Evaluation of a Polyherbal Formulation on the Management of Migraine Headaches due to Functional Dyspepsia: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.

A holistic concept based on traditional Persian medicine (TPM) describes a headache with a gastrointestinal (GI) origin (gastric-headache). Although the neurological manifestations of this headache are similar to those of other headaches, its etiology is different. Considering its simultaneous effects on the brain and GI system, a formulation was designed based on this concept. This study aimed to determine the safety and efficacy of the designed formulation on migraine headache (MH) associated with functional dyspepsia (FD). A total of 75 diagnosed cases of MH patients with concurrent FD were randomly divided equally into 3 groups: (i) the polyherbal formulation, sodium valproate (VPA), and amitriptyline group, (ii) VPA, amitriptyline, and polyherbal formulation placebo group, and (iii) the polyherbal formulation and VPA placebo group. The primary outcomes, including frequency, duration, and severity of MH attacks, were measured at baseline and weeks 4, 8, and 12. However, secondary outcomes, including the Headache Impact Test 6 (HIT-6) Questionnaire and Parkman's score, were evaluated at baseline and end of treatment. The frequency, duration, and severity of migraine (P < 0.001 for all cases), HIT-6 (P < 0.001 for all cases), and FD (P < 0.001 for all cases) scores at the end of treatment showed a significant decrease in the 3 groups compared to the baseline. However, the differences in those variables between the 3 groups were not significant at the end of the study. The polyherbal formulation alone may improve the symptoms of migraine patients and other groups. This effect could be due to improving digestion and FD in migraine patients.

The efficacy of camel milk and Tarangabin (manna of Alhagi maurorum( combination therapy on glomerular filtration rate in patients with chronic kidney disease: A randomized controlled trial.

OBJECTIVE: This study was designed to investigate the effect of camel milk and Tarangabin (manna of Alhagi maurorum) combination therapy in addition to conventional treatments in patients with chronic kidney disease (CKD). MATERIALS AND METHODS: Forty-four patients of 15 to 70 years old, with CKD due to hypertension or diabetes, and estimated glomerular filtration rate (eGFR) of 15-60 ml/min per 1.73 m2, were enrolled in this trial. The patients were randomized to receive either 400 cc of camel milk with 10 cc of Tarangabin syrup orally in two divided daily doses for 3 months plus conventional therapy or conventional therapy alone. The conventional treatment included diabetes medications and angiotensin converting enzyme inhibitors or angiotensin receptor blockers. RESULTS: The baseline characteristics of patients were similar in the two groups. Serum levels of creatinine (p=0.01), blood levels of urea nitrogen (p=0.0001), triglyceride (p=0.02), and potassium (p=0.05), and diastolic blood pressure (p=0.0001) decreased, while eGFR (p=0.001) improved in intervention group significantly. CONCLUSION: It seems that the therapeutic protocol used in this study can improve renal function in patients with CKD through regulating glucose and anti-inflammatory, laxative, and immunostimulatory properties.

Comparing Effectiveness of a Combined Herbal Drug Based on Echium Amoenum with Citalopram in the Treatment of Major Depressive Disorder.

BACKGROUND: According to new studies, only 60% of depressed patients respond to pharmaceutical treatment while suffering from their side effects. Natural products as adjuvant or alternative therapies should be examined to find safer and more effective ways to cope with depression. OBJECTIVE: To find out the potential benefits of a combined herbal drug based on Echium amoenum compared with citalopram in the treatment of Major Depressive Disorder. DESIGN AND SETTING: In psychiatry clinics of Mashhad University of Medical Sciences, 50 patients who met the criteria for Major Depressive Disorder based on DSM-5 were studied in a parallel randomized controlled trial. INTERVENTION: Subjects were randomly assigned to receive Echium amoenum compound syrup (EACS) or citalopram tablet for 8 weeks. OUTCOME MEASURES: The efficacy of treatments and recurrence of disease were surveyed and compared according to Hamilton depression rating scale at weeks 0, 4, 8, 12. RESULTS: Patients in both groups of citalopram and EACS showed remarkable reduction in scores of Hamilton questionnaire. At the eighth week of treatment, the mean scores in EACS group were significantly lower than citalopram group (p-value = 0.03). 52% of patients suffered from various complications in citalopram group while just 12% of patients in EACS group reported few complications. CONCLUSION: Clinical efficacy of this herbal drug was significantly higher than citalopram, and complications were also less and lower in EACS group. Further studies with larger groups and para-clinical assessments such as serologic tests and QEEG would improve our understanding of the impacts and mechanisms of EACS.

Comparison of the therapeutic effect of the Persian Medicine Protocol with the common treatment of chronic rhinosinusitis: a randomized clinical trial.

