Homeopathic Arnica for Prevention of Pain and Bruising: Randomized Placebo-Controlled Trial in Hand Surgery

Homeopathic arnica is widely believed to control bruising, reduce swelling and promote recovery after local trauma; many patients therefore take it perioperatively. To determine whether this treatment has any effect, we conducted a double-blind, placebo-controlled, randomized trial with three parallel arms. 64 adults undergoing elective surgery for carpal tunnel syndrome were randomized to take three tablets daily of homeopathic arnica 30C or 6C or placebo for seven days before surgery and fourteen days after surgery. Primary outcome measures were pain (short form McGill Pain Questionnaire) and bruising (colour separation analysis) at four days after surgery. Secondary outcome measures were swelling (wrist circumference) and use of analgesic medication (patient diary). 62 patients could be included in the intention-to-treat analysis. There were no group differences on the primary outcome measures of pain ( P=0.79) and bruising ( P=0.45) at day four. Swelling and use of analgesic medication also did not differ between arnica and placebo groups. Adverse events were reported by 2 patients in the arnica 6C group, 3 in the placebo group and 4 in the arnica 30C group. The results of this trial do not suggest that homeopathic arnica has an advantage over placebo in reducing postoperative pain, bruising and swelling in patients undergoing elective hand surgery.

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A randomized, double-blind, placebo-controlled trial of memantine in a behaviorally enriched sample of patients with moderate-to-severe Alzheimer's disease

International Psychogeriatrics ◽

10.1017/s1041610213000239 ◽

2013 ◽

Vol 25 (6) ◽

pp. 919-927 ◽

Cited By ~ 34

Author(s):

Nathan Herrmann ◽

Serge Gauthier ◽

Neli Boneva ◽

Ole Michael Lemming

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Outcome Measures ◽

Primary Outcome ◽

Controlled Trial ◽

Neuropsychiatric Symptoms ◽

Primary Outcome Measure ◽

Community Dwelling ◽

Secondary Outcome ◽

Double Blind

ABSTRACTBackground: Agitation and aggression in Alzheimer's disease (AD) are amongst the most serious of neuropsychiatric symptoms, and contribute to poor outcomes and worse quality of life. Previous studies have suggested a benefit for memantine on agitation and aggression, but none have examined its efficacy in community-dwelling patients with significant agitation and aggression at baseline, utilizing these behaviors as a primary outcome measure.Methods: Patients with moderate-to-severe AD with Neuropsychiatric Inventory (NPI) total score ≥13 and NPI agitation/aggression score ≥1 were randomized to placebo or 20-mg memantine in a double-blind, 24-week trial. Co-primary outcome measures were behavior, measured by total NPI score, and cognition, using the Severe Impairment Battery (SIB). Secondary outcome measures included global assessment, function and other measures of behavior. This trial was registered as Clinicaltrials.gov: NCT00857649.Results: A total of 369 patients (average age = 75, average MMSE = 12) were randomized to placebo or memantine. The study was prematurely terminated due to recruitment problems. There were no statistically significant differences between memantine and placebo in mean change from baseline in NPI, SIB, or any of the secondary outcome measures. Behavior improved in both groups (total NPI change scores −3.90 ± 1.24 for memantine and −5.13 ± 1.23 for placebo). Memantine was generally well tolerated and patient retention in both treatment arms was good.Conclusions: The study failed to show the superiority of memantine in this sample of patients with moderate-to-severe AD with significant baseline agitation and aggression. Methodological limitations could have contributed to these results.

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Methotrimeprazine versus haloperidol in palliative care patients with cancer-related nausea: a randomised, double-blind controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-029942 ◽

2019 ◽

Vol 9 (9) ◽

pp. e029942 ◽

Cited By ~ 2

Author(s):

Janet Rea Hardy ◽

Helen Skerman ◽

Jennifer Philip ◽

Phillip Good ◽

David C Currow ◽

...

Keyword(s):

