Laser Acupuncture for Migraine and Muscle Tension Headache: A Double-Blind Controlled Trial

Twelve patients with chronic migraine recruited from a neurology clinic or a self-help group were randomly allocated to receive either 6 weeks active laser acupuncture or 6 weeks dummy laser acupuncture. Patients completed headache diaries for the 6 weeks prior to treatment and for 6 weeks following. They were then crossed over to receive the alternative treatment for a further 6 weeks. Neither patients nor operator knew which unit was the active one. There was a reduction in mean total headache score (combining duration and severity) of 18% in the active group and 43% in the control group following the first treatment period. This difference was not significant. Following the second treatment period, mean scores increased by 50% in the active group and 5% in the control group but again this difference was not significant due to inconsistent responses by some patients. When active and placebo treatments were computed for all patients, there were still no significant differences. It is concluded that laser acupuncture does not have an important clinical effect in migraine over and above the expected placebo response.

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Developmental Moderators of a Single-Session Incremental Theory of Personality Intervention on Aggressive Behavior

Journal of Interpersonal Violence ◽

10.1177/0886260520969234 ◽

2020 ◽

pp. 088626052096923

Author(s):

Esther Calvete ◽

Liria Fernández-González ◽

Ainara Echezarraga ◽

Izaskun Orue ◽

Javier Muga ◽

...

Keyword(s):

Aggressive Behavior ◽

Controlled Trial ◽

Control Group ◽

Aggressive Behaviors ◽

Single Session ◽

Double Blind ◽

Incremental Theory ◽

Preventative Interventions ◽

To Receive ◽

Trial Participants

This study examines two indicators of developmental level (testosterone and grade) as moderators of the effects of a single-session incremental theory of personality intervention on both traditional and online aggressive behaviors. A sample of 535 Spanish adolescents (boys: 50%; age: 12–17 years) participated in a double-blind, randomized controlled trial. Participants were randomized to receive the incremental theory of personality intervention or an alternative educational control condition. The intervention consisted of teaching the belief that people can change. Aggressive behaviors were measured at baseline, one-week posttest, and six-month and twelve-month follow-ups. Testosterone level moderated the effectiveness of the intervention for online aggressive behavior so that, among adolescents with low and medium testosterone levels, those in the control group increased online aggressive behavior, whereas adolescents receiving the intervention remained at similar levels of perpetration. Grade moderated the effectiveness of the intervention on both forms of aggressive behavior, being only effective in Grade 8. Overall, the findings indicate that some preventative interventions can be more effective among adolescents with lower levels of development.

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Laser Acupuncture Alleviates Symptoms and Improves Quality of Life in Women with Overactive Bladder: A Double-Blind, Pilot Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/1705964 ◽

2020 ◽

Vol 2020 ◽

pp. 1-11

Author(s):

Yu-Wei Chang ◽

Tsia-Shu Lo ◽

Hsin-Ning Chang ◽

Yi-Hsien Shiao ◽

Yuan-Chieh Yeh

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Overactive Bladder ◽

Controlled Trial ◽

Laser Acupuncture ◽

Control Group ◽

Double Blind ◽

Randomized Controlled ◽

Experimental Group

Objective. The aim of this study was to investigate the clinical efficacy of laser acupuncture for the treatment of women with overactive bladder (OAB) in Taiwan. Methods. A double-blind randomized controlled trial was conducted on female patients with OAB symptoms referred from gynecologists, and subjects were divided into two groups using blocked randomization. LaserPan (RJ-Laser, Germany) was applied to seven selected acupuncture points. The subjects received laser acupuncture 3 times per week for 3 weeks, 9 sessions in total. Basic patient data, Overactive Bladder Symptom Score (OABSS), Incontinence Impact Questionnaire (IIQ-7), and Urogenital Distress Inventory (UDI-6) scores were recorded prior to first treatment and at the end of 3rd, 6th, and 9th treatments. Results. Thirty patients were enrolled, and twenty-seven patients completed all treatments in this study. The OABSS total score of the experimental group decreased significantly by 3.13 (p≤0.001), 4.60 (p≤0.001), and 3.79 (p≤0.001) after 3rd, 6th, and 9th treatments, respectively, compared with that of the control group. The IIQ-7 score declined significantly from baseline by 4.57 (p=0.003) and 3.63 (p=0.023) after 3rd and 6th treatments, respectively, compared with that of the control group. Similarly, the UDI-6 score of the experimental group exhibited a significant decrease from baseline by 1.90 (p=0.042) and 2.25 (p=0.025) after 6th and 9th interventions, respectively, compared with that of the control group. Conclusions. This study demonstrates that laser acupuncture can alleviate OAB symptoms and improve quality of life. This noninvasive device could be an effective therapy for women with OAB.

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Vitamin B12 Supplementation in Diabetic Neuropathy: A 1-Year, Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽

10.3390/nu13020395 ◽

2021 ◽

Vol 13 (2) ◽

pp. 395

Author(s):

Triantafyllos Didangelos ◽

Eleni Karlafti ◽

Evangelia Kotzakioulafi ◽

Eleni Margariti ◽

Parthena Giannoulaki ◽

...

Keyword(s):

Diabetic Neuropathy ◽

Vitamin B12 ◽

Pain Score ◽

Sural Nerve ◽

Controlled Trial ◽

Active Group ◽

Control Group ◽

Double Blind ◽

Double Blind Placebo ◽

Sudomotor Function

Aim: To investigate the effect of normalizing vitamin B12 (B12) levels with oral B12 (methylcobalamin) 1000 μg/day for one year in patients with diabetic neuropathy (DN). Patients and methods: In this prospective, double-blind, placebo-controlled trial, 90 patients with type 2 diabetes on metformin for at least four years and both peripheral and autonomic DN were randomized to an active treatment group (n = 44) receiving B12 and a control group (n = 46) receiving a placebo. All patients had B12 levels less than 400 pmol/L. Subjects underwent measurements of sural nerve conduction velocity (SNCV), sural nerve action potential (amplitude) (SNAP), and vibration perception threshold (VPT), and they performed cardiovascular autonomic reflex tests (CARTs: mean circular resultant (MCR), Valsalva test, postural index, and orthostatic hypotension). Sudomotor function was assessed with the SUDOSCAN that measures electrochemical skin conductance in hands and feet (ESCH and ESCF, respectively). We also used the Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE, respectively) and questionnaires to evaluate quality of life (QoL) and level of pain (pain score). Results: B12 levels increased from 232.0 ± 71.8 at baseline to 776.7 ± 242.3 pmol/L at follow-up, p < 0.0001, in the active group but not in the control group. VPT, MNSIQ, QoL, pain score, SNCV, SNAP, and ESCF significantly improved in the active group (p < 0.001, p = 0.002, p < 0.0001, p < 0.000, p < 0.0001, p < 0.0001, and p = 0.014, respectively), whereas CARTS and MNSIE improved but not significantly. MCR, MNSIQ, SNCV, SNAP, and pain score significantly deteriorated in the control group (p = 0.025, p = 0.017, p = 0.045, p < 0.0001, and p < 0.0001, respectively). Conclusions: The treatment of patients with DN with 1 mg of oral methylcobalamin for twelve months increased plasma B12 levels and improved all neurophysiological parameters, sudomotor function, pain score, and QoL, but it did not improve CARTS and MNSIE.

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Do prebiotics reduce the number of fever episodes in healthy children in their first year of life: a randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114511004053 ◽

2011 ◽

Vol 106 (11) ◽

pp. 1740-1748 ◽

Cited By ~ 23

Author(s):

Margriet van Stuijvenberg ◽

Annemieke M. Eisses ◽

Christoph Grüber ◽

Fabio Mosca ◽

Sertac Arslanoglu ◽

...

Keyword(s):

Reference Group ◽

Controlled Trial ◽

Formula Feeding ◽

Control Group ◽

First Year ◽

Healthy Children ◽

Double Blind ◽

Standard Formula ◽

First Year Of Life ◽

To Receive

The objective of the present study was to assess the effect of adding specific prebiotics to standard formula feeding on the number of fever episodes in the first year of life. In the present randomised, double-blind, placebo-controlled trial in seven centres in five West European countries, 830 healthy term infants, without a first-degree family history of allergic disease, of mothers who indicated to give only formula feeding were randomised either to receive a standard non-hydrolysed cows' milk-based formula to which a mixture of specific oligosaccharides was added (prebiotics group (PG)), or to receive a similar formula without oligosaccharides (control group (CG)). A separate reference group consisted of 300 breast-fed infants. The primary outcome was the number of fever episodes prospectively documented by the parents. There was no difference in the number of fever episodes between the PG (median value 1·19; 25th–75th percentile 0·09–2·34) and CG (1·16; 25th–75th percentile 0·06–2·38). The median number of fever episodes in the separate breast-feeding reference group was 1·24 (25th–75th percentile 0·51–3·45). There was no effect of adding specific prebiotics to standard formula feeding in reducing the number of fever episodes in the present study.

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Laser Acupuncture for Adolescent Smokers — A Randomized Double-Blind Controlled Trial

The American Journal of Chinese Medicine ◽

10.1142/s0192415x00000520 ◽

2000 ◽

Vol 28 (03n04) ◽

pp. 443-449 ◽

Cited By ~ 17

Author(s):

Yiming Cai ◽

Changxin Zhao ◽

Song Ung Wong ◽

Lei Zhang ◽

Seuk Kean Lim

Keyword(s):

Smoking Cessation ◽

Acupuncture Treatment ◽

Controlled Trial ◽

Sham Acupuncture ◽

Laser Acupuncture ◽

Control Group ◽

Control Groups ◽

Double Blind ◽

Adolescent Smokers ◽

Significant Difference

A double blind, randomized, placebo-controlled clinical study was conducted to evaluate the efficacy of laser acupuncture treatment in adolescent smokers. Three hundred and thirty adolescent smokers at the Smoking Cessation Clinic of Child Guidance Clinic, Institute of Health, Singapore, were randomly assigned in equal numbers to laser acupuncture treatment and sham acupuncture (control) groups. The proportions of patients with complete smoking cessation after completing treatment for four weeks were 21.9% in the treatment group and 21.4% in the control group. At three months post-treatment, the rates for complete cessation were 24.8% and 26.2%, respectively. Thus, there was no significant difference in the rates of smoking cessation in the treatment and control groups.

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The Effect of Prophylactic Dexmedetomidine on Hemodynamic Disturbances to Double-Lumen Endotracheal Intubation: A Prospective, Randomized, Double-Blind, and Placebo-Controlled Trial

Anesthesiology Research and Practice ◽

10.1155/2013/236089 ◽

2013 ◽

Vol 2013 ◽

pp. 1-8

Author(s):

Tanyong Pipanmekaporn ◽

Yodying Punjasawadwong ◽

Somrat Charuluxananan ◽

Worawut Lapisatepun ◽

Pavena Bunburaphong

Keyword(s):

Blood Pressure ◽

Adverse Effects ◽

Controlled Trial ◽

Rate Pressure Product ◽

Control Group ◽

Hemodynamic Responses ◽

Double Blind ◽

The Mean ◽

Mean Differences ◽

To Receive

The purpose of this study was to determine the effect of dexmedetomidine on hemodynamic responses to DLT intubation compared to placebo and to assess the adverse effects related to dexmedetomidine. Sixty patients were randomly allocated to receive 0.7 μg/kg dexmedetomidine (n=30) or normal saline (n=30) 10 minutes before general anesthesia. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), and rate pressure product (RPP) between groups were recorded. During intubation and 10 minutes afterward (T1-T10), the mean SBP, DBP, MAP, HR, and RPP in the control group were significantly higher than those in the dexmedetomidine group throughout the study period except at T1. The mean differences of SBP, DBP, MAP, HR, and RPP were significantly higher in the control group, with the value of 15.2 mmHg, 10.5 mmHg, 14 mmHg, 10.5 beats per minute, and 2,462.8 mmHg min−1. Four patients in the dexmedetomidine group and 1 patient in the control group developed hypotension, while 2 patients in the dexmedetomidine group had bradycardia. Prophylactic dexmedetomidine can attenuate the hemodynamic responses to laryngoscopy and DLT intubation with minimal adverse effects. This trial is registered with ClinicalTrials.govNCT01289769.

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The Effects of a Caffeine Placebo and Experimenter Expectation on Blood Pressure, Heart Rate, Well-Being, and Cognitive Performance

European Psychologist ◽

10.1027//1016-9040.6.1.15 ◽

2001 ◽

Vol 6 (1) ◽

pp. 15-25 ◽

Cited By ~ 18

Author(s):

Harald Walach ◽

Stefan Schmidt ◽

Yvonne-Michelle Bihr ◽

Susanne Wiesch

Keyword(s):

Blood Pressure ◽

Heart Rate ◽

Cognitive Task ◽

Well Being ◽

Control Group ◽

Double Blind ◽

Main Effect ◽

The Difference ◽

Being There ◽

To Receive

We studied the effect of experimenter expectations and different instructions in a balanced placebo design. 157 subjects were randomized into a 2 × 4 factorial design. Two experimenters were led to expect placebos either to produce physiological effects or not (pro- vs. antiplacebo). All subjects except a control group received a caffeine placebo. They were either made to expect coffee, no coffee, or were in a double-blind condition. Dependent measures were blood pressure, heart rate, well-being, and a cognitive task. There was one main effect on the instruction factor (p = 0.03) with the group “told no caffeine” reporting significantly better well-being. There was one main effect on the experimenter factor with subjects instructed by experimenter “proplacebo” having higher systolic blood pressure (p = 0.008). There was one interaction with subjects instructed by experimenter “proplacebo” to receive coffee doing worse in the cognitive task than the rest. Subjects instructed by experimenter “antiplacebo” were significantly less likely to believe the experimental instruction, and that mostly if they had been instructed to receive coffee. Contrary to the literature we could not show an effect of instruction, but there was an effect of experimenters. It is likely, however, that these experimenter effects were not due to experimental manipulations, but to the difference in personalities.

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Frühgeborene unter maschineller Beatmung: Immunmodulatorischer Effekt der präventiven Gabe von Azithromycin

Karger Kompass Pneumologie ◽

10.1159/000513487 ◽

2020 ◽

pp. 1-3

Author(s):

Maximilian Jorczyk

Keyword(s):

Very Low Birth Weight ◽

Controlled Trial ◽

Preterm Neonates ◽

Double Blind ◽

Mechanically Ventilated ◽

Before And After ◽

Anti Inflammatory ◽

To Receive ◽

Therapeutic Possibilities ◽

Inflammatory Effect

Introduction: Macrolides have anti-inflammatory and immunomodulatory properties that give this class of antibiotics a role that differs from its classical use as an antibiotic, which opens new therapeutic possibilities. Objective: The aim of this study was to evaluate the anti-inflammatory effect of azithromycin in preventing mechanical ventilation (MV)-induced lung injury in very-low-birth-weight preterm neonates. Methods: This is a randomized, double-blind, placebo-controlled trial of preterm neonates who received invasive MV within 72 h of birth. Patients were randomized to receive intravenous azithromycin (at a dose of 10/mg/kg/day for 5 days) or placebo (0.9% saline) within 12 h of the start of MV. Two blood samples were collected (before and after intervention) for measurement of interleukins (ILs) and PCR for Ureaplasma. Patients were followed up throughout the hospital stay for the outcomes of death and bronchopulmonary dysplasia defined as need for oxygen for a period of ≥28 days of life (registered at ClinicalTrials.gov, No. NCT03485703). Results: Forty patients were analyzed in the azithromycin group and 40 in the placebo group. Five days after the last dose, serum IL-2 and IL-8 levels dropped significantly in the azithromycin group. There was a significant reduction in the incidence of death and O2 dependency at 28 days/death in azithromycin-treated patients regardless of the detection of Ureaplasma in blood. Conclusions: Azithromycin has anti-inflammatory effects, with a decrease in cytokines after 5 days of use and a reduction in death and O2 dependency at 28 days/death in mechanically ventilated preterm neonates.

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Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽

10.1177/0333102421989232 ◽

2021 ◽

Vol 41 (3) ◽

pp. 294-304 ◽

Cited By ~ 2

Author(s):

Messoud Ashina ◽

Uwe Reuter ◽

Timothy Smith ◽

Judith Krikke-Workel ◽

Suzanne R Klise ◽

...

Keyword(s):

Controlled Trial ◽

Study Drug ◽

Statistical Testing ◽

Control Group ◽

Double Blind ◽

Treatment Groups ◽

Primary Endpoints ◽

Registration Number ◽

Secondary Endpoints ◽

Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

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Single High-Dose Vitamin D Supplementation as an Approach for Reducing Ultramarathon-Induced Inflammation: A Double-Blind Randomized Controlled Trial

Nutrients ◽

10.3390/nu13041280 ◽

2021 ◽

Vol 13 (4) ◽

pp. 1280

Author(s):

Jan Mieszkowski ◽

Andżelika Borkowska ◽

Błażej Stankiewicz ◽

Andrzej Kochanowicz ◽

Bartłomiej Niespodziński ◽

...

Keyword(s):

Vitamin D ◽

Inflammatory Marker ◽

Controlled Trial ◽

Vitamin D Supplementation ◽

Oncostatin M ◽

Control Group ◽

High Dose ◽

Double Blind ◽

Single High Dose ◽

High Dose Vitamin

Purpose: A growing number of studies indicate the importance of vitamin D supplementation for sports performance. However, the effects of a single high-dose vitamin D supplementation on ultramarathon-induced inflammation have not been investigated. We here analyzed the effect of a single high-dose vitamin D supplementation on the inflammatory marker levels in ultramarathon runners after an ultramarathon run (maximal run 240 km). Methods: In the study, 35 runners (amateurs) were assigned into two groups: single high-dose vitamin D supplementation group, administered vitamin D (150,000 IU) in vegetable oil 24 h before the start of the run (n = 16); and placebo group (n = 19). Blood was collected for analysis 24 h before, immediately after, and 24 h after the run. Results: Serum 25(OH)D levels were significantly increased after the ultramarathon in both groups. The increase was greater in the vitamin D group than in the control group. Based on post-hoc and other analyses, the increase in interleukin 6 and 10, and resistin levels immediately after the run was significantly higher in runners in the control group than that in those in the supplementation group. Leptin, oncostatin M, and metalloproteinase tissue inhibitor levels were significantly decreased in both groups after the run, regardless of the supplementation. Conclusions: Ultramarathon significantly increases the serum 25(OH)D levels. Attenuation of changes in interleukin levels upon vitamin D supplementation confirmed that vitamin D has anti-inflammatory effect on exercise-induced inflammation.

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