Comparison of Crocus sativus L. and imipramine in the treatment of mild to moderate depression: A pilot double-blind randomized trial [ISRCTN45683816]

BACKGROUND: The morbidity and mortality associated with depression are considerable and continue to increase. Depression currently ranks fourth among the major causes of disability worldwide, after lower respiratory infections, prenatal conditions, and HIV/AIDS. Crocus sativus L. is used to treat depression. Many medicinal plants textbooks refer to this indication whereas there is no evidence-based document. Our objective was to compare the efficacy of stigmas of Crocus sativus (saffron) with imipramine in the treatment of mild to moderate depression in a 6-week pilot double-blind randomized trial. METHODS: Thirty adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 4(th )edition for major depression based on the structured clinical interview for DSM IV participated in the trial. Patients have a baseline Hamilton Rating Scale for Depression score of at least 18. In this double-blind, single-center trial, patients were randomly assigned to receive capsule of saffron 30 mg/day (TDS) (Group 1) and capsule of imipramine 100 mg/day (TDS) (Group 2) for a 6-week study. RESULTS: Saffron at this dose was found to be effective similar to imipramine in the treatment of mild to moderate depression (F = 2.91, d.f. = 1, P = 0.09). In the imipramine group anticholinergic effects such as dry mouth and also sedation were observed more often that was predictable. CONCLUSION: The main overall finding from this study is that saffron may be of therapeutic benefit in the treatment of mild to moderate depression. To the best of our knowledge this is the first clinical trial that supports this indication for saffron. A large-scale trial with placebo control is warranted

A Randomised Placebo-Controlled Trial of a Traditional Chinese Herbal Formula in the Treatment of Primary Dysmenorrhoea

BACKGROUND: Most traditional Chinese herbal formulas consist of at least four herbs. Four-Agents-Decoction (Si Wu Tang) is a documented eight hundred year old formula containing four herbs and has been widely used to relieve menstrual discomfort in Taiwan. However, no specific effect had been systematically evaluated. We applied Western methodology to assess its effectiveness and safety for primary dysmenorrhoea and to evaluate the compliance and feasibility for a future trial. METHODOLOGY/PRINCIPAL FINDINGS: A randomised, double-blind, placebo-controlled, pilot clinical trial was conducted in an ad hoc clinic setting at a teaching hospital in Taipei, Taiwan. Seventy-eight primary dysmenorrheic young women were enrolled after 326 women with self-reported menstrual discomfort in the Taipei metropolitan area of Taiwan were screened by a questionnaire and subsequently diagnosed by two gynaecologists concurrently with pelvic ultrasonography. A dosage of 15 odorless capsules daily for five days starting from the onset of bleeding or pain was administered. Participants were followed with two to four cycles for an initial washout interval, one to two baseline cycles, three to four treatment cycles, and three follow-up cycles. Study outcome was pain intensity measured by using unmarked horizontal visual analog pain scale in an online daily diary submitted directly by the participants for 5 days starting from the onset of bleeding or pain of each menstrual cycle. Overall-pain was the average pain intensity among days in pain and peak-pain was the maximal single-day pain intensity. At the end of treatment, both the overall-pain and peak-pain decreased in the Four-Agents-Decoction (Si Wu Tang) group and increased in the placebo group; however, the differences between the two groups were not statistically significant. The trends persisted to follow-up phase. Statistically significant differences in both peak-pain and overall-pain appeared in the first follow-up cycle, at which the reduced peak-pain in the Four-Agents-Decoction (Si Wu Tang) group did not differ significantly by treatment length. However, the reduced peak-pain did differ profoundly among women treated for four menstrual cycles (2.69 (2.06) cm, mean (standard deviation), for the 20 women with Four-Agents-Decoction and 4.68 (3.16) for the 22 women with placebo, p = .020.) There was no difference in adverse symptoms between the Four-Agents-Decoction (Si Wu Tang) and placebo groups. CONCLUSION/SIGNIFICANCE: Four-Agents-Decoction (Si Wu Tang) therapy in this pilot post-market clinical trial, while meeting the standards of conventional medicine, showed no statistically significant difference in reducing menstrual pain intensity of primary dysmenorrhoea at the end of treatment. Its use, with our dosage regimen and treatment length, was not associated with adverse reactions. The finding of statistically significant pain-reducing effect in the first follow-up cycle was unexpected and warrants further study. A larger similar trial among primary dysmenorrheic young women with longer treatment phase and multiple batched study products can determine the definitive efficacy of this historically documented formula. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN23374750

Biodiversity, traditional medicine and public health: where do they meet?

Given the increased use of traditional medicines, possibilities that would ensure its successful integration into a public health framework should be explored. This paper discusses some of the links between biodiversity and traditional medicine, and addresses their implications to public health. We explore the importance of biodiversity and ecosystem services to global and human health, the risks which human impacts on ecosystems and biodiversity present to human health and welfare

Targeting Outpatient Drug Safety Recommendations of the Dutch HARM-Wrestling Task Force

