Acupuncture for tension-type headache: a multicentre,sham-controlled,patient-and observer-blinded,randomised trial

Acupuncture treatment is frequently sought for tension-type headache (TTH), but there is conflicting evidence as to its effectiveness. This randomised, controlled, multicentre, patient-and observer-blinded trial was carried out in 122 outpatient practices in Germany on 409 patients with TTH, defined as > or =10 headache days per month of which < or =1 included migraine symptoms. Interventions were verum acupuncture according to the practice of traditional Chinese medicine or sham acupuncture consisting of superficial needling at nonacupuncture points. Acupuncture was administered by physicians with specialist acupuncture training. Ten 30-min sessions were given over a six-week period, with additional sessions available for partial response. Response was defined as >50% reduction in headache days/month at six months and no use of excluded concomitant medication or other therapies. In the intent-to-treat analysis (all 409 patients), 33% of verum patients and 27% of sham controls (p=0.18) were classed as responders. Verum was superior to sham for most secondary endpoints, including headache days (1.8 fewer; 95% CI 0.6, 3.0; p=0.004) and the International Headache Society response criterion (66% vs. 55% response, risk difference 12%, 95% CI: 2%-21%; p=0.024).). The relative risk on the primary and secondary response criterion was very similar ( approximately 0.8); the difference in statistical significance may be due to differences in event rate. TTH improves after acupuncture treatment. However, the degree to which treatment benefits depend on psychological compared to physiological effects and the degree to which any physiological effects depend on needle placement and insertion depth are unclear.     

Acupuncture and moxibustion for endometriosis: A systematic review and analysis

ObjectivesThis study aimed to examine the effect of acupuncture on symptoms and health-related quality of life in patients with endometriosis.MethodsNine biomedical databases were searched to April 2022 to identify randomized controlled trials of acupuncture and/or moxibustion used alone or as adjunct to guideline-recommended pharmacotherapy for the treatment of endometriosis. One reviewer extracted data and another verified the data. A random effects model was used to calculate mean differences.ResultsFifteen trials involving 1018 patients met the inclusion criteria, but diversity in comparisons and outcome measures prevented meta-analysis. Compared to sham acupuncture, manual acupuncture was more effective at reducing dysmenorrhea VAS pain score (mean difference [MD] − 2.40, 95 % CI [− 2.80, − 2.00]; moderate certainty evidence), pelvic pain VAS score (MD − 2.65, 95 % CI [− 3.40, − 1.90]; high certainty evidence) and dyspareunia VAS scores (MD − 2.88, [− 3.83, − 1.93]), lessened the size of ovarian cyst (MD − 3.88, 95 % CI [− 7.06, − 0.70]), and improved quality of life. Compared to conventional therapy, manual acupuncture plus conventional therapy and warm needle alone resulted in greater improvements in quality of life than conventional therapy. Among the six studies that reported safety, fewer adverse events were reported in participants who received acupuncture or moxibustion.ConclusionsLow to moderate certainty evidence from single studies showed that manual acupuncture may improve pain-related symptoms and quality of life; however, there is insufficient evidence on the overall effectiveness of acupuncture and moxibustion for endometriosis.     

Acupuncture in migraine prevention: a randomized sham controlled study with 6-months posttreatment follow-up

OBJECTIVE: To assess the efficacy of acupuncture in migraine prophylaxis. METHODS: Thirty-seven patients with migraine were enrolled in a randomized control trial at the Headache clinic located in a University Hospital. Real and sham acupuncture groups received 16 acupuncture sessions over 3 months. Treatment was individualized in the real acupuncture group and minimal acupuncture was used in the sham group. The primary end point was the percentage of patients with a >or=50% reduction in their migraine attack frequency in the second, third, fourth, fifth, and sixth (months) compared with the first one (baseline period). Primary and secondary end points were measured comparing headache diaries. RESULTS: Real acupuncture group showed improvement with significant differences compared with the sham acupuncture group in the primary efficacy end point (P=0.021) at the second month of the treatment. Differences also appeared in 2 secondary end points: number of days with migraine per month (P=0.007) in the second month and the percentage of patients with >or=40% reduction in migraine attack frequency in the first (P=0.044) and second months (P=0.004) of the treatment. These differences disappeared in the third (last) month of the treatment as a consequence of the high improvement of the sham acupuncture group. Comparisons within each group showed that several migraine parameters evaluated improved significantly in both groups. CONCLUSIONS: Individualized treatment based on traditional Chinese medicine plays a role in preventing migraine attacks. Nevertheless, sham acupuncture had similar effects. Major conclusions were limited by the small sample sizes however the observed trends may contribute to design future trials.     

