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 We searched the World Health Organization (WHO) Clinical Trials Registry Platform to February 2016 for ongoing and unpublished trials.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.

Acupuncture and related interventions for smoking cessation.

BACKGROUND: Acupuncture and related techniques are promoted as a treatment for smoking cessation in the belief that they may reduce nicotine withdrawal symptoms. OBJECTIVES: The objectives of this review are to determine the effectiveness of acupuncture and the related interventions of acupressure, laser therapy and electrostimulation in smoking cessation, in comparison with no intervention, sham treatment, or other interventions. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group Specialized Register (which includes trials of smoking cessation interventions identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and PsycINFO) and AMED in October 2013. We also searched four Chinese databases in September 2013: Sino-Med, China National Knowledge Infrastructure, Wanfang Data and VIP. SELECTION CRITERIA: Randomized trials comparing a form of acupuncture, acupressure, laser therapy or electrostimulation with either no intervention, sham treatment or another intervention for smoking cessation. DATA COLLECTION AND ANALYSIS: We extracted data in duplicate on the type of smokers recruited, the nature of the intervention and control procedures, the outcome measures, method of randomization, and completeness of follow-up.We assessed abstinence from smoking at the earliest time-point (before six weeks) and at the last measurement point between six months and one year. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. Those lost to follow-up were counted as continuing smokers. Where appropriate, we performed meta-analysis pooling risk ratios using a fixed-effect model. MAIN RESULTS: We included 38 studies. Based on three studies, acupuncture was not shown to be more effective than a waiting list control for long-term abstinence, with wide confidence intervals and evidence of heterogeneity (n = 393, risk ratio [RR] 1.79, 95% confidence interval [CI] 0.98 to 3.28, I² = 57%). Compared with sham acupuncture, the RR for the short-term effect of acupuncture was 1.22 (95% CI 1.08 to 1.38), and for the long-term effect was 1.10 (95% CI 0.86 to 1.40). The studies were not judged to be free from bias, and there was evidence of funnel plot asymmetry with larger studies showing smaller effects. The heterogeneity between studies was not explained by the technique used. Acupuncture was less effective than nicotine replacement therapy (NRT). There was no evidence that acupuncture is superior to psychological interventions in the short- or long-term. There is limited evidence that acupressure is superior to sham acupressure for short-term outcomes (3 trials, n = 325, RR 2.54, 95% CI 1.27 to 5.08), but no trials reported long-term effects, The pooled estimate for studies testing an intervention that included continuous auricular stimulation suggested a short-term benefit compared to sham stimulation (14 trials, n = 1155, RR 1.69, 95% CI 1.32 to 2.16); subgroup analysis showed an effect for continuous acupressure (7 studies, n = 496, RR 2.73, 95% CI 1.78 to 4.18) but not acupuncture with indwelling needles (6 studies, n = 659, RR 1.24, 95% CI 0.91 to 1.69). At longer follow-up the CIs did not exclude no effect (5 trials, n = 570, RR 1.47, 95% CI 0.79 to 2.74). The evidence from two trials using laser stimulation was inconsistent and could not be combined. The combined evidence on electrostimulation suggests it is not superior to sham electrostimulation (short-term abstinence: 6 trials, n = 634, RR 1.13, 95% CI 0.87 to 1.46; long-term abstinence: 2 trials, n = 405, RR 0.87, 95% CI 0.61 to 1.23). AUTHORS' CONCLUSIONS: Although pooled estimates suggest possible short-term effects there is no consistent, bias-free evidence that acupuncture, acupressure, or laser therapy have a sustained benefit on smoking cessation for six months or more. However, lack of evidence and methodological problems mean that no firm conclusions can be drawn. Electrostimulation is not effective for smoking cessation. Well-designed research into acupuncture, acupressure and laser stimulation is justified since these are popular interventions and safe when correctly applied, though these interventions alone are likely to be less effective than evidence-based interventions.

Assessing the environmental sustainability of consumer-centric poultry chain in the UK through life cycle approaches and the household simulation model.

