The dilemma of arranged marriages in people with epilepsy. An expert group appraisal.

INTRODUCTION: Matrimony remains a challenging psychosocial problem confronting people with epilepsy (PWE). People with epilepsy are less likely to marry; however, their marital prospects are most seriously compromised in arranged marriages. AIMS: The aim of this study was to document marital prospects and outcomes in PWE going through arranged marriage and to propose optimal practices for counseling PWE contemplating arranged marriage. METHODS: A MEDLINE search and literature review were conducted, followed by a cross-disciplinary meeting of experts to generate consensus. RESULTS: People with epilepsy experience high levels of felt and enacted stigma in arranged marriages, but the repercussions are heavily biased against women. Hiding epilepsy is common during marital negotiations but may be associated with poor medication adherence, reduced physician visits, and poor marital outcome. Although divorce rates are generally insubstantial in PWE, divorce rates appear to be higher in PWE undergoing arranged marriages. In these marriages, hiding epilepsy during marital negotiations is a risk factor for divorce. CONCLUSIONS: In communities in which arranged marriages are common, physicians caring for PWE are best-equipped to counsel them about their marital prospects. Marital plans and aspirations should be discussed with the family of the person with epilepsy in a timely and proactive manner. The benefits of disclosing epilepsy during marital negotiations should be underscored.

Nonpharmacological treatment of epilepsy.

Nonpharmacological treatment of epilepsy includes surgery, vagal nerve stimulation, ketogenic diet, and other alternative/complementary therapies, e.g., yoga, Ayurveda, electroencephalography (EEG) biofeedback technique, aerobic exercise, music therapy, transcranial magnetic stimulation, acupuncture, and herbal remedies (traditional Chinese medicine). Alternative therapies, despite the term, should not be considered as an alternative to antiepileptic medication; they complement accepted drug treatment. Alternative therapies like yoga, through techniques that relax the body and mind, reduce stress, improve seizure control, and also improve quality of life. Ketogenic diet is a safe and effective treatment for intractable epilepsies; it has been recommended since 1921. The diet induces ketosis, which may control seizures. The most successful treatment of epilepsy is with modern antiepileptic drugs, which can achieve control of seizures in 70-80% cases. Patients opt for alternative therapies because they may be dissatisfied with antiepileptic drugs due to their unpleasant side effects, the long duration of treatment, failure to achieve control of seizures, cultural beliefs and, in the case of women, because they wish to get pregnant Surgical treatment may lead to physical and psychological sequelae and is an option only for a minority of patients. This article presents supportive evidence from randomized controlled trials done to assess the benefit of non-pharmacological treatment.

A randomized double blind placebo controlled clinical evaluation of extract of Andrographis paniculata (KalmCold) in patients with uncomplicated upper respiratory tract infection.

A randomized, double blind placebo controlled clinical study was conducted to evaluate the efficacy of KalmCold, an extract of Andrographis paniculata, in patients with uncomplicated upper respiratory tract infection (URTI). The assessment involved quantification of symptom scores by Visual Analogue Scale. Nine self evaluated symptoms of cough, expectoration, nasal discharge, headache, fever, sore throat, earache, malaise/fatigue and sleep disturbance were scored. A total of 223 patients of both sexes were randomized in two groups which received either KalmCold (200 mg/day) or placebo in a double blind manner. In both the treatments, mean scores of all symptoms showed a decreasing trend from day 1 to day 3 but from day 3 to day 5 most of the symptoms in placebo treated group either remained unchanged (cough, headache and earache) or got aggravated (sore throat and sleep disturbance) whereas in KalmCold treated group all symptoms showed a decreasing trend. Within groups, mean scores of symptoms in both the groups decreased significantly (p < or = 0.05) from day 1 to day 3 and day 5 while from day 3 to day 5 all symptoms except expectoration in placebo group did not improve significantly whereas in KalmCold treated group all symptoms improved significantly (p < or = 0.05) except earache. Comparing mean between both groups, all symptoms at day 1 and day 3 were found to be the same while at day 5 all symptoms except earache in KalmCold treated group improved significantly (p < or = 0.05) than placebo group. Similarly, within groups, overall scores of all symptoms in both the groups decreased significantly (p < or = 0.05) from day 1 to day 3 and day 5 while from day 3 to day 5 placebo group did not improve significantly whereas KalmCold treated group showed significant improvement (p < or = 0.05). On between groups analysis, KalmCold group showed significant reduction (p < or = 0.05) in overall symptom scores as compared to placebo group. In both placebo and KalmCold treated groups, there were only a few minor adverse effects with no significant difference in occurrence (Z = 0.63; p > 0.05). The comparison of overall efficacy of KalmCold over placebo was found to be significant (p < or = 0.05) and it was 2.1 times (52.7%) higher than placebo. The findings of this study revealed that KalmCold was effective in reducing symptoms of upper respiratory tract infection.

