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A pilot study of Hypericum perforatum for the treatment of premenstrual syndrome
Abstract
Objective To investigate whether Hypericum perforatum could relieve symptoms of premenstrual syndrome in a small group of women in order to establish a hypothesis and to test methods for conducting a future randomised controlled trial.
Design Prospective, open, uncontrolled, observational study.
Setting Department of Complementary Medicine, University of Exeter.
Population Nineteen women with premenstrual syndrome who were in otherwise good physical and mental health and not taking other treatments for premenstrual syndrome.
Method Volunteers underwent a preliminary screening interview, completed Daily Symptom Ratings for one cycle, and attended a medical screening visit before being diagnosed with premenstrual syndrome. Participants took hypericum tablets for two complete menstrual cycles (1 × 300 mg hypericum extract per day standardised to 900 μg hypericin).
Main outcome measures Symptoms were rated daily throughout the trial using a validated measure. The Hospital Anxiety and Depression scale and modified Social Adjustment Scale were administered at baseline and after one and two cycles of treatment.
Results There were significant reductions in all outcome measures. The degree of improvement in overall premenstrual syndrome scores between baseline and the end of the trial was 51%, with over two thirds of the sample demonstrating at least a 50% decrease in symptom severity. Tolerance and compliance with the treatment were encouraging.
Conclusion The results of this pilot study suggest that there is scope for conducting a randomised, placebo-controlled, double-blind trial to investigate the value of hypericum as a treatment for premenstrual syndrome.
... H. perforatum seems to reduce premenstrual symptoms at 8 weeks of treatment, consistent with previous studies [2][3][4].I n their pilot study, Stevinson and Ernst [2] observed that daily intake of H. perforatum was associated with a 51% reduction in symptom ratings-consistent with the 40% reduction in the present study. Canning et al. [3] reported that H. perforatum was more effective than placebo in the treatment of PMS. ...
... H. perforatum seems to reduce premenstrual symptoms at 8 weeks of treatment, consistent with previous studies [2][3][4].I n their pilot study, Stevinson and Ernst [2] observed that daily intake of H. perforatum was associated with a 51% reduction in symptom ratings-consistent with the 40% reduction in the present study. Canning et al. [3] reported that H. perforatum was more effective than placebo in the treatment of PMS. ...
... Women with abnormal vaginal discharge were subjected to a vaginal pH test, whiff test, and clue-cell examination. Bacterial vaginosis was diagnosed when 3 out of 4 Amsel's criteria were present [2]. Cervical smears were taken with Ayre's wooden spatula and cervical brush by rotating 360°in the cervical canal. ...
... A decrease in plasma PRL levels, and thus dopaminergic activity, has been reported for Echinacea purpurea, Hypericum perforatum, and Ginkgo biloba [21][22][23]. Pilot studies in patients with PMS could show that H. perforatum and G. biloba could reduce PMS symptoms [24,25]. However, the compounds responsible for the dopaminergic effects of these plants still remain unknown. ...
Pre-clinical studies suggest that extracts prepared from the fruits of Vitex agnus castus (VAC) interact with dopamine D2 receptors, leading to reduced prolactin secretion. In previous experiments, dopaminergic activity was mostly evaluated using radioligand binding assays or via the inhibition of prolactin release from rat pituitary cells. Diterpenes featuring a clerodadienol scaffold were identified as major active compounds, but no conclusive data regarding their potency and intrinsic activity are available. Utilising advances in chromatography, we re-examined this topic using HPLC-based tracking of bioactivity via microfractionation of the VAC extract Ze 440. Using a cAMP-based assay, we measured dopaminergic activity in CHO-K1 cells that overexpress the human D2 receptor. Six diterpenes were isolated from two active HPLC microfractions. Viteagnusin I emerged as the most potent diterpene (EC50: 6.6 µM), followed by rotundifuran (EC50: 12.8 µM), whereas vitexilactone was inactive (EC50: >50 µM). Interestingly, triterpenes were also identified as active, with 3-epi-maslinic acid being the most active compound (EC50: 5.1 µM). To better understand these interactions at the molecular level, selected diterpenes and triterpenes were analysed through molecular docking against D2 receptor structures. Our data show that the dopaminergic activity of VAC diterpenes seems to depend on the configuration and on ring substitution in the side chain. This study also highlights for the first time the dopaminergic contribution of triterpenes such as 3-epi-maslinic acid.
... The purpose of this pilot study is not to test a hypothesis, but to confirm the validity of the main study. 24,25 In this study, descriptive statistics were ...
... Some herbs such as vitex agnus castus (VAC) or chasteberry and Hypericum perforatum (St. John's wort) can be effective in the control of PMD symptoms, but it is essential to perform these treatments after gathering sufficient evidence [28][29][30]. Garlic (Allium sativum) is an herb with immunoregulatory effects [31] and reduces anxiety and depression behaviors in diabetic rats, possibly by reducing brain oxidative stress [32]. Recent animal studies have found evidence of the effects of garlic on reducing cognitive and behavioral symptoms through interference with neurotransmitters [33][34][35]. ...
Background:
Premenstrual disorders involve physical, behavioral, and mood variations that affect women of childbearing age and interfere with family relationships, household responsibilities, professional duties, and social activities.
Objectives:
Considering the side effects of conventional medications, their use is not recommended except in severe cases of premenstrual disorders. Nowadays, there is a tendency to use traditional and complementary medicine that offers various treatments. The purpose of the current study was to investigate the impacts of garlic as a herbal medicine on the severity of premenstrual symptoms.
Methods:
This study was a double-blind, randomized, controlled trial. After identification of participants with moderate-to-severe PMS through the premenstrual symptoms screening tools questionnaire (PSST), they were randomly assigned to placebo (n = 64) or garlic (n = 65) groups. Each participant received one tablet daily for three consecutive cycles and logged the severity of their symptoms in the PSST questionnaire during the intervention period.
Results:
There was no significant difference between the two groups in the baseline level of premenstrual symptoms before the intervention. After treatment with garlic for three consecutive cycles, the total score of the severity of premenstrual symptoms significantly (P < 0.001) reduced from 34.09 ± 7.31 to 11.21 ± 7.17. In the placebo group, this score changed from 33.35 ± 7.96 to 24.28 ± 7.22. The difference between mean changes in the two groups was 13.78, with a 95% Confidence Interval (CI) of 11.23-16.33. No serious side effects were observed in either group.
Conclusion:
Our findings highlight the potential effect of garlic in reducing the severity of premenstrual symptoms; therefore, the use of garlic can be considered as an alternative therapy in the prevention and treatment of premenstrual disorders.
... The global popularity of SJW was likely enhanced by its inclusion in official recommendations for the treatment of depression [141]. Other traditional indications for SJW include somatoform disorders, premenstrual syndrome, and alcohol withdrawal [142][143][144]. Several constituents have been isolated and characterized from SJW, with hyperforin identified as the antidepressant entity capable of centrally inhibiting the synaptic reuptake of serotonin, dopamine, and norepinephrine [145]. ...
The management of neuropsychiatric disorders relies heavily on pharmacotherapy. The use of herbal products as complimentary medicine, often concomitantly, is common among patients taking prescription neuropsychiatric drugs. Herb-drug interaction, a clinical consequence of this practice, may jeopardize the success of pharmacotherapy in neuropsychiatry. Besides the well-known ability of phytochemicals to inhibit and/or induce drug-metabolizing enzymes and transport proteins, several phytoconstituents are capable of exerting pharmacological effects on the central nervous system. The consequent pharmacokinetic and pharmacodynamic interactions with orthodox medications often result in deleterious clinical consequences. This study reviewed the relevant literature and identified 13 commonly used herbal products – celery, echinacea, ginkgo, ginseng, hydroxycut, kava, kratom, moringa, piperine, rhodiola, St John’s wort, terminalia/commiphora ayurvedic mixture and valerian – which have shown clinically relevant interactions with prescription drugs used in the management of neuropsychiatric disorders. The clinical focus is aimed to provide easily accessible information that will be of interest to clinicians, researchers, and the drug-consuming public.
... According to some authors, the analysis of any type of pilot or feasibility study should be primarily descriptive [54] and may focus on estimating the confidence interval of the outcomes [55]. Feasibility studies are independent studies, and there are controversies as to whether they should be analyzed using hypothesis testing [56,57]. However, it is not appropriate to assign undue significance to the results of the hypothesis tests, as no formal calculation of power is performed in these types of studies. ...
Background
Diabetic neuropathy dramatically affects musculoskeletal structure and function of the lower limbs by impairing their muscle strength and mobility. Specific muscle strengthening through physiotherapy strategies appears to be promising; however, adherence to physiotherapy treatment is low in people with chronic diseases. Thus, an internet-based foot-ankle exercise program was created as a potential telerehabilitation alternative for people with diabetes to improve their self-monitoring and self-care management. This study assessed the feasibility, safety, acceptability, and changes in foot health and neuropathy symptoms in people with diabetes after 12 weeks of the intervention program with the Sistema de Orientação ao Pé diabético - Diabetic Foot Guidance System (SOPeD).
Methods
Fourteen individuals were recruited and randomized to either the usual care (control group) or usual care plus an internet-based foot-ankle exercise program through SOPeD (intervention group) three times per week for 12 weeks. For feasibility, we assessed contact and recruitment rates per week; program adherence, determined as completing over 70% of the 36 sessions; and participant satisfaction and safety assessed through a questionnaire and scored on a 5-point Likert scale. We assessed changes in neuropathy symptoms and foot health and functionality from baseline to 12 weeks estimating differences or median of differences and 95% confidence intervals in the intervention group.
