Implementation of an internet-based asthma patient education program in primary care: results of a single-arm trial.

Asthma education programs (AEPs) for patients are known to be important to provide skills to effectively manage the disease. We developed an electronic AEP (eAEP) and assessed the extent to which patients with asthma in primary care are capable to use the eAEP and whether asthma knowledge improved after eAEP.A single-arm pilot study was performed between November 2019 and December 2020 in 12 general practices in Upper Bavaria, Germany. Asthma knowledge was assessed by the Asthma Knowledge Test (AKT) at baseline, 2 weeks after completion of the eAEP, as well as after 3 and 6 months. AKT sum scores at baseline and follow-up were compared with each other using the Wilcoxon test.In total, 72 patients with asthma were included, of whom all participated in the 2-week follow-up, while data on the 3- and 6-month follow-up was available in 62 and 51 patients, respectively. The eAEP was well accepted and positively evaluated by participants. The mean AKT score significantly (p < .001) increased from 22.8 ± 11.0 at baseline to 44.6 ± 8.3 two weeks after completion of the eAEP. After 3 months, the mean score was still 41.8 ± 7.6, and after 6 months it was 40.2 ± 9.3 (p < .001 each compared to baseline).The internet-based asthma education program was well accepted by primary care patients and resulted in a major increase of asthma knowledge. Thus, it has the potential to be an important adjunct in the treatment of patients with asthma in general practice.

Incidence of post-COVID syndrome and associated symptoms in outpatient care in Bavaria, Germany: a retrospective cohort study using routinely collected claims data.

OBJECTIVES: To estimate the treatment incidence of post-COVID syndrome (postinfectious sequelae present at least 12 weeks following infection) in the context of ambulatory care in Bavaria, Germany, and to establish whether related diagnoses occur more frequently than in patients with no known history of COVID-19. DESIGN: Retrospective cohort analysis of routinely collected claims data. SETTING: Ambulatory care in Bavaria, Germany, observed from January 2020 to March 2022 (data accessed May 2022). PARTICIPANTS: 391 990 patients with confirmed COVID-19 diagnosis, 62 659 patients with other respiratory infection and a control group of 659 579 patients with no confirmed or suspected diagnosis of COVID-19. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome is diagnosis of post-COVID syndrome documented in ambulatory care. Secondary outcomes are: chronic fatigue syndrome, psychological disorder, fatigue, mild cognitive impairment, disturbances of taste and smell, dyspnoea, pulmonary embolism and myalgia. RESULTS: Among all patients with confirmed COVID-19, 14.2% (95% CI 14.0% to 14.5%) received a diagnosis of a post-COVID syndrome, and 6.7% (95% CI 6.5% to 6.9%) received the diagnosis in at least two quarterly periods during a 2-year follow-up. Compared with patients with other respiratory infections and with controls, patients with COVID-19 more frequently received a variety of diagnoses including chronic fatigue syndrome (1.6% vs 0.6% and 0.3%, respectively), fatigue (13.3% vs 9.2% and 6.0%), dyspnoea (9.9% vs 5.1% and 3.2%) and disturbances of taste and smell (3.2% vs 1.2% and 0.5%). The treatment incidence of post-COVID syndrome was highest among adults aged 40-59 (19.0%) and lowest among children aged below 12 years (2.6%). CONCLUSIONS: Our results demonstrate a moderately high incidence of post-COVID syndrome 2 years after COVID-19 diagnosis. There is an urgent need to find efficient and effective solutions to help patients with dyspnoea, fatigue, cognitive impairment and loss of smell. Guidelines and treatment algorithms, including referral criteria, and occupational and physical therapy, require prompt and coherent implementation.

SARS-CoV-2 infection and cardiovascular or pulmonary complications in ambulatory care: A risk assessment based on routine data.

