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We are writing because we have a number of concerns about the Takakura et al. [...].
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Terapia por Acupuntura , Dolor Crónico , Dolor de Cuello , Humanos , Terapia por Acupuntura/métodos , Terapia por Acupuntura/estadística & datos numéricos , Dolor de Cuello/terapia , Método Doble Ciego , Dolor Crónico/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Japón , Pueblos del Este de AsiaRESUMEN
INTRODUCTION: Fatigue is a common symptom observed in post-cancer treatment, yet its underlying mechanisms remain poorly understood. Acupuncture has been employed to alleviate cancer-related fatigue (CRF); however, its effectiveness in addressing associated comorbidities that may influence fatigue is also poorly understood. This study represents the first investigation to use acupuncture as an intervention for fatigue in breast cancer survivors within a Norwegian cohort. The study will employ questionnaires to evaluate various facets of fatigue. As a pragmatic trial, it statistically assesses its clinical relevance, documents adverse events and evaluates the cost-effectiveness of the acupuncture treatment. METHODS AND ANALYSIS: This assessor-blinded, pragmatic, randomised, mixed method, controlled trial with two parallel arms aims to evaluate the effectiveness, safety and cost-effectiveness of acupuncture. It will recruit 250 participants presented with CRF for 6 months or longer. Patients will be randomly allocated either to acupuncture and usual care (n=125) or to usual care alone (n=125). Acupuncture treatments (12 in total) are to be given within 12 weeks. The statistician who will analyse the data will be blinded to group allocation. The primary outcome will be changes in CRF measured by the Chalder fatigue scale. Measurements will be taken 12 weeks and 6 months after randomisation. The secondary outcomes include patient-reported outcomes of pain, anxiety, depression, hot flashes, insomnia and sleepiness. Health-related quality of life and economic evaluation will also be conducted 12 weeks and 6 months after randomisation. Nested within this randomised controlled trial are two qualitative studies and one sub-study measuring biomarkers (C-reactive protein, interleukin (IL)-1, IL-6, tumour necrosis factor alpha (TNF-α) and aPL in addition to the current genotype genes TNF-308 and IL-6-174) from blood samples (n=80). Such biomarkers can potentially address changes in CRF. ETHICS AND DISSEMINATION: Ethical approval of this study has been granted by the Regional Committees for Medical and Health Research Ethics (REC southeast ID number: 112285). Written informed consent will be obtained from all participants. The outcomes of the trial will be disseminated through peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT04418115.
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Terapia por Acupuntura , Neoplasias de la Mama , Supervivientes de Cáncer , Fatiga , Calidad de Vida , Humanos , Fatiga/terapia , Fatiga/etiología , Neoplasias de la Mama/complicaciones , Femenino , Terapia por Acupuntura/métodos , Ensayos Clínicos Pragmáticos como Asunto , Noruega , Análisis Costo-BeneficioRESUMEN
INTRODUCTION: Erectile dysfunction (ED) is a widespread disorder, and the worldwide incidence is rapidly increasing. Acupuncture, an intervention out of the spectrum of traditional Chinese medicine (TCM), has a long tradition as treatment for ED. Nonetheless, a best-practice treatment protocol is currently missing. A recent systematic review and meta-analysis confirmed a huge diversity of acupuncture treatments for ED and concluded that there is an urgent need to standardise acupuncture treatment for ED. Consequently, the authors conducted a Delphi process with the aim to achieve an expert consensus as a basis for the development of a best-practice protocol. METHODS: The Delphi process consisted of four rounds of questionnaires with closed and open-ended questions. Eleven acupuncture experts participated. The therapeutic aim was defined as "to achieve an erection sufficient for sexual satisfaction." RESULTS: Consensus was achieved on 24 acupoints corresponding to 12 TCM syndromes. The syndromes were KI Yang xu, KI Yin xu, KI Qi xu, Ki and HT not harmonised, LR Qi Stagnation, LR Qi stagnation and Heat, Liver Blood xu, Liver Blood xu and Liver Qi stagnation, Damp-heat sinking to the lower Jiao5, HT and GB Qi xu, SP xu and HT Blood xu, Yin xu. The suggested optimal dose was between 11 and 15 treatments given once or twice a week. CONCLUSION: An expert consensus-based, semi-standardised best-practice treatment protocol for the treatment of ED was developed. Moreover, the Delphi process also revealed inconsistencies as to which signs and symptoms constitute a TCM syndrome. Further Delphi studies including a broader range of experts from various acupuncture traditions are needed to establish further agreement. Nonetheless, the best-practice protocol introduced in this study provides a first point of departure for the implementation of a more standardised treatment approach. Moreover, since a recent meta-analysis concluded that more high-quality clinical studies on the topic are needed, this study provides a first standardised acupuncture treatment protocol for ED.
