med. 2008, 19, 201–210. [Google Scholar]
  56. Jeong, S.M.; Park, C.K.; Kim, K.H.; Kim, J.Y.; Sohn, S.C. The clinical study on effects of bee venom pharmacupuncture therapy in patients with lumbar spinal stenosis. J. Korean Acupunct. Moxibustion Soc. 2008, 25, 97–106. [Google Scholar]
  57. Kim, D.M.; Kim, Y.S.; Baek, Y.H.; Nam, S.S. The effects of acupuncture and bee-venom acupuncture on lumbar hypolordosis. J. Korean Acupunct. Moxibustion Soc. 2008, 25, 155–167. [Google Scholar]
  58. Kwon, H.J.; Jeong, H.C.; Kim, H.J.; Park, Y.H.; Keum, D.H.; Lee, M.J. Clinical study for patients with lumbar disc herniation on change of magnetic resonance imaging after conservative treatment. J. Oriental. Rehab. Med. 2009, 19, 81–90. [Google Scholar]
  59. Yu, D.S.; Kim, S.Y.; Kim, D.E.; Jung, I.M.; Yeom, S.R.; Kwon, Y.D. A clinical case of oriental medical treatment for the paraplegia after lumbar epidural nerve block. J. Oriental. Rehab. Med. 2009, 19, 219–228. [Google Scholar]
  60. Lee, J.H.; Min, K.S.; Kim, S.Y.; Kim, S.J. The case report on 3 case of conservative treatment on failed back surgery syndrome. J. Korean Chuna Man. Med. Spine Nerves 2010, 5, 57–68. [Google Scholar]
  61. Lee, J.H.; Kim, J.S.; Yang, K.Y.; Han, S.Y.; Lee, J.Y.; Hwang, E.M. Effect of bee-venom acupuncture on low back pain by traffic accidents. J. Korean Chuna Man. Med. Spine Nerves 2011, 6, 61–70. [Google Scholar]
  62. Lim, G.M.; Moon, S.J.; Jun, K.S.; Shin, H.K.; Ko, Y.S. A clinical case of Oriental medical treatment on failed back surgery syndrome. J. Korean Chuna Man. Med. Spine Nerves 2011, 6, 23–32. [Google Scholar]
  63. Shin, Y.J. A clinical pilot study comparing sweet bee venom parallel treatment with only acupuncture treatment in patient diagnosed with lumbar spine sprain. J. Pharm. 2011, 14, 37–43. [Google Scholar]
  64. Han, K.W.; Kim, E.S.; Woo, J.H.; Lee, S.J.; Lee, J.S.; Nam, J.H.; Kim, K.W.; Koh, K.H.; Yoo, I.S. Clinical observation on 119 patients with lumbar spinal stenosis treatment with bee venom pharmacopuncture therapy. J. Korean Acupunct. Moxibustion Soc. 2011, 28, 21–31. [Google Scholar]
  65. Shin, H.Y.; Lee, S.M.; Kim, J.H.; Kim, S.J.; Choi, Y.J.; Jung, T.Y.; Kim, J.S.; Lim, S.C.; Lee, Y.K.; Lee, B.H.; et al. Comparative study of effects on intracutaneous bee venom pharmacopuncture and intramuscular bee venom pharmacopuncture in lumbar disc herniation. J. Korean Acupunct. Moxibustion Soc. 2011, 28, 1–11. [Google Scholar]
  66. Cho, E.; Kang, J.H.; Choi, J.Y.; Yoon, K.S.; Lee, H. The clinical study on effects of bee venom pharmacopuncture therapy in patients with FBSS(Failed back surgery syndrome). J. Korean Acupunct. Moxibustion Soc. 2011, 28, 77–86. [Google Scholar]
  67. Ro, H.R.; Park, S.H.; Lee, J.Y.; Choo, W.J.; Han, S.W.; Kim, S.W.; Son, S.K.; Eom, T.W. The comparative study on the effects of ShinBaro pharmacopuncture treatment and bee venom pharmacopuncture treatment of patient with spondylolisthesis. J. Korean Chuna Man. Med. Spine Nerves 2012, 7, 53–61. [Google Scholar]
  68. Kim, T.H.; Park, W.H.; Cha, Y.Y. Comparative study of effects on bee venom pharmacopuncture and Ouhyul herbal acupuncture in low back pain caused by traffic accident. J. Oriental. Rehab. Med. 2012, 22, 177–184. [Google Scholar]
  69. Yeon, C.H.; Park, H.G.; Yi, W.S.; Kim, J.Y.; Chung, S.H. The two cases report of bee venom injection on patient with low back pain maintaining after heating-conduction acupuncture therapy. J. Korean Chuna Man. Med. Spine Nerves 2012, 7, 75–81. [Google Scholar]
  70. Jung, J.H.; Kim, W.W.; Seong, I.H.; Lee, K.S.; Cho, C.Y.; Kum, C.J.; Kim, H.K.; Ha, I.H. The study on effectiveness of Oriental medicine treatment for lumbar disc herniation inpatients on 208 cases. J. Oriental. Rehab. Med. 2013, 23, 77–86. [Google Scholar]
