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1.
Breast Cancer Res Treat ; 178(3): 617-628, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31520284

RESUMO

PURPOSE: This study investigated the effect of additional prophylactic acupuncture during chemotherapy on quality of life and side effects compared to standard treatment alone in breast cancer patients. METHODS: In a pragmatic trial, newly diagnosed breast cancer patients were randomized to additional acupuncture treatments over 6 months or standard care alone (control group). The primary outcome was the disease-specific quality of life (FACT-B). Twenty qualitative semi-structured interviews were conducted with ten patients from each group regarding their subjective experiences. RESULTS: A total of 150 women (mean age 51.0 (SD 10.0) years) were randomized. For the primary endpoint, FACT-B total score after 6 months, no statistically significant difference was found between groups (acupuncture: 103.5 (95%, CI 88.8 to 107.2); control (101.4 (- 97.5 to 105.4); difference 2.0 (- 3.4 to 7.5) p = 0.458)). Qualitative content analyses showed that patients in the acupuncture group described positive effects on psychological and physical well-being. For both patient groups, coping strategies were more important than reducing side effects. CONCLUSIONS: Breast cancer patients receiving prophylactic acupuncture during chemotherapy did not show better quality of life in the questionnaires in contrast to the reported positive effects in the qualitative interviews. Coping strategies for cancer appear to be important. TRIAL REGISTRATION: clinicaltrials.gov; NCT01727362. Prospectively registered 11 July 2012; https://clinicaltrials.gov/ct2/show/NCT01727362 . The manuscript adheres to CONSORT guidelines.

2.
Complement Med Res ; 26(5): 310-321, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31141810

RESUMO

OBJECTIVE: Some nursing homes for the elderly in Germany integrate complex complementary and integrative medicine interventions in the form of hydrotherapy, herbal and mind-body therapies, physical activities, and healthy eating, known as Kneipp therapy (KT), in care. This pilot study explored health- and work-related characteristics and acceptance of KT amongst residents and caregivers. METHODS: Within a mixed-methods cross-sectional study in nursing homes who had integrated KT, we assessed work ability, psychosocial burden at work and health-related quality of life of caregivers, as well as a broad selection of health-related data of residents by questionnaires and assessments. Data were analyzed descriptively. RESULTS: The data from 29 female caregivers (42.0 ± 11.7 years) and 64 residents (83.2 ± 8.1 years) were analyzed. Both caregivers (96%) and residents (89%) considered KT to be beneficial for health and well-being. Ninety percent of the caregivers indicated an improved relationship to residents since implementing KT. Caregivers showed a good work ability and quality of life. Residents attained remarkable ratings in social relation and affect-related aspects of quality of life. CONCLUSION: The results of this cross-sectional study indicate a high acceptance of integrating KT by residents and caregivers. The effectiveness and safety of KT should be explored in further comparative studies.

4.
Complement Med Res ; 26(3): 195-205, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30947178

RESUMO

BACKGROUND: Intentional Touch (InTouch) refers to a soft physical touch with the aim to ease complaints and enhance well-being. Central questions were perception of InTouch by nurses and patients and possible effects on pain perception. PATIENTS AND METHODS: InTouch was developed by stakeholder involvement. Nurses working in geriatric care received expert training in InTouch. Semi-structured interviews and participant observation (including video recording) were conducted with nurses applying and patients with chronic pain receiving InTouch after the beginning of the intervention and after 4 weeks. Interviews were analyzed based on Qualitative Content Analysis and video recordings based on Qualitative Visual Analysis. RESULTS: Six elderly patients with chronic pain and 6 nurses were included. Nurses and patients equally described relaxation, well-being, and a sensation of warmth during the intervention. Patients reported no pain during the intervention. After the intervention, 3 patients each experienced pain relief or no change. Patients described better drive and positive feelings, and nurses felt empowered in their nursing work. Empathetic attention had special importance for improving the therapeutic relationship. CONCLUSION: The results of this study suggest that InTouch promoted relaxation, well-being, and pain relief for elderly people suffering from chronic pain and may contribute positively to the therapeutic relationship.


Assuntos
Dor Crônica/enfermagem , Dor Crônica/terapia , Enfermagem Geriátrica/estatística & dados numéricos , Toque Terapêutico/normas , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Alemanha , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Percepção da Dor , Projetos Piloto , Toque Terapêutico/enfermagem , Toque Terapêutico/psicologia
5.
Patient ; 12(3): 349-360, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30565073