Acupuncture for episodic tension-type headache: a multicentre randomized controlled trial

A multicentre, randomized clinical trial was undertaken to test the hypothesis that acupuncture is more efficacious than sham control procedure in the prevention of episodic tension-type headache. Fifty subjects were randomized to receive a course of treatment with either brief acupuncture or a sham procedure. Subjects were followed up for 3 months. Changes in headache were assessed by daily diary, the primary outcome measure being the number of days with headache. No significant differences were found between the changes in the two groups for any measure at any time point. Results also show that patient blinding was successful. In conclusion, this study does not provide evidence that this form of acupuncture is effective in the prevention of episodic tension-type headache.     

Role of the needling per se in acupuncture as prophylaxis for menstrually related migraine: a randomized placebo-controlled study

The objectives were to introduce a new method for controlled trials of acupuncture in the field of headache research and to examine the role of needling per se. Women with menstrually related migraine were randomized to three months of treatment with verum or placebo needles. Three standard size casts were moulded to secure the placebo needles in the head. No significant differences were found between the verum group (n=15) and the placebo group (n=13) during treatment or follow up three and six months later, either in the attack frequency or in the number of days per month with migraine, headache intensity or drug-use. The casts held the needles exactly in place despite movements of the head, and are validated as practical, hygienic and extremely durable. This method is satisfactory for controlled studies of acupuncture in headache. It is possible that the positive results in earlier clinical trials on acupuncture in migraine are attributable to other mechanisms than needling of subcutaneous tissue.     

Traditional Chinese acupuncture in tension-type headache: a controlled study.

Thirty patients with tension-type headache were randomly chosen to undergo a trial of traditional Chinese acupuncture and sham acupuncture. Five measures were used to assess symptom severity and treatment response: intensity, duration and frequency of headache pain episodes, headache index and analgesic intake. The five measures were assessed during a 4 week baseline period, after 4 and 8 weeks of treatment, and 1, 6 and 12 months thereafter. Before the start of the study, each patient was administered the MMPI. Split-plot ANOVAs showed that, compared to baseline, at 1 month after the end of treatment and for the 12 month follow-up, the frequency of headache episodes, analgesic consumption and the headache index (but not the duration or intensity of headache episodes) significantly decreased over time; however, no difference between acupuncture and placebo treatment was found. No single MMPI scale predicted the response to treatment, but the mean MMPI profile of acupuncture non-responders showed the presence of 'Conversion V'.     

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.

Effects of artichoke on blood pressure: A systematic review and meta-analysis

PurposeClinical trials considering the effects of artichoke supplementation on blood pressure have yielded different and contradictory outcomes. Thus, a systematic review and meta-analysis were performed to assess effects of artichoke administration on blood pressure.MethodsRelated studies were detected by searching the Cochrane Library, PubMed, Embase and Scopus databases up to 15 March 2020. Weighted Mean Differences (WMD) were pooled using a random-effects model. Heterogeneity, sensitivity analyses, and publication bias were evaluated using standard methods.ResultsPooled analysis of eight randomized controlled trials revealed that artichoke supplementation did not have an effect on systolic blood pressure (SBP), (WMD: -0.77 mmHg, 95 % CI: −2.76 to 1.22) or diastolic blood pressure (DBP) (WMD: −0.11 mmHg, 95 % CI: −1.72 to 1.50) when compared to the placebo group. However, subgroup analyses based on health status suggested that artichoke administration among hypertensive patients may significantly reduce SBP (WMD: −3.19 mmHg, 95 % CI: −3.32 to −3.06) and DBP (WMD: −2.33 mmHg, 95 % CI: −2.23 to −2.43), but no such reduction was found in NAFLD patients. Furthermore, our results indicated that artichoke supplementation for 12 weeks led to a significantly decreased DBP (WMD: -2.33 mmHg, 95 % CI: −2.43 to −2.23), but 8 weeks of intervention did not (WMD: 0.80 mmHg, 95 % CI: −1.06 to 2.66).ConclusionArtichoke supplementation may potentially lead to SBP and DBP reduction in hypertensive patients. In addition, artichoke supplementation for 12 weeks may significantly improve DBP.     

