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PURPOSE: To assess the effectiveness and safety of acupuncture for the prevention of chemotherapy-induced nausea and vomiting (CINV), with a specific intention on exploring sources of between-study variation in treatment effects. METHODS: MEDLINE, EMBASE, Cochrane CENTRAL, CINAHL, Chinese Biomedical Literature Database, VIP Chinese Science and Technology Periodicals Database, China National Knowledge Infrastructure, and Wanfang were searched to identify randomized controlled trials (RCTs) that compared acupuncture to sham acupuncture or usual care (UC). The main outcome is complete control (no vomiting episodes and/or no more than mild nausea) of CINV. GRADE approach was used to rate the certainty of evidence. RESULTS: Thirty-eight RCTs with a total of 2503 patients were evaluated. Acupuncture in addition to UC may increase the complete control of acute vomiting (RR, 1.13; 95% CI, 1.02 to 1.25; 10 studies) and delayed vomiting (RR, 1.47; 95% CI, 1.07 to 2.00; 10 studies) when compared with UC only. No effects were found for all other review outcomes. The certainty of evidence was generally low or very low. None of the predefined moderators changed the overall findings, but in an exploratory moderator analysis we found that an adequate reporting of planned rescue antiemetics might decrease the effect size of complete control of acute vomiting (p = 0.035). CONCLUSION: Acupuncture in addition to usual care may increase the complete control of chemotherapy-induced acute vomiting and delayed vomiting but the certainty of evidence was very low. Well-designed RCTs with larger sample sizes, standardized treatment regimens, and core outcome measures are needed.
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Terapia por Acupuntura , Antieméticos , Antineoplásicos , Neoplasias , Humanos , Antineoplásicos/efectos adversos , Vómitos/inducido químicamente , Vómitos/prevención & control , Náusea/inducido químicamente , Náusea/prevención & control , Antieméticos/uso terapéutico , Neoplasias/tratamiento farmacológicoRESUMEN
INTRODUCTION: Dysgeusia is a common side effect of chemotherapy in patients with cancer, but to date, there is no effective treatment. Many patients with cancer request complementary medicine treatment in addition to their cancer treatments, and acupuncture is highly accepted for patients with cancer; however, evidence regarding the effectiveness of acupuncture for dysgeusia is scarce.The study investigates the effectiveness of an additional dysgeusia-specific acupuncture plus self-acupressure intervention compared with supportive acupuncture plus self-acupressure intervention alone for chemotherapy-induced dysgeusia in patients with cancer. METHODS AND ANALYSIS: This is a multicentre, randomised, controlled and two-armed parallel-group, single-blind trial involving 130 patients. Both groups will receive eight sessions of acupuncture treatment over a period of 8 weeks and will be trained to perform self-acupressure (eLearning combined with therapist instruction) at predefined acupressure points once a day during the whole treatment period. Patients in the control group will receive supportive routine care acupuncture and self-acupressure treatment only; in addition to this treatment, the intervention group will receive the dysgeusia-specific acupuncture and acupressure within the same treatment session. The primary outcome is the perceived dysgeusia over 8 weeks, measured weekly after the acupuncture treatment. Secondary outcomes include the indices from the objective taste and smell test, weight loss, perceived dysgeusia, fatigue, distress, nausea and vomiting, odynophagia, xerostomia and polyneuropathy, as well as quality of life at the different time points. ETHICS AND DISSEMINATION: The study has been approved by the Cantonal Ethics Committee (CEC) (Kanton Zürich Kantonale Ethikkommission) (approval no. KEK-ZH-Nr. 2020-01900). The results will be submitted to a peer-reviewed journal for publication. TRIAL REGISTRATION NUMBERS: DRKS00023348, SNCTP000004128.
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Acupresión , Terapia por Acupuntura , Antineoplásicos , Neoplasias , Humanos , Disgeusia/inducido químicamente , Disgeusia/tratamiento farmacológico , Calidad de Vida , Método Simple Ciego , Terapia por Acupuntura/métodos , Acupresión/métodos , Neoplasias/tratamiento farmacológico , Resultado del Tratamiento , Antineoplásicos/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
OBJECTIVE: This secondary analysis of a randomised controlled patient-blinded trial comparing effectiveness and side effect briefings in patients with chronic low back pain (CLBP) investigated the association between patients' pre-treatment expectations about minimal acupuncture treatment and pain intensity as outcome during and after the end of the treatment. METHODS: Chronic low back pain patients with a pain intensity of at least 4 on a numeric rating scale from 0 to 10 received eight sessions of minimal acupuncture treatment over 4 weeks. The primary outcome was change in pain intensity rated on a Numerical Rating Scale (NRS 0-10) from inclusion visit to treatment session 4 and to the end of the treatment. Patients' expectations about the effectiveness of acupuncture were assessed using the Expectation for Treatment Scale (ETS) before randomization. Linear regression was applied to investigate whether patients' pre-treatment expectations predicted changes in pain intensity during and after treatment. RESULTS: A total of 142 CLBP patients (40.1 ± 12.5 years; 65.5% female) were included in our analysis. Patients' pre-treatment expectations about acupuncture treatment were associated with changes in pain intensity after four sessions of minimal acupuncture treatment (b = -0.264, p = 0.002), but not after the end of the treatment. This association was found in females and males. CONCLUSIONS: Our results imply that higher pre-treatment expectations only lead to larger reductions in pain intensity in the initial phase of a treatment, with a similar magnitude for both females and males. As the treatment progresses in the second half of the treatment, adapted expectations or other non-specific effects might play a more important role in predicting treatment outcome.
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Terapia por Acupuntura , Dolor Crónico , Dolor de la Región Lumbar , Dolor Crónico/terapia , Femenino , Humanos , Dolor de la Región Lumbar/terapia , Masculino , Motivación , Dimensión del Dolor , Resultado del TratamientoRESUMEN
BACKGROUND: Chronic neck pain is a highly prevalent condition. Learning a relaxation technique is recommended by numerous guidelines for chronic neck pain. Smartphone apps can provide relaxation exercises; however, their effectiveness, especially in a self-care setting, is unclear. OBJECTIVE: The aim of this pragmatic randomized trial is to evaluate whether app-based relaxation exercises, including audio-based autogenic training, mindfulness meditation, or guided imagery, are more effective in reducing chronic neck pain than usual care alone. METHODS: Smartphone owners aged 18 to 65 years with chronic (>12 weeks) neck pain and the previous week's average neck pain intensity ≥4 on the Numeric Rating Scale (0=no pain to 10=worst possible pain) were randomized into either an intervention group to practice app-based relaxation exercises or a control group (usual care and app for data entry only). For both groups, the follow-up data were collected using app-based diaries and questionnaires. The primary outcome was the mean neck pain intensity during the first 3 months based on daily measurements. Secondary outcomes included neck pain based on weekly measurements, pain acceptance, neck pain-related stress, sick-leave days, pain medication intake, and adherence, which were all measured until the 6-month follow-up. For the primary analysis, analysis of covariance adjusted for baseline neck pain intensity was used. RESULTS: We screened 748 participants and enrolled 220 participants (mean age 38.9, SD 11.3 years; mean baseline neck pain 5.7, SD 1.3 points). The mean neck pain intensity in both groups decreased over 3 months; however, no statistically significant difference between the groups was found (intervention: 4.1 points, 95% CI 3.8-4.4; control: 3.8 points, 95% CI 3.5-4.1; group difference: 0.3 points, 95% CI -0.2 to 0.7; P=.23). In addition, no statistically significant between-group differences regarding neck pain intensity after 6 months, responder rate, pain acceptance, pain medication intake, or sick-leave days were observed. There were no serious adverse events that were considered related to the trial intervention. In week 12, only 40% (44/110) of the participants in the intervention group continued to practice the exercises with the app. CONCLUSIONS: The study app did not effectively reduce chronic neck pain or keep the participants engaged in exercising in a self-care setting. Future studies on app-based relaxation interventions should take into account the most recent scientific findings for behavior change techniques. TRIAL REGISTRATION: ClinicalTrials.gov NCT02019134; https://clinicaltrials.gov/ct2/show/NCT02019134. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/1745-6215-15-490.
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Dolor Crónico , Aplicaciones Móviles , Adulto , Dolor Crónico/terapia , Ejercicio Físico , Humanos , Dolor de Cuello/terapia , Teléfono InteligenteRESUMEN
Importance: In observational studies, patients' treatment outcome expectations have been associated with better outcomes (ie, a placebo response), whereas concerns about adverse side effects have been associated with an in increase in the negative effects of treatments (ie, a nocebo response). Some randomized trials have suggested that communication from clinicians could affect the treatment outcomes by changing patients' expectations. Objective: To investigate whether treatment outcome expectations and reported adverse side effects could be affected by different briefing contents before a minimal acupuncture treatment in patients with chronic low back pain (CLBP). Design, Setting, and Participants: This randomized single-blinded clinical trial was conducted among patients with CLBP at 1 outpatient clinic in Switzerland who had a pain intensity of at least 4 on a numeric rating scale from 0 to 10. Different recruitment channels were used to enroll patients. Data were collected from May 2016 to December 2017 and were analyzed from June to November 2018. Interventions: Patients were randomized to receive either a regular expectation briefing or a high expectation briefing (effectiveness) and either a regular adverse side effect briefing or an intense adverse side effect briefing (adverse side effect) in a 2 × 2 factorial design. The intervention (briefing sessions and written materials) was standardized and delivered before the acupuncture treatment, with additional booster informative emails provided during the 4-week, 8-session acupuncture course. Main Outcomes and Measures: The primary end point was the patients' expectations regarding the effectiveness of the acupuncture treatment (Expectation for Treatment Scale [ETS]) after the briefing and the subsequent pain intensity (numeric rating scale). The primary end point for the adverse side effect briefing was the adverse side effect score at the end of the acupuncture treatment, derived from session-by-session assessments of adverse side effects. Results: A total of 152 patients with CLBP (mean [SD] age, 39.54 [12.52] years; 100 [65.8%] women) were included. The estimated group difference (regular vs high) for the ETS was -0.16 (95% CI -0.81 to 0.50, P = .64), indicating no evidence for a difference between intervention groups. There was also no evidence for a difference in pain intensity at the end of the acupuncture treatment between the groups with different expectation briefings. The adverse side effects score in the group with the intense adverse side effect briefing were estimated to be 1.31 times higher (95% CI, 0.94 to 1.82; P = .11) than after a regular adverse side effect briefing, but the finding was not statistically significant. Conclusions and Relevance: In this study, suggestions regarding treatment benefits (placebo) and adverse side effects (nocebo) did not affect treatment expectations or adverse side effects. Information regarding adverse side effects might require more research to understand nocebo responses. Trial Registration: German Clinical Trials Register Identifier: DRKS00010191.