Safety evaluation of BacoMind in healthy volunteers: a phase I study.

BacoMind is an enriched phytochemical composition of Bacopa monniera (B. monniera), a common medicinal plant used in the traditional systems of medicine as a memory-enhancing agent. BacoMind was standardized with reference to bioactive compounds and was evaluated for short-term safety and tolerability in healthy adult volunteers. The study plan employed randomized, open label, dose escalation design. Each of 23 participants were orally given one single capsule of BacoMind daily for 30 days, i.e., 300 mg for first 15 days and 450 mg for next 15 days. Detailed examination of clinical, hematological, biochemical and electrocardiographic parameters done in pre and post-treatment periods did not indicate any untoward effects in any of the treated volunteers. Mild adverse events related to gastrointestinal system were observed in the trial, which subsided spontaneously. BacoMind was found to meet the safety criteria at the dose administered for the given duration of trial period in healthy adult volunteers.

Anti-inflammatory activities of Aller-7, a novel polyherbal formulation for allergic rhinitis.

Allergic rhinitis is an immunological disorder and an inflammatory response of nasal mucosal membranes. Allergic rhinitis, a state of hypersensitivity, occurs when the body overreacts to a substance such as pollens or dust. A novel, safe polyherbal formulation (Aller-7/NR-A2) has been developed for the treatment of allergic rhinitis using a unique combination of extracts from seven medicinal plants including Phyllanthus emblica, Terminalia chebula, Terminalia bellerica, Albizia lebbeck, Piper nigrum, Zingiber officinale and Piper longum. Since inflammation is an integral mechanistic component of allergy, the present study aimed to determine the anti-inflammatory activity of Aller-7 in various in vivo models. The efficacy of Aller-7 was investigated in compound 48/80-induced paw edema both in Balb/c mice and Swiss Albino mice, carrageenan-induced paw edema in Wistar Albino rats and Freund's adjuvant-induced arthritis in Wistar Albino rats. The trypsin inhibitory activity of Aller-7 was also determined and compared with ovomucoid. At a dose of 250 mg/kg, Aller-7 demonstrated 62.55% inhibition against compound 48/80-induced paw edema in Balb/c mice, while under the same conditions prednisolone at an oral dose of 14 mg/kg exhibited 44.7% inhibition. Aller-7 significantly inhibited compound 48/80-induced paw edema at all three doses of 175, 225 or 275 mg/kg in Swiss Albino mice, while the most potent effect was observed at 225 mg/kg. Aller-7 (120 mg/kg, p.o.) demonstrated 31.3% inhibition against carrageenan-induced acute inflammation in Wistar Albino rats, while ibuprofen (50 mg/kg, p.o.) exerted 68.1% inhibition. Aller-7 also exhibited a dose-dependent (150-350 mg/kg) anti-inflammatory effect against Freund's adjuvant-induced arthritis in Wistar Albino rats and an approximately 63% inhibitory effect was observed at a dose of 350 mg/kg. The trypsin inhibitory activity of Aller-7 was determined, using ovomucoid as a positive control. Ovomucoid and Aller-7 demonstrated IC50 concentrations at 1.5 and 9.0 microg/ml, respectively. These results demonstrate that this novel polyherbal formulation is a potent anti-inflammatory agent that can ameliorate the symptoms of allergic rhinitis.