Results
In 24 weeks, of the 822 patients in the database, 192 were contacted, 65 were assessed for eligibility, and 20 were considered eligible. The recruitment rate was 0.83 participants per week. Fourteen out of the 20 eligible participants agreed to participate, resulting in recruitment success of 70%. Adherence to the program was 66.7%, and there was no dropout. Participants’ median level of satisfaction was 5.0 (IQR: 4.5–5.0) and perceived safety was 5.0 (IQR: 5.0–5.0).
Conclusion
The internet-based foot-ankle exercise program using SOPeD is feasible, satisfactory, and safe. Although this study had moderate adherence and a zero-dropout rate, recruitment needs to be improved in the larger trial.
Trial registration
ClinicalTrials.gov, NCT04011267 . Registered on 8 July 2019.
... There were no adverse events attributed to LI-160 treatment. Stevinson and Ernst (2000) conducted a pilot study on H. perforatum extract 34 (300 mg standardized to 900 μg hypericin) as a remedy for PMS. Nineteen women met the enrollment criteria and completed the study. ...
Hypericum perforatum (St. John’s wort) is the most commonly used and best studied nutraceutical. The most common preparations, made from the flowering aerial parts (Hyperici herba), are extracts and oleums. The method and solvent determine the phytochemicals that are extracted from H. herba. In Germany, standardized H. perforatum extracts are sold as prescription phytopharmaceuticals for mild to moderate depression. H. perforatum has substantial scientific evidence that standardized extracts are efficacious for mild to moderate depression. H. perforatum extracts are also used to treat premenstrual and menopause syndromes. H. perforatum extracts are used in pain management and likely act synergistically with morphine, including reduction of morphine tolerance. H. perforatum oleums are used to treat burns and wounds including boiling water burns in children, and surgical wounds from excision of scalp neoplasms, cesarean sections, and episiotomies. The phytochemicals in H. perforatum extracts, when taken orally, can alter drug-transporter and drug-metabolizing enzymes (CYPs). Excessive use of H. perforatum can cause photosanitization. H. perforatum extracts should be taken under the supervision of a physician or pharmacist, and the patient should advise physicians and nurses if they are using H. perforatum extracts. Also, it is important that physicians and nurses include nutraceuticals and supplements when taking a use of medications history and be knowledgeable of potential interactions.
... According to some authors, the analysis in any type of a pilot or feasibility study should be primarily descriptive [45] and may focus on estimating the confidence interval [46]. Pilot and feasibility studies are treated as independent studies, and whether they should be analyzed using hypothesis testing is controversial [47,48]. Given that it is inappropriate to assign undue significance to the results of hypothesis testing as no formal calculation of power was performed in these studies, such studies should not be analyzed using hypothesis testing. ...
Foot-ankle strengthening and mobility exercises are part of international guideline recommendations for people at risk of diabetic foot disease. We examined the feasibility and preliminary efficacy of a 12-week foot-ankle exercise program on clinical, functional and biomechanical outcomes in people with diabetic neuropathy (DPN). We randomly allocated 30 people with DPN to usual care (control) or usual care plus a supervised exercise program (intervention). For feasibility, we assessed recruitment rate and participant adherence and satisfaction. For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests (p < 0.05). In 52 weeks, we recruited 45 eligible participants (0.90/week). Program adherence was 80% and participants’ satisfaction had a mean (SD) of 4.57 (0.70) out of 5. The intervention group significantly improved on toes strength, contact time during gait and DPN symptoms, and peak forefoot pressures increased over time; controls showed significantly increased heel peak pressures and force. The exercise program was feasible, based on a moderate recruitment rate and an adherent and satisfied population, and the intervention showed several positive preliminary effects over time compared to usual care.
... A pilot study was conducted to check the validity and reliability of the questionnaire and to check the understanding level of respondents. One of the key explanations for performing a pilot test is that preliminary evidence from the primary studies used to define sample measurements for a broader analysis needs to be evaluated (Lancaster et al., 2004;Stevinson and Ernst, 2000). Research respondents included 30 students, having prior knowledge in entrepreneurship and active involvement in earlier surveys were asked to verify correctness, easiness of completion and viable inconsistency of the instrument (Zollo et al., 2017). ...
Purpose
Entrepreneurial intention plays a crucial role in the research and application of social entrepreneurship (SE). The purpose of this paper is to investigate the influence of the factors affecting students’ intention towards social entrepreneurship (ISE). The study has taken entrepreneurial self-efficacy, along with entrepreneurial education, entrepreneurial network and perceived university support that have an impact on intentions, which instills interest amongst students in being future entrepreneurs.
Design/methodology/approach
Data were primarily taken from a survey of 380 university students from public and private universities in Chattogram, the business capital of Bangladesh. Students were preliminarily selected, focussing on different profiles such as male/female, age, socio-economic status, education level, university status and employment level. Initially, using factor analysis factors were analyzed and later multiple regression analysis was used to identify the relationship with ISE.
Findings
The study on the student reveals that four aspects significantly impacted the preference of students’ ISE. This study reinforces the influence of entrepreneurial self-efficacy, along with entrepreneurial education, as the factors contributing to aid young graduates recognizing and fostering an ISE. Entrepreneurial networks and perceived university support were found to have no association with social entrepreneurial intentions.
Originality/value
This paper contributes to the understanding of the factors and provides a basis for explaining factors that affect the intention of students towards SE. It can contribute to future research related to social entrepreneurial intention. Furthermore, it was concluded that forming social entrepreneurial intention is highly influenced by entrepreneurial self-efficacy and entrepreneurship education.
... Today it is widely used for depression in Germany, other parts of Europa and the United States. And besides depression, it is used for conditions like anxiety, insomnia [1], attention deficit disorder [2], seasonal affective disorder [3], social phobia [4], menopausal symptoms [5] and premenstrual syndrome [6] that antidepressants are prescribed. Also, it has used for diabetic neuropathy and atopic dermatitis. ...
ntroduction: Its known that St Johns wort is widely used for treating depression symptoms.This report is a presantation of the case induced by this herbal drug. Case report: A 29 year old male who had a psychotic episode induced by St.Johns wort(Hypericum Perforatum). In this case patient did not get diagnosed with a mental disorder before but had a positive family history including psychotic depression. Conclusion: It should be noted that there are number of potential safety risks with St Johns wort.
... These changes involve isolation, work absentees, distraction, criminal behaviors and suicide. These symptoms at the end of luteal phase of menstrual period increase severely in such a way that they create irregularity in personal functions in individual's job, education as well as family and personal affairs (6)(7)(8)(9)(10)(11)(12)(13). The findings of Diegoli's study on the 100 women with PMS showed reduction in the following items: 27.5% job efficiency, 22.1% job miscomm unication, 82.2% clashes with spouse, 61% sibling misunderstanding and 41.5% social relation. ...
Background and Purpose: The premenstrual syndrome is the emergence of a set of symptoms before menstrual which results in imbalance in individual's life and daily activities. Today the prescription of herbals is recommended for the treatment of the illnesses. The present study aimto pinpoint the effect of primrose oil on the premenstrual syndrome.
Methods: The study was a triple blind clinical-trial which was conducted with 80 female university students residing in Lorestan Medical University hostels. The samples were selected based on the DSMIV-TR criterion for the premenstrual syndrome. Using block-randomization method, they were categorized into two groups (each 40), one treated with primrose oil and the other with placebo. The dose of the primrose oil is 1500 mg per day for the first group. The total score for sever symptom (for each from 0 to 10) was assigned at first monthly and then for three months. For the data analysis χ2 and repeated measures were deployed.
Results: The score for symptom severity before the intervention for the primrose group was 53.20 ± 14.31 at the beginning. At the end of the third month, it got 33.62 ± 16.94 therewas a significant difference in the reduction of symptom severity in the follow-up periods (p < 0001). In the Placebo group, the score for sever it ysymptom before the intervention was 53.38 ± 13.93. At the end of the third month after treatment, it was 50.27 ± 16.94. This didn't show any significant difference in the decrease of the symptom severity in the follow-up period. There was a significant difference for the symptom severity in both primrose and Placebo group (p < 0.001).
Conclusion: Taking the effect of primrose oil on premenstrual syndrome reduction and the harmlessness of hessrb medicals into account, bioresearches recommend primrose oil for the treatment of premenstrual syndrome.
... John's wort extract is also aid in irritability, insomnia, sciatica, irregular menstruation, rheumatoid arthritis, and also influence the serotonergic system (Ghazanfarpour 2011) [45]. In an open-label trial, 19 PMS women were administered with St. John's wort extract for 2 cycles of menstruation that showed an average decrease in 51% symptom scores by the trial end and 50% in severity symptom reduction in two-third participants (Stevinson 2000) [46]. Pineapple fruit (Ananas comosus (L.) is also used as a meat tenderizer and remedy for inflammatory reactions pineapple consists a mixture of compound ingredients bromelain that acts as a protease inhibitor and helps in reducing irritation, cramps, bloating in menstruation, increase post-traumatic wound healing, immune modulator with anti-tumour and anti-cancer activity. ...
Sexual Maturation and pubertal development is the period of adolescence from childhood to adult life. Adolescence is a transition from girl to motherhood that is accompanied by various changes in Cognition, Pubertal development, changes in Hormones, Physical development, Psychological and physiological changes occur simultaneously. Hence, "menarche is the onset of puberty in adolescent girl characterized by excessive bleeding, irregular menstruation, face problems such as acne and dysmenorrhoea". So, to identify Relevant Randomized Controlled Trials (RCTs), Cochrane Menstrual Disorders, Scopus, Dysmenorrhoea Group Register of controlled trials, PubMed, Google Scholar and Medline were some of the electronic searches. Therefore, to treat primary dysmenorrhoea or to prevent herbal medicine can be used alone or with other therapies (pharmaceutical, nutritional, and hydrotherapy).
... Official guidelines in multiple countries have recommended St John's wort for the treatment of depression, which has increased the popularity and consumption of St John's wort among various patient groups (66). Other popular uses of St John's wort include in the treatment of premenstrual syndrome, alcohol withdrawal, and somatoform disorders (67)(68)(69)(70). Several active phytochemical constituents including naphthodianthrones (like hypericin), phloroglucinols (like hyperforin), and flavonol glycoside (like hyperosides) have been isolated and characterized from St John's wort (71). ...
One of the most consequential risks associated with the concomitant use of herbal products and chemotherapeutic agents is herb-drug interactions. The risk is higher in patients with chronic conditions taking multiple medications. Herb-drug interaction is particularly undesirable in cancer management because of the precipitous dose-effect relationship and toxicity of chemotherapeutic agents. The most common mechanism of herb-drug interaction is the herbal-mediated inhibition and/or induction of drug-metabolizing enzymes (DME) and/or transport proteins leading to the alteration in the pharmacokinetic disposition of the victim drug. Most mechanistic research has focused on laboratory-based studies, determining the effects of herbal products on DMEs and extrapolating findings to predict clinical relevance; however, not all DME/transporter protein inhibition/induction results in clinical herb-drug interaction. This study reviews relevant literature and identified six herbal products namely echinacea, garlic, ginseng, grapefruit juice, milk thistle, and St John's wort, which have shown interactions with chemotherapeutic agents in humans. This focus on clinically significant herb-drug interaction, should be of interest to the public including practitioners, researchers, and consumers of cancer chemotherapy.
... Major goals of this pilot study are to explore the feasibility and estimate the intervention's effect size to help determine sample size needs for a future full-scale RCT. [52][53][54] We will use a two-group comparison of proportions at the two-tailed alpha level. We assume that the intracluster correlation will be low (0.01). ...
Construction workers have the highest smoking rate among all occupations (39%). Hispanic/Latino workers constitute a large and increasing group in the US construction industry (over 2.6 million; 23% of all workers). These minority workers have lower cessation rates compared to other groups due to their limited access to cessation services, and lack of smoking cessation interventions adapted to their culture and work/life circumstances. Formative research was conducted to create an intervention targeting Hispanic/Latino construction workers. This paper describes the intervention development and the design, methods, and data analysis plans for an ongoing cluster pilot two-arm randomized controlled trial comparing an Enhanced Care worksite cessation program to Standard Care. Fourteen construction sites will be randomized to either Enhanced Care or Standard Care and 126 participants (63/arm) will be recruited. In both arms, recruitment and intervention delivery occur around "food trucks" that regularly visit the construction sites. Participants at Enhanced Care sites will receive the developed intervention consisting of a single face-to-face group counseling session, 2 phone calls, and a fax referral to Florida tobacco quitline (QL). Participants at Standard Care sites will receive a fax referral to the QL. Both groups will receive eight weeks of nicotine replacement treatment and two follow-up assessments at three and six months. Feasibility outcomes are estimated recruitment yield, barriers to delivering the intervention onsite, and rates of adherence/compliance to the intervention, follow-ups, and QL enrollment. Efficacy outcomes are point-prevalence and prolonged abstinence rates at six month follow-up confirmed by saliva cotinine <15 ng/ml.
... In pilot studies, determining feasibility should be the first priority, and data regarding treatment effects should be descriptively analyzed to avoid exaggerated interpretations [47][48][49][50][51]. Therefore, this trial primarily aims to obtain information about the recruitment, consent, and integrity of the study protocol based on recruitment rate, compliance rate, and completion rate. Clinical effects will be assessed to explore the effects and safety of the intervention and to determine the effect size [47,52,53]. We will present Cohen's d, which provides an estimated effect size, because the effect size provides numerical information about the actual difference between two outcomes whereas p values are affected by sample size and only provide a dichotomous assessment of statistical significance [54][55][56][57]. ...
Background:
Hwa-byung (HB) is an anger syndrome caused by an inadequate release of accumulated anger that leads to somatic and psychiatric symptoms. As HB results from long-term inadequately treated negative emotions, its symptoms are complex, intractable and concomitant with other psychiatric disorders. Therefore, studies aiming to develop effective and safe treatment options for HB are needed. We plan to conduct a pilot study for a future, full-scale, randomized controlled trial (RCT) of an optimal acupuncture procedure using semi-individualized acupuncture points that consider participants' personal disposition and type of emotional stress.
Method/design:
This randomized, sham-controlled, participant- and assessor-blinded pilot trial aims to determine the study feasibility of acupuncture for HB and to explore its clinical effects and safety. This clinical trial will be conducted with two groups: one treated with real acupuncture and the other with sham acupuncture for 10 sessions over 4 weeks. The experimental group (EG) will receive semi-individualized acupuncture, whereas the control group (CG) will receive sham acupuncture, namely minimal acupuncture on non-acupuncture points. The recruitment, compliance, and completion rate and clinical evaluations, including a Visual Analogue Scale (VAS), the Korean version of the Beck Depression Inventory (BDI), the short form of the Stress Response Inventory (SRI-short form) and the Instrument of the Oriental Medical Evaluation for HB (IOME-HB), will be assessed to evaluate feasibility and possible effects and safety. Four weeks after completing treatment, follow-up assessments will be performed.
Discussion:
As this is a pilot study mainly aiming to investigate trial feasibility, the results of this study will be analyzed descriptively and interpreted for the study purposes. Cohen's d will be reported to determine the effect of acupuncture for HB and to enable comparisons with other treatment methods. This protocol is significant in that it provides optimal semi-individualized acupuncture treatment. We expect this study to offer information about the feasibility of this treatment and data about the possible effects and safety.
Trial registration:
Clinical Research Information Service (CRIS), Republic of Korea: KCT0001732 . Registered on 14 December 2015.
... There is the question of whether the hypothesis can be tested in the analysis of a pilot study. Considering that the appropriate power and sample size were not calculated for the pilot study, the researchers must recognize the fact that pilot studies are not for testing the hypothesis testing [7,19]. Therefore, they must be cautious about reporting the results of a pilot study. ...
A pilot study asks whether something can be done, should the researchers proceed with it, and if so, how. However, a pilot study also has a specific design feature; it is conducted on a smaller scale than the main or full-scale study. In other words, the pilot study is important for improvement of the quality and efficiency of the main study. In addition, it is conducted in order to assess the safety of treatment or interventions and recruitment potentials, examine the randomization and blinding process, increase the researchers' experience with the study methods or medicine and interventions, and provide estimates for sample size calculation. This review discusses with a focus on the misconceptions and the ethical aspect of a pilot study. Additionally how to interpret the results of a pilot study is also introduced in this review.
... The effect of vitamin B6 on premenstrual syndrome was shown in several systematic reviews (9)(10)(11)(12); therefore, the current study performed a comprehensive literature review regarding the effect of H. perforutum on premenstrual syndrome. In the first study, Stevinson et al. (13) performed a pilot study on 19 females with premenstrual syndrome. The patients received 900 mcg hypericin and a gradual decrease was observed in the mean total score of premenstrual syndrome (128.42 ± 68.15, 70.11 ± 46.10 and 57.63 ± 42.74) during the baseline, cycle 1 and cycle 2. ...
... Symptoms with notably large decreases in severity were anxiety, depression, nervous tension and insomnia. As a pilot experiment, this allowed for preliminary information needed for placebo-controlled studies on St. John's wort (Stevinson et al., 2000). ...
A major concern for many aging women is menopause and how to deal with bodily changes associate with this phase of life. Menopause, most commonly occurring in women between the ages of 48 and 55, is the end of menstruation. Imbalances in both estrogen and progesterone often cause women to endure discomforts such as mood swings, hot flashes, depression and sleeping disorders. In order to remedy menopause, women in the past would have the choice of undergoing Hormone Replacement Therapy (HRT), which consists of taking doses of synthetic hormones. This treatment, however, has been shown to be linked to health problems such as an increased risk of heart disease, stroke, and breast cancer. In fact, the number of health professionals completely disapproving this treatment is ever-increasing. To alleviate the anxiety of HRT many sought out natural alternatives. Many countries in Asia are known to have lower rates of problems related to menopause due to use of natural products as alternatives to HRT. One notable herb that has attracted a great deal of attention is black cohosh. Other important natural products are isoflavonoids from soybeans, as well as chasteberry, red clover, St. John's wort, vitamin E, and wild yam. The effectiveness of each of these natural products has been assessed in various studies.
... Hypericum perforatum: Only an observational study with a low number of participants noted improvement in symptoms. There is no evidence supporting recommendation [13]. ...
