Flexible Dosed Duloxetine in the Treatment of Fibromyalgia: A Randomized, Double-blind, Placebo-controlled Trial

2010 ◽  
Vol 37 (12) ◽  
pp. 2578-2586 ◽  
Author(s):  
LESLEY M. ARNOLD ◽  
DANIEL CLAUW ◽  
FUJUN WANG ◽  
JONNA AHL ◽  
PAULA J. GAYNOR ◽  
...  
Keyword(s):  
Short Form ◽  
Controlled Trial ◽  
Brief Pain Inventory ◽  
Pain Severity ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Global Improvement ◽  
Sf 36 ◽  
Average Pain ◽  
Sleep Difficulties

Objective.To investigate the efficacy of flexible dose duloxetine 60–120 mg/day on changes in fibromyalgia (FM) symptoms assessed by the Patient Global Impression of Improvement (PGI-I) scale.Methods.Outpatients ≥ 18 years of age who met American College of Rheumatology criteria for FM, and had ≥ 4 score on the Brief Pain Inventory (BPI) average pain item, were randomized to duloxetine (n = 263) or placebo (n = 267) for 24 week double-blind treatment (primary endpoint at Week 12). Key secondary measures included BPI average pain severity, patient-rated scales assessing mood, anxiety, pain, sleep, and stiffness, Clinical Global Impression of Severity (CGI-S), Multidimensional Fatigue Inventory, Cognitive and Physical Functioning Questionnaire, Beck Depression Inventory (BDI), Beck Anxiety Inventory, and Medical Outcome Study Short-Form Health Survey (SF-36).Results.At Week 12, duloxetine-treated patients reported significantly greater global improvement with mean PGI-I scores of 2.8 compared to 3.4 in the placebo group (p < 0.001). Significantly more duloxetine- versus placebo-treated patients (57% vs 32%; p < 0.001) reported feeling “much” or “very much better” (PGI-I score ≤ 2). There was significantly greater improvement with duloxetine versus placebo treatment in BPI average pain severity, mood (including BDI total), anxiety (patient-rated only), stiffness, CGI-S, fatigue, all SF-36 domains (except role-physical and physical component summary), and being less bothered by pain or sleep difficulties. Treatment-emergent adverse events occurring significantly more frequently with duloxetine included: nausea, headache, constipation, dry mouth, dizziness, diarrhea, and hyperhidrosis.Conclusion.Treatment with duloxetine 60, 90, and 120 mg/day was associated with feeling much better, pain reduction, being less bothered by sleep difficulties, and improvement in mood, stiffness, fatigue and functioning. (Clinical trial registryNCT00673452).

scholarly journals Improved pain, physical functioning and health status in patients with rheumatoid arthritis treated with CP-690,550, an orally active Janus kinase (JAK) inhibitor: results from a randomised, double-blind, placebo-controlled trial

2009 ◽  
Vol 69 (2) ◽  
pp. 413-416 ◽  
Author(s):  
J H Coombs ◽  
B J Bloom ◽  
F C Breedveld ◽  
M P Fletcher ◽  
D Gruben ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Health Status ◽  
Short Form ◽  
Controlled Trial ◽  
Health Assessment ◽  
Janus Kinase ◽  
Inadequate Response ◽  
Double Blind ◽  
Sf 36 ◽  
Factor Α

Objectives:To determine the efficacy of CP-690,550 in improving pain, function and health status in patients with moderate to severe active rheumatoid arthritis (RA) and an inadequate response to methotrexate or a tumour necrosis factor α inhibitor.Methods:Patients were randomised equally to placebo, CP-690,550 5, 15 or 30 mg twice daily for 6 weeks, with 6 weeks’ follow-up. The patient’s assessment of arthritis pain (pain), patient’s assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 (SF-36) were recorded.Results:At week 6, significantly more patients in the CP-690,550 5, 15 and 30 mg twice-daily groups experienced a 50% improvement in pain compared with placebo (44%, 66%, 78% and 14%, respectively), clinically meaningful reductions in HAQ-DI (⩾0.3 units) (57%, 75%, 76% and 36%, respectively) and clinically meaningful improvements in SF-36 domains and physical and mental components.Conclusions:CP-690,550 was efficacious in improving the pain, function and health status of patients with RA, from week 1 to week 6.

scholarly journals Administration of an Amino Acid–Based Regimen for the Management of Autonomic Nervous System Dysfunction Related to Combat-Induced Illness

