Overall Survival of Nonmetastasized NSCLC Patients Treated With Add-On Viscum album L: A Multicenter Real-World Study.

BACKGROUND: Recent data suggest a beneficial effect of add-on treatment with Viscum album L (VA) on the survival in cancer patients. The objective of this study was to compare the impact of standard oncological therapy plus add-on VA treatment (S+VA) versus standard oncological therapy alone (S) on the overall survival (OS) of patients with nonmetastasized non-small cell lung carcinoma (NSCLC). METHODS: The multicenter real-world data study was conducted using data from the Network Oncology Clinical Registry. The primary end point was OS. OS and impact on hazard in both treatment groups were compared. RESULTS: A total of 275 patients with stages I to IIIA NSCLC were enrolled (mean age = 67.6 years, 57.2% male patients). No significant difference of OS was observed between both groups. Even though not significant, for a subgroup of unresected patients with stage I NSCLC, adenocarcinoma or squamous cell carcinoma, a medium effect size OS improvement was observed for S+VA compared to S. CONCLUSIONS: Our findings support the importance of surgery as the most effective intervention in nonmetastasized NSCLC patients. Add-on VA therapy shows here no additional effect in resected patients. However, a small subgroup analysis suggests a possible role of add-on VA for nonresected subgroups. Our results complement existing knowledge on the clinical impact of add-on VA therapy in NSCLC patients and may serve as hypothesis-generating data for further examinations in this cohort. Further research could be directed towards the role of combined therapy for nonresected early-stage NSCLC.

Cost-effectiveness of real-world administration of chemotherapy and add-on Viscum album L. therapy compared to chemotherapy in the treatment of stage IV NSCLC patients.

BACKGROUND: For stage IV lung cancer patients receiving add-on Viscum album L. (VA) treatment an improved overall survival was detected. Information regarding cost-effectiveness (CE) for comparisons between chemotherapy (CTx) and CTx plus additive VA in stage IV lung cancer treatment is limited. The present study assessed the costs and cost-effectiveness of CTx plus VA (V) compared to CTx alone (C) for stage IV non-small cell lung cancer (NSCLC) patients treatment in a hospital in Germany. METHODS: In the observational real-world data study, data from the Network Oncology clinical registry were utilized. Enrolled stage IV lung cancer patients received the respective therapy (C or V) in a certified German Cancer Center. Cost and cost-effectiveness analyses from the hospital's perspective were investigated on the basis of overall survival (OS) and routine financial controlling data. In addition, the incremental cost-effectiveness ratio (ICER) was calculated. The primary result of the analysis was tested for robustness in a bootstrap-based sensitivity analysis. RESULTS: 118 patients (C: n = 86, V: n = 32) were included in the analysis, mean age 63.8 years, the proportion of male patients was 55.1%. Adjusted hospital's total mean costs for patients from the C and V group were €16,289, 95%CI: 13,834€-18,744€ (over an adjusted mean OS time of 13.4 months) and €17,992, 95%CI: 13,658-22,326 (over an adjusted mean OS time of 19.1 months), respectively. The costs per additional OS year gained (ICER) with the V-therapy compared to C therapy were €3,586. CONCLUSION: The findings of the present study suggest that the combined use of chemotherapy and VA was clinically effective and comparably cost-effective to chemotherapy alone in our analysed patient sample from the hospital's perspective. Further randomized and prospective cost-effectiveness studies are necessary to complement our findings.

Impact of Oncological Therapy and Viscum album L Treatment on Cancer-Related Fatigue and Internal Coherence in Nonmetastasized Breast Cancer Patients.

Introduction:Viscum album L extracts (VA) are frequently used in integrative oncology. Aim of this study was to evaluate the impact of add-on VA applications on various patient-reported outcome measures. Methods: A longitudinal real-world study was conducted, using data from the Network Oncology clinical registry. Primary, nonmetastasized breast cancer patients treated with oncological standard therapy partly combined with VA applications were included. Internal Coherence Cancer-related Fatigue, and EORTC QLQ-C30 questionnaires were assessed at baseline and 6, 12, and 24 months later. Results: A total of 319 patients received standard oncological therapy and 40% of them additionally VA applications. After 6 and 12 months for patients treated with chemotherapy (Ctx) only a significant decline of the thermo-coherence, and worsening of fatigue was observed. For patients receiving VA applications but no Ctx, significant beneficial effects on thermo-coherence, fatigue, and seven EORTC QLQ-C30 scales were observed 24 months later. Adjusted multivariable long-term subgroup (n = 106) regression analysis revealed that Ctx, immuno-, and endocrine therapies had a worsening of 17, 17, and 6 point changes, respectively, for EORTC QLQ-C30 fatigue (P = .0004), while VA applications showed an improvement of 12 point change. A similar impact of improvement (add-on VA) and worsening (standard oncological treatment regimens) on EORTC QLQ-C30 insomnia (P = .009) and physical functioning (P = .005) were observed. Conclusions: In the present real-world study, add-on VA applications had a supportive effect on cancer-related fatigue, insomnia, physical functioning, and thermo-coherence. Thus, VA applications might be suited to alleviate symptom burden during anticancer therapy in breast cancer patients.

