Randomised clinical trials on acupuncture in the Korean literature: bibliometric analysis and methodological quality.

OBJECTIVE: Acupuncture systematic reviewers have increasingly searched Chinese databases and journals to identify eligible randomised clinical trials (RCTs). However, reviewers have infrequently searched for eligible RCTs in Korean databases and journals. This study aimed to identify difficult to locate acupuncture RCTs in Korean databases and journals and to assess the characteristics and quality of the identified RCTs. METHODS: Eleven electronic databases and seven journals were searched up to December 2012. All RCTs using needle acupuncture were considered for inclusion. Key study characteristics were extracted and risk of bias was assessed using the Cochrane Collaboration tool. RESULTS: One hundred and forty-three publications met our inclusion criteria. Acupuncture RCTs in the Korean literature emerged in the mid-1990s and increased in the mid-2000s. Diverse methods of acupuncture were used, including some methods unique to Korea (eg, Saam acupuncture). The largest proportion of trials evaluated acupuncture for musculoskeletal conditions (27.3%). The mean sample size was 44.3±25.3 per trial. Random sequence generation methods were reported in 44.8% of the RCTs, whereas only 11.9% reported methods of allocation concealment. A low proportion of trials reported participant blinding (32.9%) and outcome assessment blinding (18.9%). CONCLUSIONS: Korean acupuncture trials, many of which evaluate acupuncture styles unique to Korea, are typically omitted from systematic reviews of acupuncture, resulting in the potential for language bias. The development of this database of difficult to locate Korean trials, which includes English language translations of abstracts, will enable these trials of varying quality to be assessed for inclusion in future acupuncture systematic reviews.

Impact of including Korean randomized controlled trials in Cochrane reviews of acupuncture.

OBJECTIVE: Acupuncture is commonly practiced in Korea and is regularly evaluated in clinical trials. Although many Cochrane reviews of acupuncture include searches of both English and Chinese databases, there is no information on the value of searching Korean databases. This study aimed to investigate the impact of searching Korean databases and journals for trials eligible for inclusion in existing Cochrane acupuncture reviews. METHODS: We searched 12 Korean databases and seven Korean journals to identify randomised trials meeting the inclusion criteria for acupuncture reviews in the Cochrane Database of Systematic Reviews. We compared risk of bias assessments of the Korean trials with the trials included in the Cochrane acupuncture reviews. Where possible, we added data from the Korean trials to the existing meta-analyses in the relevant Cochrane review and conducted sensitivity analyses to test the robustness of the results. RESULTS: Sixteen Korean trials (742 participants) met the inclusion criteria for eight Cochrane acupuncture reviews (125 trials; 13,041 participants). Inclusion of the Korean trials provided data for 20% of existing meta-analyses (24 out of 120). Inclusion of the Korean trials did not change the direction of effect in any of the existing meta-analyses. The effect size and heterogeneity remained mostly unchanged. In only one meta-analysis did the significance change. Compared to the studies included in the Cochrane acupuncture reviews, the risk of bias in the Korean trials was higher in terms of outcome assessor blinding and allocation concealment. CONCLUSIONS: Many Korean studies contributed additional data to the existing meta-analyses in Cochrane acupuncture reviews. Although inclusion of these studies did not alter the results of the meta-analyses, comprehensive searches of the literature are important to avoid potential language bias. The identification and inclusion of eligible Korean trials should be considered for reviews of acupuncture.

Acupuncture for functional recovery after stroke: a systematic review of sham-controlled randomized clinical trials.