RESUMO

BACKGROUND: The effects of health interventions are often complex, and it is argued that they comprise more than pure changes in clinical parameters. Aspects of the treatment process, so-called 'benefits beyond health', are often overlooked in the evaluation of health interventions but can be of value to the patients. OBJECTIVES: The aim of this study was to assess patients' preferences and willingness to pay regarding the treatment process and its attributes in patients using acupuncture, homeopathy or general medicine (GM). METHODS: A systematic literature search, six semi-structured interviews and a stakeholder involvement were conducted to determine the attributes of the treatment process. Five process attributes and one cost attribute were used to construct the experimental design of the discrete choice experiment (DCE) (6 × 3), a cross sectional survey method. Patients were recruited by outpatient physicians practicing in Berlin and Munich, Germany. Process attributes were effects-coded. Data were analyzed in a conditional logit regression. RESULTS: Data from 263 patients were analyzed. DCE results showed that the treatment process attributes 'active listening' and 'time' were most relevant to all patients. Preferences for the attributes 'holistic treatment' (more relevant to the acupuncture and homeopathy groups) and 'information' (more relevant to the GM group) seemed to differ slightly between the groups. Willingness-to-pay values were higher in the acupuncture and homeopathy groups. CONCLUSIONS: The time physicians take and the extent to which they listen attentively are most important and are equally important to all patients. These results may contribute to the debate about more patient-centered healthcare. They support a strengthening of medical consultations in the German healthcare system. We suggest giving physicians the opportunity to spend more time with their patients, which may be achieved by changing the general conditions of remuneration (e.g., improved reimbursement of medical consultations). GERMAN CLINICAL TRIAL REGISTER: DRKS00013160.

6.
Acupunct Med ; 36(3): 139-145, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29440045

RESUMO

BACKGROUND: Seasonal allergic rhinitis (SAR) is a common disease that has detrimental effects on the quality of life (QoL) of affected individuals. Approximately 18% of patients try to alleviate their symptoms through acupuncture. The ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) study (ClinicalTrials.gov registration no. NCT00610584) assessed the impact of acupuncture on SAR, showing significant improvements in rhinitis-specific QoL (RQoL) and in rescue medication (RM) use. OBJECTIVE: A secondary analysis of SAR patients' use of antihistamine. METHODS: Patients were randomised into three study groups: acupuncture plus RM, sham acupuncture plus RM, and RM alone. The patients documented their medication use before and during the intervention period (8 weeks). The main outcome was the number of days with antihistamine use. Statistical analyses were conducted using parametric and non-parametric tests. The robustness of the results was tested by sensitivity analyses using non-parametric bootstrapping. RESULTS: The data from 414 patients were analysed. The acupuncture group used antihistamines significantly less often compared with the other groups (acupuncture vs sham acupuncture: mean difference -4.49 days, p=0.01; acupuncture vs RM: mean difference -9.15 days, p<0.001). Approximately 38% of the acupuncture group did not use any antihistamine in contrast to only 16% in the RM group. The pre-post comparison suggested that the acupuncture patients did not need to increase the days of antihistamine use to alleviate their symptoms, unlike the other groups. CONCLUSIONS: Acupuncture appeared to significantly reduce the number of days of antihistamine use while improving RQoL and SAR symptoms; it can therefore be considered a valuable, additional treatment option for patients with SAR. TRIAL REGISTRATION NUMBER: NCT00610584; Post-results.


Assuntos
Terapia por Acupuntura , Antagonistas dos Receptores Histamínicos/administração & dosagem , Rinite Alérgica Sazonal/terapia , Adolescente , Adulto , Relação Dose-Resposta a Droga , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Rinite Alérgica Sazonal/tratamento farmacológico , Resultado do Tratamento , Adulto Jovem
7.
Clin Rehabil ; 31(11): 1457-1465, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-29050510

RESUMO

OBJECTIVE: The aim of this review was to systematically assess and meta-analyze the effectiveness of yoga in relieving chronic neck pain. METHODS: PubMed/MEDLINE, the Cochrane Library, Scopus, and IndMED were screened through January 2017 for randomized controlled trials assessing neck pain intensity and/or neck pain-related disability in chronic neck pain patients. Secondary outcome measures included quality of life, mood, and safety. Risk of bias was assessed using the Cochrane tool. RESULTS: Three studies on 188 patients with chronic non-specific neck pain comparing yoga to usual care were included. Two studies had overall low risk of bias; and one had high or unclear risk of bias for several domains. Evidence for short-term effects was found for neck pain intensity (standardized mean difference (SMD) = -1.28; 95% confidence interval (CI) = -1.18, -0.75; P < 0.001), neck pain-related disability (SMD = -0.97; 95% CI = -1.44, -0.50; P < 0.001), quality of life (SMD = 0.57; 95% CI = 0.17, 0.197; P = 0.005), and mood (SMD = -1.02; 95% CI = -1.38, -0.65; P < 0.001). Effects were robust against potential methodological bias and did not differ between different intervention subgroups. In the two studies that included safety data, no serious adverse events occurred. CONCLUSION: Yoga has short-term effects on chronic neck pain, its related disability, quality of life, and mood suggesting that yoga might be a good treatment option.


