scholarly journals Efficacy and Safety of the Two Ayurveda Drug Regimens in Uterine Fibroids: A Randomized Single-Blind Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
K. P. K. R. Karunagoda ◽  
P. K. Perera ◽  
H. Senanayake ◽  
S. De Silva Weliange

This study aims to assess the efficacy and safety of two Ayurveda drug regimens for the treatment of uterine fibroids (UF) in a randomized single-blind clinical trial. 120 participants with UF (volume ≥ 2 cm3) were randomly allocated at a 1 : 1 : 1 ratio to 2 experimental groups and the control group. The 12-week intervention period was followed by 12-week follow-up. The primary efficacy endpoint was the change of the largest UF volume. The secondary efficacy endpoints were assessed by the pictorial bleeding assessment score (PBAC), UF symptoms, and quality of life score. The safety endpoints were changed in hepatic and renal safety parameters and patients experiencing adverse effects. Significant decrease was observed in the volume of UF in the arm II but not in arm I, while a significant increase was observed in the volume of the largest UF in the control group at 12th week. The PBAC score remained stable in all groups. Further mean value of the intervention arms symptom severity subscale (SSS) was significantly reduced compared to the control arm. Health-related quality of life (HRQL) value improved in 12th week of both experimental arms compared to baseline. Control arm HRQL value was reduced compared to baseline. The volume of the largest UF and both SSS and HRQL values remained stable within the follow-up period in the tested arms. The findings of this study demonstrated the safety and efficacy of selected two Ayurveda drug regimens in reducing the volume of UF and related symptoms and improving quality of life.

2021 ◽  
Vol 12 ◽  
Author(s):  
Tianye Hu ◽  
Hantong Hu ◽  
Feng Chen ◽  
Bin Jiang ◽  
Fengfei Shen ◽  
...  

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.


2017 ◽  
Vol 17 (2) ◽  
pp. 437-443 ◽  
Author(s):  
Hua-dong Zhu ◽  
Zhen Gong ◽  
Bing-wei Hu ◽  
Qiao-ling Wei ◽  
Jun Kong ◽  
...  

Introduction. Opioid-induced constipation (OIC) is a principal complication secondary to analgesic therapy for cancer pain patients who suffer moderate to severe pain. In this study, we observe the efficacy and safety of transcutaneous acupoint interferential current (IFC) stimulation in those patients with OIC. Methods. A total of 198 patients were randomly allocated to the IFC group and control group in a 1:1 ratio. Finally, 98 patients in the IFC group received 14 sessions administered over 2 weeks, whereas 100 patients in the control group took lactulose orally during the same period. Observation items were documented at management stage and at follow-up stage according to Cleveland Constipation Scales (CCS), pain Numeric Rating Scales (NRS) and Patient Assessment of Constipation Quality of Life (PAC-QoL). Results. The total curative effects of the IFC group and the control group were indistinguishable (76.5% vs 70.0%, P = .299). Regarding CCS and PAC-QoL scores, no significant difference was observed between the 2 groups during the management time and at the follow-up stage of week 3 ( P > .05, respectively), but groups were distinguished at the follow-up stage of week 4 ( P < .001 and P = .031, respectively). The pain NRS decreased significantly at management stage week 2 and follow-up stage week 3 and week 4 ( P = .013, P = .041, P = .011, respectively). Conclusions. Transcutaneous acupoint IFC therapy over acupoints of Tianshu (ST25) and Zhongwan (RN12) may improve constipation and quality of life in cancer patients receiving opiates; further studies are worthwhile.