BACKGROUND: Acupuncture is frequently advocated as an adjunct treatment during stroke rehabilitation. The aim of this review was to assess its effectiveness in this setting. METHODS: We searched 25 databases and 12 major Korean traditional medicine journals from their inception to October 2009. We included randomized controlled trials, with no language restrictions, that compared the effects of acupuncture (with or without electrical stimulation) with sham acupuncture. We assessed the methodologic quality of the trials using the Cochrane risk-of-bias criteria and the PEDro (Physiotherapy Evidence Database) scale. RESULTS: Ten of 664 potentially relevant studies met our inclusion criteria. For acute and subacute stages after stroke, we included seven trials. A meta-analysis of the five studies that assessed functionality did not show a significant difference in favour of acupuncture, with high heterogeneity. A post-hoc sensitivity analysis of three trials with low risk of bias did not show beneficial effects of acupuncture on activities of daily living at the end of the intervention period (n = 244; standard mean difference 0.07, 95% confidence interval [CI] -0.18 to 0.32; I(2) = 0%) or after follow-up (n = 244; standard mean difference 0.10, 95% CI -0.15 to 0.35; I(2) = 0%). For the chronic stage after stroke, three trials tested effects of acupuncture on function according to the Modified Ashworth Scale; all failed to show favourable effects. INTERPRETATION: Our meta-analyses of data from rigorous randomized sham-controlled trials did not show a positive effect of acupuncture as a treatment for functional recovery after stroke.

Developing and validating a sham cupping device.

OBJECTIVES: The aims of this study were to develop a sham cupping device and to validate its use as a placebo control for healthy volunteers. METHODS: A sham cupping device was developed by establishing a small hole to reduce the negative pressure after suction such that inner pressure could not be maintained in the cup. We enrolled 34 healthy participants to evaluate the validity of the sham cupping device as a placebo control. The participants were informed that they would receive either real or sham cupping and were asked which treatment they thought they had received. Other sensations and adverse events related to cupping therapy were investigated. RESULTS: 17 patients received real cupping therapy and 17 received sham cupping. The two groups felt similar sensations. There was a tendency for subjects to feel that real cupping created a stronger sensation than sham cupping (48.9±21.4 vs 33.3±20.3 on a 100mm visual analogue scale). There were only mild to moderate adverse events observed in both groups. CONCLUSION: We developed a new sham cupping device that seems to provide a credible control for real cupping therapy by producing little or no negative pressure. This conclusion was supported by a pilot study, but more rigorous research is warranted regarding the use of this device.

Acupuncture for spinal cord injury survivors in Chinese literature: a systematic review.

OBJECTIVE(S): To systematically review Chinese literature on the effectiveness of acupuncture for treating patients with spinal cord injury (SCI). DATA SOURCES: The Chinese electronic databases (China National Knowledge Infrastructure) were searched from their inceptions to May 2008. STUDY SELECTION: Trials reporting randomized controlled trials (RCTs) where patients with SCI (with or without operation) were treated with acupuncture including electroacupuncture. DATA EXTRACTION: Methodological quality was assessed with the PEDro scale. Discrepancies were resolved through discussions and arbitration by two co-authors. RESULTS: The searches identified 236 potentially relevant studies, of which 7 RCTs met the inclusion criteria. Five studies assessed functional recovery, and two bladder dysfunction. All the studies reported favourable effects of acupuncture on functional recovery or urinary function; however methodological quality of studies is poor in general. Meanwhile, pooled analysis of two trials assessing bladder dysfunction showed positive effectiveness compared with conventional treatment (n = 128, RR 1.51 [1.21, 1.90], P = 0.0004, heterogeneity Tau(2) < 0.01, Chi(2) = 0.01, P = 0.94, I(2) = 0%). CONCLUSION(S): Based on 7 RCTs done in China, the effectiveness of acupuncture for functional recovery and bladder dysfunction in SCI is suggestive. With the methodological quality of the included studies on functional recovery and the small number of studies on bladder dysfunction taken into consideration, further rigorous studies prove needed.

Randomized clinical trials on acupuncture in korean literature: a systematic review.