Cost-Effectiveness of Real-World Administration of Concomitant Viscum album L. Therapy for the Treatment of Stage IV Pancreatic Cancer.

BACKGROUND: For patients receiving add-on Viscum album L. (VA) treatments for late-stage pancreatic cancer, an improved overall survival (OS) was observed. Only limited information regarding cost-effectiveness (CE) for comparisons between standard of care and standard of care plus add-on VA in stage IV pancreatic cancer treatment is available. The present study assessed the costs and cost-effectiveness of standard of care plus VA (V) compared to standard of care alone (C) for a hospital in Germany. METHODS: An observational study was conducted using data from the Network Oncology clinical registry. Patients included had stage IV pancreatic cancer at diagnosis and received C or V treatment in a certified German Cancer Center. Cost and cost-effectiveness analyses (CEA) including the analysis of the incremental cost-effectiveness ratios (ICER) were performed from the hospital's perspective based on routine data from the financial controlling department and observed data on OS. The primary result of the analysis was tested for robustness in a bootstrap-based sensitivity analysis. RESULTS: 88 patients (C or n = 34; V treatment in a certified German Cancer Center. Cost and cost-effectiveness analyses (CEA) including the analysis of the incremental cost-effectiveness ratios (ICER) were performed from the hospital's perspective based on routine data from the financial controlling department and observed data on OS. The primary result of the analysis was tested for robustness in a bootstrap-based sensitivity analysis. n = 34; C or V treatment in a certified German Cancer Center. Cost and cost-effectiveness analyses (CEA) including the analysis of the incremental cost-effectiveness ratios (ICER) were performed from the hospital's perspective based on routine data from the financial controlling department and observed data on OS. The primary result of the analysis was tested for robustness in a bootstrap-based sensitivity analysis. V treatment in a certified German Cancer Center. Cost and cost-effectiveness analyses (CEA) including the analysis of the incremental cost-effectiveness ratios (ICER) were performed from the hospital's perspective based on routine data from the financial controlling department and observed data on OS. The primary result of the analysis was tested for robustness in a bootstrap-based sensitivity analysis. C or V treatment in a certified German Cancer Center. Cost and cost-effectiveness analyses (CEA) including the analysis of the incremental cost-effectiveness ratios (ICER) were performed from the hospital's perspective based on routine data from the financial controlling department and observed data on OS. The primary result of the analysis was tested for robustness in a bootstrap-based sensitivity analysis. C or V treatment in a certified German Cancer Center. Cost and cost-effectiveness analyses (CEA) including the analysis of the incremental cost-effectiveness ratios (ICER) were performed from the hospital's perspective based on routine data from the financial controlling department and observed data on OS. The primary result of the analysis was tested for robustness in a bootstrap-based sensitivity analysis. C or. CONCLUSION: Based on this CEA analysis, from the hospital's point of view, the costs per mean month of OS and per mean hospital stay were lower for patients under combinational standard of care plus VA compared to patients receiving standard of care alone for the treatment of stage IV pancreatic cancer. Further prospective cost-effectiveness studies are mandatory to reevaluate our findings.

Acupuncture for Breathlessness in Advanced Diseases: A Systematic Review and Meta-analysis.