BACKGROUND: Chronic rhinosinusitis is one of the most common diseases affecting the quality of life of patients. Patients suffer from high costs in the diagnosis and treatment of the disease. Frequent recurrence and failure of therapeutic protocols are among the most important issues in the management of this disease. In view of this, the use of traditional and complementary therapies to promote the treatment of this disease has been increasingly taken into account. OBJECTIVE: Comparison of the effectiveness of the Persian Medicine Protocol with the conventional therapy in the treatment of chronic rhinosinusitis. METHODS: A randomized clinical trial was conducted at Imam Reza Hospital in Mashhad, Iran from July 2016 to March 2017. For patients with chronic rhinosinusitis symptoms, endoscopy of the sinuses was performed by an ENT specialist and in the case of negative endoscopy, paranasal sinus CT scan was requested. A total of 42 patients with chronic rhinosinusitis were randomly assigned to two groups. The first group (classical) received systemic and intranasal cortisone, and the second group (traditional) received a therapeutic Persian medicine protocol including intranasal lavender oil, and Liquorice Marjoram Tea (L. M. tea) for six weeks. The symptoms of the patients were evaluated using the SNOT-22 questionnaire at the beginning of the study and at the sixth week. If no improvement occurs, treatment continued for 12 weeks. Data were analyzed by SPSS version 16, using ANOVA, independent-samples and paired-samples t-test, Wilcoxon signed-rank test, and simple linear regression. RESULTS: In 20 patients in the traditional group, the decrease in SNOT score was observed as 56% after 6 weeks treatment (p=0.001), which is similar to the effect of the first group (classical). Although there was no statically significant difference between the two groups, in clinical terms, the difference in mean systemic symptoms such as confusion with 1.05 (p=0.5) and fatigue with 1.63 (p=0.01) had more improvement in the traditional group, and the difference in mean local symptoms such as nasal congestion with 2.37 (p=0.78) and runny nose with 1.95 (p=0.14) had a more decrease in the classical group. CONCLUSION: The results of this trial indicate the effectiveness of the Persian Medicine Protocol (including Lavender oil and L.M tea) in the treatment of chronic rhinosinusitis, especially on improving systemic symptoms. Nevertheless more clinical studies are necessary to support the acquired results. TRIAL REGISTRATION: This trial was registered at the Iranian Center for Clinical Trials (ID: IRCT2015112425217N1). FUNDING: This research is part of a PhD thesis and is funded by the Vice-Chancellor for Research at Mashhad University of Medical Sciences, Grant No. 931673.

Effect of vaginal suppository on bacterial vaginitis based on Persian medicine (Iranian traditional medicine): a randomised double blind clinical study.

This trial was conducted on 127 women aged 18-50 years with bacterial vaginosis to compare the vaginal suppository of metronidazole with Forzejeh, a vaginal suppository of herbal Persian medicine combination of Tribulus terrestris, Myrtus commuis, Foeniculum vulgare and Tamarindus indica. The patients (63 in metronidazole group and 64 in Forzejeh group) received the medications for 1 week. Their symptoms including the amount and odour of discharge and cervical pain were assessed using a questionnaire. Cervical inflammation and Amsel criteria (pH of vaginal discharge, whiff test, presence of clue cells and Gram staining) were investigated at the beginning of the study and 14 days after treatment. The amount and odour of discharge, Amsel criteria, pelvic pain and cervical inflammation significantly decreased in Forzejeh and metronidazole groups (p = <.001). There was no statistically significant difference between the metronidazole and Fozejeh groups with respect to any of the clinical symptoms or the laboratory assessments. This study showed that Forzejeh, which is an herbal Persian medicine preparation, has a therapeutic effect the same as metronidazole in bacterial vaginosis. Impact statement What is already known on this subject? Bacterial vaginosis (BV) is a common problem in women. Common antibiotics for the treatment of BV include: metronidazole, tinidazole and clindamycin. Unfortunately, treatments often occur with a recurrence and failure. Therefore, alternative treatments are necessary. Many natural treatments are recommended for this condition in Persian Traditional Medicine sources. One of them is the vaginal suppository "Forzejeh" which is the combination of Tribulus terrestris, Myrtus commuis, Foeniculum vulgare and Tamarindus indica. These plants have antimicrobial activities. Forzejeh has been used for the treatment of BV in folk medicine for many years and has been formulated and standardised recently. What do the results of this study add? This study showed that the therapeutic effect of Forzejeh on bacterial vaginosis is similar to metronidazole. What are the implications of these findings for clinical practice and/or further research? A clinical study with a longer follow-up time is suggested for assessing the recurrence of BV after treatment with Forzejeh metronidazole.

Depression from the perspective of modern and Persian medicine.