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Terapia por Acupuntura , Técnica Delphi , Disfunción Eréctil , Humanos , Disfunción Eréctil/terapia , Masculino , Medicina Tradicional China , Encuestas y Cuestionarios , Puntos de Acupuntura , ConsensoRESUMEN
Objective: In sham acupuncture-controlled acupuncture clinical trials, although sham acupuncture techniques are different from those of verum acupuncture, the same acupuncture points are often used for verum and sham acupuncture, raising the question of whether sham acupuncture is an appropriate placebo. We aimed to examine the effects of sham and verum acupuncture according to the points needled (same or different between verum and sham acupuncture) in knee osteoarthritis. Methods: Ten databases were searched to find randomized controlled clinical trials (RCTs) assessing the effects of verum acupuncture with sham acupuncture or waiting lists on knee osteoarthritis. Sham acupuncture was classified as using the same acupuncture points as those in verum acupuncture (SATV) or using sham points (SATS). A frequentist network meta-analysis (NMA) was conducted, and the certainty of evidence was evaluated. Results: A total of 10 RCTs involving 1628 participants were included. Verum acupuncture was significantly superior to SATS but not different from SATV in terms of pain reduction. Additionally, SATV was significantly superior to the waiting list. For physical function, no difference were found between verum acupuncture, SATV, and SATS. The certainty of evidence was low to moderate. Conclusion: For knee osteoarthritis, the pain reduction effect of acupuncture may differ according to the needling points of sham acupuncture, and the control group should be established according to the specific aim of the study design and treatment mechanism.
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INTRODUCTION: Traditional medicine (TM) is an important part of healthcare either as the main healthcare system or as a complement to conventional medicine. The effectiveness of TM has been assessed in clinical trials that have been synthesised into thousands of systematic reviews (SRs). This study is commissioned by the World Health Organization (WHO) and is aimed at providing a systematic map of SRs of TM interventions across health conditions, as well as identifying gaps in the research literature in order to prioritise future primary research. METHODS AND ANALYSIS: This is the protocol for a systematic map of SRs reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P). We will search 17 electronic databases to identify SRs of TM. The literature search covers the last 5 years, from January 2018 to December 2022. At least two independent reviewers will perform the database search, screening of eligible SRs, data extraction and quality assessments using the A MeaSurement Tool to Assess Systematic Reviews (AMSTAR 2). The characteristics and extent of SRs will be analysed according to disease classification, and type of TM intervention, and visualised by means of (interactive) graphical maps. ETHICS AND DISSEMINATION: Ethical approval is not required as this is a systematic map of published studies. The findings of the study will be disseminated through online-available maps, presentations and scientific publications. PROSPERO REGISTRATION NUMBER: CRD42023416355.
