China rubra for side-effects of quinine: a prospective, randomised study in pregnant women with malaria in Cotonou, Benin.

BACKGROUND: In endemic areas, gestational malaria is responsible for low birth weight and maternal anaemia. Quinine is the reference treatment for acute malaria in pregnant women, irrespective of term. However, quinine administration is associated with various side-effects. We evaluated the impact of the homeopathic medicine China rubra 7CH on the side-effects of quinine used as treatment for acute malaria in pregnant women in Cotonou, Benin. METHODS: This prospective, comparative, randomised study was carried out between June and December 2007 in the Saint Jean-Baptiste Medical Centre, Cotonou. Women were included if they were >3 months pregnant and had a clinical diagnosis of malaria confirmed by a positive thick blood smear. The study population was divided into two groups: (i) patients who presented between the 1st and 15th of each month and who received China rubra 7CH plus quinine (China group); and (ii) patients who presented from the 16th to the end of each month and who received treatment with quinine only (Standard group). The aim was to compare the frequency of side-effects of quinine in the two groups until day 6 after the start of treatment. Neither the patients nor the care givers were blinded to study treatment. Statistical comparison of the two groups was carried out with an alpha risk fixed at 5%. RESULTS: 211 women were recruited: 105 received quinine plus China rubra 7CH (China group) and 106 received quinine only (Standard group). A decrease in proportion of patients presenting with side-effects was observed in the China group from day 0 to day 6 of follow-up (53.9%-23.3%) whereas the proportion of patients with side-effects in the Standard group did not change significantly (85.9% on day 0 vs. 82.5% on day 6). Ninety-six (72.4%) patients in the China group and 103 (97.2%) in the Standard group reported at least one side-effect during follow-up (p < 0.0001). The most frequently reported side-effects were tinnitus, dizziness and asthenia. CONCLUSIONS: This preliminary study shows the interest of China rubra 7CH in limiting the side-effects of quinine used for the treatment of acute malaria in pregnant women.

Open-label uncontrolled pilot study to evaluate complementary therapy with Ruta graveolens 9c in patients with advanced cancer.

BACKGROUND: Patients with advanced metastatic disease are often treated aggressively with multiple lines of chemotherapy, even in the last month of life. The benefit of such an approach remains uncertain. The objective of the study was to investigate whether Ruta graveolens 9c homeopathic medicine can improve quality of life (QoL) and tumour progression in patients with advanced cancer. MATERIAL AND METHODS: This was a single-centre, open-label, uncontrolled, pilot study. Patients (>18-years, life-expectancy ≥3 months, performance status ≤2) with locally-advanced solid tumours or metastases, previously treated with all available standard anti-cancer treatments were recruited. Oral treatment consisted of two 1-mL ampoules of Ruta graveolens (9c dilution) given daily for a minimum of 8 weeks, or until tumour and/or clinical progression. Primary outcome was QoL measured using the EORTC QLQ-C30 questionnaire. Secondary outcome measures were anxiety/depression measured using the Hospital Anxiety and Depression Scale (HADS), WHO performance status (PS), tumour progression assessed using RECIST criteria and tumour markers, survival and tolerance. RESULTS: Thirty-one patients were included (mean age: 64.3 years). Mean duration of treatment was 3.3 months (median: 2.1). QoL global health status improved significantly between baseline and week 8 (P < 0.001) and week 16 (P = 0.035), but was at the limit of significance (P = 0.057) at the end of the study. There was no significant change in anxiety/depression or PS during treatment. Ruta graveolens 9c had no obvious effect on tumour progression. Median survival was 6.7 months [95%CI: 4.8-14.9]. Ruta graveolens 9c was well-tolerated. CONCLUSION: Some patients treated with Ruta graveolens 9c had a transitory improvement in QoL, but the effectiveness of this treatment remains to be confirmed in further studies.

Fast Dissolving/Disintegrating Dosage Forms of Natural Active Compounds and Alternative Medicines.