Palliative Care ◽

Outcome Measures ◽

Controlled Trial ◽

Response Rates ◽

Complete Response ◽

Response To Treatment ◽

Secondary Outcome ◽

Double Blind ◽

Intention To Treat ◽

Point Reduction

ObjectivesMethotrimeprazine is commonly used for the management of nausea but never tested formally against other drugs used in this setting. The aim was to demonstrate superior antiemetic efficacy.DesignDouble-blind, randomised, controlled trial of methotrimeprazine versus haloperidol.Setting11 palliative care sites in Australia.ParticipantsParticipants were >18 years, had cancer, an average nausea score of ≥3/10 and able to tolerate oral medications. Ineligible patients had acute nausea related to treatment, nausea for which a specific antiemetic was indicated, were about to undergo a procedure or had received either of the study drugs or a change in glucocorticoid dose within the previous 48 hours.InterventionsBased on previous studies, haloperidol was used as the control. Participants were randomised to encapsulated methotrimeprazine 6·25 mg or haloperidol 1·5 mg one time or two times per day and assessed every 24 hours for 72 hours.Main outcome measuresA ≥two-point reduction in nausea score at 72 hours from baseline. Secondary outcome measures were as follows: complete response at 72 hours (end nausea score less than 3), response at 24 and 48 hours, vomiting episodes, use of rescue antiemetics, harms and global impression of change.ResultsResponse to treatment at 72 hours was 75% (44/59) in the haloperidol (H) arm and 63% (36/57) in the methotrimeprazine (M) arm with no difference between groups (intention-to-treat analysis). Complete response rates were 56% (H) and 51% (M). In theper protocolanalysis, there was no difference in response rates: (85% (44/52) (H) and 74% (36/49) (M). Completeper protocolresponse rates were 64% (H) and 59% (M). Toxicity worse than baseline was minimal with a trend towards greater sedation in the methotrimeprazine arm.ConclusionThis study did not demonstrate any difference in response rate between methotrimeprazine and haloperidol in the control of nausea.Trial registration numberACTRN 12615000177550.

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Association between Age, Weight, and Dose and Clinical Response to Probiotics in Children with Acute Gastroenteritis

Journal of Nutrition ◽

10.1093/jn/nxaa313 ◽

2020 ◽

Vol 151 (1) ◽

pp. 65-72

Author(s):

David Schnadower ◽

Robert E Sapien ◽

T Charles Casper ◽

Cheryl Vance ◽

Phillip I Tarr ◽

...

Keyword(s):

Acute Gastroenteritis ◽

Primary Outcome ◽

Controlled Trial ◽

Interaction Effects ◽

Secondary Outcome ◽

Z Score ◽

Double Blind ◽

Multicenter Randomized Controlled Trial ◽

Weight Percentile ◽

Age And Sex

ABSTRACT Background Gastroenteritis is a common and impactful disease in childhood. Probiotics are often used to treat acute gastroenteritis (AGE); however, in a large multicenter randomized controlled trial (RCT) in 971 children, Lactobacillus rhamnosus GG (LGG) was no better than placebo in improving patient outcomes. Objectives We sought to determine whether the effect of LGG is associated with age, weight z score and weight percentile adjusted for age and sex, or dose per kilogram administered. Methods This was a preplanned secondary analysis of a multicenter double-blind RCT of LGG 1 × 1010 CFU twice daily for 5 d or placebo in children 3–48 mo of age with AGE. Our primary outcome was moderate to severe gastroenteritis. Secondary outcomes included diarrhea and vomiting frequency and duration, chronic diarrhea, and side effects. We used multivariable linear and nonlinear models testing for interaction effects to assess outcomes by age, weight z score and weight percentile adjusted for age and sex, and dose per kilogram of LGG received. Results A total of 813 children (84%) were included in the analysis; 413 received placebo and 400 LGG. Baseline characteristics were similar between treatment groups. There were no differential interaction effects across ranges of age (P-interaction = 0.32), adjusted weight z score (P-interaction = 0.43), adjusted weight percentile (P-interaction = 0.45), or dose per kilogram of LGG received (P-interaction = 0.28) for the primary outcome. Whereas we found a statistical association favoring placebo at the extremes of adjusted weight z scores for the number of vomiting episodes (P-interaction = 0.02) and vomiting duration (P-interaction = 0.0475), there were no statistically significant differences in other secondary outcome measures (all P-interactions > 0.05). Conclusions LGG does not improve outcomes in children with AGE regardless of the age, adjusted weight z score, and adjusted weight percentile of participants, or the probiotic dose per kilogram received. These results further strengthen the conclusions of low risk of bias clinical trials which demonstrate that LGG provides no clinical benefit in children with AGE. This trial was registered at clinicaltrials.gov as NCT01773967.

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Thunder-fire moxibustion for cervical spondylotic radiculopathy: Study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-019-4012-1 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Yunxuan Huang ◽

Jiabi Zhang ◽

Buhui Xiong ◽

Ruina Huang ◽

Wenjing Zhao ◽

...