Assuntos
Dor Crônica/reabilitação , Cervicalgia/reabilitação , Ioga , Afeto , Dor Crônica/psicologia , Humanos , Cervicalgia/psicologia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
8.
Complement Med Res ; 24(6): 385-389, 2017.
Artigo em Alemão | MEDLINE | ID: mdl-29080893

RESUMO

Hintergrund: Das Vorhandensein einer Hiatushernie kann das Auftreten einer gastroösophagealen Refluxerkrankung (GERD) als Komplikation bedingen. Konventionelle medizinische Therapiemaßnahmen können zu unerwünschten Ereignissen und Rezidiven führen. Bisher sind die Effekte von osteopathischen Behandlungen bei Hiatushernie und GERD nicht bekannt. Fallbericht: Eine 59-jährige Patientin mit endoskopisch diagnostizierter chronischer Gastritis, GERD und Hiatushernie beklagte einen persistierenden gastroösophagealen Reflux trotz konventionell-medizinischer konservativer Therapie. Die osteopathische Diagnostik ergab eine funktionelle Störung im Bereich des Magens und der Kardia mit einer Beteiligung zugehöriger Reflexzonen. Nach einer osteopathischen Behandlung als individuelle, befundorientierte Therapie ließen die Beschwerden erheblich nach. Die Hiatushernie war nach einer dieser Behandlung endoskopisch nicht mehr nachweisbar. Schlussfolgerungen: Dieser Fallbericht schildert die Symptomreduktion einer GERD nach osteopathischer Behandlung. In der endoskopischen Folgeuntersuchung fand sich die initial diagnostizierte Hiatushernie nicht mehr, diese Befund änderung könnte jedoch auf die unterschiedlichen Untersucher zurückgeführt werden. Prospektive kontrollierte klinische Studien sind notwendig, um den Stellenwert von osteopathischen Behandlungen bei GERD mit Hiatushernie zu untersuchen.


Assuntos
Gastrite/terapia , Refluxo Gastroesofágico/terapia , Hérnia Hiatal/terapia , Manipulação Osteopática , Feminino , Humanos , Pessoa de Meia-Idade , Resultado do Tratamento
10.
BMC Cancer ; 17(1): 166, 2017 03 02.
Artigo em Inglês | MEDLINE | ID: mdl-28253845

RESUMO

BACKGROUND: Cancer-related fatigue (CRF) and insomnia are major complaints in breast cancer survivors (BC). Aerobic training (AT), the standard therapy for CRF in BC, shows only minor to moderate treatment effects. Other evidence-based treatments include cognitive behavioral therapy, e.g., sleep education/restriction (SE) and mindfulness-based therapies. We investigated the effectiveness of a 10-week multimodal program (MT) consisting of SE, psycho-education, eurythmy- and painting-therapy, administered separately or in combination with AT (CT) and compared both arms to AT alone. METHODS: In a pragmatic comprehensive cohort study BC with chronic CRF were allocated randomly or by patient preference to (a) MT, (b) CT (MT + AT) or (c) AT alone. Primary endpoint was a composite score of the Pittsburgh Sleep Quality Index and the Cancer Fatigue Scale after 10 weeks of intervention (T1); a second endpoint was a follow-up assessment 6 months later (T2). The primary hypothesis stated superiority of CT and non-inferiority of MT vs. AT at T1. A closed testing procedure preserved the global α-level. The intention-to-treat analysis included propensity scores for the mode of allocation and for the preferred treatment, respectively. RESULTS: Altogether 126 BC were recruited: 65 were randomized and 61 allocated by preference; 105 started the intervention. Socio-demographic parameters were generally balanced at baseline. Non-inferiority of MT to AT at T1 was confirmed (p < 0.05), yet the confirmative analysis stopped as it was not possible to confirm superiority of CT vs. AT (p = 0.119). In consecutive exploratory analyses MT and CT were superior to AT at T1 and T2 (MT) or T2 alone (CT), respectively. CONCLUSIONS: The multimodal CRF-therapy was found to be confirmatively non-inferior to standard therapy and even yielded exploratively sustained superiority. A randomized controlled trial including a larger sample size and a longer follow-up to evaluate multimodal CRF-therapy is highly warranted. TRIAL REGISTER: DRKS-ID: DRKS00003736 . Recruitment period June 2011 to March 2013. Date of registering 19 June 2012.


Assuntos
Neoplasias da Mama/complicações , Sobreviventes de Câncer/psicologia , Terapia Combinada/métodos , Terapia por Exercício/métodos , Fadiga/terapia , Distúrbios do Início e da Manutenção do Sono/terapia , Adulto , Idoso , Neoplasias da Mama/psicologia , Terapia Cognitivo-Comportamental , Estudos de Coortes , Fadiga/etiologia , Fadiga/psicologia , Feminino , Humanos , Pessoa de Meia-Idade , Atenção Plena , Pinturas , Estudos Prospectivos , Distribuição Aleatória , Projetos de Pesquisa , Sono , Distúrbios do Início e da Manutenção do Sono/etiologia , Distúrbios do Início e da Manutenção do Sono/psicologia , Resultado do Tratamento , Adulto Jovem
11.
J Altern Complement Med ; 23(4): 268-277, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28287818

RESUMO

BACKGROUND: Although the available evidence is insufficient, acupuncture is used in patients suffering from chronic asthma. The aim of this pragmatic study was to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone. METHODS: Patients with allergic asthma were included in a randomized controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1-7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0-100). Outcome parameters were assessed at baseline and at 3 and 6 months. RESULTS: A total of 1,445 patients (mean age 43.8 [SD 13.5] years, 58.7% female) were randomized and included in the analysis (184 patients randomized to acupuncture and 173 to control, and 1,088 in the nonrandomized acupuncture group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5-1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0-4.0]; mental 4.0 [2.1-6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group. CONCLUSIONS: In patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone.