Antioxidant properties of Aller-7, a novel polyherbal formulation for allergic rhinitis.

Allergic rhinitis, a frequently occurring immunological disorder affecting men, women and children worldwide, is a state of hypersensitivity that occurs when the body overreacts to a substance such as pollen, mold, mites or dust. Allergic rhinitis exerts inflammatory response and irritation of the nasal mucosal membranes leading to sneezing; stuffy/runny nose; nasal congestion; and itchy, watery and swollen eyes. A novel, safe polyherbal formulation (Aller-7/NR-A2) has been developed for the treatment of allergic rhinitis using a unique combination of extracts from seven medicinal plants including Phyllanthus emblica, Terminalia chebula, Terminalia bellerica, Albizia lebbeck, Piper nigrum, Zingiber officinale and Piper longum. In this study, the antioxidant efficacy of Aller-7 was investigated by various assays including hydroxyl radical scavenging assay, superoxide anion scavenging assay, 1,1-diphenyl-2-picryl hydrazyl (DPPH) and 2,2-azinobis-ethyl-benzothiozoline-sulphonic acid diammonium salt (ABTS) radical scavenging assays. The protective effect of Aller-7 on free radical-induced lysis of red blood cells and inhibition of nitric oxide release by Aller-7 in lipopolysaccharide-stimulated murine macrophages were determined. Aller-7 exhibited concentration-dependent scavenging activities toward biochemically generated hydroxyl radicals (IC50 741.73 microg/ml); superoxide anion (IC50 24.65 microg/ml by phenazine methosulfate-nicotinamide adenine dinucleotide [PMS-NADH] assay and IC50 4.27 microg/ml by riboflavin/nitroblue tetrazolium [NBT] light assay), nitric oxide (IC50 16.34 microg/ml); 1,1-diphenyl-2-picryl hydrazyl (DPPH) radical (IC50 5.62 microg/ml); and 2,2-azinobis-ethyl-benzothiozoline-sulphonic acid diammonium salt (ABTS) radical (IC50 7.35 microg/ml). Aller-7 inhibited free radical-induced hemolysis in the concentration range of 20-80 microg/ml. Aller-7 also significantly inhibited nitric oxide release from lipopolysaccharide-stimulated murine macrophages. These results demonstrate that Aller-7 is a potent scavenger of free radicals and that it may serve.

Multicenter clinical trials on a novel polyherbal formulation in allergic rhinitis.

Allergic rhinitis is the most frequently occurring immunological disorder. It affects men, women and children and represents significant cost in terms of suffering and loss of productivity. Allergy is termed as an excessive reaction to an environmental allergen. Pollen, mold, dust, mite and animal allergens that contact the nasal or eye lining cause sneezing, nasal congestion and itchy, watery, swollen, red eyes. Although a broad spectrum of therapeutic options is available, the treatment of allergic rhinitis appears to be far from satisfactory. A novel polyherbal formulation (PF; Aller-7/NR-A2) comprising seven medicinal herbal extracts was assessed in a multicenter clinical trial involving 545 patients (321 males and 224 females) aged 18-59 years for 12 weeks to evaluate its clinical efficacy in patients suffering from allergic rhinitis. A total of 171 patients participated in double-blind, randomized, placebo-controlled studies in three centers, while 374 patients were included in the open-label studies in 11 centers. The three major symptoms (sneezing, rhinorrhea and nasal congestion) of allergic rhinitis were significantly reduced. Significant improvement was also observed in absolute eosinophil count, mucociliary clearance time, peak expiratory flow rate and peak nasal flow rate. No serious adverse events that warranted cessation of treatment were observed. Minor adverse effects were noted in both the treatment and placebo groups. Thus, this study demonstrates that Aller-7/NR-A2 is well tolerated and efficacious in patients with allergic rhinitis.

Safety of a novel botanical extract formula for ameliorating allergic rhinitis.

