- Volume 24 Issue 4
Reporting of Adverse Events in Randomized Controlled Trials of Bee Venom Acupuncture: A Systematic Review
봉침을 이용한 무작위배정 비교임상시험연구에서의 유해사례 보고에 대한 체계적 문헌고찰
- Yi, Woon-Sup ;
- Kim, Sung-Soo
- 이운섭 ;
- Received : 2014.09.25
- Accepted : 2014.10.15
- Published : 2014.10.31
Objectives Bee venom acupuncture (BVA) is emerging as a potential therapeutic option for several conditions. However, evidence regarding accurate estimates of its adverse events are not available. Therefore, by combining occurrence rates of adverse events in relevant randomized controlled trials (RCTs), we have aimed to give an overall estimated rate of each adverse event following BVA intervention. Methods A systematic search for adverse events of BVA in Pubmed, Cochrane Central Register of Controlled Trials, Embase, NDSL, KoreaMed, KISS, RISS, KISTI, and KMbase was performed. For the quality assessment of the trials, we applied the CONSORT harms reporting recommendations. The overall occurrence rate of each adverse event was assessed as the primary outcome. The overall drop-out rate due to adverse events was assessed as the secondary outcome. Results Ten RCTs reported adverse events following BVA. Two RCTs were eligible of further synthesis. Adverse events of pruritus, localized edema, and erythema occurred significantly more frequently in the BVA group compared to the control group. Data of drop-outs were available in seven RCTs. However, no comparisons showed a significant difference. Conclusions Currently evidence of adverse events is far from sufficient for assessing a reliable, precise occurrence rate. Still, limited evidence shows a tendency that adverse events occur more frequently after the appliance of BVA compared to the control. Thus, we await well designed future studies of BVA with more proper and strict harms reporting methods.
Bee venom acupuncture;Adverse events;Systematic review;Randomized controlled trials
- World Health Organization Regional Office for the Western Pacific (WPRO). WHO International Standard Terminologies on Traditional Medicine in the Western Pacific Region. Manila, Philippines: WPRO; 2007. Available from: http://www.wpro.who.int/publications/who_ istrm_ file. pdf.
- Lee JD, Park HJ, Chae Y, Lim S. An Overview of Bee Venom Acupuncture in the Treatment of Arthritis. Evidence- based complementary and alternative medicine : eCAM. 2005;2(1):79-84. https://doi.org/10.1093/ecam/neh070
- Son DJ, Lee JW, Lee YH, Song HS, Lee CK, Hong JT. Therapeutic application of anti-arthritis, pain-releasing, and anti-cancer effects of bee venom and its constituent compounds. Pharmacology & therapeutics. 2007;115(2):246-70. https://doi.org/10.1016/j.pharmthera.2007.04.004
- Shin BC, Kong JC, Park TY, Yang CY, Kang KW, Choi SM. Bee venom acupuncture for chronic low back pain: A randomised, sham-controlled, triple-blind clinical trial. European journal of integrative medicine. 2012;4(3):e271-e80. https://doi.org/10.1016/j.eujim.2012.02.005
- Koh PS, Seo BK, Cho NS, Park HS, Park DS, Baek YH. Clinical effectiveness of bee venom acupuncture and physiotherapy in the treatment of adhesive capsulitis: a randomized controlled trial. J Shoulder Elbow Surg. 2013;22(8):1053-62. https://doi.org/10.1016/j.jse.2012.10.045
- Orsolic N. Bee venom in cancer therapy. Cancer metastasis reviews. 2012;31(1-2):173-94. https://doi.org/10.1007/s10555-011-9339-3
- Han CH, Lee YS, Kwon OM, Lee YJ. The Review on the Study of Bee Venom in the Journals of Korean Medicine. Korean journal of acupuncture. 2013;30(1):27-36.
- Loke YK, Price D, Herxheimer A. Systematic reviews of adverse effects: framework for a structured approach. BMC medical research methodology. 2007;7:32. https://doi.org/10.1186/1471-2288-7-32
- Chen J, Lariviere WR. The nociceptive and anti-nociceptive effects of bee venom injection and therapy: a double- edged sword. Progress in neurobiology. 2010;92(2):151-83. https://doi.org/10.1016/j.pneurobio.2010.06.006
- Park JY, Kim SY, Chae YB, Chae H, Koo ST, Kim ST, et al. Systematic Review of Adverse Events Related to Acupuncture and Moxibustion in Korea. Journal of Korean Oriental Medicine. 2010;31(2):78-90.
