The journal of alternative and complementary medicine : research on paradigm, practice, and policy
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J Altern Complement Med · Oct 2004
Randomized Controlled Trial Clinical TrialA pilot study to examine the effects of a mindfulness-based stress-reduction and relaxation program on levels of stress hormones, physical functioning, and submaximal exercise responses.
Stress has been cited as a causal factor in heart disease. The objective of this study was to examine the effects of an 8-week mindfulness-based stress-reduction program on the resting levels of stress hormones, physical functioning, and submaximal exercise responses in women with heart disease. ⋯ While the 8-week stress reduction program for women with heart disease did not show significant interactions between groups for resting levels of stress hormones, physical functioning, or submaximal exercise responses, there was a significant difference in breathing patterns between the 2 groups during exercise following the mindfulness-based stress-reduction program. There was also a trend for change in the intervention group in the resting levels of cortisol and physical function scores that was not seen in the control group. Future studies could use the effect size generated from this pilot study to calculate the number of subjects needed for adequate power to detect significant differences between groups.
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J Altern Complement Med · Oct 2003
Randomized Controlled Trial Multicenter Study Clinical TrialThe German multicenter, randomized, partially blinded, prospective trial of acupuncture for chronic low-back pain: a preliminary report on the rationale and design of the trial.
The efficacy of acupuncture treatment for chronic low-back pain has not been reliably proven because of a lack of good quality studies, leading to the necessity of developing the German Acupuncture Trial for Chronic Low-Back Pain (GERAC-cLBP) study. ⋯ This trial is a nationwide, multicenter, randomized, prospective, partially blinded study. The primary endpoint is the success rate after 6 months. Success is defined as an improvement of 33% or more of three pain-related items on the Van-Korff Pain Score or an improvement of 12% or more in the disability measured by the Hanover Functional Ability Questionnaire. Assessment of the effectiveness of the blinding of patients to the form of acupuncture they received will be conducted. All clinical endpoints are assessed centrally by blinded independent observers. The sample size, with a total of 1062 patients to be enrolled, is based on power calculations. Independent central randomization, data collection, data processing, and statistical analysis are provided. Success rates will be tested for differences using two-sided Fisher exact tests. In the primary analysis, all tests will be carried out on the basis of the intention-to-treat principle. Secondary analyses will be conducted according to protocol approaches.
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J Altern Complement Med · Oct 2003
Randomized Controlled Trial Clinical TrialThe effects of electro-acupuncture and transcutaneous electrical nerve stimulation on patients with painful osteoarthritic knees: a randomized controlled trial with follow-up evaluation.
To examine the relative effectiveness of electro-acupuncture (EA) and transcutaneous electrical nerve stimulation (TENS) in alleviating osteoarthritic (OA)-induced knee pain. ⋯ Both EA and TENS treatments were effective in reducing OA-induced knee pain. EA had the additional advantage of enhancing the TUGT results as opposed to TENS treatment or no treatment, which did not produce such corollary effect.
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J Altern Complement Med · Apr 2003
Randomized Controlled Trial Multicenter Study Clinical TrialSafety and efficacy of a traditional herbal medicine (Throat Coat) in symptomatic temporary relief of pain in patients with acute pharyngitis: a multicenter, prospective, randomized, double-blinded, placebo-controlled study.
To investigate the safety and efficacy of Throat Coat) (Traditional Medicinals,) Sebastopol, CA), a traditional demulcent herbal tea, in comparison with a placebo tea in the symptomatic treatment of acute pharyngitis. ⋯ Compared to placebo, intensity of throat pain when swallowing was significantly reduced by Throat Coat in intention to treat and valid for efficacy analysis (VEA). Significant differences in change from baseline pain were observed at 5 min (p = 0.007), 10 min (p = 0.005), 15 minutes (p = 0.01), 20 minutes (p = 0.05), and 30 minutes (p = 0.04) after completion of the first dose (VEA analysis). There was a statistically significant improvement of SPID in the Throat Coat-treated group: Least square means +/- standard error of the means (SEM) of SPID were -16.5 +/- 13.9 in the placebo group and -43.8 +/- 11.9 in the Throat Coat-treated group (p = 0.012). TOTPAR was also significantly higher in the Throat Coat-treated group: Least square means +/- SEM of TOTPAR were 32.4 +/- 12.8 in the placebo group and 53.6 +/- 10.9 in the Throat Coat-treated group (p = 0.031). This study shows that Throat Coat is significantly superior to placebo and provided a rapid, temporary relief of sore throat pain in patients with pharyngitis.
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J Altern Complement Med · Dec 2002
Randomized Controlled Trial Clinical TrialAcupuncture and bronchial asthma: a long-term randomized study of the effects of real versus sham acupuncture compared to controls in patients with bronchial asthma.
Acupuncture has traditionally been used in China in the treatment of bronchial asthma and is being increasingly applied in Western countries. Although there are many published studies on acupuncture and asthma, few meet the scientific criteria necessary to prove the effectiveness of acupuncture. ⋯ In view of the fact that the effects after real and sham acupuncture compared to controls who had no needling at all were small, in all likelihood clinically irrelevant, our data do not seem to support the use of acupuncture in the management of pharmacologically well-treated patients with mild-to-moderate persistent asthma.