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Terapia por Acupuntura , Dolor de la Región Lumbar/terapia , Educación del Paciente como Asunto , Adulto , Dolor Crónico/terapia , Femenino , Humanos , Masculino , Dimensión del Dolor , Método Simple Ciego , Resultado del TratamientoRESUMEN
Objective: We evaluated digital consultations at a University Hospital in Switzerland within an integrative medicine outpatient setting. Patients' and treatment providers' (physicians and therapists) evaluated digital conversation-based consultations as well as the digital delivery of practical exercises. Methods: Digital consultations between March 15, 2020 and April 30, 2020 were identified. Between June and July 2020, patients and treatment providers completed online questionnaires addressing challenges and advantages of their digital consultations. Both groups documented their satisfaction and working alliance (Working Alliance Inventory). In addition, semistructured qualitative interviews with treatment providers were conducted. Findings: A total of 82 online surveys (response rate 47%) about the digital consultations were available for analyses, with 60 patients correctly identifying at least one treatment provider, and 9 interviews were performed. Patients and treatment providers overall evaluated the new setting of digital consultation as feasible and an efficient consultation format. Interestingly, the working alliance was rated as good. Technical problems were mentioned as the main challenge and the delivery of practical exercises in digital consultations was seen more challenging than having digital conversation-based consultations. Conclusion: Digital consultations were established with overall positive evaluations and with a good working alliance between patients and providers. For the delivery of practical exercises it might be required to develop more innovative digital settings to overcome shortcomings of the digital format. Hybrid settings that combine the best of both settings could be a good option for future in postpandemic times.
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Actitud del Personal de Salud , Accesibilidad a los Servicios de Salud , Medicina Integrativa , Satisfacción del Paciente , Telemedicina/métodos , Adulto , Anciano , Anciano de 80 o más Años , COVID-19/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pandemias , SARS-CoV-2 , Encuestas y Cuestionarios , Suiza/epidemiología , Adulto JovenRESUMEN
Background: Cancer patients often suffer from high levels of distress. Mobile health (mHealth) applications might be an innovative way to deliver mindfulness and relaxation interventions for cancer patients. However, data about the implementation of apps in health care are lacking. Adherence to mHealth interventions is an important indicator for a successful implementation and might be needed to maximize treatment effects. However, the decrease in distress might reduce the motivation of patients to engage in such self-care tools in the long run. Therefore, the aim of this analysis was to investigate the association between the course of distress over time and the adherence to a relaxation self-care app in cancer patients. Methods: We developed an app for cancer patients (CanRelax) and 83 patients who participated in the prospective observational study used the app at least once. The evaluation was guided by the RE-AIM framework, and this analysis focused on the implementation of the app. Patients were grouped into five subgroups according to their course of distress over 10 weeks (Distress Thermometer). These subgroups of patients were compared with each other to identify different user groups. Findings: About half of the patients were adherent over 10 weeks. However, a decrease in distress was associated with lower adherence to the app intervention, whereas patients with moderate distress or an increase in distress showed more adherence. Conclusion: Adherence to an app intervention might be also driven by patients' distress level. A decrease in distress might reduce patients' motivation to continue with a self-care intervention. The interplay between adherence and treatment outcomes should be explored in upcoming mHealth trials to get a better understanding for the implementation of such interventions. Encouraging patients to continue self-care interventions is a major challenge in integrative medicine if they are delivered digitally. The Clinical Trial Registration number: DRKS00010481.
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Aplicaciones Móviles , Neoplasias , Cooperación del Paciente , Autocuidado , Adolescente , Adulto , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Atención Plena , Neoplasias/psicología , Neoplasias/terapia , Calidad de Vida , Terapia por Relajación , Estrés Psicológico/terapia , Telemedicina , Adulto JovenRESUMEN
BACKGROUND: Chinese eye acupuncture, focuses on treating different diseases by applying needle stimulation around the orbit of the eye. Since 1970, it has been used in China for the management of pain-related disorders. This scoping review systematically collected clinical studies on the use of eye acupuncture to treat pain conditions and identify any adverse events. METHODS: Six databases including PubMed, the Cochrane Library, CNKI, VIP, Wan Fang Data and SinoMed were searched from 1970 to March 2019. Randomized controlled trials (RCTs), clinical controlled trials (CCTs) and case series on eye-acupuncture for pain conditions meeting the inclusion criteria were identified. Data were extracted on patients, interventions, details of eye acupuncture, control treatments and outcomes. RESULTS: Searches identified 81 clinical studies and a trend demonstrating an increasing number of published studies. All studies were conducted in China and published in Chinese. These included, 45 (55.6%) RCTs, 5 (6.2%) CCTs, and 31 (38.3%) case series, treating 7113 patients with 44 different pain-related diseases or symptoms. The most frequently reported conditions were headache (18, 16.2%), acute lumbar pain (7, 6.3%) and lumbar disc herniation (7, 6.3%). Treatment using small needles (φ0.25 × 13 mm), retained ≤30 min, needling the horizontal outer orbital edge and the avoidance of manipulation during treatment were the most frequent descriptions of the interventions used. Eye acupuncture was used alone in about half of the studies and of the remaining studies it was combined with other treatment. All studies suggested some beneficial effects including: pain relief, improved quality of life and mental health, and 18 (22.2%) adverse events. CONCLUSION: Eye acupuncture, predominantly studied in China, may be a promising intervention for managing diverse pain conditions. However, given the variety of study designs and reported treatment outcomes, conclusions about the evidence for eye acupuncture for specific conditions are not possible at this stage.