Background: Two Dutch observational studies (HARM [Hospital Admissions Related to Medication] and IPCI [Integrated Primary Care Information]) have shown that approximately 5% of all unplanned hospital admissions are associated with adverse drug events (ADEs), of which 40-46% are potentially preventable. These studies prompted the initiation of a Dutch multidisciplinary task force, which was assigned to reduce the number of prescriber-related hospital admissions related to medications (HARMs) in a quick-win way. Objective: The aim of the study was to identify the most relevant ADEs and to develop a limited number of recommendations for concrete interventions, which should be feasible and relatively easy to convert into computerized drug safety alerts. Method: To identify the major ADEs, crude data of HARM and IPCI were reanalysed and compared with different international studies, followed by structured literature searches for further characterization of the identified ADEs, their risk factors and potential risk-reduction strategies. Based on this information, the Task Force drew up general and drug-specific recommendations. As the recommendations of the Task Force are a mixture of evidence- and expert-based risk-reducing strategies, they have Results: Seven pharmacologically predictable ADEs associated with ten drug classes were responsible for more than half of all potentially preventable hospital admissions in the IPCI and HARM studies, which was comparable to the results of international studies. Gastrointestinal and other bleedings were the most frequent ADE, followed by disturbances of diabetes mellitus control, electrolyte disturbances, fractures, renal insufficiency and heart failure. Nine general and 34 drug-specific recommen Conclusions: As HARMs constitute a significant public health problem, the Task Force underlines the need to implement its recommendations as soon as possible. They do not replace existing guidelines, but reinforce, complement and fine-tune existing Dutch and international guidelines. Further research is still required to assess the cost consequences and cost effectiveness of some recommendations, and to monitor the implementation of the recommendations and their effect on the incidence of poten

Self-reported uptake of recommendations after dissemination of medication incident alerts

Introduction: In the Netherlands, a Central Medication Incidents Registration (CMR) system is operational. To prevent recurrence of reported medication incidents the CMR sends medication incident alerts with recommendations. It is up to the healthcare workers whether or not to implement the recommendations in clinical practice, which may lead to variations in degrees of uptake of the recommendations. Objective: The aim of this study was to explore the degree of self-reported uptake of the recommendations and to identify potential determinants associated with successful uptake. Design: This is a cross-sectional study conducted within a convenience sample of 33 Dutch hospital pharmacies. The study was carried out from April 2009 to September 2010. Measurements: Three alerts were selected for the study: administration of methotrexate in a dosage of once a day instead of once a week, administration of undiluted potassium-sodium-phosphate concentrate, and administration of glucose 50% instead of 5%. The primary outcome was the degree of self-reported uptake of the specific recommendations and the associations of the degree of uptake with several potential determinants. Results: Twenty-one hospitals (63.6%) had adopted all recommendations about methotrexate. A quarter of the hospitals (24.2%) had adopted all recommendations related to potassium-sodium-phosphate concentrate. For the alert about glucose 50%, none of the hospitals had implemented all the recommendations. No statistically significant associations between potential determinants and the degree of uptake were found. Conclusions: This study is the first to investigate the degree of uptake of the recommendations of three different CMR alerts. The alerts varied in the degrees of self-reported uptake of the recommendations, with the methotrexate alert having the highest degree of uptake. No significant associations with potential determinants were found

Communication during counseling sessions about inhaled corticosteroids at the community pharmacy

Jeanine A Driesenaar,1 Peter AGM De Smet,2,3 Rolf van Hulten,4,5 Litje Hu,1 Sandra van Dulmen1,6,7 1NIVEL, Netherlands institute for health services research, Utrecht, the Netherlands; 2Department of Clinical Pharmacy, Radboud University Medical Center, Nijmegen, the Netherlands; 3IQ Healthcare, Radboud University Medical Center, Nijmegen, the Netherlands; 4Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, the Netherlands; 5Department of Pharmacotherapy and Pharmaceutical Care, University of Groningen, Groningen, the Netherlands; 6Department of Primary and Community Care, Radboud University Medical Center, Nijmegen, the Netherlands; 7Faculty of Health Sciences, University College of Southeast Norway, Drammen, Norway Background: Pharmaceutical care is one of the major tasks of pharmacists, which aims to improve patient outcomes. Counseling patients with asthma or chronic obstructive pulmonary disease about their use of inhaled corticosteroids (ICS) might enhance medication adherence and symptom control. Therefore, effective pharmacist–patient communication is very important. In this regard, both affective communication, for handling emotions, and instrumental communication, for exchanging biomedical and lifestyle information, are relevant. Until now, only few studies have explored pharmacist–patient communication, and further insight is needed in this regard. The aim of this study is to investigate how pharmacists and pharmacy technicians communicate about ICS with patients with asthma and/or chronic obstructive pulmonary disease, what topics are discussed by them, and whether pharmacists and pharmacy technicians differ in their communication during counseling sessions. Methods: Patients aged ≥18 years who had used ICS for at least 1 year and filled at least two ICS prescriptions in the preceding year were recruited through 12 pharmacies. Participants had one counseling session with a pharmacist or a pharmacy technician, which was video-recorded. The process and content of the provider–patient communication were analyzed using the Roter interaction analysis system, adapted to the pharmaceutical setting. Results: A total of 169 sessions were recorded and analyzed. The communication appeared largely instrumental. Lifestyle, psychosocial issues, and ICS adherence were not discussed in detail. The pharmacists had longer conversations and more affective talk than the pharmacy technicians. Conclusion: Pharmacists and pharmacy technicians may need to pay more attention to ICS adherence, lifestyle, and psychosocial topics. They differed in their communication; the pharmacists exhibited more affective behavior and discussed medical and therapeutic issues more extensively compared to the pharmacy technicians. Educational courses for pharmacists and pharmacy technicians could focus more on the discussion of adherence, lifestyle, and psychosocial topics with patients. Keywords: community pharmacy, communication, inhaled corticosteroids, pharmacist–patient interaction, Roter interaction analysis syste