The aim of this systematic review was to summarize randomized clinical trials (RCTs) assessing the effectiveness of acupuncture as published in Korean literature. Systematic searches were conducted on eight Korean medical databases. Manual searches were also conducted through eight major Korean medical journals. The methodological quality was assessed using a Jadad score. Studies evaluating needle acupuncture or auricular acupuncture (AA) with or without electrical stimulation were considered if they were sham or placebo-controlled or controlled against a comparative intervention. We also excluded acupuncture as an adjuvant to other treatments and other forms of acupuncture were excluded. Seven hundred and nine possibly relevant studies were identified and 10 RCTs were included. The methodological quality of the trials was generally poor. Manual acupuncture was compared to placebo acupuncture in four studies of patients with chronic low back pain, shoulder pain, premenstrual syndrome and allergic rhinitis. Three studies tested AA (two trials) and electroacupuncture (one trial) against no treatment, while three trials compared acupuncture with other active therapeutic controls. The methodological limitations of the included trials make their contribution to the current clinical evidence of acupuncture somewhat limited. The trial for premenstrual syndrome, shoulder pain and chronic low back pain added a limited contribution among those included RCTs. However, well-designed RCTs of acupuncture with a rigorous methodology are in progress or have been completed in Korea and will contribute to establish or contribute to the current progress of research in this field.

Effectiveness of acupuncture for Parkinson's disease: a systematic review.

The objective of this review is to assess the clinical evidence for or against acupuncture as a treatment for Parkinson's disease (PD). We searched the literature using 17 databases from their inception to September 2007 (searched again 3rd January 2008), without language restrictions. We included all randomized clinical trials (RCTs) regardless of their design. Methodological quality was assessed using the Jadad score. Eleven RCTs met all inclusion criteria. Three RCTs assessed the effectiveness of acupuncture on Unified Parkinson's Disease Rating Scale (UPDRS) compared with placebo acupuncture. A meta-analysis of these studies showed no significant effect (n = 96, WMD, 5.7; 95% CI -2.8 to 14.2, P = 0.19, heterogeneity: tau(2) = 0, chi(2) = 0.97, P = 0.62, I(2) = 0%). Another six RCTs compared acupuncture plus conventional drugs on improvement of symptoms of PD with drugs only. A meta-analysis of two of these studies suggested a positive effect of scalp acupuncture (n = 106, RR, 1.46, 95% CI = 1.15 to 1.87, P = 0.002; heterogeneity: tau(2) = 0.00, chi(2) = 1.14, P = 0.29, I(2) = 12%). Two further RCTs tested acupuncture versus no treatment. The meta-analysis of these studies also suggested beneficial effects of acupuncture. The results of the latter two types of RCTs fail to adequately control for nonspecific effects. In conclusion, the evidence for the effectiveness of acupuncture for treating PD is not convincing. The number and quality of trials as well as their total sample size are too low to draw any firm conclusion. Further rigorous trials are warranted.

Bee venom acupuncture for musculoskeletal pain: a review.

UNLABELLED: Bee venom (BV) acupuncture (BVA) involves injecting diluted BV into acupoints and is used for arthritis, pain, and rheumatoid diseases. The objective of this systematic review was to evaluate the evidence for the effectiveness of BVA in the treatment of musculoskeletal pain. Seventeen electronic databases were systematically searched up to September 2007 with no language restrictions. All randomized clinical trials (RCTs) of BVA for patients with musculoskeletal pain were considered for inclusion if they included placebo controls or were controlled against a comparator intervention. Methodology quality was assessed and, where possible, statistical pooling of data was performed. A total of 626 possibly relevant articles were identified, of which 11 RCTs met our inclusion criteria. Four RCTs that tested the effects of BVA plus classic acupuncture compared with saline injection plus classic acupuncture were included in the main meta-analysis. Pain was significantly lower with BVA plus classic acupuncture than with saline injection plus classic acupuncture (weighted mean difference: 100-mm visual analog scale, 14.0 mm, 95% CI = 9.5-18.6, P < .001, n = 112; heterogeneity: tau(2) = 0, chi(2) = 1.92, P = .59, I(2) = 0%). Our results provide suggestive evidence for the effectiveness of BVA in treating musculoskeletal pain. However, the total number of RCTs included in the analysis and the total sample size were too small to draw definitive conclusions. Future RCTs should assess larger patient samples for longer treatment periods and include appropriate controls. PERSPECTIVE: Bee venom acupuncture involves injecting diluted BV into acupoints and is used for arthritis, pain, and rheumatoid diseases. A meta-analysis produced suggestive evidence for the effectiveness of BVA in musculoskeletal pain management. However, primary data were scarce. Future RCTs should assess larger patient samples for longer treatment periods and include appropriate controls.