Keyword(s):

Short Form ◽

Controlled Trial ◽

Neck Disability Index ◽

Life Assessment ◽

Secondary Outcome ◽

Mcgill Pain Questionnaire ◽

Social Evaluation ◽

Clinical Trial Registry ◽

Link Type ◽

Cervical Spondylotic Radiculopathy

Abstract Background Thunder-fire moxibustion originated in China and contains traditional Chinese medicine. It can produce strong firepower, infrared thermal radiation, and medicinal effects when burning on the acupoints. Thunder-fire moxibustion is commonly used in patients with neck pain, but its efficacy has rarely been systematically demonstrated. We designed a randomized trial of thunder-fire moxibustion on cervical spondylotic radiculopathy (CSR) to investigate whether it is more effective than ibuprofen sustained-release capsules. Methods One hundred patients will be recruited and randomly divided into thunder-fire moxibustion and ibuprofen groups. The intervention consists of ten treatments and will last for 2 weeks. The Yasuhisa Tanaka 20 Score Scale is used as the primary outcome measure. It contains a combination of the self-conscious symptom in patients, objective clinical evaluation from doctors, and social evaluation (the ability to work and live). The objective and comprehensive evaluation of CSR patients before and after treatment is particularly needed. The Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2), Neck Disability Index score scale (NDI), and the Quality of Life Assessment (SF-36) are applied as secondary outcome measures. The assessment will take place at the baseline and the first and second weekends of treatment. If an adverse event (AEs) occurs, it will be reported. Discussion The aim of this trial is to determine whether thunder-fire moxibustion is more effective than ibuprofen in the treatment of patients with CSR. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn), ChiCTR1800018820. Registered on 11 October 2018.

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860 Impact of Orally Administered Tramadol Combined with Self-selected Music on Adult Outpatients with Burns Undergoing Dressing Change: A Randomized Controlled Trial

Journal of Burn Care & Research ◽

10.1093/jbcr/iraa024.426 ◽

2020 ◽

Vol 41 (Supplement_1) ◽

pp. S267-S268

Author(s):

Xiu-Hang Zhang ◽

Jia-Ao Yu ◽

Xin-Xin Chen

Keyword(s):

Wound Healing ◽

Primary Outcome ◽

Short Form ◽

Controlled Trial ◽

Healing Process ◽

Total Body Surface Area ◽

Control Group ◽

Mcgill Pain Questionnaire ◽

Wound Healing Process ◽

Dressing Change

Abstract Introduction Burn injuries have significant physiological and psychological consequences. Dressing changes have been considered the most painful among all non-surgical procedures. Anxiety, which is closely associated with pain, is a part of the burn and wound-healing process and can cause delays in wound healing and recovery procedures. In addition, anxiety may have a devastating mental and physical influence on patients.What’s more,patients whose symptoms were not adequately alleviated are likely to suffer more in their subsequent dressing changes. Pharmacological treatment is the primary approach for relieving pain and anxiety related to burns. In comparison with traditional analgesics, tramadol is a more manageable drug under clinical conditions. However, due to the variability of the intensity of pain and anxiety in patients, the two symptoms remain under-treated. Recently, much attention has been paid to pain management approaches that combine pharmacological treatments with non-pharmacological therapies. In this regard, this study was designed to analyze the effect of tramadol and its combination with self-selected music on burn patient. Methods To investigate the effects of music and/or tramadol on pain and anxiety in burn outpatients undergoing dressing changes. Patients (N = 180) with burns on up to 10%-30% of the total body surface area (TBSA). The patients were selected using a convenience sampling method and randomly allocated to 4 equal-sized groups as follows: 1) tramadol group (TG), patients received 100 mg of tramadol orally 20 min before the dressing change; 2) music group (MG), patients listened to self-selected music during the dressing change; 3) music-plus-tramadol group (MTG), patients received tramadol and listened to self-selected music; and 4) control group (CG), patients received a routine dressing change only. All patients underwent the interventions once per day for 2 days. McGill Pain Questionnaire Short Form (MPQ-SF) (primary outcome), McGill Pain Persian version of Burn Specific Pain Anxiety Scale (BSPAS) (primary outcome), and heart rate (HR) and overall patient satisfaction (secondary outcomes). Results The results showed that MTG had better outcomes with respect to pain and anxiety management during dressing changes. Conclusions In comparison with music or tramadol alone, the integration of music and tramadol offers a secure and favorable treatment choice to relieve pain and anxiety, ultimately improving the satisfaction levels of burn outpatients during dressing changes. Applicability of Research to Practice The findings showed that the combined approach was more effective in reducing pain and anxiety among the outpatients, as the findings outline the potential use of this technique in the management of dressing changes in burn outpatients.

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Key lessons learned from short-term treatment trials of cholinesterase inhibitors for amnestic MCI

International Psychogeriatrics ◽

10.1017/s1041610207005650 ◽

2008 ◽

Vol 20 (1) ◽

pp. 40-46 ◽

Cited By ~ 10

Author(s):

Stephen Salloway ◽

Stephen Correia ◽

Sharon Richardson

Keyword(s):

Cognitive Impairment ◽

Outcome Measures ◽

Primary Outcome ◽

Rating Scales ◽

Controlled Trial ◽

Term Treatment ◽

Lessons Learned ◽

Secondary Outcome ◽

Short Term ◽

Short Term Treatment

ABSTRACTObjective: This paper reviews the key lessons learned from the first published short-term, placebo-controlled trial of a cholinesterase inhibitor for treatment of mild cognitive impairment (MCI).Methods: The study was a 24-week placebo-controlled trial designed to evaluate the efficacy and safety of donepezil HCl (donepezil) in the treatment of cognitive impairment in subjects with MCI. Primary outcome measures were the NYU Paragraphs Test and the ADCS Clinicians Global-Impression of Change in the intent-to-treat last-observation-carried-forward group.Results: There was no benefit of donepezil treatment on primary outcome measures (NYU Paragraphs and ADCS CGI-C) in the ITT-LOCF group but positive findings were seen on NYU Paragraphs in the fully evaluable group and in certain secondary outcome measures across both groups.Conclusions: The results highlight the need for the use of primary cognitive and functional measures that are reliable and sensitive to change in patients with MCI. Measures of episodic memory, psychomotor speed and complex attention were most sensitive in this study. Functional rating scales are needed that measure change in individual subjects' key areas of functional deficit, which typically involve executive aspects of instrumental ADLs. Tolerability can be increased by use of flexible dosing and efficacy is likely to be enhanced by increasing the length of the trial from six to 12 months and by enriching the sample with subjects more likely to decline during the trial.

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Evaluation of Epidural Analgesic Paste Components in Lumbar Decompressive Surgery

Neurosurgery ◽

10.1227/neu.0b013e3182315f05 ◽

2011 ◽

Vol 70 (2) ◽

pp. 414-424 ◽

Cited By ~ 12

Author(s):

Roberto Jose Diaz ◽

S. Terry Myles ◽

R. John Hurlbert

Keyword(s):

Postoperative Pain ◽

Outcome Measures ◽

Short Form ◽

Decompressive Surgery ◽

Secondary Outcome ◽

Mcgill Pain Questionnaire ◽

Analgesic Consumption ◽

Sf 36 ◽

Cord Injury ◽

Discharge From Hospital

Abstract BACKGROUND: Adjuncts for pain management in lumbar decompressive surgery are needed to reduce narcotic consumption and promote early mobility. OBJECTIVE: To evaluate the efficacy and active components of a previously described epidural analgesic paste in controlling postoperative pain and facilitating early discharge from hospital after lumbar decompressive surgery. METHODS: A randomized double-blind controlled trial was conducted. Two-hundred and one patients were randomized to 1 of 4 analgesic epidural pastes at the time of lumbar spinal surgery: combination paste (morphine + methylprednisolone), steroid paste (methylprednisolone alone), morphine paste (morphine alone), or placebo. The primary outcome measures used were analgesic consumption and the McGill Pain Questionnaire (MPQ). Secondary outcome measures were: modified American Spinal Cord Injury Association (ASIA) score, Short Form 36 General Health Survey (SF-36), Aberdeen Pain Index (ABPI), time to ambulation and time to discharge from hospital. RESULTS: Administration of combination and steroid paste, but not morphine paste, resulted in a statistically significant reduction in mean pain rating index (PRI) and present pain intensity (PPI) components of the MPQ in the first 3 days after surgery. Likewise, postoperative in-patient narcotic analgesic consumption was reduced in the combination paste and steroid paste group, but not in the morphine paste group. No difference in time to ambulation or discharge, SF-36 scores, ABPI scores, or neurologic recovery was observed. CONCLUSION: An analgesic paste containing methylprednisolone acetate is effective at reducing postoperative pain after lumbar decompressive surgery. Mixing effective doses of morphine sulfate in the paste abrogates the expected analgesic effects of epidural morphine.

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Placebo-controlled trial of moclobemide in social phobia

The British Journal of Psychiatry ◽

10.1192/bjp.172.1.70 ◽

1998 ◽

Vol 172 (1) ◽

pp. 70-77 ◽

Cited By ~ 93

Author(s):

Franklin R. Schneier ◽

Deborah Goetz ◽

Raphael Campeas ◽

Randall Marshall ◽

Brian Fallon ◽

...