German Acupuncture Trials (gerac) address problems of methodology associated with acupuncture studies

OBJECTIVE: Conflicting or ambivalent findings on the effectiveness of body acupuncture in pain treatment are often attributed to flaws in study methodology. The paper describes the methodology used for the German Acupuncture Trials (gerac), which demonstrates that it is possible to design acupuncture studies in accordance with the standards of good clinical practice. METHOD: Approximately 1000 chronic pain sufferers per indication (migraine, tension-type headache, low back pain (cLBP), or gonarthrosis) are randomly allocated to one of three treatment groups (verum acupuncture, sham acupuncture, or established conservative therapy). Patients are blind to the type of acupuncture. All patients receive ten sessions of treatment (two per week) with an option of adding five more treatments in cases of slight but insufficient improvement (number of headache days or von Korff pain score). Participating physicians are in private practice, representing a variety of specialties. All have completed at least a 140-hour training course in acupuncture. Mandatory and optional verum and sham points are predefined. The point selection is individualized according to the criteria of traditional Chinese medicine (TCM). Primary outcome measures are number of headache days per month, von Korff Graded Chronic Pain Scale or Hannover Functional Ability Questionnaire (cLBP), or WOMAC scores (gonarthrosis). Data are assessed by trained telephone interviewers not involved in treatment and blind to types of acupuncture. PRESENT STATUS: Over 500 participating physicians in ten urban areas of Germany. Patient recruitment for cLBP and gonarthrosis was completed in November 2003 and March 2004 respectively. Recruitment for chronic headaches will be completed in autumn 2004. CONCLUSIONS: The gerac trials prove that it is possible to design and carry out acupuncture studies in accordance to stringent standards of methodology and clinical practice. The results will form a basis for the assessment of acupuncture effectiveness in Germany and abroad.     

Effectiveness of acupuncture for patients with vascular dementia: A systematic review and meta-analysis

ObjectivesThis meta-analysis assessed the treatment effectiveness of acupuncture in patients with vascular dementia.MethodsThe PubMed, Embase, Cochrane library, and China National Knowledge Infrastructure were searched to identify eligible randomized controlled trials (RCTs). The odds ratios (ORs) and weighted mean differences (WMDs) with 95 % confidence intervals (CIs) were used to assess the pooled effect estimates using a random-effects model for categorical and continuous outcomes, respectively.ResultsThirty-four RCTs (2672 patients) were selected for the final meta-analysis. The use of acupuncture showed association with an increased incidence of effective rate (OR: 3.28; 95 % CI: 2.54–4.24; P < 0.001). The pooled WMDs revealed that acupuncture was significantly associated with an improvement in the Hasegawa dementia scale (HDS) (WMD: 4.31; 95 % CI: 3.15–5.47; P < 0.001), and Mini-Mental State Examination scores (MMSE) (WMD: 3.07; 95 % CI: 2.40–3.74; P < 0.001). However, the use of acupuncture showed no association with the level of Activities of daily living (ADL) (WMD: 1.93; 95 % CI: − 2.53 to 6.38; P = 0.397). Finally, acupuncture was associated with lower levels of Scale for the differentiation of syndromes of vascular dementia (SDSVD) (WMD: − 2.15; 95 % CI: − 4.14 to − 0.16; P = 0.034), and National Institutes of Health stroke scale (NIHSS) (WMD: − 3.90; 95 % CI: − 4.87 to − 2.94; P < 0.001).ConclusionsAcupuncture is probably helpful in vascular stroke, but strong supportive data are not yet available. Acupuncture should be used cautiously, owing to the analysis of this study based on low to moderate evidence. Further high-quality, large-scale RCTs should be conducted.     

Electroacupuncture for tension-type headache on distal acupoints only: a randomized, controlled, crossover trial