Assuntos
Terapia por Acupuntura , Asma/terapia , Qualidade de Vida , Terapia por Acupuntura/efeitos adversos , Terapia por Acupuntura/métodos , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
13.
Cochrane Database Syst Rev ; (6): CD001218, 2016 Jun 28.
Artigo em Inglês | MEDLINE | ID: mdl-27351677

RESUMO

BACKGROUND: Acupuncture is often used for migraine prevention but its effectiveness is still controversial. We present an update of our Cochrane review from 2009. OBJECTIVES: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than sham (placebo) acupuncture; and c) as effective as prophylactic treatment with drugs in reducing headache frequency in adults with episodic migraine. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL: 2016, issue 1); MEDLINE (via Ovid, 2008 to January 2016); Ovid EMBASE (2008 to January 2016); and Ovid AMED (1985 to January 2016). We checked PubMed for recent publications to April 2016. We searched the World Health Organization (WHO) Clinical Trials Registry Platform to February 2016 for ongoing and unpublished trials. SELECTION CRITERIA: We included randomized trials at least eight weeks in duration that compared an acupuncture intervention with a no-acupuncture control (no prophylactic treatment or routine care only), a sham-acupuncture intervention, or prophylactic drug in participants with episodic migraine. DATA COLLECTION AND ANALYSIS: Two reviewers checked eligibility; extracted information on participants, interventions, methods and results, and assessed risk of bias and quality of the acupuncture intervention. The primary outcome was migraine frequency (preferably migraine days, attacks or headache days if migraine days not measured/reported) after treatment and at follow-up. The secondary outcome was response (at least 50% frequency reduction). Safety outcomes were number of participants dropping out due to adverse effects and number of participants reporting at least one adverse effect. We calculated pooled effect size estimates using a fixed-effect model. We assessed the evidence using GRADE and created 'Summary of findings' tables. MAIN RESULTS: Twenty-two trials including 4985 participants in total (median 71, range 30 to 1715) met our updated selection criteria. We excluded five previously included trials from this update because they included people who had had migraine for less than 12 months, and included five new trials. Five trials had a no-acupuncture control group (either treatment of attacks only or non-regulated routine care), 15 a sham-acupuncture control group, and five a comparator group receiving prophylactic drug treatment. In comparisons with no-acupuncture control groups and groups receiving prophylactic drug treatment, there was risk of performance and detection bias as blinding was not possible. Overall the quality of the evidence was moderate. Comparison with no acupunctureAcupuncture was associated with a moderate reduction of headache frequency over no acupuncture after treatment (four trials, 2199 participants; standardised mean difference (SMD) -0.56; 95% CI -0.65 to -0.48); findings were statistically heterogeneous (I² = 57%; moderate quality evidence). After treatment headache frequency at least halved in 41% of participants receiving acupuncture and 17% receiving no acupuncture (pooled risk ratio (RR) 2.40; 95% CI 2.08 to 2.76; 4 studies, 2519 participants) with a corresponding number needed to treat for an additional beneficial outcome (NNTB) of 4 (95% CI 3 to 6); there was no indication of statistical heterogeneity (I² = 7%; moderate quality evidence). The only trial with post-treatment follow-up found a small but significant benefit 12 months after randomisation (RR 2.16; 95% CI 1.35 to 3.45; NNT 7; 95% 4 to 25; 377 participants, low quality evidence). Comparison with sham acupunctureBoth after treatment (12 trials, 1646 participants) and at follow-up (10 trials, 1534 participants), acupuncture was associated with a small but statistically significant frequency reduction over sham (moderate quality evidence). The SMD was -0.18 (95% CI -0.28 to -0.08; I² = 47%) after treatment and -0.19 (95% CI -0.30 to -0.09; I² = 59%) at follow-up. After treatment headache frequency at least halved in 50% of participants receiving true acupuncture and 41% receiving sham acupuncture (pooled RR 1.23, 95% CI 1.11 to 1.36; I² = 48%; 14 trials, 1825 participants) and at follow-up in 53% and 42%, respectively (pooled RR 1.25, 95% CI 1.13 to 1.39; I² = 61%; 11 trials, 1683 participants; moderate quality evidence). The corresponding NNTBs are 11 (95% CI 7.00 to 20.00) and 10 (95% CI 6.00 to 18.00), respectively. The number of participants dropping out due to adverse effects (odds ratio (OR) 2.84; 95% CI 0.43 to 18.71; 7 trials, 931 participants; low quality evidence) and the number of participants reporting adverse effects (OR 1.15; 95% CI 0.85 to 1.56; 4 trials, 1414 participants; moderate quality evidence) did not differ significantly between acupuncture and sham groups. Comparison with prophylactic drug treatmentAcupuncture reduced migraine frequency significantly more than drug prophylaxis after treatment ( SMD -0.25; 95% CI -0.39 to -0.10; 3 trials, 739 participants), but the significance was not maintained at follow-up (SMD -0.13; 95% CI -0.28 to 0.01; 3 trials, 744 participants; moderate quality evidence). After three months headache frequency at least halved in 57% of participants receiving acupuncture and 46% receiving prophylactic drugs (pooled RR 1.24; 95% CI 1.08 to 1.44) and after six months in 59% and 54%, respectively (pooled RR 1.11; 95% CI 0.97 to 1.26; moderate quality evidence). Findings were consistent among trials with I² being 0% in all analyses. Trial participants receiving acupuncture were less likely to drop out due to adverse effects (OR 0.27; 95% CI 0.08 to 0.86; 4 trials, 451 participants) and to report adverse effects (OR 0.25; 95% CI 0.10 to 0.62; 5 trials 931 participants) than participants receiving prophylactic drugs (moderate quality evidence). AUTHORS' CONCLUSIONS: The available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, are lacking.


