1. A controlled clinical trial was conducted to assess the effectiveness of a homoeopathic preparation in the treatment of influenza-like syndromes. 2. 237 cases received the test drug and 241 were assigned to placebo. Patients recorded their rectal temperature twice a day, and the presence or absence of five cardinal symptoms (headache, stiffness, lumbar and articular pain, shivers) along with cough, coryza and fatigue. 3. Recovery was defined as a rectal temperature less than 37.5 degrees C and complete resolution of the five cardinal symptoms. 4. The proportion of cases who recovered within 48 h of treatment was greater among the active drug group than among the placebo group (17.1% against 10.3%, P = 0.03). 5. The result cannot be explained given our present state of knowledge, but it calls for further rigorously designed clinical studies.

OBJECTIVE: 1) To assess the efficacy of homeopathic prepared Galphimia glauca compared to placebo in the treatment of pollinosis. 2) To estimate the corresponding overall success rate of Galphimia glauca. Meta-analysis of clinical trials. STUDY SELECTION: 7 randomized double-blind placebo-controlled trials and 4 not placebo-controlled trials (1 randomized and controlled, 1 prospective uncontrolled, 2 retrospective uncontrolled) performed by our study group between 1980 and 1989. An additional MEDLINE search revealed no further trials on this topic. Exclusion and inclusion criteria were identical over all trials. In total, 1038 ambulatory patients that suffered from acute pollinosis (752 in placebo-controlled trials) entered the analysis. MAIN OUTCOME MEASURES: Relative frequency and relative risk for showing noticeable and soothing relief in ocular symptoms as assessed by the patient. The overall rate of improved eye-symptoms is about 1.25 (CI: 1.09 to 1.43) times higher in the verum than in the placebo group. Verum success rate is estimated by 79.3% (CI: 74.1% to 85.0%). Across the single studies the results were highly comparable except for the study run in 1985. A significant superiority of Galphimia glauca over placebo is demonstrated. Estimates of verum success rates are comparable with those of conventional antihistaminics, but no side effects occurred. As not all of the single studies were analyzed by intention to treat analysis the results may be biased.

OBJECTIVE:There is no management regime for chronic fatigue syndrome (CFS) that has been found to be universally beneficial and no treatment can be considered a "cure". Patients with CFS may use complementary and alternative medicine (CAM). Our aim was to evaluate homeopathic treatment in reducing subjective symptoms of CFS.

METHOD:Using a triple-blind design (patient and homeopath blind to group assignment and data analyst blind to group until after initial analyses to reduce the possibility of bias due to data analyst), we randomly assigned patients to homeopathic medicine or identical placebo. One hundred and three patients meeting the Oxford criteria for CFS were recruited from two specialist hospital out patient departments. Patients had monthly consultations with a professional homeopath for 6 months. Main outcome measures were scores on the subscales of the Multidimensional Fatigue Inventory (MFI) and proportions of each group attaining clinically significant improvements on each subscale. Secondary outcome measures were the Fatigue Impact Scale (FIS) and the Functional Limitations Profile (FLP). Ninety-two patients completed treatment in the trial (47 homeopathic treatment, 45 placebo). Eighty-six patients returned fully or partially completed posttreatment outcome measures (41 homeopathic treatment group who completed treatment, 2 homeopathic treatment group who did not complete treatment, 38 placebo group who completed treatment, and 5 placebo group who did not complete treatment).

RESULTS:Seventeen of 103 patients withdrew from treatment or were lost to follow-up. Patients in the homeopathic medicine group showed significantly more improvement on the MFI general fatigue subscale (one of the primary outcome measures) and the FLP physical subscale but not on other subscales. Although group differences were not statistically significant on four out of the five MFI subscales (the primary outcome measures), more people in the homeopathic medicine group showed clinically significant improvement. More people in the homeopathic medicine group showed clinical improvement on all primary outcomes (relative risk=2.75, P=.09).