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Terapia por Acupuntura , Ojo , Manejo del Dolor/métodos , Puntos de Acupuntura , Cefalea/terapia , Humanos , Dolor de la Región Lumbar/terapia , Dolor , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Cancer diagnosis and cancer treatment can cause high levels of distress, which is often not sufficiently addressed in standard medical care. Therefore, a variety of supportive nonpharmacological treatments have been suggested to reduce distress in patients with cancer. However, not all patients use these interventions because of limited access or lack of awareness. To overcome these barriers, mobile health may be a promising way to deliver the respective supportive treatments. OBJECTIVE: The aim of this study is to evaluate the effects and implementation of a mindfulness and relaxation app intervention for patients with cancer as well as patients' adherence to such an intervention. METHODS: In this observational feasibility study with a mixed methods approach, patients with cancer were recruited through the web and through hospitals in Switzerland. All enrolled patients received access to a mindfulness and relaxation app. Patients completed self-reported outcomes (general health, health-related quality of life, anxiety, depression, distress, mindfulness, and fear of progression) at baseline and at weeks 4, 10, and 20. The frequency of app exercise usage was gathered directly through the app to assess the adherence of patients. In addition, we conducted interviews with 5 health professionals for their thoughts on the implementation of the app intervention in standard medical care. We analyzed patients' self-reported outcomes using linear mixed models (LMMs) and qualitative data with content analysis. RESULTS: A total of 100 patients with cancer (74 female) with a mean age of 53.2 years (SD 11.6) participated in the study, of which 25 patients used the app regularly until week 20. LMM analyses revealed improvements in anxiety (P=.04), distress (P<.001), fatigue (P=.01), sleep disturbance (P=.02), quality of life (P=.03), and mindfulness (P<.001) over the course of 20 weeks. Further LMM analyses revealed a larger improvement in distress (P<.001), a moderate improvement in anxiety (P=.001), and a larger improvement in depression (P=.03) in patients with high levels of symptoms at baseline in the respective domains. The interviews revealed that the health professionals perceived the app as a helpful addition to standard care. They also made suggestions for improvements, which could facilitate the implementation of and adherence to such an app. CONCLUSIONS: This study indicates that a mindfulness and relaxation app for patients with cancer can be a feasible and effective way to deliver a self-care intervention, especially for highly distressed patients. Future studies should investigate if the appeal of the app can be increased with more content, and the effectiveness of such an intervention needs to be tested in a randomized controlled trial.
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Background: There is currently no effective treatment against coronavirus disease 2019 (COVID-19). The optimal selection of interventions targeting the virus is unknown. Therefore, evidence from randomized controlled trials (RCTs) to support specific treatment against COVID-19 is urgently needed. The use of Chinese herbal medicines (CHMs) might have a role in the treatment and symptomatic management of patients with COVID-19. It was aimed at providing an overview of the available evidence and ongoing trials concerning the effects of CHMs for the treatment of COVID-19. Methods: This is a narrative review of relevant studies. Searches were conducted to identify documents published till April 22, 2020. Electronic databases, evidence-based collections, websites of relevant organizations, and trial registries were consulted. Results: A total of 25 guidelines on the treatment of patients with COVID-19 were identified. Four guidelines provided recommendations on the use of CHMs; these guidelines were developed in China and South Korea and were based on the consensus of experts exclusively. The remaining 21 guidelines provided no guidance on CHMs. No finished RCTs of CHMs for the treatment of patients with COVID-19 was found. According to the evidence evaluated in this review, a Cochrane review of CHMs for severe acute respiratory syndrome and five uncontrolled observational studies of the effects of CHMs in patients with COVID-19, the effects of CHMs for COVID-19 are unknown. A total of 52 ongoing clinical trials of CHM interventions for the treatment of COVID-19 were found. These trials will be carried out mostly in China (n = 51). Forty (77%) of the ongoing trials will be randomized, whereas 12 (23%) have an unclear sequence generation procedure. Forty-seven trials (90%) will have a sample size <400 participants. Conclusions: To the authors' knowledge, only the Chinese and the South Korean guidelines recommend CHMs as a treatment option for patients with COVID-19. These guidelines base their recommendations on the consensus of experts. Clinical guidelines or health authorities from other countries do not provide advice on CHMs. Due to the absence of RCT, there is currently no reliable evidence on the effects of any specific CHM intervention for the treatment of patients with COVID-19. A high number of clinical trials of different herbal products are being currently conducted in China.
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Infecciones por Coronavirus/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Medicina Tradicional China/métodos , Fitoterapia/métodos , Neumonía Viral/tratamiento farmacológico , COVID-19 , China , Humanos , Control de Infecciones/métodos , Pandemias , República de Corea , Resultado del Tratamiento , Tratamiento Farmacológico de COVID-19RESUMEN
Acupuncture is a complementary and nonpharmacological intervention that can be effective for the management of chronic pain in addition to or instead of medication. Various animal models for neuropathic pain, inflammatory pain, cancer-related pain, and visceral pain already exist in acupuncture research. We used a newly validated human pain model and examined whether acupuncture can influence experimentally induced dental pain. For this study, we compared the impact of manual acupuncture (real acupuncture), manual stimulation of a needle inserted at nonacupuncture points (sham acupuncture) and no acupuncture on experimentally induced dental pain in 35 healthy men who were randomized to different sequences of all 3 interventions in a within-subject design. BORG CR10 pain ratings and autonomic responses (electrodermal activity and heart rate variability) were investigated. An initial mixed model with repeated measures included preintervention pain ratings and the trial sequence as covariates. The results showed that acupuncture was effective in reducing pain intensity when compared to no acupuncture (ßâ¯=â¯-.708, Pâ¯=â¯.002), corresponding to a medium Cohen's d effect size of .56. The comparison to the sham acupuncture revealed no statistically significant difference. No differences in autonomic responses between real and sham acupuncture were found during the intervention procedures. PERSPECTIVE: This study established a dental pain model for acupuncture research and provided evidence that experimentally induced dental pain can be influenced by either real acupuncture or manual stimulation of needles at nonacupuncture points. The data do not support that acupoint specificity is a significant factor in reducing experimental pain.