2021 ◽  
pp. 096452842110563
Author(s):  
Sandra Calvo ◽  
Natalia Brandín-de la Cruz ◽  
Carolina Jiménez-Sánchez ◽  
Elisabeth Bravo-Esteban ◽  
Pablo Herrero

Background: Persons with stroke commonly have impairments associated with a reduction in functionality. Motor impairments are the most prevalent, causing an impact on activities of daily life. Objective: The aim of this study was to evaluate the effect of a session of dry needling (DN) applied to the upper extremity muscles on the sensorimotor function, hypertonia, and quality of life of persons with chronic stroke. Methods: A randomized, sham-controlled clinical trial was performed. Participants were randomly assigned into an intervention group that received a single session DN in the biceps brachii, brachialis, flexor digitorum superficialis and profundus, extensor digitorum, adductor pollicis and triceps brachii muscles, or into a control group that received the same treatment but with a sham DN intervention. Treatment outcomes included the Fugl–Meyer Assessment Scale for the upper extremity, the Modified Modified Ashworth Scale, and the EuroQol-5D questionnaire. Measurements were carried out before, immediately after, and 14 days after intervention. Results: Twenty-three persons participated in the study. Significant differences between groups were observed after the intervention in the total wrist–hand motor score (p = 0.023) and sensorimotor score (p = 0.022), for hypertonia in the elbow extensors both after treatment (p = 0.002) and at follow-up (p = 0.018), and in quality of life at follow-up (p = 0.030). Conclusions: A single session of DN improved total wrist–hand motor function and total sensorimotor function in persons with chronic stroke immediately after treatment, as well as quality of life 2 weeks after treatment. Trial registration number: NCT03546517 (ClinicalTrials.gov)


2021 ◽  
Author(s):  
Kyou-Young Lee ◽  
In-Sik Han ◽  
Dong-Nyung Lee ◽  
Dong-Il Kim ◽  
Junsang Yu ◽  
...  

Abstract Background: Cold hypersensitivity in the hands and feet (CHHF) is defined as the symptom of a sensation of coldness in the extremities under conditions that are not considered cold by an unaffected person. CHHF is common in East Asian women. CHHF can affect the quality of life by placing restrictions on one's daily activities. Although electroacupuncture (EA) and acupuncture have been widely used for treating CHHF, randomized clinical trial (RCT) has not yet been conducted for evaluating the safety and efficacy of EA or acupuncture for the treatment of CHHF. This study aims to evaluate the effects of EA in CHHF patients. Methods: This study is a randomized, multicenter, and parallel design clinical trial. Overall, 72 participants will be randomly assigned to the EA treatment group, acupuncture treatment group, and untreated control group in 1:1:1 ratio via a web-based randomization system. The EA treatment group and acupuncture treatment group will receive EA or acupuncture treatment by visiting ten times at intervals of twice a week for five weeks. Follow-up visits will be made four weeks after the end of treatment. For the untreated control group, three visits will be made. The primary outcome measures will be the CHHF visual analogue scale score. Secondary outcome measures will be the body temperature of hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale abbreviated version, the results of the questionnaire of health-related quality of life, questionnaire of demonstration, and questionnaire of cold hypersensitivity.Discussion: This study will be the first clinical trial to evaluate the efficacy and safety of EA for the treatment of CHHF. We expect this study to provide basic evidence for the treatment of CHHF with EA, future large-scale RCT, and the development of general clinical guidelines for CHHF in the Korean medical field.Trial registration: CRIS, KCT0004306. Registered on October 14, 2019. https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=14865


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Ya Zheng ◽  
Jessica Ching ◽  
Chung Wah Cheng ◽  
Wai Ching Lam ◽  
Kam Leung Chan ◽  
...  

Abstract Background Irritable bowel syndrome (IBS) is a common gastrointestinal functional disease. Adults with IBS may experience abdominal pain, change of bowel habits, and abnormal stool form without organic disease. IBS can seriously affect their work productivity and quality of life, especially diarrhea-predominant irritable bowel syndrome (IBS-D). The Chinese medicine JCM-16021 has been shown to be potentially effective in improving the symptoms of IBS-D based on a small scale clinical trial. Hence, a large scale clinical study is designed to further evaluate the efficacy and safety of the Chinese medicine JCM-16021 for IBS-D with traditional Chinese medicine (TCM) pattern of Liver Stagnation and Spleen Deficiency (LSSD). Methods This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. 392 eligible participants will be enrolled with 2-week run-in, 8-week treatment and 8-week follow-up. After run-in period, participants will be randomized to receive either the Chinese medicine JCM-16021 or placebo for 8 weeks, and will have post-treatment follow up for another 8 weeks. The primary outcome is the improvement rate on the global assessment of improvement (GAI) at week 10. The secondary outcomes consist of changes of IBS-D symptoms, TCM pattern improvement, IBS-Quality of Life (IBS-QoL), IBS-Symptom Severity Score (IBS-SSS), safety, etc. Results A standard protocol has been developed for the study. The protocol will provided a detailed procedure to conduct a clinical trial and verify if the Chinese medicine JCM-16021 would significantly improve the overall symptoms of IBS-D with LSSD pattern of TCM by relieving abdominal pain, reducing stool frequency, improving the stool consistency and improving quality of life. The consolidated evidence from the study can shed light on the treatment of IBS-D with Chinese medicine. Conclusion The protocol will provide details for investigators about the study following SPIRIT Statement. High-quality evidence on the efficacy and safety of Chinese medicine JCM-16021 for IBS-D will be provided through strict compliance with the protocol. Trial registration: ClinicalTrial.gov identifier: NCT03457324. Registered 8 February 2018, https://clinicaltrials.gov/ct2/show/NCT03457324?term=NCT03457324&draw=2&rank=1


2021 ◽  
Author(s):  
Ya Zheng ◽  
Jessica Ching ◽  
Chung-wah Cheng ◽  
Wai-ching Lam ◽  
Kam-Leung Chan ◽  
...  

Abstract Background: Irritable bowel syndrome (IBS) is a common gastrointestinal functional disease. Adults with IBS may experience abdominal pain, change of bowel habits, and abnormal stool form without organic disease. IBS can seriously affect their work productivity and quality of life, especially diarrhea-predominant Irritable bowel syndrome (IBS-D). Chinese Herbal Medicine JCM-16021 has been shown to be potentially effective in improving the symptoms of IBS-D based on a small scale clinical trial. Hence, a large scale clinical study is designed to further evaluate the efficacy and safety of JCM-16021 for IBS-D with traditional Chinese medicine (TCM) pattern of Liver Stagnation and Spleen Deficiency (LSSD).Methods: This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. 392 eligible participants will be enrolled with two-week run-in, eight-week treatment and eight-week follow-up. After run-in period, participants will be randomized to receive either JCM-16021 or placebo for eight weeks, and will have post-treatment follow up for another 8 weeks. The primary outcome is the improvement rate on the Global Assessment of Improvement (GAI) at week 10. The secondary outcomes consist of changes of IBS-D symptoms, TCM pattern improvement, IBS-Quality of Life (IBS-QoL), IBS-Symptom Severity Score (IBS-SSS), safety, etc. Results: A standard protocol has been developed for the study. The protocol will provided a detailed procedure to conduct a clinical trial and verify if the Chinese medicine JCM-16021 would significantly improve the overall symptoms of IBS-D with LSSD pattern of TCM by relieving abdominal pain, reducing stool frequency, improving the stool consistency and improving quality of life. The consolidated evidence from the study can shed light on the treatment of IBS-D with Chinese medicine.Conclusion: The protocol will provide details for investigators about the study following SPIRIT Statement. High-quality evidence on the efficacy and safety of Chinese Medicine JCM-16021 for IBS-D will be provided through strict compliance with the protocol.Trial registration: ClinicalTrial.gov identifier: NCT03457324. Registered 8 February 2018, https://clinicaltrials.gov/ct2/show/NCT03457324?term=NCT03457324&draw=2&rank=1


2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Ghasem Bordbar ◽  
Mohammad Bagher Miri ◽  
Mahmoud Omidi ◽  
Saeed Shoja ◽  
Malihe Akhavan

Background. The unresponsiveness to conventional pharmacological treatments and their side effects have led patients with irritable bowel syndrome (IBS) to use complementary and alternative medicine such as herbal remedies. Beside, Zataria multiflora Boiss (ZM), Trachyspermum ammi L. (TA), and Anethum graveolens L. (AG) are being used as an antiseptic, carminative, and antispasmodic in traditional medicine. This trial investigated the efficacy and safety of a combination of ZM, AG, and TA essential oils in the treatment of IBS. Method. The present study was a randomized double-blind clinical trial with parallel groups in Iran. Patients in the control arm received three tablets of 10 mg hyoscine butylbromide daily for two weeks, and the intervention arm was daily treated with two 250 mg softgel capsules containing 180 mg of essential oils of ZM, AG, and TA for two weeks. Primary outcomes were the response rates based on the IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR), and IBS Global Assessment Improvement (IBS-GAI) at the end and two weeks after the end of the intervention. Secondary outcomes were the improvement rates in IBS-SSS scores, improving the quality of life, safety, and tolerability. Results. The posttreatment improvement percentage based on IBS-AR, IBS-GAI, and IBS-SSS scales was 83.9%, 75%, and 87% in the intervention group and 37.9%, 27.5%, and 34.4% in the control group, respectively (P<0.001). Also, the improvement of the quality of life in the herbal medicine arm was significantly more than that in the control arm (P<0.001). Conclusions. According to the results, the herbal medicine investigated in this study can be considered an appropriate alternative treatment for IBS.


Author(s):  
José Antonio Mingorance ◽  
Pedro Montoya ◽  
José García Vivas Miranda ◽  
Inmaculada Riquelme

Whole body vibration has been proven to improve the health status of patients with fibromyalgia, providing an activation of the neuromuscular spindles, which are responsible for muscle contraction. The present study aimed to compare the effectiveness of two types of whole body vibrating platforms (vertical and rotational) during a 12-week training program. Sixty fibromyalgia patients (90% were women) were randomly assigned to one of the following groups: group A (n = 20), who performed the vibration training with a vertical platform; group B (n = 20), who did rotational platform training; or a control group C (n = 20), who did not do any training. Sensitivity measures (pressure pain and vibration thresholds), quality of life (Quality of Life Index), motor function tasks (Berg Scale, six-minute walking test, isometric back muscle strength), and static and dynamic balance (Romberg test and gait analysis) were assessed before, immediately after, and three months after the therapy program. Although both types of vibration appeared to have beneficial effects with respect to the control group, the training was more effective with the rotational than with vertical platform in some parameters, such as vibration thresholds (p < 0.001), motor function tasks (p < 0.001), mediolateral sway (p < 0.001), and gait speed (p < 0.05). Nevertheless, improvements disappeared in the follow-up in both types of vibration. Our study points out greater benefits with the use of rotational rather than vertical whole body vibration. The use of the rotational modality is recommended in the standard therapy program for patients with fibromyalgia. Due to the fact that the positive effects of both types of vibration disappeared during the follow-up, continuous or intermittent use is recommended.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xiao-Lin Wei ◽  
Ru-Zhen Yuan ◽  
Yong-Mei Jin ◽  
Shu Li ◽  
Ming-Yue Wang ◽  
...  