CONCLUSIONS:There is weak but equivocal evidence that the effects of homeopathic medicine are superior to placebo. Results also suggest that there may be nonspecific benefits from the homeopathic consultation. Further studies are needed to determine whether these differences hold in larger samples.

OBJECTIVE:: To evaluate the efficacy and safety of a homeopathic gel vs an NSAID (piroxicam) gel in the treatment of osteoarthritis of the knee.

METHOD:: One hundred and eighty-four out-patients with radiographically confirmed symptomatic osteoarthritis of the knee were entered into a pragmatic, randomized, double-blind controlled trial and treated with 1 g of gel three times daily for 4 weeks. Main outcome measures were pain on walking as a Visual Analogue Score (VAS) and a single-joint Ritchie index.

RESULTS:: One hundred and seventy-two of the 184 enrolled patients had endpoints for the main outcome parameters. The pain reduction was 16.5 mm VAS in the homeopathy group (n = 86) and 8.1 mm in the piroxicam group (n = 86); the difference between treatment groups was 8.4 mm (95% confidence interval 0.8-15.9), and after adjustment for pain at baseline it was 6.8 mm (95% confidence interval -0.3 to 13.8). There was no significant difference between treatment groups in the single-joint Ritchie index (P = 0.78). Adverse events occurred in 28 patients (12 homeopathy group, 5 withdrawn; 16 piroxicam group, 9 withdrawn); 18 of the events involved a local reaction (7 homeopathy group, 2 withdrawn; 11 piroxicam group, 5 withdrawn).

CONCLUSION:: The homeopathic gel was at least as effective and as well tolerated as the NSAID gel. The presence of a clinically relevant difference between treatment groups cannot be excluded. The homeopathic gel supplemented by simple analgesics if required may provide a useful treatment option for patients with osteoarthritis.

BACKGROUND:The objective of the clinical study was to investigate the efficacy and tolerance of a homeopathic nasal spray in cases of hay fever (seasonal allergic rhinitis) in comparison with the conventional intranasal cromolyn sodium therapy.

PATIENTS AND METHODS:In total, 146 outpatients with symptoms of hay fever were enrolled into the clinical study (randomized, double-blind, equivalence trial) (time of treatment: 42 days). The homeopathic remedy (Luffa comp.-Heel trade mark Nasal Spray, dosage: 0.14 ml per application, 4 times per a day / naris) consisted of a fixed combination made up of Luffa operculata, Galphimia glauca, histamine, and sulfur. The main outcome measure of the efficacy was the quality of life as measured by means of the Rhinoconjunctivitis Quality of Life-Questionnaire (RQLQ). The tolerance of the trial medication was registered by means of global assessment, rhinoscopy, recording of adverse events and with the aid of vital and laboratory parameters.

RESULTS:The results of the study demonstrate a quick and lasting effect of the treatment. This effect was independent from the medication applied and produced a nearly complete remission of the hay fever symptoms. The RQLQ global score changed significantly in the course of the treatment, indicating therapeutic equivalence between the two forms of treatment. Adverse systemic effects did not occur. Local adverse events appeared in 3 patients.

CONCLUSIONS:The study proved that, for the treatment of hay fever, the homeopathic nasal spray is as efficient and well tolerable as the conventional therapy with cromolyn sodium.

BACKGROUND:Mortality in patients with severe sepsis remains high despite the development of several therapeutic strategies. The aim of this randomized, double-blind, placebo-controlled trial was to evaluate whether homeopathy is able to influence long-term outcome in critically ill patients suffering from severe sepsis.

METHODS:Seventy patients with severe sepsis received homeopathic treatment (n = 35) or placebo (n = 35). Five globules in a potency of 200c were given at 12h interval during the stay at the intensive care unit. Survival after a 30 and 180 days was recorded.