Allergic rhinitis (also known as hay fever) is the most commonly occurring immunological disorder, and it affects 40 million men, women, and children in the United States. Symptomatically, it is an inflammation and irritation of the mucous membranes that line the nose. Allergy is defined as a state of hypersensitivity or hyperimmunity caused by exposure to a particular antigen (allergen) that results in increased reactivity upon subsequent exposure. A novel botanical formulation, Aller-7/NR-A2, was developed for the treatment of allergic rhinitis; it is a combination of medicinal plant extracts from Phyllanthus emblica, Terminalia chebula, Terminalia bellerica, Albizia lebbeck, Piper nigrum, Zingiber officinale, and Piper longum. This novel formulation has demonstrated potent antihistaminic, anti-inflammatory, antispasmodic, antioxidant, and mast-cell-stabilization activities. All of the doses for these toxicity studies were selected according to the guidelines of the Organization for Economic Cooperation and Development, the World Health Organization, and the Environmental Protection Agency. Acute toxicity of Aller-7 was evaluated in Swiss Albino mice at doses of 125, 250, 500, 1000, and 1500 mg/kg. After 15 days of treatment, the animals were sacrificed. No histopathological changes were observed in major vital organs. A similar study was conducted in Albino Wistar rats, which were sacrificed at the end of 15 days. No histopathological changes or toxicity was observed at up to 2 g/kg body weight. Subacute toxicity was conducted in Albino Wistar rats at a dose of 90 mg/kg body weight for 3 days, then at 180 mg/kg for the next 3 days, and then at 270 mg/kg for 3 weeks. After 28 days, the animals were sacrificed and tested; no toxicity was observed. In a subchronic toxicity study, there was no observed adverse effect level at 1 g/kg body weight in rats. In a teratological assay, at doses of 3.0 g/kg (20 times the recommended dose) and 1.8 g/kg, respectively, no visceral or skeletal anomalies were observed in the fetuses. No maternal changes were observed when Aller-7 was administered during gestation and lactation. No evidence of mutagenicity was observed at doses up to 5000 mug per plate of Aller-7 in Salmonella typhimurium cells. The present study evaluated the safety of Aller-7 by conducting several in vitro and in vivo studies. Further studies of the 90-day chronic toxicity of Aller-7 are currently in progress.

Mast cell stabilization, lipoxygenase inhibition, hyaluronidase inhibition, antihistaminic and antispasmodic activities of Aller-7, a novel botanical formulation for allergic rhinitis.

Allergic rhinitis, also known as hay fever, rose fever or summer catarrh, is a major challenge to health professionals. A large number of the world's population, including approximately 40 million Americans, suffers from allergic rhinitis. A novel, botanical formulation (Aller-7) has been developed for the treatment of allergic rhinitis using a combination of extracts from seven medicinal plants, including Phyllanthus emblica, Terminalia chebula, T. bellerica, Albizia lebbeck, Piper nigrum, Zingiber officinale and P. longum, which have a proven history of efficacy and health benefits. The clinical manifestations of allergy are due to a number of mediators that are released from mast cells. The effect of Aller-7 on rat mesenteric mast cell degranulation was studied by incubating different concentrations of Aller-7 and challenging them with a degranulating agent, compound 48/80. The inhibitory activity of Aller-7 was determined against lipoxygenase and hyaluronidase, the key enzymes involved in the initiation and maintenance of inflammatory responses. Furthermore, most of these manifestations are due to histamine, which causes vasodilatation, increasing capillary permeability and leading to bronchoconstriction. Hence, the antihistaminic activity of Aller-7 was determined is isolated guinea pig ileum substrate using cetirizine as a positive control. The antispasmodic effect of Aller-7 on contractions of guinea pig tracheal chain was determined using papaverine and cetirizine as controls. Aller-7 exhibited potent activity in all these in vitro models tested, thus demonstrating the novel anti-allergic potential of Aller-7.

Using simulation data to predict lung geometry for inhomogeneity corrections in breast cancer treatments.

PURPOSE: To develop a statistical model based only on simulation measurement data, to predict the lung geometry in the central slice of the tangential radiation treatment fields for breast cancer. METHODS AND MATERIALS: A linear regression analysis was performed on 22 patients to determine the shape of lung in the central axis plane of the tangential radiation fields. Data collected include the greatest perpendicular distance (GPD) measured from the chest wall to the field border on computed tomography (CT) images, the central lung distance (CLD) measured from the posterior field border to the chest wall on the simulation portal images, and the lung contours digitized at 1 cm intervals. The lung contours of these patients were fitted to a parabolic curve through a polynomial regression model. A lung template based on the regression model is used to construct a "generic lung" contour on patients' external body contours for treatment planning. The accuracy of this technique was tested on another group of 15 patients for its ability to predict the shape of lung on the central axis plane and the accuracy of dose to the prescription point. RESULTS: The polynomial regression indicates that all the patients' lung contours in the tangential fields follow a parabolic curve: Y = -0.0808 X2 + 0.0096 X + 0.0326. The maximum lung involvement (GPD) can be determined from the value of CLD measured on the simulation film by the linear regression model with a determination coefficient of 0.712. The 15-patient test results indicate that our model predicts the lung separation on the central axis with an average deviation of 1.35 cm, and the average absolute dose deviation to the dose prescription point is 1.46%. CONCLUSION: The model presented in this article provides an efficient method to estimate the lung geometry for breast cancer treatment planning without the requirement of CT data. The lung contour predicted by our model is useful for calculating dose distributions with inhomogeneity correction and may potentially benefit patients at higher risk of pulmonary toxicity.

Long-term results of curative irradiation in pathologically staged IA and IIA Hodgkin disease.

One hundred seventy-six patients with pathologically staged IA and IIA Hodgkin disease (HD) treated with irradiation alone were evaluated for long-term survival and freedom from relapse (FFR). Most of the patients received treatment to mantle and paraaortic fields; chemotherapy was not given except as salvage therapy. For pathologically staged IA disease, the 5-, 10-, and 15-year survival rates were 94%; the corresponding FFR rates were 96%, 93%, and 93%. For pathologically staged IIA disease, respective survival rates were 93%, 89%, and 80%, with FFR rates of 86%, 84%, and 84%. Twenty-one patients (12%) had relapse of HD; salvage therapy was successful in 11 of these patients. Pelvic recurrence was uncommon (three of 176 cases [2%]). No patient developed leukemia, and only two patients developed second malignancies (lung cancer in both cases). The authors conclude that radiation therapy is effective in treatment of early-stage HD.

Results of radiotherapeutic management of primary carcinoma of the vagina.

Forty-five previously untreated patients with primary carcinoma of the vagina were treated with curative radiotherapy from 1965 through 1985. All patients were staged according to the FIGO system. One patient was classified as Stage 0, 15 as Stage I, 22 as Stage II, 6 as Stage III, and 1 as Stage IV. Treatment consisted of intracavitary irradiation alone in Stage 0 patients. Stage I patients received intracavitary/interstitial irradiation alone or in combination with external irradiation and an implant when feasible. When treated with an implant only, the total tumor dose delivered was between 65-70 Gy. External irradiation consisted of delivering a dose of 45-50 Gy over a period of 4 1/2-5 weeks to the whole pelvis to treat the regional lymph nodes. An additional dose of 20-25 Gy was delivered to the site of original involvement using an implant when feasible. If not technically feasible, as in advanced stages, the patient was treated with additional external irradiation to a total dose of 65-70 Gy by a shrinking field technique. All patients except one were followed either until death or for a minimum of 2 years. The actuarial 5-year survival rates were 100% for Stage 0, 78% for Stage I, and 71% for Stage II patients. None of the patients with Stage III or IV disease survived. Of the patients who recurred, all but two did so within 16 months after diagnosis. Pelvic recurrence as the first site of recurrence occurred in 86% of the patients who recurred. Distant recurrence as a component occurred in 20% of all failures. Complications as a consequence of therapy occurred in 18% of the patients. Vaginal necrosis that healed with conservative treatment was seen in four patients and the other four patients had rectal complications of varying severity. Thus, curative radiotherapy is an effective method of treatment, with acceptable morbidity, in patients with early stage primary carcinoma of the vagina.

Stage I and II non-Hodgkin's lymphomas: long-term results of radiation therapy.