BACKGROUND: Risk factors of severe COVID-19 have mainly been investigated in the hospital setting. We investigated pre-defined risk factors for testing positive for SARS-CoV-2 infection and cardiovascular or pulmonary complications in the outpatient setting. METHODS: The present cohort study makes use of ambulatory claims data of statutory health insurance physicians in Bavaria, Germany, with polymerase chain reaction (PCR) test confirmed or excluded SARS-CoV-2 infection in first three quarters of 2020. Statistical modelling and machine learning were used for effect estimation and for hypothesis testing of risk factors, and for prognostic modelling of cardiovascular or pulmonary complications. RESULTS: A cohort of 99 811 participants with PCR test was identified. In a fully adjusted multivariable regression model, dementia (odds ratio (OR) = 1.36), type 2 diabetes (OR = 1.14) and obesity (OR = 1.08) were identified as significantly associated with a positive PCR test result. Significant risk factors for cardiovascular or pulmonary complications were coronary heart disease (CHD) (OR = 2.58), hypertension (OR = 1.65), tobacco consumption (OR = 1.56), chronic obstructive pulmonary disease (COPD) (OR = 1.53), previous pneumonia (OR = 1.53), chronic kidney disease (CKD) (OR = 1.25) and type 2 diabetes (OR = 1.23). Three simple decision rules derived from prognostic modelling based on age, hypertension, CKD, COPD and CHD were able to identify high risk patients with a sensitivity of 74.8% and a specificity of 80.0%. CONCLUSIONS: The decision rules achieved a high prognostic accuracy non-inferior to complex machine learning methods. They might help to identify patients at risk, who should receive special attention and intensified protection in ambulatory care.

Ambulatory specialist costs and morbidity of coordinated and uncoordinated patients before and after abolition of copayment: A cohort analysis.

To strengthen the coordinating function of general practitioners (GPs) in the German healthcare system, a copayment of €10 was introduced in 2004. Due to a perceived lack of efficacy and a high administrative burden, it was abolished in 2012. The present cohort study investigates characteristics and differences of GP-coordinated and uncoordinated patients in Bavaria, Germany, concerning morbidity and ambulatory specialist costs and whether these differences have changed after the abolition of the copayment. We performed a retrospective routine data analysis, using claims data of the Bavarian Association of the Statutory Health Insurance Physicians during the period 2011-2012 (with copayment) and 2013-2016 (without copayment), covering 24 quarters. Coordinated care was defined as specialist contact only with referral. Multinomial regression modelling, including inverse probability of treatment weighting, was used for the cohort analysis of 500 000 randomly selected patients. Longitudinal regression models were calculated for cost estimation. Coordination of care decreased substantially after the abolition of the copayment, accompanied by increasing proportions of patients with chronic and mental diseases in the uncoordinated group, and a corresponding decrease in the coordinated group. In the presence of the copayment, uncoordinated patients had €21.78 higher specialist costs than coordinated patients, increasing to €24.94 after its abolition. The results indicate that patients incur higher healthcare costs for specialist ambulatory care when their care is uncoordinated. This effect slightly increased after abolition of the copayment. Beyond that, the abolition of the copayment led to a substantial reduction in primary care coordination, particularly affecting vulnerable patients. Therefore, coordination of care in the ambulatory setting should be strengthened.

Are Invasive Procedures Effective for Chronic Pain? A Systematic Review.

OBJECTIVE: To assess the evidence for the safety and efficacy of invasive procedures for reducing chronic pain and improving function and health-related quality of life compared with sham (placebo) procedures. DESIGN: Systematic review with meta-analysis. METHODS: Studies were identified by searching multiple electronic databases, examining reference lists, and communicating with experts. Randomized controlled trials comparing invasive procedures with identical but otherwise sham procedures for chronic pain conditions were selected. Three authors independently extracted and described study characteristics and assessed Cochrane risk of bias. Two subsets of data on back and knee pain, respectively, were pooled using random-effects meta-analysis. Overall quality of the literature was assessed through Grading of Recommendations, Assessment, Development, and Evaluation. RESULTS: Twenty-five trials (2,000 participants) were included in the review assessing the effect of invasive procedures over sham. Conditions included low back (N = 7 trials), arthritis (4), angina (4), abdominal pain (3), endometriosis (3), biliary colic (2), and migraine (2). Thirteen trials (52%) reported an adequate concealment of allocation. Fourteen studies (56%) reported on adverse events. Of these, the risk of any adverse event was significantly higher for invasive procedures (12%) than sham procedures (4%; risk difference = 0.05, 95% confidence interval [CI] = 0.01 to 0.09, P = 0.01, I2 = 65%). In the two meta-analysis subsets, the standardized mean difference for reduction of low back pain in seven studies (N = 445) was 0.18 (95% CI = -0.14 to 0.51, P = 0.26, I2 = 62%), and for knee pain in three studies (N = 496) it was 0.04 (95% CI = -0.11 to 0.19, P = 0.63, I2 = 36%). The relative contribution of within-group improvement in sham treatments accounted for 87% of the effect compared with active treatment across all conditions. CONCLUSIONS: There is little evidence for the specific efficacy beyond sham for invasive procedures in chronic pain. A moderate amount of evidence does not support the use of invasive procedures as compared with sham procedures for patients with chronic back or knee pain. Given their high cost and safety concerns, more rigorous studies are required before invasive procedures are routinely used for patients with chronic pain.

