Acupuncture in diabetic peripheral neuropathy-protocol for the randomized, multicenter ACUDPN trial.

BACKGROUND: Acupuncture is used to treat patients with diabetic peripheral neuropathy; however, the evidence is unclear. We present the design and methodology of the ACUDPN (ACUpuncture in Diabetic Peripheral Neuropathy) trial, which investigates the effectiveness of acupuncture for the treatment of diabetic peripheral neuropathy (DPN) symptoms. The aim of this study is to investigate whether acupuncture is effective for the treatment of DPN symptoms. METHODS: This study is a two-armed, randomized, controlled, parallel group, open-label, confirmatory, multicenter trial (8-week intervention period plus 16 weeks of follow-up). Physicians in outpatient units in Germany who specialize in acupuncture treatment will treat 110 diabetes type II patients with clinical symptoms of peripheral neuropathy in the feet and legs with signs of neuropathy according to nerve conduction testing. The patients will be randomized in a 1:1 ratio to one of the following two groups: (a) semi-standardized acupuncture plus routine care or (b) routine care alone. Acupuncture will consist of 12 treatments per patient over 8 weeks. The primary outcome will be the overall DPN-related complaints in the extremities after 8 weeks as measured by the Visual Analog Scale (VAS). Further outcome measures will include DPN-related pain, the Neuropathic Pain Symptom Inventory (NPSI), Diabetic Peripheral Neuropathic Pain Impact (DPNPI) scores, and nerve conduction parameters of the sural nerve at weeks 8, 16, and 24. DISCUSSION: The results of this trial will be available in 2021 and will help clarify whether acupuncture can be considered effective for the treatment of DPN with regard to the subdimensions of the neuropathic clinical picture. TRIAL REGISTRATION: ClinicalTrials.gov NCT03755960 . Registered on 11 August 2018.

The persistence of the effects of acupuncture after a course of treatment: a meta-analysis of patients with chronic pain.

There is uncertainty regarding how long the effects of acupuncture treatment persist after a course of treatment. We aimed to determine the trajectory of pain scores over time after acupuncture, using a large individual patient data set from high-quality randomized trials of acupuncture for chronic pain. The available individual patient data set included 29 trials and 17,922 patients. The chronic pain conditions included musculoskeletal pain (low back, neck, and shoulder), osteoarthritis of the knee, and headache/migraine. We used meta-analytic techniques to determine the trajectory of posttreatment pain scores. Data on longer term follow-up were available for 20 trials, including 6376 patients. In trials comparing acupuncture to no acupuncture control (wait-list, usual care, etc), effect sizes diminished by a nonsignificant 0.011 SD per 3 months (95% confidence interval: -0.014 to 0.037, P = 0.4) after treatment ended. The central estimate suggests that approximately 90% of the benefit of acupuncture relative to controls would be sustained at 12 months. For trials comparing acupuncture to sham, we observed a reduction in effect size of 0.025 SD per 3 months (95% confidence interval: 0.000-0.050, P = 0.050), suggesting approximately a 50% diminution at 12 months. The effects of a course of acupuncture treatment for patients with chronic pain do not seem to decrease importantly over 12 months. Patients can generally be reassured that treatment effects persist. Studies of the cost-effectiveness of acupuncture should take our findings into account when considering the time horizon of acupuncture effects. Further research should measure longer term outcomes of acupuncture.

[Secondary data analysis of the prevalence of alcohol dependence (F10.2) in Germany]. / Sekundärdatenanalyse der Prävalenz der Alkoholabhängigkeit (F10.2) in Deutschland.