2014 ◽  
Vol 6 ◽  
pp. JCNSD.S13793
Author(s):  
William E Shell ◽  
Marcus Charuvastra ◽  
Mira Breitstein ◽  
Stephanie L. Pavlik ◽  
Anthony Charuvastra ◽  
...  
Keyword(s):  
Mental Health ◽  
Amino Acid ◽  
Short Form ◽  
Controlled Trial ◽  
Initial Study ◽  
Nutritional Deficiencies ◽  
Autonomic Nervous System Dysfunction ◽  
Double Blind ◽  
Average Decrease ◽  
Sf 36

The etiology and pathophysiology of posttraumatic stress disorder (PTSD) remains poorly understood. The nutritional deficiencies associated with the altered metabolic processes of PTSD have not previously been studied in detail. This pilot study measured the reduction in symptoms in 21 military veterans reporting moderate to severe symptoms associated with PTSD. Two amino acid-based medical foods specifically formulated with biogenic amines and other nutrients were administered to study subjects targeting specific neurotransmitter deficiencies resulting from altered metabolic activity associated with PTSD. This study included the Physician Checklist – Military (PCL-M), Short Form General Health Survey (SF-36), and Epworth Sleepiness Scale to measure the change in each subject's score after 30 days of administration. An average decrease of 17 points was seen in the PCL-M, indicating a reduction in PTSD symptoms ( P < 0.001). The mental health component of the SF-36 showed an average 57% increase in the subjects’ mental health rating ( P < 0.001). The results of this initial study demonstrate that addressing the increased dietary requirements of PTSD can improve symptoms of the disease while eliminating significant side effects. A larger, double-blind, randomized, placebo-controlled trial is warranted.

A Randomized Controlled Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain

2015 ◽  
Vol 105 (4) ◽  
pp. 281-294 ◽  
Author(s):  
James S. Wrobel ◽  
Adam E. Fleischer ◽  
Ryan T. Crews ◽  
Beth Jarrett ◽  
Bijan Najafi
Keyword(s):  
Physical Activity ◽  
Outcome Measures ◽  
Plantar Fasciitis ◽  
Short Form ◽  
Controlled Trial ◽  
Heel Pain ◽  
Foot Orthoses ◽  
Double Blind ◽  
Sf 36 ◽  
Spontaneous Physical Activity

Background Up to 10% of people will experience heel pain. The purpose of this prospective, double-blind, randomized clinical trial was to compare custom foot orthoses (CFO), prefabricated foot orthoses (PFO), and sham insole treatment for plantar fasciitis. Methods Seventy-seven patients with plantar fasciitis for less than 1 year were included. Outcome measures included first step and end of day pain, Revised Foot Function Index short form (FFI-R), 36-Item Short Form Health Survey (SF-36), activity monitoring, balance, and gait analysis. Results The CFO group had significantly improved total FFI-R scores (77.4 versus 57.2; P = .03) without group differences for FFI-R pain, SF-36, and morning or evening pain. The PFO and CFO groups reported significantly lower morning and evening pain. For activity, the CFO group demonstrated significantly longer episodes of walking over the sham (P = .019) and PFO (P = .03) groups, with a 125% increase for CFOs, 22% PFOs, and 0.2% sham. Postural transition duration (P = .02) and balance (P = .05) improved for the CFO group. There were no gait differences. The CFO group reported significantly less stretching and ice use at 3 months. Conclusions The CFO group demonstrated 5.6-fold greater improvements in spontaneous physical activity versus the PFO and sham groups. All three groups improved in morning pain after treatment that included standardized athletic shoes, stretching, and ice. The CFO changes may have been moderated by decreased stretching and ice use after 3 months. These findings suggest that more objective measures, such as spontaneous physical activity improvement, may be more sensitive and specific for detecting improved weightbearing function than traditional clinical outcome measures, such as pain and disease-specific quality of life.

scholarly journals Intra-articular Injection of Type I Atelocollagen to Alleviate Knee Pain: A Double-Blind, Randomized Controlled Trial

Cartilage ◽  
2019 ◽  
pp. 194760351986530 ◽  
Author(s):  
Hwa Sung Lee ◽  
Kwang Jun Oh ◽  
Young Wan Moon ◽  
Yong In ◽  
Han Jun Lee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Knee Pain ◽  
Short Form ◽  
Controlled Trial ◽  
Cartilage Defects ◽  
Type I ◽  
Double Blind ◽  
Randomized Controlled ◽  
Sf 36