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Medicina Tradicional , Publicaciones , Humanos , Revisiones Sistemáticas como Asunto , Metaanálisis como Asunto , Proyectos de InvestigaciónRESUMEN
Numerous acupuncture studies have been conducted on cancer-related pain; however, its efficacy compared to sham acupuncture remains controversial. We confirmed whether the outcome of acupuncture differs according to the needling points of sham acupuncture for cancer-related pain. We searched 10 databases on 23 May 2023 to screen acupuncture trials using sham acupuncture or waiting list as controls for cancer-related pain. Sham acupuncture was classified into two types, depending on whether the needling was applied at the same locations as verum acupuncture (SATV) or not (SATS). A network meta-analysis (NMA) was performed on the basis of a frequentist approach to assess pain severity. Eight studies (n = 574 participants) were included in the review, seven of which (n = 527 participants) were included in the NMA. The pain severity was not significantly different between SATV and verum acupuncture, but verum acupuncture significantly improved pain severity compared to SATS. The risk of bias affecting the comparisons between the verum and sham acupuncture was generally low. Previous acupuncture trials for cancer-related pain showed differing outcomes of sham and verum acupuncture, depending on the needling points of sham acupuncture. The application of SATV cannot be considered a true placebo, which leads to an underestimation of the efficacy of verum acupuncture.
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Introduction: Case reports on acupuncture-related adverse events (AEs) have been consistently published in the literature. This review aims to assess the current publication status of case reports on acupuncture-related AEs and evaluate their reporting quality in order to identify areas for improvement. Methods: This study is a systematic review (SR) of case reports. Studies describing cases for acupuncture-related AEs between 2010 and 2023 (until July) were searched in PubMed, Embase, and local databases (China and Korea), as well as by hand-searching references included in published relevant SRs. A bibliometric analysis was conducted to examine the publication trends of the included literature. The appropriateness of the acupuncture described in the cases, the causality assessment between AEs and acupuncture treatment, and the presence of necessary items from the CAse REport guidelines (CARE) checklist were narratively analyzed. Results: A total of 169 case reports were included in this review. Over the past decade, an average of 12 case reports on acupuncture-related AEs were published annually. However, only 38.2% of the articles provided sufficient information to determine the appropriateness of the acupuncture treatment used in the reported cases, and considerable numbers of the included case reports did not suggest enough information for the assessment of a causal relationship. The majority of cases did not report the timeline (n = 164), patient perspectives (n = 157), and informed consent (n = 121) items from the CARE checklist. Discussion: Acupuncture-related AEs persist in being frequently reported in the literature. Nonetheless, the information concerning acupuncture and causality assessment within these publications is still found to be insufficient. The development of reporting guidelines for future case reports on acupuncture-related AEs is anticipated to promote an academic environment conducive to more comprehensive reporting.
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Importance: When sham acupuncture is set as a control in evaluating acupuncture, the sham needling technique is usually different from acupuncture. However, the sham procedure is conducted either at the same points that are used for the acupuncture group or at nonindicated points. Objective: To assess whether the outcome of sham acupuncture varies according to the needling points in sham-controlled trials of acupuncture for chronic nonspecific low back pain (CLBP) as an example. Data sources: Searches of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and the Allied and Complementary Medicine Database were conducted on February 12, 2023. Study selection: Randomized clinical trials (RCTs) assessing the outcomes of acupuncture in sham acupuncture-controlled or waiting list-controlled trials on CLBP were included. Data extraction and synthesis: Two researchers independently extracted data on study characteristics and outcomes and assessed quality. Sham acupuncture was classified according to whether it was conducted at the same acupuncture points used in the acupuncture group, referred to as sham acupuncture therapy (verum) (SATV) or at different points, referred to as sham acupuncture therapy (sham) (SATS). Clinical similarity, transitivity, and consistency tests were conducted, followed by a random-effects frequentist network meta-analysis (NMA). Main outcomes and measures: The primary outcome was pain, and the secondary outcome was back-specific function. The first assessment after the end of treatment was chosen for analysis. Effect sizes are reported as standardized mean differences (SMD) with 95% CIs. The risk of bias was assessed using the Cochrane risk of bias tool, and the certainty of evidence for findings was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach. Results: Ten RCTs involving 4379 participants were included. In comparison with SATS, acupuncture was significantly associated with improvements in both pain (SMD, -0.33; 95% CI, -0.52 to -0.15) and function outcomes (SMD, -0.13; 95% CI, -0.25 to -0.02); however, there were no differences between acupuncture and SATV. In comparison with SATS, SATV was significantly associated with better pain (SMD, -0.45; 95% CI, -0.88 to -0.03) and function outcomes (SMD, -0.30; 95% CI, -0.56 to -0.05). The risk of bias that could affect the interpretation of the results was usually low, and the certainty of evidence was moderate to low. Conclusions and relevance: In this NMA, sham acupuncture needling at the same points as those in acupuncture was not a true placebo control for assessing the efficacy of acupuncture for CLBP and might underestimate the outcome of acupuncture in clinical settings.