- Centre for Reviews and Dissemination (CRD). Systematic Reviews: CRD's guidance for undertaking systematic reviews in health care. York: Centre for Reviews and Dissemination, University of York; 2009. Available from: www.york.ac.uk/inst/crd/pdf/Systematic_Reviews.pdf.
- National Cancer Institute. Common terminology criteria for adverse events (CTCAE) 2010. Available from: http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf.
- National Evidence-based Healthcare Collaborating Agency (NECA). NECA's guidance for undertaking systematic reviews and meta-analyses for intervention. Seoul: National Evidence-based Healthcare Collaborating Agency; 2013.
- Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141(10):781-8. https://doi.org/10.7326/0003-4819-141-10-200411160-00009
- Hartling L, Bond K, Santaguida PL, Viswanathan M, Dryden DM. Testing a tool for the classification of study designs in systematic reviews of interventions and exposures showed moderate reliability and low accuracy. Journal of clinical epidemiology. 2011;64(8):861-71. https://doi.org/10.1016/j.jclinepi.2011.01.010
- Loke YK, Price D, Herxheimer A. Chapter 14: Adverse effects. In: Higgins JPT, Green S (editors), Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
- Smith SM, Chang RD, Pereira A, Shah N, Gilron I, Katz NP, et al. Adherence to CONSORT harms-reporting recommendations in publications of recent analgesic clinical trials: an ACTTION systematic review. Pain. 2012;153(12):2415-21. https://doi.org/10.1016/j.pain.2012.08.009
- Mueller UR. Insect sting allergy. Stuttgart, New York: Gustav Fischer Verlag; 1990.
- Mueller HL. Diagnosis and treatment of insect sensitivity. J Asthma Res. 1966;3:331-3. https://doi.org/10.3109/02770906609106941
- Ko CN, Min IK, Park SW, Jung WS, Moon SK, Park JM, et al. Effectiveness of Bee Venom Acupuncture on Shoulder Pain after Stroke. Journal of Korean Oriental Medicine. 2007;28(1):11-24.
- Cho SY, Park JY, Jung WS, Moon SK, Park JM, Ko CN, et al. Bee venom acupuncture point injection for central post stroke pain: a preliminary single-blind randomized controlled trial. Complementary therapies in medicine. 2013;21(3):155-7. Epub 2013/05/07. https://doi.org/10.1016/j.ctim.2013.02.001
- Cho SY, Shim SR, Rhee HY, Park HJ, Jung WS, Moon SK, et al. Effectiveness of acupuncture and bee venom acupuncture in idiopathic Parkinson's disease. Parkinsonism & related disorders. 2012;18(8):948-52. https://doi.org/10.1016/j.parkreldis.2012.04.030
- Kim HB, Lee RM, Ho LM, Choi YS, Kim JI, Lee YH, et al. The effects of 'Intramuscular Bee Venom Herbal Acupuncture' and 'Intracutaneous Bee Venom Herbal Acupuncture' in Knee Osteoarthritis Patients. The journal of Korean Acupuncture & Moxibustion Society. 2008;25(2):151-64.
- Kim S-C, Na W-M, Lee S-Y, Jang E-H, Lim S-I. A Study on Pain relief effects and Allergic responses for the Osteoarthritis of the knee joint Between Sweet Bee Venom and Bee Venom Pharmacopuncture. Journal of Korean pharmacopuncture institute. 2008;11(1):31-40. https://doi.org/10.3831/KPI.2008.11.1.031
- Wesselius T, Heersema DJ, Mostert JP, Heerings M, Admiraal-Behloul F, Talebian A, et al. A randomized crossover study of bee sting therapy for multiple sclerosis. Neurology. 2005;65(11):1764-8. https://doi.org/10.1212/01.wnl.0000184442.02551.4b
- Song HS. The Effect of Bee Venom Acupuncture(BVA) on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study. Journal of Korean pharmacopuncture institute. 2005;8(2):11-6.
- Lee SH, Hong SJ, Kim SY, Yang HI, Lee JD, Choe DY, et al. Randomized Controlled Double Blind Study of Bee Venom Therapy on Rheumatoid Arthritis. The journal of Korean Acupuncture & Moxibustion Society. 2003;20(6):80-8.
- Won CH, Choi ES, Hong SS. Efficacy of Bee Venom Injection for Osteoarthritis Patients. The Journal of the Korean Rheumatism Association. 1999;6(3):218-26.