CONTEXT: Nonpharmacological approaches are effective strategies for difficult to palliate breathlessness. Although acupuncture is effective for dyspnea in early-stage chronic obstructive pulmonary disease (COPD), little is known about its effects in patients with advanced (non)malignant diseases. OBJECTIVES: The objective of this study was to identify and examine the evidence of acupuncture on breathlessness in advanced malignant and nonmalignant diseases. METHODS: Systematic literature review of randomized controlled trials of acupuncture and acupressure searched in five databases. Included were adult participants with at least 25% having advanced diseases such as cancer or COPD with severe breathlessness. Primary outcome was severity of dyspnea on Visual Analogue Scale or Borg Scale. Secondary outcomes included quality of life, function, and acceptability. Data were pooled using a random effects model of standardized mean differences. RESULTS: Twelve studies with 597 patients (347 COPD, 190 advanced cancer) were included. For breathlessness severity, significant differences were obtained in a meta-analysis (10 studies with 480 patients; standardized mean difference (SMD) = -1.77 [95% CI -3.05, -0.49; P = 0.007; I2 = 90%]) and in a subgroup analysis of using sham acupuncture control groups and a treatment duration of at least three weeks (6 studies with 302 patients; SMD = -2.53 [95% CI -4.07, -0.99; P = 0.001; I2 = 91%]). Exercise tolerance (6-minute walk test) improved significantly in the acupuncture group (6 studies with 287 patients; SMD = 0.93 [95% CI 0.27, 1.59; P = 0.006; I2 = 85%]). In four of six studies, quality of life improved in the acupuncture group. CONCLUSION: Acupuncture improved breathlessness severity in patients with advanced diseases. The methodological heterogeneity, low power, and potential morphine-sparing effects of acupuncture as add-on should be further addressed in future trials.

Qigong and exercise therapy for elderly patients with chronic neck pain (QIBANE): a randomized controlled study.

UNLABELLED: The aim of this study was to evaluate the effectiveness of qigong compared with exercise therapy and no treatment. Elderly patients with chronic neck pain (>6 months) were randomly assigned to qigong or exercise therapy (each 24 sessions over a period of 3 months) or to a waiting list control. Patients completed standardized questionnaires at baseline and after 3 and 6 months. The main outcome measure was average neck pain on the visual analogue scale after 3 months. Secondary outcomes were neck pain and disability (NPAD) and quality of life (SF-36). One hundred seventeen patients (age, 76 +/- 8 years, 95% women) were included in the intention-to-treat analysis. The average duration of neck pain was 19.0 +/- 14.9 years. After 3 months, no significant differences were observed between the qigong group and the waiting list control group (visual analogue scale mean difference, -11 mm [CI, -24.0; 2.1], P = .099) or between the qigong group and the exercise therapy group (-2.5 mm [ - 15.4; 10.3], P = .699). Results for the NPAD were similar (qigong vs waiting list -6.7 (-15.4; 2.1), P = .135; qigong vs exercise therapy 2.3 (-6.2; 10.8); P = .600). We found no significant effect after 3 months of qigong or exercise therapy compared with no treatment. Further studies should include outcomes more suitable to elderly patients, longer treatment, and patients with less chronic pain. PERSPECTIVE: In a randomized controlled study, we evaluated whether a treatment of 24 qigong sessions over a period of 3 months is (1) superior to no treatment and (2) superior to the same amount of exercise therapy in elderly patients (age, 76 +/- 8 years, 95% women) with long-term chronic neck pain (19.0 +/- 14.9 years). After 3 and 6 months, we found no significant differences for pain, neck pain, disability, and quality of life among the 3 groups.

Developing a qigong intervention and an exercise therapy for elderly patients with chronic neck pain and the study protocol.

BACKGROUND: In the so far published trials on qigong and exercise therapies, the methods and especially the interventions applied are rarely described in detail. Therefore, we report on the development of the interventions, the study design and protocols of a randomised controlled multi-centre trial. OBJECTIVE: The aim of the study was to develop a qigong intervention and an exercise therapy for elderly patients and to evaluate whether qigong is more effective than (1) no treatment or (2) the exercise therapy. DEVELOPMENT OF THE INTERVENTIONS: In a consensus process with qigong experts and physiotherapists special interventions for elderly patients were developed allowing most exercises to be performed in a sitting position. Both interventions will be held by qualified therapists for a period of 3 months twice per week for 45 min. In addition, patients will be encouraged to exercise on their own. STUDY PROTOCOL: In a randomised controlled multi-centre study with 3 groups and a total follow-up time of 6 months, 120 patients from 4 residences for elderly people in Berlin (age >or= 55 years) with chronic neck pain should be included. MAIN OUTCOME MEASURE: Average pain intensity of the past 7 days measured by a visual analogue scale (VAS). Secondary parameters are neck pain and disability (Neck Pain and Disability Scale, NPAD), depression (General Depression Scale, ADS) and health-related quality of life (SF-36). IMPLICATIONS: The results of this study may help clarify, if qigong is a feasible, safe and effective intervention for elderly people with neck pain.