Clinical effects of Kneipp hydrotherapy: a systematic review of randomised controlled trials.

OBJECTIVE: Hydrotherapy is a traditional prevention and treatment strategy. This study's aim is to systematically review all available randomised controlled trials (RCTs) investigating clinical effects of hydrotherapy according to Kneipp which is characterised by cold water applications. METHODS: RCTs on disease therapy and prevention with Kneipp hydrotherapy were included. Study participants were patients and healthy volunteers of all age groups. MEDLINE (via PubMed), Scopus, Central, CAMbase, and opengrey.eu were systematically searched through April 2021 without language restrictions and updated by searching PubMed until April 6th 2023. Risk of bias was assessed using the Cochrane tool version 1.ResultsTwenty RCTs (N=4247) were included. Due to high heterogeneity of the RCTs, no meta-analysis was performed. Risk of bias was rated as unclear in most of the domains. Of 132 comparisons, 46 showed significant positive effects in favour of hydrotherapy on chronic venous insufficiency, menopausal symptoms, fever, cognition, emotional function and sickness absenteeism. However, 81 comparisons showed no differences between groups and 5 were in favour of the respective control group. Only half of the studies reported safety issues. CONCLUSION: Although RCTs on Kneipp hydrotherapy seem to show positive effects in some conditions and outcomes, it remains difficult to ascertain treatment effects due to the high risk of bias and heterogeneity of most of the considered studies. Further high-quality RCTs on Kneipp hydrotherapy are urgently warranted. PROSPERO REGISTRATION NUMBER: CRD42021237611.

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.

Nonpharmacological Interventions for Pediatric Migraine: A Network Meta-analysis.

CONTEXT: Migraine is a common neurologic disorder in children and adolescents. However, a comparison of multiple nonpharmacological treatments is lacking. OBJECTIVE: To examine whether nonpharmacological treatments are more effective than waiting list and whether there are differences between interventions regarding efficacy. DATA SOURCES: Systematic review and network meta-analysis of studies in Medline, Cochrane, Embase, and PsycINFO published through August 5, 2019. STUDY SELECTION: Randomized controlled trials of nonpharmacological treatments in children and adolescents diagnosed with episodic migraine. DATA EXTRACTION: Effect sizes, calculated as standardized mean differences (SMDs) for the primary outcome efficacy, were assessed in a random-effects model. RESULTS: Twelve studies (N = 576) were included. When interventions were classified into groups on the basis of similarity of treatment components, self-administered treatments, biofeedback, relaxation, psychological treatments, and psychological placebos were significantly more effective than waiting list with effect sizes ranging between SMD = 1.14 (95% confidence interval, 0.09 to 2.19) for long-term psychological placebos to SMD = 1.44 (95% confidence interval, 0.26 to 2.62) for short-term self-administered treatments. However, when all interventions were examined individually (ie, 1 node per intervention), none were significantly more effective compared with waiting list, mainly because of lack of statistical power. LIMITATIONS: Because of our focus on pediatric migraine, only a small number of studies could be included. CONCLUSIONS: Our findings reveal that components of nonpharmacological interventions are effective in treating pediatric migraine. Some effects have to be interpreted carefully because they are based on small studies. Future researchers should identify factors associated with individual responses in large, multicentered studies.

Do the effects of acupuncture vary between acupuncturists? Analysis of the Acupuncture Trialists' Collaboration individual patient data meta-analysis.

