Randomized Controlled Trials Of Acupuncture Research Articles

Analysis of the outcomes in treatment of ulcerative colitis with acupuncture and moxibustion

To clarify the key outcomes of acupuncture-moxibustion treatment of ulcerative colitis. The clinical randomized controlled trials (RCTs) for ulcerative colitis treated with acupuncture and moxibustion were searched from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science, from the inception of each database to March 20th, 2023. The basic information of literature, intervention measures and outcome indexes were collected. The selection of primary and secondary outcomes, the use frequency of each index and the combination of them in utility were analyzed; and index domains of acupuncture and moxibustion for ulcerative colitis were summarized. A total of 215 RCTs were included and 54 outcomes were involved, classified into 6 categories, i.e. TCM syndromes, symptoms/physical signs, physical and chemical tests, quality of life, long-term prognosis and safety events. The top 3 outcomes with high use frequency were clinical effect evaluation, adverse reactions of acupuncture and moxibustion and the score of main symptoms. Only 3 articles clearly reported the primary outcome and the secondary ones, 180 articles used two types of outcomes simultaneously, 3 articles clearly described the time points of the observation indexes, and 126 articles determined the sources of the evaluation criteria of therapeutic effect, with 57 criteria involved. At present, the outcomes have not been standardized in RCTs of acupuncture and moxibustion for ulcerative colitis. It needs to clarify the primary one and the secondary ones. The criteria have not been unified for the evaluation of therapeutic effects and there is less consideration on the quality of life in patients, the follow-up visit and safety events. The attention should be paid to develop the outcome set, in which, the endoscopic score is taken as the objective, and the improvements in the symptoms/physical signs and the biochemical examination as the supplementary.

The impact of blinding on estimated treatment effects in randomized clinical trials on acupuncture: A meta-epidemiological study.

To evaluate the sole impact of blinding patients and outcome assessors in acupuncture randomized controlled trials (RCTs) on treatment effects while considering the type of outcome measures. We searched databases for the meta-analyses on acupuncture with both blinded and non-blinded RCTs. Mixed-effects meta-regression models estimated the average ratio of odds ratios (ROR) and differences in standardized mean differences (dSMD) for non-blinded RCTs versus blinded mixed-effects meta-regression model. The study included 96 meta-analyses (1012 trials). The average ROR for lack of patient blinding was 1.08 (95% confidence intervals 0.79-1.49) in 18 meta-analyses with binary patient-reported outcomes. The average ROR for lack of outcome assessor blinding was 0.98 (0.77-1.24) in 43 meta-analyses with binary subjective outcomes. The average dSMD was -0.38 (-0.96 to 0.20) in 10 meta-analyses with continuous patient-reported outcomes. The average dSMD was -0.13 (-0.45 to 0.18) in 25 meta-analyses with continuous subjective outcomes. The results of the subgroup analysis were consistent with the primary analysis findings. Blinding of participants and outcome assessors does not significantly influence acupuncture treatment efficacy. It underscores the practical difficulties of blinding in acupuncture RCTs and the necessity to distinguish between trials with and without successful blinding to understand treatment expectations' effects. Enhancing blinding procedures' quality and assessment in future research is crucial for improving RCTs' internal validity and reliability.

Factors and Their Impact on Treatment Effect of Acupuncture in Different Outcomes: A Meta-Regression of Acupuncture Randomized Controlled Trials.

The effects of acupuncture have varied in different randomized controlled trials (RCTs), and there are many factors that influence treatment effect of acupuncture in different outcomes, with conflicting results. To identify factors and their impact on the treatment effect of acupuncture in different outcomes. Acupuncture RCTs were searched from 7 databases including Medline (PubMed), Embase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Database, VIP Database, and China Biology Medicine disc between January 1st, 2015 and December 31st, 2019. Eligible studies must compare acupuncture to no acupuncture, sham acupuncture, or waiting lists, and report at least 1 patient-important outcome. A multi-level meta-regression was conducted using a 3-level robust mixed model and univariate analyses were performed for all independent variables, even those excluded from the multivariable model due to collinearities. We used thresholds of 0.2 and 0.4 for the difference of standardized mean differences (SMDs), categorising them as small (<0.2), moderate (0.2-0.4), or large (>0.4) effects. The pain construct analysis involved 211 effect estimates from 153 studies and 14 independent variables. High-frequency acupuncture treatment sessions produced larger effects compared to low-frequency sessions [large magnitude, the difference of adjusted SMDs 0.46, 95% confidence interval (CI) 0.07 to 0.84; P=0.02]. The non-pain symptoms construct analysis comprised 323 effect estimates from 231 studies and 15 independent variables. Penetrating acupuncture showed moderately larger effects when compared to non-penetrating acupuncture (0.30, 95% CI 0.06 to 0.53; P=0.01). The function construct analysis included 495 effect estimates from 274 studies and 14 independent variables. Penetrating acupuncture and the flexible acupuncture regimen showed moderately larger effects, compared to non-penetrating acupuncture and fixed regimen, respectively (0.40, 95% CI 0 to 0.80; P=0.05; 0.29, 95% CI 0.06 to 0.53; P=0.01). High-frequency acupuncture sessions appear to be a more effective approach to managing painful symptoms. Penetrating acupuncture demonstrated greater effect in relieving non-painful symptoms. Both penetrating acupuncture type and flexible acupuncture regimen were linked to significant treatment effects in function outcomes. Future studies should consider the factors that are significantly associated with the effects of acupuncture in patient-important outcomes.