... The effect of vitamin B6 on premenstrual syndrome was shown in several systematic reviews (9)(10)(11)(12); therefore, the current study performed a comprehensive literature review regarding the effect of H. perforutum on premenstrual syndrome. In the first study, Stevinson et al. (13) performed a pilot study on 19 females with premenstrual syndrome. The patients received 900 mcg hypericin and a gradual decrease was observed in the mean total score of premenstrual syndrome (128.42 ± 68.15, 70.11 ± 46.10 and 57.63 ± 42.74) during the baseline, cycle 1 and cycle 2. ...
... This serves as a reward system whereby users can " earn " more stars and move to a higher level as they make improvements. & Ernst, 2000). As a result, there is no clear methodological guidance as to what constitutes or justifies an adequate sample size for the pilot study itself (Lancaster, Dodd, & Williamson, 2002). ...
This paper goes in search of the organic relationships between branding and design, and raises the key question: Can the symbolic construction of brand images and brand design influence the positioning of commodities? An experimental project was the basis of the following study, whereby a brand was systematically and purposefully defined, designed and cultivated to identify a viable business opportunity in the Malaysian retail entertainment sector. Underlying the mission of research were two key areas of inquiry, namely: How does brand building processes and branding aesthetics affect consumers’ perspectives, and vice versa? Could technological content mediate consumer behaviour? The challenge of designing for local consumers is to provide products with expressive context that not only represents the target market’s cultural identity with its diverse tastes, but to inject key insights in aspects of advertising and marketing and creative content design, while reminding them to embrace what matters to the specific cultural imagination, thus value-adding the designers’ role in branding.
Premenstrual syndrome (PMS) is a common disorder affecting women of reproductive age, with an estimated global prevalence of 47.8%, with severe symptoms occurring in 3-8%, significantly affecting daily functioning. GABA conductance and changes in neurosteroid levels, particularly allopregnanolone, are suspected to play a substantial role in the disorder’s etiology. In this paper, we provide an overview of recent reports on the etiology and recognized therapeutic approaches, encompassing both pharmacological and non-pharmacological interventions. Our examination includes studies on SSRIs, hormonal agents, neurosteroids, supplementation, and therapeutic roles. We aim to determine the most favorable treatment regimen by comparing medication effects and alternative methods. The treatment of PMS is crucial for enhancing the quality of life for affected women. Medications used in PMS treatment should be individually selected to achieve the best therapeutic effect, considering the clinical situation of the patients.
Background: Plant-based remedies have been used since antiquity to treat menstrual-related diseases (MD). From the late nineteenth to the early to mid-twentieth century, Italian folk remedies to treat “women’s diseases” were documented in a vast corpus of literature sources. Aim: The purpose of this paper is to bring to light the plant-based treatments utilized by Italian folk medicine to heal clinical manifestations of premenstrual syndrome (PMS), dysmenorrhea, amenorrhea and menstrual disorders in an attempt to discuss these remedies from a modern pharmacological point of view. Moreover, we compare the medical applications described by Hippocrates with those utilized by Italian folk medicine to check if they result from a sort of continuity of use by over two thousand years. Results: Out of the 54 plants employed in Italian folk medicine, 25 (46.3%) were already documented in the pharmacopoeia of the Corpus Hippocraticum for treating MD. Subsequently, a detailed search of scientific data banks such as Medline and Scopus was undertaken to uncover recent results concerning bioactivities of the plant extracts to treat MD. About 26% of the plants used by Italian folk medicine, nowadays, have undergone human trials to assess their actual efficacy. At the same time, about 41% of these herbal remedies come back to in different countries. Conclusions: Active principles extracted from plants used by Italian folk healers could be a promising source of knowledge and represent strength candidates for future drug discovery for the management of MD.
A pilot study investigates whether something is feasible, whether it should be followed by the researchers, and if so, how Pilot research, however, also has a unique design element; it is carried out on a smaller scale than the primary or full-size investigation. In other words, the pilot study is crucial for enhancing the effectiveness and quality of the main study. Additionally, it is carried out to examine the randomization and blinding process, evaluate recruitment potentials, increase researcher experience with the study methods or medications and interventions, and provide estimates for sample size calculation. The misconceptions and the ethical implications of a pilot study are the main topics of this paper. This review also introduces how to interpret the findings of a pilot research.
Written with the busy practice in mind, this book delivers clinically focused, evidence-based gynecology guidance in a quick-reference format. It explores etiology, screening, tests, diagnosis, and treatment for a full range of gynecologic health issues. The coverage includes the full range of gynecologic malignancies, reproductive endocrinology and infertility, infectious diseases, urogynecologic problems, gynecologic concerns in children and adolescents, and surgical interventions including minimally invasive surgical procedures. Information is easy to find and absorb owing to the extensive use of full-color diagrams, algorithms, and illustrations. The new edition has been expanded to include aspects of gynecology important in international and resource-poor settings.
Written with the busy practice in mind, this book delivers clinically focused, evidence-based gynecology guidance in a quick-reference format. It explores etiology, screening, tests, diagnosis, and treatment for a full range of gynecologic health issues. The coverage includes the full range of gynecologic malignancies, reproductive endocrinology and infertility, infectious diseases, urogynecologic problems, gynecologic concerns in children and adolescents, and surgical interventions including minimally invasive surgical procedures. Information is easy to find and absorb owing to the extensive use of full-color diagrams, algorithms, and illustrations. The new edition has been expanded to include aspects of gynecology important in international and resource-poor settings.
In this study, chemical compositions of methanolic extracts prepared from flowered aerial parts of the following species collected from Uludağ, Hypericum calycinum, H. confertum and H. perforatum were investigated by LC-MS/MS. Total phenolic and total flavonoid contents were determined as pyrocatechol and quercetin equivalents, respectively. Antioxidant activities of the species were carried out by using DPPH free radical scavenging, ABTS cation radical scavenging, metal chelate and CUPRAC activity. Acetylcholinesterase, butyrylcholinesterase, urease, tyrosinase, collagenase, elastase, hyaluronidase inhibition and antimicrobial activity were also investigated.
Written with the busy practice in mind, this book delivers clinically focused, evidence-based gynecology guidance in a quick-reference format. It explores etiology, screening, tests, diagnosis, and treatment for a full range of gynecologic health issues. The coverage includes the full range of gynecologic malignancies, reproductive endocrinology and infertility, infectious diseases, urogynecologic problems, gynecologic concerns in children and adolescents, and surgical interventions including minimally invasive surgical procedures. Information is easy to find and absorb owing to the extensive use of full-color diagrams, algorithms, and illustrations. The new edition has been expanded to include aspects of gynecology important in international and resource-poor settings.
Written with the busy practice in mind, this book delivers clinically focused, evidence-based gynecology guidance in a quick-reference format. It explores etiology, screening, tests, diagnosis, and treatment for a full range of gynecologic health issues. The coverage includes the full range of gynecologic malignancies, reproductive endocrinology and infertility, infectious diseases, urogynecologic problems, gynecologic concerns in children and adolescents, and surgical interventions including minimally invasive surgical procedures. Information is easy to find and absorb owing to the extensive use of full-color diagrams, algorithms, and illustrations. The new edition has been expanded to include aspects of gynecology important in international and resource-poor settings.
Written with the busy practice in mind, this book delivers clinically focused, evidence-based gynecology guidance in a quick-reference format. It explores etiology, screening, tests, diagnosis, and treatment for a full range of gynecologic health issues. The coverage includes the full range of gynecologic malignancies, reproductive endocrinology and infertility, infectious diseases, urogynecologic problems, gynecologic concerns in children and adolescents, and surgical interventions including minimally invasive surgical procedures. Information is easy to find and absorb owing to the extensive use of full-color diagrams, algorithms, and illustrations. The new edition has been expanded to include aspects of gynecology important in international and resource-poor settings.
Background: Depression has been recorded since antiquity. It is an illness that affects both the mind and the body and is a leading cause of disability, workplace absenteeism, decreased productivity and high suicide rates. The present study was conducted in the rural field practice areas of Department of Community Medicine, Jawaharlal Nehru Medical College, Aligarh, Uttar Pradesh. The purpose of this study was to determine the prevalence and severity of depression in the study population and to assess the knowledge regarding causes of depression. Methods: 360 adult respondents were chosen using systematic random sampling to participate in the study. Face to face interviews were then conducted using a semi-structured proforma for collecting the data for socio-demographic and other factors. Depression in the subjects was assessed using the structured and pre-validated Patient Health Questionnaire-9 (PHQ-9). Results: The overall prevalence of depression was 11.9%. Majority of the subjects had moderate grades of depression. But knowledge regarding the causes of depression still comprised of certain supernatural causes. Conclusions: Rates of depression were quite comparable with the other studies. Depression was twice more in females. Apart from increasing mental health services and integrating this with general health services in our community there is also a dire need to focus on greater Information, Education and Communication activities regarding awareness of causes of depression and its prevention.
Herbal remedies are used in the treatment of menstrual irregularities, premenstrual syndrome (PMS), dysmenorrhea, and menopausal complaints in cases where stronger-acting drugs are not indicated or are declined by the patient. Two medicinal plants stand out in the frequency with which they are prescribed for gynecologic complaints: chasteberries (used chiefly for PMS) and black cohosh rhizome (used principally for menopausal complaints) (Schwabe and Rabe, 1998). Table 7.1 also lists four other herbs recommended by the German Commission E as having gynecologic indications. It can be seen that the range of recommended dosages (column 3 in Table 7.1) is greater for gynecologic herbal remedies than for any other class of phytomedicenes. Some of the dosages are many times lower than the traditional single dose of about 1–4 g of crude drug (i.e., dried herbal material) taken in a cup of medicinal tea. There is an urgent need for pharmacologic and clinical studies to investigate the dose-dependency of the actions and efficacy of these herbal drugs.
Pflanzliche Arzneimittel werden bei Regeltempoanomalien, prämenstruellem Syndrom, Dysmenorrhoe und klimakterischen Ausfallerscheinungen angewendet, wenn stark wirkende Arzneimittel nicht angezeigt sind oder von den Patientinnen abgelehnt werden.Hinsichtlich der Häufigkeit ihrer Verordnung stehen mit weitem Abstand zwei pflanzliche Drogen, nämlich Mönchspfeffer (vorwiegend eingesetzt bei „prämenstruellem Syndrom“) und Traubensilberkerzenwurzelstock (vorwiegendes Indikationsgebiet: klimakterische Beschwerden) an der Spitze (Schwabe und Rabe, 1998).Die Tabelle 7.1 enthält darüber hinaus 4 weitere Drogen, denen von der Kommission E Indikationen im gynäkologischen Bereich zugeordnet wurden.Auffällig ist die Spanne der empfohlenen Dosierungen (Tabelle 7.1, 3. Spalte), die bei keiner anderen Gruppe von Phytopharmaka so weit auseinanderdriftet wie bei den pflanzlichen Gynäkologika. Die traditionellerweise angewendete Einzeldosis im Sinne einer Tasse Medizinaltee, entsprechend etwa 1–4 g der Droge, wird bei den Fertigpräparaten dieser Gruppe um bis zu 2 Zehnerpotenzen unterschritten. Pharmakologische und klinische Studien zur Prüfung der Dosisabhängigkeit von Wirkungen und Wirksamkeit sind hier dringend erforderlich.
Introduction Colposcopy was first described by Hinselmann in 1925 using a fixed binocular instrument mounted on a tripod with a light source and a mirror. Since the early 1900s, colposcopy has been the clinician's instrument for identifying cellular abnormalities detected by the Papanicolaou (Pap) test or for evaluating gross lesions suspicious for cancer. The main purpose of colposcopy is to identify the most abnormal lesions within the lower genital tract for directed sampling, confirmation of grade of disease, and to exclude invasive disease. Of the approximately 50 million Papanicolaou (Pap) tests performed each year in the USA, 10% will show some cytological abnormality and 5% will reveal a squamous intraepithelial lesion (SIL) of low-grade (LSIL) or higher (HSIL). There are 2–2.75 million colposcopic examinations performed each year for atypical squamous cells of undetermined significance (ASC-US) and/or LSIL. These cellular abnormalities will require evaluation with colposcopy, and the ability to accurately detect disease will depend on the experience and expertise of the colposcopist. Box 13.1 contains the key terms that are used in this chapter and in discussions of colposcopy studies. Accuracy of colposcopy Several studies have evaluated the efficacy and accuracy of colposcopy as a tool for identification of cervical intraepithelial neoplasia (CIN) and invasive disease of the cervix. Over time, the accuracy of colposcopy has been questioned particularly since being adopted as the standard triage approach for women with abnormal cervical cytology more than three decades ago.
Anatomy The vagina is 7.5 cm in average length, extending from the cervix to the vulva; it lies between the bladder and urethra anteriorly and the rectum posteriorly. The pouch of Douglas separates the upper portion of the vagina from the rectum. The vaginal wall is composed of three layers: the non-keratinizing stratified squamous epithelium (“mucosa”), the fibromuscular vaginal muscularis, and the adventitial layer. The epithelium contains no glands (so not a true mucosa) and overlies a basement membrane rich in elastin. The muscularis consists of smooth muscle fibers arranged in inner circular and outer longitudinal layers. At the introitus, a skeletal muscle ring forms the vaginal “sphincter.” The adventitia is a thin connective tissue layer that merges with that of adjacent organs.
Introduction The anatomy of the adrenal glands was described 450 years ago by Bartholomeo Eustachius; however, a functional role for the adrenal glands was not defined until the pioneering work of Thomas Addison in 1855. Table 68.1 demonstrates the remarkable pathway of the history of the adrenal gland that allows us to manipulate and manage the steroidogenic disorders discussed in this chapter. A review of mineralocorticoids, pheochromocytomas, and other disorders of endocrine hypertension is not included in this discussion. The control of adrenocortical function by a pituitary factor was demonstrated in the 1920s, and this led to the isolation of sheep adrenocorticotropic hormone (ACTH) in 1943. Such a concept was supported through clinical studies, notably in 1932 by Harvey Cushing, who associated his original clinical observations of 1912 (a “polyglandular syndrome” caused by pituitary basophilism) with adrenal hyperactivity. The neural control of pituitary ACTH secretion by corticotropin-releasing hormone (CRH) was defined by Harris and other workers in the 1940s, but CRH was not characterized and synthesized until 1981 in the laboratory of Wylie Vale. Physiology The adrenal glands are located immediately superior to the kidneys, are triangular in shape, and measure approximately 13 mm in height and 75 mm in length. The inner adrenal medulla secretes epinephrine and norepinephrine, which affect blood pressure, heart rate, and sweating.
Background: Premenstrual syndrome (PMS) is a common condition. Some of the most widely prescribed medications are selective serotonin reuptake inhibitors (SSRIs), based on the hypothesized role of serotonin in the production of PMS symptoms. PMS sufferers, especially those experiencing mild to moderate symptoms, are often reluctant to take this form of medication and instead buy over-the-counter preparations to treat their symptoms, for which the evidence base with regard to efficacy is limited. Hypericum perforatum (St John's wort) influences the serotonergic system. As such, this widely available herbal remedy deserves attention as a PMS treatment. Objective: To investigate the effectiveness of Hypericum perforatum on symptoms of PMS. Study design: This randomized, double-blind, placebo-controlled, crossover study was conducted between November 2005 and June 2007. Setting: Institute of Psychological Sciences, University of Leeds, Leeds, UK. Participants: 36 women aged 18-45 years with regular menstrual cycles (25-35 days), who were prospectively diagnosed with mild PMS. Intervention: Women who remained eligible after three screening cycles (n = 36) underwent a two-cycle placebo run-in phase. They were then randomly assigned to receive Hypericum perforatum tablets 900 mg/day (standardized to 0.18% hypericin; 3.38% hyperforin) or identical placebo tablets for two menstrual cycles. After a placebo-treated washout cycle, the women crossed over to receive placebo or Hypericum perforatum for two additional cycles. Main outcome measures: Symptoms were rated daily throughout the trial using the Daily Symptom Report. Secondary outcome measures were the State Anxiety Inventory, Beck Depression Inventory, Aggression Questionnaire and Barratt Impulsiveness Scale. Plasma hormone (follicle-stimulating hormone [FSH], luteinizing hormone [LH], estradiol, progesterone, prolactin and testosterone) and cytokine (interleukin [[IL]-1 beta, IL-6, IL-8, interferon [IFN]-gamma and tumour necrosis factor [TNF]-alpha) levels were measured in the follicular and luteal phases during Hypericum perforatum and placebo treatment. Results: Hypericum perforatum was statistically superior to placebo in improving physical and behavioural symptoms of PMS (p < 0.05). There were no significant effects of Hypericum perforatum compared with placebo treatment for mood- and pain-related PMS symptoms (p>0.05). Plasma hormone (FSH, LH, estradiol, progesterone, prolactin and testosterone) and cytokine (IL-1 beta, IL-6, IL-8, IFN gamma and TNF alpha) levels, and weekly reports of anxiety, depression, aggression and impulsivity, also did not differ significantly during the Hypericum perforatum and placebo cycles (p > 0.05). Conclusion: Daily treatment with Hypericum perforatum was more effective than placebo treatment for the most common physical and behavioural symptoms associated with PMS. As proinflammatory cytokine levels did not differ significantly between Hypericum perforatum and placebo treatment, these beneficial effects are unlikely to be produced through this mechanism of action alone. Further work is needed to determine whether pain- and mood-related PMS symptoms benefit from longer treatment duration.
Introduction The introduction of oral contraceptives (OCs) in the 1960s defines the major starting point for today's contraceptive methods. Despite the introduction of OCs and the development of many new or improved methods of contraception, unintended or unplanned pregnancies continue to be a major problem in the USA with unintended and unplanned pregnancy rates at approximately 50% for most age groups. Consequently, despite more than 50 years' experience with modern contraceptives, substantial challenges still remain in optimal selection of and improved adherence to the chosen method. When evaluating contraceptive methods, efficacy is narrowly defined as the frequency of pregnancy prevention while a method is being used correctly and consistently. Effectiveness of a contraceptive method usually reflects typical use rates of unintended pregnancy, which would include method or perfect use failures as well as user failure (e.g. not using the method correctly or consistently). Most method or typical use rates are calculated using either the Pearl index or a life-table analysis. The Pearl index is calculated by dividing the number of unintended pregnancies by the total months or menstrual cycles of exposure; the result is multiplied by 1200 if months are used and 1300 if menstrual cycles are used. The result is expressed in number of pregnancies per 100 woman-years of exposure.
Introduction Cancer during pregnancy is reported to occur at an incident rate of 0.07–0.1%, or 1 in 1000 pregnancies. Age remains the most important risk factor for cancer. An increase in incidence of cancer during pregnancy has been observed since the mid 1990s, as more and more women, particularly in industrialized countries, tend to defer pregnancy until later reproductive years. When encountered, cancer in a pregnant patient presents a medical dilemma posing a challenge for the patient, the family, and medical staff. Management of pregnant patients with cancer is a diagnostic, therapeutic, and social challenge, requiring a multidisciplinary approach and close follow-up. Any decision regarding the timing and choice of treatment should take into account the stage and severity of the disease, its prognosis, gestational age at time of diagnosis, maternal choice for the current pregnancy, and the potential effects on the fetus and the mother’s future fertility. It is important to note that in recent years maternal profile has drastically changed, hence in view of decreased fertility with increasing age and if cancer complicates a gestation, this pregnancy may represent the only opportunity for the patient to become a mother. Cancers during pregnancy can be either originating from the gestational tissue or originating from any other tissue.
Introduction Postoperative pelvic infections as well as postoperative infections distant from the operative site continue to be responsible for significant postoperative morbidity and mortality. The most important contributor to the increase in infection morbidity is delay in making the diagnosis of a surgical site infection. One of the factors contributing to this delay is the failure to accept that infection can occur on the first postoperative day and attributing early clinical signs of infection to non-infectious causes. The most common infection, in the surgical patient, is a surgical site infection. In the gynecological patient there is usually more than one surgical site; for example, the patient undergoing an abdominal hysterectomy will have an abdominal incision, a vaginal incision, and tissue pedicles. Patients undergoing a vaginal hysterectomy will have an apical vaginal incision plus tissue pedicles and, if there are additional procedures such as those associated with pelvic reconstructive surgery, there will be additional sites that can become infected. Therefore, the gynecological surgeon must be cognizant of the following: (1) most infections are caused by the patient's own endogenous vaginal microflora; (2) once the vagina is entered into the situation, the woman now becomes potentially contaminated (clean contaminated surgical procedure); and (3) microbial contamination can occur during the operative procedure. Therefore, the state of the patient's vaginal microflora may serve as a predictor of the patient's potential risk for developing a postoperative pelvic or surgical site infection. Knowing the state of the patient's endogenous vaginal microflora can be used to determine appropriate antibiotic prophylaxis to assist in reducing the risk of postoperative pelvic infections.
Written with the busy practice in mind, this book delivers clinically focused, evidence-based gynecology guidance in a quick-reference format. It explores etiology, screening, tests, diagnosis, and treatment for a full range of gynecologic health issues. The coverage includes the full range of gynecologic malignancies, reproductive endocrinology and infertility, infectious diseases, urogynecologic problems, gynecologic concerns in children and adolescents, and surgical interventions including minimally invasive surgical procedures. Information is easy to find and absorb owing to the extensive use of full-color diagrams, algorithms, and illustrations. The new edition has been expanded to include aspects of gynecology important in international and resource-poor settings.
Clinical research into the effectiveness of any therapy usually progresses in a series of steps that are aimed at providing evidence that will lead to improved patient care. One important early step is the uncontrolled trial. Uncontrolled trials serve several crucial purposes, including establishing firmly that there is a clinical effect worth investigating, identifying the most suitable patients and the most appropriate treatments, and providing information on how large the effect might be. They can be conducted relatively easily by practitioners in the course of their normal work, and are an excellent first step for anyone interested in clinical research. Such studies are not only satisfying, but develop skills in searching the literature and writing protocols, and promote rigorous thinking and attention to detail. The ultimate purpose of uncontrolled trials is to facilitate subsequent definitive studies that will help define the place of CAM in health care.
Introduction Female genital mutilation/cutting (FGM/C) is a traditional practice that has no medical benefit and confers severe health consequences for girls and women. It occurs mainly in countries along a belt stretching from Senegal in West Africa to Somalia in East Africa and to Yemen in the Middle East, but it is also practiced in some parts of Southeast Asia. Definition Female genital mutilation/cutting has been defined as any procedure “involving partial or total removal of the external female genitalia without medical reasons.”1 It has been classified by the World Health Organization (WHO) into four types (Fig. 8.1). I: partial or total removal of the clitoris and/or the prepuce (clitoroidectomy) (Fig. 8.1B) II: partial or total removal of the clitoris and the labia minora, with or without excision of the labia majora (excision) (Fig. 8.1C) III: narrowing of the vaginal orifice with creation of a covering seal by cutting and appositioning the labia minora and/or the labia majora, with or without excision of the clitoris (infibulation) (Fig. 8.1D) IV: all other harmful procedures to the female genitalia for non-medical purposes, for example: pricking, piercing, incising scraping and cauterization. History The exact origin of FGM/C remains unclear but it has been practiced at least as early as in ancient Egyptian culture.
Herbal medicine is being increasingly used by women to prevent diseases, promote health and treat different diseases including a number of psychiatric disorders. The use of herbal drugs is increasing in the western world. The use of herbal drugs during pregnancy has been studied to various extents in different countries. However, more information is required regarding the impact of herbal medicine on conventional treatment, because such information can have important for public health and mental health care. This review focuses on herbal medicine and mental health of women in particular premenstrual syndrome and maternal depression.
To investigate if extracts of Hypericum perforatum (St John's wort) are more effective than placebo in the treatment of depression, are as effective as standard antidepressive treatment, and have fewer side effects than standard antidepressant drugs.
Systematic review and meta-analysis of trials revealed by searches. TRIALS: 23 randomised trials including a total of 1757 outpatients with mainly mild or moderately severe depressive disorders: 15 (14 testing single preparations and one a combination with other plant extracts) were placebo controlled, and eight (six testing single preparations and two combinations) compared hypericum with another drug treatment.
A pooled estimate of the responder rate ratio (responder rate in treatment group/responder rate in control group), and numbers of patients reporting and dropping out for side effects.
Hypericum extracts were significantly superior to placebo (ratio = 2.67; 95% confidence interval 1.78 to 4.01) and similarly effective as standard antidepressants (single preparations 1.10; 0.93 to 1.31, combinations 1.52; 0.78 to 2.94). There were two (0.8%) drop outs for side effects with hypericum and seven (3.0%) with standard antidepressant drugs. Side effects occurred in 50 (19.8%) patients on hypericum and 84 (52.8%) patients on standard antidepressants.
There is evidence that extracts of hypericum are more effective than placebo for the treatment of mild to moderately severe depressive disorders. Further studies comparing extracts with standard antidepressants in well defined groups of patients and comparing different extracts and doses are needed.
Reduced magnesium (Mg) levels have been reported in women affected by premenstrual syndrome (PMS). To evaluate the effects of an oral Mg preparation on premenstrual symptoms, we studied, by a double-blind, randomized design, 32 women (24-39 years old) with PMS confirmed by the Moos Menstrual Distress Questionnaire. After 2 months of baseline recording, the subjects were randomly assigned to placebo or Mg for two cycles. In the next two cycles, both groups received Mg. Magnesium pyrrolidone carboxylic acid (360 mg Mg) or placebo was administered three times a day, from the 15th day of the menstrual cycle to the onset of menstrual flow. Blood samples for Mg measurement were drawn premenstrually, during the baseline period, and in the second and fourth months of treatment. The Menstrual Distress Questionnaire score of the cluster "pain" was significantly reduced during the second month in both groups, whereas Mg treatment significantly affected both the total Menstrual Distress Questionnaire score and the cluster "negative affect." In the second month, the women assigned to treatment showed a significant increase in Mg in lymphocytes and polymorphonuclear cells, whereas no changes were observed in plasma and erythrocytes. These data indicate that Mg supplementation could represent an effective treatment of premenstrual symptoms related to mood changes.
The hypothesis that the many non-specific changes normally associated with cyclical ovarian activity are the primary aetiological factors in the premenstrual syndrome was tested by suppressing ovulation with subcutaneous oestradiol implants. Sixty eight women with proved premenstrual syndrome were treated under placebo controlled conditions for up to 10 months in a longitudinal study. Active treatment was combined with cyclical oral norethisterone to produce regular withdrawal periods. Symptoms were monitored with daily menstrual distress questionnaires, visual analogue scales, and the 60 item general health questionnaire. Of the 35 women treated with placebo 33 improved, giving an initial placebo response rate of 94%. The placebo effect gradually waned, but the response to the active combination was maintained for the duration of the study. Analysis of the prospective symptom ratings showed a significant superiority of oestradiol implants over placebo after two months for all six symptom clusters in the menstrual distress questionnaire. Changes seen in the retrospective assessments were less significant but the trend was the same. Treatment with oestradiol implants and cyclical progestogen was well tolerated and appears to be both rational and effective for severe cases of the premenstrual syndrome.
We performed a double-blind, placebo-controlled, crossover trial of fluoxetine in 17 women with prospectively confirmed PMS who also met criteria for premenstrual dysphoric disorder (PMDD). A subset of 10 women with PMDD and an additional 10 controls participated in a single-dose m-chlorophenylpiperazine (m-CPP) challenge during the follicular and luteal phases of the menstrual cycle. We evaluated the ability of the acute behavioral response to luteal phase m-CPP administration to predict therapeutic response to fluoxetine. compared with baseline, fluoxetine, but not placebo, treatment significantly improved both emotional and physical symptoms. We identified 11 (65%) fluoxetine responders who no longer met diagnostic criteria for PMDD during fluoxetine but remained symptomatic during placebo treatment. In addition, acute symptomatic improvement also occurred following m-CPP administration in 7 of 10 women with PMDD. The small number of m-CPP nonresponders did not respond to fluoxetine either. Our findings confirm that fluoxetine is an effective treatment of PMDD.
Background
Premenstrual dysphoria shares certain features with depression and anxiety states, which have been linked to serotonergic dysregulation. We evaluated the efficacy and safety of fluoxetine (which selectively inhibits the reuptake of serotonin) in the treatment of premenstrual dysphoria.
Methods
The trial consisted of a single-blind, placebo washout period lasting two menstrual cycles, followed by a randomized, double-blind, placebo-controlled trial of fluoxetine at a dose of either 20 mg or 60 mg per day or placebo for six menstrual cycles. Healthy women meeting criteria for what was then called late-luteal-phase dysphoric disorder were recruited at seven university-affiliated women's health clinics in Canada. The primary outcome measure consisted of visual-analogue scales for tension, irritability, and dysphoria during the late luteal phase of each cycle.
Results
Of 405 women enrolled in the placebo washout period, 313 subsequently entered the randomized phase of the study, which lasted six menstrual cycles, and 180 completed it. Fluoxetine at a dose of 20 or 60 mg per day was significantly superior to placebo in reducing symptoms of tension, irritability, and dysphoria, as measured by the visual-analogue scales (P<0.001). The women who received 60 mg of fluoxetine per day reported significantly more side effects than those who received 20 mg per day or placebo (P<0.001).
Conclusions
Fluoxetine is useful in the treatment of premenstrual dysphoria. Treatment with fluoxetine at a dose of 20 mg per day reduces the potential for side effects while maximizing therapeutic efficacy.
A herbal remedy Vitex agnus castus was tested against a placebo for the relief of symptoms associated with the premenstrual syndrome (PMS). The trial was a formally conducted double-blind randomised controlled trial on a volunteer sample of self-diagnosed sufferers of PMS using a form of the long-established Moos menstrual distress questionnaire. The main focus of interest after pilot studies was in symptoms of negative effect. These were fully explored both by individual symptoms and as a group. In only one reported symptom (‘feel jittery or restless’) was a statistically significant difference shown between Vitex and placebo. The other main symptoms' groups studied included those of impaired concentration, fluid retention and pain. Statistical analysis revealed a similar pattern of effect for Vitex and placebo with the exception of the fluid retention group where there was some difference, but not of statistical significance. Generally the pattern of effect for both treatments was a dramatic improvement at the end of the first cycle with relative stability over the next two cycles. The only exception to this was the reported symptom ‘feel jittery or restless’ in the negative affect group which, under Vitex, had a sustained effect in comparison to placebo. At the end of the trial period detailed statistical analysis could find no difference between those who completed and those who withdrew with respect to age, marital status, cycle length and employment. It is concluded that, in this clinical trial, Vitex showed little difference in treatment effect to that of the placebo in the majority of symptoms associated with PMS. There were suggestions, however, from both the subjects' spontaneous responses and the findings with the fluid retention group, that further investigations would be justified.
Context.
—Premenstrual dysphoric disorder is an important cause of symptoms and functional impairment in menstruating women.
ABSTRACT– A self-assessment scale has been developed and found to be a reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. The anxiety and depressive subscales are also valid measures of severity of the emotional disorder. It is suggested that the introduction of the scales into general hospital practice would facilitate the large task of detection and management of emotional disorder in patients under investigation and treatment in medical and surgical departments.
• Current emphasis on early case finding, outpatient care, and on longitudinal studies of asymptomatic patients has focused attention on the community adjustment of psychiatric patients. Thus, simple and inexpensive methods such as self-report scales, which allow the routine assessment of patient adjustment, are potentially useful.
The derivation and testing of such a method, the Social Adjustment Scale Self-Report, is described. This scale covers the patient's role performance, interpersonal relationships, friction, feelings and satisfaction in work, and social and leisure activities with the extended family, as a spouse, parent, and member of a family unit. Self-report results based on 76 depressed outpatients were comparable to those obtained from relatives as well as by a rater who interviewed the patient directly.
During a 5-month study, we examined the effects of the relaxation response on premenstrual syndrome in 46 women who were randomly assigned to one of three groups: a charting group, a reading group, and a relaxation response group. The relaxation response group showed significantly greater improvement than the charting and the reading groups on physical symptoms (P less than .025 for both comparisons). There was a significant group-by-severity effect for charting versus relaxation response and for reading versus relaxation response on symptoms measured daily (P less than .01 for both comparisons), on emotional symptoms measured retrospectively (P less than .001 and P less than .025, respectively), and on symptoms of social withdrawal measured retrospectively (P less than .01 and P less than .025, respectively). Women with severe symptoms in the relaxation response group showed a 58.0% improvement, compared with a 27.2% improvement for the reading group and a 17.0% improvement for the charting group. We conclude that regular elicitation of the relaxation response is an effective treatment for physical and emotional premenstrual symptoms, and is most effective in women with severe symptoms.
Episodic depression, a prominent but poorly defined symptom of premenstrual syndrome, was quantitated in 24-hour cortisol secretory episodes (determined by sampling at 20-minute intervals) as biochemical markers, as well as the Beck Depression Inventory and Profile of Mood States as psychometric measures. Results of 16 patients with premenstrual syndrome were compared with six age-matched women with endogenous depression and 16 control women. On both the Profile of Mood States and Beck Depression Inventory, women with premenstrual syndrome showed a marked worsening of scores (p less than 0.01) during the luteal phase compared with either their own follicular phase scores or the scores of controls in either cycle phase. However, Beck Depression Inventory scores were threefold higher (p less than 0.005) in women with depression than in those with luteal phase premenstrual syndrome (3.37 +/- 3.6 vs. 11.9 +/- 2.5). The Profile of Mood States depression scale was also higher (p less than 0.05) in women with depression than in those with premenstrual syndrome, while scores on other Profile of Mood States scales were similar. The numbers of cortisol secretory pulses identified by the cluster algorithm were similar (5 to 6 per 24 hours) in all groups, and the time of circadian nadirs as determined by cosinor rhythmometry were comparable. While the mean amplitude and duration of the cortisol pulses were also similar in women with premenstrual syndrome and controls, both were significantly higher (p less than 0.05) in women with depression. This resulted in markedly enhanced (p less than 0.005) cortisol secretion during a given secretory episode in women with depression and in higher 24-hour transverse mean cortisol values in women with depression (87.8 +/- 5.8 ng/ml) than in either those with premenstrual syndrome (66.7 +/- 3.3 ng/ml) or controls (58.9 +/- 3.3 ng/ml). These data affirm the clinical impression that depressive episodes occurring selectively in the luteal phase of the cycle in women with premenstrual syndrome are not present in controls and demonstrate, for the first time, that these episodes are distinct from endogenous depression as measured by both cortisol secretory parameters and psychological indices.
Many different treatments have been suggested for the premenstrual syndrome (PMS), including such nutritional supplements as vitamins, minerals and essential fatty acids. There is little agreement about the causes or treatments of the syndrome. The effect of a nutritional supplement, at high and low dosage, on premenstrual symptoms was assessed in a double-blind, placebo-controlled study. Also, the nutritional state of 11 women with PMS was evaluated. There was laboratory evidence of significant deficiencies in vitamin B6 and magnesium; other deficiencies occurred frequently, also. The multivitamin/multimineral supplement was shown to correct some of these deficiencies and, at the appropriate dosage, to improve the symptoms of premenstrual tension.
A self-assessment scale has been developed and found to be a reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. The anxiety and depressive subscales are also valid measures of severity of the emotional disorder. It is suggested that the introduction of the scales into general hospital practice would facilitate the large task of detection and management of emotional disorder in patients under investigation and treatment in medical and surgical departments.
A self-report Social Adjustment Scale (SAS-M) for use in British populations was devised by modifying the original North American version, its usefulness was evaluated among 331 women drawn from two local populations. In a group of mothers of one year old babies (n = 130), high levels of agreement were found between the subjects' self-ratings on the SAS-M and (i) a psychiatrist's ratings of their social adjustment made at interview; (ii) ratings of the subjects' social adjustment made by their husbands on the SAS-M; (iii) measures of concurrent mental state. In a group of women undergoing elective sterilization (n = 201), the SAS-M was found to be sensitive to changes in mental state over time. Possible application of the SAS-M in psychiatric research, particularly when an interview is not feasible, are discussed.
To test the efficacy of a specially-formulated, carbohydrate-rich beverage (one known to increase the serum ratio of tryptophan to other large neutral amino acids) on the mood, cognitive, and appetitive disturbances of premenstrual syndrome (PMS).
Twenty-four women with confirmed PMS were enrolled in a double-blind, crossover study to test the efficacy of the specially-formulated beverage compared with two other isocaloric products on PMS symptoms. The study was conducted over three menstrual cycles preceded by a 1-month placebo run-in. Patients were tested at home or work using an interactive computer-telephone system. Standardized measurements of mood, cognitive performance, and food cravings were made before and 30, 90, and 180 minutes after consumption of active and placebo beverages during the late luteal phase of the menstrual cycle.
The experimental carbohydrate intervention significantly decreased self-reported depression, anger, confusion, and carbohydrate craving 90-180 minutes after intake. Memory word recognition was also improved significantly compared with scores obtained during the placebo run-in month (P < .05). The isocaloric placebo interventions had no significant effect on any of these measures.
The results suggest that the psychological and appetitive symptoms of PMS can be relieved after consuming a specially-formulated, carbohydrate-rich beverage known to increase serum tryptophan levels.
Premenstrual dysphoria shares certain features with depression and anxiety states, which have been linked to serotonergic dysregulation. We evaluated the efficacy and safety of fluoxetine (which selectively inhibits the reuptake of serotonin) in the treatment of premenstrual dysphoria.
The trial consisted of a single-blind, placebo washout period lasting two menstrual cycles, followed by a randomized, double-blind, placebo-controlled trial of fluoxetine at a dose of either 20 mg or 60 mg per day or placebo for six menstrual cycles. Healthy women meeting criteria for what was then called late-luteal-phase dysphoric disorder were recruited at seven university-affiliated women's health clinics in Canada. The primary outcome measure consisted of visual-analogue scales for tension, irritability, and dysphoria during the late luteal phase of each cycle.
Of 405 women enrolled in the placebo washout period, 313 subsequently entered the randomized phase of the study, which lasted six menstrual cycles, and 180 completed it. Fluoxetine at a dose of 20 or 60 mg per day was significantly superior to placebo in reducing symptoms of tension, irritability, and dysphoria, as measured by the visual-analogue scales (P < 0.001). The women who received 60 mg of fluoxetine per day reported significantly more side effects than those who received 20 mg per day or placebo (P < 0.001).
Fluoxetine is useful in the treatment of premenstrual dysphoria. Treatment with fluoxetine at a dose of 20 mg per day reduces the potential for side effects while maximizing therapeutic efficacy.
In a previous controlled trial we have shown that premenstrual irritability and depressed mood (premenstrual syndrome) can be effectively reduced by low doses of the potent (but nonselective) serotonin reuptake inhibitor clomipramine taken each day of the menstrual cycle. The present study was undertaken to examine to what extent intermittent administration of clomipramine, during the luteal phase only, is also effective against premenstrual complaints. Twenty-nine nondepressed women displaying severe premenstrual irritability and/or depressed mood and fulfilling the DSM-III-R criteria of late luteal phase dysphoric disorder were treated daily from the day of ovulation until the onset of the menstruation either with clomipramine (25 to 75 mg) (n = 15) or with placebo (n = 14) for three consecutive menstrual cycles; another nine subjects (seven on clomipramine, two on placebo) dropped out during treatment. In both treatment groups self-rated premenstrual irritability and depressed mood (as registered daily using a visual analogue scale) were significantly reduced during treatment; in the placebo group, this symptom reduction was about 45%, whereas in the clomipramine group it was greater than 70%. The mean premenstrual ratings of irritability and depressed mood during the three treatment cycles were significantly lower in the clomipramine group than in the placebo group. Also with respect to the rating of global improvement, the result obtained with clomipramine was significantly better than that obtained with placebo. The study confirms the previously reported effectiveness of low doses of clomipramine in the treatment of premenstrual syndrome and demonstrates that the time lag between onset of medication and clinical effect is shorter when clomipramine is used for premenstrual syndrome than when it is used for depression, panic disorder, or obsessive compulsive disorder.
To determine whether essential fatty acids are effective in the treatment of premenstrual syndrome (PMS).
In a randomized, double-blind, crossover trial, we studied 27 women diagnosed with PMS over ten menstrual cycles and 22 symptom-free controls over one cycle. The first cycle was used for diagnostic assessment. For the women with PMS, placebos were administered during the second cycle. This was followed by randomization to four cycles of active treatment with essential fatty acids and four cycles of placebo, with a crossover after completion of the fourth cycle. Assessment of symptoms and diagnosis of PMS were based on daily self-ratings made by the women throughout the study.
Treatment with essential fatty acids did not reduce premenstrual symptoms or symptom cyclicity. However, time had a significant effect on a number of symptoms, indicating either a placebo effect or an effect from participation in the study. Women with PMS had a significantly higher frequency of dysmenorrhea and familial PMS than did the symptom-free controls.
Treatment with essential fatty acids is ineffective therapy for PMS. The improvement we observed over time can be ascribed to either a placebo effect or participation in the study.
Daily ratings of symptoms are essential to confirm a diagnosis of premenstrual syndrome (PMS). The 17-item Daily Symptom Report (DSR) is relatively brief and appropriate for clinical and primary care settings. We report the reliability, factor structure and relationships with other standard mood measures of the DSR as a measure of PMS. The sample includes 170 women who sought medical treatment for severe PMS and a non-clinical comparison group of 54 healthy women in the same age range. Cronbach's coefficient alpha was 0.92 for the premenstrual DSR scores, indicating very high internal consistency for the 17 symptoms. Factor analysis yielded four factors describing mood, behavioral items, pain, and physical symptoms. In the PMS sample, there were moderate correlations between the DSR and the Hamilton Rating Scale for Depression, the Profile of Mood States, and the Premenstrual Assessment Form. The moderate correlations of the DSR with other standard symptom measures add to the evidence that PMS overlaps with other mood disorders at the premenstrual time but is not simply a brief depression or a truncated anxiety disorder.
Premenstrual dysphoric disorder is an important cause of symptoms and functional impairment in menstruating women.
To evaluate the efficacy of sertraline hydrochloride for treatment of premenstrual dysphoria by measuring changes in symptom expression and functional impairment.
Two screening cycles followed by 1 single-blind placebo cycle and 3 cycles of randomized, double-blind, placebo treatment.
Twelve university-affiliated outpatient psychiatry and gynecology clinics.
Of the 447 women who requested participation, 243 met criteria for premenstrual dysphoric disorder and were randomized; 200 women completed the study.
A flexible (50-150 mg) daily dose of sertraline hydrochloride.
The Daily Record of Severity of Problems, Hamilton Rating Scale for Depression, Clinical Global Impression Scale, and Social Adjustment Scale.
Mean (+/-SD) total daily symptom scores decreased significantly (P<.001) in the sertraline-treated (64+/-22 to 44+/-19) compared with the placebo-treated (62+/-22 to 54+/-24) groups. Significant improvement (P<.05) was found for all clinically derived symptom clusters (depressive, physical, and anger/irritability symptoms). Hamilton Rating Scale for Depression scores decreased by 44% and 29% in the sertraline and placebo groups, respectively (P<.002). End-point global ratings showed much or very much improvement in 62% of the active treatment group and 34% of the placebo treatment group (P<.001). Reported functional impairment was substantial at baseline. Improvement in psychosocial functioning with treatment was similar to what is found in studies of major depression.
Sertraline was significantly better than placebo for treatment of premenstrual dysphoria as reflected by symptomatic improvement and change in reported functional impairment. Serotonin reuptake inhibitors such as sertraline are useful therapeutic options for women with premenstrual dysphoria.
Since the mechanism of the antidepressant activity of hypericum extract is not yet understood, we tested possible effects of standardized hypericum extract (LI 160) in several biochemical models relevant for the mechanism of action of other antidepressant drugs. While LI 160 was only a weak inhibitor of MAO-A and MAO-B activity, it inhibited the synaptosomal uptake of serotonin, dopamine and norepinephrine with about equal affinity-2 micrograms/ml). Moreover, subchronic treatment of rats with hypericum extract led to a significant down-regulation of beta-receptors and to a significant up-regulation of 5-HT2-receptors in the frontal cortex. The data might suggest that hypericum extract acts via similar biochemical mechanisms to other antidepressants (e.g. tricyclics).
During the past decade premenstrual syndrome has become a well-defined entity.1 The hallmark of the syndrome is the repeated occurrence of behavioral and somatic symptoms severe enough to impair a woman's social and work-related functioning during the luteal phase of the menstrual cycle. On the basis of strict diagnostic criteria, the prevalence of the disorder is estimated to be 2.5 percent among women of reproductive age. No marked racial or ethnic differences in the prevalence of the disorder have been identified. There are several effective treatments for premenstrual syndrome that have largely supplanted older, unproved therapies such as dietary restrictions, . . .
Premenstrual syndrome is believed to affect 30% to 80% of women. Studies in various cultures have used a variety of methodologies to determine prevalence, symptom profile, and effectiveness of available treatments. This study was designed to provide information on incidence of PMS and therapies used based on a national probability sample of US women.
In 1996 a national probability sample (N = 1052) of women aged 21 to 64 years was surveyed by telephone using random digit dial methods. The survey included demographic information, questions concerning respondent knowledge of premenstrual syndrome, incidence rates of common premenstrual syndrome symptoms, and any remedies that were used to control the symptoms.
Forty-one percent of the women responded "yes" to the question, "Do you suffer from premenstrual syndrome?" An additional 17% indicated that they experienced symptoms prior to their menstrual cycle that are commonly associated with premenstrual syndrome (e.g., pain, bloating, feeling more emotional, weight gain, food cravings), though without associating these symptoms with premenstrual syndrome explicity. The most frequently noted severe symptom was that of "[feeling] more emotional." Of those reporting premenstrual syndrome symptoms, approximately 42% took either prescription or over-the-counter medications to relieve them. Eighty percent of the women taking any type of medication relied on over-the-counter medications. Prescription drug use for premenstrual syndrome symptoms focused on medications to control pain; hormone supplements were the second most frequently prescribed rugs. Fewer than 3% of the respondents used prescription medications. Respondents were asked to indicate whether they had used a complementary medical therapy to control symptoms. Exercise was used most frequently (18%), and acupuncture was the least frequently used. Although only a small percentage of women used complementary therapies, for most of these therapies a near-perfect concordance was found between usage and belief in efficacy.
Women were aware of symptoms related to premenstrual syndrome more frequently than they recognized a formalized medical syndrome. Less than half of the women reporting symptoms had taken either over-the-counter or prescription drugs. Those who tried complementary therapies generally found them to be effective.
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