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K Linde

Publications and source records attributed to K Linde.

At least 19 recordsLinked to original sources
PubMed2006

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.

Common Cold↗
PubMed2006

[The specific placebo effect].

Placebo effects are considered a relevant component of any therapeutic intervention. At the same time clinical researchers try to control for them as if they were unspecific noise which cannot be differentiated any further. This article shows that the evidence for clinically relevant placebo effects is contradictory. The author believes that these contradictions are mainly due to the misleading terms and concepts of placebo, specific and unspecific effects. A model interpreting all effects of an intervention (excluding spontaneous changes and measurement error) as specific (having a clear-cut mechanism and a size depending on the specific conditions) is proposed. The part of the total effect caused by the postulated mechanism (the specific effect in common terms) is interpreted as attributable while the other parts are considered associated effects. The size of associated effects depends on the characteristics of interventions, patients and providers. This model would better explain the contradictory results reported in placebo research. Further implications for research and health care decision making are discussed.

Controlled Clinical Trials as Topic↗
PubMed2006

[Acupuncture for chronic pain patients. Treatment outcomes--the role of the acupuncturist].

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.

Acupuncture Therapy↗
PubMed2005

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 Therapy↗
PubMed2005

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.

Adult↗
PubMed2005

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.

Adult↗
PubMed2005

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.

Antidepressive Agents↗
PubMed2005

[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].

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.

Acupuncture↗
PubMed2004

Acupuncture for chronic asthma.

BACKGROUND: Acupuncture has traditionally been used to treat asthma in China and is used increasingly for this purpose internationally. OBJECTIVES: The objective of this review was to assess the effects of acupuncture for the treatment of asthma or asthma-like symptoms. SEARCH STRATEGY: We searched the Cochrane Airways Group trials register (searched August 2003), the Cochrane Complementary Medicine Field trials register, the Alternative Medicine Database (August 2003) and reference lists of articles. We also contacted trialists and researchers in the field of complementary and alternative medical research. SELECTION CRITERIA: Randomised and possibly randomised trials using needle acupuncture or other forms of stimulation of acupuncture. Any form of control treatment was considered (no treatment in addition to conventional asthma treatment, sham or placebo interventions, active comparator interventions). Studies were included provided outcome was assessed at one week or more. DATA COLLECTION AND ANALYSIS: At least two reviewers independently assessed trial quality. A reviewer experienced in acupuncture assessed the adequacy of the active and sham acupunctures used in the studies. Study authors were contacted for missing information. MAIN RESULTS: Eleven studies met the inclusion criteria with 324 participants. Trial reporting was poor and trial quality was deemed inadequate to generalise findings. There was variation in the type of active and sham acupunctures, the outcomes measured and time-points presented. The points used in the sham arm of some studies are used for the treatment of asthma according to traditional Chinese medicine. Two studies used individualised treatment strategies and one study used a combination strategy of formula acupuncture with the addition of individualised points. No statistically significant or clinically relevant effects were found for acupuncture compared to sham acupuncture. Data from two small studies were pooled for lung function (post-treatment FEV1): Standardised Mean Difference 0.12, 95% confidence interval -0.31 to 0.55). REVIEWER'S CONCLUSIONS: There is not enough evidence to make recommendations about the value of acupuncture in asthma treatment. Further research needs to consider the complexities and different types of acupuncture.

Acupuncture Therapy↗
PubMed2004

Homeopathy for chronic asthma.

BACKGROUND: Homeopathy involves the use, in dilution, of substances which cause symptoms in their undiluted form. It is one of the most widespread forms of complementary medicines and is also used to treat asthma. OBJECTIVES: The objective of this review was to assess the effects of homeopathy in people with chronic stable asthma. SEARCH STRATEGY: We searched the Cochrane Airways Group trials register, the Cochrane Complementary Medicine Field trials register, the Glasgow Homeopathic Hospital database, the Münchener Modell database and reference lists of articles. Searches were current as of August 2003. SELECTION CRITERIA: Randomised trials of homeopathy for the treatment of stable chronic asthma, with observation periods of at least one week were included. DATA COLLECTION AND ANALYSIS: Data extraction was undertaken by two reviewers. Trial quality was assessed by the reviewers. MAIN RESULTS: Six trials with a total of 556 people were included. These trials were all placebo-controlled and double-blind, but of variable quality. They used different homeopathic treatments which precluded quantitative pooling of results for the primary outcome. Standardised treatments in these trials are unlikely to represent common homeopathic practice, where treatment tends to be individualised. No trial reported a significant difference on validated symptom scales. There were conflicting results in terms of lung function between the studies. There has been only a limited attempt to measure a 'package of care' effect (i.e., the effect of the medication as well as the consultation, which is considered a vital part of individualised homeopathic practice). REVIEWER'S CONCLUSIONS: There is not enough evidence to reliably assess the possible role of homeopathy in asthma. As well as randomised trials, there is a need for observational data to document the different methods of homeopathic prescribing and how patients respond. This will help to establish to what extent people respond to a 'package of care' rather than the homeopathic intervention alone.

Asthma↗
PubMed2004

Propranolol for migraine prophylaxis.

BACKGROUND: Propranolol is one of the most commonly prescribed drugs for migraine prophylaxis. OBJECTIVES: We aimed to determine whether there is evidence that propranolol is more effective than placebo and as effective as other drugs for the interval (prophylactic) treatment of patients with migraine. SEARCH STRATEGY: Potentially eligible studies were identified by searching MEDLINE/PubMed (1966 to May 2003) and the Cochrane Central Register of Controlled Trials (Issue 2, 2003), and by screening bibliographies of reviews and identified articles. SELECTION CRITERIA: We included randomised and quasi-randomised clinical trials of at least 4 weeks duration comparing clinical effects of propranolol with placebo or another drug in adult migraine sufferers. DATA COLLECTION AND ANALYSIS: Two reviewers extracted information on patients, methods, interventions, outcomes measured, and results using a pre-tested form. Study quality was assessed using two checklists (Jadad scale and Delphi list). Due to the heterogeneity of outcome measures and insufficient reporting of the data, only selective quantitative meta-analyses were performed. As far as possible, effect size estimates were calculated for single trials. In addition, results were summarised descriptively and by a vote count among the reviewers. MAIN RESULTS: A total of 58 trials with 5072 participants met the inclusion criteria. The 58 selected trials included 26 comparisons with placebo and 47 comparisons with other drugs. The methodological quality of the majority of trials was unsatisfactory. The principal shortcomings were high dropout rates and insufficient reporting and handling of this problem in the analysis. Overall, the 26 placebo-controlled trials showed clear short-term effects of propranolol over placebo. Due to the lack of studies with long-term follow up, it is unclear whether these effects are stable after stopping propranolol. The 47 comparisons with calcium antagonists, other beta-blockers, and a variety of other drugs did not yield any clear-cut differences. Sample size was, however, insufficient in most trials to establish equivalence. REVIEWERS' CONCLUSIONS: Although many trials have relevant methodological shortcomings, there is clear evidence that propranolol is more effective than placebo in the short-term interval treatment of migraine. Evidence on long-term effects is lacking. Propranolol seems to be as effective and safe as a variety of other drugs used for migraine prophylaxis.

Adrenergic beta-Antagonists↗
PubMed2004

An overview of two Cochrane systematic reviews of complementary treatments for chronic asthma: acupuncture and homeopathy.

BACKGROUND: Acupuncture and homeopathy are commonly used complementary treatments for chronic asthma. This review summarizes two recently updated Cochrane systematic reviews that assess the safety and efficacy of homeopathy or acupuncture in individuals with chronic stable asthma. INCLUSION CRITERIA: Only randomized-controlled trials were considered for inclusion. Statistical aggregation of the data was undertaken where possible. SEARCH STRATEGY: Searches for both reviews were done with the assistance of the Cochrane Airways Group, and through electronic alerts. RESULTS: ACUPUNCTURE: 11 studies with 324 participants met the inclusion criteria. Trial reporting was poor, and the trial quality was deemed inadequate to generalize the findings. There was variation in the type of active and sham acupunctures, the outcomes assessed and the time points measured. The points used in the sham arm of some studies are used for the treatment of asthma according to traditional Chinese medicine. Two studies used individualized treatment strategies, and one study used a combination strategy of formula acupuncture with the addition of individualized points. No statistically significant or clinically relevant effects were found for acupuncture compared with sham acupuncture. When data from two small studies were pooled, no difference in lung function was observed (post-treatment FEV1): standardized mean difference 0.12, 95% confidence interval 0.31 to 0.55). CONCLUSION: ACUPUNCTURE: There is not enough evidence to recommend the use of acupuncture in the treatment of asthma. Further research needs to be undertaken, and this should take into account the different types of acupuncture practiced. RESULTS: HOMEOPATHY: Six trials with a total of 556 people were included in the review. These trials were all placebo-controlled and double-blind, but were of variable quality. Standardized treatments in these trials are unlikely to represent common homeopathic practice where treatment tends to be individualized. The results of the studies are conflicting in terms of effects on lung function. There has been only a limited attempt to measure a "package of care" effect (i.e. the effect of the medication as well as the consultation, which is considered a vital part of individualized homeopathic practice). CONCLUSION: HOMEOPATHY: There is not enough evidence to reliably assess the possible role of homeopathy in the treatment of asthma. Further studies could assess whether individuals respond to a "package of care" rather than the homeopathic intervention alone.

Acupuncture Therapy↗
PubMed2004

Change in quality of life in the year following cardiac rehabilitation.

The aim of the present study was to assess change in health-related quality of life (HRQoL) after cardiac rehabilitation in the usual care setting, and to determine predictors for change. In the Post Infarction Care Study, 2441 patients were consecutively included at admission to 18 inpatient cardiac rehabilitation centres following coronary events. HRQoL was assessed with the SF-36 questionnaire at baseline as well as 6 and 12 months after discharge. HRQoL improved significantly in patients after coronary artery bypass grafting (CABG) but not in patients after myocardial infarction. Significant baseline predictors for change of the SF-36 physical component summary (PCS) score were the exercise ECG result at admission (0.59 absolute change/10-watt increase; 95% CI: 0.39, 0.79), an income > or = 1750 euros (1.64; 95% CI: 0.35, 2.93), baseline PCS score (-0.63; 95% CI: -0.69, -0.57), and CABG as indication for admission (3.65; 95% CI: 2.27, 5.04). Significant predictors for change of the mental component summary (MCS) score were age (1.28/10-year increase; 95% CI: 0.62, 1.94), East Germany as area of residence (2.62; 95% CI: 1.32, 3.91), baseline MCS score (-0.58; 95% CI: -0.63, -0.52), and CABG as indication for admission (1.68; 95% CI: 0.36, 3.01). The identification of predictors of HRQoL in the present study may aid in the further development and evaluation of cardiac rehabilitation programmes.

Aged↗
PubMed2004

Treatment outcomes in patients with migraine: an ex-post-facto comparison of two in-patient facilities.

BACKGROUND: In two hospitals we performed an open, prospective observational study on patients with chronic headache as a measure of internal quality assurance using identical methods. Available data were subordinately analysed in order to compare both studies. QUESTIONS: Are the patient samples of both hospitals comparable? If not, which form of statistical adjustment is recommended? Are there differences in the outcome measures of both facilities? METHODS: The outcomes were defined as differences between baseline values and values at discharge from hospital, respectively 6 months after. Frequency of headache attacks, intensity of pain, intensity of general complaints as well as of concomitant symptoms, and quality of life were determined in advance as dependent variables. To compare both patient groups univariate analysis of variance without and with inclusion of covariates were used. For calculating propensity scores (conditional probability of belonging to one of two groups) a logistic regression with the same covariates serving as independent variables was performed. PATIENTS: 426 patients with the main diagnosis "Migraine" and complete data sets concerning the covariates were selected for analysis. 87% of patients are female, the mean age is 45.5 +/- 11.7 years (range 14-73 yrs). RESULTS: 4 out of 11 potential covariates show statistically significant differences between the patients of both hospitals. Correct classification of patients by means of the propensity score succeeds in 67%. Comparing the outcomes at discharge from hospital, significant differences between both groups exist which are, with one exception, not affected by controlling for covariates. 6 months after discharge two of the initial differences between both patient groups are no longer present. These findings are independent from the statistical technique of risk adjustment. CONCLUSIONS: Because of the observed differences between both patient groups it is recommended to adjust data by regression analysis in order to enhance comparability. The choice for one of the two proposed techniques is secondary. With respect to the analyses clear differences between both hospitals exist in short-term outcomes, disappearing 6 months later.

Adolescent↗
PubMed2003

Sham interventions in randomized clinical trials of acupuncture--a review.

BACKGROUND AND OBJECTIVES: For non-drug interventions such as acupuncture, it is difficult to establish placebo or sham controls that are both inert and indistinguishable. We reviewed sham-controlled clinical trials of acupuncture to investigate (a) which types of sham interventions have been used in the past; (b) in what respects true and sham interventions differed; and (c) whether trials using different types of sham yielded different results. METHODS: 47 randomized controlled trials comparing true and sham acupuncture interventions for pain and a variety of other conditions were identified from systematic reviews and through a search in PubMed. Details of patients, interventions, sham interventions and outcomes were extracted in a standardized manner. RESULTS: In two trials the sham intervention consisted of superficial needling of the true acupuncture points, four trials used true acupuncture points which were not indicated for the condition being treated, in 27 trials needles were inserted outside true acupuncture points, five trials used placebo needles and nine trials used pseudo-interventions such as switched off-laser acupuncture devices. True and sham interventions often differed in a variety of other variables, such as manipulation of needles, depth of insertion, achievement of an irradiating needling sensation (de-chi), etc. There was no clear association between the type of sham intervention used and the results of the trials. CONCLUSION: Randomized trials investigating the specific effects of acupuncture have used a great variety of sham interventions as controls. Summarizing all the different sham interventions as "placebo" controls seems misleading and scientifically unacceptable.

Acupuncture↗
PubMed2003

Acupuncture versus placebo versus sumatriptan for early treatment of migraine attacks: a randomized controlled trial.

OBJECTIVES: To investigate whether acupuncture is superior to placebo and equivalent to sumatriptan for the early treatment of an acute migraine attack. DESIGN: Randomized, partly double-blind (sumatriptan versus placebo) trial. SETTING: Two hospitals in Germany (one specialized in traditional Chinese medicine and one in the treatment of headache). SUBJECTS: A total of 179 migraineurs experiencing the first symptoms of a developing migraine attack. INTERVENTIONS: Traditional Chinese acupuncture, sumatriptan (6 mg subcutaneously) or placebo injection. MAIN OUTCOME MEASURE: Number of patients in whom a full migraine attack (defined as severe migraine headache) within 48 h was prevented. In patients who developed a migraine attack in spite of early treatment, acupuncture and sumatriptan were applied a second time, whilst patients initially randomized to placebo received sumatriptan. RESULTS: A full migraine attack was prevented in 21 of 60 (35%) patients receiving acupuncture, 21 of 58 (36%) patients receiving sumatriptan and 11 of 61 (18%) patients receiving placebo (relative risk of having a full attack 0.79 (95% CI, 0.64-0.99) for acupuncture versus placebo, and 0.78 (95% CI, 0.62-0.98) for sumatriptan versus placebo). Response to the second intervention in patients who developed a full attack was better with sumatriptan (17/31 patients who received sumatriptan twice and 37/46 patients who had had placebo first) than with acupuncture (4/31). The number of patients reporting side-effects was 14 in the acupuncture group, 23 in the sumatriptan group and 10 in the placebo group. CONCLUSIONS: In this trial acupuncture and sumatriptan were more effective than a placebo injection in the early treatment of an acute migraine attack. When an attack could not be prevented, sumatriptan was more effective than acupuncture at relieving headache.

Acupuncture Therapy↗
PubMed2003

Characteristics and quality of systematic reviews of acupuncture, herbal medicines, and homeopathy.

BACKGROUND: We aimed to describe the approaches and characteristics of systematic reviews on three major complementary therapies and to assess their methodological quality. METHODS: Systematic reviews of clinical trials of acupuncture, herbal medicines, and homeopathy were identified from a database developed for the Cochrane Collaboration Complementary Medicine Field. Information on conditions, interventions, methods, results, and conclusions was extracted using a pre-tested form; methodological quality was assessed using the Oxman scale. RESULTS: 115 reviews were included (39 on acupuncture, 58 on herbal medicine, 18 on homeopathy). Research questions were most specific in herbal medicine, and tended to be very general in homeopathy. The main comparison in most reviews was with placebo. The methodological quality of reviews was highly variable. Deficiencies were most frequent for the description of the selection process and the summary of the results of primary studies. CONCLUSION: Systematic reviews tend to approach different complementary therapies in different manner. Compared to a set of reviews on analgesic interventions methodological quality was slightly better on the average, but there is ample room for improvement in future complementary medicine reviews.

Acupuncture Therapy↗