Trials Of Acupuncture Research Articles

Comparing physicians\u2019 and patients\u2019 reporting on adverse reactions in randomized trials on acupuncture\u2014a secondary data analysis

BackgroundWe aimed to compare patients’ and physicians’ safety reporting using data from large acupuncture trials (44,818 patients) and to determine associations between patient characteristics and reporting of adverse reactions.MethodsSix pragmatic randomized trials with an additional non-randomized study arm that included those patients who refused randomization were evaluated. Patients received acupuncture treatment for osteoarthritis of the hip or knee, chronic neck pain, chronic low back pain, chronic headache, dysmenorrhea, or allergic rhinitis or asthma. Safety outcomes were evaluated by questionnaires from both the physicians and the patients. To determine level of agreement between physicians and patients on the prevalence of adverse reactions, Cohen’s kappa was used. With multilevel models associations between patient characteristics and reporting of adverse reactions were assessed.ResultsPatients reported on average three times more adverse reactions than the study physicians: for bleeding/haematoma, 6.7% of patients (n = 2458) vs. 0.6% of physicians (n = 255) and for pain, 1.7% of patients (n = 636) vs. 0.5% of physicians (n = 207). We found only minor agreements between patients and physicians (maximum Cohen’s kappa: 0.50, 95% confidence interval [0.49;0.51] for depressive mood). Being a female and participation in the randomization were associated with higher odds of reporting an adverse reaction.ConclusionsIn our study, patients’ and physicians’ reports on adverse reactions of acupuncture differed substantially, possibly due to differences in patients’ and physicians’ questionnaires and definitions. For the assessment of safety, we strongly support the inclusion of patients’ and physicians’ reports while ensuring standardization of data collection and definitions.

Acupuncture for overactive bladder in adults: a systematic review and meta-analysis.

Overactive bladder is prevalent in adults over 40 years of age and its prevalence increases with age. The use of acupuncture in adults with overactive bladder is increasing globally. However, its effectiveness/efficacy and safety have not yet been confirmed. To determine the effectiveness/efficacy and safety of acupuncture and to identify the pattern of commonly used traditional acupuncture points in the management of overactive bladder in adults. Ten electronic English and Chinese language databases were systematically searched and two English together with four Chinese journals relevant to acupuncture were manually searched in libraries for randomised controlled trials (RCTs) of acupuncture for overactive bladder in adults from their inception to March 2017. The Cochrane risk of bias tool was used to assess the methodological quality of the RCTs. RevMan v.5.3 software was employed for data analysis. Seven eligible trials involving 695 participants were included. Meta-analysis showed that acupuncture was comparable to drugs (tolterodine tartrate/solifenacin) in the reduction of micturition episodes over 24 hours (pooled standardised mean difference (SMD) 0.36, 95% CI -0.23 to 0.95; I2=83%), increase in voided volume of each micturition episode (pooled SMD -0.15, 95% CI -0.36 to 0.05; I2=0%), and reduction of overactive bladder symptom score (pooled SMD -0.23, 95% CI -1.30 to 0.85; I2=91%). In addition, acupuncture was not significantly different compared with placebo in the reduction of overactive bladder symptom score (pooled SMD -2.36, 95% CI -5.64 to 0.93; I2=97%). No serious adverse events were reported. No significant differences in effectiveness or efficacy were found between acupuncture and drug or between verum and sham acupuncture, respectively. Further high-quality studies are required.

