Nwcsu evidence Service Evidence Review Summary Sheet




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NWCSU Evidence Service

Evidence Review Summary Sheet

Sources used for this review included NICE Evidence Search, AMED, BNI, CINAHL, EMBASE, HMIC, MEDLINE and PSYCHINFO and key resources for the location of grey literature.


Most documents listed can be accessed electronically by following the links – if there are any problems accessing any of the documents please contact the North West CSU Library. An NHS Athens user ID is required to access some of the journal articles. Where an electronic version of the document is not available this is stated.


Completed by: Kieran Lamb


Date: 29/01/16

NWCSU Library

Tel: 01244 650 343 or 0151 285 4493

library@cmcsu.nhs.uk


Articles and Other Information


Title: A specific mistletoe preparation (Iscador-Qu) in Colorectal Cancer (CRC) patients: More than just supportive care?
Citation: Journal of Cancer Science and Therapy, 2012, vol./is. 4/9(264-270), 1948-5956 (2012)
Author(s): Zaenker K.S., Matthes H., Bock P.R., Hanisch J.
Language: English
Abstract: Rationale: In 2009 we reported the results of a pharmaco-epidemiological, retrospective observational cohort study in colorectal carcinoma (CRC) patients UICC stage I-III, receiving chemo- and/or radiotherapy together with European Viscum album L. ("Viscum") extract (Iscador) as supportive care (n = 429) versus the conventional treatment (n = 375) after R0 resection (J. Soc. Int. Oncol. 7: 173-145). The endpoints have been therapy induced adverse effects, disease symptoms and disease-free survival (DSF). Objective: Here, we present the secondary and confirmatory analysis of this original data set with respect to the host tree specificity of Viscum. Results: Patients receiving the extract from Viscum harvested from oak (Quercus) trees, Iscador Qu (Isc- Qu), in a supportive care mode simultaneously with chemo- and/or radiotherapy (n = 106) showed a significant improvement in therapy induced adverse effects, and, most remarkable, a significant delay of metastasis formation and longer DFS compared to conventionally treated patients (n = 212) (control). To make the analysis more robust, patients treated by the chemo- and/or radiotherapy protocols were also analyzed and stratified for the UICC I-III stages. Accordingly to the overall Kaplan-Meier analysis result, patients receiving Isc-Qu as supportive care presented significantly longer median time to distant metastases formation (metastasis-free survival, MFS) within the course of the observational cohort study (133+ months (Isc-Qu) versus 94 months (control), p (Log Rank) = 0.002. In the Cox regression analysis, the confounder-adjusted hazard ratio, HR, (95% confidence interval) came up to HR (metastasis) = 0.31 (0.13-0.711), p = 0.006. This result indicates an estimated 69% metastasis-hazardreduction in the Isc-Qu group relative to the controls. In summary, patients concomitantly treated by Iscador showed fewer persisting disease- and therapy-induced symptoms and the DSF hazard ratio suggested a survival benefit. Clinical implication: This secondary and confirmatory analysis of the original data set suggests that a mistletoe (Viscum) preparation, harvested from oak (Quercus) trees (Isc-Qu), appears to be a naturally tailored molecular composition to target CRC patients by reducing therapy-related adverse effects, improving the cancerrelated symptoms and showing a potential to increasing the metastases-free survival. Limitations: The effect on prolonged survival should be interpreted with some caution because the applied study design shares some potential risk for bias common to all non-randomized observational studies. Also, potential biases were tried to minimize by systematic multivariable adjusting of end point criteria for baseline imbalance, treatment regimen, and other potential confounders. © 2012 Zaenker KS, et al.
Publication Type: Journal: Article
Source: EMBASE