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Terapia por Acupuntura , Dolor de la Región Lumbar , Humanos , Metaanálisis en Red , Procedimientos Quirúrgicos Vasculares , Bases de Datos FactualesRESUMEN
We are grateful for the relevant comments by Hu et al. [...].
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OBJECTIVE: A prospective cohort study on changes of health complaints after removal of amalgam restorations was carried out at the request of the Norwegian Directorate of Health. The aim was to provide and evaluate experimental treatment to patients with health complaints attributed to dental amalgam fillings. METHODS: Patients (n = 32) with medically unexplained physical symptoms (MUPS), which were attributed to dental amalgam restorations had all their amalgam restorations removed and replaced with other dental restorative materials. Samples of blood were collected before and 1 year after removal of the fillings, and concentration of inorganic mercury (I-Hg), methylmercury (MeHg), silver (Ag) and selenium (Se) in serum was determined by inductively coupled plasma-sector field mass spectrometry. The comparison groups (one with MUPS but without attribution to amalgam [n = 28] and one group of healthy individuals [n = 19]) received no treatment. The participants responded to questionnaires at baseline and at follow-up after 1 and 5 years. RESULTS: Concentration of I-Hg and Ag in serum decreased significantly after removal of all amalgam restorations. Concentration of MeHg and Se in serum were not changed. Intensity of health complaints was significantly reduced after amalgam removal, but there were no statistically significant correlations between exposure indicators and health complaints. CONCLUSIONS: Removal of all amalgam restorations is followed by a decrease of concentration of I-Hg and Ag in serum. The results support the hypothesis that exposure to amalgam fillings causes an increase of the daily dose of both I-Hg and Ag. Even though intensity of health complaints decreased after removal of all amalgam restorations there was no clear evidence of a direct relationship between exposure and health complaints. Trial registration: The project is registered at Clinicaltrials.gov (NCT01682278).
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Mercurio , Compuestos de Metilmercurio , Selenio , Humanos , Mercurio/análisis , Selenio/análisis , Plata/análisis , Amalgama Dental/efectos adversos , Amalgama Dental/química , Estudios Prospectivos , NoruegaRESUMEN
Breast cancer (BC) is the most common cancer in women and is a serious threat to women's health. Cancer-related fatigue (CRF) is a distressing symptom in BC patients during and after chemotherapy or radiation therapy that severely affects quality of life (QoL). AT is widely used for fatigue management. However, the effect of AT on CRF is still uncertain. This study aimed to evaluate the efficacy and safety of AT in the management of CRF in patients with BC. Eleven databases were searched through June 2022. Two researchers independently performed the database search, study selection, data extraction, and risk of bias assessment. Study selection was performed based on predefined Participants, Intervention, Comparators, Outcomes, Study design (PICOS) criteria, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed when reporting the results. A meta-analysis was performed according to the Cochrane systematic review method using RevMan 5.3. A total of 12 studies including a total of 1084 participants were included. The results showed that AT had a beneficial effect compared with sham AT (n = 256, SMD = -0.26, 95% CI [-0.51, -0.01], p = 0.04, I2 = 0%) and a long-term effect on fatigue score (n = 209, MD = -0.32, 95% CI [-0.59, -0.04], p = 0.02, I2 = 0%). Meta-analysis showed that AT had a beneficial effect compared with usual care (UC) on fatigue scores (n = 238, SMD = -0.39, 95% CI [-0.66 to -0.12], p = 0.005, I2 = 0%). Of the 12 articles, 3 articles were judged as having a low risk of bias in all domains and hence were of high quality. No serious adverse effects were identified. AT is an effective and safe treatment for CRF, and AT is more effective than sham AT or UC or wait-list control (WLC). Nevertheless, the methodological quality of most of these studies was low, and the included studies/sample sizes were small, so the ability to derive decisive implications was limited. Further research is needed to confirm these findings.
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Although acupuncture (AT) is used in the treatment of CRF, the evidence from different systematic reviews (SRs) of AT has not yet been comprehensively evaluated. Moxibustion, which is a treatment method that is well established within Traditional East Asian Medicine, applies the heat of burning herbs towards or onto special points on the skin. Commonly, the herb Artemisia vulgaris, is used. It has been used for palliative cancer care, as well as for CRF. The aim of this overview was to evaluate the efficacy of AT and moxibustion in the management of CRF. Eleven databases were searched through for studies that were published from their dates of inception to February 2022. The study selection, the data extraction, and the assessment were performed independently by two researchers. The methodological and report quality were assessed by using the Assessment of Multiple Systematic Reviews-2 (AMSTAR-2) tool. The evidence quality was evaluated by using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Fifteen SRs on AT (n = 10) and moxibustion (n = 5) treatments for CRF were included, and they include 169 randomized controlled trials and 14,392 participants. All of the SRs that were evaluated by the AMASTAR-2 had more than one deficiency, and so all of the SRs were rated as either low or critically low. For the GRADE, 18 outcomes were rated as very-low-quality evidence, 13 as low-quality evidence, 3 as moderate-quality evidence, and 0 as high-quality evidence. Most of the SRs reached the potential benefits of AT for CRF. No serious adverse effects were identified. In conclusion, the evidence suggests that, despite the advantages of AT in terms of the improvement in and the safety of the treatment of CRF, the methodological quality of most of these studies is low, which limits our ability to draw definitive meanings. Further research of high quality is needed in order to confirm these findings.
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There are many patients in general practice with health complaints that cannot be medically explained. Some of these patients attribute their health complaints to dental amalgam restorations. This study examined the cost-effectiveness of the removal of amalgam restorations in patients with medically unexplained physical symptoms (MUPS) attributed to amalgam fillings compared to usual care, based on a prospective cohort study in Norway. Costs were determined using a micro-costing approach at the individual level. Health outcomes were documented at baseline and approximately two years later for both the intervention and the usual care using EQ-5D-5L. Quality adjusted life year (QALY) was used as a main outcome measure. A decision analytical model was developed to estimate the incremental cost-effectiveness of the intervention. Both probabilistic and one-way sensitivity analyses were conducted to assess the impact of uncertainty in costs and effectiveness. In patients who attribute health complaints to dental amalgam restorations and fulfil the inclusion and exclusion criteria, amalgam removal is associated with modest increase in costs at societal level as well as improved health outcomes. In the base-case analysis, the mean incremental cost per patient in the amalgam group was NOK 19 416 compared to the MUPS group, while mean incremental QALY was 0.119 with a time horizon of two years. Thus, the incremental costs per QALY of the intervention was NOK 162 680, which is usually considered cost effective in Norway. The estimated incremental cost per QALY decreased with increasing time horizon, and amalgam removal was found to be cost saving over both 5 and 10 years. This study provides insight into the costs and health outcomes associated with the removal of amalgam restorations in patients who attribute health complaints to dental amalgam fillings, which are appropriate instruments to inform health care priorities.