Chicken fillets, predominantly encased in disposable plastic packaging, represent a common perishable commodity frequently found in the shopping baskets of British consumers, with an annual slaughter exceeding 1.1 billion chickens. The associated environmental implications are of considerable significance. However, a noticeable gap exists concerning the household-level ramifications of chicken meat consumption, which remains a prominent driver (165 kg CO2eyr-1 per capita) of environmental impacts in the United Kingdom (UK). This study's primary objective is to integrate Life Cycle Assessment (LCA) methodology with insights derived from a spectrum of interventions simulated within the Household Simulation Model (HHSM). The interventions that are simulated are influenced by various consumer behaviours related to the purchase, consumption, storage and disposal of chicken fillets. The overarching aim is to provide a comprehensive understanding of the environmental consequences associated with each intervention. The research encompasses eight distinct household archetypes and the UK average, with a focus on discerning differences in their environmental influence. The introduction of shelf-life extension measures leads to a reduction in the overall environmental impacts (in µPt), with reductions ranging from 1 % to 18 %. Concurrently, waste treatment's environmental burdens can be curtailed by 9 % to 69 % for the UK average. Of the 12 interventions tested, the intervention that combines a one-day extension in the shelf life of open packs and a three-day extension for unopened packs leads to the greatest reduction in environmental impacts, at 18 % for the entire process and 69 % for the waste treatment. This intervention is estimated to yield annual reductions of 130,722 t of CO2 emissions across the entire process and 34,720 t of CO2 emissions from waste treatment, as compared to the default scenario. These findings demonstrate the importance of integrating consumer behaviour, food waste, and packaging considerations within the domain of food LCA research.

Acupuncture and related interventions for smoking cessation.

BACKGROUND: Acupuncture and related techniques are promoted as a treatment for smoking cessation in the belief that they may reduce nicotine withdrawal symptoms. OBJECTIVES: The objectives of this review are to determine the effectiveness of acupuncture and the related interventions of acupressure, laser therapy and electrostimulation in smoking cessation, in comparison with no intervention, sham treatment, or other interventions. SEARCH STRATEGY: We searched the Cochrane Tobacco Addiction Group specialized register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, BIOSIS Previews, PsycINFO, Science Citation Index, AMED, Acubriefs in November 2010; and four Chinese databases: Chinese Biomedical Database, China National Knowledge Infrastructure, Wanfang Data and VIP in November 2010. SELECTION CRITERIA: Randomized trials comparing a form of acupuncture, acupressure, laser therapy or electrostimulation with either no intervention, sham treatment or another intervention for smoking cessation. DATA COLLECTION AND ANALYSIS: We extracted data in duplicate on the type of smokers recruited, the nature of the intervention and control procedures, the outcome measures, method of randomization, and completeness of follow up.We assessed abstinence from smoking at the earliest time-point (before six weeks), and at the last measurement point between six months and one year. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. Those lost to follow up were counted as continuing smokers. Where appropriate, we performed meta-analysis using a fixed-effect model. MAIN RESULTS: We included 33 reports of studies. Compared with sham acupuncture, the fixed-effect risk ratio (RR) for the short-term effect of acupuncture was 1.18 (95% confidence interval 1.03 to 1.34), and for the long-term effect was 1.05 (CI 0.82 to 1.35). The studies were not judged to be free from bias. Acupuncture was less effective than nicotine replacement therapy (NRT). There was no evidence that acupuncture is superior to waiting list, nor to psychological interventions in short- or long-term. The evidence on acupressure and laser stimulation was insufficient and could not be combined. The evidence suggested that electrostimulation is not superior to sham electrostimulation. AUTHORS' CONCLUSIONS: There is no consistent, bias-free evidence that acupuncture, acupressure, laser therapy or electrostimulation are effective for smoking cessation, but lack of evidence and methodological problems mean that no firm conclusions can be drawn. Further, well designed research into acupuncture, acupressure and laser stimulation is justified since these are popular interventions and safe when correctly applied, though these interventions alone are likely to be less effective than evidence-based interventions.

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement.

The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word 'controlled' in STRICTA is replaced by 'clinical', to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture.

[Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement (Chinese version)].

The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical", to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture.

Acupuncture for migraine prophylaxis.