Literature quality analysis of RCTs regarding acupuncture for chronic neck pain

The internationally-accepted Consolidated Standards for Reporting of Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) were applied to evaluate the literature quality of randomized controlled trials (RCTs) regarding acupuncture for chronic neck pain in past 10 years. The literature of RCTs regarding acupuncture for chronic neck pain was searched by computer; the English literature was searched in PubMed and EMbase, while the Chinese literature was searched in CNKI, Wanfang database, VIP database and China Biomedical Literature Database. The literature published from January 2008 to January 2018 was searched. As a result, 29 Chinese articles and 10 English articles were included. According to CONSORT, among Chinese articles, 28 articles (96.6%) described baseline data, 23 articles (79.3%) described randomization, 0 articles (0.0%) described allocation concealment, 3 articles (10.3%) described blind method; among English articles, 6 articles (60.0%) described baseline data, 8 articles (80.0%) described randomization, 8 articles (80.0%) described allocation concealment, and 7 articles (70.0%) described blind method. According to STRICTA, among Chinese articles, 8 articles (27.6%) described needle instrument selection, 18 articles (62.1%) described needle depth, 24 articles (82.8%) described needling sensation, and 0 articles (0.0%) described acupuncturist' qualifications; among English articles, 5 articles (50.0%) described needle instrument selection, 8 articles (80.0%) described needle depth, 3 articles (30.0%) described needling sensation, and 4 articles (40.0%) described acupuncturist' qualifications. In conclusion, the reporting of acupuncture details in Chinese literature is superior to that in English literature, while the reporting of trial design in English literature is slightly superior to that in Chinese literature. Moreover, both Chinese and English literature need to further improve clinical trial design to improve the reporting quality of clinical evidence based on CONSORT and STRICTA.

Society for Acupuncture Research 2019: Putting the Whole Acupuncturist Back Together Again-To Set Them to Work!

Society for Acupuncture Research 2019: Putting the Whole Acupuncturist Back Together Again-To Set Them to Work!

Acupotomy versus acupuncture for cervical spondylotic radiculopathy: protocol of a systematic review and meta-analysis

IntroductionCervical spondylotic radiculopathy (CSR) is the most common pattern of cervical spondylosis, which is a serious and common degenerative disease. Both acupotomy and acupuncture have been widely used clinically to...

Efficacy and Safety of Acupuncture for Chronic Discogenic Sciatica, a Randomized Controlled Sham Acupuncture Trial.

To evaluate the efficacy and safety of acupuncture for discogenic sciatica. Single-center, parallel, randomized controlled sham acupuncture trial. Twelve sessions of acupuncture or sham acupuncture at the same traditional acupoints over four weeks. The primary outcome was change from baseline in weekly mean leg pain, measured by the visual analog scale (VAS) over the four-week treatment period. The secondary outcomes were determined by the change from baseline in mean VAS scores for leg pain, VAS scores for low back pain, Oswestry Disability Index (ODI) scores, and 36-Item Short Form Health Survey (SF-36) scores. Patients were followed for 28 weeks. Forty-six patients were enrolled in this study between June 2017 and January 2018, of which 23 were in the acupuncture group and 23 were in the sham acupuncture group. The between-group difference in weekly mean leg pain measured by the VAS over the four-week treatment period was -7.28 mm (95% confidence interval = -13.76 to -0.80, P = 0.029), which is larger than the minimum clinically important difference of 5 mm. The between-group differences in mean VAS scores for low back pain, ODI scores, and SF-36 scores were not significant in the study period (P > 0.05 for all). The proportion of acupuncture-related adverse events was 4.3%, and all adverse events were mild and transient. Twelve sessions of acupuncture showed short-term clinical benefits in relieving the symptoms of leg pain for patients with chronic discogenic sciatica compared with sham acupuncture. Acupuncture is safe in treating chronic discogenic sciatica. Further studies with larger sample sizes, a longer treatment period, and long-term follow-up should be conducted to verify these results.

Invasive and non-invasive acupuncture techniques for pain management in neonates: a systematic review.

Neonatal pain is an extensive research field and there are many possibilities to treat pain in neonates. Acupuncture is one new and non-pharmacological option and a promising tool to reduce pain in neonates undergoing minor painful interventions during routine medical care. This review summarises trials of acupuncture for pain reduction in neonates undergoing painful interventions during routine medical care. MEDLINE, Embase, CINAHL, electronic clinical trials registry platforms and reference lists were systematically screened for trials from their dates of inception to February 2017 (English language database search). Inclusion criteria were (1) preterm or term neonates, (2) acupuncture for painful medical interventions and (3) formal pain assessment as a primary or secondary study outcome. We included only randomised controlled trials. Data were extracted using a standardised protocol and individual risk of bias was assessed. The literature search revealed a total of 12 196 records. After application of inclusion criteria, five studies were included in this review. Two studies demonstrated significant pain reduction, one found equal outcomes in comparison to standard care, and two showed significantly higher pain scores with acupuncture alone. The main limitation of the results is the heterogeneity across trials in acupuncture modality, acupuncture point selection, control groups and pain assessment (heterogeneity: I2=87%). The results of this review suggest that acupuncture may have a positive pain-relieving effect in neonates. However, due to the low number of available high-quality trials and heterogeneity across the studies it is not possible to state clear recommendations.

Assessing the reporting quality in randomized controlled trials of acupuncture for postherpetic neuralgia using the CONSORT statement and STRICTA guidelines.

BackgroundThis study evaluates the reporting quality of randomized controlled trials (RCTs) on acupuncture use for the treatment of postherpetic neuralgia and explores related factors.MethodsThe following six databases PubMed, Embase, Cochrane Library, VIP, CNKI, and SinoMed, were systematically searched from their inception to December 2018. RCTs using acupuncture as an intervention for postherpetic neuralgia were selected and incorporated in this study. The reporting quality was assessed based on the CONSORT statement and the STRICTA guidelines. Regression analyses were also conducted on pre-specified study characteristics searching for factors associated with reporting quality.ResultsA total of 137 RCTs were included in this study. The CONSORT based median OQS was 12 (minimum 3, maximum 29). Of the items comprised in the statement, ten were sufficiently reported (reported in over 70% of trials). The remaining fifty-five items were poorly reported (reported by fewer than 5% of trials). The STRICTA based median OQS was 9 (minimum 2, maximum 15). The results showed that eight of the comprised items were well reported (reported in over 70% of trials), and only three were incompletely reported (reported in fewer than 20% of trials). Based on the CONSORT statement related analysis, a post-2010 publication (β coefficient 2.394, 95% confidence interval [CI] 1.168–3.620) and funding (β coefficient 4.456, 95% CI: 3.009–5.903) represented independent and significant predictors of a high overall reporting quality. However, only a funding source (β coefficient 1.305, 95% CI 0.219–2.391) was associated with an increased OQS based on STRICTA analysis.ConclusionThe findings indicated that RCTs on acupuncture for PHN generally had a sub-optimal reporting quality, a situation that improved for those published after 2010 or with funding sources. Therefore, rigorous adherence to the CONSORT statement and the STRICTA guidelines should be emphasized in future studies.

Acupuncture for chemotherapy-induced peripheral neuropathy: a randomised controlled pilot study

Chemotherapy-induced peripheral neuropathy (CIPN) can cause loss of independence and poor quality of life (QoL) due to severe disabilities, but in spite of its importance there is still a lack...

What Is the Appropriate Acupuncture Treatment Schedule for Chronic Pain? Review and Analysis of Randomized Controlled Trials.

Background Acupuncture is widely used for the treatment of chronic pain. Different protocols of acupuncture practice exist and lack agreement on the optimal schedule of acupuncture treatment. Objective To review the appropriate acupuncture treatment schedule for chronic pain. Methods Embase, Pubmed, Cochrane Central Register of Controlled Trials, and reference lists were searched from 2009 to 2018 to identify randomized controlled trials of acupuncture for chronic pain conditions. We collected factors of treatment schedule (D, duration of each treatment session; N, number of treatment sessions; T, total duration of treatment in weeks) from each of the trials, and the linear regression analysis with real pain relief rate (both treatment and follow-up) was performed. Furthermore, we recommend the concept of “DOSE” and frequency (F) to evaluate the dose and frequency effect of acupuncture. Results Twenty-four trials with a total number of 3461 patients met the inclusion criteria. Of these, data from 23 studies were available for analysis. Firstly, the results showed that follow-up pain relief rate was decreased slightly with the increase of the duration of each session and DOSE (r=-0.3414 and r=-0.3246, respectively), but those two factors had no correlation with the pain relief rate after treatment. Secondly, it showed that either lower frequency with 2 sessions/week and higher frequency greater than 2 sessions/week or DOSE of 30 mins/week can achieve higher pain relief rate after treatment. Thirdly, we found the rate of pain relief remained at a high level greater than 20% up to 18 weeks after the treatment, and then it dropped sharply below 10% with the follow-up extended. A positive relationship was found between study score and pain relief both in treatment and follow-up (r=0.4654 and r=0.3046, respectively). Conclusions The effect of acupuncture varies greatly with the different schedules of acupuncture, so it is necessary to review and choose the appropriate schedule. Although the current work is based on a limited number of trials, the findings suggest that acupuncture has a dose and frequency effect presenting within a certain range, which would have considerable implications for the design and interpretation of clinical trials. More high-quality randomized controlled trials on acupuncture schedule research were needed for providing more definitive evidence.

Assessment of the quality of reporting in studies of acupuncture for patients with cancer using the STRICTA guidelines.

There has been a burgeoning of research evaluating acupuncture for various symptoms of cancer and the side-effects associated with its treatment. A systematic review was conducted to examine the quality of reporting in published studies of acupuncture in cancer according to the STRICTA (STandards for Reporting Interventions in Clinical Trials of Acupuncture) guidelines. Systematic review of published research of acupuncture for symptoms of cancer and the side-effects associated with its treatment. Databases searched were: Medline, CINAHL, Cochrane (all databases), Scopus, and PubMed from their inception to December 2014. Clinical trials, pilot/feasibility studies, observational studies, and case studies were included. Only full journal papers published in English were included. The quality of reporting was evaluated using STRICTA guidelines. Each included paper was assessed by two independent reviewers, with disagreements adjudicated by a third reviewer. 88 papers were identified which met the inclusion criteria. The median number of STRICTA items reported in trials with a control or comparator arm (n=47) was 14 out of 17 (range 8 to 17, IQR 4). For studies without a control or comparator arm the median was 11 out of a possible 15 (range 5 to 15, IQR 3). Key weaknesses in reporting included details of other components of treatments, and details of the acupuncturist administering treatments. Despite the widespread use of the STRICTA guidelines in acupuncture research, adherence remains poor for a few specific items. Further research is required to explore the reasons why authors fail to report those items, and to develop strategies to improve the adherence to the guidelines.

Effect of acupuncture at 3 anti-fatigue acupoints in the treatment of cancer-related fatigue in patients with cancer: Protocol for a systematic review and meta-analysis of randomized controlled trials.

Background:Cancer-related fatigue (CRF), is a common distressing symptom of cancer. What's more, “Three anti-fatigue acupoints” is one of the most important components of “Jin's 3-needle therapy” created by Rui Jin, a professor of Guangzhou University of Chinese Medicine, which can be used in the treatment of CRF. In this article, researchers will assess the safety and effect of acupuncture at 3 anti-fatigue acupoints on CRF in patients with cancer.Methods:Literature search for relevant articles up to October 2018 will be carried out in 9 databases: Cochrane Library, Embase, PubMed, VIP, CBM, CNKI, Wanfang Database, CiNii, and OASIS. The included literatures will be randomized controlled trials of acupuncture at 3 anti-fatigue acupoints on CRF in patients with cancer. The certain common scales, which reflect the patients’ fatigue degree or life quality will be the primary outcome measures. The secondary outcome measures will be defined with the blood index. After collecting the data, we will utilize Stata V.13.0. to perform data synthesis, subgroup analysis, partial sequence analysis, sensitivity analysis, and so on. A funnel plot will be used to assess reporting biases. And the funnel plot will be evaluated by the Egger and Begg tests. The quality of evidence will be judged by the grading of recommendations assessment, development, and evaluation.Results:The results of this systematic review and meta-analysis will be published in a peer-reviewed journal.Conclusion:Our study will provide the evidence for the clinical efficacy and safety of acupuncture at 3 anti-fatigue acupoints in the treatment of CRF.

A Randomized Clinical Trial of Group Acupuncture for Painful Diabetic Neuropathy Among Diverse Safety Net Patients.

Existing pharmacologic approaches for painful diabetic neuropathy (PDN) are limited in efficacy and have side effects. We examined the feasibility, acceptability, and effects of group acupuncture for PDN. We randomized patients with PDN from a public safety net hospital to 1) usual care, 2) usual care plus 12 weeks of group acupuncture once weekly, or 3) usual care plus 12 weeks of group acupuncture twice weekly. The primary outcome was change in weekly pain intensity (daily 0-10 numerical rating scale [NRS] averaged over seven days) from baseline to week 12. We also assessed health-related quality of life and related symptoms at baseline and weeks 6, 12, and 18. We enrolled 40 patients with PDN (baseline pain = 5.3). Among participants randomized to acupuncture, 92% attended at least one treatment (mean treatments = 10.1). We observed no significant differences between once- vs twice-weekly acupuncture and combined those groups for the main analyses. Compared with usual care, participants randomized to acupuncture experienced greater decreases in pain during the 12-week intervention period (between-group differences from baseline = -2.06, 95% confidence interval [CI] = -3.01 to -1.10), but benefits were not maintained after acupuncture ended (baseline to week 18 = -0.61, 95% CI = -1.46 to 0.24). Quality of life improved for acupuncture participants (baseline to week 12 difference = 11.79, 95% CI = 1.92 to 21.66), but group differences were not significant compared with usual care (25.58, 95% CI = -3.90 to 55.06). Group acupuncture is feasible and acceptable among linguistically and racially diverse safety net patients. Findings suggest clinically relevant reduction in pain from PDN and quality of life improvements associated with acupuncture, with no differences based on frequency.

Battlefield acupuncture for post-partum pain: A randomized controlled trial

Postpartum pain affects quality of life. Clinicians are increasingly using acupuncture for management of pain. Evidence based strategies that incorporate acupuncture for postpartum pain are lacking. We performed an exploratory, randomized clinical trial of Battlefield Auricular Acupuncture (BFA) plus standard analgesia versus standard analgesia alone for reduction of pain in the immediate postpartum period. The mean time to 50% sustained reduction of initial pain in the standard analgesia group (n = 33) was 6 days compared to 5 days in the standard analgesia plus BFA (n = 37) group (p = 0.35). The mean total morphine equivalent units (MEUs) in the standard group compared to standard plus BFA group were 88 mg and 82 mg respectively (p = 0.45). This exploratory comparison suggests that BFA may not provide additional benefit to standard analgesia for immediate postpartum pain; however, the trend toward faster reduction in pain indicates that a larger definitive study may be required.

The Effect of Patient Characteristics on Acupuncture Treatment Outcomes: An Individual Patient Data Meta-Analysis of 20,827 Chronic Pain Patients in Randomized Controlled Trials.

To optimally select chronic pain patients for different treatments, as it is of interest to identify patient characteristics that might moderate treatment effect. Our aim was to evaluate the impact of possible moderators on the effect of acupuncture treatment using a large data set. We used data from an individual patient data meta-analysis of high-quality randomized trials of acupuncture for chronic headache and migraine, osteoarthritis, and back, neck, and shoulder pain. Using meta-analytic trial-level and patient-level regression analyses, we explored the impact of 5 documented patient characteristics (patients' age at baseline, sex, pain duration, baseline pain severity and baseline psychological distress) on the effect of acupuncture. A total of 39 trials met the inclusion criteria: 25 use sham-acupuncture controls (n = 7097) and 25 non-acupuncture controls (n = 16,041). Of the 5 patient characteristics analyzed, only baseline pain severity was found to potentially moderate the treatment effect of acupuncture, with patients reporting more severe pain at baseline experiencing more benefit from acupuncture compared to either sham-control or non-acupuncture control. Baseline psychological distress showed small treatment moderating effects, and results for sex were inconsistent. There was no strong evidence that age or duration of pain influenced the response to acupuncture. Of 5 patient characteristics tested, we found only baseline severity of pain to potentially moderate the effect of acupuncture treatment. For clinical practice, the evidence from this analysis does not justify stratifying chronic pain patients into subgroups that should or should not receive acupuncture on the basis of these 5 characteristics. Future acupuncture trials should assess other potentially important effect moderators.