To what extent are surgery and invasive procedures effective beyond a placebo response? A systematic review with meta-analysis of randomised, sham controlled trials.

OBJECTIVES: To assess the quantity and quality of randomised, sham-controlled studies of surgery and invasive procedures and estimate the treatment-specific and non-specific effects of those procedures. DESIGN: Systematic review and meta-analysis. DATA SOURCES: We searched PubMed, EMBASE, CINAHL, CENTRAL (Cochrane Library), PILOTS, PsycInfo, DoD Biomedical Research, clinicaltrials.gov, NLM catalog and NIH Grantee Publications Database from their inception through January 2015. STUDY SELECTION: We included randomised controlled trials of surgery and invasive procedures that penetrated the skin or an orifice and had a parallel sham procedure for comparison. DATA EXTRACTION AND ANALYSIS: Three authors independently extracted data and assessed risk of bias. Studies reporting continuous outcomes were pooled and the standardised mean difference (SMD) with 95% CIs was calculated using a random effects model for difference between true and sham groups. RESULTS: 55 studies (3574 patients) were identified meeting inclusion criteria; 39 provided sufficient data for inclusion in the main analysis (2902 patients). The overall SMD of the continuous primary outcome between treatment/sham-control groups was 0.34 (95% CI 0.20 to 0.49; p<0.00001; I(2)=67%). The SMD for surgery versus sham surgery was non-significant for pain-related conditions (n=15, SMD=0.13, p=0.08), marginally significant for studies on weight loss (n=10, SMD=0.52, p=0.05) and significant for gastroesophageal reflux disorder (GERD) studies (n=5, SMD=0.65, p<0.001) and for other conditions (n=8, SMD=0.44, p=0.004). Mean improvement in sham groups relative to active treatment was larger in pain-related conditions (78%) and obesity (71%) than in GERD (57%) and other conditions (57%), and was smaller in classical-surgery trials (21%) than in endoscopic trials (73%) and those using percutaneous procedures (64%). CONCLUSIONS: The non-specific effects of surgery and other invasive procedures are generally large. Particularly in the field of pain-related conditions, more evidence from randomised placebo-controlled trials is needed to avoid continuation of ineffective treatments.

Effects of a guided web-based smoking cessation program with telephone counseling: a cluster randomized controlled trial.

BACKGROUND: Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation. To date, very few findings are available for primary care patients, and especially for the involvement of general practitioners. OBJECTIVE: Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting. METHODS: The study was an unblinded cluster-randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily short message service (SMS) reminding, weekly feedback through Internet, and active monitoring by general practitioners. All components of the program are fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was the biochemically confirmed smoking status after 12 weeks. RESULTS: We recruited 168 participants (86 intervention group, 82 control group) into the study. For 51 participants from the intervention group and 70 participants from the control group, follow-up data were available both at baseline and 12 weeks. Very few patients (9.8%, 5/51) from the intervention group and from the control group (8.6%, 6/70) successfully managed smoking cessation (OR 0.86, 95% CI 0.25-3.0; P=.816). Similar results were found within the intent-to-treat analysis: 5.8% (5/86) of the intervention group and 7.3% (6/82) of the control group (OR 1.28, 95% CI 0.38-4.36; P=.694). The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group (2.7 mean difference; 95% CI -5.33 to -0.58; P=.045). After adjustment for the baseline value, age, gender, and height, this significance decreases (mean difference 2.2; 95% CI -4.7 to 0.3; P=.080). CONCLUSIONS: This trial did not show that the tested Web-based intervention was effective for achieving smoking cessation compared to usual care. The limited statistical power and the high drop-out rate may have reduced the study's ability to detect significant differences between the groups. Further randomized controlled trials are needed in larger populations and to investigate the long-term outcome. TRIAL REGISTRATION: German Register for Clinical Trials, registration number DRKS00003067; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ ID=DRKS00003067 (Archived by WebCite at http://www.webcitation.org/6Sff1YZpx).

Differential effectiveness of placebo treatments: a systematic review of migraine prophylaxis.