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Terapia por Acupuntura , Evaluación de Resultado en la Atención de Salud , Odontalgia/terapia , Adulto , Estudios Cruzados , Respuesta Galvánica de la Piel/fisiología , Frecuencia Cardíaca/fisiología , Humanos , Masculino , Medicina Tradicional China , Dimensión del Dolor , Placebos , Adulto JovenRESUMEN
OBJECTIVE: To develop a short self-report instrument for the assessment of expectations (Expectation for Treatment Scale(ETS)) using acupuncture as a case example. DESIGN: A cross-sectional assessment with retest after 1 week. SETTING: A web-based survey with patients suffering from pain. METHODS: In a three-step approach, we reduced the initially collected number of items from 17 to 9 and to 5, including expectations about coping ability, vitality, physical health and reduction of patient complaints. Items were selected according to internal consistency (Cronbach's alpha); convergent and divergent validities with related constructs (optimism, pessimism, resilience, perceived sensitivity to medicines, depression and others); 1-week retest reliability (intraclass correlation coefficient (ICC)); and exploratory and confirmatory factor analysis (CFA). RESULTS: A total of 102 patients suffering from pain were included, and 54 of these patients completed the retest assessment. The final version of the ETS consisted of five items and had an excellent Cronbach's alpha (0.90), with 72.33% variance on one single factor. Depression, pessimism and perceived sensitivity to medicines showed positive correlations with our expectation measure (r=0.23, r=0.20 and r=0.34, respectively); the correlation between the ETS and optimism was low (r=-0.07) and no correlation between the ETS and resilience was found (r=-0.07). Convergent validity was confirmed with a high correlation (r>0.90) between ETS and a treatment-specific measure of expectations. The retest ICC was 0.86, which showed high stability over 1 week. A CFA (n=439) with data from patients with low back pain confirmed the single-factor structure of the instrument. CONCLUSION: The ETS showed strong psychometric properties and covered a distinct construct. As the next step, the ETS might be implemented in different clinical conditions and settings to investigate psychometrics and its predictive power for treatment outcomes.
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Terapia por Acupuntura , Manejo del Dolor/métodos , Dimensión del Dolor/instrumentación , Satisfacción del Paciente/estadística & datos numéricos , Autoinforme/estadística & datos numéricos , Adulto , Estudios Transversales , Evaluación de la Discapacidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Manejo del Dolor/normas , Medición de Resultados Informados por el Paciente , PsicometríaRESUMEN
BACKGROUND: Cancer is highly prevalent worldwide and can cause high levels of distress in patients, which is often neglected in medical care. Smartphone apps are readily available and therefore seem promising to deliver distress-reducing interventions such as mindfulness and relaxation programs. OBJECTIVE: This study aimed to evaluate the feasibility of a mindfulness and relaxation app for cancer patients. We looked at characteristics of participating patients in a mobile health (mHealth) study, including adherence to the app intervention, predictors for adherence, and patients' feedback regarding the app. METHODS: In this prospective observational study with a mixed-methods approach, cancer patients received a mindfulness and relaxation self-care app. Cancer patients were recruited online and through hospitals in Switzerland. We assessed self-reported measures (eg, quality of life, anxiety, depressive symptoms, openness to experience, resistance to change) at baseline, and the app gathered data on patients' practicing time. With 8 semistructured interviews, we obtained patients' feedback about the app and recommendations for improvements. We looked at 3 dimensions of the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework (reach, adoption, and maintenance) and analyzed data for adherence for the first 10 weeks of the app intervention. We report descriptive statistics for patient characteristics and app use. For the prediction of adherence, we used Kaplan-Meier analyses with log-rank tests and a Cox proportional hazards regression. RESULTS: Data from 100 cancer patients (74 female) showed that 54 patients were using the app exercises continuously until week 10. In continuous app users, the median number of exercises per week dropped from 4 (interquartile range, IQR 1-7) at week 1 to a median of 2 (IQR 1-4) at week 10. Our analyses revealed 4 significant predictors for better adherence: female gender, higher openness to experience, higher resistance to change, and more depressive symptoms. Interviews revealed that the patients generally were satisfied with the app but also made suggestions on how to improve it. CONCLUSIONS: Our study indicates that a mindfulness and relaxation mHealth intervention for cancer patients is feasible with acceptable adherence and largely positive feedback from patients. TRIAL REGISTRATION: German Clinical Trials Register DRKS00010481; https://www.drks.de/drks_web/navigate.do?navigation Id=trial.HTML&TRIAL_ID=DRKS00010481 (Archived by WebCite at http://www.webcitation.org/73xGE1B0P).