BACKGROUND: Acupuncture is often used for migraine prophylaxis but its effectiveness is still controversial. This review (along with a companion review on 'Acupuncture for tension-type headache') represents an updated version of a Cochrane review originally published in Issue 1, 2001, 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 patients with migraine. SEARCH STRATEGY: The Cochrane Pain, Palliative & Supportive Care Trials Register, CENTRAL, MEDLINE, EMBASE and the Cochrane Complementary Medicine Field Trials Register were searched to January 2008. SELECTION CRITERIA: We included randomized trials with a post-randomization observation period of at least 8 weeks that compared the clinical effects of an acupuncture intervention with a control (no prophylactic treatment or routine care only), a sham acupuncture intervention or another intervention in patients with migraine. DATA COLLECTION AND ANALYSIS: Two reviewers checked eligibility; extracted information on patients, interventions, methods and results; and assessed risk of bias and quality of the acupuncture intervention. Outcomes extracted included response (outcome of primary interest), migraine attacks, migraine days, headache days and analgesic use. Pooled effect size estimates were calculated using a random-effects model. MAIN RESULTS: Twenty-two trials with 4419 participants (mean 201, median 42, range 27 to 1715) met the inclusion criteria. Six trials (including two large trials with 401 and 1715 patients) compared acupuncture to no prophylactic treatment or routine care only. After 3 to 4 months patients receiving acupuncture had higher response rates and fewer headaches. The only study with long-term follow up saw no evidence that effects dissipated up to 9 months after cessation of treatment. Fourteen trials compared a 'true' acupuncture intervention with a variety of sham interventions. Pooled analyses did not show a statistically significant superiority for true acupuncture for any outcome in any of the time windows, but the results of single trials varied considerably. Four trials compared acupuncture to proven prophylactic drug treatment. Overall in these trials acupuncture was associated with slightly better outcomes and fewer adverse effects than prophylactic drug treatment. Two small low-quality trials comparing acupuncture with relaxation (alone or in combination with massage) could not be interpreted reliably. AUTHORS' CONCLUSIONS: In the previous version of this review, evidence in support of acupuncture for migraine prophylaxis was considered promising but insufficient. Now, with 12 additional trials, there is consistent evidence that acupuncture provides additional benefit to treatment of acute migraine attacks only or to routine care. There is no evidence for an effect of 'true' acupuncture over sham interventions, though this is difficult to interpret, as exact point location could be of limited importance. Available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects. Acupuncture should be considered a treatment option for patients willing to undergo this treatment.

Acupuncture for tension-type headache.

BACKGROUND: Acupuncture is often used for tension-type headache prophylaxis but its effectiveness is still controversial. This review (along with a companion review on 'Acupuncture for migraine prophylaxis') represents an updated version of a Cochrane review originally published in Issue 1, 2001, 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 patients with episodic or chronic tension-type headache. SEARCH STRATEGY: The Cochrane Pain, Palliative & Supportive Care Trials Register, CENTRAL, MEDLINE, EMBASE and the Cochrane Complementary Medicine Field Trials Register were searched to January 2008. SELECTION CRITERIA: We included randomized trials with a post-randomization observation period of at least 8 weeks that 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 intervention in patients with episodic or chronic tension-type headache. DATA COLLECTION AND ANALYSIS: Two reviewers checked eligibility; extracted information on patients, interventions, methods and results; and assessed risk of bias and quality of the acupuncture intervention. Outcomes extracted included response (at least 50% reduction of headache frequency; outcome of primary interest), headache days, pain intensity and analgesic use. MAIN RESULTS: Eleven trials with 2317 participants (median 62, range 10 to 1265) met the inclusion criteria. Two large trials compared acupuncture to treatment of acute headaches or routine care only. Both found statistically significant and clinically relevant short-term (up to 3 months) benefits of acupuncture over control for response, number of headache days and pain intensity. Long-term effects (beyond 3 months) were not investigated. Six trials compared acupuncture with a sham acupuncture intervention, and five of the six provided data for meta-analyses. Small but statistically significant benefits of acupuncture over sham were found for response as well as for several other outcomes. Three of the four trials comparing acupuncture with physiotherapy, massage or relaxation had important methodological or reporting shortcomings. Their findings are difficult to interpret, but collectively suggest slightly better results for some outcomes in the control groups. AUTHORS' CONCLUSIONS: In the previous version of this review, evidence in support of acupuncture for tension-type headache was considered insufficient. Now, with six additional trials, the authors conclude that acupuncture could be a valuable non-pharmacological tool in patients with frequent episodic or chronic tension-type headaches.