  71. Ji, M.J.; Lee, Y.J.; Lee, H.J.; Kim, J.S.; Lim, S.C.; Lee, Y.K. A clinical case study about the patient of neurogenic claudication diagnosed spinal stenosis treated by bee venom therapy. J. Korean Skelet. Jt. Med. 2013, 10, 1–10. [Google Scholar]
  72. Park, O.J.; Kim, S.G.; Lee, J.J.; Lee, S.M.; Kim, S.J.; Cho, N.G. The effect of Shinbaro and bee venom pharmacopuncture in treating lumbar disc herniation. Acupuncture 2013, 30, 41–50. [Google Scholar] [CrossRef]
  73. Lee, Y.E.; Lee, C.I.; Kim, S.J.; Kim, J.S.; Lee, H.J. Comparative study for therapeutic effects of the low back pain patients according to the bee venom pharmacopuncture-induced skin hyperseneitivity reaction and Sasang constitution. Acupuncture 2014, 31, 1–10. [Google Scholar] [CrossRef]
  74. Kim, K.M.; Yuk, D.I.; Kim, J.H.; Kim, Y.I.; Jeon, J.H. A case of cauda equina syndrome cared with acupuncture, sweet bee venom pharmacopuncture, herbal medicine combined treatment. Acupuncture 2014, 31, 91–102. [Google Scholar] [CrossRef] [Green Version]
  75. Kim, H.S.; Lee, C.H.; Jeon, J.Y.; Lim, S.J.; Bae, Y.H.; Kim, H.S.; Song, J.H.; Kim, M.H.; Cho, C.Y.; Jung, Y.H. A case report on a patient with lumbar HIVD and femoroacetabular impingement, treated by bee venom pharmacopuncture and conservative Oriental medical treatment. J. Korean Chuna Man. Med. Spine Nerves 2014, 9, 81–92. [Google Scholar]
  76. Kwon, H.K.; Park, S.A.; Ahn, C.B. The case study on 1 case of patients with ruptured intervertebral lumbar disc, treated with Korean medicine. J. East-West Med. 2014, 39, 21–32. [Google Scholar]
  77. Ji, M.J.; Lim, S.C.; Kim, J.S.; Lee, H.J.; Lee, Y.K. A clinical case study of residual symptoms after decompression of traumatic compartment syndrome. Acupuncture 2015, 32, 197–202. [Google Scholar] [CrossRef] [Green Version]
  78. Yang, T.J.; Kim, S.W.; Jang, Y.J.; Hyun, M.K.; Lee, E.J.; Yoon, T.K.; Yang, M.S.; Wei, T.S. A case of Korean medical treatments for lumbar herniated intervertebral disc with piriformis muscle tenderness. J. Korean Skelet. Jt. Med. 2015, 12, 83–91. [Google Scholar]
  79. Kim, S.Y.; Seo, J.C.; Seo, Y.J.; Park, J.H.; Lee, Y.J.; Kim, C.H.; Song, C.H.; Jang, K.J.; Lee, Y.J.; Yoon, H.M. The effect of Korean medical treatment with postural yinyang correction of temporomandibular joint on chronic low back pain. Korean J. Acupunct. 2016, 33, 157–165. [Google Scholar] [CrossRef]
  80. Ok, S.Y.; Sohn, S.A.; Lee, Y.J.; Shin, M.S. A case report of bee venom pharmacopuncture therapy at facet joint for the two patients with herniated intervertebral disc of lumbar spine. J. Korean Med. Rehabi. 2017, 27, 155–161. [Google Scholar] [CrossRef] [Green Version]
  81. Nam, S.H.; Kim, D.H.; Choi, H.M.; Kang, J.H.; Hyun, M.K. A case report of lumbar spinal stenosis improved with diarrhea-inducing treatment by Gamsui-mal and Korean medicine treatment. J. Korean Med. Rehabi. 2017, 27, 67–75. [Google Scholar] [CrossRef] [Green Version]
  82. Hwang, J.H.; Kim, D.H. Case report of two cases on effect of combined bee venom and CS pharmacopuncture with Korean medicine treatment on HIVD of L-spine. Korean J. Acupunct. 2018, 35, 239–246. [Google Scholar] [CrossRef]
  83. Ryu, G.H.; Moon, H.Y.; Ju, A.R.; Choo, W.J.; Choi, Y.S.; Moon, Y.; Chai, J.; Shin, W. A case report on a patient with acute herniated lumbar disc due to coughing treated with megadose pharmacopuncture and combined Korean medicine. J. Int. Korean Med. 2019, 40, 1248–1258. [Google Scholar] [CrossRef] [Green Version]
  84. Bong, S.M.; Jang, W.S.; Kim, K.H. Effects of sweet bee venom pharmacopuncture combined with Korean medicine treatment for acute low back pain syndrome patients: A case report. Korean J. Acupunct. 2020, 37, 54–62. [Google Scholar] [CrossRef]
  85. Koh, W.I.; Kang, K.W.; Lee, Y.J.; Kim, M.R.; Shin, J.S.; Lee, J.H.; Lee, J.H.; Shin, K.M.; Ha, I.H. Impact of acupuncture treatment on the lumbar surgery rate for low back pain in Korea: A nationwide matched retrospective cohort study. PLoS ONE 2018, 13, e0199042. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  86. Lee, Y.J.; Shin, J.S.; Lee, J.H.; Kim, M.R.; Park, K.B.; Lee, H.D.; Lee, Y.M.; Hong, J.W.; Ha, I.H. Usage report of pharmacopuncture in musculoskeletal patients visiting Korean medicine hospitals and clinics in Korea. BMC Complement. Altern. Med. 2016, 17, 292. [Google Scholar] [CrossRef] [Green Version]
  87. Lee, J.D.; Park, H.J.; Chae, Y.; Lim, S. An overview of bee venom acupuncture in the treatment of arthritis. Evid. Based Complement. Altern. Med. 2005, 2, 79–84. [Google Scholar] [CrossRef] [PubMed]
  88. Ko, S.H.; Oh, H.M.; Kwon, D.Y.; Yang, J.E.; Kim, B.J.; Ha, H.J.; Lim, E.J.; Oh, M.S.; Son, C.G.; Lee, E.J. Incidence rate of bee venom acupuncture related anaphylaxis: A systematic review. Toxins 2022, 26, 238. [Google Scholar] [CrossRef] [PubMed]
  89. Kim, K.; Jeong, H.; Lee, G.; Jang, S.; Yook, T. Characteristics of adverse events in bee venom therapy reported in South Korea: A survey study. Toxins 2021, 27, 18. [Google Scholar] [CrossRef] [PubMed]
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Figure 1. Flowchart of the study selection process. BVA: bee venom acupuncture; CCTs: case-control trials; RCTs: randomized controlled trials.
Figure 1. Flowchart of the study selection process. BVA: bee venom acupuncture; CCTs: case-control trials; RCTs: randomized controlled trials.
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Figure 2. Number of clinical studies in Korea by publication year.
Figure 2. Number of clinical studies in Korea by publication year.
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Figure 3. Outcome measures of included clinical studies on BVA for back pain. DITI: digital infrared thermography imaging, MRI: magnetic resonance imaging, ODI: Oswestry disability index, PRS: pain relief scale, RMDQ: Roland–Morris disability questionnaire, ROM: range of motion, SLR: straight leg raise, VAS: visual analogue scale.
Figure 3. Outcome measures of included clinical studies on BVA for back pain. DITI: digital infrared thermography imaging, MRI: magnetic resonance imaging, ODI: Oswestry disability index, PRS: pain relief scale, RMDQ: Roland–Morris disability questionnaire, ROM: range of motion, SLR: straight leg raise, VAS: visual analogue scale.
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Table
Table 1. Characteristics of clinical studies of bee venom acupuncture for lower back pain in the Korean literature.
Table 1. Characteristics of clinical studies of bee venom acupuncture for lower back pain in the Korean literature.
First AuthorStudy DesignNumber of PatientsMedical ConditionsIntervention
(Form, Concentration, Treatment Sessions and Dosage)		Adverse EventsOutcome MeasureMain Result
Lee (1999) [21]Retrospective studyn = 12HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.5 mg/mL
3. 1 session: n.r.
4. Total 1–9 sessions: n.r.		n.r.1. Symptom change (back pain)1. Improved
Kim (1999) [22]Retrospective studyn = 22HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.05 mg/mL
3. 1 session: 0.9 mL
4. Total 8 sessions: 7.2 mL		n.r.1. Symptom change (back pain)
2. L-spine MRI (degree of HIVD)
3. Satisfaction of patients		1. Improved
2. Positive a
3. Improved
Park (1999) [23]Case studiesn = 100Patients with lower back pain1. Form: injection
2. Concentration: n.r.
3. 1 session: n.r.
4. Total session and dose: n.r.		n.r.1. SLR test1. Improved
Lee (2000) [24]Case studiesn = 18Patients with back pain (degenerative arthritis and HIVD of L-spine)1. Form: injection
2. Concentration: n.r.
3. 1 session: n.r.