- Choi SH, Cha BC, Kwon KR. Component Analysis of Sweet BV and Clinical Trial on Antibody Titer and Allergic Reactions. Journal of Pharmacopuncture. 2006;9(2):79-86.
- Bagul NB, Kirkham JJ. The reporting of harms in randomized controlled trials of hypertension using the CONSORT criteria for harm reporting. Clin Exp Hypertens. 2012;34(8):548-54. https://doi.org/10.3109/10641963.2012.681724
- Shukralla AA, Tudur-Smith C, Powell GA, Williamson PR, Marson AG. Reporting of adverse events in randomised controlled trials of antiepileptic drugs using the CONSORT criteria for reporting harms. Epilepsy research. 2011;97(1-2):20-9. https://doi.org/10.1016/j.eplepsyres.2011.06.015
- Puhan MA, Singh S, Weiss CO, Varadhan R, Boyd CM. A framework for organizing and selecting quantitative approaches for benefit-harm assessment. BMC Med Res Methodol. 2012;12:173. https://doi.org/10.1186/1471-2288-12-173
- Schroll JB, Maund E, Gotzsche PC. Challenges in coding adverse events in clinical trials: a systematic review. PLoS One. 2012;7(7):e41174. https://doi.org/10.1371/journal.pone.0041174
- Jung JW, Jeon EJ, Kim JW, Choi JC, Shin JW, Kim JY, et al. A fatal case of intravascular coagulation after bee sting acupuncture. Allergy, asthma & immunology research. 2012;4(2):107-9. https://doi.org/10.4168/aair.2012.4.2.107
- Kim CW, Lee YH, Lee KH. The case report of an Anaphylaxis occurred when using Sweet Bee Venom and common Bee Venom at the same time. Journal of pharmacopuncture. 2011;14(4):59-61. https://doi.org/10.3831/KPI.2011.14.4.059
- Kwon KR, Kang KS, Lee KH, Lim CS, Jeong HS, Kwon HY. Clinical observation of anaphylaxis after treated with Sweet BV. Journal of Korean pharmacopuncture institute. 2009;12(2):85-90. https://doi.org/10.3831/KPI.2009.12.2.085
- Song HJ, Suh YJ, Yang YM, Jung JW, Lee YM, Suh CH, et al. Two cases of anaphylaxis due to bee venom acupuncture. J Asthma Allergy Clin Immunol. 2002;22(2):481-6.
- Yang MS, Lee SH, Kim TW, Kwon JW, Lee SM, Kim SH, et al. Epidemiologic and clinical features of anaphylaxis in Korea. Ann Allergy Asthma Immunol 2008;100(1):31-6. https://doi.org/10.1016/S1081-1206(10)60401-2
- Park JS, Lee MJ, Chung KH, Ko DK, Chung H. Live bee acupuncture (Bong-Chim) dermatitis: dermatitis due to live bee acupuncture therapy in Korea. International journal of dermatology. 2013;52(12):1519-24. https://doi.org/10.1111/ijd.12161
- Shim WH, Park HJ, Kim HS, Chin HW, Kim SH, Ko HC, et al. Mybacterium chelonae Infection Occurring at the Site of Bee Sting Therapy. Korean journal of dermatology. 2011;49(4):374-8.
- Lee JS, Cho YS, Song KH, Hwang SR, Park J, Yun SK, et al. Foreign Body Granuloma Following Dried Honey Bee Venom (Apitoxin Inj) Injection. Korean J Dermatol. 2011;49(10):943-7.
- Bae EJ, Son SB, Seo SH, Son SW, Kim IH. A Case of Foreign Body Granuloma with Skin Necrosis Occurring after Bee Sting Therapy. Korean J Dermatol. 2009;47(3):350-3.
- Rhee DYL, H. W.; Chung, W. K.; Chang, S. E.; Lee, M. W.; Choi, J. H.; Moon, K. C.; Koh, J. K. Giant dermatofibroma with granular cell changes: side-effect of beevenom acupuncture? Clinical and experimental dermatology. 2009;34(5):e18-20. Epub 2009/06/03. https://doi.org/10.1111/j.1365-2230.2008.03149.x
- Lee MS, Pittler MH, Shin BC, Kong JC, Ernst E. Bee venom acupuncture for musculoskeletal pain: a review. J Pain. 2008;9(4):289-97. https://doi.org/10.1016/j.jpain.2007.11.012