Efficacy of a topical herbal and mineral formulation (Dynamiclear) for the treatment of herpes simplex labialis in the community setting : study protocol for a randomised, double-blind placebo-controlled trial

Introduction Herpes simplex labialis (HSL) is a common infection that can cause painful lesions on the oral mucosa, commonly referred to as cold sores. Current biomedical treatments include topical aciclovir, which reduces the episode duration by an average of 0.5 days. This study will examine the efficacy and tolerability of an over-the- counter topical treatment, Dynamiclear in reducing duration and severity of HSL episodes. Methods and analysis This prospective, randomised, double-blind, placebo-controlled, multi-centre trial will recruit a minimum of 292 adult participants across Australia and New Zealand who present with a cold sore within 48 hours of onset. They will be randomly allocated in a 2:1 ratio to receive either topical Dynamiclear (active) or placebo. Dynamiclear’s active ingredients are Hypericum perforatum, Calendula Officinalis and copper sulfate. A single topical treatment of active or placebo will be applied by a pharmacy-based investigator, and participants will be provided with a viral swab kit to confirm presence of herpes virus 1 or 2 from ulcerated lesions. Participants will receive reminders by email and/ or SMS to complete an online daily diary assessing their cold sore lesion using a visual guide, and recording other symptoms on numeric scales until healed. The primary outcome variable is median duration of HSL episode in days (participant evaluated) from presentation to return to normal skin. Secondary outcomes include severity of lesion pain, itching, burning and tingling during the symptomatic phase and proportion of lesions progressing to ulceration

Use of traditional and complementary medicine by ethnic Indian women living with polycystic ovary syndrome: a global survey

Background: Traditional, complementary, and integrative medicine (TCIM) is commonly used by those living with Polycystic Ovary Syndrome (PCOS) but little is known about the use of TCIM such as yoga and Ayurveda in ethnic Indian women with PCOS living worldwide. This survey aimed to explore the prevalence and types of TCIM used and in particular the pattern of use of yoga and Ayurveda including reasons for not using and future interest in using them among non-users. Method: An online, international cross-sectional survey was conducted using a pre-designed survey tool. Participants were ethnic Indian women of reproductive age who reported that they were medically diagnosed with PCOS. Descriptive analysis was used to identify the proportion of TCIM users, while a multivariable binary logistic regression was used to analyze their characteristics. Results: Data from 3130 respondents were analysed. The prevalence of TCIM use was 80% (2515/3130). Yoga and Ayurveda were the most frequently practised TCIM modalities with a prevalence of 57% and 37% respectively. We found a high future interest in using yoga (81%) and Ayurveda (70%) among the non-users. The motivation for most Ayurveda use was a recommendation from family/friends (66%), rather than personal choice (38%) or the internet (19%). Most women used Ayurveda because it has natural ingredients (64%) and it is safe (60%) and cited its use to be safe and somewhat helpful. The majority of women were currently practising yoga (73%) up to four times a week (54%) at home (93%). Yoga was primarily used to improve overall health (67%), manage weight (64%), stress (54%) hormonal imbalance (49%) and emotional well-being (48%). Barriers to practising yoga were common among the current users and non-users and included lack of motivation (59% and 59%), time constraints (48% and 39%), and non-availability of yoga teachers specialised in PCOS (31% and 23%). Most women found yoga to be helpful and preferred individual one-on-one (52%) yoga sessions specifically tailored for PCOS (58%). Conclusion: This is the first international study that discovered the prevalence and pattern of TCIM use among ethnic Indian women with PCOS living worldwide. We support the urgent need for more research, education, and regulation of different TCIM modalities to promote safe and effective practices globally

Complementary therapies and medicines and reproductive medicine

Complementary therapies and medicines are a broad and diverse range of treatments, and are frequently used by women and their partners during the preconception period to assist with infertility, and to address pregnancy-related conditions. Despite frequent use, the evidence examining the efficacy, effectiveness, and safety for many modalities is lacking, with variable study quality. In this article, we provide an overview of research evidence with the aim of examining the evidence to inform clinical practice. During the preconception period, there is mixed evidence for acupuncture to improve ovulation, or increase pregnancy rates. Acupuncture may improve sperm quality, but there is insufficient evidence to determine whether this results in improved pregnancy and live birth rates. Acupuncture can be described as a low-risk intervention. Chinese and Western herbal medicines may increase pregnancy rates; however, study quality is low. The evaluation of efficacy, effectiveness, and safety during the first trimester of pregnancy has most commonly reported on herbs, supplements, and practices such as acupuncture. There is high-quality evidence reporting the benefits of herbal medicines and acupuncture to treat nausea in pregnancy. The benefit from ginger to manage symptoms of nausea in early pregnancy is incorporated in national clinical guidelines, and vitamin B6 is recommended as a first-line treatment for nausea and vomiting in pregnancy. The safety of ginger and vitamin B6 is considered to be well established, and is based on epidemiological studies. Acupuncture has been shown to reduce back pain and improve function for women in early pregnancy. There is little evidence to support the use of cranberries in pregnancy for prevention of urinary tract infections, and chiropractic treatment for back pain. Overall the numbers of studies are small and of low quality, although the modalities appear to be low risk of harm

Naturopaths' approach to care of women with infertility : a cross-sectional survey

Introduction: Infertility affects approximately one in six couples of reproductive age. Many women use traditional, complementary and integrative medicine to improve their chances of conceiving. While there is evidence of the use of naturopathy by women attempting to conceive, there is no evidence of the way that naturopaths approach and manage their treatment. This study aims to describe how naturopaths manage female infertility, including their approaches, clinical decisions, knowledge sources, and safety considerations in providing naturopathic care. Methods: Naturopaths in Australia or New Zealand, routinely treating female reproductive health concerns and practicing for at least two years were invited to complete an online survey through their professional naturopathic associations. Results: Data from 45 respondents were included. Women seeking preconception health and fertility promotion were frequently seen by 53 % and 44 % of the naturopaths, respectively. The naturopaths’ clinical management approaches for infertility were wide-ranging and extended beyond fertility. They reported prioritising peer-reviewed journal articles in guiding clinical decisions, collaborating with health practitioners (mostly general practitioners) and reporting adverse events. Most naturopaths (95 %) utilised multiple treatment strategies, recommending dietary and lifestyle modifications and a combination of ingestible substances. Conclusions: The naturopathic approach to management of women with infertility is holistic, considering physical, emotional, and environmental factors and promoting natural healing mechanisms. Greater knowledge of scientific methods for clinical decision-making and improved awareness of adverse event reporting would enhance naturopathic care. Additionally, evaluating the effectiveness of naturopathic treatment would improve safety, inform the profession, and clarify the role of naturopathy within a multidisciplinary approach to infertility

Individual agency, community capacity building, and chronic illness care: Using participatory methods to implement the Stanford Chronic Disease Self Management Program in a Housing First Program

Research questions: Is a standardized chronic disease self management program (CDSMP) experienced as a valuable intervention by Pathways\u27 consumers? What is the impact of collaborative inquiry into health program development on participant\u27s critical agency

The effectiveness of a modified Gui Zhi Fu Ling Wan formulation (Gynoclear™) for the treatment of endometriosis : a study protocol for a placebo-controlled, double-blind, randomised controlled trial

Background: Endometriosis is the presence of tissue similar to that of the endometrium outside the uterine cavity and is the most common cause of chronic pelvic pain. Current non-surgical treatments such as non-steroidal anti-inflammatories, oral contraceptive pills and hormonal treatments have limited effectiveness, and the side effect profile is bothersome. This study will evaluate the efficacy of Gynoclear™ by change in endometriosis-related pain based on the Endometriosis Pain Daily Diary (EPPD) scores. Methods: This randomised, double-blind, placebo-controlled trial will recruit a minimum of 90 adult participantsacross Australia who have a laparoscopic visualisation/confirmation of endometriosis in the last 5 years and have current moderate or greater pelvic pain. Participants will be randomly allocated in a 1:1 ratio to receive either Gynoclear™ (active) or placebo. Gyncolear’s active ingredients are Carthamus tinctorius (Safflower), Cinnamomum cassia (Chinese cinnamon), Poria cocos (Hoelen), Paeonia suffriticosa (Tree peony), Paeonia lactiflora (Peony) and Salvia miltiorrhiza (Red sage). Participants are asked to complete a total of 5 months’ worth of pain diary entries via the EPDD v3, including 1-month screening, 2-month treatment period and 1-month post-treatment follow-up. The primary outcome variable is change in endometriosis-related pain based on the EPDD v3 scores. Secondary outcomes include change in health-related quality of life via the Endometriosis Health Profile (EHP-30), SF-12 and EQ-5D scores as well as changes in rescue analgesic usage, dyspareunia and fatigue via the EPDD. Discussion: This study will determine the safety and efficacy of Gynoclear™ to reduce the severity and duration of non-cyclical pelvic pain, dysmenorrhoea, dyspareunia and other symptoms of endometriosis. Study outcomes will be of interest to health professionals and members of the public who suffer from endometriosis

Mindfulness-based interventions for adults with type 2 diabetes mellitus [Intervention Protocol]

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of mindfulness-based interventions for adults with type 2 diabetes mellitus (T2D)

Acupuncture and acupressure for premenstrual syndrome

Background: Acupuncture has a history of traditional use in China for women's health conditions including premenstrual syndrome (PMS), but its effectiveness for this condition remains unclear. This review examined the available evidence supporting the use of acupuncture or acupressure to treat PMS. Objectives To evaluate the effectiveness and safety of acupuncture or acupressure for women with PMS or premenstrual dysphoric disorder (PMDD). Search methods We searched the Cochrane Gynaecology and Fertility Specialised Register, Cochrane Central Register of Studies Online (CENTRAL CRSO), MEDLINE, Embase, AMED, PsycINFO, CINAHL (from inception to 21 September 2017), two clinical trial databases (from their inception to 21 September 2017), and four electronic databases in China (from their inception to 15 October 2017): Chinese Biomedical Literature database (CBM), China National Knowledge Infrastructure (CNKI), VIP information/ Chinese Scientific Journals database and WANFANG. Reference lists from included articles were handsearched. Selection criteria: We included studies if they randomised women with PMS and associated disorders (PMDD and late luteal phase dysphoric disorder/LPDD) to receive acupuncture or acupressure versus sham, usual care/waiting‐list control or pharmaceutical interventions mentioned by the International Society for Premenstrual Disorders (ISPMD). If acupuncture or acupressure were combined with another therapy, these studies were also included where the additional therapy was the same in both groups. Cross‐over studies were eligible for inclusion, but only data from the first phase could be used. Data collection and analysis: Two review authors independently selected the studies, assessed eligible studies for risk of bias, and extracted data from each study. Study authors were contacted for missing information. The quality of the evidence was assessed using GRADE. Our primary outcomes were overall premenstrual symptoms and adverse events. Secondary outcomes included specific PMS symptoms, response rate and quality of life. Main results Five trials (277 women) were included in this review. No trials compared acupuncture or acupressure versus other active treatments. The number of treatment sessions ranged from seven to 28. The quality of the evidence ranged from low to very low quality, the main limitations being imprecision due to small sample sizes and risk of bias related to detection bias and selective reporting. Acupuncture versus sham acupuncture: Acupuncture may provide a greater reduction in mood‐related PMS symptoms (mean difference (MD) ‐9.03, 95% confidence interval (CI) ‐10.71 to ‐7.35, one randomised controlled trial (RCT), n = 67, low‐quality evidence) and in physical PMS symptoms (MD ‐9.11, 95% CI ‐10.82 to ‐7.40, one RCT, n = 67, low‐quality evidence) than sham acupuncture, as measured by the Daily Record of Severity of Problems scale (DRSP). The evidence suggests that if women have a mood score of 51.91 points with sham acupuncture, their score with acupuncture would be between 10.71 and 7.35 points lower and if women have a physical score of 46.11 points, their score with acupuncture would be between 10.82 and 7.4 points lower.There was insufficient evidence to determine whether there was any difference between the groups in the rate of adverse events (risk ratio (RR) 1.74, 95% CI 0.39 to 7.76, three RCTs, n = 167, I2 = 0%, very low‐quality evidence). Specific PMS symptoms were not reported: There may be little or no difference between the groups in response rates. Use of a fixed‐effect model suggested a higher response rate in the acupuncture group than in the sham group (RR 2.59, 95% CI 1.71 to 3.92; participants = 100; studies = 2; I2 = 82%), but owing to the high heterogeneity we tested the effect of using a random‐effects model, which provided no clear evidence of benefit for acupuncture (RR 4.22, 95% CI 0.45 to 39.88, two RCTs, n = 100, I2 = 82%, very low‐quality evidence). Acupuncture may improve quality of life (measured by the WHOQOL‐BREF) compared to sham (MD 2.85, 95% CI 1.47 to 4.23, one RCT, n = 67, low‐quality evidence). Acupuncture versus no treatment: Due to the very low quality of the evidence, we are uncertain whether acupuncture reduces PMS symptoms compared to a no treatment control (MD ‐13.60, 95% CI ‐15.70 to ‐11.50, one RCT, n = 14). No adverse events were reported in either group. No data were available on specific PMS symptoms, response rate or quality of life outcomes. Acupressure versus sham acupressure: We found low‐quality evidence that acupressure may reduce the number of women with moderate to severe PMS symptoms at the end of the trial compared to sham acupressure (RR 0.64 95% CI 0.52 to 0.79, one RCT, n = 90, low‐quality evidence). The evidence suggests that if 97 women out of 100 in the sham acupressure group had moderate to severe PMS symptoms, the number of women in the acupressure group with moderate to severe symptoms would be 50 to 76 women. Acupressure may improve both physical (MD 24.3, 95% CI 17.18 to 31.42, one RCT, n = 90, low‐quality evidence) and mental (MD 17.17, 95% CI 13.08 to 21.26, one RCT, n = 90, low‐quality evidence) quality of life. No data were available on adverse events, specific symptoms or response rates. Authors' conclusions: The limited evidence available suggests that acupuncture and acupressure may improve both physical and psychological symptoms of PMS when compared to a sham control. There was insufficient evidence to determine whether there was a difference between the groups in rates of adverse events.There is no evidence comparing acupuncture or acupressure versus current ISPMD recommended treatments for PMS such as selective serotonin reuptake inhibitors (SSRIs). Further research is required, using validated outcome measures for PMS, adequate blinding and suitable comparator groups reflecting current best practice