4. Total 21–64 sessions: n.r.		None1. Symptom change (back pain)1. Improved
Yun (2000) [25]Case studiesn = 1HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.3 mg/mL
3. 1 session: 1 mL
4. Total 20 sessions: 20 mL		n.r.1. VAS for back pain
2. L-spine ROM		1. Improved
2. Improved
Kim (2001) [26]Case studiesn = 19Patients with back pain (myofascial pain syndrome, HIVD of L-spine, degenerative spondylitis, and ankylosing spondylitis)1. Form: injection
2. Concentration: n.r.
3. 1 session: n.r.
4. Total 1–20 sessions: n.r.		n.r.1. Symptom change (back pain)1. Improved in 12 cases, not improved in 7 cases
Lee (2001) [27]Case studiesn = 1HIVD of L-spine patient with back pain1. Form: injection
2. Concentration: 0.03 mg/mL
3. 1 session: 0.5–1.4 mL
4. Total 13 sessions: 13.7 mL		n.r.1. VAS for back pain
2. L-spine ROM
3. L-spine CT (degree of HIVD)		1. Improved
2. Improved
3. Not improved
Lim (2002) [28]Case studiesn = 1Sequestrated disc patient with back pain1. Form: injection
2. Concentration: 0.25 mg/mL
3. 1 session: 0.4–2.0 mL
4. Total 20 sessions: 8–40 mL 		n.r.1. VAS for back pain
2. ODI for back pain
3. L-spine ROM		1. Improved
2. Improved
3. Improved
Yoo (2002) [29]Case studiesn = 1Klippel–Trenaunay–Weber syndrome patient with back pain1. Form: injection
2. Concentration: 0.5 mg/mL
3. 1 session: 0.2–0.4 mL
4. Total 10 sessions: 2.0–4.0 mL		n.r.1. Symptom change (back pain)
2. DITI of back		1. Improved
2. Improved
Bae (2002) [30]Case studiesn = 1HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.5 mg/mL
3. 1 session: n.r.
4. Total session and dosage: n.r.		n.r.1. SLR Test
2. Symptom change (back pain)		1. Improved
2. Improved
Moon (2002) [31]Case studiesn = 1Diffuse idiopathic skeletal hyperostosis patient with back pain1. Form: injection
2. Concentration: 0.1 mg/mL and 0.5 mg/mL
3. 1 session: 0.3–1.2 mL
4. Total session and dose: n.r.		n.r.1. SLR Test
2. Symptom change (back pain)		1. Improved
2. Improved
Jun (2003) [32]RCTn = 45HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.16 mg/mL
3. 1 session: 0.1–1.0 mL
4. Total above 12 sessions: above 1.2–12 mL		n.r.1. VAS for back pain
2. PRS for back pain
3. DITI of back		1. Positive b
2. Positive b
3. Positive b
Chung (2003) [33]Retrospective studyn = 24HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.05 mg/mL (1–2 visit), 0.1 mg/mL (3 visit), 0.2 mg/mL (4 visit), 0.4 mg/mL (5–6 visit)
3. 1 session: 0.05 mL
4. Total 6 sessions: 0.3 mL		n.r.1. VAS for back pain
2. ODI for back pain
3. L-spine ROM		1. Positive b
2. Positive b
3. Positive a
Hwang (2003) [34]Case studiesn = 1Spinal meningeal cyst patient with back pain1. Form: injection
2. Concentration: 0.16 mg/mL
3. 1 session: 0.08 mL
4. Total 21 sessions: 1.68 mL		n.r.1. VAS for back pain
2. PRS for back pain
3. L-spine MRI (degree of HIVD)
4. L-spine ROM		1. Improved
2. Improved
3. Improved
4. Improved
Cha (2004) [35]CCTn = 29HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.1 mg/mL, 0.25 mg/mL or 0.5 mg/mL
3. 1 session: 0.05 mL
4. Total 7 sessions: 0.35 mL		n.r.1. VAS for back pain
2. ODI for back pain		1. Positive c
2. Positive c
Lee (2004) [36]Retrospective studyn = 20HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.05 mg/mL or 0.25 mg/mL
3. 1 session: 0.1–1.5 mL
4. Total 9 sessions: 0.9–13.5 mL		Fever in 3 cases1. VAS for back pain
2. Grade classification of recovery degree		1. Positive c
2. Improved