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INTRODUCTION: Post-traumatic stress disorder (PTSD) is common among children and adolescents who are exposed to trauma, and it is often associated with significant negative impacts on their psychosocial functioning and quality of life. Many types of psychotherapies have been found to be effective for PTSD in children and adolescents. However, due to the lack of direct comparisons between different psychotherapies, the hierarchy of treatment efficacy is still unclear. Therefore, we plan to conduct a systematic review and network meta-analysis to evaluate the efficacy and acceptability of various types of psychotherapies for PTSD in children and adolescents. METHODS AND ANALYSIS: A systematic search will be conducted among eight electronic databases, including PubMed, Cochrane, Embase, Web of Science, PsycINFO, Cumulative Index of Nursing and Allied Health, Published International Literature on Traumatic Stress (PILOTS) and ProQuest Dissertations, from inception to October 2017. Randomised controlled trials, regardless of language, publication year and publication type, comparing any psychotherapies for PTSD to any control condition or alternative treatment in children and adolescents (18 years old or less) diagnosed with full or subclinical PTSD will be included. Study duration and the number of treatment sessions will not be limited. The primary outcome will be PTSD symptom severity at post-treatment as measured by a rating scale reported by the child, parent or a clinician. The secondary outcomes will include: (1) efficacy at follow-up; (2) acceptability (all-cause discontinuation); (3) anxiety symptom severity; (4) depressive symptom severity and (5) quality of life and functional improvement. Bayesian network meta-analyses for all relative outcome measures will be performed. We will conduct subgroup and sensitivity network meta-analyses to determine whether the findings are affected by study characteristics. The quality of the evidence contributing to network estimates of the primary outcome will be evaluated by the Grading of Recommendations, Assessment, Development and Evaluations framework. ETHICS AND DISSEMINATION: No ethical issues are foreseen. The results will be published in a peer-reviewed journal, which will be disseminated electronically and in print. This network meta-analysis may be updated to inform and guide the clinical management of PTSD in children and adolescents. PROSPERO REGISTRATION NUMBER: CRD42016051786.
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Salud Mental , Aceptación de la Atención de Salud/estadística & datos numéricos , Psicoterapia , Trastornos por Estrés Postraumático/terapia , Adolescente , Niño , Protocolos Clínicos , Medicina Basada en la Evidencia , Humanos , Metaanálisis en Red , Aceptación de la Atención de Salud/psicología , Trastornos por Estrés Postraumático/psicología , Revisiones Sistemáticas como Asunto , Resultado del TratamientoRESUMEN
PURPOSE: This systematic review aims to summarize eHealth studies with mindfulness- and relaxation-based interventions for medical conditions and to determine whether eHealth interventions have positive effects on health. METHOD: A comprehensive search of five databases was conducted for all available studies from 1990 to 2015. Studies were included if the intervention was mainly technology delivered and included a mindfulness- or relaxation-based intervention strategy and if patients with a medical condition were treated. Treatment effects were summarized for different outcomes. RESULTS: A total of 2383 records were identified, of which 17 studies with 1855 patients were included in this systematic review. These studies were conducted in patients with irritable bowel syndrome, chronic fatigue syndrome, cancer, chronic pain, surgery, and hypertension. All but one study were delivered online through a web-based platform; one study delivered the intervention with iPods. The studies indicate that mindfulness- and relaxation-based eHealth interventions can have positive effects on patients' general health and psychological well-being. No effects were found for stress or mindfulness. Only five studies reported economic analyses of eHealth interventions without any clear conclusion. CONCLUSION: There is some evidence that mindfulness- and relaxation-based eHealth interventions for medical conditions can have positive effects on health outcomes. Therefore, such interventions might be a useful addition to standard medical care. No app studies were retrieved, even though a vast number of smartphone apps exist which aim at increasing users' health. Therefore, more studies investigating those health apps are needed.
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Dolor Crónico/terapia , Terapia Cognitivo-Conductual/métodos , Atención Plena/métodos , Educación del Paciente como Asunto , Terapia por Relajación/métodos , Telemedicina/métodos , Adaptación Psicológica , Dolor Crónico/psicología , HumanosRESUMEN
Fragestellung: Im Zusammenhang mit der Einführung ambulanter KM-Sprechstunden am Regionalspital Burgdorf wurde die ärztliche Einstellung zu Komplementärmedizin (KM) untersucht. Weiterhin wurden der Anteil der Ärzte mit KM-Angeboten im Versorgungsgebiet des Regionalspitals, deren KM-Erfahrungen sowie der Einfluss dieser Erfahrungen auf die Einstellung gegenüber KM untersucht. Material und Methoden: Alle Ärzte jeglicher Fachrichtung (n = 170) im Versorgungsgebiet wurden 2011 und 2012 schriftlich zu ihrer Einstellung gegenüber KM (Befürwortung/Ablehnung und Ambivalenz), ihrem KM-Angebot und ihren KM-Erfahrungen befragt (Rücklaufquote 45% bzw. 36%). Ergebnisse: Die Einstellung gegenüber KM war im Durchschnitt neutral (M = 2,47, Standardabweichung (SD) = 0,61; Befürwortung von KM von 1 = «stimme völlig zu¼ bis 4 = «stimme überhaupt nicht zu¼) und klar (M = 1,59, SD = 0,46; Einstellungsambivalenz von 1 = «habe klare Meinung¼ bis 4 = «bin mir sehr unsicher in meiner Meinung¼). Die höchste Zustimmung erhielten die Forderungen nach wissenschaftlicher Untersuchung der KM (M = 2,10, SD = 0,95) und nach zertifizierter ärztlicher KM in der Grundversicherung (M = 2,53, SD = 1,15). Knapp ein Drittel der Ärzte bot KM an, und 77% bzw. 69% überwiesen Patienten zu KM-Behandlungen. Die wichtigsten Prädiktoren der KM-Befürwortung waren eine zertifizierte KM-Ausbildung und unerwartete positive bzw. negative Verläufe unter einer KM-Behandlung (R22011 = 0,44, p < 0,001). 25% der Ärzte hatten Erfahrungen mit der neuen KM-Sprechstunde, die überwiegend positiv waren. Schlussfolgerung: Die teilnehmenden Ärzte aus einer ländlichen Region der Schweiz zeigten im Durchschnitt eine neutrale und klare Einstellung zur KM, die sich im eigenen KM-Angebot bzw. in der Überweisungspraxis spiegelte.