Using evidence-based research approach and exploratory studies before conducting a new acupuncture randomized controlled trial

Adequate preliminary research is a prerequisite for ensuring the quality of randomized controlled trials (RCTs) on acupuncture. This paper proposes that prior to conducting a new RCT of acupuncture, an evidence-based research (EBR) approach and exploratory studies should be adopted to ensure value and avoid waste of research. EBR, defined as using systematic reviews of relevant clinical studies and obtain the perspectives of end users in a systematic and transparent way to justify research questions and inform trial design, is recommended as the first step before embarking on an acupuncture RCT to ensure its value and rationality. The subsequent exploratory studies can aid researchers in pre-evaluating the effect of acupuncture treatment protocols, identifying key factors that influence the outcome, and test trial feasibility for protocol optimization. This article elucidates the significance and implementation of the EBR approach and exploratory studies, with the aim of providing practical methods to enhance the quality of acupuncture RCTs.

Systematic review of acupuncture to improve ovarian function in women with poor ovarian response.

To determine the effect of acupuncture in treating poor ovarian response (POR). We searched MEDLINE (via PubMed), EMBASE, Allied and Complementary Medicine Database, CNKI, CBM, VIP database, Wanfang Database, and relevant registration databases from inception to January 30, 2023. In this review, both Chinese and English peer-reviewed literature were included. Only randomized controlled trials (RCTs) using acupuncture as an intervention for POR patients undergoing in vitro fertilization were considered. Seven clinical randomized controlled trials (RCTs) were eventually included for comparison (516 women). The quality of included studies was generally low or very low. For the meta-analysis, seven studies showed that compared with controlled ovarian hyperstimulation (COH) therapy, acupuncture combined with COH therapy could significantly increase the implantation rate (RR=2.13, 95%CI [1.08, 4.21], p=0.03), the number of oocytes retrieved (MD=1.02, 95%CI [0.72, 1.32], p<0.00001), the thickness of endometrium (MD=0.54, 95%CI [0.13, 0.96], p=0.01), and the antral follicle count (MD=1.52, 95%CI [1.08, 1.95], p<0.00001), reduce follicle-stimulating hormone (FSH) levels (MD=-1.52, 95%CI [-2.41, -0.62], p=0.0009) and improve estradiol (E2) levels (MD=1667.80, 95%CI [1578.29, 1757.31], p<0.00001). Besides, there were significant differences in the duration of Gn (MD=0.47, 95%CI [-0.00, 0.94], p=0.05) between the two groups. However, no statistical variation was observed in improving clinical pregnancy rate (CPR), fertilization rate, high-quality embryo rate, luteinizing hormone (LH) value, anti-mullerian hormone (AMH) value, or reducing the dose of gonadotropin (Gn) values between the acupuncture plus COH therapy group and the COH therapy group. Acupuncture combined with COH therapy is doubtful in improving the pregnancy outcome of POR patients. Secondly, acupuncture can also improve the sex hormone level of POR women, and improve ovarian function. Furthermore, more RCTs of acupuncture in POR are needed to be incorporated into future meta-analyses. PROSPERO, identifier CRD42020169560.