OBJECTIVES: The degree to which the effects of acupuncture treatment vary between acupuncturists is unknown. We used a large individual patient dataset of trials of acupuncture for chronic pain to assess practitioner heterogeneity. METHODS: Individual patient data linked to identifiable acupuncturists were drawn from a dataset of 39 high-quality trials of acupuncture, where the comparators were either sham acupuncture or non-acupuncture controls, such as standard care or waitlist. Heterogeneity among acupuncturists was assessed by meta-analysis. RESULTS: A total of 1206 acupuncturists in 13 trials were included. Statistically significant heterogeneity was found in trials with sham-control groups (p < 0.0001) and non-acupuncture control groups (p <0.0001). However, the degree of heterogeneity was very small, with the observed distribution of treatment effects virtually overlapping that expected by chance. For instance, for non-acupuncture-controlled trials, the proportion of acupuncturists with effect sizes half a standard deviation greater or less than average was expected to be 34%, but was observed to be 37%. A limitation is that the trials included a relatively limited range of acupuncturists, mainly physician-acupuncturists. DISCUSSION: Although differences in effects between acupuncturists were greater than expected by chance, the degree of variation was small. This suggests that most chronic pain patients in clinical practice would have similar results to those reported in high-quality trials; comparably, we did not find evidence to suggest that greater standardization of acupuncture practice would improve outcomes. Further research needs to be conducted exploring variability using a sample of acupuncturists with a broader range of practice styles, training and experience.

Identifying patients with chronic pain who respond to acupuncture: results from an individual patient data meta-analysis.

BACKGROUND: In a recent individual patient data meta-analysis, acupuncture was found to be superior to sham and non-sham controls in patients with chronic pain. It has been suggested that a subgroup of patients has an exceptional response to acupuncture. We hypothesized the presence of exceptional acupuncture responders would lead to a different distribution of pain scores in acupuncture versus control groups, with the former being skewed to the right. METHODS: This individual patient data meta-analysis included 39 high-quality randomized trials of acupuncture for chronic headache, migraine, osteoarthritis, low back pain, neck pain and shoulder pain published before December 2015 (n = 20,827). In all, 25 involved sham acupuncture controls (n = 7097) and 25 non-acupuncture controls (n = 16,041). We analyzed the distribution of change scores and calculated the difference in the skewness statistic-which assesses asymmetry in the data distribution-between acupuncture and either sham or non-acupuncture control groups. We then entered the difference in skewness along with standard error into a meta-analysis. FINDINGS: Control groups were more right-skewed than acupuncture groups, although this difference was very small. The difference in skew was 0.124 for non-acupuncture-controlled trials (p = 0.047) and 0.141 for sham-controlled trials (p = 0.029). In a pre-specified sensitivity analysis excluding three trials with outlying results known a priori, the difference in skew between acupuncture and sham was no longer statistically significant (p = 0.2). CONCLUSION: We did not find evidence to support the notion that there are exceptional acupuncture responders. The challenge remains to identify features of chronic pain patients that can be used to distinguish those that have a good response to acupuncture treatment.

How Young German General Practitioners View and Use Complementary and Alternative Medicine: A Qualitative Study.

BACKGROUND: Qualitative and quantitative surveys show that many German general practitioners (GPs) use complementary and alternative medicine (CAM) in their daily work. However, participants in such studies were mostly experienced GPs. OBJECTIVE: The aim of this study was to investigate systematically how young GPs view CAM and to what extent and how they use CAM treatments. METHODS: Thirteen young physicians in specialist training for general practice as well as GPs who had completed their specialist training within the last 2 years participated in problem-oriented interviews. Interviews were evaluated by qualitative content analysis. RESULTS: The attitudes of participants towards CAM in general and towards specific CAM modalities varied strongly, but doubts regarding a firm evidence base and specific effects over placebo were expressed frequently. Nevertheless, participants were generally open to herbal medicines and all seemed to use them more or less regularly in clinical practice. Other CAM treatments seemed to be used infrequently. Participants used CAM often for minor illnesses; largely as a first low-intensity therapeutic trial to avoid potentially harmful conventional treatments; and to comply with patient preferences. CONCLUSIONS: Compared to more experienced GPs, the participants in our study tended to be more critical towards CAM. Apart from herbal medicines, CAM treatments were used rarely.

How German general practitioners justify their provision of complementary and alternative medicine - a qualitative study.