One hundred and sixteen patients with Stages I and II non-Hodgkin's lymphomas were treated with curative radiotherapy between 1964 and 1977. The initial biopsy material was classified according to the criteria of Rappaport et al. All the patients except six were followed for a minimum of 8 years or until death with ninety-two patients having been followed for 10 or more years. Histological pattern was found to be an important prognostic factor with better survival in patients with nodular histology. There were forty-three patients with an initial involvement of an extra-nodal site forming 37% of the total group. Stage I extra-nodal lymphomas had a survival and recurrence-free survival rates of 80% and 74% respectively, similar to those of nodal lymphomas. Stage II patients in both groups did worse than those with Stage I. Survival rates and disease-free survival rates for different histologic types and their pattern of recurrence are presented.

Radiation therapy in primary carcinoma of the vagina.

A retrospective analysis of 32 patients with carcinoma of the vagina treated with curative radiotherapy between 1965 and 1981 is presented. Squamous cell carcinoma was the most common histologic type, found in 78% of the patients. Patients were staged according to the FIGO system. Stage I and II disease was found in 8 and 18 patients, respectively. Six patients had either Stage III or IV disease. The absolute survival rate was 100% for Stage I and 72% for Stage II patients. The pattern of failure was analyzed. All patients who failed had done so within 14 months of completion of treatment. Treatment failure in the pelvis occurred only in 16% of the patients with early disease (Stages I and II) while 81% of the patients with late stage had failed in the pelvis.

Malignant metastatic disease of the eye: management of an uncommon complication.

Twenty-four patients with metastatic cancer of the choroid were seen in the Department of Therapeutic Radiology, Rush-Presbyterian--St. Luke's Medical Center, Chicago, between 1964 and 1975. One fourth of the patients had involvement in both eyes, for a total of 30 eyes involved with metastatic cancer. The most common site of the primary carcinoma was the breast. Most of the patients had inadequate vision, proptosis, pain, heaviness, and double vision. Retinal detachment was a common finding. All the patients received a palliative course of radiotherapy to the posterior chamber of the eye; between 2100--3000 rad in 7/10 fractions were given. Of the patients, 33% had complete recovery of symptoms, and 37% had only partial recovery; 30% showed no response to therapy. Survival period from the time of radiotherapy to death varied from one to 21 months, with a median of four months and a mean of 6.6 months. All patients responding to therapy showed marked improvement in their quality of life until death.

Late effects of para-aortic irradiation in carcinoma of the uterine cervix and endometrium.

Twenty-one patients with cervical or endometrial carcinoma and metastases to the para-aortic lymph nodes were treated with extended-field para-aortic irradiation. The late effects of this treatment were evaluated in 16 patients who had a minimum follow-up of six months. All of the patients with massive pelvic tumours died of active disease in the pelvis with or without metastases. Three patients had small-bowel complications; none of the patients who underwent exploratory laparotomy for lymph node biospy had bowel complications. The results indicate that patients with central lesions and minimal para-aortic disease benefit most from para-aortic irradiation. It is concluded that metastases to the para-aortic lymoh nodes do not necessarily indicate more distant spread, and can be cured with irradiation. The late complication rate can be minimized by reducing the dosage to the small bowel with a combination of anterior-posterior fields and 360 degree rotation or opposing lateral 120 degree arc fields, and by using the extraperitoneal approach for lymph node biopsy.

Early nodal and extra-nodal non-Hodgkin's lympnomas.

There were 54 Stage I and 38 Stage II patients with non-Hodgkin's lymphomas treated with curative radiotherapy between 1964 and 1975. The initial biopsy material was reclassified according to the criteria of Rappaport el at.10 The frequency of nodular vs diffuse histological pattern was 26% vs 74%. The survival and recurrence free survival were significantly superior for the nodular pattern as compared with diffuse in both Stages I and II. The sites of first recurrence were evaluated. Fourteen out of 20 Stage I and 18 out of 26 Stage II patients recurred in one of the nodal areas only as their first site of recurrence. In 50%, this was in contiguous lymph node areas only. Extra-nodal non-Hodgkin's lymphomas survival and recurrence-free survival rates at five years were identical.