Acupuncture in patients with a vertebral compression fracture: a protocol for a randomized, controlled, pilot clinical trial.

OBJECTIVES: A vertebral compression fracture (VCF) is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. METHODS: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total). The primary outcomes will be the pain intensity (visual analogue scale and PainVision(TM) system). The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five) will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article describes the protocol.

Acupuncture in subjects with cold hands sensation: study protocol for a randomized controlled trial.

BACKGROUND: Cold hands sensation is a common disorder within the Korean population. Many Korean family physicians believe that it is a mild early manifestation of Raynaud's phenomenon (RP), or may be related to RP. RP is characterized by reversible digital vasospasm provoked by cold temperatures and/or emotional stress, and doctors often prescribe medications that are used in treatment of RP for subjects with cold hands. However, this has not shown a clear benefit, and these medications can cause unwanted side effects. It is also reported that traditional Korean medicine, including acupuncture, is widely used to treat cold hands, although the current level of evidence for this approach is also poor and to date, there have been no published randomized controlled clinical trials (RCTs) evaluating the efficacy and safety of acupuncture for cold hands. We have therefore designed a pilot RCT to obtain information for the design of a further full-scale trial. METHODS/DESIGN: The proposed study is a five-week pilot RCT. A total of 14 subjects will be recruited and randomly allocated to two groups: an acupuncture plus medication group (experimental group) and a medication-only group (control group). All subjects will take nifedipine (5 mg once daily) and beraprost (20 mg three times daily) for three weeks. The experimental group will receive additional treatment with three acupuncture sessions per week for three weeks (nine sessions total). The primary outcome will be measured using a visual analogue scale. Secondary outcomes will be measured by blood perfusion in laser Doppler perfusion imaging of the hands, frequency and duration of episodes of cold hands, and heart rate variability. Assessments will be made at baseline and at one, three, and five weeks thereafter. DISCUSSION: This study will provide an indication of the feasibility and a clinical foundation for a future large-scale trial. TRIAL REGISTRATION: This study was registered at Korean Clinical Research Information Service (CRIS) registry on 5 August 2013 with the registration number #KCT0000817.

Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial.

BACKGROUND: Spondylolisthesis is the major cause of refractory low back pain. There are many studies of the surgical treatment of spondylolisthesis, but few of conservative treatments. There is also no optimal conservative treatment protocol, however, low back pain caused by low-grade spondylolisthesis is controlled with non-surgical pain management. Acupuncture has become a useful method for treating low back pain, but there has not been any study of its efficacy in relation to spondylolisthesis. This study was designed to establish the feasibility of a randomized controlled trial and the safety of acupuncture for low back pain due to low-grade spondylolisthesis. METHODS/DESIGN: The study is a randomized controlled pilot clinical trial of five weeks duration. Fourteen patients will be recruited and randomly allocated to two groups: an acupuncture plus interlaminar epidural steroid injection group (experimental group), and an interlaminar epidural steroid injection group (control group). All patients will be administered an interlaminar epidural steroid injection once a week for three weeks (three injections in total), but only the experimental group will receive additional treatment with three acupuncture sessions a week for three weeks (nine acupuncture sessions in total). The primary outcome will be measured by the visual analogue scale (VAS). Our primary end point is three-week VAS. The secondary outcome will be measured using the PainVision system, the short-form McGill Pain Questionnaire, and the Oswestry Disability Index. Assessments will be made at baseline and at one, three and five weeks thereafter (that is, the five-week assessment will be made two weeks after treatment cessation). DISCUSSION: This randomized controlled pilot trial will inform the design of a further full-scale trial. The outcomes will provide some resources for incorporating acupuncture into existing pain management methods such as interlaminar epidural steroid injection in low-grade spondylolisthesis. TRIAL REGISTRATION: This trial is registered with the US National Institutes of Health Clinical Trials registry: NCT01909284.

Biodiesel production via the transesterification of soybean oil using waste starfish (Asterina pectinifera).

Calcined waste starfish was used as a base catalyst for the production of biodiesel from soybean oil for the first time. A batch reactor was used for the transesterification reaction. The thermal characteristics and crystal structures of the waste starfish were investigated by thermo-gravimetric analysis and X-ray diffraction. The biodiesel yield was determined by measuring the content of fatty acid methyl esters (FAME). The calcination temperature appeared to be a very important parameter affecting the catalytic activity. The starfish-derived catalyst calcined at 750 °C or higher exhibited high activity for the transesterification reaction. The FAME content increased with increasing catalyst dose and methanol-over-oil ratio.

Catalytic pyrolysis of mandarin residue from the mandarin juice processing industry.

In this study, the catalytic pyrolysis of mandarin residue from the mandarin juice processing industry was carried out using pyrolysis gas chromatography/mass spectroscopy and employing microporous zeolite catalysts, HZSM-5 (SiO2/Al2O3=23 and 80) and HBeta (SiO2/Al2O3=25). The effect of acidity of the catalyst was investigated by comparing the activity of two HZSM-5 catalysts with different SiO2/Al2O3 ratios. The effect of catalyst structure was explored by comparing the results obtained using HZSM-5 (23) and HBeta. Most oxygenates produced from non-catalytic pyrolysis were removed by catalytic upgrading, whereas the yields of mono-aromatics, which are important feedstock materials for the chemical industry, increased considerably, improving the quality of the bio-oil produced. HZSM-5 (23), having the highest acidity among the catalysts used in this study, showed superior catalytic activity to those of HZSM-5 (80) and HBeta. Pt/HZSM-5 (23) and Ga/HZSM-5 (23) resulted in an even higher yield of aromatics.

NaCl plus chitosan as a dietary salt to prevent the development of hypertension in spontaneously hypertensive rats.

The effect of NaCl plus 3% chitosan on the systolic blood pressure of spontaneously hypertensive rats (SHR) were evaluated and compared with NaCl plus KCl (NaCl, 49.36% + KCl 49.36%) and chitosan or NaCl treatment alone. In SHR, administration of NaCl plus chitosan (44 mM Na/day) for two months significantly decreased the systolic blood pressure greater than of NaCl plus KCl and NaCl alone. NaCl plus chitosan resulted, though not statistically significant, in decreased urinary Na(+) excretion and decreased blood urea nitrogen levels. Urinary creatinine of NaCl plus chitosan was slightly decreased compared to 3 treated groups. Serum electrolytes levels, however, remained unchanged. The combination of NaCl and chitosan may be superior to the conventional use of NaCl plus KCl or NaCl alone in the prevention of hypertension. Even though these supplementary diets have demonstrated potential anti-hypertensive effects in the experimental animal model, further research is needed before any recommendations can be made.

Change in serum uric acid between baseline and 1-year follow-up and its associated factors in male subjects.

A number of cross-sectional analysis studies have been conducted to determine the relationships between serum uric acid and related variables or clinical manifestations. However, few data related to changes in serum uric acid within the same cohort population at two separate periods of time have been reported. In this study, we investigated the changes in serum uric acid in a population from baseline to 1-year follow-up and examined the associations with related parameters and medical conditions. A total of 1,437 eligible male subjects who underwent 2 medical examinations at a health promotion center at an interval of approximately 12 months were enrolled in this study. Data were obtained from routine physical assessments such as blood pressure, height, waist circumference, blood analyses for liver function, renal function, lipid profile, and electrolytes, along with standardized questionnaires including self-reported data. In this population, serum uric acid was significantly increased at 1-year follow-up compared with the baseline level (5.94 +/- 1.20 vs 5.99 +/- 1.22, p = 0.003). Changes of some confounders such as total bilirubin, creatinine, BUN, phosphorus, total cholesterol, and triglyceride were significantly associated with changes in serum uric acid. Among them, serum creatinine may be the most influential in determining the serum uric acid level (odds ratio = 21.691, 95%CI = 5.110-92.086). A change of serum uric acid over 1 year did not seem to affect changes in the clinical status for some medical conditions including hypertension, diabetes mellitus, cardiovascular disease, and metabolic syndrome. This analysis showed that a change in serum creatinine level between baseline and 1-year follow-up might be the most potent factor affecting a change in serum uric acid in healthy, male subjects. Changes of serum uric acid did not show any meaningful impact on the development of hypertension, heart failure, diabetes mellitus, and metabolic syndrome in this 1-year follow-up study.