Fast Dissolving/Disintegrating Dosage Forms (FDDFs) are a group of dosage forms which dissolve or disintegrate quickly, leading to fast distribution of active ingredients at the site of administration; thereby providing ease of oral ingestion of solid unit dosage forms and have the potential to enhance transmucosal absorption. With time, the use of FDDFs in alternative systems has significantly increased. Homeopathic systems and traditional Chinese medicine have embraced FDDFs for the delivery of active compounds. Most of the patents in this area are from China or by the Chinese innovators. In Europe and US, FDDFs have been extensively studied for the delivery of natural active compounds. It was fascinating to know that some new dosage forms and new routes of delivering active compounds are also making their way to the family of FDDFs. The dose of active compound, size of dosage forms, standardization of extracts, polyherbal mixtures, stability of active compounds, safety, efficacy and pharmacokinetics are challenging issues for developing FDDF herbal formulations or phytopharmaceuticals.

A case of oesophageal ulcer developed after taking homeopathic pill in a young woman.

Oesophageal ulcers occur mainly as a result of gastro-oesophageal reflux disease (GERD). However, pill-induced oesophageal ulcers are a fairly common event. The lesion is mainly due to entrapment of the pill and/or its chemical composition thereof. This case report describes an oesophageal mucosa ulcer occurred in a healthy 35-year old woman who had no previous history of oesophageal disorders and received homeopathic medication. The present case reveals that pill entrapment can occur even in the oesophagus of healthy young individuals and that oesophageal mucosal ulcer can be triggered by substances generally thought devoid of any potentially mucosal aggressive effect.

Efficacy of a homeopathic Crataegus preparation compared with usual therapy for mild (NYHA II) cardiac insufficiency: results of an observational cohort study.

OBJECTIVES: To compare the efficacy of the homeopathic Crataegus preparation Cralonin for non-inferiority to standard treatment for mild cardiac insufficiency. METHODS: Multicentre non-randomised cohort study in patients aged 50-75 years in New York Heart Association class II. Patients received Cralonin (n=110) or ACE inhibitor/diuretics (n=102) for 8 weeks. To adjust for confounding by baseline factors, populations were stratified according to propensity score. After adjusting, there were no statistically significant differences between treatment groups. Treatment efficacy was assessed on 15 variables. A stringent non-inferiority criterion for the upper limit of the 97.5% one-sided confidence interval of the treatment difference was set to 0.2x the standard deviation (S.D.). RESULTS: Both treatment regimens improved scores on most variables studied, with the greatest effect on double product after exercise (average score reduction 15.4% with Cralonin vs. 16.0% for the control group). Stringent non-inferiority of Cralonin was demonstrated on 7 variables. Medium-stringent (0.5xS.D.) non-inferiority was indicated by 13 variables (exceptions: systolic blood pressure (BP) during exercise and diastolic BP at rest; for these, differences between treatments were not significant). Both treatments were well tolerated. CONCLUSION: The Crataegus-based preparation Cralonin is non-inferior to usual ACE inhibitor/diuretics treatment for mild cardiac insufficiency on all parameters except BP reduction.

Co-ingestion of herbal medicines and warfarin.

BACKGROUND: A large proportion of patients use herbal remedies with a potential to interact with prescribed drugs. Such interactions can be dangerous, particularly if the therapeutic window of the prescribed drug is small, as with warfarin. AIMS: Our aim was to estimate the prevalence of the use of herbal medicines by patients taking warfarin (co-ingestion). DESIGN OF STUDY: Postal questionnaire. SETTING: General practices in the South West of England. METHOD: Thirty-five general practices in Devon and Somerset identified 2600 patients taking warfarin and sent postal questionnaires to them. RESULTS: One thousand, three hundred and sixty usable responses were received (response rate = 54.2%). One or more of the specified herbal remedies thought to interact with warfarin were taken by 8.8% of all patients. Complementary or homeopathic treatments not specified in the survey questionnaire were taken by 14.3% of responders. Overall, 19.2% of responders were taking one or more such medicines. The use of herbal medicines had not been discussed with a conventional healthcare professional by 92.2% of patients. Twenty-eight point three per cent of responders thought that herbal medicines might or definitely could interfere with other drugs prescribed by their doctor, however, patients taking any non-prescribed medication were less likely to believe this (chi2 = 20, degrees of freedom = 1, P<0.001). CONCLUSION: A substantial proportion of patients taking warfarin in southwest England self-medicate with both herbal medicines that are thought to interact with warfarin and with others of unknown effect, usually without informing their healthcare team. Patients have a responsibility to mention such non-prescribed medication to their general practitioners, and general practitioners also have a responsibility to ask whether such co-ingestion is occurring.

