Factors influencing further acupuncture usage and a more positive outcome in patients with osteoarthritis of the knee and the hip: a 3-year follow-up of a randomized pragmatic trial.

OBJECTIVE: Considering the chronicity of osteoarthritis-associated pain, we aimed to evaluate long-term outcome differences between patients who received immediate or delayed acupuncture in addition to usual care, and to identify predictors for further acupuncture usage and a better long-term outcome. MATERIALS AND METHODS: The Acupuncture in Routine Care study was an open-label randomized pragmatic trial. As adjunct to usual care patients (>40 y, clinical and radiologic diagnosis of primary osteoarthritis of the knee or hip, pain duration >6 mo) received either immediate acupuncture in the first 3 months or delayed acupuncture in the subsequent 3 months. After 36 months 613 of 632 patients were available and asked to complete follow-up questionnaires. Primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). RESULTS: A total of 500 (82%) of the contacted patients completed questionnaires. After 36 months the WOMAC Index did not differ significantly between groups (immediate acupuncture 36.53±26.19 vs. delayed acupuncture 38.24±25.54; P=0.420). Further acupuncture treatment during the follow-up period was reported by 202 patients and predicted by previous successful acupuncture treatment at baseline (odds ratio=2.5; 95% confidence interval, 1.6-3.9). Less osteoarthritis symptoms (WOMAC Index) after 36 months were predicted by being an acupuncture responder at 6 months (P<0.001), having higher school education (P=0.005), not wanting to use medications (P=0.016), and using additional therapies (P≤0.001 to P=0.025). DISCUSSION: No long-term outcome differences were found between patients who received immediate versus those who received delayed acupuncture treatment. Education level and additional therapies were identified as predictors for a better long-term outcome.

Homeopathy for depression: a randomized, partially double-blind, placebo-controlled, four-armed study (DEP-HOM).

BACKGROUND: The specific clinical benefit of the homeopathic consultation and of homeopathic remedies in patients with depression has not yet been investigated. AIMS: To investigate the 1) specific effect of individualized homeopathic Q-potencies compared to placebo and 2) the effect of an extensive homeopathic case taking (case history I) compared to a shorter, rather conventional one (case history II) in the treatment of acute major depression (moderate episode) after six weeks. METHODS: A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2×2 factorial design with a six-week study duration per patient was performed. RESULTS: A total of 44 from 228 planned patients were randomized (2∶1∶2∶1 randomization: 16 homeopathic Q-potencies/case history I, 7 placebo/case history I, 14 homeopathic Q-potencies/case history II, 7 placebo/case history II). Because of recruitment problems, the study was terminated prior to full recruitment, and was underpowered for the preplanned confirmatory hypothesis testing. Exploratory data analyses showed heterogeneous and inconclusive results with large variance in the sample. The mean difference for the Hamilton-D after 6 weeks was 2.0 (95%CI -1.2;5.2) for Q-potencies vs. placebo and -3.1 (-5.9;-0.2) for case history I vs. case history II. Overall, no consistent or clinically relevant results across all outcomes between homeopathic Q-potencies versus placebo and homeopathic versus conventional case taking were observed. The frequency of adverse events was comparable for all groups. CONCLUSIONS: Although our results are inconclusive, given that recruitment into this trial was very difficult and we had to terminate early, we cannot recommend undertaking a further trial addressing this question in a similar setting. Prof. Dr. Claudia Witt had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. TRIAL REGISTRATION: clinicaltrials.gov identifier NCT01178255. Protocol publication: http://www.trialsjournal.com/content/12/1/43.