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Técnicas de Apoyo para la Decisión , Amalgama Dental , Estudios de Cohortes , Análisis Costo-Beneficio , Amalgama Dental/efectos adversos , Humanos , Estudios ProspectivosRESUMEN
INTRODUCTION: Sham acupuncture was developed to be used as an inert control intervention in clinical trials of acupuncture. However, controversies exist regarding the validity of sham acupuncture. In this systematic review (SR) of acupuncture trials, we assessed whether serum biomarkers showed significant differences after sham and verum acupuncture treatments. METHODS: Any acupuncture clinical trials that evaluated serum biomarker changes between sham acupuncture and verum acupuncture were included in this review. Relevant literature was searched in the PubMed database, EMBASE, and The Cochrane Central Register of Controlled Trials (CENTRAL) database from inception until June 2021. The Cochrane risk of bias was assessed. Summary effect estimates for each biomarker between groups were calculated with a random effect model. RESULTS: From 51 sham acupuncture trials, we found that there were no significant differences in most of the 36 serum biomarkers after sham acupuncture and verum acupuncture needling. Only VEGF, IG-E, TNF-a, NGF, GABA, NPY, and VIP serum levels were identified as being different between the groups. The overall risk of bias of the included studies and the limited numbers of studies for meta-analysis do not strongly support the results of this SR. CONCLUSION: Sham acupuncture techniques might have similar effects on biomarkers as the so-called "real acupuncture" techniques, which indicates that sham acupuncture, as an inert intervention similar to a placebo drug, needs to be reconsidered. SYSTEMATIC REVIEW PROSPERO REGISTRATION: identifier [CRD42021260889].
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Objectives: Although many trials have assessed the effect of acupuncture on knee osteoarthritis (KOA), its efficacy remains controversial. Sham acupuncture techniques are regarded as representative control interventions in acupuncture trials and sometimes incorporate the use of sham devices (base units) to support a non-penetrating needle. To achieve successful blinding, these trials also use acupuncture base units in the verum acupuncture group. Base units are not used in real-world clinical settings. We aimed to assess the effect sizes of verum and sham acupuncture for KOA in sham-controlled trials with or without base units. Methods: A total of 10 electronic databases for randomized controlled trials (RCTs) comparing the efficacy of verum manual acupuncture and sham acupuncture for the treatment of KOA were searched for articles published before April 12, 2022. The primary outcome was pain intensity, and the secondary outcomes included physical function. The first assessment after the end of treatment was chosen for analysis. Effect sizes are reported as standardized mean differences (SMDs) with 95% confidence intervals (95% CIs). The risk of bias was assessed using the Cochrane risk of bias tool, and publication bias was evaluated using a funnel plot and Egger's test. The quality of evidence for estimates was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach. Results: Fifteen RCTs were included. There was generally a low risk of bias except for the difficulty in blinding acupuncture therapists (performance bias). Compared to verum acupuncture in sham-controlled trials using base units, verum acupuncture in sham-controlled trials without base units was more effective for improving pain (SMD -0.56, 95% CI -1.09 to -0.03) and function (SMD -0.73, 95% CI -1.36 to -0.10) in KOA. The quality of evidence for network estimates was moderate to low due to the risk of bias and imprecision. Conclusion: These findings suggest that verum acupuncture in different types of sham-controlled trials has different effect sizes for KOA. Because base units are not used in clinical settings, the results of verum acupuncture in sham-controlled trials with base units need to be interpreted carefully. Systematic review registration: https://www.researchregistry.com/browse-the-registry#registryofsystematicreviewsmeta-analyses/registryofsystematicreviewsmeta-analysesdetails/6269f962606c5e001fd8790c/, identifier reviewregistry1351.