BACKGROUND: Depression is one of the five most-common diseases globally, and is expected to be the second leading cause of disability by 2020 and its economic and social burden is a major problem worldwide. OBJECTIVE: The aim of this research was to elucidate the causes and symptoms of depression according to Persian Medicine (PM) and classic medicine. METHODS: In this study, works that were investigated were the Canon of Medicine, Al-Hawi Fi Teb, Kamel Al-Sina'a, Zakhireh Kharazmshahi and Exir A'azam. Classic medicine sources investigated were Kaplan and Sadock's Synopsis of Psychiatry and related articles in the Web of Science, Medline, Scopus, SID and Magiran. Research was done from January through April 2017, using keywords. RESULTS: To explain the biologic causes, various factors including humoral dystemperaments, cold and hot dystemperaments of chief organs especially heart and brain and some qualitative and quantitative changes in medical spirit should be considered. According to manuscripts some mental-emotional events in life can cause these changes. They independently may cause depression. Semiologically some symptoms and signs happen consequently to in the above-mentioned causes which are in common with depression signs and symptoms including grief, crying, low libido, weight loss, appetite and sleep disorders, exhaustion, slow cognitive processing, indecisiveness and willingness to die. CONCLUSION: The major biological causes of depression is a group of dystemperamental syndromes (hot, cold, dry, and wet) on different bodily structures (humors, organs, and spirits). So preventive and therapeutic strategies for depression couldn't be the same for all patients and the treatment should be designed according to the exact diagnosis.

A systematic review of randomized controlled trials with herbal medicine on chronic rhinosinusitis.

Chronic rhinosinusitis (CRS) is a common disease with evidence to show that its incidence and prevalence are increasing. Medicinal plants are commonly used to treat CRS. This systematic review aimed to assess the effectiveness and safety of herbal preparations for treatment of the patients with CRS. Cochran, Embase, ISI, PubMed, and Scopus databases were searched until August 1, 2016. Only randomized controlled trials were included. Four randomized controlled trials were included in this systematic review. Various medicinal plants were studied in each article. Inclusion and exclusion criteria, and outcome measures varied among different articles. The results of this trials showed that this special medicinal plants may be effective in the treatment of CRS. No serious reactions were reported during the administration of herbal remedies in the 4 studies. However, trials with a well-designed approach are needed to study the actual safety and efficacy of herbs in the treatment of CRS.

A Viewpoint on the Leaky Gut Syndrome to Treat Allergic Asthma: A Novel Opinion.

Asthma is a common respiratory disease characterized by airway inflammation, airway hyperreactivity, and reversible airflow obstruction. Despite current treatments, the prevalence of asthma has increased markedly over decades. According to the theories proposed to explain the pathophysiology of autoimmune diseases in integrative medicine, leaky gut syndrome is a phenomenon of increased intestinal permeability due to the disruption of tight junctions and is thought to be related to many chronic diseases, such as food intolerance, inflammatory bowel disease, rheumatoid arthritis, asthma, and other autoimmune disease. One of the classical approaches used by integrative physicians to treat leaky gut syndrome is to repair intestinal permeability to prevent allergic cascade. Due to several mechanisms that have been mentioned in the protective effects of plant gums and plantain family seeds on the intestinal epithelium, we can propose an effective management for leaky gut syndrome to treat asthma.

Categorization of Functional Constipation in Traditional Persian Medicine: A Descriptive Study.

Functional constipation (FC) is a common clinical condition without any specific physiological causes with economic cost and adverse effects on patients' quality of life. The present study aimed to evaluate the causes of nonobstructive constipation in traditional Persian medicine and its prevalence in patients with functional constipation by content analysis of patients' interviews and clinical exams. In this study, almost two thirds of the patients with functional constipation had mild to severe cold distemperament of the gastrointestinal system, and in almost half of them the signs and symptoms were compatible with dry distemperament of the gastrointestinal. This observational study reports high prevalence of gastrointestinal system distemperaments in patients with functional constipation. According to the results, we can consider the proposed management of distemperaments in traditional Persian medicine for functional constipation treatment and pathophysiology explanation. This project is a novel study that provides the opportunity for investigating the epidemiological aspects of these distemperaments and their relationship with functional constipation.

Efficacy of the Malva sylvestris L. flowers aqueous extract for functional constipation: A placebo-controlled trial.

OBJECTIVE: To evaluate the efficacy of Malva sylvestris L. flowers extract for treatment of FC. METHOD: Adults with FC were allocated to receive the M. sylvestris L. flowers aqueous extract syrup (MSL, 1 g extract/day) or placebo for four weeks. Frequency of constipation symptoms and stool forms were assessed every week. Self-reported improvement was assessed after treatment. RESULTS: Compared with placebo, more increase was observed in defecation frequency (F = 18.8, P < 0.001) and more decrease was observed in frequency of all constipation symptoms by MSL (F = 16.5 to 25.3, all P values <0.001). Also, the MSL group experienced more reduction in frequency of hard stool forms (45.4% vs. 9.1%, P < 0.001) and reported more improvement in all symptoms (all P values <0.01) than placebo. CONCLUSION: The M. sylvestris L. flowers aqueous extract is efficacious and safe for the treatment of FC in adult patients. Investigating the mechanisms of action is warranted. IRCT2014031617032N1.