BACKGROUND AND AIM: Compared to other European countries, alcohol consumption and abuse in Germany is on a high level. Even in smaller quantities, frequent alcohol consumption can generate organic damages and thus lead to secondary diseases that have a significant societal relevance regarding direct and indirect costs for the healthcare system. After several publications have already addressed the prevalence of acute alcohol intoxication and alcohol abuse in adolescents, the question arises how the prevalence of alcohol abuse develops on the basis of the accounting data of outpatient and inpatient care providers in the population of adults aged 18 and over and what tendency can be observed within a multi-year period. Within this study, the coding of alcohol abuse (F10.2 diagnosis) was analyzed separately for outpatient and inpatient sector in the insured population ≥ 18 years and presented over time. PATIENTS AND METHODS: The development of the prevalence of alcohol abuse was analyzed on the basis of secondary random sample data from one nation-wide working statutory health insurance with a total population of more than 3 million insurants in the 5-year period from 2006 to 2010. For the presentation of the prevalences, insurant numbers were used. For the identification of the relevant insurants, only confirmed outpatient F10.2 diagnoses or inpatient F10.2 diagnoses were used. The age and sex distributions of the dataset were adjusted to the distribution in the statutory health insurance to ensure representativeness. The analyses of each single year only allude to insured persons aged ≥ 18 years. With the help of the statistics of the insured of statutory health insurance, for each calendar year, projections of the detected prevalence rates were determined to estimate the number of cases on the statutory health insurance level and their development over time. RESULTS: The results show a tendency of slightly increasing prevalence of alcohol dependence from 2006 to 2010. For insured persons with at least one inpatient or outpatient F10.2 diagnosis, the prevalence continuously rises from 1,04% in 2006 to 1.14% in 2010; the prevalence of insured persons who received an alcohol dependence diagnosis only in the outpatient sector, increased from 0,67% to 0,79% in that time scale. In all analyzes, there was a ratio of 30% affected women to 70% affected men. From 2006 to 2010, the proportion of insured persons with hospitalization caused by alcohol dependence decreased steadily from 14,51% to 12,24%. CONCLUSION: For the analyzed group of persons aged ≥ 18 years, the present analysis results show a tendency of slightly increasing prevalences of alcohol abuse, however at the same time combined with a decreasing proportion of hospitalized patients. Similar nationwide studies from 2010 on the basis of secondary data of a health insurance company and inclusion of outpatient and inpatient diagnoses also indicate prevalences of alcohol dependence of about 1.18%, but they base on the age range of 15- to 64-year-old insurants.

Over-the-counter-drugs for the treatment of mood and anxiety disorders--the views of German pharmacists.

INTRODUCTION: Depression, anxiety, agitation and sleep disorders are highly prevalent in the general population, but few persons receive psychiatric care. METHODS: Our aim was to study the views of 690 German pharmacists on "over-the counter" (OTC) drugs for these indications. RESULTS: They reported dispensing OTC medication to an average of 12 customers per day, and this corresponded to almost one quarter of the medications provided for these indications. Herbal drugs and complex homeopathic formulations were used most frequently. Patients preferring OTC substances were described as being younger, with shorter durations of illness and less severe symptoms, and more skeptical regarding psychopharmacology. While genuine pharmacological effects were considered as most relevant, pharmacists were highly aware of placebo and interpersonal factors. Symptoms, comorbidity and advice on drug intake were prominent topics during pharmacy consultations. CONCLUSION: German pharmacists report dispensing large amounts of OTC drugs for anxiety, agitation, sleep disturbances or depression. It is unclear whether this constitutes a rational and cost effective method to deal with mild courses of high prevalence diseases or must be seen critically.

The use of placebo interventions in clinical practice.

Although a considerable number of mostly quantitative surveys have investigated the frequency and circumstances of the use of placebo interventions in clinical practice, it remains rather unclear what role placebo interventions really have outside clinical and laboratory research and why they are used. In this article I discuss two aspects which have to be taken into account when future research aims to provide further insights: (1) the different perspectives of patients, providers and scientists when it comes to decide whether a treatment is a placebo or not and (2) the fact that applying placebos intentionally is not only an ethical but also a professional problem.

Reporting experiments in homeopathic basic research-description of the checklist development.

The objective of this study was to develop a criteria catalogue serving as a guideline for authors to improve quality of reporting experiments in basic research in homeopathy. A Delphi Process was initiated including three rounds of adjusting and phrasing plus two consensus conferences. European researchers who published experimental work within the last 5 years were involved. A checklist for authors provide a catalogue with 23 criteria. The "Introduction" should focus on underlying hypotheses, the homeopathic principle investigated and state if experiments are exploratory or confirmatory. "Materials and methods" should comprise information on object of investigation, experimental setup, parameters, intervention and statistical methods. A more detailed description on the homeopathic substances, for example, manufacture, dilution method, starting point of dilution is required. A further result of the Delphi process is to raise scientists' awareness of reporting blinding, allocation, replication, quality control and system performance controls. The part "Results" should provide the exact number of treated units per setting which were included in each analysis and state missing samples and drop outs. Results presented in tables and figures are as important as appropriate measures of effect size, uncertainty and probability. "Discussion" in a report should depict more than a general interpretation of results in the context of current evidence but also limitations and an appraisal of aptitude for the chosen experimental model. Authors of homeopathic basic research publications are encouraged to apply our checklist when preparing their manuscripts. Feedback is encouraged on applicability, strength and limitations of the list to enable future revisions.

[Validity of clinical trials: are there differences between conventional and complementary alternative medicine?]. / Studienvalidität: Gibt es Unterschiede zwischen Schul- und Komplementärmedizin?

So far there has been no consensus on the criteria which confirm the validity of scientific contributions in conventional medicine (CM) and complementary/ alternative medicine (CAM). An interdisciplinary group of experts from various disciplines within each of the areas of medicine held six well-documented sessions in an effort to reach a consensus. The group agreed that the methods to confirm the validity of clinical trials are identical in CM and CAM. There are differences in research strategies and there may also be differences in interpreting the results, depending on the concept of medicine.

Reporting experiments in homeopathic basic research (REHBaR)--a detailed guideline for authors.

BACKGROUND: Reporting experiments in basic research in homeopathy is an important issue as comprehensive description of what exactly was done is required. So far, there is no guideline for authors available, unlike criteria catalogues common in clinical research. METHODS: A Delphi Process was conducted, including a total of five rounds, three rounds of adjusting and phrasing plus two consensus conferences. European researchers who published experimental work within the last five years were involved. RESULTS: A checklist of 23 items was obtained and supplemented with detailed examples emphasizing what each item implies. Background, objectives and possible hypotheses should be given in the part 'introduction'. Special emphasis is put on the 'materials and methods' section, where a detailed description of chosen controls, object of investigation, experimental setup, replication, parameters, intervention, allocation, blinding, and statistical methods is required. The section 'results' should present sufficient details on analysed data, descriptive as well as inferential. Authors should discuss their results and give an interpretation in the context of current evidence. CONCLUSION: A guideline for Reporting Experiments in Homeopathic Basic Research (REHBaR) was compiled to be applied by authors when preparing their manuscripts, and to be used by scientific journals in the reviewing process. Furthermore the guideline is a commitment to a certain minimum quality level needed in basic research, e.g. blinding and randomisation. Feedback is encouraged on applicability, strength and limitations of the list to enable future revisions.

Mistletoe therapy in oncology.

