scholarly journals Efficacy and safety of over-the-counter analgesics for primary dysmenorrhea

Medicine ◽  
2020 ◽  
Vol 99 (19) ◽  
pp. e19881 ◽  
Author(s):  
Wenbo Nie ◽  
Ping Xu ◽  
Chunyan Hao ◽  
Yingying Chen ◽  
Yanling Yin ◽  
...  
Keyword(s):  
Primary Dysmenorrhea ◽  
Efficacy And Safety ◽  
Over The Counter

scholarly journals Efficacy of Guizhi Fuling Wan for primary dysmenorrhea: protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yun Du ◽  
Yatong Li ◽  
Xianyun Fu ◽  
Chenjie Li ◽  
Lou Yanan
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Blood Stasis ◽  
The Self ◽  
Blood Stasis Syndrome ◽  
Control Group ◽  
Primary Dysmenorrhea ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Self Rating

Abstract Background Primary dysmenorrhea (PD) is one of the main gynecological complaints in women of child-bearing age, but limited effective treatments are available. Guizhi Fuling Wan (GFW), one of the most widely known traditional Chinese medicine (TCM) formulations, has been commonly used in clinical practice to treat gynecological disorders in China. In recent years, a growing number of studies have shown that GFW is beneficial for patients with PD. However, the quality of evidence is limited, and there are few studies on specific TCM syndromes of GFW for PD. Therefore, we plan to conduct a randomized controlled trial to explore the efficacy and safety of GFW for PD patients with heat-burning blood-stasis syndrome. Methods and analysis The clinical study is a randomized, double-blinded, placebo-controlled trial. Eligible patients will be randomly assigned to the GFW group (treated with GFW) and the control group (treated with a matching placebo) in a 1:1 ratio for three menstrual cycles with a 3-month follow-up. The primary outcome will be the mean change of pain intensity measured by the visual analog scale (VAS). The secondary outcomes will include the Cox Menstrual Symptom Scale (CMSS), the Self-rating Depression Scale (SDS), the Self-rating Anxiety Scale (SAS), and the TCM syndrome scale. Adverse events will also be reported. Discussion This randomized trial will be the first rigorous study designed to assess the efficacy and safety of GFW in treating PD with heat-burning blood-stasis syndrome. The finding of this study will provide an objective clinical basis for the use of GFW for PD in the future. Trial registration Chinese Clinical Trial Registry ChiCTR2000034118. Registered on 24 June 2020

scholarly journals Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Geng Li ◽  
Zhe Zhang ◽  
Li Zhou ◽  
Shaojun Liao ◽  
Jing Sun ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Intensity ◽  
Controlled Trial ◽  
Primary Dysmenorrhea ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Symptom Scale ◽  
Double Blind ◽  
Chinese Herbal

Abstract Background Epidemiological studies have shown that young women often suffer from primary dysmenorrhea (PD) which is a common cause that affects their routine work and quality of life. Chinese herbal medicine has been widely used for PD in China. A systematic review found that Xuefu Zhuyu (XFZY) has a promising effect on PD management, yet there is a dearth of high-quality evidence in support of this claim. We want to conduct a randomized controlled trial to evaluate the efficacy and safety of XFZY for PD patients. Methods This is a protocol for a multicenter, randomized, placebo-controlled trial. A total of 248 participants with PD will be recruited at 6 centers and randomized into two groups—a herbal treatment group and a placebo group. The participants will receive either XFZY or placebo, three times per day, for 3 menstrual cycles, with a 12-week follow-up. The primary outcome will be the mean change in pain intensity as measured by VAS, while the change in menstrual pain duration, the change in peak pain intensity as measured by VAS, the Cox Menstrual Symptom Scale (CMSS), quality of life EQ-5D-5L, cumulative painkiller consumption, and health economics will be included as secondary outcomes. Adverse events will also be reported. Discussion This protocol describes a multicenter, double-blind, randomized, placebo-controlled trial that investigates the efficacy and safety of XFZY for primary dysmenorrhea. Validated evaluation tools will assess dysmenorrhea severity. We believe that this research will provide important evidence regarding the use of XFZY to treat dysmenorrhea. Trial registration Chinese Clinical Trial Registry ChiCTR1900026819. Registered on 23 October 2019

scholarly journals Manual acupuncture versus sham acupuncture and usual care for the prevention of primary dysmenorrhea (PD): study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Lingling Yu ◽  
Shiqin Liu ◽  
Cuihong Zheng ◽  
Wenhua Liu ◽  
Hua Wang ◽  
...  
Keyword(s):  
Usual Care ◽  
Short Form ◽  
Sham Acupuncture ◽  
Acupuncture Points ◽  
Primary Dysmenorrhea ◽  
Efficacy And Safety ◽  
Manual Acupuncture ◽  
Menstrual Cycles ◽  
Randomized Controlled ◽  
High Quality Evidence

Abstract Background Primary dysmenorrhea (PD) is a leading cause of dysmenorrhea among adolescent girls. Manual acupuncture may be considered as an effective treatment for PD, but high-quality evidence remains limited. This trial aims to evaluate the efficacy and safety of acupuncture for the prevention of PD as compared with sham acupuncture and usual care. Methods/design This is a three-arm, randomized, controlled clinical trial in which the patients, assessors, and statisticians will be blinded. A total of 300 acupuncture-naive patients who were diagnosed as PD will be randomly allocated to the verum acupuncture, sham acupuncture, or usual care groups in a 2:2:1 ratio. Patients in the verum acupuncture group will receive manual acupuncture at specific acupuncture points with penetrating needling, while those in the sham acupuncture group will receive non-penetrating needling at non-acupuncture points. They will be given five sessions over a menstrual cycle for 3 menstrual cycles. Patients in the usual care group will receive health education and informed to receive manual acupuncture for free after waiting for 7 menstrual cycles. The primary outcome will be the change from baseline in the Cox Menstrual Symptom Scale Score (CMSS). The secondary outcomes will be the changes in Massachusetts General Hospital Acupuncture Sensation Scale (MASS), visual analog scale (VAS), Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2), Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), Beck Depression Inventory II (BDI- II), Acupuncture Expectancy Scale (AES), 60-item NEO Personality Inventory-Short Form (NEO-FFI), and acute medication intake. The adverse events will be recorded at every visit. The analyses will be performed base on a full analysis set (FAS) and a per-protocol set (PPS). Discussion This study may provide high-quality evidence regarding the efficacy and safety of manual acupuncture for PD. In addition, the results of this study will help to identify the efficacy of acupuncture due to the specific effects of acupuncture or placebo effects of acupuncture ritual. Trial registration Clinical Trials.gov NCT02783534. Registered on 26 May 2016

An Assessment of Herbal Weight Loss Products

1999 ◽  
Vol 12 (3) ◽  
pp. 240-250 ◽  
Author(s):  
Michelle R. Easton ◽  
W. Alexander Morton
Keyword(s):  
Weight Loss ◽  
Water Retention ◽  
Medication Use ◽  
Efficacy And Safety ◽  
Over The Counter ◽  
Herbal Products ◽  
Herbal Medication ◽  
Safety And Efficacy ◽  
Amount Of Information

Although herbal medication use has exploded over the last several years, the amount of information regarding efficacy and safety has not been as generous. There are numerous herbal weight loss products available over-the-counter that claim to“increase energy,”“decrease water retention,”“curb sugar cravings,”“suppress hunger,” and“build muscles.” However, verified and validated studies to confirm these weight loss claims are lacking in the scientific arena. Issues of safety and efficacy are discussed as well as guidelines for patients taking herbal products and suggestions for interventions that pharmacists can provide to consumers.

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