Abstract Background More than 50% cognitive impairment was reported by cancer patients before and after medical treatment. However, there are no effective interventions to manage the cognitive problem in women with breast cancer. This pilot study was designed to evaluate the protective effect of Baduanjin exercise on cognitive function and cancer-related symptoms in women with early-stage breast cancer undergoing chemotherapy. Method A single-blinded, randomized control trial was designed. The trial will recruit 70 patients with early-stage breast cancer scheduled to receive chemotherapy from Shanghai in China. All participants will be randomly assigned to (1:1) the supervised Baduanjin group (5 times/week, 30 min each time) or the wait-list control group for 3 months. The effect of Baduanjin exercise intervention will be evaluated by outcome measures including subjective and objective cognitive function, symptoms (fatigue, depression, and anxiety), and health-related quality of life at pre-intervention (T0), 8 weeks (T1), and 12 weeks (T2). The PCI score in the FACT-Cog as the primary cognitive outcome will be reported descriptively, while effect sizes and 95% confidence intervals (CIs) will be calculated. The collected data will be analyzed by using an intention-to-treat principle and linear mixed-effects modeling. Discussion This is the first randomized clinical trial to investigate whether Baduanjin exercise will have a positive role in improving cognitive function in women with breast cancer receiving chemotherapy. If possible, Baduanjin exercise will be a potential non-pharmacological intervention to manage cognitive dysfunction and promote survivorship care among breast cancer survivors. Trial registration Chinese Clinical Trial Registry (ChiCTR) ChiCTR2000033152. Registered on 22 May 2020


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Evdokimov ◽  
E Yushchuk ◽  
A Evdokimova ◽  
S Ivanova ◽  
I Sadulaeva

Abstract Purpose To compare clinical efficacy and safety of various treatment regimens with the inclusion of beta-blockers, RAAS antagonists (ACE inhibitors or ARBs), prolonged bronchodilators (LABA, LAMA) in heart failure patients with CAD and COPD. Methods 385 patients (292 men and 93 women), aged 66.3±4.1 years, with CHF classes II to III (NYHA) combined with moderate to severe COPD (GOLD) and with LVEF less than 45% were randomized into nine groups: enalapril + LAMA (control group), nebivolol + enalapril + LAMA, nebivolol + losartan + LAMA, nebivolol + losartan + LABA, nebivolol + losartan + LAMA/LABA, carvedilol + enalapril + LAMA, carvedilol + losartan + LAMA, carvedilol + losartan + LABA, carvedilol + losartan + LAMA/LABA. Patients of all groups received complex CHF treatment comprising diuretics, nitrates, cardiac glycosides (if necessary). Clinical examination, TTE, 6-minute walk test (6MWT), 24-hour electrocardiogram and blood pressure monitoring, respiratory function test were assessed at baseline and after 6 months of treatment. The quality of life was evaluated by MYHFQ, SGRQ and mMRC scale. Results After 6 months of therapy the improvement of clinical condition and quality of life were marked in all groups. At the end of observation period there was a significant improvement of patients clinical condition, quality of life, reduction of mean CHF FC and dyspnea severity, increase of exercise tolerance, slowing of progression of CHF and COPD, improvement of the parameters of intracardiac hemodynamics, structural and functional parameters of the left and right heart (a decrease in the size of the atria, LV volumes and internal dimension at end-diastole and end-systole, cardiac index, LVMMI, an increase of LVEF, a significant decrease in systemic vascular resistance and the pulmonary hypertension grade, significant improvement in systolic and diastolic function of the ventricles, regression of pathological remodeling of the heart, reduction of heart rate, duration and frequency of myocardial ischemia episodes (including its “silent” form). The best results were obtained in groups using a beta-blocker (nebivolol or carvedilol), a RAAS antagonist, and a combination of long-acting bronchodilators (indacaterol and tiotropium) – group 5 and 9. It is worth noting that beta-blockers, LABA and LAMA were well tolerated in all observation groups and serious adverse events were absent. Conclusions The appointment of 3-generation beta-blockers to patients with CHF on the background of CAD and COPD can significantly increase the effectiveness of treatment and does not cause a deterioration in spirometry in patients with such cardiopulmonary pathology. In our opinion, the most important point in the appointment of beta blockers to patients with moderate to severe COPD is low start dose and slow titration of the dose at the beginning of the therapy. It is advisable to include in the complex therapy of such patients a combination of LABA and LAMA as a basic bronchodilator support. Funding Acknowledgement Type of funding source: None


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