OBJECTIVE: To investigate the efficacy of electroacupuncture, applied to distal acupoints only, for tension-type headache. BACKGROUND: Electroacupuncture is commonly used for tension-type headache, but when applied to distal acupoints only, evidence of its efficacy is lacking. DESIGN: A randomized, single-blinded, sham-controlled, crossover clinical trial. Methods.-The trial had 5 stages: baseline (2 weeks), phases I and II (each 4 weeks), washout period (2 weeks), and follow-up (3 months after phase II). Forty patients were randomly assigned to either group A or group B. Group A received real electroacupuncture during phase I, then sham electroacupuncture in phase II. Group B received the treatments in reverse order. Outcome measures were headache frequency and duration, pain intensity using a visual analog scale, mechanical pain threshold, headache disability, and sickness impact. Data were analyzed by univariate 2-way analysis of variance. RESULTS: Thirty-seven patients completed the trial. There were no significant differences between the 2 groups at baseline. At the end of phase I, group A, but not group B, demonstrated significant improvement in mean (standard error of the mean [SEM]) headache frequency (3.0 per month [0.3] versus 12.0 per month [1.7]), duration (13.3 hours [3.5] versus 32.0 hours [6.2]), pain intensity (32.8 mm [4.1] versus 47.5 mm [2.7]), pain threshold (right side, 2.9 kg/second [0.1] versus 0.9 kg/second [0.1]; left side, 2.4 kg/second [0.1] versus 1.1 kg/second [0.1]), headache disability score (6.0 [1.0] versus 16.3 [1.6]), and sickness impact score (288.7 [48.0] versus 687.1 [77.2]). For each parameter, significant differences also were demonstrated for both groups between baseline and phase II, and baseline and follow-up. There were no significant differences between the groups at the end of follow-up (P >.05). CONCLUSION: Electroacupuncture to distal points alone is effective for short-term symptomatic relief of tension-type headache.     

The effects of pomegranate supplementation on biomarkers of inflammation and endothelial dysfunction: A meta-analysis and systematic review

ObjectsCardiovascular disease (CVD) is one of the leading causes of death worldwide. CVD is associated with increased levels of reactive oxygen species which are pro-inflammatory and can damage the endothelium. The pomegranate fruit is a rich source of phytochemicals with a high antioxidant and anti-inflammatory activity, possessing thus health benefits. This systematic review and meta-analysis aims to evaluate the effect of pomegranate juice on the biomarkers of inflammation and vascular dysfunction.MethodsStudies were identified using the PubMed/Medline and SCOPUS databases. Screening of relevant articles and references was carried out from inception until May 2019. This systematic review and meta-analysis was performed using the Preferred Items for Reporting of Systematic Reviews and Meta-Analyses (PRISMA) guidelines.ResultsOverall, 16 randomized controlled trials (RCTs) involving 572 subjects were included in this study. Combining effect sizes from 16 studies, we recorded that pomegranate supplementation significantly reduced hs-CRP, IL-6 and TNF-α (Weighted Mean Diff ;erences (WMD): −6.57 mg/L, 95 % CI: −10.04 to −3.10, P = 0.000; WMD: −1.68 pg/mL, 95 % CI: −3.52, 0.157, P = 0.000; WMD: −2.37 pg/mL, 95 % CI: −3.67, −1.07, P = 0.00, respectively) levels, when compared to placebo. No significant reduction was found in CRP (WMD: 2.19 mg/dL, 95 % CI: −3.28, 7.67, P = 0.61), E-selectin (WMD: 8.42 ng/mL, 95 % CI: −22.9, 39.8, P = 0.599), ICAM (WMD= −17.38 ng/mL, 95 % CI: −53.43, 18.66, P = 0.107), VCAM (WMD: −69.32 ng/mL, 95 % CI: −229.26, 90.61, P = 0.396) or MDA (WMD: 0.031 μmol/L, 95 % CI: −1.56, 0.218, P = 0.746) comparing pomegranate supplementation to placebo.ConclusionWe found a significant effect of pomegranate supplementation on hs-CRP, IL-6 and TNF-α in adults. However, the effects of pomegranate supplementation on CRP, E-selectin, ICAM, VCAM or MDA were not significant in this meta-analysis.     

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.     

The effects of saffron (Crocus sativus L.) on mental health parameters and C-reactive protein: A meta-analysis of randomized clinical trials

BackgroundThe findings of trials investigating the effects of saffron (Crocus sativus L.) supplementation on depression, anxiety, and C-reactive protein (CRP) are inconsistent. The current meta-analysis of randomized controlled trials (RCTs) was carried out to assess the effects of saffron (Crocus sativus L.) administration on mental health parameters and CRP levels.MethodsTwo independent authors systematically searched online databases including EMBASE, Scopus, PubMed, Cochrane Library, and Web of Science from inception until 30^th July 2019. Cochrane Collaboration risk of bias tool was applied to assess the methodological quality of included trials. The heterogeneity among the included studies was assessed using Cochrane’s Q test and I-square (I²) statistic. Data were pooled using a random-effects model and weighted mean difference (WMD) was considered as the overall effect size.ResultsTwenty one trials were included in this meta-analysis. Consumption of saffron resulted in a significant reduction in Beck Depression Inventory (BDI) (11 studies with 12 effect size) (WMD: −4.86; 95 % CI: −6.58, −3.14), Beck Anxiety Inventory (BAI) (5 studies) (WMD: −5.29; 95 % CI: −8.27, −2.31) and Pittsburgh Sleep Quality Index (PSQI) scores (3 studies with 4 effect size) (WMD: −2.22; 95 % CI: −2.73, −1.72). Saffron intake did not affect Hamilton Depression Rating Scale (HDRS-D), Hamilton Anxiety Rating Scale (HARS-A) scores and C-reactive protein (CRP) levels.ConclusionsThis meta-analysis demonstrated that saffron intake significantly reduced BDI, BAI and PSQI scores, but did not affect HDRS-D, HARS-A scores and CRP levels.     

