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Biomedical subjects

Klaus Linde

Publications and source records attributed to Klaus Linde.

At least 19 recordsLinked to original sources
PubMed2006

Pragmatic randomized trial evaluating the clinical and economic effectiveness of acupuncture for chronic low back pain.

In a randomized controlled trial plus a nonrandomized cohort, the authors investigated the effectiveness and costs of acupuncture in addition to routine care in the treatment of chronic low back pain and assessed whether the effects of acupuncture differed in randomized and nonrandomized patients. In 2001, German patients with chronic low back pain were allocated to an acupuncture group or a no-acupuncture control group. Persons who did not consent to randomization were included in a nonrandomized acupuncture group. All patients were allowed to receive routine medical care in addition to study treatment. Back function (Hannover Functional Ability Questionnaire), pain, and quality of life were assessed at baseline and after 3 and 6 months, and cost-effectiveness was analyzed. Of 11,630 patients (mean age=52.9 years (standard deviation, 13.7); 59% female), 1,549 were randomized to the acupuncture group and 1,544 to the control group; 8,537 were included in the nonrandomized acupuncture group. At 3 months, back function improved by 12.1 (standard error (SE), 0.4) to 74.5 (SE, 0.4) points in the acupuncture group and by 2.7 (SE, 0.4) to 65.1 (SE, 0.4) points among controls (difference=9.4 points (95% confidence interval 8.3, 10.5); p<0.001). Nonrandomized patients had more severe symptoms at baseline and showed improvements in back function similar to those seen in randomized patients. The incremental cost-effectiveness ratio was euro10,526 (euros) per quality-adjusted life year. Acupuncture plus routine care was associated with marked clinical improvements in these patients and was relatively cost-effective.

Acupuncture↗
PubMed2006

Treatment in a randomized multicenter trial of acupuncture for migraine (ART migraine).

BACKGROUND: This paper aims to describe the characteristics of physicians and interventions of a large, multicenter randomized trial of acupuncture for migraine (ART Migraine) in order to enable acupuncturists to assess the study interventions. PATIENTS AND METHODS: 302 patients suffering from migraine were randomized to 12 sessions of semi-standardized acupuncture (6 predefined basic points, recommendations for optional individual choice of additional points given), standardized minimal acupuncture (superficial needling of at least 5 of 10 predefined, distant non-acupuncture points) or a waiting list. 30 physicians trained and experienced in acupuncture from 18 centers in Germany participated in the trial. RESULTS: The median duration of acupuncture training of trial physicians was 500 h (range 140-1350). Physicians had acupuncture experience for 10 (<1 to 25) years and had treated 200 (60 to >1000) patients with acupuncture in the year preceding trial participation. The 6 basic points were needled in 76-93% of sessions. Compliance with treatment instructions varied considerably among centers in the acupuncture group. In contrast, compliance with the minimal acupuncture protocol was very good. 6 of the 30 physicians stated that they would have treated patients somewhat differently outside the trial, 1 completely differently. The trial found a significant effect of those treated with acupuncture compared to those on the waiting list for treatment, but minimal acupuncture was as effective as acupuncture. CONCLUSIONS: The treatment protocols for acupuncture and minimal acupuncture in ART Migraine appeared an adequate compromise in the specific situation and for the predefined purposes. However, a relevant minority of participating physicians would have treated patients differently outside the trial.

Acupuncture Points↗
PubMed2006

Acupuncture and acupressure for the prevention of chemotherapy-induced nausea--a randomised cross-over pilot study.

OBJECTIVE: To investigate whether a combination of acupuncture and acupressure is effective for reducing chemotherapy-induced nausea and vomiting. PATIENTS AND METHODS: In a randomised cross-over trial, 28 patients receiving moderately or highly emetogenic chemotherapy and conventional standard antiemesis were treated for one chemotherapy cycle with a combination of acupuncture and acupressure at point P6 and for one cycle at a close sham point. The main outcome measure was a nausea score derived from daily intensity rating. RESULTS: There was no difference between combined acupuncture and acupressure treatment at P6 and at the sham point for the nausea score, but the level of nausea was very low in both phases. The mean nausea score was 6.2 (standard deviation 9.0) for treatment at P6 and 6.3 (9.1) for treatment at the sham point (mean difference -0.1, 95% confidence interval -3.9 to 3.7; p=0.96). Seventeen of 21 participants completing the study would desire acupuncture and acupressure for future chemotherapy cycles, but there was no clear preference for either point. CONCLUSION: In this small pilot study a significant difference between treatment at P6 and a close sham point could not be detected. However, it cannot be ruled out that an existing difference was missed due to the small sample size.

Acupressure↗
PubMed2006

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

BACKGROUND: Acupuncture is widely used by patients with low back pain, although its effectiveness is unclear. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with chronic low back pain. METHODS: Patients were randomized to treatment with acupuncture, minimal acupuncture (superficial needling at nonacupuncture points), or a waiting list control. Acupuncture and minimal acupuncture were administered by specialized acupuncture physicians in 30 outpatient centers, and consisted of 12 sessions per patient over 8 weeks. Patients completed standardized questionnaires at baseline and at 8, 26, and 52 weeks after randomization. The primary outcome variable was the change in low back pain intensity from baseline to the end of week 8, as determined on a visual analog scale (range, 0-100 mm). RESULTS: A total of 298 patients (67.8% female; mean +/- SD age, 59 +/- 9 years) were included. Between baseline and week 8, pain intensity decreased by a mean +/- SD of 28.7 +/- 30.3 mm in the acupuncture group, 23.6 +/- 31.0 mm in the minimal acupuncture group, and 6.9 +/- 22.0 mm in the waiting list group. The difference for the acupuncture vs minimal acupuncture group was 5.1 mm (95% confidence interval, -3.7 to 13.9 mm; P = .26), and the difference for the acupuncture vs waiting list group was 21.7 mm (95% confidence interval, 13.9-30.0 mm; P<.001). Also, at 26 (P=.96) and 52 (P=.61) weeks, pain did not differ significantly between the acupuncture and the minimal acupuncture groups. CONCLUSION: Acupuncture was more effective in improving pain than no acupuncture treatment in patients with chronic low back pain, whereas there were no significant differences between acupuncture and minimal acupuncture.

Acupuncture Analgesia↗
PubMed2006

Summary consensus statement of the Review Board of the Swiss Complementary Medicine Evaluation Programme, (Programme Evaluation Komplementärmedizin, PEK) regarding the PEK process and products.

The international review board was set up as the scientific advisory body of the Swiss Complementary Medicine Evaluation Programme (PEK) in 2002. It has met several times and has given advice with respect to the most important aspects of the programme. It would have been the normal procedure for the review board to have had the opportunity to comment on the drafts of the final scientific products as well as the draft of the summary report, in order to advise on them, before the documents became publicly available and formed the basis for political decision making. But the responsible authorities changed this process. In the following, the review board comments both on this process and on the products.

Advisory Committees↗
PubMed2006

Interventions and physician characteristics in a randomized multicenter trial of acupuncture in patients with low-back pain.

OBJECTIVE: Descriptions of the interventions used in acupuncture studies are often incomplete. The aim of this paper is to describe participating trial physicians and interventions in a randomised trial of acupuncture for low back pain. DESIGN: Three-armed, randomized, controlled multicenter trial with 1-year follow-up. A total of 301 patients with low-back pain were randomized to 12 sessions of semistandardized acupuncture (at least six local and two distant points needled bilaterally from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), minimal acupuncture (superficial needling of at least 6 of 10 predefined, bilateral, distant nonacupuncture points), or a waiting list control (2 months no acupuncture followed by semistandardised acupuncture described above). OUTCOME MEASURES: Participating trial physicians and interventions. RESULTS: Forty-five (45) physicians specializing in acupuncture (mean age 44 +/- 7.8 years, 23 (51%) female) in 30 outpatient centers in Germany provided the interventions. The median duration of acupuncture training of trial physicians was 350 hours (range 140-2508). The most frequently reported Chinese diagnosis was Kidney deficiency (39%), followed by qi and Blood stagnation (24%), and bi syndrome (20%). The total number of needles used was 17.3 +/- 4.2 in the acupuncture group compared to 12.3 +/- 1.2 in the minimal acupuncture group. In total, 40 physicians (89%) stated that they would have treated patients similarly or in exactly the same way outside of the trial, whereas 5 (11%) stated that they would have treated patients differently. CONCLUSIONS: For most trial physicians, the semistandardized acupuncture strategy used in this trial was an acceptable compromise for an efficacy study. However, a relevant minority of participating trial physicians stated that they would have treated patients differently outside of the trial.

Acupuncture Therapy↗
PubMed2006

Acupuncture for chronic headaches--an epidemiological study.

OBJECTIVE: To investigate the characteristics and outcomes of patients undergoing acupuncture treatment for chronic headaches under conditions of routine care provided within the framework of statutory health insurance in Germany. Furthermore, we investigated correlations between different outcomes. PATIENTS AND METHODS: Patients with migraine, episodic or chronic tension-type headache (TTH), or several other forms of chronic headache (cluster, vascular, drug-induced headache; other specific headaches) treated with acupuncture (mean number of sessions 8.6 +/- 3.0) were included into an observational study. Detailed questionnaires including questions on headache days and instruments measuring disability (Pain Disability Index) and quality of life (SF-36) were completed before treatment, after treatment, and at 6 months after inclusion. RESULTS: A total of 2,022 patients (732 with migraine, 351 with episodic and 440 with chronic TTHs, and 499 with other diagnoses) treated by 1,418 physicians were included in the main analysis. Sociodemographic and baseline characteristics differed considerably in the four diagnostic groups. Statistically highly significant and clinically relevant improvements were seen for all clinical outcome measures in all diagnostic groups. In 52.6% of patients headache frequency decreased by at least 50% compared to baseline. The comparison of headache frequency, pain intensity, and generic outcome measures showed that some of these outcomes correlate only weakly. CONCLUSIONS: In this epidemiological study, headache patients reported clinically relevant improvements after receiving acupuncture. Randomized trials performed in parallel to this study confirm the relevant overall effect, however, the effect may largely be due to potent unspecific needling and placebo effects.

Acupuncture Therapy↗
PubMed2005

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

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.

Acupuncture Therapy↗
PubMed2005

Acupuncture for patients with migraine: a randomized controlled trial.

CONTEXT: Acupuncture is widely used to prevent migraine attacks, but the available evidence of its benefit is scarce. OBJECTIVE: To investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine. DESIGN, SETTING, AND PATIENTS: Three-group, randomized, controlled trial (April 2002-January 2003) involving 302 patients (88% women), mean (SD) age of 43 (11) years, with migraine headaches, based on International Headache Society criteria. Patients were treated at 18 outpatient centers in Germany. INTERVENTIONS: Acupuncture, sham acupuncture, or waiting list control. Acupuncture and sham acupuncture were administered by specialized physicians and consisted of 12 sessions per patient over 8 weeks. Patients completed headache diaries from 4 weeks before to 12 weeks after randomization and from week 21 to 24 after randomization. MAIN OUTCOME MEASURES: Difference in headache days of moderate or severe intensity between the 4 weeks before and weeks 9 to 12 after randomization. RESULTS: Between baseline and weeks 9 to 12, the mean (SD) number of days with headache of moderate or severe intensity decreased by 2.2 (2.7) days from a baseline of 5.2 (2.5) days in the acupuncture group compared with a decrease to 2.2 (2.7) days from a baseline of 5.0 (2.4) days in the sham acupuncture group, and by 0.8 (2.0) days from a baseline if 5.4 (3.0) days in the waiting list group. No difference was detected between the acupuncture and the sham acupuncture groups (0.0 days, 95% confidence interval, -0.7 to 0.7 days; P = .96) while there was a difference between the acupuncture group compared with the waiting list group (1.4 days; 95% confidence interval; 0.8-2.1 days; P<.001). The proportion of responders (reduction in headache days by at least 50%) was 51% in the acupuncture group, 53% in the sham acupuncture group, and 15% in the waiting list group. CONCLUSION: Acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were more effective than a waiting list control.

Acupuncture Therapy↗
PubMed2005

The acupuncture randomised trial (ART) for tension-type headache--details of the treatment.

OBJECTIVE: The goal of this paper is to describe the characteristics of physicians and their interventions in a large, multicentre randomised trial of acupuncture for tension-type headache known as ART TTH, in order to enable acupuncturists to assess the study interventions. METHODS: Participating physicians were recruited whose qualifications met or surpassed those of physicians currently accredited for providing acupuncture by state health funding agencies in Germany. Semi-standardised treatment strategies for acupuncture and minimal acupuncture were developed in a consensus process with acupuncture experts. A total of 270 patients suffering from episodic or chronic tension-type headache were randomised to 12 sessions of semi-standardised acupuncture (three predefined 'basic' points, recommendations for additional points given, but individual choice of additional points possible), standardised minimal acupuncture (superficial needling of at least 5 of 10 predefined, bilateral, distant non-acupuncture points) or a waiting list. Forty two physicians, trained and experienced in acupuncture, from 28 centres in Germany participated in the trial. RESULTS: The median duration of acupuncture training of trial physicians was 500 hours (range 140 to 1350 hours). Physicians had 10 (< 1 to 25) years acupuncture experience. The three 'basic' points (GB20, GB21 and LR3) were treated in 96%, 82% and 97% of sessions, respectively. Frequently treated optional points included LI4 (67%), SP6 (50%) and ST36 (46%). Ten of the 42 physicians stated that they would have treated patients differently outside the trial. The trial found a significant effect of acupuncture over waiting list but not over minimal acupuncture. CONCLUSIONS: In general, trial physicians complied well with the predefined interventions. A relevant minority of participating trial physicians stated that they would have treated patients differently outside the trial.

Acupuncture↗
PubMed2005

St John's wort for depression: meta-analysis of randomised controlled trials.

BACKGROUND: Extracts of Hypericum perforatum (St John's wort) are widely used to treat depression. Evidence for its efficacy has been criticised on methodological grounds. AIMS: To update evidence from randomised trials regarding the effectiveness of Hypericum extracts. METHODS: We performed a systematic review and meta-analysis of 37 double-blind randomised controlled trials that compared clinical effects of Hypericum monopreparation with either placebo or a standard antidepressant in adults with depressive disorders. RESULTS: Larger placebo-controlled trials restricted to patients with major depression showed only minor effects over placebo, while older and smaller trials not restricted to patients with major depression showed marked effects. Compared with standard antidepressants Hypericum extracts had similar effects. CONCLUSIONS: Current evidence regarding Hypericum extracts is inconsistent and confusing. In patients who meet criteria for major depression, several recent placebo-controlled trials suggest that Hypericum has minimal beneficial effects while other trials suggest that Hypericum and standard antidepressants have similar beneficial effects.

Antidepressive Agents↗
PubMed2004

How informed is consent in sham-controlled trials of acupuncture?

OBJECTIVES: We sought to investigate whether, and if so, how published sham-controlled trials of acupuncture report on the information given to patients about true and sham interventions. We asked acupuncture therapists to provide original patient information leaflets in order to study how interventions were described in more detail. METHODS: Forty-seven (47) published sham-controlled trials of acupuncture collected for a systematic review on sham techniques were screened to determine whether they reported on information given to patients about study interventions; any such information was extracted. We contacted authors of published studies and other researchers in the field and asked them to provide copies of original patient information leaflets. Information given to patients about true and sham interventions was extracted. RESULTS: Ten (10; 21%) of the 47 published studies included some information on how patients were informed. None of these studies appear to have used the term "sham" or "placebo" and most appear to have suggested that two types of acupuncture were compared. In the 16 original patient information leaflets obtained, the way patients were informed varied greatly: 7 leaflets explicitly included words such as "sham," "placebo," or "dummy." Others described the control intervention as not meeting all criteria of acupuncture. Finally, one group of studies simply suggested that different types of acupuncture were being compared. CONCLUSION: Our results indicate that (1) only a minority of published trials report on information given to patients about true and sham interventions and (2) that information strategies vary considerably and are often not fully explicit. This has not only ethical relevance but also might influence results of trials.

Acupuncture Therapy↗
PubMed2004

Adverse effects of St. John's Wort: a systematic review.

OBJECTIVE: To obtain an overview of the available clinical evidence on safety and tolerability of hypericum extracts, we reviewed (1) dropout rates and adverse effects in double-blind randomized trials comparing hypericum extracts and placebo or synthetic standard antidepressants; (2) dropout rates and adverse effects in large-scale observational studies; and (3) adverse effects reported in published cases and to public drug surveillance agencies. METHOD: Data on dropout rates and adverse effects were extracted from double-blind randomized trials of hypericum monopreparations collected for a Cochrane review (last search July 2003) and from a PubMed search (text word hypericum; search dates 1998-January 2003). Similar data were extracted from uncontrolled observational studies including at least 100 patients identified through a PubMed search (search term hypericum NOT animal, last update May 2003), contacts with manufacturers, and screening of review articles. Case reports and case series on adverse events associated with hypericum products were identified through a MEDLINE search (1966-November 2002; search term: hypericum AND [adverse effects OR interaction]) and a PubMed search (February 2003) and were collected from 5 public drug surveillance agencies (data through May 2001). All database searches were conducted as English and non-English language searches. RESULTS: Data from 35 double-blind randomized trials showed that dropout and adverse effects rates in patients receiving hypericum extracts were similar to placebo, lower than with older antidepressants, and slightly lower than with selective serotonin reuptake inhibitors. Dropout rates due to adverse effects in 17 observational studies including 35,562 patients ranged from 0% to 5.7%; interactions or serious adverse effects were not reported in any study. Published cases and cases reported to drug surveillance agencies suggest that interactions with a variety of drugs (particularly cyclosporine in transplant patients) are the most relevant adverse effects of hypericum extracts. CONCLUSIONS: The available evidence suggests that hypericum extracts are well tolerated and safe if taken under control of a physician who is aware of potentially relevant risks in specific circumstances.

Antidepressive Agents↗
PubMed2004

[Should acupuncture be reimbursed? Three acupuncture programmes of German Statutory Health Insurance Funds (SHI) and their scientific evaluation].

An estimated 40,000 physicians offer acupuncture treatment to patients in Germany. Due to a decision of the German Federal Committee of SHI-accredited Physicians and Health Insurance Funds, acupuncture treatment for chronic low back pain, headache and osteoarthritic pain may be reimbursed from 2000 onwards if patients and physicians participate in specific scientifically evaluated model projects of the Statutory Health Insurance Funds. Currently, three separate acupuncture programmes are offered by different Statutory Health Insurance Funds. The scientific evaluation of all these programmes includes both randomised trials (comparing acupuncture to no treatment, sham acupuncture or standard treatment in 300 to several thousands of patients) and large cohort studies. Details of the three programmes will be presented in the following chapters.

Acupuncture Therapy↗