Title: Quality of life and related dimensions in cancer patients treated with mistletoe extract (iscador): a meta-analysis.
Citation: Evidence-based complementary and alternative medicine : eCAM, Jan 2012, vol. 2012, p. 219402. (2012)
Author(s): Büssing, Arndt, Raak, Christa, Ostermann, Thomas
Abstract: Objectives. The aim of this meta-analysis was to determine the effectiveness of the fermented plant extract Iscador, produced from the white-berry European mistletoe, in the treatment of patients with cancer with respect to quality-of-life- (QoL-) associated measures. Methods. We searched databases such as PubMed/Medline, Excerpta Medica Database (EMBASE), CAMbase, and other for controlled clinical studies on parameters associated with QoL. Outcome data were extracted and converted into standardized mean differences and their standard errors. Results. Thirteen prospective and controlled studies which met the inclusion/exclusion criteria reported positive effects in favor of the Iscador application. A random-effect meta-analysis estimated the overall treatment effect at standardized mean difference = 0.56 (CI: 0.41 to 0.71, P < .0001). However, the methodological quality of the studies was poor. Conclusions. The analyzed studies give some evidence that Iscador treatment might have beneficial short-time effects on QoL-associated dimensions and psychosomatic self-regulation.
Source: Medline
Full Text:

Available from National Library of Medicine in Evidence-based Complementary and Alternative Medicine : eCAM





Title: Does a treatment with Viscum album (Iscador P) in patients with breast cancer influence the expression of the T-cell receptor (TCR)-zeta chains of T- and NK-cells
Citation: Phytomedicine, October 2011, vol./is. 18/(S24), 0944-7113 (15 Oct 2011)
Author(s): Hagens C.V., Giese T., Staudt A., Glenz A., Reinhard-Hennch B., Loewe-Mesch A., Kuehn J.J., Abel U., Munzinger J., Schneeweiss A., Sohn C., Strowitzki T.
Language: English
Abstract: 1 Annette Loewe-Mesch passed away on April 6, 2009, before theresults of our work could be published. Her fellow authors honourher substantial contribution to the design and clinical performanceof this study. Purpose: One purpose of this feasibility study was the identification of new surrogate parameters for the investigation of theinfluence of Viscum album (Iscador P, IP) on immune functions inpatientswith breast cancer during adjuvant or palliative treatment.Methods: After completing screening 48 patients with early(M0, n = 24) or advanced (MI, n = 24) breast cancerwere randomizedto receive treatment with IP immediately (therapy group - TG) or3months later (waiting group -WG). The target dose of IP (20mg)should be reached after 2months and given at least 4weeks beforemeasuring primary endpoints for comparison of TG and WG after3 months.Results: At screening the expression of TCR-zeta chains on CD4+lymphocytes (307.3 +/- 192.2 MESF-units vs. 168.2 +/- 133.7 MESF-units, p = 0.006), CD8+ lymphocytes (268.8 +/- 159.1 MESF-units vs.170.0 +/- 174.8 MESF-units, p = 0.006) and NK-cells (636.2 +/- 498.3MESF-units vs. 455.3 +/- 329.0 MESF-units, p = 0.047) differedbetween patients with early and advanced stages. In patientsreceiving adjuvant treatment we saw an increased expression ofthe TCR-zeta chains after the first 3 months followed by a dropafter the next 3 months in the TG, whereas patients in the WG hada continuous drop duringwaiting and treatment period in all investigated lymphocyte subsets. This contrasted to patients receivingpalliative treatment (MI) inwhomwe observed a stable expressionof lymphocyte subsets after 3 and 6 months whereas the WG hada slight initial drop followed by a stabilisation of the expression ofthe TCR-zeta chains after IP treatment.Conclusions: The expression of zeta-chains on CD4+, CD8+ lymphocytes and NK-cells did not change consistently in breast cancerpatients receiving IP for 3 or 6 months. The observed differencesmight reflect an unequal impairment of immune reactivity in earlyand advanced stages.
Publication Type: Journal: Conference Abstract
Source: EMBASE


Title: Individual patient data meta-analysis of survival and psychosomatic self-regulation from published prospective controlled cohort studies for long-term therapy of breast cancer patients with a mistletoe preparation (iscador)
Citation: Evidence-based Complementary and Alternative Medicine, June 2010, vol./is. 7/2(157-166), 1741-427X;1741-4288 (June 2010)
Author(s): Ziegler R., Grossarth-Maticek R.
Language: English
Abstract: Mistletoe preparations such as Iscador are in common use as complementary/anthroposophic medications for many cancer indications, particularly for solid cancers. The efficacy is still discussed controversially. This paper presents an individual patient data meta-analysis of all published prospective matched-pair studies with breast cancer patients concerned with long-term application of a complementary/anthroposophic therapy with the mistletoe preparation Iscador. Six sets of data were available for individual patient meta-analysis of breast cancer patients, matched according to prognostic factors into pairs with and without mistletoe (Iscador) therapy. The main outcome measures were overall survival and psychosomatic self-regulation. Overall survival was almost significant in favor of the Iscador group in the combined data set of the randomized studies: estimate of the hazard ratio with 95% confidence interval 0.59 (0.34, 1.02). Overall survival was highly significant in the combined data set of the non-randomized studies: 0.43 (0.34, 0.56). In the combined analysis of the randomized studies, improvement of psychosomatic self-regulation, as a measure of autonomous coping with the disease, was highly significant in favor of the Iscador group: estimate of the median difference 0.45 (0.15, 0.80), P=0.0051. The analyzed studies show that therapy with Iscador might prolong overall survival and improve psychosomatic self-regulation of breast cancer patients. © 2008 The Author(s).
Publication Type: Journal: Review
Source: EMBASE
Full Text:

Available from National Library of Medicine in Evidence-based Complementary and Alternative Medicine : eCAM





Title: Survival of cancer patients treated with mistletoe extract (Iscador): a systematic literature review.
Citation: BMC cancer, Jan 2009, vol. 9, p. 451. (2009)
Author(s): Ostermann, Thomas, Raak, Christa, Büssing, Arndt
Abstract: In Europe, extracts from Viscum album (VA-E), the European white-berry mistletoe, are widely used to treat patients with cancer. We searched several databases such as Cochrane, EMBASE, NCCAM, NLM, DIMDI, CAMbase, and Medline. Inclusion criteria were controlled clinical studies on parameters associated with survival in cancer patients treated with Iscador. Outcome data were extracted as they were given in the publication, and expressed as hazard ratios (HR), their logarithm, and the respective standard errors using standard formulas. We found 49 publications on the clinical effects of Iscador usage on survival of cancer patients which met our criteria. Among them, 41 studies and strata provided enough data to extract hazard ratios (HR) and their standard errors (Iscador versus no extra treatment). The majority of studies reported positive effects in favour of the Iscador application. Heterogeneity of study results was moderate (I2 = 38.3%, p < 0.0001). The funnel plots were considerably skewed, indicating a publication bias, a notion which is corroborated by statistical means (AC = -1.3, CI: -1.9 to -0.6, p <= 0.0001). A random effect meta-analysis estimated the overall hazard ratio at HR = 0.59 (CI: 0.53 to 0.66, p < 0.0001). Randomized studies showed less effects than non-randomized studies (ratio of HRs: 1.24, CI: 0.79 to 1.92, p = 0.35), and matched-pair studies gave significantly better results than others (ratio of HRs: 0.33; CI: 0.17 to 0.65, p = 0.0012). Pooled analysis of clinical studies suggests that adjuvant treatment of cancer patients with the mistletoe extract Iscador is associated with a better survival. Despite obvious limitations, and strong hints for a publication bias which limits the evidence found in this meta-analysis, one can not ignore the fact that studies with positive effects of VA-E on survival of cancer patients are accumulating. Future studies evaluating the effects of Iscador should focus on a transparent design and description of endpoints in order to provide greater insight into a treatment often being depreciated as ineffective, but highly valued by cancer patients.
Source: Medline
Full Text:

Available from ProQuest in BMC Cancer

Available from EBSCOhost in BMC Cancer

Available from National Library of Medicine in BMC Cancer





Title: Randomized and non-randomized prospective controlled cohort studies in matched pair design for the long-term therapy of corpus uteri cancer patients with a mistletoe preparation (Iscador)
Citation: European Journal of Medical Research, March 2008, vol./is. 13/3(107-120), 0949-2321 (31 Mar 2008)
Author(s): Grossarth-Maticek R., Ziegler R.
Language: English
Abstract: Background: Mistletoe preparations such as Iscador are in common use as complementary/anthroposophic medications for many cancer indications, particularly for solid cancers. Efficacy of this complementary therapy is still discussed controversially. Objective: Does the long-term therapy with Iscador show any effect on survival or psychosomatic self-regulation of patients with corpus uteri cancer? Patients and Methods: Prospective recruitment and long-term follow-up in the following 4 controlled cohort studies. (1) Two randomized matched-pairs studies: corpus uteri cancer patients without (30 pairs) and with distant metastases (26 pairs) that never used any kind of mistletoe therapy were matched for prognostic factors. By pairwise random allocation, one of the patients was suggested mistletoe therapy to be applied by the attending physician. (2) Two non-randomized matched-pairs studies: corpus uteri cancer patients without (103 pairs) and with distant metastases (95 pairs) that already received mistletoe (Iscador) therapy were matched by the same criteria to control patients without Iscador therapy. Results: Concerning overall survival in the randomized studies, a significant effect in favour of Iscador therapy was present only in the first study, the second showed no evidence for an effect: estimate of the hazard ratio and 95% confidence interval: 0.36 (0.16, 0.82) and 1.00 (0.46, 2.16) respectivoly. In the non-randomized studies, the results that adjusted for relevant prognostic variables were: 0.41 (0.26, 0.63), and 0.61 (0.39, 0.93). The effect of therapy with Iscador within 12 months on psychosomatic self-regulation as a measure of autonomous coping with the disease shows a significant rise in the Iscador group against the control group in the randomized as well as in the non-randomized study on patients with corpus uteri cancer without metastases: estimate of the median difference and 95% confidence interval: 0.40 (0.15, 0.70) and 0.70 (0.25, 1.15) respectively. Conclusion: The mistletoe preparation Iscador in these studies has the effect of prolonging overall survival of corpus uteri cancer patients. Psychosomatic self-regulation as a measure of autonomous coping with the disease, rises significantly more under Iscador therapy than under conventional therapy alone. © I. Holzapfel Publishers 2008.
Publication Type: Journal: Article
Source: EMBASE


Title: Successful treatment of metastatic malignant melanoma with Viscum album extract (ISCADOR M)
Citation: Journal of Alternative & Complementary Medicine, 2007, vol./is. 13/4(443-445), 10755535
Author(s): Kirsch A
Language: English
Abstract: Background: Recent study results demonstrate possible clinical benefit from adjuvant treatment with a standardized mistletoe (Viscum album) extract in patients with malignant melanoma. Patient and method: We present a male patient, currently 68 years of age, with one malignant melanoma at the upper part of the right arm since 1992, and another nodular melanoma at the left shoulder, first diagnosed in 1999. After discovery of the second melanoma and surgical resection, the patient was exclusively treated with standardized mistletoe extract (Iscador, (R)M; Weleda AG, CH-Arlesheim, Switzerland). Course of therapy and results: In June 1992, histologic analysis confirmed the presence of stage IA superficially spreading malignant melanoma with low infiltration of the papillary dermis in a skin excision sample from the upper part of the right arm. In November 1999, another melanoma was surgically removed at the patient's right shoulder. In this case, the histologic examination revealed nodular melanoma, stage IIA (pT3, pN0, M0). Therapy with mistletoe extract was introduced shortly afterwards as the sole adjuvant treatment. During the course of the mistletoe therapy, axillary removal of 8 lymph nodes became necessary, 3 of which proved to be metastatic. First signs of a defined solitary liver metastasis in an area next to segments IV and V were detected during an abdominal ultrasound examination in September 2001. This finding was confirmed by further sonographic examinations. The solitary liver metastasis was not resected, nor was classical antitumor treatment (chemotherapy or radiotherapy) initiated. The patient continued subcutaneous treatment with Iscador M after dose adaptation to 2 mg twice weekly (0.2 mL of a 10-mg vial); the treatment is still ongoing to the present. By June 2002, complete remission of the liver metastasis was diagnosed by liver ultrasound examination. There has been no local relapse so far, and the patient has been in stable condition ever since. No further metastases were discovered so far (as of May 2006). Conclusions: The use of low-dose Iscador as the sole postoperative modality for the adjuvant treatment of metastatic melanoma was extremely effective and very well tolerated in this patient. It achieved complete response and absence of all complaints.
Publication Type: Academic Journal
Source: CINAHL
Full Text:

Available from EBSCOhost in Journal of Alternative & Complementary Medicine

Available from EBSCOhost in Journal of Alternative & Complementary Medicine

Available from EBSCOhost in Journal of Alternative & Complementary Medicine





Title: Mistletoe as complementary treatment in patients with advanced non-small-cell lung cancer treated with carboplatin-based combinations: A randomised phase II study.
Citation: European Journal of Cancer, 2013, vol./is. 49/5(1058-1064), 09598049
Author(s): Bar-Sela, Gil, Wollner, Mira, Hammer, Liat, Agbarya, Abed, Dudnik, Elizabeth, Haim, Nissim
Language: English
Abstract: Abstract: Introduction: Mistletoe preparations, such as iscador, are common complementary medications. This randomised phase II study of iscador combined with carboplatin-containing regimens was conducted in chemotherapy-naïve advanced non-small-cell lung cancer (NSCLC) patients to assess its influence on chemotherapy-related side-effects and QoL. Methods: Patients with advanced NSCLC were randomised to receive chemotherapy alone or chemotherapy plus iscador thrice weekly until tumour progression. Chemotherapy consisted of 21-day cycles of carboplatin combined with gemcitabine or pemetrexed. Results: Seventy-two patients (control: 39; iscador: 33) were enrolled in the study. Most (65%) were in stage IV, and 62% had squamous histology. Median overall survival in both groups was 11months. Median TTP was 4.8months for the controls and 6months in the iscador arm (p =NS). Differences in grade 3–4 haematological toxicity were not significant but more control patients had chemotherapy dose reductions (44% versus 13%, p =0.005), grade 3–4 non-haematological toxicities (41% versus 16%, p =0.043) and hospitalisations (54% versus 24%, p =0.016). Conclusion: No effect of iscador could be found on quality of life or total adverse events. Nevertheless, chemotherapy dose reductions, severe non-haematological side-effects and hospitalisations were less frequent in patients treated with iscador, warranting further investigation of iscador as a modifier of chemotherapy-related toxicity.
Publication Type: Academic Journal
Source: CINAHL


Title: Prospective controlled cohort studies on long-term therapy of ovarian cancer patients with mistletoe (Viscum album L.) extracts Iscador
Citation: Arzneimittel-Forschung/Drug Research, 2007, vol./is. 57/10(665-678), 0004-4172 (2007)
Author(s): Grossarth-Maticek R., Ziegler R.
Language: English
Abstract: Background: Mistletoe extracts such as Iscador are commonly used as complementary/anthroposophic medications for many cancer indications, particularly for solid cancers. The efficacy of this complementary therapy is still controversial. Objective: Does long-term therapy with mistletoe extracts Iscador show any effect on survival and psychosomatic self-regulation of patients with ovarian cancer? Patients and methods: Prospective recruitment and long-term follow-up in controlled cohort studies. (1) Two randomized matched-pair studies: OvarRand (ovarian cancer patients without distant metastases; 21 pairs) and OvarMetRand (ovarian cancer patients with distant metastases; 20 pairs); patients having no mistletoe therapy were matched for prognostic factors. By paired random allocation, one of the patients of each pair was suggested therapy with mistletoe extracts Iscador to be applied by her attending physician. (2) Two non-randomized matched-pair studies: Ovar (ovarian cancer patients without distant metastases; 75 pairs) and OvarRand (ovarian cancer patients with distant metastases; 62 pairs); patients that already received therapy with mistletoe extracts Iscador were matched by the same criteria to control patients without therapy with mistletoe extracts Iscador. Results: For overall survival in the randomized studies, the effect in favor of therapy with mistletoe extracts Iscador was significant in OvarMetRand but not in OvarRand; hazard ratio estimate and 95% confidence interval: 0.40 (0.15, 1.03) and 0.33 (0.12, 0.92), respectively. In the non-randomized studies Ovar and OvarMet, the results adjusted for relevant prognostic variables were 0.47 (0.31, 0.69) and 0.62 (0.37, 1.05). Psychosomatic self-regulation in the Iscador group increases significantly within 12 months on a scale from 1 to 6 compared with the control group in the randomized study OvarRand as well as in the non-randomized study Ovar on patients with ovarian cancer without distant metastases; estimate of the median difference and 95 % confidence interval: 0.58 (0.30, 0.90) and 0.30 (0.05, 0.65), respectively. Conclusion: Mistletoe extracts Iscador might have the effect of prolonging over-all survival of ovarian cancer patients. In the short term, psychosomatic self-regulation increases more markedly under Iscador therapy than under conventional therapy alone. © ECV Editio Cantor Verlag.
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