Keyword(s):

Social Phobia ◽

Outcome Measures ◽

Primary Outcome ◽

Controlled Trial ◽

Monoamine Oxidase A ◽

Reversible Inhibitor ◽

Double Blind ◽

Intention To Treat ◽

Independent Evaluator ◽

Single Blind

BackgroundMoclobemide, a reversible inhibitor of monoamine oxidase A, previously has been reported to have efficacy in the treatment of social phobia.MethodSeventy-seven non-responders to one week of single-blind placebo were randomly assigned to moclobemide or placebo for eight weeks of double-blind treatment. Outcome was assessed by independent evaluator, treating psychiatrist and self-ratings. After eight weeks, patients who were at least minimally improved continued treatment for a further eight weeks.ResultsIntention-to-treat sample response rates at week 8 were 7/40 (17.5%) for the moclobemide group and 5/37 (13.5%) for placebo (NS). Moclobemide was significantly superior to placebo on 2 of 10 primary outcome measures. Moclobemide was well tolerated.ConclusionsMoclobemide may have efficacy in the treatment of social phobia, but absence of significant differences on most primary outcome measures and small effect sizes for all outcome measures suggest that the magnitude of its clinical effect is small.

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Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

10.21203/rs.2.510/v3 ◽

2020 ◽

Author(s):

Congcong Zeng ◽

Xi Liu ◽

Lufeng Hu ◽

Yuan Feng ◽

Nengzhi Xia ◽

...

Keyword(s):

Clinical Trial ◽

Outcome Measures ◽

Study Protocol ◽

Controlled Trial ◽

Secondary Outcome ◽

Resonance Spectroscopy ◽

Double Blind ◽

Drug Intervention ◽

Double Blind Placebo ◽

Insomnia Symptoms

Abstract Background: Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design: This is a randomized, double-blind, placebo-controlled pilot clinical trial. One hundred twenty-four participants suffering from insomnia symptoms will randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of drug intervention. The primary outcome measures will be the mean change in the Pittsburgh sleep quality index (PSQI) from baseline to the end of drug intervention. Secondary outcome measures will include the the altered sleep parameters in polysomnography, 1H-magnetic resonance spectroscopy (1H-MRS) evalution, the Disharmony of Heart and Kidney Scoring System score and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion: The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms, and will also be used to monitor the safety of JTW. Trial registration: Chinese Clinical Trial Registry, ChiCTR1800019239.Registered on 1st November 2018- Retrospectively registered, http://www.chictr.org.cn/. Keywords: Jiao-tai-wan, Insomnia, Traditional herbal medicine, Randomized controlled trial, Study protocol, Pattern identification Protocol version: Manuscript based on study protocol version 1.3, 1 November 2018.

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Chinese pediatric Tuina on children with acute diarrhea: study protocol for a randomized sham-controlled trial

Trials ◽

10.1186/s13063-019-3818-1 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Taoying Lu ◽

Huiyan Zhang ◽

Lingjia Yin ◽

Jianxiong Cai ◽

Meiling Li ◽

...

Keyword(s):

Outcome Measures ◽

Acute Diarrhea ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Double Blind ◽

Pediatric Tuina ◽

Therapeutic Benefits ◽

Appropriate Treatment ◽

Traditional Chinese Medicine Therapy

Abstract Background Acute pediatric diarrhea is one of the most common causes of morbidity and mortality worldwide and seriously affects the health of children. Previous studies have shown that pediatric Tuina, a traditional Chinese medicine therapy, has potential therapeutic benefits for acute pediatric diarrhea. However, the evidence for its effectiveness is insufficient due to the lack of high-quality clinical studies. Our aim is to evaluate the efficacy of Chinese pediatric Tuina for children aged 0–6 years with acute diarrhea. Methods/design This study is a randomized, double-blind, sham-controlled trial. We will include 122 children with acute diarrhea from Dongguan Kanghua Hospital in Guangdong province, China. The patients will be allocated into either the pediatric Tuina group or the sham Tuina group in a 1:1 ratio. The treatment will last for 3 days followed by an 11-day follow-up period. Both groups will receive usual care. In addition, the experimental group will receive 15–25 min of Chinese pediatric Tuina, while the control group will receive 15–25 min of sham pediatric Tuina. Both groups will receive treatments once per day, for 3 consecutive days. Primary outcome measures are diarrhea days from baseline and diarrhea times on the third day. Secondary outcome measures are the global change rating and period of days when the stool character changes to normal. Safety assessments will be monitored during each visit. Discussion This clinical trial is designed to evaluate the efficacy of pediatric Tuina for children with acute diarrhea. We expect results to provide solid evidence and support for pediatric Tuina as an appropriate treatment for children with acute diarrhea. Trial registration ClinicalTrials.gov, NCT03005821. Registered on 29 December 2016.

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