Objective : To develop a sham needle, which is applicable to clinical trials on acupuncture and test its credibility.
Methods : The Park Sham Needle' unit was developed. The apparatus consists of a blunt needle, the shaft of which telescopes into the handle when tapped, so that while the needle appears to have been inserted, it does not actually pierce the skin, and a Park Tube' that is composed of a standard guide tube and an oversize guide tube with a plastic flange at one end which adheres to the skin with double-sided sticky tape. The needle is held in place by the Park Tube. In a credibility test, 56 subjects received our new sham needle on the left LI-4 acupoint and were asked whether or not they felt the needle being inserted into the skin.
Results : Forty-six subjects (82%) were convinced that they received real needle insertion.
Conclusion : Park Sham Needle seems to be applicable to randomised, subject-blinded, and controlled trials on acupuncture.

The efficacy of Traditional Chinese Medicine (TCM) is less well-established than many believe and needs to be more firmly established through clinical trials. Such studies should adhere to the currently accepted standards. When planning and conducting clinical trials, one encounters numerous logistical and methodological problems. The most important logistical obstacle is a lack of funds while the most important methodological issue is to transparently minimise bias. Despite these formidable problems, clinical trials of TCM are usually feasible and certainly necessary for testing the efficacy of TCM.
Clinical Trials as Topic ; methods ; Feasibility Studies ; Humans ; Medicine, Chinese Traditional ; methods

OBJECTIVECochrane reviews have the reputation for being more transparent and rigorous than other reviews. The aim of this overview was to evaluate and summarize Cochrane reviews of acupuncture for the treatment of any type of pain.

METHODSWe searched the Cochrane Database and evaluated the Cochrane reviews that were concerned specifically with the effectiveness of acupuncture for pain. Data were extracted according to pre-defined inclusion criteria by two independent reviewers.

RESULTSEight Cochrane reviews were included. They were all of high methodological quality. They related to a wide range of pain syndromes. Four reviews concluded that acupuncture is effective for migraines, neck disorders, tension-type headaches, and peripheral joint osteoarthritis; one review failed to demonstrate type the effectiveness of acupuncture for rheumatoid arthritis; and three reviews were inconclusive for shoulder pain, lateral elbow pain, and low back pain.

CONCLUSIONSeveral Cochrane reviews of acupuncture for a wide range of pain conditions have recently been published. All of these reviews were of high quality. Their results suggest that acupuncture is effective for some but not all types of pain.

Acupuncture Therapy ; utilization ; Humans ; Libraries, Medical ; standards ; statistics & numerical data ; Pain Management ; Review Literature as Topic

OBJECTIVETo assess the effectiveness of acupuncture as a treatment option for attention deficit hyperactivity disorder (ADHD).

METHODSThe literatures were searched using 15 databases, including MEDLINE, AMED, CINAHL, EMBASE, PsycInfo, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, six Korean medical databases and two Chinese databases without language restritions. Prospective controlled clinical studies of any type of acupuncture therapy for ADHD autistic patients were included. Trials in which acupuncture was part of a complex intervention were also included. All articles were read by two independent reviewers, who extracted data from the articles according to predefined criteria. Risk of bias was assessed using the Cochrane risk of bias tool.

RESULTSOf 114 articles, only three randomized clinical trials (RCTs) met our inclusion criteria. One RCT found that electroacupuncture (EA) plus behavioural treatment was superior to sham EA plus behavioural treatment. Two RCTs reported a significant benefit of acupuncture or auricular acupuncture over conventional drug therapies.

CONCLUSIONSLimited evidence exists for the effectiveness of acupuncture as a symptomatic treatment of ADHD. Given that the risk of bias of the included studies was high, firm conclusions cannot be drawn.

Acupuncture ; Attention Deficit Disorder with Hyperactivity ; therapy ; Humans ; Information Storage and Retrieval ; Treatment Outcome

OBJECTIVETai chi has been recommended for treating type 2 diabetes mellitus. The purpose of this systematic review was to evaluate evidence from controlled clinical trials testing the effectiveness of tai chi in treating type 2 diabetes mellitus.

METHODSSystematic searches were conducted on 14 electronic databases without restrictions on either population characteristics or language of publication. The outcome measures considered for inclusion were changes in fasting blood glucose (FBG), glycosylated haemoglobin A1c (HbA1c) and quality of life (QOL).

RESULTSEight randomised clinical trials (RCTs) and two controlled clinical trials (CCTs) met all inclusion criteria. Three RCTs from 1 trial compared the effects of tai chi with sham exercise and failed to show effectiveness of tai chi on FBG, HbA1c, or QOL. The other 3 RCTs tested the effects of tai chi compared with other types of exercise on FBG. The meta-analysis failed to show an FBG-lowering effect of tai chi [n=118, weighted mean difference (WMD): -0.14 mmol/L, 95% CI: -0.86 to 0.58, P=0.70]. Four studies (2 RCTs and 2 CCT) compared tai chi with no treatment or self-management programme and failed to report significant differences between the experimental and control groups except for QOL from 1 RCT and 1 CCT.

CONCLUSIONThe existing evidence does not suggest that tai chi is an effective therapy for type 2 diabetes. Currently, there are few high-quality trials on which to make definitive judgements.

Blood Glucose ; metabolism ; Clinical Trials as Topic ; Diabetes Mellitus, Type 2 ; blood ; therapy ; Fasting ; blood ; Humans ; Publication Bias ; Tai Ji ; Treatment Outcome

OBJECTIVERed ginseng (RG, Panax ginseng C.A. Meyer) is one of the widely used herbs for treating type 2 diabetes mellitus (DM). However, no systematic review of the effectiveness of RG for type 2 DM is available. This systematic review aimed to evaluate the current evidence for the effectiveness of RG in patients with type 2 DM.

METHODSElectronic searches of 14 electronic databases were conducted without language restrictions. All randomized clinical trials (RCTs) with RG as a treatment for type 2 DM were considered for inclusion. Their methodological quality was assessed using the Cochrane criteria.

RESULTSFour RCTs met our inclusion criteria. Their methodological quality was variable. Three of the RCTs compared the effectiveness of RG with placebo. The meta-analysis of these data failed to favor RG over placebo for fasting plasma glucose (FPG) [n =76, weighted mean difference (WMD): -0.43 mmol/L; 95% confidence interval (CI): -1.16 to 0.30, =0.25] and fasting plasma insulin (FPI) (n =76, WMD: -8.43 pmol/L; 95% CI: -19.54 to 2.68, P =0.14) for 12 weeks of treatment. One RCT compared the effects of RG with no treatment. The results did not suggest favorable effects of RG on FPG, hemoglobin A(1c) (HbA(1c)) or 2-h blood glucose after a meal (PP2h).

CONCLUSIONSThe evidence for the effectiveness of RG in controlling glucose in type 2 DM is not convincing. Few included studies with various treatment regimens prohibit definitive conclusions. More rigorous studies are needed to clarify the effects of RG on this condition.

Diabetes Mellitus, Type 2 ; drug therapy ; Humans ; Panax ; chemistry ; Phytotherapy ; Plant Extracts ; adverse effects ; therapeutic use ; Publication Bias ; Randomized Controlled Trials as Topic ; Risk Factors ; Treatment Outcome