Assuntos
Terapia por Acupuntura , Transtornos de Enxaqueca/prevenção & controle , Terapia por Acupuntura/efeitos adversos , Feminino , Humanos , Masculino , Transtornos de Enxaqueca/tratamento farmacológico , Enxaqueca com Aura/prevenção & controle , Enxaqueca sem Aura/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto
14.
Cochrane Database Syst Rev ; 4: CD007587, 2016 Apr 19.
Artigo em Inglês | MEDLINE | ID: mdl-27092807

RESUMO

BACKGROUND: Acupuncture is often used for prevention of tension-type headache but its effectiveness is still controversial. This is an update of our Cochrane review originally published in Issue 1, 2009 of The Cochrane Library. OBJECTIVES: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in adults with episodic or chronic tension-type headache. SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE and AMED to 19 January 2016. We searched the World Health Organization (WHO) International Clinical Trials Registry Platform to 10 February 2016 for ongoing and unpublished trials. SELECTION CRITERIA: We included randomised trials with a post-randomisation observation period of at least eight weeks, which compared the clinical effects of an acupuncture intervention with a control (treatment of acute headaches only or routine care), a sham acupuncture intervention or another prophylactic intervention in adults with episodic or chronic tension-type headache. DATA COLLECTION AND ANALYSIS: Two review authors checked eligibility; extracted information on participants, interventions, methods and results; and assessed study risk of bias and the quality of the acupuncture intervention. The main efficacy outcome measure was response (at least 50% reduction of headache frequency) after completion of treatment (three to four months after randomisation). To assess safety/acceptability we extracted the number of participants dropping out due to adverse effects and the number of participants reporting adverse effects. We assessed the quality of the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation). MAIN RESULTS: Twelve trials (11 included in the previous version and one newly identified) with 2349 participants (median 56, range 10 to 1265) met the inclusion criteria.Acupuncture was compared with routine care or treatment of acute headaches only in two large trials (1265 and 207 participants), but they had quite different baseline headache frequency and management in the control groups. Neither trial was blinded but trial quality was otherwise high (low risk of bias). While effect size estimates of the two trials differed considerably, the proportion of participants experiencing at least 50% reduction of headache frequency was much higher in groups receiving acupuncture than in control groups (moderate quality evidence; trial 1: 302/629 (48%) versus 121/636 (19%); risk ratio (RR) 2.5; 95% confidence interval (CI) 2.1 to 3.0; trial 2: 60/132 (45%) versus 3/75 (4%); RR 11; 95% CI 3.7 to 35). Long-term effects (beyond four months) were not investigated.Acupuncture was compared with sham acupuncture in seven trials of moderate to high quality (low risk of bias); five large studies provided data for one or more meta-analyses. Among participants receiving acupuncture, 205 of 391 (51%) had at least 50% reduction of headache frequency compared to 133 of 312 (43%) in the sham group after treatment (RR 1.3; 95% CI 1.09 to 1.5; four trials; moderate quality evidence). Results six months after randomisation were similar. Withdrawals were low: 1 of 420 participants receiving acupuncture dropped out due to adverse effects and 0 of 343 receiving sham (six trials; low quality evidence). Three trials reported the number of participants reporting adverse effects: 29 of 174 (17%) with acupuncture versus 12 of 103 with sham (12%; odds ratio (OR) 1.3; 95% CI 0.60 to 2.7; low quality evidence).Acupuncture was compared with physiotherapy, massage or exercise in four trials of low to moderate quality (high risk of bias); study findings were inadequately reported. No trial found a significant superiority of acupuncture and for some outcomes the results slightly favoured the comparison therapy. None of these trials reported the number of participants dropping out due to adverse effects or the number of participants reporting adverse effects.Overall, the quality of the evidence assessed using GRADE was moderate or low, downgraded mainly due to a lack of blinding and variable effect sizes. AUTHORS' CONCLUSIONS: The available results suggest that acupuncture is effective for treating frequent episodic or chronic tension-type headaches, but further trials - particularly comparing acupuncture with other treatment options - are needed.