BACKGROUND: Many German general practitioners (GPs) use complementary and alternative medicine (CAM) in their daily work although most CAM procedures are controversial from an academic point of view. OBJECTIVE: We aimed to investigate how GPs justify their use of CAM. METHODS: We performed semi-structured, individual face-to-face interviews with 20 purposively sampled, experienced GPs providing primary care within the framework of the German statutory health insurance system. A grounded theory approach was used for data analysis. RESULTS: All GPs participating in this study used at least some CAM in their clinical practice. Participants did not have any major conflicts when justifying their use of CAM therapies. Important arguments justifying CAM provision were: using it as a supplementary tool to conventional medicine; the feeling that evidence and science leave many problems in primary care unanswered; a strong focus on helping the individual patient, justifying the use of procedures not based on science for therapeutic and communicative purposes; a strong belief in one's own clinical experience; and appreciation of placebo effects. In general, participants preferred CAM therapies which seemed at least somewhat plausible to them and which they could provide in an authentic manner. CONCLUSIONS: Our results suggest that many German GPs integrate CAM treatments in their routine primary care work without perceiving any major internal conflicts with professional ideals.

Efficacy, Safety, and Acceptability of Pharmacologic Treatments for Pediatric Migraine Prophylaxis: A Systematic Review and Network Meta-analysis.

Importance: Migraine is one of the most common neurologic disorders in children and adolescents. However, a quantitative comparison of multiple preventive pharmacologic treatments in the pediatric population is lacking. Objective: To examine whether prophylactic pharmacologic treatments are more effective than placebo and whether there are differences between drugs regarding efficacy, safety, and acceptability. Data Sources: Systematic review and network meta-analysis of studies in MEDLINE, Cochrane, Embase, and PsycINFO published through July 2, 2018. Study Selection: Randomized clinical trials of prophylactic pharmacologic treatments in children and adolescents diagnosed as having episodic migraine were included. Abstract, title, and full-text screening were conducted independently by 4 reviewers. Data Extraction and Synthesis: Data extraction was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis network meta-analysis guidelines. Quality was assessed with the Cochrane Risk of Bias tool. Effect sizes, calculated as standardized mean differences for primary outcomes and risk ratios for discontinuation rates, were assessed in a random-effects model. Main Outcomes and Measures: Primary outcomes were efficacy (ie, migraine frequency, number of migraine days, number of headache days, headache frequency, or headache index), safety (ie, treatment discontinuation owing to adverse events), and acceptability (ie, treatment discontinuation for any reason). Results: Twenty-three studies (2217 patients) were eligible for inclusion. Prophylactic pharmacologic treatments included antiepileptics, antidepressants, calcium channel blockers, antihypertensive agents, and food supplements. In the short term (<5 months), propranolol (standard mean difference, 0.60; 95% CI, 0.03-1.17) and topiramate (standard mean difference, 0.59; 95% CI, 0.03-1.15) were significantly more effective than placebo. However, the 95% prediction intervals for these medications contained the null effect. No significant long-term effects for migraine prophylaxis relative to placebo were found for any intervention. Conclusions and Relevance: Prophylactic pharmacologic treatments have little evidence supporting efficacy in pediatric migraine. Future research could (1) identify factors associated with individual responses to pharmacologic prophylaxis, (2) analyze fluctuations of migraine attack frequency over time and determine the most clinically relevant length of probable prophylactic treatment, and (3) identify nonpharmacologic targets for migraine prophylaxis.

Cupping for Patients With Chronic Pain: A Systematic Review and Meta-Analysis.

There is a growing interest in nonpharmacological pain treatment options such as cupping. This meta-analysis aimed to assess the effectiveness and safety of cupping in chronic pain. PubMed, Cochrane Library, and Scopus were searched through November 2018 for randomized controlled trials on effects of cupping on pain intensity and disability in patients with chronic pain. Risk of bias was assessed using the Cochrane risk of bias tool. Of the 18 included trials (n =1,172), most were limited by clinical heterogeneity and risk of bias. Meta-analyses found large short-term effects of cupping on pain intensity compared to no treatment (standardized mean difference [SMD] = -1.03; 95% confidence interval [CI] = -1.41, -.65), but no significant effects compared to sham cupping (SDM = -.27; 95% CI = -.58, .05) or other active treatment (SMD = -.24; 95% CI = -.57, .09). For disability, there were medium-sized short-term effects of cupping compared to no treatment (SMD = -.66; 95% CI = -.99, -.34), and compared to other active treatments (SMD = -.52; 95% CI = -1.03, -.0028), but not compared to sham cupping (SMD = -.26; 95% CI = -.57,.05). Adverse events were more frequent among patients treated with cupping compared to no treatment; differences compared to sham cupping or other active treatment were not statistically significant. Cupping might be a treatment option for chronic pain, but the evidence is still limited by the clinical heterogeneity and risk of bias. Perspective: This article presents the results of a meta-analysis aimed to assess the effectiveness and safety of cupping with chronic pain. The results suggest that cupping might be a treatment option; however, the evidence is still limited due to methodical limitations of the included trials. High-quality trials seem warranted.

On the edges of medicine - a qualitative study on the function of complementary, alternative, and non-specific therapies in handling therapeutically indeterminate situations.

BACKGROUND: In routine practice, general practitioners (GPs) see many patients for whom treatment might not be necessary, or evidence-based treatments are not available, yet often a treatment is prescribed. We denote such situations as therapeutically indeterminate. We aimed to investigate 1) whether therapeutically indeterminate situations play a role in the accounts of GPs in their practical work; 2) the role of complementary and alternative medicine (CAM) modalities or non-specific therapies, and of other strategies used in handling therapeutically indeterminate situations; and 3) factors associated with preferences for specific strategies. METHODS: We performed semi-structured, individual face-to-face interviews with 20 purposively sampled, experienced GPs from Bavaria, Germany. A grounded theory approach was used for data analysis. RESULTS: Participants reported that therapeutically indeterminate situations recur often in their daily practice. Professionally legitimate strategies such as empathetic consultations without providing a treatment intervention did not seem to suffice for coping with all of these situations. CAM treatments were used frequently, but motives varied. While some participants were convinced that these treatments were active and effective, others were uncertain or had doubts and used them as a relational tool, as a non-specific treatment or as a beneficial placebo. Conventional drugs were also used in a non-specific manner or despite doubts regarding the risk-benefit ratio. The extent to which GPs felt responsible for offering solutions in therapeutically indeterminate situations seemed to influence their preference for specific strategies. CONCLUSION: Our results demonstrate the important role of CAM and the somewhat smaller role of non-specific therapies for German general practitioners in dealing with therapeutically indeterminate situations. The concept of therapeutically indeterminate situations may be helpful in better understanding why many general practitioners treat patients in situations where treatment does not appear to be clearly indicated.

The Effect of Patient Characteristics on Acupuncture Treatment Outcomes: An Individual Patient Data Meta-Analysis of 20,827 Chronic Pain Patients in Randomized Controlled Trials.

OBJECTIVES: To optimally select chronic pain patients for different treatments, as it is of interest to identify patient characteristics that might moderate treatment effect. Our aim was to evaluate the impact of possible moderators on the effect of acupuncture treatment using a large data set. METHODS: We used data from an individual patient data meta-analysis of high-quality randomized trials of acupuncture for chronic headache and migraine, osteoarthritis, and back, neck, and shoulder pain. Using meta-analytic trial-level and patient-level regression analyses, we explored the impact of 5 documented patient characteristics (patients' age at baseline, sex, pain duration, baseline pain severity and baseline psychological distress) on the effect of acupuncture. RESULTS: A total of 39 trials met the inclusion criteria: 25 use sham-acupuncture controls (n = 7097) and 25 non-acupuncture controls (n = 16,041). Of the 5 patient characteristics analyzed, only baseline pain severity was found to potentially moderate the treatment effect of acupuncture, with patients reporting more severe pain at baseline experiencing more benefit from acupuncture compared to either sham-control or non-acupuncture control. Baseline psychological distress showed small treatment moderating effects, and results for sex were inconsistent. There was no strong evidence that age or duration of pain influenced the response to acupuncture. DISCUSSION: Of 5 patient characteristics tested, we found only baseline severity of pain to potentially moderate the effect of acupuncture treatment. For clinical practice, the evidence from this analysis does not justify stratifying chronic pain patients into subgroups that should or should not receive acupuncture on the basis of these 5 characteristics. Future acupuncture trials should assess other potentially important effect moderators.

Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis.

Despite wide use in clinical practice, acupuncture remains a controversial treatment for chronic pain. Our objective was to update an individual patient data meta-analysis to determine the effect size of acupuncture for 4 chronic pain conditions. We searched MEDLINE and the Cochrane Central Registry of Controlled Trials randomized trials published up until December 31, 2015. We included randomized trials of acupuncture needling versus either sham acupuncture or no acupuncture control for nonspecific musculoskeletal pain, osteoarthritis, chronic headache, or shoulder pain. Trials were only included if allocation concealment was unambiguously determined to be adequate. Raw data were obtained from study authors and entered into an individual patient data meta-analysis. The main outcome measures were pain and function. An additional 13 trials were identified, with data received for a total of 20,827 patients from 39 trials. Acupuncture was superior to sham as well as no acupuncture control for each pain condition (all P < .001) with differences between groups close to .5 SDs compared with no acupuncture control and close to .2 SDs compared with sham. We also found clear evidence that the effects of acupuncture persist over time with only a small decrease, approximately 15%, in treatment effect at 1 year. In secondary analyses, we found no obvious association between trial outcome and characteristics of acupuncture treatment, but effect sizes of acupuncture were associated with the type of control group, with smaller effects sizes for sham controlled trials that used a penetrating needle for sham, and for trials that had high intensity of intervention in the control arm. We conclude that acupuncture is effective for the treatment of chronic pain, with treatment effects persisting over time. Although factors in addition to the specific effects of needling at correct acupuncture point locations are important contributors to the treatment effect, decreases in pain after acupuncture cannot be explained solely in terms of placebo effects. Variations in the effect size of acupuncture in different trials are driven predominantly by differences in treatments received by the control group rather than by differences in the characteristics of acupuncture treatment. PERSPECTIVE: Acupuncture is effective for the treatment of chronic musculoskeletal, headache, and osteoarthritis pain. Treatment effects of acupuncture persist over time and cannot be explained solely in terms of placebo effects. Referral for a course of acupuncture treatment is a reasonable option for a patient with chronic pain.

Why Do Students Engage in Elective Courses on Acupuncture and Homeopathy at Medical School? A Survey.

BACKGROUND: We aimed to investigate why medical students in Germany participate in elective courses on acupuncture or homeopathy. METHODS: The study was a nationwide, cross-sectional survey. Elective courses on acupuncture and homeopathy in the academic half-year 2013/14 were identified by inquiries directed to all 37 German medical schools, to student initiatives, and organizations supporting such courses. Participants of courses were asked to fill in a questionnaire consisting of a free-text question on their motives and closed questions regarding personal experiences, personal environment, evidence, role of the therapy as a complement to conventional medicine, and opportunistic aspects in relation to the therapy chosen. RESULTS: Students participating in 16 of 18 identified acupuncture courses (n = 220) and 12 of 13 identified homeopathy courses (n = 113) filled in the questionnaire. Content analysis of the free text showed that personal experience, a feeling that conventional medicine is somehow incomplete, the belief that acupuncture or homeopathy could help to overcome this shortcoming, and positive characteristics attributed to the therapies were the main motives for participation. Quantitative analyses showed that own experiences and considering the therapy a useful complement to conventional medicine were similarly rated motives in both groups, while opportunistic aspects played almost no role. The influence of the personal environment was more important among homeopathy students, while acupuncture students considered their therapy better backed by evidence. CONCLUSION: In our survey, personal experiences and the belief that acupuncture or homeopathy allows grasping the patient more holistically were primary motives for participation.

How do medical students engaging in elective courses on acupuncture and homeopathy differ from unselected students? A survey.