Use of alternative medicine by patients with cancer in a rural area of Switzerland.

BACKGROUND: Many cancer patients use alternative therapies in addition to conventional treatment. In a survey among such patients, we assessed the prevalence of and the motivation for alternative therapy use in a rural area of Switzerland. METHODS: From 1st February to 30th November 2001, we interviewed 108 patients treated in the oncology outpatient clinic of the Langenthal District General Hospital, Switzerland, using a structured questionnaire. 77% of the patients were female. 49% of the patients (i.e., 64% of the female patients) suffered from breast cancer. RESULTS: 42 (39%) of all patients had used an alternative therapy in addition to conventional treatment at least once. Mistletoe preparations were by far the most popular with a prevalence of 74%. Homeopathy (24%) and cancer diets (12%) were used less often. 79% of the patients seeking help from alternative treatment informed their treating oncologist and/or medical practitioner accordingly. 57% of the doctors encouraged their patients to continue the alternative treatment, none discouraged the patient to do so. The main reasons for the use of alternative therapy were: the desire to feel more hopeful (83%); "to do as much as possible myself to cure the disease" (83%); and to harness mental energy (62%). Only 19% of the patients hoped to be cured of cancer by alternative therapy. CONCLUSIONS: The motivation to seek help from alternative treatment is not based on a distrust of conventional care. Maintaining hope and taking an active role in self-care are the main stimuli for using alternative medicine.

Apparent life-threatening events in infants and homeopathy: an alternative explanation.

BACKGROUND: A recent report showed increased frequency of apparent life-threatening events (ALTEs) in infants treated with the homeopathic medication GaliCol-Baby (GCB). The premise was that the ALTEs resulted from toxic effects of the drug's components. We examine an alternative explanation. METHOD: The toxicological literature was searched for known reactions to the various GCB components, noting doses and reported symptoms. Dosage quantities and severity of reaction to the GCB were ranked independently by two groups of physicians, and a dose-response curve was generated. Reported toxic doses and symptoms were compared with those of the GCB series. The homeopathic literature was searched as well to determine the propensity of the GCB components to cause ALTE symptoms, when given in homeopathic doses to healthy volunteers (proving). RESULTS: Doses ingested in the GCB series were 10-13 orders of magnitude smaller than those reported to cause toxic reactions in humans. There was poor correlation between symptoms with GCB and toxic profiles of the components. A nonsignificant, inverse relationship between dose and severity of reaction was observed. Conversely, four GCB components (in homeopathic doses) had a high propensity to produce at least one of five symptoms which define ALTE, two of which had intermediate to high propensity to produce three symptoms. CONCLUSIONS: It is unlikely that the ALTE following ingestion of GCB was a toxic reaction to any of the drug's component. Homeopathic theory may explain this linkage, though further research is needed to understand the pathogenic effects of highly diluted homeopathic compounds.

Effect of Gelsemium 5CH and 15CH on anticipatory anxiety: a phase III, single-centre, randomized, placebo-controlled study.

Therapeutics to treat or prevent anxiety are numerous but many people choose to try non-conventional medicine such as homeopathy. This study aimed at evaluating the effectiveness of Gelsemium 5CH and 15CH on provoked anxiety in healthy volunteers, in comparison with placebo. This was a double-blind, single-centre, randomized, placebo-controlled study. Eligible healthy men or women aged from 18 to 40 years without a history of psychiatric disorders were randomly allocated to receive Gelsemium 5 or 15CH or placebo. Anxiety was proved by performance of the Stroop colour word test (SCWT). The primary end-point was anxiety assessed by the State measure of the State-Trait Anxiety Inventory (STAI-S) as the absolute value and difference with baseline, according to the treatment received. We included 180 healthy volunteers. The distribution into each treatment group was homogenous. There was no statistical difference between groups for the values of STAI-S at baseline, just before the SCWT and the difference between these times (1.8 [0.20 to 3.4], 1.0 [-0.6 to 2.6] and 1.4 [-0.3 to 3.0] for Gelsemium 15CH, 5CH and placebo respectively). Likewise, no statistical difference was observed between groups in anxiety as measured by a Visual Analogue Scale and the Competitive State Anxiety Inventory. Mean arterial pressure and heart rate significantly increased (P < 0.001) but no interaction between time prior to provoked anxiety and treatment was shown (P = 0.59 and P = 0.46, respectively). Gelsemium 5CH and 15CH do not prevent anticipatory anxiety in the conditions used in this study.