IMPORTANCE: When analyzing results of randomized clinical trials, the treatment with the greatest specific effect compared with its placebo control is considered to be the most effective one. Although systematic variations of improvements in placebo control groups would have important implications for the interpretation of placebo-controlled trials, the knowledge base on the subject is weak. OBJECTIVE: To investigate whether different types of placebo treatments are associated with different responses using the studies of migraine prophylaxis for this analysis. DESIGN, SETTING, AND PARTICIPANTS: We searched relevant sources through February 2012 and contacted the authors to identify randomized clinical trials on the prophylaxis of migraine with an observation period of at least 8 weeks after randomization that compared an experimental treatment with a placebo control group. We calculated pooled random-effects estimates according to the type of placebo for the proportions of treatment response. We performed meta-regression analyses to identify sources of heterogeneity. In a network meta-analysis, direct and indirect comparisons within and across trials were combined. Additional analyses were performed for continuous outcomes. EXPOSURE: Active migraine treatment and the placebo control conditions. MAIN OUTCOMES AND MEASURES: Proportion of treatment responders, defined as having an attack frequency reduction of at least 50%. Other available outcomes in order of preference included a reduction of 50% or greater in migraine days, the number of headache days, or headache score or a significant improvement as assessed by the patients or their physicians. RESULTS: Of the 102 eligible trials, 23 could not be included in the meta-analyses owing to insufficient data. Sham acupuncture (proportion of responders, 0.38 [95% CI, 0.30-0.47]) and sham surgery (0.58 [0.37-0.77]) were associated with a more pronounced reduction of migraine frequency than oral pharmacological placebos (0.22 [0.17-0.28]) and were the only significant predictors of response in placebo groups in multivariable analyses (P = .005 and P = .001, respectively). Network meta-analysis confirmed that more patients reported response in sham acupuncture groups than in oral pharmacological placebo groups (odds ratio, 1.88 [95% CI, 1.30-2.72]). Corresponding analyses for continuous outcomes showed similar findings. CONCLUSIONS AND RELEVANCE: Sham acupuncture and sham surgery are associated with higher responder ratios than oral pharmacological placebos. Clinicians who treat patients with migraine should be aware that a relevant part of the overall effect they observe in practice might be due to nonspecific effects and that the size of such effects might differ between treatment modalities.

Kidney function and clinical recommendations of drug dose adjustment in geriatric patients.

BACKGROUND: In elderly patients chronic kidney disease often limits drug prescription. As several equations for quick assessment of kidney function by estimating glomerular filtration rate (eGFR) and several different clinical recommendations for drug dose adjustment in renal failure are published, choosing the correct approach for drug dosage is difficult for the practitioner. The aims of our study were to quantify the agreement between eGFR-equations grouped by creatinine-based or cystatin C-based and within the groups of creatinine and cystatin C-based equations and to investigate whether use of various literature and online references results in different recommendations for drug dose adjustment in renal disease in very elderly primary care patients. METHODS: We included 108 primary care patients aged 80 years and older from 11 family practices into a cross-sectional study. GFR was estimated using two serum creatinine-based equations (Cockroft-Gault, MDRD) and three serum cystatin C-based equations (Grubb, Hoek, Perkins). Concordance between different equations was quantified using intraclass correlation coefficients (ICCs). Essential changes in drug doses or discontinuation of medication were documented and compared in terms of estimated renal function as a consequence of the different eGFR-equations using five references commonly used in the US, Great Britain and Germany. RESULTS: In general, creatinine-based equations resulted in lower eGFR-estimation and in higher necessity of drug dose adjustment than cystatin C-based equations. Concordance was high between creatinine-based equations alone (ICCs 0.87) and between cystatin C-based equations alone (ICCs 0.90 to 0.96), and moderate between creatinine-based equations and cystatin C-based equations (ICCs 0.54 to 0.76). When comparing the five different references consulted to identify necessary drug dose adjustments we found that the numbers of drugs that necessitate dose adjustment in the case of renal impairment differed considerably. The mean number of recommended changes in drug dosage ranged between 1.9 and 2.5 per patient depending on the chosen literature reference. CONCLUSIONS: Our data suggest that the choice of the literature source might have even greater impact on drug management than the choice of the equation used to estimate GFR alone. Efforts should be deployed to standardize methods for estimating kidney function in geriatric patients and literature recommendations on drug dose adjustment in renal failure.

Diagnostic accuracy of clinical symptoms in obstructive airway diseases varied within different health care sectors.