Use of statistical methods among acupuncture randomized controlled trials was far from satisfactory

ObjectivesTo examine whether appropriate statistical methods were used in acupuncture randomized controlled trials (RCTs). Study Design and SettingWe searched PubMed to identify acupuncture RCTs with continuous outcome as primary outcome published in the core clinical journals and complementary and alternative medicine (CAM) journals between January 2010 and December 2019 (10 years). We compared statistical characteristics of included trials published in core clinical journals and CAM journals. ResultsWe included 262 RCTs, including 46 published in core clinical journals and 216 in CAM journals. Of included RCTs, only 132 (50.4%) clearly predefined the primary outcome, 72 (27.5%) specified the use of intention to treat or modified intention to treat population for primary analysis. In the 167 trials reported missing participant data (MPD), 118 (70.7%) used suboptimal methods (e.g., complete case analysis) for dealing with MPD; 11 (6.6%) conducted sensitivity analysis regarding MPD. Among the 161 trials with repeated measures design, only 21 (13.0%) used advanced statistical models (e.g., mixed-effects models) for handling repeated-measure data in the primary analysis. In the 72 trials involving multiple acupuncturists, only 4 (5.6%) adjusted acupuncturist variable or considered the clustering by acupuncturist in analysis. Trials in core clinical journals were more likely to predefine primary outcome (78.3% vs. 44.4%, P < 0.001), use multiple imputations for handling MPD (40% vs. 1.5%, P < 0.001), and use statistically advanced methods for assessing treatment effect at a single time point (26.1% vs. 2%, P = 0.001). ConclusionThe use of statistical methods among acupuncture RCTs is far from satisfactory. Our findings highlighted the need for researchers to carefully use the optimal statistical methods and for journal editors to strengthen the use of statistical methods.

Acupuncture as Neuromodulation: How It Can Explain Ancient and Modern Acupuncture Paradoxes

Though contemporary research meta-analyses and large randomized controlled trials of acupuncture demonstrate its efficacy and efficiency in pain and non-pain conditions, the lack of a defined mechanism for how needling an acupuncture point produces beneficial clinical effects has hindered acupuncture’s integration into allopathic medical practices. This paper provides a neuroanatomic model of acupuncture signaling that is consistent with acupuncture basic and clinical studies, and that may also potentially provide answers to 2000 year-old paradoxes contained in the Huangdi Neijing treatise.

Clinical Benefits of Acupuncture for the Reduction of Hormone Therapy–Related Side Effects in Breast Cancer Patients: A Systematic Review

Importance. Acupuncture can help reduce unpleasant side effects associated with endocrine therapy for breast cancer. Nevertheless, comprehensive evaluation of current evidence from randomized controlled trials(RCTs) is lacking. Objective. To estimate the efficacy of acupuncture for the reduction of hormone therapy-related side effects in breast cancer patients. Evidence review. RCTs of acupuncture in breast cancer patients that examined reductions in hormone therapy–related side effects were retrieved from PubMed, EMBASE, Web of Science, Ovid MEDLINE, and Cochrane Library databases through April 2016. The quality of the included studies was evaluated according to the 5.2 Cochrane Handbook standards, and CONSORT and STRICTA (Revised Standards for Reporting Interventions in Clinical Trials of Acupuncture) statements. Intervention. Interventions included conventional acupuncture treatment compared with no treatment, placebo, or conventional pharmaceutical medication. Major outcome measures were the alleviation of frequency and symptoms and the presence of hormone therapy–related side effects. Findings/Results. A total of 17 RCTs, including a total of 810 breast cancer patients were examined. The methodological quality of the trials was relatively rigorous in terms of randomization, blinding, and sources of bias. Compared with control therapies, the pooled results suggested that acupuncture had moderate effects in improving stiffness. No significant differences were observed in hot flashes, fatigue, pain, gastrointestinal symptoms, Kupperman index, general well-being, physical well-being, tumor necrosis factor (TNF), and interleukin (IL). Conclusions. Acupuncture therapy appears to be potentially useful in relieving functional stiffness. However, further large-sample trials with evidence-based design are still needed to confirm these findings.

Is acupuncture no more than a placebo? Extensive discussion required about possible bias.

Numerous randomized controlled trials (RCTs) of acupuncture have been conducted in recent years. The results of several studies implied that acupuncture was only a powerful placebo; however, certain studies demonstrated that verum acupuncture had a greater effect than placebo and the mechanisms between a verum acupuncture group and a placebo/sham group were different. Researchers attempted to investigate the inherent factors that may potentially influence the results of trials. Certain problems observed in acupuncture RCTs also occurred in RCTs in other fields, including insufficient sample size, high dropout rates, inadequate follow-up and randomization. The study of acupuncture is so complex that specific methodological challenges are raised, which are frequently overlooked, including sham interventions, blinding, powerful placebo effects (even stronger than an inert pill) and variations in acupuncture administration. The aforementioned problems may contribute to bias, and researchers systematically attempt to solve these problems. The present review aimed to suggest techniques to design high-quality studies, minimize the placebo effect and optimize acupuncture administration in acupuncture studies. If these problems are addressed, then the results of acupuncture studies may be different.

Blinding effect of non-penetrating sham needle in the randomized controlled trials of acupuncture: A systematic review

The aim of this article was to assess the clinical evidence for or against the blinding effect of non-penetrating sham needle as placebo needle. This systematic review included randomized controlled trials (RCTs) of acupuncture taking non-penetrating sham acupuncture as placebo needle. Systematic searches were conducted in 13 electronic databases up to July 2012: Medline, PubMed, the Cochrane Library, CINAHL, EMBASE, a Chinese medical database. All parallel or cross-over RCTs of acupuncture for the blinding effect of non-penetrating needle were chosen without language restrictions. Finally, totally 7 RCTs met the inclusion criteria. In conclusion, our systematic review and meta-analysis demonstrate that the non-penetrating needle is an effective instrument for placebo control in the acupuncture RCTs.

Adequate application of quantitative and qualitative statistic analytic methods in acupuncture clinical trials

Recently, proper use of the statistical methods in traditional Chinese medicine (TCM) randomized controlled trials (RCTs) has received increased attention. Statistical inference based on hypothesis testing is the foundation of clinical trials and evidence-based medicine. In this article, the authors described the methodological differences between literature published in Chinese and Western journals in the design and analysis of acupuncture RCTs and the application of basic statistical principles. In China, qualitative analysis method has been widely used in acupuncture and TCM clinical trials, while the between-group quantitative analysis methods on clinical symptom scores are commonly used in the West. The evidence for and against these analytical differences were discussed based on the data of RCTs assessing acupuncture for pain relief. The authors concluded that although both methods have their unique advantages, quantitative analysis should be used as the primary analysis while qualitative analysis can be a secondary criterion for analysis. The purpose of this paper is to inspire further discussion of such special issues in clinical research design and thus contribute to the increased scientific rigor of TCM research.

How to design the control group in randomized controlled trials of acupuncture?

In evidence-based medicine, randomized controlled trials (RCTs) are the preferred method for evaluating the efficacy of interventions. In regard to acupuncture RCTs, the most difficult issues are the design of the control group and implementation of the principle of “double-blinding.” We compared the advantages and limitations associated with different control group designs in acupuncture RCTs, to assist researchers in this field.

Review on efficacy and health services research studies of complementary and alternative medicine in inflammatory bowel disease

To assess the evidence of the use and efficacy for complementary and alternative medicine (CAM) in inflammatory bowel disease (IBD). A systematic literature search in MEDLINE was performed for randomized controlled trials (RCTs) in Crohn's disease and ulcerative colitis. Moreover, a selective literature search for health services research studies on the use of CAM in patients with IBD was performed. Health services research studies showed a high use of CAM in adult and pediatric patients with IBD worldwide. In contrast to the high use among IBD patients, there was a lack of high-quality data for many of the used CAM methods. Although most of the studies showed positive results, the methodological quality of most studies was rather low; therefore, the results had to be interpreted with caution. While there were many studies for probiotics and fish oil, RCTs for the highly used method homeopathy, for most herbal products, and for traditional Chinese medicine methods apart from acupuncture RCTs were completely lacking. The lack of high-quality studies might be the consequence of the problems: associated with the funding of clinical trials involving CAM. However, having the high user rates in mind, high-quality studies assessing efficacy and safety of those methods are urgently needed. Furthermore, there is a quality need for better representation of CAM in undergraduate and postgraduate medical education.

Critical review of 5 nonpharmacologic strategies for managing cancer pain: Sellick SM, Zaza C. Cancer prevention & Control 1998; 2: 7–14

Health care professionals at 2 Ontario cancer centres were surveyed to determine their familiarity with, perceptions of and interest in learning more about nonpharmacologic strategies for the management of cancer pain. Evidence-based education sessions were subsequently developed for the 5 strategies in which participants were most interested. This article presents the results of critical literature reviews concerning the effectiveness of the 5 strategies: acupuncture, massage therapy, hypnosis, therapeutic touch and biofeedback.The databases MEDLINE (1966 to June 1997), CINAHL (1982 to June 1997) and PsychoINFO Lit (1980 to June 1997) were searched systematically for randomized controlled trials (RCTs) of the 5 nonpharmacologic strategies. The authors' personal files and reference lists of relevant papers and main texts were also searched. The quality of the trials was reviewed according to established criteria.The search yielded 1 RCT of acupuncture, 1 of massage therapy and 6 of hypnosis. The studies of hypnosis suggested that there is much support for its use in the management of cancer pain. The evidence was either lacking or less clear for the other therapies examined.Because patients use a wide variety of nonpharmacologic strategies regardless of their effectiveness, clinicians need to be familiar with available research and able to discuss those strategies for which the evidence is strong, weak or nonexistent. More research on the effectiveness of nonpharmacologic strategies for pain management is needed.