The effects of garlic supplementation on oxidative stress markers: A systematic review and meta-analysis of randomized controlled trials

ObjectiveRecent studies have found that garlic supplementation can improve antioxidant status, however, there is no definitive consensus on this context. The present systematic review and meta-analysis aimed to investigate the effect of garlic supplementation on oxidative stress markers.SettingWe searched titles, abstracts, and keywords of relevant articles indexed in PubMed, ISI Web of Science, Scopus, and Google Scholar databases up to November 2019 to identify eligible RCT studies. To compare the effects of garlic with placebo, weighted mean difference (WMD) with 95 % confidence intervals (CI) were pooled based on the random-effects model. Quality assessment was performed using a Cochrane risk of bias assessment tool.ResultsOverall, 7 randomized controlled trials (RCTs) with 317 participants were included in this meta-analysis. Based on the Cochrane Collaboration Risk of Bias tool, five studies were considered as good quality and two studies were fair. We found that garlic supplementation significantly increased total antioxidant capacity (TAC) (WMD =11.03 mmol/L; 95 % CI: 4.78, 17.28 mmol/L; P < 0.001) and decreased malondialdehyde (MDA) levels (WMD = −1.88 mmol/L; 95 % CI: −3.30, −0.46 mmol/L; P = 0.01) compared with the control group.ConclusionIn summary, the current meta-analysis indicated that garlic supplementation might improve oxidative stress markers. However, these findings are incomplete due to the paucity of studies, and further well-designed clinical trials are needed in this field to confirm the effect of garlic supplement on oxidative stress markers.     

Treatment of chronic tension-type headache with botulinum toxin: a double-blind, placebo-controlled clinical trial

Botulinum toxin is increasingly advocated as effective treatment in chronic tension-type headache. We conducted a randomized, placebo-controlled clinical trial to prove efficacy of botulinum toxin in chronic tension-type headache. Patients were randomly assigned to receive botulinum toxin (maximum 100 units) or placebo (saline) in muscles with increased tenderness. After 12 weeks there was no significant difference between the two treatment groups in decrease of headache intensity on VAS (-3.5 mm, 95% confidence interval (CI) - 20 to +13), mean number of headache days (-7%; 95% CI - 20 to +4), headache hours per day (-1.4%; 95% CI - 3.9 to +1.1), days on which symptomatic treatment was taken (-1.9%; 95% CI - 11 to +7) and number of analgesics taken per day (-0.01; 95% CI -0.25-0.22). There was no significant difference in patient's assessment of improvement after week 4, 8 and 12. Botulinum toxin was not proven effective in treatment of chronic tension-type headache. Increased muscle tenderness might not be as important in pathophysiology of chronic tension-type headache as hitherto believed.     

Clinical evidence for acupuncture for adult asthma: Systematic review and meta-analysis of randomised sham/placebo-controlled trials

ObjectiveAcupuncture is a widely used asthma therapy, but the benefits remain uncertain. This study aimed to access the effectiveness of acupuncture for treatment of asthma in adults.MethodsFive English databases and four Chinese databases were searched from inception to November 2021. Randomised sham/placebo-controlled trials meeting inclusion criteria were included. Risk of bias was evaluated according to the Cochrane Review Handbook, and data analysis was performed in RevMan 5.4.1. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluations (GRADE) profiler.ResultsSixteen randomised controlled trials (RCTs) were included in the meta-analysis. Results indicated that acupuncture was well-tolerated and could improve FEV1% compared with sham/placebo acupuncture [MD 6.11, 95% CI 0.54–11.68, I² = 93%, number of participants (n) = 603]. Acupuncture also improved Cai’s Asthma Quality of Life Questionnaire (AQLQ) (MD 7.26, 95% CI 5.02–9.50, I² = 0, n = 358), and reduced the asthma symptom score (SMD −2.73, 95% CI −3.59 to −1.87, I² = 65%, n = 120). One study showed acupuncture increased the Asthma Control Test (ACT) score (MD 2.00, 95% CI 0.90–3.10, n = 111), and decreased exacerbation frequency (MD −1.00, 95% CI −1.55 to −1.45, n = 111). Other lung function and medication use parameters were not statistically significant.ConclusionsAcupuncture versus sham/placebo control appeared to improve quality of life, FEV1%, symptoms, and asthma control, and reduced exacerbation frequency per year. Further studies with appropriate controls, more participants, and high-quality evidence are needed.     