Acupuncture for pelvic and back pain in pregnancy: a systematic review.

The objective of our study was to review the effectiveness of needle acupuncture in treating the common and disabling problem of pelvic and back pain in pregnancy. Two small trials on mixed pelvic/back pain and 1 large high-quality trial on pelvic pain met the inclusion criteria. Acupuncture, as an adjunct to standard treatment, was superior to standard treatment alone and physiotherapy in relieving mixed pelvic/back pain. Women with well-defined pelvic pain had greater relief of pain with a combination of acupuncture and standard treatment, compared to standard treatment alone or stabilizing exercises and standard treatment. We used a narrative synthesis due to significant clinical heterogeneity between trials. Few and minor adverse events were reported. We conclude that limited evidence supports acupuncture use in treating pregnancy-related pelvic and back pain. Additional high-quality trials are needed to test the existing promising evidence for this relatively safe and popular complementary therapy.

Nettle sting for chronic knee pain: a randomised controlled pilot study.

BACKGROUND: Non-pharmacological interventions for chronic knee pain are increasingly requested by patients and are recommended in current treatment guidelines. An intervention that has been used for many years for pain relief is nettle sting. OBJECTIVES: To explore the feasibility of a definitive RCT of nettle sting for chronic knee pain, in particular the acceptability of the research to GPs and patients, and the optimal methods for recruitment and outcome measurement. METHODS: Patient blinded pilot RCT, set in two inner city primary care practices in Plymouth, UK. Potential participants were identified from practice computerised databases using three different approaches: age and analgesic use, age and appropriate Read code, or age alone. Patients had to be aged between 55 and 80 years with knee pain and a presumptive clinical diagnosis of OA knee, with a baseline WOMAC pain subscale score of more than 4. They were randomised to receive either treatment with Urtica dioica, or placebo intervention with Urtica galeopsifolia daily for 1 week. The main outcome measure for the treatment effect was the WOMAC pain subscale; other outcomes included quantitative and qualitative data to inform the design of a future study. RESULTS: Out of 45 patients who were eligible, 42 were recruited. Invitations targeted at patients who were both currently receiving repeat prescriptions for non-steroidal or analgesic drugs and had relevant Read codes proved most efficient for recruitment. Mean baseline WOMAC pain subscale scores were 9.2 (S.D. 3.4) and 7.9 (2.3) in the two groups. The mean reduction in pain score at the end of treatment in the nettles group was 1.7 (95% confidence interval 0.6, 2.9) and in the controls 1.6 (CI 0.5, 2.7). All GP practices, and all patients approached, were willing to be involved in the research. Patients liked the treatment mostly because it was 'natural'. The sting was acceptable and viewed as a minor irritation. CONCLUSION: Research into nettle sting is acceptable to patients and GPs, and patients do not find the treatment more than a minor irritation. Larger rigorous studies are justified to determine the effectiveness of this ancient therapy.

Southampton needle sensation questionnaire: development and validation of a measure to gauge acupuncture needle sensation.

OBJECTIVE: The specific sensations (deqi) generated during acupuncture are thought to be important for a positive clinical outcome, particularly when treating pain. It is important to be able to measure these sensations and discriminate between deqi and pain. A greater understanding of this will greatly aid researchers who wish to conduct mechanistic studies of acupuncture. Previous questionnaire designs failed to consider patient experience and, hence, may have been flawed. The aim of this study was to generate and validate a new sensation questionnaire, that was able to discriminate between pain and deqi, taking into account patient experience and expert opinions. DESIGN: The questionnaire was designed following qualitative interviews with patients, literature review, and consultation with experts. The questionnaire was piloted and then validated. It was successfully completed by 227 patients and analyzed using factor analysis and partial correlation. SETTING: Patients were recruited via the physical therapy department at Southampton General Hospital and from private practice clinics in and around the Southampton area. SUBJECTS: The subjects were patients receiving acupuncture for any condition. RESULTS: Two (2) factors were clearly demonstrated: "Aching deqi" (7 items) which suggested deqi with pain and "Tingling deqi" (7 items) suggesting deqi only. One (1) item related solely to pain and 2 further items did not load into any factor. CONCLUSIONS: The final questionnaire is presented containing 17 items and is shown to be a valid, rigorous, soundly grounded, and patient-centered measure, capable of accurately recording deqi. We suggest that analysis should include a partial correlation of certain sensations against a pain visual analogue scale to ascertain how painful each sensation was, particularly if the questionnaire is to be used in a context in which pain and deqi need to be separated or their relationship clarified.

