Cost-effectiveness analysis of acupuncture compared with usual care for acute non-specific low back pain: secondary analysis of a randomised controlled trial.

OBJECTIVE: To assess the cost-effectiveness of a single treatment session of acupuncture, when applied in addition to usual care for acute low back pain (ALBP). METHODS: Secondary analysis of a multicentre randomised controlled trial in Norwegian general practice. In total, 171 participants with ALBP ⩽14 days were randomised to a control group (CG) receiving usual care or to an acupuncture group (AG) receiving one additional session of Western medical acupuncture alongside usual care. Primary outcome measures for this cost-effectiveness analysis were quality-adjusted life years (QALYs), health care costs and societal costs at days 28 and 365, the incremental cost-effectiveness ratio (ICER) and net monetary benefit (NMB). The NMB was calculated on the basis of the Norwegian cost-effectiveness threshold of NOK 275,000 (USD 35,628) per QALY gained. Missing data were replaced by multiple chained imputation. RESULTS: Eighty-six participants in the CG and 81 in the AG were included in the analysis. We found no QALY gain at day 28. At day 365, the incremental QALY of 0.035 was statistically significant. The differences in health care costs and societal costs were not statistically significant. Three out of four calculations led to negative ICERs (cost saving) and positive NMBs. For the health care perspective at day 365, the ICER was USD -568 per QALY and the NMB was USD 1265, with 95.9% probability of acupuncture being cost-effective. CONCLUSION: To our knowledge, this is the first cost-effectiveness analysis of acupuncture for ALBP. The findings indicate that acupuncture may be cost-effective from a 1-year perspective, but more studies are needed. TRIAL REGISTRATION NUMBER: NCT01439412 (ClinicalTrials.gov).

Acupuncture for acute non-specific low back pain: a randomised, controlled, multicentre intervention study in general practice-the Acuback study.

OBJECTIVES: The aim of this study was to evaluate whether a single treatment session of acupuncture, when applied in addition to standard treatment for acute low back pain (ALBP), reduces the time to recovery compared with standard treatment alone. DESIGN: A multicentre, randomised, controlled trial. SETTING: Conducted at 11 Norwegian general practitioners' (GPs') offices. PARTICIPANTS: 171 adults aged 20-55 years seeking their GP for ALBP (≤14 days) between March 2014 and March 2017. Patients with secondary back pain and previous sick leave and acupuncture treatment was excluded. INTERVENTIONS: The participants were randomised to either the control group (CG) or the acupuncture group (AG) by online software. The CG received standard treatment according to the Norwegian guidelines, while the AG received one session of Western medical acupuncture treatment in addition to standard treatment. The statistician was blinded to group status. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was median days to recovery. Secondary outcomes were pain intensity, global improvement, back-specific functional status, sick leave, medication and adverse effects. RESULTS: 185 participants were randomised, 95 in the CG and 90 in the AG. 14 participants did not receive the allocated intervention and 4 were excluded from the analysis. Thus, 167 participants were included in the analysis, 86 in the CG and 81 in the AG. The groups were similar according to baseline characteristics. The median time to recovery was 14 days for the CG and 9 days for the AG, HR 1.37 (95% CI 0.95 to 1.96), (p=0.089). No serious adverse effects were reported. CONCLUSIONS: We did not find any statistically significant reduction in time-to-recovery after a single session of acupuncture for ALBP compared with standard care. TRIAL REGISTRATION NUMBER: NCT01439412.

Point-of-care ultrasound (POCUS) in Norwegian general practice.

Objective: To assess the use of point-of-care ultrasound (POCUS) in Norwegian general practice.Design: Retrospective register study based on general practitioners' (GPs') reimbursement claims.Setting: Norwegian general practice excluding out-of-hours clinics in 2009, 2012 and 2016.Subjects: GPs who scanned patients for a given set of symptoms and medical conditions.Main outcome measures: Number and characteristics of GPs performing POCUS. Number and type of scans carried out.Results: The number of scanning GPs increased from 479 in 2009 to 2078 in 2016. The number of registered scans increased from 8962 to 55921. In 2016, approximately 30% of Norwegian GPs sent at least one reimbursement claim for POCUS. Seven out of 10 GPs did not scan every month. The gender distribution of scanning GPs was equal to that of the total GP population. Male GPs scanned four times more frequent than female GPs. Specialist in family medicine scanned twice as much as non-specialist. The use of POCUS among GPs in different counties varied from 31.6 to 198.5 per 10,000 citizens.Conclusions: The number of Norwegian GPs using POCUS and the number of scans have increased substantially from 2009 to 2016. The use of the various scans, based on the use of reimbursement claims, have evolved differently. The reasons for this are not known. The low number of scans carried out by most GPs raises a concern when it comes to the quality of the performed scans.KEY POINTS30% of Norwegian general practitioners (GPs) used point-of-care ultrasound (POCUS) in 2016.The use of POCUS increased six-fold from 2009 to 2016.Three out of four scanning GPs performed less than 10 scans annually.Male GPs performed 80% of the claimed scans.