Dapoxetine for Premature Ejaculation: An Updated Meta-Analysis of Randomized Controlled Trials

PurposeDapoxetine is the first oral agent approved for the treatment of premature ejaculation (PE). However, some countries have not approved its use. The goal of this meta-analysis was to provide more information about the efficacy and safety of dapoxetine in patients with PE.MethodsWe performed a meta-analysis of randomized controlled trials (RCTs) comparing dapoxetine with a placebo in patients with PE. Relevant eligible RCTs were identified through comprehensive searches of the Cochrane Central Register of Controlled Trials, EMBASE, and PubMed. Efficacy (intravaginal ejaculatory latency time (IELT), patient global impression of change, perceived control over ejaculation, and satisfaction with sexual intercourse) and safety (treatment-emergent adverse events and discontinuation rates) were studied by using Review Manager version 5.1.0.FindingsSix RCTs involving 5934 patients met the inclusion criteria. The main outcome (IELT) in the dapoxetine group was improved significantly compared with IELT in the placebo group (mean difference, 1.59 [95% CI, 1.30 to 1.88]; P < 0.00001). The 60-mg dose of dapoxetine was more beneficial than the 30-mg dose for IELT (mean difference, −0.47 [95 % CI, −0.73 to –0.20]; P = 0.0005). Although the occurrence of treatment-emergent adverse events in the dapoxetine group was nearly twice that in the placebo group (50.5% vs 27.9%), reports of severe adverse events were rare.ImplicationsData from the meta-analysis revealed that treatment with dapoxetine was significantly efficacious in patients with PE. Although adverse events such as nausea, dizziness, diarrhea, insomnia, and headache were common, dapoxetine’s overall safety profile was acceptable.     

Needle acupuncture in tension-type headache: a randomized, placebo-controlled study

A study with needle acupuncture was performed in tension-type headache employing a new placebo acupuncture METHOD: Sixty-nine patients (mean age 48.1 years, SD = 14.1) fulfilling the International Headache Society criteria for tension-type headache were randomly assigned to verum or placebo condition. No significant differences between placebo and verum with respect to visual analogue scale and frequency of headache attacks could be observed immediately, 6 weeks and 5 months after the end of treatment. There was a significant but weak improvement in quality of life parameters (clinical global impressions, Nottingham Health Profile) after verum treatment. In decision tree analyses, the changes in clinical global impressions and headache frequency depended significantly on primary headache frequency with a limit value of 24.5 days headache per month. High values in the von Zerssen Depression Score resulted in high mean visual analogue scale values.     

The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain

In a pooled analysis of four randomized controlled trials of acupuncture in patients with migraine, tension-type headache, chronic low back pain, and osteoarthritis of the knee we investigated the influence of expectations on clinical outcome. The 864 patients included in the analysis received either 12 sessions of acupuncture or minimal (i.e. sham) acupuncture (superficial needling of non-acupuncture points) over an 8 week period. Patients were asked at baseline whether they considered acupuncture to be an effective therapy in general and what they personally expected from the treatment. After three acupuncture sessions patients were asked how confident they were that they would benefit from the treatment strategy they were receiving. Patients were classified as responders if the respective main outcome measure improved by at least fifty percent. Both univariate and multivariate analyses adjusted for potential confounders (such as condition, intervention group, age, sex, duration of complaints, etc.) consistently showed a significant influence of attitudes and expectations on outcome. After completion of treatment, the odds ratio for response between patients considering acupuncture an effective or highly effective therapy and patients who were more sceptical was 1.67 (95% confidence interval 1.20-2.32). For personal expectations and confidence after the third session, odds ratios were 2.03 (1.26-3.26) and 2.35 (1.68-3.30), respectively. Results from the 6-month follow-up were similar. In conclusion, in our trials a significant association was shown between better improvement and higher outcome expectations.