Do general practices which provide an acupuncture service have low referral rates and prescription costs? A pilot survey.

BACKGROUND: Studies by individual acupuncture practitioners have given an indication that offering acupuncture in primary care may reduce the need for referral to secondary care and reduce the costs of prescriptions. It would be informative to find out whether these findings can be supported by data from other practices. The aim of this study was to test the feasibility of surveying national data on referrals and prescribing. METHODS: Three primary care trusts (PCTs) were selected, and all practices within each trust were sent an email asking whether any member of the primary care team offered acupuncture, and if so how many appointments per week. Data on rates of referral to orthopaedic, physiotherapy, pain and rheumatology clinics were then sought from the PCT, both for the practices offering acupuncture and for the PCT as a whole. Similarly, data on costs of prescriptions for non-steroidal (NSAID) and non-opioid analgesic drugs were obtained from the Prescription Pricing Authority. RESULTS: Out of the 109 practices surveyed, a total of 14 (13%) offered acupuncture services to some extent. There was wide variation in provision between the different PCTs. The eight practices which offered at least one appointment per week for every 2000 registered patients were included in the analysis. The mean values (and SDs) for the three PCTs and for the eight acupuncture practices, respectively, were as follows: for referral to various clinics: orthopaedic 32.3 (16.2) and 27.4 (10.87); pain clinic 1.6 (1.3) and 2.8 (1.6); physiotherapy 13.4 (14.5) and 29.5 (10.0); and rheumatology 4.7 (2.3) and 6.4 (3.0). The mean values for costs of non-opioid analgesics were pound1820 ( pound442) and pound2008 ( pound762); and for NSAIDs were pound4148 ( pound269) and pound4476 ( pound1366), respectively. There were no trends towards a reduction of clinic referral or prescription costs. CONCLUSIONS: We have conducted the first survey of the effects of provision of acupuncture in UK general practice, using data provided by the NHS, and uncovered a wide variation in the availability of the service in different areas. We have been unable to demonstrate any consistent differences in the prescribing or referral rates that could be due to the use of acupuncture in these practices. The wide variation in the data means that if such a trend exists, a very large survey would be needed to identify it. However, we discovered inaccuracies and variations in presentation of data by the PCTs which have made the numerical input, and hence our results, unreliable. Thus the practicalities of access to data and the problems with data accuracy would preclude a nationwide survey.

Defining an adequate dose of acupuncture using a neurophysiological approach--a narrative review of the literature.

Many different styles of acupuncture practice exist, and lack of agreement on the optimal acupuncture treatment for any particular condition may mean that some patients do not receive the best treatment. This uncertainty also makes the negative results of sham controlled trials difficult to interpret. Unless we can be sure that both adequate acupuncture and an inactive sham were used in a particular trial, then that trial should not be interpreted as dismissing acupuncture for that condition. Acupuncture practice clearly involves much more than needling procedures, but there is a strong argument for elucidating the role of those needling procedures first. The components of acupuncture needling procedures have been described in the STRICTA document, but it is also clear that the patient's perception of needling is relevant for the outcome of treatment. We therefore recommend the concept of 'dose' of acupuncture needling, which should include both the stimulus given to the patient, and certain aspects of the patient's perceptions and response that are known to be linked to the subsequent therapeutic response. We propose the following definition of dose: the physical procedures applied in each session, using one or more needles, taking account of the patient's resulting perception (sensory, affective and cognitive) and other responses (including motor). The dose may be affected by the state of the patient (eg nervous, immune and endocrine systems); different doses may be required for different conditions. The constituents of an adequate dose can be established initially by clinical opinion and subsequently by empirical evidence from experimental studies, which may be either clinical or basic research studies. Systematic reviews which do not consider the adequacy of the acupuncture treatment may have unreliable conclusions. Out of 47 recent systematic reviews, only six have applied some criteria for adequacy. Five used a rating system or conducted a subgroup analysis, and one excluded studies from the analysis altogether if they did not meet criteria for adequacy. Research into what constitutes an adequate dose of acupuncture has long been neglected and is now urgent. Clinical studies that compare the effects of different treatment protocols are probably the most reliable source of evidence, and may also demonstrate a dose-response relationship.