Assuntos
Terapia por Acupuntura/métodos , Cefaleia do Tipo Tensional/prevenção & controle , Exercício , Humanos , Massagem , Modalidades de Fisioterapia , Ensaios Clínicos Controlados Aleatórios como Assunto
15.
Forsch Komplementmed ; 22(2): 85-92, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26021958

RESUMO

BACKGROUND: Acupuncture was shown to reduce symptoms of seasonal allergic rhinitis (SAR). The present study investigated (a) whether autonomic function would differ in SAR patients and healthy controls, and (b) whether acupuncture treatment would evoke changes in autonomic function compared to sham acupuncture. PATIENTS AND METHODS: SAR patients (n = 30) were recruited from a larger randomized controlled trial investigating the efficacy of acupuncture in SAR. 21 patients received acupuncture, and 9 patients received sham acupuncture. Among other we measured resting heart rate variability and cardiovascular reactivity to a cold pressure test prior to and after 12 sessions of acupuncture or sham acupuncture. In addition, 30 age- and sex-matched healthy controls were tested once. RESULTS: SAR patients showed higher resting heart rate and lower heart rate variability as well as blunted cardiovascular responses compared to controls. After treatment, resting heart rate had decreased, and systolic blood pressure response to the cold pressure test had increased in SAR patients. We found no significant differences in autonomic function changes between patients receiving acupuncture or sham acupuncture. CONCLUSION: SAR patients showed alterations in autonomic function, which had partially normalized after treatment. However, in this sample we found no specific effect of acupuncture compared to sham acupuncture.


Assuntos
Terapia por Acupuntura/normas , Rinite Alérgica Sazonal/terapia , Adulto , Sistema Nervoso Autônomo/fisiologia , Pressão Sanguínea , Estudos Transversais , Feminino , Frequência Cardíaca , Humanos , Masculino , Sistemas Neurossecretores/fisiologia , Projetos Piloto , Resultado do Tratamento
16.
BMC Complement Altern Med ; 14: 443, 2014 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-25391537

RESUMO

BACKGROUND: 'Kneipp Therapy' (KT) is a form of Complementary and Alternative Medicine (CAM) that includes a combination of hydrotherapy, herbal medicine, mind-body medicine, physical activities, and healthy eating. Since 2007, some nursing homes for older adults in Germany began to integrate CAM in the form of KT in care. The study investigated how KT is used in daily routine care and explored the health status of residents and caregivers involved in KT. METHODS: We performed a cross-sectional pilot study with a mixed methods approach that collected both quantitative and qualitative data in four German nursing homes in 2011. Assessments in the quantitative component included the Quality of Life in Dementia (QUALIDEM), the Short Form 12 Health Survey (SF-12), the Barthel-Index for residents and the Work Ability Index (WAI) and SF-12 for caregivers. The qualitative component addressed the residents' and caregivers' subjectively experienced changes after integration of KT. It was conceptualized as an ethnographic rapid appraisal by conducting participant observation and semi-structured interviews in two of the four nursing homes. RESULTS: The quantitative component included 64 residents (53 female, 83.2 ± 8.1 years (mean and SD)) and 29 caregivers (all female, 42.0 ± 11.7 years). Residents were multimorbid (8 ± 3 diagnoses), and activities of daily living were restricted (Barthel-Index 60.6 ± 24.4). The caregivers' results indicated good work ability (WAI 37.4 ± 5.1), health related quality of life was superior to the German sample (SF-12 physical CSS 49.2 ± 8.0; mental CSS 54.1 ± 6.6). Among both caregivers and residents, 89% considered KT to be positive for well-being.The qualitative analysis showed that caregivers perceived emotional and functional benefits from more content and calmer residents, a larger variety in basic care practices, and a more self-determined scope of action. Residents reported gains in attention and caring, and recognition of their lay knowledge. CONCLUSION: Residents showed typical characteristics of nursing home inhabitants. Caregivers demonstrated good work ability. Both reported to have benefits from KT. The results provide a good basis for future projects, e.g. controlled studies to evaluate the effects of CAM in nursing homes.


Assuntos
Atividades Cotidianas , Cuidadores , Terapias Complementares/métodos , Saúde , Instituição de Longa Permanência para Idosos , Casas de Saúde , Qualidade de Vida , Adulto , Idoso , Idoso de 80 Anos ou mais , Atitude do Pessoal de Saúde , Estudos Transversais , Demência , Feminino , Alemanha , Humanos , Hidroterapia , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Projetos Piloto , Pesquisa Qualitativa
17.
Forsch Komplementmed ; 21(2): e1-16, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24851850