Lee (2004) [37]Case studiesn = 1Failed back surgery syndrome patient with back pain1. Form: injection
2. Concentration: 0.125 mg/mL
3. 1 session: 0.3–1 mL
4. Total 10 sessions: 8.4 mL		n.r.1. VAS for back pain
2. ODI for back pain
3. Physical examination		1. Improved
2. Improved
3. Improved
Lee (2004) [38]Case studiesn = 1Causalgia patient after lumbar partial laminectomy with back pain1. Form: injection
2. Concentration: 0.5 mg/mL
3. 1 session: 0.3 mL
4. Total 44 sessions: 13.2 mL		n.r.1. VAS for back pain1. Improved
Yoo (2004) [39]Case studiesn = 1HIVD of L-spine patient with back pain1. Form: injection
2. Concentration: 0.05 mg/mL
3. 1 session: 0.3–0.6 mL
4. Total 22 sessions: n.r.		n.r.1. VAS for back pain1. Improved
Kim (2005) [40]Case studiesn = 1Neurogenic bladder after lumbar disc herniation with back pain1. Form: injection
2. Concentration: 0.5 mg/mL
3. 1 session: 0.2–1.0 mL
4. Total 17 sessions: 12.4 mL		n.r.1. VAS for back pain
2. Physical examination		1. Improved
2. Improved
Kim (2005) [41]Retrospective studyn = 15HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.5 mg/mL, 0.25 mg/mL or 0.1 mg/mL
3. 1 session: 0.1–1 mL
4. Total session and dosage: n.r.		n.r.1. VAS for back pain
2. Symptom change (back pain)		1. Improved
2. Improved
Kim (2005) [42]RCTn = 30Back sprain patients with back pain1. Form: injection
2. Concentration: 0,3 mg/mL
3. 1 session: 1 mL
4. Total 5 sessions: 5 mL		n.r.1. VAS for back pain
2. ODI for back pain		1. Improved
2. Improved
Lee (2006) [43]Case studiesn = 1HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.3 mg/mL
3. 1 session: 0.8 mL
4. Total 6 sessions: 4.8 mL		n.r.1. VAS for back pain
2. L-spine ROM		1. Improved
2. Improved
Cha (2006) [44]CCTn = 18HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.25 mg/mL
3. 1 session: 0.2–1.4 mL
4. Total 2–15 sessions: 0.4–21 mL 		n.r.1. VAS for back pain
2. L-spine ROM		1. Improved
2. Improved
Yu (2006) [45]Retrospective studyn = 35HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.25 mg/mL or 0.5 mg/mL
3. 1 session: 0.1–1.0 mL
4. Total session and dosage: n.r.		n.r.1. VAS for back pain
2. ODI for back pain
3. SLR test
4. L-spine ROM
5. Symptom change (back pain)		1. Improved
2. Improved
3. Improved
4. Improved
5. Improved
Kang (2006) [46]Case studiesn = 1Patients with lower back pain (lumbar spinal stenosis and HIVD of L-spine)1. Form: injection
2. Concentration: 0.3 mg/mL or 2 mg/mL
3. 1 session: 0.03–0.3 mL
4. Total 17 sessions: 0.51–5.1 mL		n.r.1. VAS for back pain1. Improved
Lee (2007) [47]Case studiesn = 1Lumbar spinal stenosis patients with back pain1. Form: injection
2. Concentration: 0.3 mg/mL
3. 1 session: 0.04 mL
4. Total 20 sessions: 0.8 mL		n.r.1. ODI for back pain
2. VAS for back pain
3. L-spine MRI (degree of stenosis)		1. Improved
2. Improved
3. Improved
Lee (2007) [48]Retrospective studyn = 10HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.1 mg/mL
3. 1 session: 0.6 mL
4. Total 4 sessions: 2.4 mL		n.r.1. VAS for back pain
2. SLR test		1. Improved
2. Improved
Seo (2007) [49]Case studiesn = 3HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.005–5.0 mg/mL
3. 1 session: 0.08–0.2 mL
4. Total 2–10 sessions: 0.32–0.1 mL		n.r.1. VAS for back pain
2. PRS for back pain
3. SLR test		1. Improved
2. Improved
3. Improved
Lee (2007) [50]Retrospective studyn = 60HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.05 mg/mL
3. 1 session: n.r.
4. Total session and dosage: n.r.		n.r.1. VAS for back pain
2. Symptom change (back pain)
3. SLR test		1. Improved
2. Improved
3. Improved
Kim (2008) [51]RCTn = 19Patients with lower back pain1. Form: injection
2. Concentration: 0.1 mg/mL
3. 1 session: 0.5 mL (1 and 2 visit), 0.7 mL(3 and 4 visit)
4. Total 4 sessions: 2.4 mL		Itching in 0.85 ± 1.72 cases1. VAS for back pain
2. ODI for back pain		1. Positive c
2. Positive c
Kwon (2008) [52]Retrospective studyn = 13HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.5 mg/mL
3. 1 session: 0.2 mL
4. Total 12 sessions: 2.4 mL		Itching in 8 cases1. VAS for back pain
2. RMDQ		1. Positive a
2. Positive a
Youn (2008) [53]Retrospective studyn = 20HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.125 mg/mL
3. 1 session: 1 mL
4. Total 7 sessions: 7 mL		n.r.1. VAS for back pain
2. ODI for back pain
3. Quality of life (SF-36)		1. Positive a
2. Positive b
3. Positive b
Youn (2008) [54]Retrospective studyn = 36HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.125 mg/mL
3. 1 session: 1 mL
4. Total 8 sessions: 8 mL		n.r.1. VAS for back pain
2. ODI for back pain
3. Quality of life (SF-36)		1. Positive a
2. Positive a
3. Positive a
Cho (2008) [55]Case studiesn = 1Baastrup’s disease patient with back pain1. Form: injection
2. Concentration: 0.125 mg/mL
3. 1 session: 1 mL
4. Total 34 sessions: 34 mL		n.r.1. VAS for back pain
2. ODI for back pain		1. Improved
2. Improved
Jeong (2008) [56]Case studiesn = 16Lumbar spinal stenosis patients with back pain1. Form: injection
2. Concentration: 0.2 mg/mL or 0.5 mg/mL
3. 1 session: 0.8–1.0 mL
4. Total session and dosage: n.r.		n.r.1. VAS for back pain
2. ODI for back pain
3. Symptom change (back pain)		1. Improved
2. Improved
3. Improved
Kim (2008) [57]CCTn = 33Lumbar hyperlordosis patient with back pain1. Form: injection
2. Concentration: 0.16 mg/mL
3. 1 session: n.r.
4. Total session and dosage: n.r.		n.r.1. VAS for back pain
2. ODI for back pain
3. L-spine X-ray (degree of hyperlordosis)		1. Improved
2. Improved
3. Improved
Kwon (2009) [58]Retrospective studyn = 35HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.125 mg/mL
3. 1 session: 1 mL
4. Total 24 sessions: 24 mL		n.r.1. VAS for back pain
2. ODI for back pain
3. L-spine CT (degree of HIVD)		1. Positive a
2. Positive a
3. Improved
Yu (2009) [59]Case studiesn = 1Failed back surgery syndrome patient with back pain1. Form: injection
2. Concentration: 0.3 mg/mL or 0.5 mg/mL
3. 1 session: 0.02–0.5 mL
4. Total 9 sessions: 2.5 mL		Local redness, itching, and edema in 1 case1. VAS for back pain
2. Symptom change (back pain)		1. Improved
2. Improved
Lee (2010) [60]Case studiesn = 3Failed back surgery syndrome patient with back pain1. Form: injection
2. Concentration: 0.125 mg/mL or 0.25 mg/mL
3. 1 session: 0.2–1 mL
4. Total 18–34 sessions: 3.6–34 mL		n.r.1. NRS for back pain
2. Physical examination		1. Improved
2. Improved
Lee (2011) [61]RCTn = 34Car accident patients with lower back pain1. Form: injection
2. Concentration: 0.05 mg/mL or 0.1 mL/mL
3. 1 session: 0.2–1.0 mL
4. Total 8 sessions: 1.6–8.0 mL		n.r.1. VAS for back pain
2. ODI for back pain		1. Positive b
2. Positive a
Lim (2011) [62]Case studiesn = 1Failed back surgery syndrome patient with back pain1. Form: injection
2. Concentration: 0.01 mg/mL or 0.25 mg/mL
3. 1 session: 0.6 mL
4. Total 11–13 sessions: 6.6–7.8 mL		n.r.1. VAS for back pain
2. ODI for back pain
3. SF-MPQ		1. Improved
2. Improved
3. Improved
Shin (2011) [63]CCTn = 36Back sprain patients with back pain1. Form: injection
2. Concentration: 0.1 mg/mL
3. 1 session: 0.1 mL
4. Total 8–13 sessions: 0.8–25 mL		n.r.1. VAS for back pain1. Positive c
Han (2011) [64]Case studiesn = 119Lumbar spinal stenosis patients with back pain1. Form: injection
2. Concentration: 0.13 mg/mL or 0.25 mg/mL
3. 1 session: 0.8–1.0 mL
4. Total session and dosage: n.r.		n.r.1. NRS for back pain
2. ODI for back pain
3. Symptom change (back pain)		1. Improved
2. Improved
3. Improved
Shin(2011) [65]RCTn = 34HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.1 mg/mL or 0.25 mg/mL