BACKGROUND: We aimed to investigate whether students at German medical schools participating in elective courses on acupuncture and homeopathy differ from an unselected group of students regarding attitudes and personality traits. METHODS: Elective courses on acupuncture and homeopathy in the academic half-year 2013/14 all over Germany were identified and participants invited to fill in a questionnaire including nineteen questions on attitudes towards Complementary and Alternative Medicine (CAM), orientation towards science, care and status orientation, and a short validated instrument (Big-Five-Inventory-10) to measure personality traits (extraversion, neuroticism, openness, conscientiousness, and agreeableness). Participants of a mandatory family medicine course at one university served as unselected control group. RESULTS: Two hundred twenty and 113 students from elective courses on acupuncture and homeopathy, respectively, and 315 control students participated (response rate 93%). Students participating in elective courses had much more positive attitudes towards CAM, somewhat lower science and status orientation, and somewhat higher care orientation than control group students (all p-values for three-group comparisons < 0.001). There were no differences between the three groups regarding personality traits with the exception of lower values for agreeableness in controls (p = 0.009). CONCLUSIONS: The findings of this study show that attitudes of students participating in elective courses on acupuncture or homeopathy at German medical schools differ to a considerable degree from the attitudes of unselected students.

Acupuncture for the prevention of episodic migraine.

BACKGROUND: Acupuncture is often used for migraine prevention but its effectiveness is still controversial. We present an update of our Cochrane review from 2009. OBJECTIVES: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than sham (placebo) acupuncture; and c) as effective as prophylactic treatment with drugs in reducing headache frequency in adults with episodic migraine. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL: 2016, issue 1); MEDLINE (via Ovid, 2008 to January 2016); Ovid EMBASE (2008 to January 2016); and Ovid AMED (1985 to January 2016). We checked PubMed for recent publications to April 2016. We searched the World Health Organization (WHO) Clinical Trials Registry Platform to February 2016 for ongoing and unpublished trials. SELECTION CRITERIA: We included randomized trials at least eight weeks in duration that compared an acupuncture intervention with a no-acupuncture control (no prophylactic treatment or routine care only), a sham-acupuncture intervention, or prophylactic drug in participants with episodic migraine. DATA COLLECTION AND ANALYSIS: Two reviewers checked eligibility; extracted information on participants, interventions, methods and results, and assessed risk of bias and quality of the acupuncture intervention. The primary outcome was migraine frequency (preferably migraine days, attacks or headache days if migraine days not measured/reported) after treatment and at follow-up. The secondary outcome was response (at least 50% frequency reduction). Safety outcomes were number of participants dropping out due to adverse effects and number of participants reporting at least one adverse effect. We calculated pooled effect size estimates using a fixed-effect model. We assessed the evidence using GRADE and created 'Summary of findings' tables. MAIN RESULTS: Twenty-two trials including 4985 participants in total (median 71, range 30 to 1715) met our updated selection criteria. We excluded five previously included trials from this update because they included people who had had migraine for less than 12 