Acupuncture treatments for infantile colic: a systematic review and individual patient data meta-analysis of blinding test validated randomised controlled trials.

OBJECTIVE: Needle acupuncture in small children has gained some acceptance in Western medicine. It is controversial, as infants and toddlers are unable to consent to treatment. We aimed to assess its efficacy for treating infantile colic. DESIGN: A systematic review and a blinding-test validation based on individual patient data from randomised controlled trials. Primary end-points were crying time at mid-treatment, at the end of treatment and at a 1-month follow-up. A 30-min mean difference (MD) in crying time between acupuncture and control was predefined as a clinically important difference. Pearson's chi-squared test and the James and Bang indices were used to test the success of blinding of the outcome assessors [parents]. Eligibility criteria and data sources: We included randomised controlled trials of acupuncture treatments of infantile colic. Systematic searches were conducted in Cochrane CENTRAL, MEDLINE, EMBASE, CINAHL and AMED, and in the Chinese language databases CNKI, VIP, Wang fang, SinoMed and Chinese Clinical Trial Registry. RESULTS: We included three randomised controlled trials with data from 307 participants. Only one of the included trials obtained a successful blinding of the outcome assessors in both the acupuncture and control groups. The MD in crying time between acupuncture intervention and no acupuncture control was -24.9 min [95% confidence interval, CI -46.2 to -3.6; three trials] at mid-treatment, -11.4 min [95% CI -31.8 to 9.0; three trials] at the end of treatment and -11.8 min [95% CI -62.9 to 39.2; one trial] at the 4-week follow-up. The corresponding standardised mean differences [SMDs] were -0.23 [95% CI -0.42 to -0.06], -0.10 [95% CI -0.29 to 0.08] and -0.09 [95% CI -0.48 to 0.30]. The heterogeneity was negligible in all analyses. The statistically significant result at mid-treatment was lost when excluding the apparently unblinded study in a sensitivity analysis: MD -13.8 min [95%CI -37.5 to 9.9] and SMD -0.13 [95%CI -0.35 to 0.09]. The registration of crying during treatment suggested more crying during acupuncture [odds ratio 7.7; 95% CI 2.7-20.6; one trial]. GRADE-Moderate quality evidence. CONCLUSIONS: Percutaneous needle acupuncture treatments should not be recommended for infantile colic on a general basis. Systematic review registration: PROSPERO 2015:CRD42015023253 Key points The role of acupuncture in the treatment of infantile colic is controversial. Available trials are small and present conflicting results. There were no clinically important differences between infants receiving acupuncture and no acupuncture control in this IPD meta-analysis of randomised controlled trials. The data indicate that acupuncture induces some treatment pain in many of the children. The study results indicate that percutaneous needle acupuncture should not be recommended for treatment of infantile colic on a general basis.

Survey Email Scheduling and Monitoring in eRCTs (SESAMe): A Digital Tool to Improve Data Collection in Randomized Controlled Clinical Trials.

BACKGROUND: Electronic questionnaires can ease data collection in randomized controlled trials (RCTs) in clinical practice. We found no existing software that could automate the sending of emails to participants enrolled into an RCT at different study participant inclusion time points. OBJECTIVE: Our aim was to develop suitable software to facilitate data collection in an ongoing multicenter RCT of low back pain (the Acuback study). For the Acuback study, we determined that we would need to send a total of 5130 emails to 270 patients recruited at different centers and at 19 different time points. METHODS: The first version of the software was tested in a pilot study in November 2013 but was unable to deliver multiuser or Web-based access. We resolved these shortcomings in the next version, which we tested on the Web in February 2014. Our new version was able to schedule and send the required emails in the full-scale Acuback trial that started in March 2014. The system architecture evolved through an iterative, inductive process between the project study leader and the software programmer. The program was tested and updated when errors occurred. To evaluate the development of the software, we used a logbook, a research assistant dialogue, and Acuback trial participant queries. RESULTS: We have developed a Web-based app, Survey Email Scheduling and Monitoring in eRCTs (SESAMe), that monitors responses in electronic surveys and sends reminders by emails or text messages (short message service, SMS) to participants. The overall response rate for the 19 surveys in the Acuback study increased from 76.4% (655/857) before we introduced reminders to 93.11% (1149/1234) after the new function (P<.001). Further development will aim at securing encryption and data storage. CONCLUSIONS: The SESAMe software facilitates consecutive patient data collection in RCTs and can be used to increase response rates and quality of research, both in general practice and in other clinical trial settings.

Acupuncture in the treatment of infantile colic.

Regarding the recently published review "Looking for new treatments of Infantile Colic" by Savino et al. we want to add that positive effects of acupuncture have been demonstrated to release pain and agitation and that acupuncture seems to be a safe treatment when performed by trained acupuncturists. Inconclusive results in the few published articles on the subject can be due to different acupuncture points, different insertion time, different needling methods, differences in the outcome variables, in how the crying was measured and insufficient sample sizes. Further research is needed on understanding the utility, safety, and effectiveness of acupuncture in infants with colic.

Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice.

OBJECTIVE: Infantile colic is a painful condition in the first months of infancy. Acupuncture is used in Scandinavia as a treatment for infantile colic. A randomized controlled trial was carried out with the aim of testing the hypothesis that acupuncture treatment has a clinically relevant effect for this condition. DESIGN: A prospective, blinding-validated, randomized controlled multicentre trial in general practice. Research assistants and parents were blinded. SETTING: 13 GPs' offices in Southern Norway. INTERVENTION: Three days of bilateral needling of the acupuncture point ST36, with no treatment as control. SUBJECTS: 113 patients were recruited; 23 patients were excluded, and 90 randomized; 79 diaries and 84 interviews were analysed. MAIN OUTCOME MEASURES: Difference in changes in crying time during the trial period between the intervention and control group. RESULTS: The blinding validation questions showed a random distribution with p = 0.41 and 0.60, indicating true blinding. We found no statistically significant difference in crying time reduction between acupuncture and control group at any of the measured intervals, nor in the main analysis of differences in changes over time (p = 0.26). There was a tendency in favour of the acupuncture group, with a non-significant total baseline-corrected mean of 13 minutes (95% CI -24 to + 51) difference in crying time between the groups. This was not considered clinically relevant, according to protocol. CONCLUSION: This trial of acupuncture treatment for infantile colic showed no statistically significant or clinically relevant effect. With the current evidence, the authors suggest that acupuncture for infantile colic should be restricted to clinical trials.

Acupuncture for acute non-specific low back pain: a protocol for a randomised, controlled multicentre intervention study in general practice--the Acuback Study.

INTRODUCTION: Some general practitioners (GPs) treat acute low back pain (LBP) with acupuncture, despite lacking evidence of its effectiveness for this condition. The aim of this study was to evaluate whether a single treatment session with acupuncture can reduce time to recovery when applied in addition to standard LBP treatment according to the Norwegian national guidelines. Analyses of prognostic factors for recovery and cost-effectiveness will also be carried out. METHODS AND ANALYSIS: In this randomised, controlled multicentre study in general practice in Southern Norway, 270 patients will be allocated into one of two treatment groups, using a web-based application based on block randomisation. Outcome assessor will be blinded for group allocation of the patients. The control group will receive standard treatment, while the intervention group will receive standard treatment plus acupuncture treatment. There will be different GPs treating the two groups, and both groups will just have one consultation. Adults who consult their GP because of acute LBP will be included. Patients with nerve root affection, 'red flags', pregnancy, previous sick leave more than 14 days and disability pension will be excluded. The primary outcome of the study is the median time to recovery (in days). The secondary outcomes are rated global improvement, back-specific functional status, sick leave, medication, GP visits and side effects. A pilot study will be conducted. ETHICS AND DISSEMINATION: Participation is based on informed written consent. The authors will apply for an ethical approval from the Regional Committee for Medical and Health Research Ethics when the study protocol is published. Results from this study, positive or negative, will be disseminated in scientific medical journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT01439412.

A pilot study of ST36 acupuncture for infantile colic.

OBJECTIVE: To conduct a pilot study to assess the feasibility of a proposed design of an acupuncture trial to relieve symptoms of infantile colic. METHOD: An open randomised single-blinded controlled trial, using standardised bilateral treatment of the acupuncture point ST36. Infants fulfilling Wessel's definition of infantile colic were included. PATIENTS: were randomised to active treatment or to no-treatment control. General practitioners (GPs) educated in Western medical acupuncture did the interventions. Parents and GPs' assistants were blinded. Active treatment was the bilateral insertion of 0.20×15 mm Seirin needles to 12 mm depth at ST36. The intervention consisted of daily treatments of 30 s duration for three consecutive workdays. Blinding was done with a red point mark on the skin and circular adhesive dressing covering. The parents were asked two blinding validation questions in the course of the study period. The primary end point was the effect of the intervention assessed as change in crying time per 24 h measured with a crying registration form. RESULTS: The authors improved the standardisation and changed the blinding procedure as a result of the pilot study. Blinding validation questions were considered necessary. The changes made in the main study protocol are discussed. CONCLUSION: The pilot study led to important changes that were implemented into the final trial protocol. Blinding validation is essential in no-treatment controlled trials of acupuncture on infants, where the parents are blinded assessors of symptom reduction. The authors suggest that blinding validation questions, and the answers to these questions, should be reported. Clinical Trial Registry Identifier: NCT00907621.