3. 1 session: 0.2–1.0 mL
4. Total session and dosage: n.r.		n.r.1. VAS for back pain
2. Aberdeen LBP scale		1. Improved
2. Improved
Cho (2011) [66]Case studiesn = 30Failed back surgery syndrome patient with back pain1. Form: injection
2. Concentration: 0.05 mg/mL, 0.1 mg/mL or 0.5 mg/mL
3. 1 session: 0.4–1.0 mL
4. Total session and dosage: n.r.		n.r.1. NRS for back pain
2. Symptom change
3. SLR test		1. Improved
2. Improved
3. Improved
Ro (2012) [67]RCTn = 30Spondylolisthesis patients with back pain1. Form: injection
2. Concentration: 0.1 mg/mL
3. 1 session: 0.2–1.0 mL
4. Total 14 sessions: 2.8–14 mL 		n.r.1. NRS for back pain
2. ODI for back pain		1. Positive c
2. Positive c
Kim (2012) [68]CCTn = 20Car accident patients with lower back pain1. Form: injection
2. Concentration: 0.1 mg/mL
3. 1 session: 1.0 mL
4. Total 8 sessions: 8.0 mL		n.r.1. VAS for back pain
2. Patient condition grade
3. Five-point Likert scale		1. Improved
2. Improved
3. Improved
Yeon (2012) [69]Case studiesn = 2Patients with lower back pain1. Form: injection
2. Concentration: 0.05 mg/mL
3. 1 session: 0.3 mL
4. Total 1 session: 0.3 mL		n.r.1. VAS for back pain
2. L-spine ROM
3. SLR test		1. Improved
2. Improved
3. Improved
Jung (2013) [70]Retrospective studyn = 208HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.1 mg/mL
3. 1 session: 1 mL
4. Total 8–32 sessions: 8–32 mL		n.r.1. NRS for back pain
2. ODI for back pain
3. SLR test
4. L-spine ROM		1. Positive c
2. Positive c
3. Positive c
4. Positive c
Ji (2013) [71]Case studiesn = 1Lumbar spinal stenosis patients with back pain1. Form: injection
2. Concentration: 0.1 mg/mL
3. 1 session: 0.8 mL
4. Total 18 sessions: 14.4 mL		n.r.1. VAS for back pain
2. Start time of claudication
3. DITI of back		1. Improved
2. Improved
3. Improved
Park (2013) [72]Retrospective studyn = 10HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.1 mg/mL
3. 1 session: 1 mL
4. Total session and dosage: n.r.		n.r.1. VAS for back pain
2. PRS for back pain
3. ODI for back pain
4. DITI of back		1. Improved
2. Improved
3. Improved
4. Improved
Lee (2014) [73]Retrospective studyn = 62Patients with lower back pain1. Form: injection
2. Concentration: 0.05 mg/mL
3. 1 session: 0.1–0.6 mL
4. Total 6 sessions: 0.6–2.1 mL		Skin hypersensitivity (edema, rash, and itching) in 22 cases1. VAS for back pain
2. ODI for back pain		1. Positive a
2. Positive c
Kim(2014) [74]Case studiesn = 1Cauda equina syndrome patient with back pain1. Form: injection
2. Concentration: 0.1 mg/mL
3. 1 session: 0.5–2.0 mL
4. Total 18 sessions: 9–36 mL 		n.r.1. Symptom change (back pain)
2. L-spine MRI (cauda equine syndrome)		1. Improved
2. Improved
Kim (2014) [75]Case studiesn = 1HIVD of L-spine and femoroacetabular impingement patient with back pain1. Form: injection
2. Concentration: 0.1 mg/mL
3. 1 session: 0.1–0.3 mL
4. Total 35 sessions: 3.5–10.5 mL		n.r.1. NRS for back pain
2. ODI for back pain
3. SLR test
4. Quality of life (EQ-5D)		1. Improved
2. Improved
3. Improved
4. Improved
Kwon (2014) [76]Case studiesn = 1HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.1 mg/mL
3. 1 session: 0.7 mL
4. Total 7 sessions: 4.9 mL		n.r.1. VAS for back pain
2. ODI for back pain
3. L-spine MRI (degree of HIVD)		1. Improved
2. Improved
3. Improved
Ji (2015) [77]Case studiesn = 1Back pain patient after decompression of traumatic compartment syndrome1. Form: injection
2. Concentration: 0.05 mg/mL
3. 1 session: 0.4 mL
4. Total 63 sessions: 25.2 mL		n.r.1. VAS for back pain
2. L-spine ROM		1. Improved
2. Improved
3. Improved
Yang (2015) [78]Case studiesn = 1HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.1 mg/mL
3. 1 session: n.r.
4. Total session and dosage: n.r.		None1. VAS for back pain
2. ODI for back pain		1. Improved
2. Improved
Kim (2016) [79]Retrospective studyn = 40Patients with lower back pain1. Form: injection
2. Concentration: n.r.
3. 1 session: 0.5 mL
4. Total 8 sessions: 4.0 mL		n.r.1. VAS for back pain
2. ODI for back pain		1. Positive a
2. Positive a
Ok (2017) [80]Case studiesn = 2HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: n.r.