OBJECTIVE: To determine the diagnostic accuracy and diagnostic patterns of clinical symptoms in patients suspected to suffer from obstructive airway diseases (OADs) within different health care sectors. STUDY DESIGN AND SETTING: Ten general practices (219 patients), one practice of pneumologists (259 patients) and one specialist hospital (300 patients). Sensitivities, specificities, positive (LR+), and negative (LR-) likelihood ratios of clinical symptoms were compared with lung function testing. RESULTS: Thirty-one percent had chronic obstructive pulmonary disease (COPD), 21% had asthma. Sensitivities increased and specificities decreased from outpatient to hospital setting. The multivariate model of adjusted likelihood ratios for COPD showed LR+=4.86 (95% confidence interval [CI]=2.09-11.29) and LR-=0.07 (95% CI=0.01-0.43) of the combination "wheezing," "dyspnea when going upstairs," "smoking" in general practice. In hospital, the combination "dyspnea when going upstairs," "dyspnea during minimal exercise," and "smoking" showed LR+=3.34 (95% CI=2.08-5.31) and LR-=0.02 (95% CI=0.01-0.12). The combination "no coughing," "dyspnea attacks," and "no smoking" showed LR+=4.08 (95% CI=1.67-10.4) and LR-=0.24 (95% CI=0.12-0.58) for asthma in general practice. The combination "dyspnea attacks" and "no dyspnea when walking" showed LR+=6.48 (95% CI=1.01-40.94) and LR-=0.28 (95% CI=0.11-0.75) for asthma in hospital. CONCLUSION: Clinical decision rules for OAD need to be derived from original studies in their respective settings or assessed on their transferability to other settings.

Patients of an interdisciplinary cancer treatment center: use of, knowledge about, and demand for CAM treatment options.

OBJECTIVE: to assess the use of, knowledge about, and the demand for information concerning complementary and alternative medicine (CAM) in cancer patients. METHODS: A cross-sectional survey was performed on consecutive patients visiting the outpatient tumor treatment center of a university hospital at Munich, Germany. The authors used a questionnaire with questions on sociodemographics, tumor diagnosis and treatment, current symptoms, previous use of CAM, and expectations and attitudes with respect to CAM. RESULTS: 52% used at least 1 CAM method, 24% did not use CAM but asked for consultation, and 24% neither used CAM nor were interested; 59% rated CAM treatment as personally important; 76% and 34% described themselves as well informed about conventional treatment and CAM, respectively. Current CAM use was associated with higher degrees of information and subjective importance, and not suffering from lymphatic cancer and metastases. CONCLUSIONS: CAM is a relevant topic for the care of cancer patients.

The status and future of acupuncture clinical research.

On November 8-9, 2007, the Society for Acupuncture Research (SAR) hosted an international conference to mark the tenth anniversary of the landmark National Institutes of Health Consensus Development Conference on Acupuncture. More than 300 acupuncture researchers, practitioners, students, funding agency personnel, and health policy analysts from 20 countries attended the SAR meeting held at the University of Maryland School of Medicine, Baltimore, MD. This paper summarizes important invited lectures in the area of clinical research. Specifically, included are: a review of the recently conducted German trials and observational studies on low-back pain (LBP), gonarthrosis, migraine, and tension-type headache (the Acupuncture Research Trials and the German Acupuncture Trials, plus observational studies); a systematic review of acupuncture treatment for knee osteoarthritis (OA); and an overview of acupuncture trials in neurologic conditions, LBP, women's health, psychiatric disorders, and functional bowel disorders. A summary of the use of acupuncture in cancer care is also provided. Researchers involved in the German trials concluded that acupuncture is effective for treating chronic pain, but the correct selection of acupuncture points seems to play a limited role; no conclusions could be drawn about the placebo aspect of acupuncture, due to the design of the studies. Overall, when compared to sham, acupuncture did not show a benefit in treating knee OA or LBP, but acupuncture was better than a wait-list control and standard of care, respectively. In women's health, acupuncture has been found to be beneficial for patients with premenstrual syndrome, dysmenorrhea, several pregnancy-related conditions, and nausea in females who have cancers. Evidence on moxibustion for breech presentation, induction of labor, and reduction of menopausal symptoms is still inconclusive. In mental health, evidence for acupuncture's efficacy in treating neurologic and functional bowel disorder is still inconclusive. For chronic cancer-related problems such as pain, acupuncture may work well in stand-alone clinics; however, for acute or treatment-related symptoms, integration of acupuncture care into a busy and complex clinical environment is unlikely, unless compelling evidence of a considerable patient benefit can be established.