Adverse events given in participant information leaflets of randomised sham-controlled trials of acupuncture

Spinal cord injury (SCI) is an acute neurodegenerative disorder caused by traumatic damage of the spinal cord. The neuropathological evolution of the primary trauma involves multifactorial processes that exacerbate the pathology, worsening the neurodegeneration and limiting neuroregeneration. This complexity suggests that multi-therapeutic approaches, rather than any single treatment, might be more effective. Encouraging preclinical results indicate that stem cell-based treatments may improve the disease outcome due to their multi-therapeutic ability. Mesenchymal Stem Cells (MSCs) are currently considered one of the most promising approaches. Significant improvement in the behavioral outcome after MSC treatment sustained by hydrogel has been demonstrated. However, it is still not known how hydrogel contribute to the delivery of factors secreted from MSCs and what factors are released in situ.Among different mediators secreted by MSCs after seeding into hydrogel, we have found CCL2 chemokine, which could account for the neuroprotective mechanisms of these cells. CCL2 secreted from human MSCs is delivered efficaciously in the lesioned spinal cord acting not only on recruitment of macrophages, but driving also their conversion to an M2 neuroprotective phenotype. Surprisingly, human CCL2 delivered also plays a key role in preventing motor neuron degeneration in vitro and after spinal cord trauma in vivo, with a significant improvement of the motor performance of the rodent SCI models.

Acupuncture and Vitamin D for the Management of Aromatase Inhibitor-Induced Arthralgia.

Aromatase inhibitor-induced arthralgia (AIA) is a very common syndrome which significantly affects breast cancer survivors' quality of life, and it often leads to non-compliance with aromatase inhibitor (AI) therapy. However, the treatment of AIA remains a clinical challenge. Here, we will review the current data for acupuncture and vitamin D in the management of AIA. Acupuncture has been shown to improve AIA symptoms, but it has not consistently been proven to offer significantly more clinical benefit than sham acupuncture. Similarly, while some vitamin D trials have shown benefit, the studies have not consistently shown improvement in AIA symptoms. Neither acupuncture nor vitamin D can be touted as standard treatments for AIA. However, many patients do experience subjective improvement of their symptoms with these therapies. When other treatments, such as exercise and duloxetine, are not feasible or not effective, it is reasonable to offer a trial of acupuncture or vitamin D to patients who are suffering from AIA, as the potential harms are very few, and they do offer possible relief from AIA symptoms.

A pooled analysis of three studies of nonpharmacological interventions for menopausal hot flashes.

The aim of the study was to conduct a pooled analysis of three published trials of nonpharmacological interventions for menopausal hot flashes to compare the effectiveness of interventions. Data from three randomized controlled trials of interventions for hot flashes (two acupuncture trials, one yoga trial) were pooled. All three studies recruited perimenopausal or postmenopausal women experiencing ≥4 hot flashes/d on average. The primary outcome for all three studies was frequency of hot flashes as measured by the Daily Diary of Hot Flashes. Study 1 participants were randomly assigned to 8 weeks of acupuncture treatments (active intervention), sham acupuncture (attention control), or usual care. Study 2 participants were randomly assigned to 10 weeks of yoga classes, health and wellness education classes (attention control), or waitlist control. Study 3 randomly assigned participants to 6 months of acupuncture or waitlist control. To standardize the time frame for these analyses, only the first 8 weeks of intervention from all three studies were used. The three active interventions and the two attention control groups had statistically similar trends in the percentage reduction of hot flashes over 8 weeks, ranging from 35% to 40%. These five groups did not differ significantly from each other, but all showed significantly greater reduction in hot flash frequency compared with the three usual care/waitlist groups. Acupuncture, yoga, and health and wellness education classes all demonstrated statistically similar effectiveness in reduction of hot flash frequency compared with controls.

Erratum: Attitude and willingness of attendance for participating in or completing acupuncture trials: a cross-sectional study [Corrigendum

[This corrects the article on p. 53 in vol. 13, PMID: 30636870.].

Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy