C Becker-Witt

Quality Assessment of Physical Research in Homeopathy

OBJECTIVES To assess the evidence of published experiments on homeopathic preparations (potencies) that target physical properties (i.e., assumed structural changes in solvents). METHOD A suitable instrument (the Score for Assessment of Physical Experiments on Homeopathy [SAPEH]) was developed through consensus procedure: a scale with 8 items covering 10 criteria, based on the 3 constructs, methodology, presentation, and experiment standardization. REVIEWED PUBLICATIONS: Written reports providing at least minimal details on physical experiments with methods to identify structural changes in solvents were collected. These reports were scored when they concerned agitated preparations in a dilution less than 10(-23), with no other restrictions. We found 44 publications that included 36 experiments (the identity of 2 was unclear). They were classified into 6 types (dielectric strength, 6; galvanic effects, 5; light absorption, 4; nuclear magnetic resonance [NMR], 18; Raman spectroscopy, 7; black boxes of undisclosed design, 4). RESULTS Most publications were of low quality (SAPEH < 6), only 6 were of high quality (SAPEH > 7, including 2 points for adequate controls). These report 3 experiments (1 NMR, 2 black boxes), of which 2 claim specific features for homeopathic remedies, as does the only medium-quality experiment with sufficient controls. CONCLUSIONS Most physical experiments of homeopathic preparations were performed with inadequate controls or had other serious flaws that prevented any meaningful conclusion. Except for those of high quality, all experiments should be repeated using stricter methodology and standardization before they are accepted as indications of special features of homeopathic potencies.

Acupuncture Randomized Trials (ART) in Patients with Migraine or Tension-Type Headache – Design and Protocols

Background and Objective: We report the design and essentials of the protocols of two Acupuncture Randomized Trials (ART) investigating whether acupuncture is more efficacious than no treatment and minimal acupuncture in the interval treatment of migraine and tension-type headache. Design: Randomized controlled multicenter trials with three treatment arms and a total observation period of 28 weeks. Setting: 30 practitioners and outpatient units in Germany specialized in acupuncture treatment. Patients: Per study 300 patients with migraine and episodic or chronic tension-type headache, respectively (diagnosis according to the criteria of the International Headache Society). Interventions: Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) standardized minimal acupuncture (75 patients), or (3) no interval treatment for 12 weeks followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks. Main Outcome Measure: Main outcome measure in the migraine trial is the difference between the number of days with headache of moderate or severe intensity during the 4 weeks before randomization and weeks 9 to 12 after randomization. In the study on tension-type headache the main outcome measure is similar to that described above, but for the number of headache days regardless of intensity. Outlook: The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.

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 ARTTTH, 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.