months, and included five new trials. Five trials had a no-acupuncture control group (either treatment of attacks only or non-regulated routine care), 15 a sham-acupuncture control group, and five a comparator group receiving prophylactic drug treatment. In comparisons with no-acupuncture control groups and groups receiving prophylactic drug treatment, there was risk of performance and detection bias as blinding was not possible. Overall the quality of the evidence was moderate. Comparison with no acupunctureAcupuncture was associated with a moderate reduction of headache frequency over no acupuncture after treatment (four trials, 2199 participants; standardised mean difference (SMD) -0.56; 95% CI -0.65 to -0.48); findings were statistically heterogeneous (I² = 57%; moderate quality evidence). After treatment headache frequency at least halved in 41% of participants receiving acupuncture and 17% receiving no acupuncture (pooled risk ratio (RR) 2.40; 95% CI 2.08 to 2.76; 4 studies, 2519 participants) with a corresponding number needed to treat for an additional beneficial outcome (NNTB) of 4 (95% CI 3 to 6); there was no indication of statistical heterogeneity (I² = 7%; moderate quality evidence). The only trial with post-treatment follow-up found a small but significant benefit 12 months after randomisation (RR 2.16; 95% CI 1.35 to 3.45; NNT 7; 95% 4 to 25; 377 participants, low quality evidence). Comparison with sham acupunctureBoth after treatment (12 trials, 1646 participants) and at follow-up (10 trials, 1534 participants), acupuncture was associated with a small but statistically significant frequency reduction over sham (moderate quality evidence). The SMD was -0.18 (95% CI -0.28 to -0.08; I² = 47%) after treatment and -0.19 (95% CI -0.30 to -0.09; I² = 59%) at follow-up. After treatment headache frequency at least halved in 50% of participants receiving true acupuncture and 41% receiving sham acupuncture (pooled RR 1.23, 95% CI 1.11 to 1.36; I² = 48%; 14 trials, 1825 participants) and at follow-up in 53% and 42%, respectively (pooled RR 1.25, 95% CI 1.13 to 1.39; I² = 61%; 11 trials, 1683 participants; moderate quality evidence). The corresponding NNTBs are 11 (95% CI 7.00 to 20.00) and 10 (95% CI 6.00 to 18.00), respectively. The number of participants dropping out due to adverse effects (odds ratio (OR) 2.84; 95% CI 0.43 to 18.71; 7 trials, 931 participants; low quality evidence) and the number of participants reporting adverse effects (OR 1.15; 95% CI 0.85 to 1.56; 4 trials, 1414 participants; moderate quality evidence) did not differ significantly between acupuncture and sham groups. Comparison with prophylactic drug treatmentAcupuncture reduced migraine frequency significantly more than drug prophylaxis after treatment ( SMD -0.25; 95% CI -0.39 to -0.10; 3 trials, 739 participants), but the significance was not maintained at follow-up (SMD -0.13; 95% CI -0.28 to 0.01; 3 trials, 744 participants; moderate quality evidence). After three months headache frequency at least halved in 57% of participants receiving acupuncture and 46% receiving prophylactic drugs (pooled RR 1.24; 95% CI 1.08 to 1.44) and after six months in 59% and 54%, respectively (pooled RR 1.11; 95% CI 0.97 to 1.26; moderate quality evidence). Findings were consistent among trials with I² being 0% in all analyses. Trial participants receiving acupuncture were less likely to drop out due to adverse effects (OR 0.27; 95% CI 0.08 to 0.86; 4 trials, 451 participants) and to report adverse effects (OR 0.25; 95% CI 0.10 to 0.62; 5 trials 931 participants) than participants receiving prophylactic drugs (moderate quality evidence). AUTHORS' CONCLUSIONS: The available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, are lacking.

Acupuncture for the prevention of tension-type headache.

BACKGROUND: Acupuncture is often used for prevention of tension-type headache but its effectiveness is still controversial. This is an update of our Cochrane review originally published in Issue 1, 2009 of The Cochrane Library. OBJECTIVES: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in adults with episodic or chronic tension-type headache. SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE and AMED to 19 January 2016. We searched the World Health Organization (WHO) International Clinical Trials Registry Platform to 10 February 2016 for ongoing and unpublished trials. SELECTION CRITERIA: We included randomised trials with a post-randomisation observation period of at least eight weeks, which compared the clinical effects of an acupuncture intervention with a control (treatment of acute headaches only or routine care), a sham acupuncture intervention or another prophylactic intervention in adults with episodic or chronic tension-type headache. DATA COLLECTION AND ANALYSIS: Two review authors checked eligibility; extracted information on participants, interventions, methods and results; and assessed study risk of bias and the quality of the acupuncture intervention. The main efficacy outcome measure was response (at least 50% reduction of headache frequency) after completion of treatment (three to four months after randomisation). To assess safety/acceptability we extracted the number of participants dropping out due to adverse effects and the number of participants reporting adverse effects. We assessed the quality of the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation). MAIN RESULTS: Twelve trials (11 included in the previous version and one newly identified) with 2349 participants (median 56, range 10 to 1265) met the inclusion criteria.Acupuncture was compared with routine care or treatment of acute headaches only in two large trials (1265 and 207 participants), but they had quite different baseline headache frequency and management in the control groups. Neither trial was blinded but trial quality was otherwise high (low risk of bias). While effect size estimates of the two trials differed considerably, the proportion of participants experiencing at least 50% reduction of headache frequency was much higher in groups receiving acupuncture than in control groups (moderate quality evidence; trial 1: 302/629 (48%) versus 121/636 (19%); risk ratio (RR) 2.5; 95% confidence interval (CI) 2.1 to 3.0; trial 2: 60/132 (45%) versus 3/75 (4%); RR 11; 95% CI 3.7 to 35). Long-term effects (beyond four months) were not investigated.Acupuncture was compared with sham acupuncture in seven trials of moderate to high quality (low risk of bias); five large studies provided data for one or more meta-analyses. Among participants receiving acupuncture, 205 of 391 (51%) had at least 50% reduction of headache frequency compared to 133 of 312 (43%) in the sham group after treatment (RR 1.3; 95% CI 1.09 to 1.5; four trials; moderate quality evidence). Results six months after randomisation were similar. Withdrawals were low: 1 of 420 participants receiving acupuncture dropped out due to adverse effects and 0 of 343 receiving sham (six trials; low quality evidence). Three trials reported the number of participants reporting adverse effects: 29 of 174 (17%) with acupuncture versus 12 of 103 with sham (12%; odds ratio (OR) 1.3; 95% CI 0.60 to 2.7; low quality evidence).Acupuncture was compared with physiotherapy, massage or exercise in four trials of low to moderate quality (high risk of bias); study findings were inadequately reported. No trial found a significant superiority of acupuncture and for some outcomes the results slightly favoured the comparison therapy. None of these trials reported the number of participants dropping out due to adverse effects or the number of participants reporting adverse effects.Overall, the quality of the evidence assessed using GRADE was moderate or low, downgraded mainly due to a lack of blinding and variable effect sizes. AUTHORS' CONCLUSIONS: The available results suggest that acupuncture is effective for treating frequent episodic or chronic tension-type headaches, but further trials - particularly comparing acupuncture with other treatment options - are needed.

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.

Echinacea for preventing and treating the common cold.

CLINICAL QUESTION: Are Echinacea products associated with a reduced incidence and a shorter duration of common colds compared with placebo? BOTTOM LINE: Individual prophylaxis trials show no association with prevention of the common cold, but exploratory meta-analysis suggests that Echinacea products may be associated with a small reduction in cold incidence. In treatment trials, there was no association of Echinacea products with a shorter duration of colds.

Belief in and use of complementary therapies among family physicians, internists and orthopaedists in Germany - cross-sectional survey.

BACKGROUND: Few studies have compared the belief in and the use of complementary and alternative medicine (CAM) across different medical specialties. OBJECTIVE: To investigate to what extent family physicians, internists and orthopaedists working in private practice in Germany (i) belief in the efficacy of CAM therapies; (ii) use these therapies for treating patients and (iii) whether beliefs and use are associated with basic professional attitudes. METHODS: A four-page questionnaire was sent to nation-wide random samples of the three groups of physicians. Participants were asked to indicate their belief in the efficacy and their use of seven CAM treatments and to rate their agreement to statements on orthodox and heterodox professional views, patient-provider relationship and placebo effects. RESULTS: A total of 935 of 2018 (46%) physicians contacted sent back a questionnaire. The belief in specific effects of CAM therapies varied strongly within and between specialties, but overall many physicians hold positive views. Internists were more skeptic than family physicians and orthopaedists (P < 0.001); 23% of family physicians, 6% of internists and 31% of orthopaedists reported to use four or more CAM therapies more often than once a week. Frequent CAM use was strongly associated with being an orthopaedist and a higher overall belief in CAM modalities. Holding orthodox professional views predicted low CAM use. CONCLUSIONS: Many physicians (particularly, family physicians and orthopaedists) working in private practice in Germany use CAM therapies frequently and believe in their efficacy. Professional views and the specific working situation seem to influence use and believe strongly.