Objective Collagen disruption is one of the underlying causes of knee pain in patients with osteoarthritis and/or diverse cartilage defects. Atelocollagen is a type of collagen that lacks telopeptides and thus has reduced antigenicity. The intra-articular injection of type I atelocollagen supplements collagen levels in the disrupted articular cartilage. This randomized controlled trial evaluated the effects of the intra-articular injection of atelocollagen for the management of knee pain. Design Two hundred patients with osteoarthritis, chondromalacia, or other cartilage defects were randomly assigned to receive a 3-mL intra-articular injection of atelocollagen (BioCollagen group) or saline (Placebo group). Clinical improvement was evaluated over a 24-week period using the 100-mm visual analogue scale (VAS), the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and the 36-item Short-Form Health Survey (SF-36). Results VAS scores were significantly better in the BioCollagen group as compared with the Placebo group at 24 weeks. More patients in the BioCollagen group reported exceeding 20% and 40% VAS improvements. The WOMAC and SF-36 scores were also significantly improved from baseline after the intra-articular injection of atelocollagen; although, the differences between the BioCollagen and Placebo groups were not significant. There were no unexpected or severe adverse events reported for either group. Conclusions The results show that an intra-articular injection of atelocollagen effectively alleviates knee pain, as intended. Therefore, the intra-articular injection of atelocollagen can be considered an alternative solution to controlling knee pain due to osteoarthritis and diverse cartilage defects.

scholarly journals Comparative Study on the Effect of Matricaria chamomile and Achillea millefolium Capsules on Primary Dysmenorrhea Intensity of Dormitory Students of Kurdistan University of Medical Sciences, 2018

2019 ◽  
pp. 1-7
Author(s):  
Shiva Radfar ◽  
Roonak Shahoie ◽  
Bijan Noori ◽  
Fereshteh Jalilian ◽  
Leila Hashemi Nasab
Keyword(s):  
Controlled Trial ◽  
Pain Severity ◽  
Achillea Millefolium ◽  
Data Collection Tool ◽  
Medical Sciences ◽  
Menstrual Pain ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Average Pain

Background: Menstrual pain is the most common pain and one of the main causes of referral to a doctor among young women. The aim of this study was to compare the effectiveness of Achillea millefolium (Yarrow) and Matricaria chamomile plants to treat menstrual pain. Methods: This double-blind randomized controlled trial study was performed on 50 female students of Kurdistan Medical Sciences residing in dormitory in 2018. Individuals were randomly divided into two groups of chmomile and yarrow using sealed envelopes. Twenty for people received 250 mg chamomile capsules every 8 hours and 26 people received 150 mg hydroalcoholic capsules of yarrow every 8 hours during the first three days of menstruation in two menstrual cycles. The data collection tool was a questionnaire and the severity of pain was assessed using visual analogue scale for the pain (VAS). Results: There was no significant difference between the two groups in terms of pain severity and duration of pain before taking the drug (p > 0.05). The average pain severity in the first menstrual cycle in the two groups decreased significantly (p< 0.05), which was more noticeable in the yarrow group. However, the average pain severity in the yarrow capsule group was lower than that of the chamomile capsule group, but this difference was not statistically significant (p > 0.05). Conclusion: Both capsules of yarrow and chamomile reduce the severity of pain, but the yarrow capsule, with its long-lasting sedative effect, proved more helpful to reduce the severity of menstrual pain and could be effective in solving one of the issues among women.

scholarly journals Chinese Medicinal Formula (MHGWT) for Relieving Diabetic Neuropathic Pain: A Randomized, Double-Blind, Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-11 ◽  
Author(s):  
Chia-I Tsai ◽  
Tsai-Chung Li ◽  
Ming-Hong Chang ◽  
Shih-Yi Lin ◽  
I-Te Lee ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Short Form ◽  
Controlled Trial ◽  
Brief Pain Inventory ◽  
Control Group ◽  
Mcgill Pain Questionnaire ◽  
Diabetic Neuropathic Pain ◽  
Double Blind ◽  
Significant Difference ◽  
Before And After

Objective. To investigate the effects of modifiedHungqi Guizhi Wuwu Tang(MHGWT), a formula that comprises Chinese medicinal herbs, in relieving neuropathic pain in diabetics.Method. Between March 2008 and April 2009, 112 participants were randomly assigned to either the MHGWT group, whose members received MHGWT (n=56), or the control group, whose members received a placebo (n=56). Diabetic neuropathic pain (DNP) was rated using the 15-item Short-Form Brief Pain Inventory (SF-BPI), the 17-item Short-Form McGill Pain Questionnaire (SF-MPQ), the 13-item Modified Michigan Neuropathy Screening Instrument (MMNSI), and the 36-item “SF-36.” Nerve conduction studies (NCSs) were performed before and after treatment.Results. After 12 weeks of treatment, the SF-MPQ and SF-BPI scores of the MHGWT group were significantly (P<0.05) reduced and a significant difference between the groups was observed (P<0.05). The levels of NCS in the MHGWT group were nonsignificantly (P>0.05) reduced, and no significant difference in NCS level was observed between the groups (P>0.05).Conclusions. MHGWT shows promise in relieving DNP and deserves further investigation.

scholarly journals Evaluation of the Use of Sterilized and Non-Sterilized Peruibe Black Mud in Patients with Knee Osteoarthritis

2021 ◽  
Vol 18 (4) ◽  
pp. 1666 ◽  
Author(s):  
Paulo Fávio Macedo Gouvêa ◽  
Zélia Maria Nogueira Britschka ◽  
Cristina de Oliveira Massoco Salles Gomes ◽  
Nicolle Gilda Teixeira de Queiroz ◽  
Pablo Antonio Vásquez Salvador ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Knee Osteoarthritis ◽  
Short Form ◽  
Serum Levels ◽  
Double Blind ◽  
Sf 36 ◽  
Radiographic Grade ◽  
Physical Functions ◽  
Kellgren And Lawrence

This study aimed to evaluate the effects of treatment with Peruíbe Black Mud (PBM) on the clinical parameters and quality of life of patients with knee osteoarthritis and to compare the effects of PBM samples simply matured in seawater and PBM sterilized by gamma radiation. A controlled, double-blind trial was conducted with 41 patients divided into two treatment groups composed of 20 and 21 patients: one group was treated with matured PBM and the other with sterilized PBM. Evaluations were done using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) questionnaires, the Kellgren and Lawrence (KL) radiographic scale, and the quantification of the serum levels of inflammatory biomarkers. An improvement in pain, physical functions, and quality of life was observed in all of the patients who underwent treatment with both simply matured and sterilized PBM. Nine patients showed remission in the KL radiographic scale, but no statistically significant differences were observed in the serum levels of inflammatory mediators before or after treatment. Peruíbe Black Mud proves to be a useful tool as an adjuvant treatment for knee osteoarthritis (OA), as shown by the results of the WOMAC and SF-36 questionnaires and by the remission of the radiographic grade of some patients on the Kellgren and Lawrence scale.

Comparing durability of water- and land-based exercise benefits among older adults in South Korea: A randomized controlled trial with 1-year follow-up

2021 ◽  
pp. 1-11
Author(s):  
Se Jun Oh ◽  
Sang Heon Lee
Keyword(s):  
Exercise Intervention ◽  
External Rotation ◽  
Short Form ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Aquatic Exercise ◽  
Step Test ◽  
Sf 36 ◽  
Partial Weight

BACKGROUND: Aquatic exercise can improve strength, flexibility, and aerobic function while safely providing partial weight-bearing support through viscosity and buoyancy. OBJECTIVE: The aim of the present study was to compare the effects of water-based exercise with land-based exercise before and after a 10-week exercise intervention and again at one-year follow-up. METHODS: Eighty participants aged 65 years and older were randomly assigned to either a water- or a land-based 10-week exercise program. Assessment included the Senior Fitness Test (SFT), the Modified Falls-Efficacy Scale, and the 36-Item Short-Form Health Survey (SF-36). Hip and knee strength was also measured. All assessments were completed at three time points: pre- (T1), post- (T2), and at 1-year follow-up (T3). RESULTS: Significant differences were observed between the two groups on three parameters: the SFT timed up-and-go test; lower hip muscle strength in extension, adduction, and external rotation; and quality of life (QoL) measured by the SF-36 (p< 0.05). No significant differences were observed in the SFT chair stand test, dominant arm curl test, two-minute step test, chair sit-and-reach test, back scratch test, and Modified Falls-Efficacy Scale. CONCLUSION: Aquatic exercise provided greater improvement of physical health and QoL among older people than land-based exercise.

scholarly journals Efficacy of Oral Acetaminophen and Intravenous Chlorpheniramine Maleate versus Placebo to Prevent Red Cell Transfusion Reactions in Children and Adolescent with Thalassemia: A Prospective, Randomized, Double-Blind Controlled Trial

Anemia ◽  
2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Piya Rujkijyanont ◽  
Chalinee Monsereenusorn ◽  
Pimpat Manoonphol ◽  
Chanchai Traivaree
Keyword(s):  
Blood Transfusion ◽  
Controlled Trial ◽  
Febrile Reaction ◽  
Chlorpheniramine Maleate ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Urticarial Rash ◽  
To Receive ◽  
Transfusion Reactions ◽  
Rbc Transfusion

Background. Thalassemia is a common congenital hemolytic disorder. In severe cases, regular blood transfusion is essentially required. The role of premedications to prevent transfusion reactions is varied among institutions with no standard guideline. Objective. To prospectively compare the risk of transfusion reactions in thalassemia patients premedicated with acetaminophen and chlorpheniramine maleate (CPM) versus placebo prior to blood transfusion. Material and Method. A randomized, double-blinded, placebo-controlled transfusion reaction study of 147 eligible patients was analyzed. All administered red blood cell (RBC) products were leukoreduced blood products. Patients were monitored and followed for the development of transfusion reactions for 24 hours after RBC transfusion. Results. A total of 73 patients randomized to receive active drugs consisting of acetaminophen and CPM were compared to 74 patients receiving placebo. The overall incidences of febrile reaction and urticarial rash were 6.9% and 22% in the patients randomized to receive active drugs comparing with 9.5% and 35.2% in the patients receiving placebo with no significant differences between two groups. However, delayed development of urticarial rash at 4-24 hours after RBC transfusion was significantly higher in female and patients receiving placebo. Conclusion. Administration of premedications in thalassemia patients receiving RBC transfusion without a history of transfusion reactions does not decrease the overall risk of transfusion reactions. However, the use of CPM might be beneficial to prevent delayed urticarial rash in those patients especially in females (Thai Clinical Trial Registry (TCTR) study ID: 20140526001).

scholarly journals The effect of Sang-qi Granules on blood pressure and endothelial dysfunction in stageI or II hypertension: study protocol for a randomized double-blind double-simulation controlled trial

2019 ◽  
Author(s):  
Haoyue Shi ◽  
Deshuang Yang ◽  
Jiajun Qiao ◽  
Rui Sun ◽  
Ruihan Li ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Endothelial Dysfunction ◽  
Vascular Function ◽  
Short Form ◽  
Controlled Trial ◽  
Ankle Brachial Index ◽  
Vascular Endothelial ◽  
Double Blind ◽  
Endothelial Cell Function ◽  
Self Rating

Abstract Background Hypertension is an important worldwide public health challenge because of its high prevalence and concomitant risks of cardiovascular disease. It induces half of the coronary heart disease and approximately two-thirds of the cerebrovascular disease burdens. Vascular endothelial dysfunction plays important roles in the pathophysiology of essential hypertension. Sang-qi Granules (SQG), a Chinese herbal formula, is used to treat I or II hypertension. Several animal experimental studies have shown that SQG can lower blood pressure and myocardial fibrosis by suppressing inflammatory responses. However, there is no standard clinical trial to confirm this and whether SQG can improve endothelial cell function is unknown.Methods In this randomized, double-blind, double-simulation controlled trial, 300 patients with stage I or II hypertension will be recruited and randomly allocated in a 1:1:1 ratio to group A(treatment with SQG and placebo of Cozaar), group B (treatment with Cozaar and placebo of SQG), and group C (treatment with SQG and Cozaar). SQG (or its placebo) will be administrated twice a day at the doze of 10g each time, and 50mg Cozaar(or its placebo) will be administrated once in the morning. The primary endpoint is the drug efficiency of the each three groups. The secondary endpoints are the change of average systolic and diastolic blood pressure during the day and the night, the change of blood pressure drop rate at night, target organ damage assessment (heart rate variability, ankle-brachial index and pulse wave velocity), symptoms improvement assessment (hypertension symptom scale, TCM syndrome integral scale, Pittsburgh sleep quality index scale, Self-Rating Anxiety Scale, Self-Rating Depression Scale and the Short Form-36 Health Survey), blood lipids, serum indicators of vascular function (changes in serum ET-1, TXA2, NO, PGI2 values) and safety indicators.Discussion This study will provide clinical evidence for the efficacy and safety of SQG in the treatment of hypertension. Meanwhile, the possible mechanism of SQG for lowering blood pressure will be further explored by observing the protective effect of SQG on vascular endothelial function, as well as its effect on related clinical symptoms, risk factors and target organs of hypertension.

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