RESUMO

BACKGROUND: The CAMbrella coordination action was funded within the Framework Programme 7. Its aim is to provide a research roadmap for clinical and epidemiological research for complementary and alternative medicine (CAM) that is appropriate for the health needs of European citizens and acceptable to their national research institutes and healthcare providers in both public and private sectors. One major issue in the European research agenda is the demographic change and its impact on health care. Our vision for 2020 is that there is an evidence base that enables European citizens to make informed decisions about CAM, both positive and negative. This roadmap proposes a strategic research agenda for the field of CAM designed to address future European health care challenges. This roadmap is based on the results of CAMbrella's several work packages, literature reviews and expert discussions including a consensus meeting. METHODS: We first conducted a systematic literature review on key issues in clinical and epidemiological research in CAM to identify the general concepts, methods and the strengths and weaknesses of current CAM research. These findings were discussed in a workshop (Castellaro, Italy, September 7­9th 2011) with international CAM experts and strategic and methodological recommendations were defined in order to improve the rigor and relevance of CAM research. These recommendations provide the basis for the research roadmap, which was subsequently discussed in a consensus conference (Järna, Sweden, May 9­11th 2012) with all CAMbrella members and the CAMbrella advisory board. The roadmap was revised after this discussion in CAMbrella Work Package (WP) 7 and finally approved by CAMbrella's scientific steering committee on September 26th 2012. RESULTS: Our main findings show that CAM is very heterogenous in terms of definitions and legal regulations between the European countries. In addition, citizens' needs and attitudes towards CAM as well as the use and provision of CAM differ significantly between countries. In terms of research methodology, there was consensus that CAM researchers should make use of all the commonly accepted scientific research methods and employ those with utmost diligence combined in a mixed methods framework. CONCLUSIONS: We propose 6 core areas of research that should be investigated to achieve a robust knowledge base and to allow stakeholders to make informed decisions. These are: Research into the prevalence of CAM in Europe: Reviews show that we do not know enough about the circumstances in which CAM is used by Europeans. To enable a common European strategic approach, a clear picture of current use is of the utmost importance. Research into differences regarding citizens' attitudes and needs towards CAM: Citizens are the driver for CAM utilization. Their needs and views on CAM are a key priority, and their interests must be investigated and addressed in future CAM research. Research into safety of CAM: Safety is a key issue for European citizens. CAM is considered safe, but reliable data is scarce although urgently needed in order to assess the risk and cost-benefit ratio of CAM. Research into the comparative effectiveness of CAM: Everybody needs to know in what situation CAM is a reasonable choice. Therefore, we recommend a clear emphasis on concurrent evaluation of the overall effectiveness of CAM as an additional or alternative treatment strategy in real-world settings. Research into effects of context and meaning: The impact of effects of context and meaning on the outcome of CAM treatments must be investigated; it is likely that they are significant. Research into different models of CAM health care integration: There are different models of CAM being integrated into conventional medicine throughout Europe, each with their respective strengths and limitations. These models should be described and concurrently evaluated; innovative models of CAM provision in health care systems should be one focus for CAM research. We also propose a methodological framework for CAM research. We consider that a framework of mixed methodological approaches is likely to yield the most useful information. In this model, all available research strategies including comparative effectiveness research utilising quantitative and qualitative methods should be considered to enable us to secure the greatest density of knowledge possible. Stakeholders, such as citizens, patients and providers, should be involved in every stage of developing the specific and relevant research questions, study design and the assurance of real-world relevance for the research. Furthermore, structural and sufficient financial support for research into CAM is needed to strengthen CAM research capacity if we wish to understand why it remains so popular within the EU. In order to consider employing CAM as part of the solution to the health care, health creation and self-care challenges we face by 2020, it is vital to obtain a robust picture of CAM use and reliable information about its cost, safety and effectiveness in real-world settings. We need to consider the availability, accessibility and affordability of CAM. We need to engage in research excellence and utilise comparative effectiveness approaches and mixed methods to obtain this data. Our recommendations are both strategic and methodological. They are presented for the consideration of researchers and funders while being designed to answer the important and implicit questions posed by EU citizens currently using CAM in apparently increasing numbers. We propose that the EU actively supports an EU-wide strategic approach that facilitates the development of CAM research. This could be achieved in the first instance through funding a European CAM coordinating research office dedicated to foster systematic communication between EU governments, public, charitable and industry funders as well as researchers, citizens and other stakeholders. The aim of this office would be to coordinate research strategy developments and research funding opportunities, as well as to document and disseminate international research activities in this field. With the aim to develop sustainability as second step, a European Centre for CAM should be established that takes over the monitoring and further development of a coordinated research strategy for CAM, as well as it should have funds that can be awarded to foster high quality and robust independent research with a focus on citizens health needs and pan-European collaboration. We wish to establish a solid funding for CAM research to adequately inform health care and health creation decision-making throughout the EU. This centre would ensure that our vision of a common, strategic and scientifically rigorous approach to CAM research becomes our legacy and Europe's reality. We are confident that our recommendations will serve these essential goals for EU citizens.


Assuntos
Pesquisa Biomédica/tendências , Terapias Complementares/tendências , Europa (Continente) , Previsões , Necessidades e Demandas de Serviços de Saúde/tendências , Pesquisa sobre Serviços de Saúde/tendências , Humanos
18.
BMC Complement Altern Med ; 14: 128, 2014 Apr 06.
Artigo em Inglês | MEDLINE | ID: mdl-24708643

RESUMO

BACKGROUND: In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial's participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers and physicians. METHODS: ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) was a three-armed, randomised, controlled multicentre trial. 422 SAR patients were randomised to semi-standardised acupuncture plus rescue medication (RM, cetirizine), sham acupuncture plus RM or RM alone. We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture. During the trial, acupuncturists were asked to diagnose all of their patients according to Chinese Medicine (CM) as a basis for the semi-standardised, individualized intervention in the acupuncture group. Every acupuncture point used in this trial had to be documented after each session RESULTS: Acupuncture was administered in outpatient clinics by 46 (mean age 47 ± 10 years; 24 female/ 22 male) conventionally-trained medical doctors (67% with postgraduate specialization such as internal or family medicine) with additional extensive acupuncture training (median 500 hours (1st quartile 350, 3rd quartile 1000 hours with 73% presenting a B-diploma in acupuncture training (350 hours)) and experience (mean 14 years in practice). The most reported traditional CM diagnosis was 'wind-cold invading the lung' (37%) and 'wind-heat invading the lung' (37%), followed by 'lung and spleen qi deficiency' (9%). The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group (15.7 ± 2.5 vs. 10.0 ± 1.6). CONCLUSIONS: The trial interventions were provided by well educated and experienced acupuncturists. The different number of needles in both intervention groups could be possibly a reason for the better clinical effect in SAR patients. For future trials it might be more appropriate to ensure that acupuncture and sham acupuncture groups should each be treated by a similar number of needles. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00610584.


Assuntos
Terapia por Acupuntura , Rinite Alérgica Sazonal/terapia , Pontos de Acupuntura , Adolescente , Adulto , Instituições de Assistência Ambulatorial , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Médicos , Inquéritos e Questionários , Adulto Jovem
19.
BMC Complement Altern Med ; 14: 46, 2014 Feb 06.
Artigo em Inglês | MEDLINE | ID: mdl-24499316

RESUMO

The use of complementary and alternative Medicine (CAM) has increased over the past two decades in Europe. Nonetheless, research investigating the evidence to support its use remains limited. The CAMbrella project funded by the European Commission aimed to develop a strategic research agenda starting by systematically evaluating the state of CAM in the EU. CAMbrella involved 9 work packages covering issues such as the definition of CAM; its legal status, provision and use in the EU; and a synthesis of international research perspectives. Based on the work package reports, we developed a strategic and methodologically robust research roadmap based on expert workshops, a systematic Delphi-based process and a final consensus conference. The CAMbrella project suggests six core areas for research to examine the potential contribution of CAM to the health care challenges faced by the EU. These areas include evaluating the prevalence of CAM use in Europe; the EU cititzens' needs and attitudes regarding CAM; the safety of CAM; the comparative effectiveness of CAM; the effects of meaning and context on CAM outcomes; and different models for integrating CAM into existing health care systems. CAM research should use methods generally accepted in the evaluation of health services, including comparative effectiveness studies and mixed-methods designs. A research strategy is urgently needed, ideally led by a European CAM coordinating research office dedicated to fostering systematic communication between EU governments, the public, charitable and industry funders, researchers and other stakeholders. A European Centre for CAM should also be established to monitor and further a coordinated research strategy with sufficient funds to commission and promote high quality, independent research focusing on the public's health needs and pan-European collaboration. There is a disparity between highly prevalent use of CAM in Europe and solid knowledge about it. A strategic approach on CAM research should be established to investigate the identified gaps of knowledge and to address upcoming health care challenges.


Assuntos
Terapias Complementares/estatística & dados numéricos , Assistência à Saúde , Medicina Baseada em Evidências , Necessidades e Demandas de Serviços de Saúde , Pesquisa , Comportamento Cooperativo , Europa (Continente) , Humanos , Prevalência
20.
J Altern Complement Med ; 20(3): 169-77, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24256028

RESUMO

OBJECTIVES: Acupuncture is increasingly used in patients with allergic asthma, but there is a lack of evidence on the cost-benefit relationship of this treatment. The aim of this study was to assess economic aspects of additional acupuncture treatment in patients with allergic bronchial asthma compared to patients receiving routine care alone. DESIGN, SUBJECTS, INTERVENTION, OUTCOME MEASURES: In a randomized controlled trial, patients with allergic bronchial asthma were either allocated to a group receiving acupuncture immediately or a waiting-list control group. Both groups were free to use routine care treatment. The resource consumption, costs, and health-related quality of life were evaluated at baseline, and after 3 and 6 months by using statutory health insurance information and standardized questionnaires. Main economic outcome parameters were direct and indirect cost differences during the study period and the incremental cost-effectiveness ratio (ICER) of acupuncture treatment. RESULTS: Three hundred and six (306) patients (159 acupuncture; 147 controls) were included (mean age 46.5±13.11 years, female 57.2%) and were comparable at baseline. Acupuncture treatment was associated with significantly higher costs compared to control patients (overall costs: €860.76 [95% confidence interval (CI) 705.04-1016.47] versus €518.80 [95% CI 356.66-680.93]; p=0.003; asthma-related costs: €517.52 [95% CI 485.63-549.40] versus €144.87 [95% CI 111.70-178.05]; p<0.001). These additional costs seem essentially driven by acupuncture costs themselves (€378.40 [95% CI 367.10-389.69]). However, acupuncture was associated with superior effectiveness in terms of quality-adjusted life years (QALYs). Resulting ICER lay between €23,231 (overall) and €25,315 (diagnosis-specific) per additional QALY. When using German acupuncture prices of year 2012, the ICER would improve to €12.810 (overall) versus €14,911 (diagnosis-specific) per QALY gained. CONCLUSIONS: Treating patients who have allergic bronchial asthma with acupuncture in addition to routine care resulted in additional costs and better effects in terms of patients' quality of life. Acupuncture therefore seems to be a useful and cost-effective add-on treatment.


Assuntos
Terapia por Acupuntura/economia , Asma/economia , Asma/terapia , Terapia por Acupuntura/métodos , Adulto , Análise por Conglomerados , Análise Custo-Benefício , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
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