Asunto(s)
Actitud del Personal de Salud , Terapias Complementarias/estadística & datos numéricos , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Población Rural , SuizaRESUMEN
BACKGROUND: This is an update of a Cochrane review previously published in 2014. Acute postoperative pain is one of the most disturbing complaints in open heart surgery, and is associated with a risk of negative consequences. Several trials investigated the effects of psychological interventions to reduce acute postoperative pain and improve the course of physical and psychological recovery of participants undergoing open heart surgery. OBJECTIVES: To compare the efficacy of psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention control in adults undergoing open heart surgery for pain, pain medication, psychological distress, mobility, and time to extubation. SEARCH METHODS: For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, and PsycINFO for eligible studies up to February 2017. We used the 'related articles' and 'cited by' options of eligible studies to identify additional relevant studies. We checked lists of references of relevant articles and previous reviews. We searched the ProQuest Dissertations and Theses Full Text Database, ClinicalTrials and the WHO International Clinical Trials Registry Platform to identify any unpublished material or ongoing trials. We also contacted the authors of primary studies to identify any unpublished material. In addition, we wrote to all leading heart centres in Germany, Switzerland, and Austria to check whether they were aware of any ongoing trials. SELECTION CRITERIA: Randomised controlled trials comparing psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention in adults undergoing open heart surgery. DATA COLLECTION AND ANALYSIS: Two review authors (SZ and SK) independently assessed trials for eligibility, estimated the risk of bias and extracted all data. We calculated effect sizes for each comparison (Hedges' g) and meta-analysed data using a random-effects model. We assessed the evidence using GRADE and created 'Summary of findings' tables. MAIN RESULTS: We added six studies to this update. Overall, we included 23 studies (2669 participants).For the majority of outcomes (two-thirds), we could not perform a meta-analysis since outcomes were not measured, or data were provided by one trial only.No study reported data on the number of participants with pain intensity reduction of at least 50% from baseline. Only one study reported data on the number of participants below 30/100 mm on the Visual Analogue Scale (VAS) in pain intensity (very low-quality evidence). Psychological interventions did not reduce pain intensity in the short-term interval (g 0.39, 95% CI -0.18 to 0.96, 2 studies, 104 participants, low-quality evidence), medium-term interval (g -0.02, 95% CI -0.24 to 0.20, 4 studies, 413 participants, moderate-quality evidence) or in the long-term interval (g 0.05, 95% CI -0.20 to 0.30, 2 studies, 200 participants, moderate-quality evidence).No study reported data on median time to re-medication or on number of participants re-medicated. Only two studies provided data on postoperative analgesic use in the short-term interval, showing that psychological interventions did not reduce the use of analgesic medication (g 1.18, 95% CI -2.03 to 4.39, 2 studies, 104 participants, low-quality evidence). Studies revealed that psychological interventions reduced mental distress in the medium-term (g 0.37, 95% CI 0.13 to 0.60, 13 studies, 1388 participants, moderate-quality evidence) and likewise in the long-term interval (g 0.32, 95% CI 0.10 to 0.53, 14 studies, 1586 participants, moderate-quality evidence). Psychological interventions did not improve mobility in the medium-term interval (g 0.23, 95% CI -0.22 to 0.67, 3 studies, 444 participants, low-quality evidence), nor in the long-term interval (g 0.09, 95% CI -0.10 to 0.28, 4 studies, 458 participants, moderate-quality evidence). Only two studies reported data on time to extubation, indicating that psychological interventions reduced the time to extubation (g 0.56, 95% CI 0.08 to 1.03, 2 studies, 154 participants, low-quality evidence).Overall, the very low to moderate quality of the body of evidence on the efficacy of psychological interventions for acute pain after open heart surgery cannot be regarded as sufficient to draw robust conclusions.Most 'Risk of bias' assessments were low or unclear. We judged selection bias (random sequence generation) and attrition bias to be mostly low risk for included studies. However, we judged the risk of selection bias (allocation concealment), performance bias, detection bias and reporting bias to be mostly unclear. AUTHORS' CONCLUSIONS: In line with the conclusions of our previous review, there is a lack of evidence to support or refute psychological interventions in order to reduce postoperative pain in participants undergoing open heart surgery. We found moderate-quality evidence that psychological interventions reduced mental distress in participants undergoing open heart surgery. Given the small numbers of studies, it is not possible to draw robust conclusions on the efficacy of psychological interventions on outcomes such as analgesic use, mobility, and time to extubation respectively on adverse events or harms of psychological interventions.
Asunto(s)
Dolor Agudo/terapia , Terapia Conductista/métodos , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Dolor Postoperatorio/terapia , Terapia por Relajación/métodos , Dolor Agudo/psicología , Adulto , Anciano , Analgésicos/uso terapéutico , Terapia Cognitivo-Conductual , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Dolor Postoperatorio/psicología , Ensayos Clínicos Controlados Aleatorios como Asunto , Estrés Psicológico/epidemiologíaRESUMEN
BACKGROUND: Mindfulness-based stress reduction (MBSR) is frequently used to treat pain-related conditions, but its effects on low back pain are uncertain. PURPOSE: To assess the efficacy and safety of MBSR in patients with low back pain. DATA SOURCES: Searches of MEDLINE/PubMed, Scopus, the Cochrane Library, and PsycINFO to 15 June 2016. STUDY SELECTION: Randomized controlled trials (RCTs) that compared MBSR with usual care or an active comparator and assessed pain intensity or pain-related disability as a primary outcome in patients with low back pain. DATA EXTRACTION: Two reviewers independently extracted data on study characteristics, patients, interventions, outcome measures, and results at short- and long-term follow-up. Risk of bias was assessed using the Cochrane risk-of-bias tool. DATA SYNTHESIS: Seven RCTs involving 864 patients with low back pain were eligible for review. Compared with usual care, MBSR was associated with short-term improvements in pain intensity (4 RCTs; mean difference [MD], -0.96 point on a numerical rating scale [95% CI, -1.64 to -0.34 point]; standardized mean difference [SMD], -0.48 point [CI, -0.82 to -0.14 point]) and physical functioning (2 RCTs; MD, 2.50 [CI, 0.90 to 4.10 point]; SMD, 0.25 [CI, 0.09 to 0.41 point]) that were not sustained in the long term. Between-group differences in disability, mental health, pain acceptance, and mindfulness were not significant at short- or long-term follow-up. Compared with an active comparator, MBSR was not associated with significant differences in short- or long-term outcomes. No serious adverse events were reported. LIMITATION: The number of eligible RCTs was limited; only 3 evaluated MBSR against an active comparator. CONCLUSION: Mindfulness-based stress reduction may be associated with short-term effects on pain intensity and physical functioning. Long-term RCTs that compare MBSR versus active treatments are needed in order to best understand the role of MBSR in the management of low back pain. PRIMARY FUNDING SOURCE: None.
Asunto(s)
Dolor de la Región Lumbar/psicología , Dolor de la Región Lumbar/terapia , Atención Plena , Estrés Psicológico/terapia , Humanos , Cooperación del Paciente , Calidad de Vida , Estrés Psicológico/etiologíaRESUMEN
UNLABELLED: Our study aimed to identify patient-provider clusters with different patterns of expectations for treatment outcomes. All patients (n = 885) received acupuncture treatment from physicians for their migraine, headache, osteoarthritis, or chronic low back pain. We identified 6 robust patient-provider expectation clusters (PPECs; interclassification reliability >.89) showing differences between patients and providers in their expected treatment responses (eg, unrealistic optimists, optimistic doubters). For example, the optimistic doubters had high expectations for their treatment outcomes but were skeptical of the benefits of acupuncture in general. The providers expected good improvements for these patients. These 6 PPECs differed in their clinical characteristics and in the associated treatment responses. For example, unrealistic optimists showed the weakest treatment benefits after 6 months; other PPECs and clinical patterns are also presented in the report. Our study suggests that comparing the expectations of patients and providers is a valuable approach to identify groups of patients with greater responsiveness and those with limited treatment benefits. PERSPECTIVE: Patients and providers of acupuncture might vary in their expectation of the treatment effect and in clinical practice the overlap of expectations of patients and providers should be considered as important in initial consultations.
Asunto(s)
Terapia por Acupuntura , Satisfacción del Paciente , Médicos/psicología , Resultado del Tratamiento , Terapia por Acupuntura/métodos , Terapia por Acupuntura/psicología , Adulto , Anciano , Análisis por Conglomerados , Femenino , Humanos , Dolor de la Región Lumbar/terapia , Masculino , Persona de Mediana Edad , Trastornos Migrañosos/terapia , Osteoartritis/terapia , Dimensión del Dolor , Valor Predictivo de las Pruebas , Estadística como AsuntoRESUMEN
OBJECTIVES: The aim of the study was to assess the effect of art including ambient features such as music, interior design including visual art, and architectural features on health outcomes in surgical patients. BACKGROUND: Healing environments can have a positive influence on many patients, but data focusing on art in surgical patients remain scarce. METHODS: We conducted a systematic search following the PRISMA guidelines from January 2000 to October 2014 on art in surgical patients. For music interventions, we pooled controlled studies measuring health outcomes (eg, pain, anxiety, blood pressure, and heart rate) in a meta-analysis. For other art forms (ambient and architectural features and interior design), we did a narrative review, also including nonsurgical patients, and looked for examples covering 3 countries. RESULTS: Our search identified 1101 hits with 48 studies focusing on art in surgical patients: 47 studies on musical intervention and 1 on sunlight. The meta-analysis of these studies disclosed significant effects for music on pain after surgery, anxiety, systolic blood pressure, and heart rate, when compared with control groups without music. Effects of music were larger with self-selected music, and lower in surgical interventions performed under general anesthesia. Interior design features such as nature images and more spacious rooms, and architectural features providing more sunlight had positive effects on anxiety and postoperative pain. CONCLUSIONS: Self-selected music for surgical patients is an effective and low-cost intervention to enhance well being and possibly faster recovery. Although potentially very important, the impact of environmental features and spacious architecture with wide access to sunlight remains poorly explored in surgery. Further experimental research is needed to better assess the magnitude of the impact and cost effectiveness.