3. 1 session: 1.5 mL
4. Total 12–16 sessions: 18–24 mL		n.r.1. NRS for back pain
2. SLR test
3. RMDQ		1. Improved
2. Improved
3. Improved
Nam (2017) [81]Case studiesn = 4HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.05 mg/mL
3. 1 session: 1 mL
4. Total 2–8 sessions: 2–8 mL		n.r.1. VAS for back pain
2. ODI for back pain		1. Improved
2. Improved
Hwang (2018) [82]Case studiesn = 2HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: 0.1 mg/mL
3. 1 session: 0.1–0.3 mL
4. Total 5–8 sessions: 0.5–2.4 mL 		Mild chilling, local rash, itching in 2 cases1. NRS for back pain
2. ODI for back pain
3. RMDQ		1. Improved
2. Improved
3. Improved
Ryu (2019) [83]Case studiesn = 1HIVD of L-spine patients with back pain1. Form: injection
2. Concentration: n.r.
3. 1 session: 0.2–1.5 mL
4. Total 16 sessions: 20.5 mL		n.r.1. NRS for back pain
2. ODI for back pain
3. L-spine MRI (degree of HIVD)
4. SLR test
5. Quality of life (EQ-5D)		1. Improved
2. Improved
3. Improved
4. Improved
5. Improved
Bong (2020) [84]Case studiesn = 3Patients with lower back pain1. Form: injection
2. Concentration: 0.1 mg/mL
3. 1 session: 1 mL
4. Total 8–9 sessions: 8–9 mL		None1. NRS for back pain
2. ODI for back pain
3. Quality of life (EQ-5D)		1. Improved
2. Improved
3. Improved
ap < 0.05; b p < 0.01; c p < 0.001. CT: computed tomography, DITI: digital infrared thermography imaging, EQ-5D: EuroQol 5-Dimensional, L-spine: lumbar spine, MRI: magnetic resonance imaging, NRS: numeral rating scale, ODI: Oswestry disability index, n.r.: not reported, PRS: pain relief scale, RMDQ: Roland–Morris disability questionnaire, ROM: range of motion, LBP: lower back pain, SF-36: 36-item short-form survey, SF-MPQ: short-form McGill pain questionnaire, SLR: straight leg raise, VAS: visual analogue scale.
Table
Table 2. Numbers of papers and patients according to medical condition.
Table 2. Numbers of papers and patients according to medical condition.
Medical ConditionsNumber of Papers
(N (%))		Number of Patients
(Mean)
HIVD of L-spine patients with back pain30 (47.7)22.17 ± 38.4
Back pain6 (9.2)37.7 ± 38.2
Failed back surgery syndrome patients with back pain5 (7.7)7.2 ± 12.8
Lumbar spinal stenosis patients with back pain4 (6.2)34.3 ± 56.9
Car accident patients with lower back pain2 (3.1)27 ± 9.9
Back sprain patients with back pain2 (3.1)33 ± 4.2
HIVD: herniated intervertebral disc.
Table
Table 3. Concentration and dosage of BV according to participants’ medical conditions.
Table 3. Concentration and dosage of BV according to participants’ medical conditions.
Conditions of ParticipantsConcentration
(mg/mL)		Dosage
Dosage Per 1 Session (mL)Dosage for Total Session (mL)
HIVD of L-spine patients with back pain0.01–5.00.02–2.00.3–40.0
Back pain0.05–0.50.03–1.00.51–5.1
Failed back surgery syndrome patients with back pain0.05–0.250.1–2.00.5–21
Lumbar spinal stenosis patients with back pain0.05–0.50.3–1.214.4
Car accident patients with lower back pain0.1–0.30.5–0.80.35–4.8
Back sprain patients with back pain0.050.97.2
HIVD: herniated intervertebral disc.
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MDPI and ACS Style

Sung, S.-H.; Han, J.-E.; Lee, H.-J.; Park, M.; Lee, J.-Y.; Jang, S.; Park, J.-K.; Lee, G. Clinical Studies of Bee Venom Acupuncture for Lower Back Pain in the Korean Literature. Toxins 2022, 14, 524. https://doi.org/10.3390/toxins14080524

AMA Style

Sung S-H, Han J-E, Lee H-J, Park M, Lee J-Y, Jang S, Park J-K, Lee G. Clinical Studies of Bee Venom Acupuncture for Lower Back Pain in the Korean Literature. Toxins. 2022; 14(8):524. https://doi.org/10.3390/toxins14080524

Chicago/Turabian Style

Sung, Soo-Hyun, Ji-Eun Han, Hee-Jung Lee, Minjung Park, Ji-Yeon Lee, Soobin Jang, Jang-Kyung Park, and Gihyun Lee. 2022. "Clinical Studies of Bee Venom Acupuncture for Lower Back Pain in the Korean Literature" Toxins 14, no. 8: 524. https://doi.org/10.3390/toxins14080524

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