Acupuncture and acupressure for the prevention of chemotherapy-induced nausea--a randomised cross-over pilot study.

OBJECTIVE: To investigate whether a combination of acupuncture and acupressure is effective for reducing chemotherapy-induced nausea and vomiting. PATIENTS AND METHODS: In a randomised cross-over trial, 28 patients receiving moderately or highly emetogenic chemotherapy and conventional standard antiemesis were treated for one chemotherapy cycle with a combination of acupuncture and acupressure at point P6 and for one cycle at a close sham point. The main outcome measure was a nausea score derived from daily intensity rating. RESULTS: There was no difference between combined acupuncture and acupressure treatment at P6 and at the sham point for the nausea score, but the level of nausea was very low in both phases. The mean nausea score was 6.2 (standard deviation 9.0) for treatment at P6 and 6.3 (9.1) for treatment at the sham point (mean difference -0.1, 95% confidence interval -3.9 to 3.7; p=0.96). Seventeen of 21 participants completing the study would desire acupuncture and acupressure for future chemotherapy cycles, but there was no clear preference for either point. CONCLUSION: In this small pilot study a significant difference between treatment at P6 and a close sham point could not be detected. However, it cannot be ruled out that an existing difference was missed due to the small sample size.

Integrating patient preferences in clinical trials: a pilot study of acupuncture versus midazolam for gastroscopy.

BACKGROUND AND OBJECTIVES: Patient preferences play an important role when choosing between different treatment options and may have an influence on outcome. We performed a study to investigate (1) to what extent patients make use of the offer to receive acupuncture as a pretreatment for gastroscopy, (2) whether this is perceived as being as effective as sedation, and (3) whether characteristics and outcomes differ between patients giving consent to random allocation and patients choosing their pretreatment. DESIGN: Partially randomized patient preference trial. Patients who gave consent to randomization were allocated randomly while patients who had a preference received the treatment of their choice. PATIENTS: One hundred and six (106) inpatients of a district hospital in southern Germany undergoing gastroscopy for diagnostic purposes. INTERVENTIONS: Pretreatment with a sedative (midazolam) or acupuncture. MAIN OUTCOME MEASURE: Patient's overall assessment on a visual analogue scale (VAS). RESULTS: Twenty-eight (28) patients (26%) agreed to be randomized, 21 (20%) chose acupuncture, 51 (47%) midazolam, and 8 (7%) did not want pretreatment. Patients receiving midazolam rated the examination as slightly less troublesome than those receiving acupuncture. Oxygen saturation, blood pressure, and heart rate were significantly lower in patients receiving midazolam. Characteristics and outcomes of randomized and nonrandomized patients did not differ significantly. CONCLUSIONS: Because of the low number of patients giving consent to random allocation conclusions on effectiveness are difficult to draw. The partially randomized patient preference design is recommended for use in future trials of acupuncture for gastroscopy. Such trials should be performed in an outpatient setting.

Polysaccharides isolated from Echinacea purpurea herba cell cultures to counteract undesired effects of chemotherapy--a pilot study.

In an open prospective study with matched historical controls we aimed to evaluate whether a polysaccharide fraction isolated from the herb Echinacea purpurea could counteract the undesired effects of chemotherapy. Fifteen patients with advanced gastric cancer undergoing palliative chemotherapy with etoposide, leucovorin and 5-fluorouracil (ELF) received for 10 days (beginning 3 days before chemotherapy) daily i.v. injections of 2 mg of a polysaccharide fraction isolated from Echinacea purpurea herb cell cultures (EPS-EPO VIIa). The median number of leukocytes 14-16 days after chemotherapy was 3630/microL (range 1470-5770) in the patients receiving EPS-EPO VIIa compared with 2370/microL (870-3950) in the patients of the historical control group (p = 0.015). EPS-EPO VIIa had no clinically relevant effects on phagocytic activity of granulocytes or on lymphocyte subpopulations. Sixty-eight adverse events including two deaths were observed, most likely due to chemotherapy and the general condition of the patients. However, an association with the test intervention cannot be ruled out completely. The results of this pilot study suggest that EPS-EPO VIIa might be effective in reducing chemotherapy-induced leukopenia. The efficacy and safety should be investigated in further studies.