BACKGROUND: Mistletoe extracts are commonly used in cancer patients. It is claimed that they improve survival and quality of life (QOL) in cancer patients. OBJECTIVES: To determine the effectiveness, tolerability and safety of mistletoe extracts given either as monotherapy or adjunct therapy for patients with cancer. SEARCH STRATEGY: Search sources included the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3, 2007) Cochrane Complementary Medicine Field Registry of randomized clinical trials (RCTs) and controlled clinical trials, MEDLINE, EMBASE, HEALTHSTAR, INT. HEALTH TECHNOLOGY ASSESSMENT, SOMED, AMED, BIOETHICSLINE, BIOSIS, CancerLit, CATLINE, CISCOM (August 2007). For the search the Standard Operating Procedures of the Information System in Health Economics at the German Institute for Medical Documentation and Information (DIMDI) were utilized. Reference lists of relevant articles and authors extensive files were searched for additional studies. Manufacturers of mistletoe preparations were contacted. SELECTION CRITERIA: We included RCTs of adults with cancer of any type. The interventions were mistletoe extracts as sole treatments or given concomitantly with chemo- or radiotherapy. The outcome measures were survival times, tumor response, QOL, psychological distress, adverse effects from antineoplastic treatment and safety of mistletoe extracts. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trials for inclusion in the review. All review authors independently took part in the extraction of data and assessment of study quality and clinical relevance. Disagreements were resolved by consensus. Study authors were contacted where information was unclear. Methodological quality was narratively described and additionally assessed with the Delphi list and the Jadad score. High methodological quality was defined if six out of nine Delphi criteria, or four out of five Jadad criteria were fulfilled. Results were presented qualitatively. MAIN RESULTS: Eighty studies were identified. Fifty-eight were excluded for various reasons, usually as there was no prospective trial design with randomised treatment allocation. Of the 21 included studies 13 provided data on survival, 7 on tumour response, 16 on measures of QOL or psychological outcomes, or prevalence of chemotherapy-related adverse effects and 12 on side effects of mistletoe treatment; overall comprising 3484 randomised cancer patients. Interventions evaluated were 5 preparations of mistletoe extracts from 5 manufacturers and one commercially not available preparation. The general reporting of RCTs was poor. Of the 13 trials investigating survival, 6 showed some evidence of a benefit, but none of them was of high methodological quality. The results of two trials in patients with melanoma and head and neck cancer gave some evidence that the used mistletoe extracts are not effective for improving survival. Of the 16 trials investigating the efficacy of mistletoe extracts for either improving QOL, psychological measures, performance index, symptom scales or the reduction of adverse effects of chemotherapy, 14 showed some evidence of a benefit, but only 2 of them including breast cancer patients during chemotherapy were of higher methodological quality. Data on side effects indicated that, depending on the dose, mistletoe extracts were usually well tolerated and had few side effects. AUTHORS' CONCLUSIONS: The evidence from RCTs to support the view that the application of mistletoe extracts has impact on survival or leads to an improved ability to fight cancer or to withstand anticancer treatments is weak. Nevertheless, there is some evidence that mistletoe extracts may offer benefits on measures of QOL during chemotherapy for breast cancer, but these results need replication. Overall, more high quality, independent clinical research is needed to truly assess the safety and effectiveness of mistletoe extracts. Patients receiving mistletoe therapy should be encouraged to take part in future trails.

Acupuncture for chronic pain within the research program of 10 German Health Insurance Funds--basic results from an observational study.

OBJECTIVES: To investigate which patients receive acupuncture in the framework of statutory health insurance in Germany, how treatment was carried out, and what results were achieved. DESIGN: Basic documentation (carried out by physician) within a prospective observational study. SETTING: 454,920 patients with at least one of the three chronic pain conditions including headache, low back pain and osteoarthritis treated by 8727 medical acupuncturists (panel doctors) within the scope of a reimbursement program. RESULTS: Fifty-three percent of the patients were treated by general practitioners, 19% by orthopaedists and 9% by internists. Eighty percent of patients were female, mean age was 53.6 (S.D.=15.7) years. Primary indication for acupuncture was low back pain (45%), headache (36%), and osteoarthritis (12%). Median time since the initial diagnosis was 3 years. 8.4 (S.D.=3.0) acupuncture sessions (body acupuncture) were administered on average. In 28% a concomitant treatment was reported. Effectiveness of acupuncture was rated by physicians in 22% of the patients as marked, in 54% as moderate, in 16% as minimal and in 4% as poor (unchanged). In 8% of the patients mild adverse reactions were reported, severe side effects occurred in 13 patients (0.003%). Orthopaedists rated the effectiveness of acupuncture lower, showing shortest time for face-to-face contact with the patient. More acupuncture training did not correspond to better therapeutic effect assessed by physicians. CONCLUSIONS: Acupuncture proved a highly demanded treatment option for chronic pain conditions within the German research program. Results indicate that acupuncture provided by qualified therapists is safe, and patients benefited from the treatment.

Physician and treatment characteristics in a randomised multicentre trial of acupuncture in patients with osteoarthritis of the knee.

OBJECTIVE: The aim of this paper is to describe the treatment and physician characteristics in a randomised trial of acupuncture for osteoarthritis of the knee. DESIGN: Three-armed, randomised, controlled multicentre trial with 1-year follow-up. SETTING: Twenty-eight outpatient centres in Germany. INTERVENTIONS: A total of 294 patients with osteoarthritis of the knee were randomised to 12 sessions of semi-standardised acupuncture (at least 6 local and 2 distant points needled per affected knee from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), 12 sessions of minimal acupuncture (superficial needling of at least 8 of 10 predefined, bilateral, distant non-acupuncture points) or a waiting list control (2 months no acupuncture). OUTCOME: Participating trial physicians and interventions. RESULTS: Forty-seven physicians specialised in acupuncture (mean age 43+/-8 years, 26 females) provided study interventions in 28 outpatient centres in Germany. The median duration of acupuncture training completed by participating physicians was 350 h (range 140-2508). The total number of needles used was 17.4+/-4.8 in the acupuncture group compared to 12.9+/-3.3 in the minimal acupuncture group. In total, 39 physicians (83%) stated that they would have treated patients in either a similar or in exactly the same way outside of the trial, whereas 7 (15%) stated that they would have treated patients differently (1 missing). CONCLUSIONS: Our documentation of the trial interventions shows that semi-standardised acupuncture strategy represents an acceptable compromise for efficacy studies. However, a substantial minority of participating trial physicians stated that they would have treated patients differently outside of the trial.

[Acupuncture for chronic pain patients. Treatment outcomes--the role of the acupuncturist]. / Akupunktur bei chronischen Schmerzpatienten. Behandlungsergebnisse--Rolle des Akupunkteurs.

These results are relevant to the choice of appropriate criteria for quality assessment of acupuncture and emphasize the role of patient satisfaction within quality assurance. Pre- and post-treatment differences in a set of pain related measurements were determined using a combination of data from an observational study and a survey of physicians. The following features of the physicians' study were investigated: specialisation, qualification in acupuncture, rate at which patients received acupuncture, use of further, complementary methods in the practice. The results were statistically adjusted according to different basic conditions (case-mix). A total of 4,084 patients with chronic headache, lower back pain or arthritic pain were treated by 1,838 acupuncturists. There were no differences in success for patients treated by physicians passing through shorter (A diploma) or longer (B diploma) training courses in acupuncture. Patients treated by orthopedists showed less improvement than those treated by physicians with other specialisations. However, these differences had disappeared 6 months after the onset of acupuncture.These longer term effects were more pronounced for physicians offering additional complementary methods in their practice. Improvement after acupuncture and patient satisfaction were positively correlated.

Echinacea for preventing and treating the common cold.

BACKGROUND: Preparations of the plant Echinacea (family Compositae) are widely used in some European countries and in North America for common colds. Most consumers and physicians are not aware that products available under the term Echinacea differ appreciably in their composition, mainly due to the use of variable plant material, extraction methods and addition of other components. OBJECTIVES: The objective of this review was to assess whether there is evidence that Echinacea preparations are 1) more effective than no treatment; 2) more effective than placebo; 3) similarly effective to other treatments in A) the prevention and B) the treatment of the common cold. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2005); PubMed (1997 to April 2005), EMBASE (1998 to June 2005), AMED (to August 2005), Centre for Complementary Medicine Research (in Munich) (1988 to May 2005), contacted experts, and screened references of reviews. SELECTION CRITERIA: We included randomized controlled trials that compared mono-preparations of Echinacea with a placebo, no treatment, or another treatment for the prevention or treatment of common colds. Trials on combinations of Echinacea and other herbs were excluded. DATA COLLECTION AND ANALYSIS: For all studies, at least two authors independently assessed eligibility and trial quality, and extracted data. Outcomes of interest in prevention trials were: numbers of individuals with one or more colds, and severity and duration of colds; and in treatment trials: total symptom scores, nasal symptoms, and duration of colds. MAIN RESULTS: Sixteen trials including a total of 22 comparisons of an Echinacea preparation and a control group (19 with placebo, 2 with no treatment, 1 with another herbal preparation) met the inclusion criteria. All trials except one were described as double-blind. The majority had reasonable to good methodological quality. Three comparisons investigated prevention of colds and 19 comparisons tested treatment of colds. A variety of different Echinacea preparations were used. None of the three comparisons in the prevention trials showed an effect over placebo. Comparing an Echinacea preparation with placebo as treatment, a significant effect was reported in nine comparisons, a trend in one, and no difference in six. More than one trial was available only for preparations based on the aerial parts from Echinacea purpurea (E. purpurea). AUTHORS' CONCLUSIONS: Echinacea preparations tested in clinical trials differ greatly. There is some evidence that preparations based on the aerial parts of Echinacea purpurea might be effective for the early treatment of colds in adults but results are not fully consistent. Beneficial effects of other Echinacea preparations, and for preventative purposes might exist but have not been shown in independently replicated, rigorous randomized trials.

Acupuncture for osteoarthritic pain: an observational study in routine care.

OBJECTIVE: To investigate characteristics and outcomes of patients undergoing acupuncture treatment for osteoarthritic pain under conditions of routine care in the framework of statutory health insurance in Germany. METHODS: Patients with chronic pain due to osteoarthritis (ICD-10 diagnoses M15 to M19) treated with acupuncture as the leading form of therapy were included in an observational study. Detailed questionnaires including instruments to measure pain intensity (numerical rating scales from 0 to 10), disability (Pain Disability Index) and quality of life (SF-36) were filled in before treatment, after treatment and at 6 months. Patients suffering from osteoarthritis of the knee and hip also filled in the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index questionnaire. RESULTS: A total of 736 patients were included in the main analysis. Seventy (10%) patients and 278 (38%) patients, respectively, suffered exclusively from primary osteoarthritis of the hip or knee, 239 (33%) from another type of osteoarthritis and 149 (20%) had more than one affected joint. On average, patients received 8.7 +/- 3.1 acupuncture treatments. Statistically significant and clinically relevant improvements were seen in all subgroups both after treatment and at 6 months in all major outcome measures. In patients with osteoarthritis of the hip, the WOMAC sum score was 47.9 +/- 20.7 at baseline, 34.8 +/- 20.0 after treatment and 33.1 +/- 22.2 at 6 months. The respective values in patients with osteoarthritis of the knee were 51.7 +/- 20.9, 34.1 +/- 23.3 and 34.6 +/- 25.1. CONCLUSIONS: In this study, patients with chronic pain due to osteoarthritis reported clinically relevant improvements after acupuncture treatment. Due to the uncontrolled design and the high proportion of patients lost to follow-up, the study findings must be interpreted cautiously.

Acupuncture in patients with osteoarthritis of the knee: a randomised trial.

BACKGROUND: Acupuncture is widely used by patients with chronic pain although there is little evidence of its effectiveness. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with osteoarthritis of the knee. METHODS: Patients with chronic osteoarthritis of the knee (Kellgren grade < or =2) were randomly assigned to acupuncture (n=150), minimal acupuncture (superficial needling at non-acupuncture points; n=76), or a waiting list control (n=74). Specialised physicians, in 28 outpatient centres, administered acupuncture and minimal acupuncture in 12 sessions over 8 weeks. Patients completed standard questionnaires at baseline and after 8 weeks, 26 weeks, and 52 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index at the end of week 8 (adjusted for baseline score). All main analyses were by intention to treat. RESULTS: 294 patients were enrolled from March 6, 2002, to January 17, 2003; eight patients were lost to follow-up after randomisation, but were included in the final analysis. The mean baseline-adjusted WOMAC index at week 8 was 26.9 (SE 1.4) in the acupuncture group, 35.8 (1.9) in the minimal acupuncture group, and 49.6 (2.0) in the waiting list group (treatment difference acupuncture vs minimal acupuncture -8.8, [95% CI -13.5 to -4.2], p=0.0002; acupuncture vs waiting list -22.7 [-27.5 to -17.9], p<0.0001). After 52 weeks the difference between the acupuncture and minimal acupuncture groups was no longer significant (p=0.08). INTERPRETATION: After 8 weeks of treatment, pain and joint function are improved more with acupuncture than with minimal acupuncture or no acupuncture in patients with osteoarthritis of the knee. However, this benefit decreases over time.

St John's wort for depression.

BACKGROUND: Extracts of the plant Hypericum perforatum L. (popularly called St. John's wort) have been used in folk medicine for a long time for a range of indications including depressive disorders. OBJECTIVES: To investigate whether extracts of hypericum are more effective than placebo and as effective as standard antidepressants in the treatment of depressive disorders in adults; and whether they have have less adverse effects than standard antidepressant drugs. SEARCH STRATEGY: Trials were searched in computerized databases (Cochrane Collaboration Depression, Anxiety & Neurosis Group Clinical Trials Registers; PubMed); by checking bibliographies of pertinent articles; and by contacting manufacturers and researchers. SELECTION CRITERIA: Trials were included if they: (1) were randomized and double-blind; (2) included patients with depressive disorders; (3) compared extracts of St. John's wort with placebo or standard antidepressants; and (4) included clinical outcomes such as scales assessing depressive symptoms. DATA COLLECTION AND ANALYSIS: Information on patients, interventions, outcomes and results was extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of hypericum with placebo and standard antidepressants was the responder rate ratio (responder rate in treatment group/responder rate in control group). The main outcome measure for adverse effects was the number of patients dropping out for adverse effects. MAIN RESULTS: A total of 37 trials, including 26 comparisons with placebo and 14 comparisons with synthetic standard antidepressants, met the inclusion criteria. Results of placebo-controlled trials showed marked heterogeneity. In trials restricted to patients with major depression, the combined response rate ratio (RR) for hypericum extracts compared with placebo from six larger trials was 1.15 (95% confidence interval (CI), 1.02-1.29) and from six smaller trials was 2.06 (95% CI, 1.65 to 2.59). In trials not restricted to patients with major depression, the RR from six larger trials was 1.71 (95% CI, 1.40-2.09) and from five smaller trials was 6.13 (95% CI, 3.63 to 10.38). Trials comparing hypericum extracts and standard antidepressants were statistically homogeneous. Compared with selective serotonin reuptake inhibitors (SSRIs) and tri- or tetracyclic antidepressants, respectively, RRs were 0.98 (95% CI, 0.85-1.12; six trials) and 1.03 (95% CI, 0.93-1.14; seven trials). Patients given hypericum extracts dropped out of trials due to adverse effects less frequently than those given older antidepressants (Odds ratio (OR) 0.25; 95% CI, 0.14-0.45); such comparisons were in the same direction, but not statistically significantly different, between hypericum extracts and SSRIs (OR 0.60, 95% CI, 0.31-1.15). AUTHORS' CONCLUSIONS: Current evidence regarding hypericum extracts is inconsistent and confusing. In patients who meet criteria for major depression, several recent placebo-controlled trials suggest that the tested hypericum extracts have minimal beneficial effects while other trials suggest that hypericum and standard antidepressants have similar beneficial effects. As the preparations available on the market might vary considerably in their pharmaceutical quality, the results of this review apply only to the products tested in the included studies.

Manual therapy for asthma.

BACKGROUND: A variety of manual therapies with similar postulated biologic mechanisms of action are commonly used to treat patients with asthma. Manual therapy practitioners are also varied, including physiotherapists, respiratory therapists, chiropractic and osteopathic physicians. A systematic review across disciplines is warranted. OBJECTIVES: To evaluate the evidence for the effects of manual therapies for treatment of patients with bronchial asthma. SEARCH STRATEGY: We searched for trials in computerized general (EMBASE, CINAHL and MEDLINE) and specialized databases (Cochrane Complementary Medicine Field, Cochrane Rehabilitation Field, Index to Chiropractic Literature (ICL), and Manual, Alternative and Natural Therapy (MANTIS)). In addition, we assessed bibliographies from included studies, and contacted authors of known studies for additional information about published and unpublished trials. Date of most recent search: August 2004. SELECTION CRITERIA: Trials were included if they: (1) were randomised; (2) included asthmatic children or adults; (3) examined one or more types of manual therapy; and (4) included clinical outcomes with observation periods of at least two weeks. DATA COLLECTION AND ANALYSIS: All three reviewers independently extracted data and assessed trial quality using a standard form. MAIN RESULTS: From 473 unique citations, 68 full text articles were retrieved and evaluated, which resulted in nine citations to three RCTs (156 patients) suitable for inclusion. Trials could not be pooled statistically because studies that addressed similar interventions used disparate patient groups or outcomes. The methodological quality of one of two trials examining chiropractic manipulation was good and neither trial found significant differences between chiropractic spinal manipulation and a sham manoeuvre on any of the outcomes measured. One small trial compared massage therapy with a relaxation control group and found significant differences in many of the lung function measures obtained. However, this trial had poor reporting characteristics and the data have yet to be confirmed. AUTHORS' CONCLUSIONS: There is insufficient evidence to support the use of manual therapies for patients with asthma. There is a need to conduct adequately-sized RCTs that examine the effects of manual therapies on clinically relevant outcomes. Future trials should maintain observer blinding for outcome assessments, and report on the costs of care and adverse events. Currently, there is insufficient evidence to support or refute the use of manual therapy for patients with asthma.

[Structure, realization and data synopsis of an observational study as part of the patient care evaluation programme on acupuncture (PEP-AC) drafted by German statutory insurance institutions]. / Aufbau, Realisierung und Datenübersicht einer Beobachtungsstudie im Rahmen des Programms zur Evaluation der Patientenversorgung mit Akupunktur (PEP-AK) des Modellvorhabens der Ersatzkassen.

This paper describes the concept and realization of a nation-wide observational study which is part of the patient care evaluation programme on acupuncture as part of a model project of German statutory insurance bodies. The study aimed describing medical care with acupuncture to estimate the incidence of adverse reactions as well as the treatment effects of acupuncture in chronically ill patients with headache, low back pain or osteoarthritic pain. It was also intended to analyse relations between treatment effects and specialties of the treating acupuncturists. During the two-year period of report 9,918 acupuncturists took part in the study documenting 503,397 cases. A more comprehensive documentation is available for a sample of 10,366 patients with complete longitudinal data of 6,140 patients. The difficulties with data management and sampling technique are presented with reference to restricted capacities for monitoring. Furthermore the question of generalising of the results is discussed. There were differences in some respects (for example, frequencies of different indications) between the patient sample and the population of all patients included in the project. Patients also differed slightly with respect to the completeness of the longitudinal documentation. The results indicated that we cannot claim global representativeness for the sample-based findings, but there is no reason to assume a "positive" selection.

Large-scale observational studies of hypericum extracts in patients with depressive disorders--a systematic review.

We present a systematic review of observational studies of hypericum extracts in the treatment of depressive disorders. We included non-randomized studies with at least 100 patients suffering from depressive disorders treated with hypericum mono-preparations for at least 4 weeks, which reported clinical outcomes. Potentially relevant studies were identified through searches in electronic databases (Medline, PubMed), contacts with manufacturers, and handsearching of proceedings of phytomedicine congresses. Information on patients, interventions, methods an results were extracted by two reviewers. Sixteen studies including a total of 34,804 (range 101-11,296) patients met the inclusion criteria. Most studies investigated short-term effects (4-6 weeks) in patients with mild to moderate depression. Response rates (according to physician assessment) varied between 65% and 100%, the proportion of patients dropping out due to side effects varied between 0.0% and 2.8%. Two studies investigated long-term effects (52 weeks). Reponse rates were 60% and 69%, respectively, and the proportions of patients dropping out due to side effects were 3.4% and 5.7%, respectively. Serious side effects or interactions were not reported in any study. The quality of reporting was insufficient in the majority of publications. The available studies show that hypericum extract are well tolerated and seem to be effective in routine treatment of mild to moderate depressive disorders.