Variability of criteria used to diagnose myofascial trigger point pain syndrome--evidence from a review of the literature.

OBJECTIVES: The aim of the literature review was to investigate the criteria adopted by "experts" to diagnose myofascial trigger point (MTrP) pain syndrome. Experts were defined as being either researchers investigating MTrP pain syndrome or the "authority" the researchers cited as a source of reference for MTrP pain syndrome diagnosis. METHODS: We searched electronic databases to identify relevant empirical research (excluding studies not in English and those relating to dental pathology). Of 607 possibly relevant publications 93 met our inclusion criteria. We recorded (1) the individual criterion and criteria combinations used to diagnose MTrP pain syndrome; (2) the cited "authoritative" publications and (3) the criteria recommended by the authoritative publications as being essential for MTrP pain syndrome diagnosis. RESULTS: The review identified 19 different diagnostic criteria. The 4 most commonly applied criteria were: "tender spot in a taut band" of skeletal muscle, "patient pain recognition," "predicted pain referral pattern," and "local twitch response." There was no consistent pattern to the choice of specific diagnostic criteria or their combinations. However, one pair of criteria "tender point in a taut band" and "predicted or recognized pain referral" were used by over half the studies. The great majority of studies cited publications by Travell and more recently Simons as a principal authoritative source for MTrP pain syndrome diagnosis, yet most of these studies failed to apply the diagnostic criteria as described by these authorities. DISCUSSION: We conclude that there is as yet limited consensus on case definition in respect of MTrP pain syndrome. Further research is needed to test the reliability and validity of diagnostic criteria. Until reliable diagnostic criteria have been established, there is a need for greater transparency in research papers on how a case of MTrP pain syndrome is defined, and claims for effective interventions in treating the condition should be viewed with caution.

Acupressure for smoking cessation--a pilot study.

BACKGROUND: Tobacco smoking is a serious risk to health: several therapies are available to assist those who wish to stop. Smokers who approach publicly funded stop-smoking clinics in the UK are currently offered nicotine replacement therapy (NRT) or bupropion, and group behaviour therapy, for which there is evidence of effectiveness. Acupuncture and acupressure are also used to help smokers, though a systematic review of the evidence of their effectiveness was inconclusive. The aim of this pilot project was to determine the feasibility of a study to test acupressure as an adjunct to one anti-smoking treatment currently offered, and to inform the design of the study. METHODS: An open randomised controlled pilot study was conducted within the six week group programme offered by the Smoking Advice Service in Plymouth, UK. All participants received the usual treatment with NRT and group behavioural therapy, and were randomised into three groups: group A with two auricular acupressure beads, group B with one bead, and group C with no additional therapy. Participants were taught to press the beads when they experienced cravings. Beads were worn in one ear for four weeks, being replaced as necessary. The main outcome measures assessed in the pilot were success at quitting (expired CO < or = 9 ppm), the dose of NRT used, and the rating of withdrawal symptoms using the Mood and Symptoms Scale. RESULTS: From 49 smokers attending four clinics, 24 volunteered to participate, 19 attended at least once after quitting, and seven remained to the final week. Participants who dropped out reported significantly fewer previous quit attempts, but no other significant differences. Participants reported stimulating the beads as expected during the initial days after quitting, but most soon reduced the frequency of stimulation. The discomfort caused by the beads was minor, and there were no significant side effects. There were technical problems with adhesiveness of the dressing. Reporting of NRT consumption was poor, with much missing data, but reporting of ratings of withdrawal symptom scores was nearly complete. However, these showed no significant changes or differences between groups for any week. CONCLUSION: Any effects of acupressure on smoking withdrawal, as an adjunct to the use of NRT and behavioural intervention, are unlikely to be detectable by the methods used here and further preliminary studies are required before the hypothesis can be tested.

The effect of TCM acupuncture on hot flushes among menopausal women (ACUFLASH) study: a study protocol of an ongoing multi-centre randomised controlled clinical trial.

