Susanne Jena

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.

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.

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.

Acupuncture in Patients With Headache

We aimed to investigate the effectiveness of acupuncture in addition to routine care in patients with primary headache (> 12 months, two or more headaches/month) compared with treatment with routine care alone and whether the effects of acupuncture differ in randomized and non-randomized patients. In a randomized controlled trial plus non-randomized cohort, patients with headache were allocated to receive up to 15 acupuncture sessions over 3 months or to a control group receiving no acupuncture during the first 3 months. Patients who did not consent to randomization received acupuncture treatment immediately. All subjects were allowed usual medical care in addition to study treatment. Number of days with headache, intensity of pain and health-related quality of life (SF-36) were assessed at baseline, and after 3 and 6 months using standardized questionnaires. Of 15 056 headache patients (mean age 44.1 ± 12.8 years, 77% female), 1613 were randomized to acupuncture and 1569 to control, and 11 874 included in the non-randomized acupuncture group. At 3 months, the number of days with headache decreased from 8.4 ± 7.2 (estimated mean ± S.E.) to 4.7 ± 5.6 in the acupuncture group and from 8.1 ± 6.8 to 7.5 ± 6.3 in the control group (P < 0.001). Similarly, intensity of pain and quality of life improvements were more pronounced in the acupuncture vs. control group (P < 0.001). Treatment success was maintained through 6 months. The outcome changes in non-randomized patients were similar to those in randomized patients. Acupuncture plus routine care in patients with headache was associated with marked clinical improvements compared with routine care alone.

Acupuncture in patients with dysmenorrhea: a randomized study on clinical effectiveness and cost-effectiveness in usual care

OBJECTIVE To investigate the clinical effectiveness and cost-effectiveness of acupuncture in patients with dysmenorrhea. STUDY DESIGN In a randomized controlled trial plus non-randomized cohort, patients with dysmenorrhea were randomized to acupuncture (15 sessions over three months) or to a control group (no acupuncture). Patients who declined randomization received acupuncture treatment. All subjects were allowed to receive usual medical care. RESULTS Of 649 women (mean age 36.1 +/- 7.1 years), 201 were randomized. After three months, the average pain intensity (NRS 0-10) was lower in the acupuncture compared to the control group: 3.1 (95% CI 2.7; 3.6) vs. 5.4 (4.9; 5.9), difference -2.3 (-2.9; -1.6); P<.001. The acupuncture group had better quality of life and higher costs. (overall ICER 3,011 euros per QALY). CONCLUSION Additional acupuncture in patients with dysmenorrhea was associated with improvements in pain and quality of life as compared to treatment with usual care alone and was cost-effective within usual thresholds.

Cost-Effectiveness of Acupuncture Treatment in Patients With Headache

The aim was to assess costs and cost-effectiveness of additional acupuncture treatment in patients with headache compared with patients receiving routine care alone. A randomized, controlled trial was conducted, including patients (≥18 years old) with primary headache (more than 12 months, at least two headaches/month). Outcome parameters were quality of life (Short Form 36), direct and indirect costs differences during the 3-month study period and the incremental cost-effectiveness ratio (ICER) of acupuncture treatment. A total of 3182 patients (1613 acupuncture; 1569 controls) with headache were included (77.4% women, mean age and standard deviation 42.6 ± 12.3; 22.6% men, 47.2 ± 13.4). Over 3 months costs were higher in the acupuncture group compared with the control [€857.47; 95% confidence interval 790.86, 924.07, vs. €527.34 (459.81, 594.88), P < 0.001, mean difference: €330.12 (235.27, 424.98)]. This cost increase was primarily due to costs of acupuncture [€365.64 (362.19, 369.10)]. The ICER was €11 657 per QALY gained. According to international cost-effectiveness threshold values, acupuncture is a cost-effective treatment in patients with primary headache.

Acupuncture in patients with allergic rhinitis: a pragmatic randomized trial

BACKGROUND Acupuncture is widely used in patients with allergic rhinitis, but the available evidence of its effectiveness is insufficient. OBJECTIVE To evaluate the effectiveness of acupuncture in addition to routine care in patients with allergic rhinitis compared with treatment with routine care alone. METHODS In a randomized controlled trial, patients with allergic rhinitis were randomly allocated to receive up to 15 acupuncture sessions during a period of 3 months or to a control group receiving no acupuncture. Patients who did not consent to random assignment received acupuncture treatment. All patients were allowed to receive usual medical care. The Rhinitis Quality of Life Questionnaire (RQLQ) and general health-related quality of life (36-Item Short-Form Health Survey) were evaluated at baseline and after 3 and 6 months. RESULTS Of 5,237 patients (mean [SD] age, 40 [12] years; 62% women), 487 were randomly assigned to acupuncture and 494 to control, and 4,256 were included in the nonrandomized acupuncture group. At 3 months, the RQLQ improved by a mean (SE) of 1.48 (0.06) in the acupuncture group and by 0.50 (0.06) in the control group (3-month scores, 1.44 [0.06] and 2.42 [0.06], respectively; difference in improvement, 0.98 [0.08]; P < .001). Similarly, quality-of-life improvements were more pronounced in the acupuncture vs the control group (P < .001). Six-month improvements in both acupuncture groups were lower than they had been at 3 months. CONCLUSIONS The results of this trial suggest that treating patients with allergic rhinitis in routine care with additional acupuncture leads to clinically relevant and persistent benefits. In addition, it seems that physician characteristics play a minor role in the effectiveness of acupuncture treatment, although this idea needs further investigation.

Cost-Effectiveness of Acupuncture in Women and Men With Allergic Rhinitis: A Randomized Controlled Study in Usual Care

To assess quality of life and cost-effectiveness of additional acupuncture treatment for allergic rhinitis, patients were randomly allocated to 2 groups; both received usual care, but one group received an additional 10 acupuncture sessions. Quality of life (according to the SF-36 Health Survey), and direct and indirect costs, were assessed at baseline and after 3 months, and the incremental cost-effectiveness ratio of acupuncture treatment was calculated. This German study (December 2000-June 2004) involved 981 patients (64% women, mean age 40.9 years (standard deviation, 11.2); 36% men, mean age 43.2 years (standard deviation, 13.0)). At 3 months, quality of life was higher in the acupuncture group than in the control group (mean Physical Component Score 51.99 (standard error (SE), 0.33) vs. 48.25 (SE, 0.33), P < 0.001; mean Mental Component Score 48.55 (SE, 0.42) vs. 45.35 (SE, 0.42), respectively, P < 0.001). Overall costs in the acupuncture group were significantly higher than those in the control group (Euro (euro; 1 euro = US

Acupuncture in Patients with Allergic Asthma: A Randomized Pragmatic Trial

1.27) 763, 95% confidence interval: 683, 844 vs. 332 euro, 95% confidence interval: 252, 412; mean difference 432 euro, 95% confidence interval: 318, 545). The incremental cost-effectiveness ratio was 17,377 euro per quality-adjusted life year (women, 10,155 euro; men, 44,871 euro) and was robust in sensitivity analyses. Acupuncture, supplementary to routine care, was beneficial and, according to international benchmarks, cost-effective. However, because of the study design, it remains unclear whether the effects are acupuncture specific.

Acupuncture in patients with chronic low back pain: a randomized controlled trial.

BACKGROUND Although the available evidence is insufficient, acupuncture is used in patients suffering from chronic asthma. The aim of this pragmatic study was to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone. METHODS Patients with allergic asthma were included in a randomized controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1-7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0-100). Outcome parameters were assessed at baseline and at 3 and 6 months. RESULTS A total of 1,445 patients (mean age 43.8 [SD 13.5] years, 58.7% female) were randomized and included in the analysis (184 patients randomized to acupuncture and 173 to control, and 1,088 in the nonrandomized acupuncture group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5-1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0-4.0]; mental 4.0 [2.1-6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group. CONCLUSIONS In patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone.