Hay Fever Treatment in General Practice: A Randomised Controlled Trial Comparing Standardised Western Acupuncture with Sham Acupuncture

1996 ◽  
Vol 14 (1) ◽  
pp. 6-10 ◽  
Author(s):  
L Williamson ◽  
P Yudkin ◽  
R Livingstone ◽  
K Prasad ◽  
A Fuller ◽  
...  
Keyword(s):  
Treatment Group ◽  
Active Treatment ◽  
Sham Group ◽  
Controlled Trial ◽  
Active Treatment Group ◽  
Sham Acupuncture ◽  
Hay Fever ◽  
Good Effect ◽  
Symptom Scores ◽  
Randomised Controlled

The effect of standardised, Western acupuncture on hay fever symptoms was investigated in a randomised, controlled, single-blind trial in comparison with “sham” acupuncture. Three general practices, in Oxfordshire (rural), Lincolnshire (semi-rural), and Peterborough (urban), recruited 102 patients aged 16 or over with long-standing, moderate or severe hay fever symptoms that had required continuous therapy for at least one month of the year for three or more consecutive years. The patients were asked to keep a diary to record: the amount of medication used daily; a daily symptom score (using a ten-point scale), from which was derived a weekly remission of symptoms score; and their assessment of the effect of acupuncture on the hay fever symptoms. Symptom scores and use of medication were similar in the two groups. In the four-week period following each patient's first treatment, remission of symptoms was reported by 39.0% in the active treatment group and 45.2% in the sham group; mean weekly symptom scores were 18.4 and 17.6 respectively; and mean units of medication used were 4.1 and 5.0 respectively. Sixteen out of 43 patients in the active treatment group and 14 out of 43 in the sham group felt that the acupuncture had had an excellent or very good effect on their hay fever. The treatments were simple, safe, reproducible and perceived as equally effective. Whether this represented an acupuncture effect, a placebo effect, or natural variation in a fluctuating condition, is not clear.

scholarly journals Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years. A randomised clinical trial

2020 ◽  
Author(s):  
Susanne Lynge ◽  
Kristina Boe Dissing ◽  
Werner Vach ◽  
Henrik Wulf Christensen ◽  
Lise Hestbaek
Keyword(s):  
Treatment Group ◽  
Side Effects ◽  
Pain Intensity ◽  
Active Treatment ◽  
Spinal Manipulation ◽  
Controlled Trial ◽  
Active Treatment Group ◽  
Text Messages ◽  
Control Group ◽  
Fixed Sequence

Abstract Background: To investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7-14 with recurrent headaches. Methods: Design: A two-arm , single - blind, superiority randomised superiority single-blinded clinical controlled trial. Setting: One chiropractic clinic and one paediatric specialty practice in Denmark Participants : 199 children aged 7 to 14 years, who experienced at least one episode of headache per week for the previous 6 months and with at least one musculoskeletal dysfunction identified. Interventions: All participants and parents received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. The n N umber and frequency of treatments were based on the chiropractor’s individual evaluation in the active treatment group, and the children in the control group received approximately eight visits during the treatment period. Primary outcome measures: ‘Number of days with headache’, ‘pain intensity’ and ‘medication’ were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. ‘Number of days with headache’ and ‘pain intensity’ were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account. Results: Chiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p=0.019, NNT=7 for 20% improvement ) and better global perceived effect ( dichotomized into improved/not improved, OR= 2.8 (95% CI: 1.5-5.3) 2.63 vs. 3.24 , p<0.001 , NNT=5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use. Conclusions: Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches. Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches.

scholarly journals Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7–14 years - a randomised clinical trial

2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Susanne Lynge ◽  
Kristina Boe Dissing ◽  
Werner Vach ◽  
Henrik Wulff Christensen ◽  
Lise Hestbaek
Keyword(s):  
Treatment Group ◽  
Side Effects ◽  
Pain Intensity ◽  
Active Treatment ◽  
Spinal Manipulation ◽  
Controlled Trial ◽  
Active Treatment Group ◽  
Text Messages ◽  
Control Group ◽  
Fixed Sequence

Abstract Background To investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7–14 with recurrent headaches. Methods Design: A two-arm, single-blind, superiority randomised controlled trial. Setting: One chiropractic clinic and one paediatric specialty practice in Denmark, November 2015 to August 2020. Participants: 199 children aged 7 to 14 years, with at least one episode of headache per week for the previous 6 months and at least one musculoskeletal dysfunction identified. Interventions: All participants received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. Number and frequency of treatments were based on the chiropractor’s individual evaluation in the active treatment group; the children in the control group received approximately eight visits during the treatment period. Primary outcome measures: ‘Number of days with headache’, ‘pain intensity’ and ‘medication’ were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. ‘Number of days with headache’ and ‘pain intensity’ were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account. Results Chiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p = 0.019, NNT = 7 for 20% improvement) and better global perceived effect (dichotomized into improved/not improved, OR = 2.8 (95% CI: 1.5–5.3), NNT = 5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use. Conclusions Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches. Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches. Trial registration ClinicalTrials.gov, identifier NCT02684916, registered 02/18/2016 – retrospectively registered.

scholarly journals Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years. A randomised clinical trial

2020 ◽  
Author(s):  
Susanne Lynge ◽  
Kristina Boe Dissing ◽  
Werner Vach ◽  
Henrik Wulf Christensen ◽  
Lise Hestbaek
Keyword(s):  
Treatment Group ◽  
Side Effects ◽  
Pain Intensity ◽  
Active Treatment ◽  
Spinal Manipulation ◽  
Controlled Trial ◽  
Active Treatment Group ◽  
Text Messages ◽  
Control Group ◽  
Fixed Sequence

Abstract Background To investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7-14 with recurrent headaches.Methods Design: A two-arm, single-blind, superiority randomised controlled trial.Setting: One chiropractic clinic and one paediatric specialty practice in Denmark Participants: 199 children aged 7 to 14 years, who experienced at least one episode of headache per week for the previous 6 months and with at least one musculoskeletal dysfunction identified. Interventions: All participants and parents received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. Number and frequency of treatments were based on the chiropractor’s individual evaluation in the active treatment group, and the children in the control group received approximately eight visits during the treatment period.Primary outcome measures: ‘Number of days with headache’, ‘pain intensity’ and ‘medication’ were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. ‘Number of days with headache’ and ‘pain intensity’ were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account.Results Chiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p=0.019, NNT=7 for 20% improvement) and better global perceived effect (dichotomized into improved/not improved, OR=2.8 (95% CI: 1.5-5.3), NNT=5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use.Conclusions Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches.Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches.Trial registration ClinicalTrials.gov, identifier NCT02684916, registered 02/18/2016 – retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT02684916

A Clinical Trial of Hydroxyethylrutosides in the Treatment of Haemorrhoids of Pregnancy

1992 ◽  
Vol 20 (1) ◽  
pp. 54-60 ◽  
Author(s):  
H Wijayanegara ◽  
JC Mose ◽  
L Achmad ◽  
R Sobarna ◽  
W Permadi
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Side Effects ◽  
Active Treatment ◽  
Controlled Trial ◽  
Active Treatment Group ◽  
Subjective Symptoms ◽  
Drug Related Problems ◽  
Double Blind ◽  
Safety And Efficacy

The safety and efficacy of 500 mg O-( β-hydroxyethyl)rutosides given orally twice daily in the treatment of 97 patients with first-, second-, or third-degree haemorrhoids were investigated in a double-blind, randomized placebo-controlled trial. The rutosides produced a significant ( P < 0.001) improvement in patient-assessed subjective symptoms (pain, bleeding, exudation and pruritus) compared with placebo. There was also a significant ( P < 0.0001) improvement in clinician-assessed subjective and objective signs (bleeding, inflammation and dilatation of the haemorrhoidal plexus) after 2 and 4 weeks' treatment compared with placebo. There were three mild, transient side-effects reported in the active treatment group and no drug-related problems in the pregnancy or delivery were observed. The results suggest that O-( β-hydroxyethyl)rutosides provide a safe and effective treatment for women with haemorrhoids of pregnancy.

scholarly journals Effectiveness of an app for perinatal home visitation by nurses in preventing infant abuse in Japan

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
A Isumi ◽  
S Doi ◽  
T Fujiwara
Keyword(s):  
Public Health ◽  
Treatment Group ◽  
Child Maltreatment ◽  
Active Treatment ◽  
Intervention Study ◽  
Home Visitation ◽  
Active Treatment Group ◽  
Health Centers ◽  
Public Health Nurses ◽  
Control Group

Abstract Background In Japan, public health nurses provide home visitation with pregnant women who are at high risk for child maltreatment, but its effectiveness in preventing child maltreatment has not been evaluated because contents and quality of home visitation vary from municipality to municipality. This study aims to evaluate whether the tablet app developed to standardize and assist perinatal home visitation by public health nurses is effective in preventing child maltreatment. Methods An intervention study was conducted in 2018 in Adachi City, Tokyo, Japan. Public health nurses at two public health centers used the tablet app when they support high-risk pregnant women through home visitation and interviews, while public health nurses at the other three public health centers provided support as in the past. Because two public health centers were different in usage of the app, the treatment group was further divided into two groups: active and inactive. As fatal abuse among infants, frequency of shaking and smothering was assessed as an outcome through a self-reported questionnaire at the 4-month health check, and compared between the active treatment group, inactive treatment group, and control group, using multiple logistic regression (N = 5,651). Results Prevalence of infant abuse was 0.82% in the active treatment group, 1.34% in the inactive treatment group, and 1.50% in the control group. When adjusted for parental demographics and parenting situations, mothers in the active treatment group were less likely to shake or smother their baby than those in the control group (Odds ratio: 0.51, p = 0.093). Conclusions It possibly suggests that the tablet app developed to assist perinatal home visitation by public health nurses was effective in preventing infant abuse. Key messages An intervention study was conducted at public health centers in Adachi City, Tokyo, Japan, using the tablet app developed to standardize and assist perinatal home visitation by public health nurses. The finding suggested that the tablet app may be effective in preventing shaking and smothering among 4-month old infants.

Suicide Prevention in First Episode Psychosis: The Development of a Randomised Controlled Trial of Cognitive Therapy for Acutely Suicidal Patients With Early Psychosis

2003 ◽  
Vol 37 (4) ◽  
pp. 414-420 ◽  
Author(s):  
P.J.R. Power ◽  
R.J. Bell ◽  
R. Mills ◽  
T. Herrman-Doig ◽  
M. Davern ◽  
...  
Keyword(s):  
Early Intervention ◽  
Treatment Group ◽  
Young People ◽  
Controlled Trial ◽  
First Episode Psychosis ◽  
Early Psychosis ◽  
First Episode ◽  
Episode Psychosis ◽  
Randomised Controlled ◽  
Suicidal Patients

Background: Young people with early psychosis are at particularly high risk of suicide. However, there is evidence that early intervention can reduce this risk. Despite these advances, first episode psychosis patients attending these new services still remain at risk. To address this concern, a program called LifeSPAN was established within the Early Psychosis Prevention and Intervention Centre (EPPIC). The program developed and evaluated a number of suicide prevention strategies within EPPIC and included a cognitively oriented therapy (LifeSPAN therapy) for acutely suicidal patients with psychosis. We describe the development of these interventions in this paper. Method: Clinical audit and surveys provided an indication of the prevalence of suicidality among first episode psychosis patients attending EPPIC. Second, staff focus groups and surveys identified gaps in service provision for suicidal young people attending the service. Third, a suicide risk monitoring system was introduced to identify those at highest risk. Finally, patients so identified were referred to and offered LifeSPAN therapy whose effectiveness was evaluated in a randomised controlled trial. Results: Fifty-six suicidal patients with first episode psychosis were randomly assigned to standard clinical care or standard care plus LifeSPAN therapy. Forty-two patients completed the intervention. Clinical ratings and measures of suicidality and risk were assessed before, immediately after the intervention, and 6 months later. Benefits were noted in the treatment group on indirect measures of suicidality, e.g., hopelessness. The treatment group showed a greater average improvement (though not significant) on a measure of suicide ideation. Conclusions: Early intervention in psychosis for young people reduces the risk of suicide. Augmenting early intervention with a suicide preventative therapy may further reduce this risk.

Developing and Validating a Sham Acupuncture Needle

2009 ◽  
Vol 27 (3) ◽  
pp. 118-122 ◽  
Author(s):  
Elizabeth A Tough ◽  
Adrian R White ◽  
Suzanne H Richards ◽  
Brian Lord ◽  
John L Campbell
Keyword(s):  
Randomised Controlled Trial ◽  
Trigger Point ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Previous Experience ◽  
Credibility Scale ◽  
Significant Difference ◽  
Sham Intervention ◽  
Sham Acupuncture Group ◽  
Randomised Controlled

Objectives To develop a sham needle device and test its credibility as a control for acupuncture when used in a randomised controlled trial of myofascial trigger point needling in patients with whiplash associated pain. Methods Sham needles were developed by blunting true acupuncture needles. Whiplash injured patients (<16 weeks duration) were randomly allocated to receive either true acupuncture or the “placebo” sham needle control. The true and sham needling interventions were delivered using the same standardised procedure. Patients were informed that they would receive either real or placebo needles, and asked (i) to state which treatment they believed they had received (treatment belief); (ii) to complete the four item Borkovec and Nau self-assessment credibility scale. Results were compared between groups and the analysis explored whether a patient's previous experience of acupuncture was related to their treatment belief. Other outcomes of the study will be reported elsewhere. Results 20 patients received the true acupuncture and 21 received the sham. There was no significant difference between the treatment beliefs of the two groups (χ 2 = 1.51; p>0.2) nor in the mean item scores on the Borkovec and Nau credibility scale (t test, p values ranged from 0.38 to 0.87). Of the patients in the sham acupuncture group who had previous experience of acupuncture, none recorded receiving the sham intervention. Conclusion Within the context of this pilot study, the sham acupuncture intervention was found to be a credible control for acupuncture. This supports its use in a planned, definitive, randomised controlled trial on a similar whiplash injured population.

scholarly journals Comparative study of treatment interventions for patellar tendinopathy: a protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034304 ◽  
Author(s):  
Maria Pilar López-Royo ◽  
Eva Maria Gómez-Trullén ◽  
Maria Ortiz-Lucas ◽  
Rita Maria Galán-Díaz ◽  
Ana Vanessa Bataller-Cervero ◽  
...  
Keyword(s):  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Eccentric Exercise ◽  
Short Form ◽  
Controlled Trial ◽  
Exercise Programme ◽  
Patellar Tendinopathy ◽  
Ultrasound Images ◽  
Perceived Quality Of Life ◽  
Randomised Controlled

IntroductionPatellar tendinopathy is a degenerative disease of the patellar tendon, which affects athletes from a variety of sports, and is especially predominant in sports involving high-impact jumping. The aim of this study is to determine the additional effect of two interventions combined with eccentric exercise and compare which one is the most effective at short-term and long-term follow-up for patients with patellar tendinopathy.Methods and analysisThis study is a randomised controlled trial with blinded participants. Measurements will be carried out by a specially trained blinded assessor. A sample of 57 patients with a medical diagnosis of patellar tendinopathy will participate in this study and will be divided into three treatment groups. Eligible participants will be randomly allocated to receive either: (a) treatment group with percutaneous needle electrolysis, (b) treatment group with dry needling or (c) treatment group with placebo needling. In addition, all groups will perform eccentric exercise. Functionality and muscle strength parameters, pain, ultrasound appearances and patient perceived quality of life shall be evaluated using the Victorian Institute of Sports Assessment for patellar (VISA-P), jump tests, Visual Analogue Scale, ultrasound images and Short Form-36 (SF-36), respectively. Participants will be assessed at baseline, at 10 weeks and at 22 weeks after baseline. The expected findings will allow us to advance in the treatment of this injury, as they will help determine whether a needling intervention has additional effects on an eccentric exercise programme and whether any of the needling modalities is more effective than the other.Ethics and disseminationThis protocol has been approved by the Ethics Committee of Aragon (N° PI15/0017). The trial will be conducted in accordance with the Declaration of Helsinki.Trial registration numberNCT02498795

Immediate Effect of Scalp Acupuncture on the Gait of Patients with Subacute Intracerebral Haemorrhage Analysed by Three-Dimensional Motion: Secondary Analysis of a Randomised Controlled Trial

2018 ◽  
Vol 36 (2) ◽  
pp. 71-79 ◽  
Author(s):  
Hai-Qiao Wang ◽  
Gui-Rong Dong ◽  
Chun-Ling Bao ◽  
Zhi-Hua Jiao
Keyword(s):  
Treatment Group ◽  
Acupuncture Treatment ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Three Dimensional ◽  
Scalp Acupuncture ◽  
Control Group ◽  
Kinematic Parameters ◽  
Spatiotemporal Parameters ◽  
Randomised Controlled

Objective To investigate the immediate effect of scalp acupuncture on walking pattern, using three-dimensional gait analysis (3D-GA), among patients in the subacute stage of intracerebral haemorrhage (ICH). Methods A subset of 30 patients with subacute ICH participating in a recently published randomised controlled trial who were able to walk independently were assessed by 3D-GA before and immediately after scalp acupuncture treatment (treatment group) or no intervention (control group) and the results presented here as a secondary analysis. The acupuncture manipulation was repeated three times with an interval of 5 min. Spatiotemporal and kinematic parameters during walking were collected and analysed using a 3D motion analysis system. Results After treatment, there were significant differences between the treatment and control groups in the spatiotemporal parameters of step length, velocity and cadence (p<0.05) and double-limb support. No significant difference was found in step width. When kinematic parameters were evaluated, the treatment group showed a significantly decreased peak pelvic anterior tilt angle and an increased hip extension angle after scalp acupuncture treatment, whereas the control group demonstrated no temporal changes. There were no significant changes in any other kinematic parameters in either group. Conclusions As the first exploratory study to investigate the effect of the scalp acupuncture on gait performance in patients with subacute ICH, this secondary analysis of a recent randomised trial suggested an immediate effect of treatment on spatiotemporal parameters. Improvement in gait pattern may be associated with a decreased anterior tilt of the pelvis and augmented hip joint motion during walking. Trial Registration Number ChiCTR-TRC-08000225; Post-results.

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