A Guideline for Randomized Controlled Trials of Acupuncture.

Guidelines for clinical trials of acupuncture are scarce, particularly in their guidance on choosing an adequate control in an acupuncture trial. This guideline was developed to address the research methodology for clinical research in acupuncture which contains the essential elements to be considered in the design, preparation and reporting of an acupuncture RCT. Particularly, investigators focused on the control design because of the unique feature of acupuncture. As one size does not fit all, one single design cannot answer all research questions. Therefore, we recommend that the clinical questions be answered in different stages of trials by choosing the appropriate control or comparator. This concept is adapted from classical drug trials developed by the Food and Drug Administration (FDA) of USA in which trials are staged in four phages in order to address different research questions. From the points listed above, this guideline offers the specific recommendations in an acupuncture RCT.

Sinew acupuncture for knee osteoarthritis: study protocol for a randomized sham-controlled trial.

BACKGROUND: Sinew acupuncture is a new modality of acupuncture in which needles are inserted into acupoints, ashi points or spasm points of sinew and muscles along the meridian sinew pathway. A previous observational study revealed that sinew acupuncture has immediate analgesic effects on various soft tissue injuries, including knee injuries. However, no rigorous trials have been conducted. This study aims to examine whether sinew acupuncture can safely relieve pain and symptoms of knee osteoarthritis (KOA) and improve patients' functional movement and quality of life. METHODS/DESIGN: A randomized, sham-controlled, patient- and assessor-blinded trial will be conducted to compare the efficacy of sinew acupuncture and sham acupuncture. Subjects will be assessed by the physician and acupuncturists. A sample of eighty-six eligible subjects will be randomized into either the sinew acupuncture group or the sham acupuncture group. The intervention will be performed in the Hong Kong Tuberculosis Association Chinese Medicine Clinic cum Training Centre of the University of Hong Kong by acupuncturists with over 3 years of acupuncture experience. Subjects will receive 10 sessions of interventions for 4 weeks, followed by a 6-week follow-up. The visual analogue scale (VAS) score at week 4 will be the primary outcome. The Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed Up & Go Test (TUG), 8-step Stair Climb Test (SCT) and the 36-Item Short Form Survey (SF-36) will be secondary outcomes. DISCUSSION: Sinew acupuncture is a potential alternative non-pharmacological therapy for KOA. This rigorous trial will expand our knowledge of whether sinew acupuncture reduces pain intensity and improves symptoms, functional movements, and quality of life of KOA patients. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (Identifier: NCT03099317) in March 2017.

Efficacy of abdominal acupuncture for neck pain: A randomized controlled trial.

OBJECTIVE: This study aims to provide evidence regarding the clinical efficacy of abdominal acupuncture for neck pain. METHODS: This randomized, patient and assessor-blind, sham-controlled trial was conducted at a Chinese medicine center in Hong Kong between November 2014 and March 2016. A total of 154 eligible participants (age range, 18-65 years) with neck pain were randomly assigned to receive abdominal (n = 77) or non-penetrating sham abdominal (sham group; n = 77) acupuncture. Each participant was administered treatment over six sessions by Registered Chinese Medicine Practitioners, in accordance with a standardized protocol. The primary outcome was mean improvement in neck pain disability scores evaluated by the Northwick Park Neck Pain Questionnaire (NPQ). Secondary outcomes included intensity of neck pain and health-related quality-of-life measures. The outcomes were assessed at baseline and at 2 and 6 weeks from baseline. Patients in the abdominal acupuncture group received additional follow-up evaluation at 14 weeks from baseline. Outcomes were evaluated by intention-to-treat analysis. RESULTS: All participants provided informed consent for treatment and follow-up evaluation. Patients who received abdominal acupuncture exhibited greater improvement in NPQ scores than those who received sham treatment at both 2 and 6 weeks from baseline (intergroup mean differences, -5.75; 95% confidence interval [CI], -9.48 to -2.03; P = 0.008 and -8.65; 95% CI, -12.13 to -5.16; P < 0.001, respectively). The improvement in NPQ scores in the abdominal acupuncture group was even more significant at 14 weeks from baseline. Patients in the abdominal acupuncture group also exhibited significantly greater improvements in intensity of neck pain and a few quality-of-life measures than those in the sham abdominal acupuncture group, without any serious adverse events. CONCLUSION: These findings suggest that abdominal acupuncture is an effective alternative treatment for neck pain. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-TRC-14004932.

Types of Control in Acupuncture Clinical Trials Might Affect the Conclusion of the Trials: A Review of Acupuncture on Pain Management.

Analgesic effects of acupuncture have been extensively studied in various clinical trials. However, the conclusion remains controversial, even among large scale randomized controlled trials. This study aimed to evaluate the association between the conclusion of the trials and the types of control used in those trials via systematic review. Published randomized controlled trials of acupuncture for pain were retrieved from electronic databases (Medline, AMED, Cochrane libraries, EMBASE, PsycINFO, Clinicaltrials.gov, and CAB Abstracts) using a prespecified search strategy. One hundred and thirty-nine studies leading to 166 pairs of acupuncture-control treatment effect comparisons (26 studies comprised of 53 intervention-control pairs) were analyzed based on the proportion of positive conclusions in different control designs. We found that treatment effects of acupuncture compared with nontreatment controls had the highest tendency to yield a positive conclusion (84.3%), compared with nonneedle-insertion controls (53.3%). Whereas with needle-insertion controls, the lowest tendency of positive conclusions was observed (37.8%). Consistently, in studies reporting successful blinding, a higher tendency of positive findings on the treatment effect of acupuncture was found in the noninsertion sham controls compared with that in the insertion sham controls. We conclude that the type of control is likely to affect the conclusion in acupuncture analgesic trials. Appropriate control should be chosen according to the aims of studies.

Prescription of Chinese Herbal Medicine in Pattern-Based Traditional Chinese Medicine Treatment for Depression: A Systematic Review.

Traditional Chinese medicine (TCM) treatments are often prescribed based on individuals' pattern diagnoses. A systematic review of randomized controlled trials in Chinese and English literatures on TCM pattern-based treatment for depression has therefore been conducted. A total of 61 studies, 2504 subjects, and 27 TCM patterns were included. Due to the large variation of TCM pattern among participants, we only analyzed the top four commonly studied TCM patterns: liver qi depression, liver depression and spleen deficiency, dual deficiency of the heart, and spleen and liver depression and qi stagnation. We found that Xiaoyao decoction was the most frequently used herbal formula for the treatment of liver qi depression and liver depression with spleen deficiency, while Chaihu Shugan decoction was often used for liver depression and qi stagnation. Bai Shao (Paeonia lactiflora Pall.) and Chai Hu (Bupleurum chinense DC.) were commonly used across different TCM patterns regardless of the prescribed Chinese herbal formulas. The rationale underlying herb selection was seldom provided. Due to the limited number of studies on TCM pattern-based treatment of depression and their low methodological quality, we are unable to draw any conclusion regarding which herbal formulas have higher efficacy and which TCM patterns respond better to CHM.

Measuring body constitution: validation of the Body Constitution Questionnaire (BCQ) in Hong Kong.

BACKGROUND: The Body Constitution Questionnaire (BCQ) was developed in Taiwan to classify people into body constitution (BC) types based on Traditional Chinese Medicine (TCM) theories. Since the culture of Hong Kong is different from Taiwan, the BCQ must be validated before a wider application can be preceded. AIM AND OBJECTIVES: To adapt and validate the Hong Kong version of BCQ in Hong Kong Chinese population. METHODS: The content validity of BCQ was investigated by the cognitive debriefing with 10 patients and 10 Chinese Medicine Practitioners (CMP). A cross-sectional study of 1084 Chinese patients recruited from TCM and Western Medicine (WM) outpatient clinics to confirm the construct validity, reliability, sensitivity and responsiveness of BCQ. 225 of the patients were assessed after 2 weeks for the test-retest reliability. 404 subjects were followed up to evaluate the responsiveness after 3-6 months. RESULTS: Cognitive debriefing confirmed the content validity of the BCQ (HK version) with content validity index of all items ranged from 70 to 100%. 1084 out of 2128 patients (51%) completed the cross-sectional study. The construct validity was confirmed with scaling success rates that ranged from 87.5 to 89.5%, moderate correlations between with SF-12v2 scores, and 3-factors structure with confirmatory factor analysis. The reliability was confirmed by the Cronbach's alphas >0.8 and test-retest reliability (intra-class correlation coefficients >0.8). CONCLUSION: BCQ was adapted and validated on Hong Kong Chinese population. Patients with imbalanced BC types had lower health-related quality of life (HRQOL) than those with balanced BC types, which supported the validity and importance of the body constitution under the concept of TCM.

A systematic review on the efficacy, safety and types of Chinese herbal medicine for depression.

Chinese herbal medicine (CHM) is one of the commonly used complementary and alternative medicine therapies for major depressive disorder. The objective of this study was to review the efficacy, safety and types of CHM for depression. We systematically searched key databases (9 Chinese and 7 English) up until May 2013 for randomized controlled trials (RCTs) and examined 7 systematic reviews for additional articles. Methodological quality was assessed by modified Jadad scale and Cochrane's risk of bias assessment. Only studies with moderate methodological quality, defined as modified Jadad scale score ≥3, were included in meta-analysis for efficacy. Of the 296 RCTs that were assessed in details, 278 (93.9%) had modified Jadad scale score < 3, and only 21 scored ≥ 3. The frequently used formulas were Xiao Yao decoction, Chaihu Shugan decoction and Ganmai Dazao decoction; while Chaihu, Bai Shao and Fu Ling were the frequently used single herb. Meta-analyses showed that CHM monotherapy was better than placebo and as effective as antidepressants in reducing Hamilton Depression Rating Scale (HDRS) score (CHM vs. placebo: mean difference: -7.97, 95% CI: -10.25 to -5.70, P < 0.00001, 2 studies; CHM vs. antidepressants: mean difference: 0.01, 95% CI: -0.28 to 0.30, P = 0.95, 7 studies). CHM were associated with less adverse events than antidepressants, and adding CHM to antidepressants reduced adverse events. Despite the overall positive results, due to the small number of studies with sufficient methodological quality, it is premature to accurately conclude the benefits and risks of CHM for depression.

A meta-analysis of the efficacy and safety of traditional Chinese medicine formula Ganmai Dazao decoction for depression.

ETHNOPHARMACOLOGICAL RELEVANCE: Ganmai Dazao (GMDZ) decoction is a traditional Chinese herbal formula commonly used for the treatment of depression. The objective of this study was to assess the efficacy and safety of GMDZ, either alone or as co-therapy, for depression. MATERIALS AND METHODS: We systematically searched key databases (9 Chinese and 7 English) up until May 2013 for randomized controlled trials (RCTs). The primary outcomes were effective rate and self-rated or clinician-rated severity of depression. The secondary outcome was the occurrence of adverse events. Methodological quality of the RCTs was assessed by the Cochrane׳s risk of bias assessment. RESULTS: Ten RCTs were included. All were written in Chinese and the methodological quality was generally low. Pooled analysis of 5 studies which compared GMDZ with antidepressants showed that GMDZ was significantly more efficacious than antidepressants in effective rate (risk ratio: 1.14, 95% CI: 1.02 to 1.27, P=0.02, I(2)=0%), but comparable in Hamilton Depression Rating Scale (HDRS) score (mean difference: -2.10, 95% CI: -4.62 to -0.41, P=0.10, I(2)=92%). With regard to the other 5 studies which compared GMDZ plus antidepressants with antidepressants alone, there was no significant difference in effective rate (risk ratio: 1.24, 95% CI: 0.99 to 1.55, P=0.07, I(2)=93%), but the end-point HDRS score was significantly lower in GMDZ antidepressants combination (mean difference: -4.25, 95% CI: -6.50 to -2.00, P=0.0002, I(2)=96%). Adverse events were more common with antidepressants than GMDZ (rate ratio: 0.52, 95% CI: 0.32 to 0.82, P=0.005, I(2)=37%) and in antidepressants alone compared to GMDZ antidepressants combination (rate ratio: 0.23, 95% CI: 0.08 to 0.68, P=0.08, I(2)=0%). CONCLUSION: The overall results suggest that GMDZ has few side effects and the potential as an antidepressant. Adding GMDZ to antidepressants reduces side effects and enhances efficacy of antidepressants. However, due to the small number of studies and their limitations, further studies with better methodological quality and more comprehensive safety assessment are needed to determine the benefits and risks of GMDZ in the treatment of depression.

Prescription of chinese herbal medicine and selection of acupoints in pattern-based traditional chinese medicine treatment for insomnia: a systematic review.

Traditional Chinese medicine (TCM) treatments are often prescribed based on individuals' pattern diagnoses. A systematic review of Chinese and English literatures on TCM pattern differentiation, treatment principle, and pattern-based treatment for insomnia has therefore been conducted. A total of 227 studies, 17916 subjects, and 87 TCM patterns were analyzed. There was a limited consistency in pattern-based TCM treatment of insomnia across practitioners. Except for Gui Pi Tang, An Shen Ding Zhi Wan, and Wen Dan Tang which were used more commonly for deficiency of both the heart and spleen, internal disturbance of phlegm-heat, and qi deficiency of the heart and gallbladder, respectively, the selection of herbal formula for other patterns and pattern-based prescription of individual herbs and acupoints were not consistent. Suanzaoren (Semen Z. spinosae), Fuling (Poria), Yejiaoteng (Caulis P. multiflori), Gancao (Radix Glycyrrhizae), Baishao (Radix P. alba), Shenmen (HT7), Yintang (EX-HN3), Sanyinjiao (SP6), Baihui (GV20), Anmian (EX-HN22), and Sishencong (EX-HN1) were commonly used, but nonspecifically for many patterns. Treatment principles underlying herb and acupoint selection were seldom reported. Although many studies were reviewed, the study quality and diagnostic process were inadequate. More high quality studies are needed to examine the additional benefits of pattern differentiation and pattern-based TCM treatment.

Acupressure, reflexology, and auricular acupressure for insomnia: a systematic review of randomized controlled trials.

Previous randomized controlled trials (RCTs) have shown that acupuncture may be efficacious for insomnia. Instead of needling, acupressure, reflexology, and auricular acupressure are procedures involving physical pressure on acupoints or reflex areas. These variants of acupuncture are gaining popularity, perhaps due to their non-invasive nature. A systematic review has therefore been conducted to examine their efficacy and safety for insomnia. Two independent researchers searched five English and 10 Chinese databases from inception to May 2010. Forty RCTs were identified for analysis. Only 10 studies used sham controls, four used double-blind design, nine studies scored three or more by the Jadad scale, and all had at least one domain with high risk of bias. Meta-analyses of the moderate-quality RCTs found that acupressure as monotherapy fared marginally better than sham control. Studies that compared auricular acupressure and sham control showed equivocal results. It was also found that acupressure, reflexology, or auricular acupressure as monotherapy or combined with routine care was significantly more efficacious than routine care or no treatment. Owing to the methodological limitations of the studies and equivocal results, the current evidence does not allow a clear conclusion on the benefits of acupressure, reflexology, and auricular acupressure for insomnia.

Randomized non-invasive sham-controlled pilot trial of electroacupuncture for postpartum depression.

BACKGROUND: Postpartum depression affects 10-15% of mothers. Although acupuncture was efficacious for major depressive disorder in pregnancy and in women outside the perinatal period, there has been no randomized controlled study on the feasibility, tolerability, and efficacy of acupuncture for postpartum depression. METHODS: This was a randomized, subject- and assessor-blind, parallel-group, sham-controlled trial. Twenty women within six months postpartum with DSM-IV-diagnosed major depressive disorder of mild severity, defined as a 17-item Hamilton Depression Rating Scale (HDRS(17)) score of 12 to 19, were randomly assigned to either electroacupuncture or non-invasive sham acupuncture two sessions weekly for four weeks. RESULTS: There was significant reduction in HDRS(17) score from baseline to 4-week posttreatment in both groups, with an effect size 1.4 and 1.8 for electroacupuncture and sham acupuncture, respectively. Improvement was observed as early as two weeks after commencing acupuncture. The response and remission rate in the electroacupuncture group at 4-week posttreatment was 33% and 44%, respectively; for the sham acupuncture group, it was 60% and 50%, respectively. There was no significant between-group difference in all outcome measures, including the HDRS(17), Edinburgh Postnatal Depression Scale, Hospital Anxiety and Depression Scale, Clinical Global Impression, and Sheehan Disability Scale. Treatment credibility, success of blinding, and adverse events were similar between groups. LIMITATION: Small sample size and high attrition rate. No waiting list observation group. CONCLUSION: Both electroacupuncture and non-invasive sham acupuncture were effective for postpartum depression. Further studies utilizing larger sample size, better recruitment strategies, and home-based acupuncture treatment are warranted. CLINICAL TRIAL INFORMATION: Pilot Study on the Use of Acupuncture for Postpartum Depression; ClinicalTrials.gov Registration #NCT01178008; URL - http://clinicaltrials.gov/ct2/show/NCT01178008?term=postpartum+acupuncture&rank=1.

A systematic review of the effectiveness of qigong exercise in cardiac rehabilitation.

The objective of this study was to assess evidence for the efficacy and effectiveness of Chinese qigong exercise in rehabilitative programs among cardiac patients. Thirteen databases were searched through to November 2010, and all controlled clinical trials on Chinese qigong exercise among patients with chronic heart diseases were included. For each included study, data was extracted and validity was assessed. Study quality was evaluated and summarized using both the Jadad Scale and the criteria for levels of evidence. Seven randomized controlled trials (RCTs) and one non-randomized controlled clinical trial (CCT) published between 1988 and 2007 met the inclusion criteria. In total, these studies covered 540 patients with various chronic heart diseases including atrial fibrillation, coronary artery disease, myocardial infarct, valve replacement, and ischemic heart disease. Outcome measures emerged in these studies included subjective outcomes such as symptoms and quality of life; and objective outcomes such as blood pressure, ECG findings, and exercise capacity, physical activity, balance, co-ordination, heart rate, and oxygen uptake. Overall, these studies suggest that Chinese qigong exercise seems to be an optimal option for patients with chronic heart diseases who were unable to engage in other forms of physical activity; however, its efficacy and effectiveness in cardiac rehabilitation programs should be further tested.

Chinese herbal medicine for insomnia: a systematic review of randomized controlled trials.

Chinese herbal medicine (CHM), either in single herb or in herbal formula, has been used to treat insomnia for more than 2000 years. A systematic review including Chinese and English literature of randomized controlled trials was conducted to examine the efficacy, safety, and composition of CHM for insomnia. Among the 217 studies we have reviewed, only eight had a Jadad score ≥3, and seven out of these eight studies had at least one domain with high risks of bias. Meta-analyses of the studies with Jadad score ≥3 found that CHM was similar to Western medication (three studies) and placebo (three studies) in treating insomnia. Due to the poor methodological quality of the studies and the small number of trials included in meta-analyses, the current evidence is insufficient to support the efficacy of CHM for insomnia. The frequency of adverse events associated with CHM was similar to that of placebo, but lower than with Western medication. Gui Pi Tang was the most commonly used standardized formula, while Suan Zao Ren (Ziziphus jujuba) was the most frequently used single herb. Further studies with a double-blind placebo-controlled design are needed to accurately determine the benefits and risks of CHM for insomnia.