A Systematic Evaluation Of Clinical Evidence Of Acupoint - Injection Therapy

BackgroundAcupoint injection is a common practice in China which integrates Chinese medicine theory and acupuncture therapy for treatment of disease. It has been used in China for more than 60 years, but there is no evidence-based systematic evaluation of clinical research on this practice.ObjectivesWe aimed to understand and evaluate the overall clinical research evidence of acupoint injection for different conditions or diseases.We performed a systematic review to evaluate the beneficial effect and safety of acupoint injection compared with non-acupoint injection with the same medicine for chronic hepatitis B (CHB).Methods1. Clinical research evidence of acupoint injection:a systematic literature reviewWe included any clinical studies ranging from case reports to randomized trials on acupoint injection regardless of diseases/conditions from PubMed, Cochrane Library and four Chinese electronic databases till September 2013. We extracted and analyzed data on the type of injected medicine and type of diseases treated. The methodological quality of randomized trials was evaluated by the risk of bias tool of the Cochrane Collaboration, including random sequence generation, allocation concealment, blinding, incomplete outcome reporting, selective reporting and other sources of bias.2. Acupoint injection versus non-acupoint injection for chronic hepatitis B:a systematic review of randomised controlled trialsWe searched six English and Chinese electronic databases until October 2014 for randomised controlled trials (RCTs). Two authors independently selected trials and extracted data. Data were analyzed using RevMan 5.3 software. The methodological quality of randomized trials was evaluated by the risk of bias tool of the Cochrane Collaboration.Results1. Clinical research evidence of acupoint injection:a systematic literature review10007 clinical studies were identified published between 1957 and 2013, including 3472 randomized trials,988 non-randomized studies,5241 case series, and 472 case reports. The number of various types of clinical studies was increasing from 1957 to 2013. However, though the number of the case series soared from 1982, it had a decline since 2002, while the randomized trials increased significantly from 1990. The quality of randomized trials was generally poor in terms of risk of bias. The diseases in which acupoint injection was commonly employed included Diseases of the musculoskeletal system and connective tissue (1921,18.9%), Diseases of the nervous system (1414,13.9%), Diseases of the digestive system (1095,10.8%). In the studies, the injected medicines included western medicine (4182, 41.1%), Chinese herbal medicine (2219,21.8%), vitamin (991,9.7%), multi-type medicines (2353,23.1%), and other (318,3.1%) such as autologous blood, bee venom, and air.2. Acupoint injection versus non-acupoint injection for chronic hepatitis B:a systematic review of randomised trialsA total of 12 RCTs involving 1551 participants with CHB were identified. The methodological quality of the trials was poor. Six trials (50%) injected Chinese herbal medicine Ganyanling, Oxymatrine, Polyporusus Bellatus, or Huangqi injection, and the remaining six trials injected antiviral drugs (a-interferon, IL-2 or polyinosinic-polycytidylic acid (poly I:C)). The acupoints included Zusanli (ST36), Ganshu (BL18), Yanglingquan (GB34), Sanyinjiao (SP6), Pishu (BL20), etc. No trial compared acupoint injection with hypodermic injection, three trials compared acupoint injection with intramuscular injection, five trials compared acupoint injection with intramuscular injection on the basis of routine treatment, one trial compared acupoint injection with intravenous injection, and three trials compared acupoint injection with intravenous injection on the basis of routine treatment. None of the twelve trials reported outcomes of mortality, hepatitis B-related disease morbidity, and quality of life. For HB V-DNA, two trials found that acupoint injection was superior to intramuscular injection and one trial found that acupoint injection was similar to intramuscular injection. On the basis of routine treatment, two trials found that acupoint injection was similar to intramuscular injection, but the doses of acupoint injection were 1/2 of intramuscular injection. On the basis of conventional treatment, two trials found that acupoint injection was similar to intravenous injection, and the doses of acupoint injection were 1/3-1/2 of intravenous injection. Ten trials reported virological markers. Eleven trails reported biochemical variables, a meta-analysis showed acupoint injection of oxymatrine had beneficial effect on ALT level (U/L) (MD-20.10,95% CI-27.99 to -12.21; n=2). Three trials found that acupoint injection was significantly superior to IM in improving HBV-DNA, ALT and AST level. Six trials reported adverse effects, and no severe adverse effects were reported in acupoint injection groups.ConclusionsIn conclusion, there is a large quantity of clinical research of acupoint injection, involving all kinds of clinical study designs, a variety of diseases/conditions, various injection drugs, and we found that acupoint injection can be used alone or combined other interventions to treat disease. For the methodological quality of randomized controlled trial of acupoint injection, problems were identified including the inadequate report of generation of random sequences, the lack of randomization concealment, the lack of application and insufficient reporting of blinded, insufficient reporting of the incomplete data, selective reporting, the lack of inclusion criteria, exclusion criteria and diagnostic criteria, small sample size and the lack of sample size estimation, and low reporting rate of primary/secondary outcome and lack of safety outcome. Clinical researchers of acupoint injection should study knowledge of methodology, including clinical epidemiology, medical statistics, evidence-based medicine and other related courses, and enhance their scientific research ability to improve the quality of randomized controlled trial of acupoint injection.Acupoint injection applied alone or in combination with routine treatment appears to be effective and safe compared with IM for viral and biochemical response for CHB. However, owing to poor methodological quality of included trials, potential promising findings must be interpreted cautiously. Rigorous RCTs are warranted in the future.