Claudia M. Witt

Acupuncture for chronic pain: individual patient data meta-analysis

BACKGROUND Although acupuncture is widely used for chronic pain, there remains considerable controversy as to its value. We aimed to determine the effect size of acupuncture for 4 chronic pain conditions: back and neck pain, osteoarthritis, chronic headache, and shoulder pain. METHODS We conducted a systematic review to identify randomized controlled trials (RCTs) of acupuncture for chronic pain in which allocation concealment was determined unambiguously to be adequate. Individual patient data meta-analyses were conducted using data from 29 of 31 eligible RCTs, with a total of 17 922 patients analyzed. RESULTS In the primary analysis, including all eligible RCTs, acupuncture was superior to both sham and no-acupuncture control for each pain condition (P < .001 for all comparisons). After exclusion of an outlying set of RCTs that strongly favored acupuncture, the effect sizes were similar across pain conditions. Patients receiving acupuncture had less pain, with scores that were 0.23 (95% CI, 0.13-0.33), 0.16 (95% CI, 0.07-0.25), and 0.15 (95% CI, 0.07-0.24) SDs lower than sham controls for back and neck pain, osteoarthritis, and chronic headache, respectively; the effect sizes in comparison to no-acupuncture controls were 0.55 (95% CI, 0.51-0.58), 0.57 (95% CI, 0.50-0.64), and 0.42 (95% CI, 0.37-0.46) SDs. These results were robust to a variety of sensitivity analyses, including those related to publication bias. CONCLUSIONS Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.

Acupuncture in patients with osteoarthritis of the knee: a randomised trial.

BACKGROUND Acupuncture is widely used by patients with chronic pain although there is little evidence of its effectiveness. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with osteoarthritis of the knee. METHODS Patients with chronic osteoarthritis of the knee (Kellgren grade < or =2) were randomly assigned to acupuncture (n=150), minimal acupuncture (superficial needling at non-acupuncture points; n=76), or a waiting list control (n=74). Specialised physicians, in 28 outpatient centres, administered acupuncture and minimal acupuncture in 12 sessions over 8 weeks. Patients completed standard questionnaires at baseline and after 8 weeks, 26 weeks, and 52 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index at the end of week 8 (adjusted for baseline score). All main analyses were by intention to treat. RESULTS 294 patients were enrolled from March 6, 2002, to January 17, 2003; eight patients were lost to follow-up after randomisation, but were included in the final analysis. The mean baseline-adjusted WOMAC index at week 8 was 26.9 (SE 1.4) in the acupuncture group, 35.8 (1.9) in the minimal acupuncture group, and 49.6 (2.0) in the waiting list group (treatment difference acupuncture vs minimal acupuncture -8.8, [95% CI -13.5 to -4.2], p=0.0002; acupuncture vs waiting list -22.7 [-27.5 to -17.9], p<0.0001). After 52 weeks the difference between the acupuncture and minimal acupuncture groups was no longer significant (p=0.08). INTERPRETATION After 8 weeks of treatment, pain and joint function are improved more with acupuncture than with minimal acupuncture or no acupuncture in patients with osteoarthritis of the knee. However, this benefit decreases over time.

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

Abstract 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.

Acupuncture in patients with tension-type headache: randomised controlled trial

Abstract Objective To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache. Design Three armed randomised controlled multicentre trial. Setting 28 outpatient centres in Germany. Participants 270 patients (74% women, mean age 43 (SD 13) years) with episodic or chronic tension-type headache. Interventions Acupuncture, minimal acupuncture (superficial needling at non-acupuncture points), or waiting list control. Acupuncture and minimal acupuncture were administered by specialised physicians and consisted of 12 sessions per patient over eight weeks. Main outcome measure Difference in numbers of days with headache between the four weeks before randomisation and weeks 9-12 after randomisation, as recorded by participants in headache diaries. Results The number of days with headache decreased by 7.2 (SD 6.5) days in the acupuncture group compared with 6.6 (SD 6.0) days in the minimal acupuncture group and 1.5 (SD 3.7) days in the waiting list group (difference: acupuncture v minimal acupuncture, 0.6 days, 95% confidence interval -1.5 to 2.6 days, P = 0.58; acupuncture v waiting list, 5.7 days, 3.9 to 7.5 days, P < 0.001). The proportion of responders (at least 50% reduction in days with headache) was 46% in the acupuncture group, 35% in the minimal acupuncture group, and 4% in the waiting list group. Conclusions The acupuncture intervention investigated in this trial was more effective than no treatment but not significantly more effective than minimal acupuncture for the treatment of tension-type headache. Trial registration number ISRCTN9737659.

Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form

Background: To evaluate the safety of acupuncture in a large number of patients receiving conventional health care and, based on these results, to develop a new medical consent form for acupuncture. Methods: The prospective observational study included patients who received acupuncture treatment for chronic osteoarthritis pain of the knee or hip, low back pain, neck pain or headache, allergic rhinitis, asthma, or dysmenorrhoea. After treatment, all patients documented adverse events associated with acupuncture (defined as adverse effects). Patients who reported a need for treatment due to an adverse effect completed an additional standardised questionnaire on the most important adverse effect. Based on this data and considering ethical and legal aspects a new consent form was developed. Results: A total of 229,230 patients received on average 10.2 ± 3.0 acupuncture treatments. Altogether, 19,726 patients (8.6%) reported experiencing at least one adverse effect and 4,963 (2.2%) reported one which required treatment. Common adverse effects were bleedings or haematoma (6.1% of patients, 58% of all adverse effects), pain (1.7%) and vegetative symptoms (0.7%). Two patients experienced a pneumothorax (one needed hospital treatment, the other observation only). The longest duration of a side effect was 180 days (nerve lesion of the lower limb). The resulting medical consent form consists of five modules: Introduction to acupuncture and moxibustion, Risks of acupuncture treatment, Conditions which can increase the risk, Doctor’s statement, and Consent. Conclusion: Acupuncture provided by physicians is a relatively safe treatment and the proposed consent form could support both patients and professionals in the process of obtaining informed consent.

Acupuncture for patients with chronic neck pain.

&NA; Acupuncture is widely used by patients with neck pain, but there is a lack of information about its effectiveness in routine medical care. The aim was to investigate the effectiveness of acupuncture in addition to routine care in patients with chronic neck pain compared to treatment with routine care alone. We performed a randomized controlled multicentre trial plus non‐randomized cohort in general practices in Germany. 14,161 patients with chronic neck pain (duration >6 months). Patients were randomly allocated to an acupuncture group or a control group receiving no acupuncture. Patients in the acupuncture group received up to 15 acupuncture sessions over three months. Patients who did not consent to randomization received acupuncture treatment. All subjects were allowed to receive usual medical care in addition to study treatment. Neck pain and disability (NPAD Scale by Wheeler) after three months. Of 14,161 patients (mean age 50.9 ± 13.1 years, 68% female) 1880 were randomized to acupuncture and 1886 to control, and 10,395 included into the non‐randomized acupuncture group. At three months, neck pain and disability improved by 16.2 (SE: 0.4) to 38.3 (SE: 0.4); and by 3.9 (SE: 0.4) to 50.5 (SE: 0.4), difference 12.3 (p < 0.001) in the acupuncture and control group, respectively. Treatment success was essentially maintained through six months. Non‐randomized patients had more severe symptoms at baseline and showed higher neck pain and disability improvement compared to randomized patients. Treatment with acupuncture added to routine care in patients with chronic neck pain was associated with improvements in neck pain and disability compared to treatment with routine care alone.

Acupuncture for chronic low back pain.

A 45-year-old construction worker with a 7-year history of intermittent low back pain is seen by his family physician. The pain has gradually increased over the past 4 months, despite pain medications, physical therapy, and two epidural corticosteroid injections. The pain is described as a dull ache in the lumbosacral area with episodic aching in the posterior aspect of both thighs; it worsens with prolonged standing and sitting. He is concerned about losing his job, while at the same time worried that continuing to work could cause further pain. The results of a neurologic examination and a straight-leg–raising test are normal. Magnetic resonance imaging (MRI) shows evidence of moderate degenerative disk disease at the L4–L5 and L5–S1 levels and a small midline disk herniation at L5–S1 without frank nerve impingement. The patient wonders whether acupuncture would be beneficial and asks for a referral to a licensed acupuncturist.

Characterizing acupuncture stimuli using brain imaging with fMRI: A systematic review and meta-analysis of the literature

Background The mechanisms of action underlying acupuncture, including acupuncture point specificity, are not well understood. In the previous decade, an increasing number of studies have applied fMRI to investigate brain response to acupuncture stimulation. Our aim was to provide a systematic overview of acupuncture fMRI research considering the following aspects: 1) differences between verum and sham acupuncture, 2) differences due to various methods of acupuncture manipulation, 3) differences between patients and healthy volunteers, 4) differences between different acupuncture points. Methodology/Principal Findings We systematically searched English, Chinese, Korean and Japanese databases for literature published from the earliest available up until September 2009, without any language restrictions. We included all studies using fMRI to investigate the effect of acupuncture on the human brain (at least one group that received needle-based acupuncture). 779 papers were identified, 149 met the inclusion criteria for the descriptive analysis, and 34 were eligible for the meta-analyses. From a descriptive perspective, multiple studies reported that acupuncture modulates activity within specific brain areas, including somatosensory cortices, limbic system, basal ganglia, brain stem, and cerebellum. Meta-analyses for verum acupuncture stimuli confirmed brain activity within many of the regions mentioned above. Differences between verum and sham acupuncture were noted in brain response in middle cingulate, while some heterogeneity was noted for other regions depending on how such meta-analyses were performed, such as sensorimotor cortices, limbic regions, and cerebellum. Conclusions Brain response to acupuncture stimuli encompasses a broad network of regions consistent with not just somatosensory, but also affective and cognitive processing. While the results were heterogeneous, from a descriptive perspective most studies suggest that acupuncture can modulate the activity within specific brain areas, and the evidence based on meta-analyses confirmed some of these results. More high quality studies with more transparent methodology are needed to improve the consistency amongst different studies.

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 procedure first. The components of acupuncture needling procedures have been described in the STRICTA document, but it is also clear that the patients 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 patients 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 patients 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.

Cost-effectiveness of acupuncture treatment in patients with chronic neck pain

&NA; Acupuncture is increasingly used in patients with chronic pain, but there is a lack of evidence on the cost–benefit relationship of this treatment strategy. The objective of this study was to assess costs and cost‐effectiveness of additional acupuncture treatment in patients with chronic neck pain compared to patients receiving routine care alone. A randomized controlled trial including patients (≥18 years of age) with chronic neck pain (>6 months) was carried out. We assessed the resource use and health related quality of life (SF‐36) at baseline and after 3 months using complete social health insurance funds and standardized questionnaires, respectively. The main outcome parameters were direct and indirect cost differences during the 3 months study period and the incremental cost‐effectiveness ratio (ICER) of acupuncture treatment. A total of 3,451 patients (1,753 acupuncture‐group, 1,698 control‐group) were randomized (31% men, age 53.5 ± 12.9 years; 69% women, 49.2 ± 12.7 years). Acupuncture treatment was associated with significantly higher costs over the 3 months study duration compared to routine care (&U20AC;925.53 ± 1,551.06 vs. &U20AC;648.06 ± 1,459.13; mean difference: &U20AC;277.47 [95% CI: &U20AC;175.71–&U20AC;379.23]). This cost increase was mainly due to costs of acupuncture (&U20AC;361.76 ± 90.16). The ICER was &U20AC;12,469 per QALY gained and proved robust in additional sensitivity analyses. Since health insurance databases were used, private medical expenses such as over the counter medication were not included. Beyond the 3 months study duration, acupuncture might be associated with further health economic effects. According to international cost‐effectiveness threshold values, acupuncture is a cost‐effective treatment strategy in patients with chronic neck pain.