BACKGROUND: After menopause, 10-20% of all women have nearly intolerable hot flushes. Long term use of hormone replacement therapy involves a health risk, and many women seek alternative strategies to relieve climacteric complaints. Acupuncture is one of the most frequently used complementary therapies in Norway. We designed a study to evaluate whether Traditional Chinese Medicine acupuncture-care together with self-care is more effective than self-care alone to relieve climacteric complaints. METHODS/DESIGN: The study is a multi-centre pragmatic randomised controlled trial with two parallel arms. Participants are postmenopausal women who document > or =7 flushes/24 hours and who are not using hormone replacement therapy or other medication that may influence flushes. According to power calculations 200 women are needed to detect a 50% reduction in flushes, and altogether 286 women will be recruited to allow for a 30% dropout rate. The treatment group receives 10 sessions of Traditional Chinese Medicine acupuncture-care and self-care; the control group will engage in self-care only. A team of experienced Traditional Chinese Medicine acupuncturists give acupuncture treatments. DISCUSSION: The study tests acupuncture as a complete treatment package including the therapeutic relationship and expectation. The intervention period lasts for 12 weeks, with follow up at 6 and 12 months. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life, assessed by the Women's Health Questionnaire. We also collect data on Traditional Chinese Medicine diagnoses, and we examine treatment experiences using a qualitative approach. Finally we measure biological variables, to examine potential mechanisms for the effect of acupuncture. The study is funded by The Research Council of Norway.

Evidence from RCTs on optimal acupuncture treatment for knee osteoarthritis--an exploratory review.

There are many differing opinions on what constitutes an optimal acupuncture dose for treating any particular patient with any particular condition, and only direct comparisons of different methods in a clinical trial will provide information on which reliable decisions can be made. This article reviews the recent research into acupuncture treatment for osteoarthritis of the knee, to explore whether any aspects of treatment seem more likely to be associated with good outcome of treatment. Among four recent, high quality RCTs, one showed a much greater treatment response than the other three, and the possible factors are discussed. A recent systematic review included 13 RCTs, and this article discusses the possible explanations for differences in their outcomes. It is speculated that optimal results from acupuncture treatment for osteoarthritis of the knee may involve: climatic factors, particularly high temperature; high expectations of patients; minimum of four needles; electroacupuncture rather than manual acupuncture, and particularly, strong electrical stimulation to needles placed in muscle; and a course of at least 10 treatments. These factors offer some support to criteria for adequate acupuncture used in the recent review. In addition, ethnic and cultural factors may influence patients' reporting of their symptoms, and different versions of an outcome measure are likely to differ in their sensitivity - both factors which may lead to apparent rather than real differences between studies. The many variables in a study are likely to be more tightly controlled in a single centre study than in multicentre studies.

Acupuncture in the treatment of fibromyalgia in tertiary care--a case series.

AIMS: Fibromyalgia is a common cause of chronic widespread pain. The benefit of medication is often limited by its side effects, and the improvements obtained with exercise and education are inconsistent. Many patients seek acupuncture treatment, which is reported to be helpful in some cases. This study aimed to explore the acceptability and benefits of acupuncture offered in the setting of a tertiary referral clinic. METHODS: An open, uncontrolled observational study was conducted among patients who met the usual fibromyalgia criteria and who had a pain score of at least 30 on a 100mm Visual Analogue Scale (VAS). Patients were allowed to continue other treatments but not to introduce new ones. Acupuncture was given using a Western approach according to a protocol developed by consensus. Patients were offered eight treatments in eight weeks. Outcome measures included VAS of pain intensity and Fibromyalgia Impact Questionnaire (range 0 - 100), and were taken before and after treatment, and at 14, 20 and 34 weeks from enrolment. RESULTS: Twenty four eligible patients were enrolled in a 12 month period. Baseline mean pain VAS score for these 24 patients was 74 (SD 18) and mean Fibromyalgia Impact Questionnaire score 78 (SD 12.4). Only 14 patients completed the course of treatment within about 10 weeks. Compliance was poor in the remaining patients because of difficulty attending clinic, and in two cases because of exacerbation of pain. Completion of outcome measures was variable and therefore the analysis of data is limited. Five patients scored at least 20% reduction in Fibromyalgia Impact Questionnaire score which is a clinically relevant improvement. Two of these scored at least 50% reduction. CONCLUSION: Acupuncture appears to offer symptomatic improvement to some patients with fibromyalgia in a tertiary clinic who have failed to respond to other treatments. In view of its safety, further acupuncture research is justified in this population.