When less is better: a comparison of Bach Flower Remedies and homeopathy.

PURPOSE: Homeopathy and Bach Flower Remedies (BFRs), historically-related complementary healing modalities classified as prescription/nonprescription drugs and over-the-counter homeopathic nutritional supplements, respectively, are compared with respect to indications, dosage philosophies, associated procedures, reported outcomes, safety profiles, and the possible operation of the placebo effect. METHODS: Original data and published research reports, including case studies, retrospective meta-analyses, and double-blind clinical trials are compiled and evaluated for both healing systems. RESULTS: Homeopathy and BFR therapy both feature highly diluted natural medicinal substances, flexible dosage schedules tailored to individual patients, and energy-based healing action. They differ with respect to practitioner training and certification, number and types of medicinal source materials, remedy combinations and applications, and potential toxicity or other side-effects. CONCLUSIONS: Extensive testing has produced mixed or equivocal results regarding the efficacy of both of these health care systems. While a variety of positive outcomes have been frequently recorded with Homoeopathy and BFR treatments, it is likely that the placebo effect operates to a significant extent in both approaches.

[Life-threatening hyponatremia provoked by alternative treatment. An occurrence in a patient with chronic lymphocytic leukemia with no indication for treatment]. / Livstruende hyponatriaemi udløst af alternativ behandling. Et tilfaelde hos en patient med ikkebehandlingskraevende kronisk lymfatisk leukaemi.

Alternative medicine is a heterogeneous group of treatments which has become increasingly popular in cancer patients in the Western world in recent years. We describe a 77-year-old female with chronic lymphocytic leukemia, who developed severe hyponatremia during treatment with alternative medicine given by a general practitioner over a 3-year-period. From a hematological point of view, there was no need for this expensive treatment as the disease was stable with a normal hemoglobin and thrombocyte count and no B-symptoms. The case illustrates a need for better control of the alternative practitioners and for the adverse reactions to their treatments by the National Health Service.

Complementary therapies for reducing body weight: a systematic review.

The prevalence of obesity is increasing at an alarming rate and a plethora of complementary therapies are on offer claiming effectiveness for reducing body weight. The aim of this systematic review is to critically assess the evidence from randomized controlled trials (RCTs) and systematic reviews of complementary therapies for reducing body weight. Literature searches were conducted on Medline, Embase, Amed, and the Cochrane Library until January 2004. Hand-searches of relevant medical journals and bibliographies of identified articles were conducted. There were no restrictions regarding the language of publication. Trial selection, quality assessment and data abstraction were performed systematically and independently by two authors. Data from RCTs and systematic reviews, which based their findings on the results of RCTs, were included. Six systematic reviews and 25 additional RCTs met our inclusion criteria and were reviewed. The evidence related to acupuncture, acupressure, dietary supplements, homeopathy and hypnotherapy. Except for hypnotherapy, Ephedra sinica and other ephedrine-containing dietary supplements the weight of the evidence is not convincing enough to suggest effectiveness. For these interventions, small effects compared with placebo were identified. In conclusion, our findings suggest that for most complementary therapies, the weight of the evidence for reducing body is not convincing. Hypnotherapy, E. sinica and other ephedrine-containing dietary supplements may lead to small reductions in body weight. However, the intake of E. sinica and ephedrine is associated with an increased risk of adverse events. Interventions suggesting positive effects in single RCTs require independent replication.

The need for the correct sequence of remedies.

In chronic disease, often several medicines are required to complete a cure. These should follow a correct sequence to have an optimal effect. Giving the second or the third indicated medicine first may result in temporary amelioration but will not start the process of cure. The following case exemplifies this rule.