RESULTS:Three patients (2 homeopathy, 1 placebo) were excluded from the analyses because of incomplete data. All these patients survived. Baseline characteristics including age, sex, BMI, prior conditions, APACHE II score, signs of sepsis, number of organ failures, need for mechanical ventilation, need for vasopressors or veno-venous hemofiltration, and laboratory parameters were not significantly different between groups. On day 30, there was non-statistically significantly trend of survival in favour of homeopathy (verum 81.8%, placebo 67.7%, P= 0.19). On day 180, survival was statistically significantly higher with verum homeopathy (75.8% vs 50.0%, P = 0.043). No adverse effects were observed.

CONCLUSIONS:Our data suggest that homeopathic treatment may be a useful additional therapeutic measure with a long-term benefit for severely septic patients admitted to the intensive care unit. A constraint to wider application of this method is the limited number of trained homeopaths.

OBJECTIVES:Evidence from clinical trials questions the benefit-risk ratio of first-line antibiotic treatment for uncomplicated acute otitis media in childhood. Alternative treatment strategies are very popular but have not been the subject of larger controlled clinical trials. This trial compares an alternative with a conventional treatment strategy for acute otitis media.

METHODS AND PATIENTS:390 children aged 1-10 years presenting with uncomplicated acute otitis media participated in a prospective, open, non-randomized, controlled, parallel-group study. According to self-assignment of investigators, children were treated either conventionally (free combinations of decongestant nose drops, mucolytics, analgesics and antibiotics) or alternatively with Otovowen (fixed combination of plant-based tinctures and homeopathic potencies), supplemented by conventional medications when considered necessary.

RESULTS:Alternatively treated patients (n = 192) had significantly less severe otoscopic findings and clinical symptom ratings at baseline than children treated in conventional centers (n = 193). Patients cared for by conventional therapists took more antibiotics (80.5% vs. 14.4%; chi2-test, p<0.001) and analgesics (66.8% vs. 53.2%; chi2-test, p = 0.007). Times to recovery were 5.3 +/- 2.4 and 5.1 +/- 2.2 days for alternative and conventional treatment, respectively. Odds ratios (OR) with a lower limit of 1-sided 97.5% confidence interval (CI) were 0.98 (0.76), 0.95 (0.73) and 0.88 (0.69) for results adjusted to baseline otoscopy, pain and symptom score, respectively (Cox-Mantel test). Absence from school or preschool nursery was 1.7 days in both groups; ORs (CI) were 1.00 (0.76), 0.96 (0.73) and 1.04 (0.80). Noninferiority of alternative treatment (CI limit of OR above 0.696) was not proven for pain resolution (-5.2 vs. -5.8 score points); OR (CI) were 0.87 (0.68), 1.15 (0.87) and 0.74 (0.58). Alternative treatment was judged both by doctors (Mann-Whitney estimator with 2-sided 95% CI 0.41 (0.35-0.47)) and parents (0.42 (0.36-0.48)), to be significantly better tolerated than conventional treatment.

CONCLUSIONS:In primary care management of uncomplicated acute otitis media in childhood, an alternative treatment strategy based on the natural medicine, Otovowen may substantially reduce the use of antibiotics without disadvantage to the clinical outcome.

To examine if a potentized homeopathic drug, Natrum Sulphuricum 200 (Nat Sulph-200) has protective potentials against hepatocarcinogenesis, liver tumors were induced in mice through chronic feeding of P-dimethylaminoazobenzene (p-DAB; initiator of hepatocarcinogenesis) and phenobarbital (PB; promoter). Mice were divided into five sub-groups: fed normal low protein diet (Gr. I, normal control); fed normal low protein plus alcohol-200 (vehicle of the homeopathic remedy) (Gr. II); fed diet mixed with 0.06% p-DAB plus 0.05% PB (Gr. III); fed diet and carcinogens like Gr.III, plus alcohol 200 (positive control for drug fed mice) (Gr. IV) and fed diet and carcinogens like Gr. III, plus Natrum Sulphuiricum-200 (Gr. V; drug fed). Mice were sacrificed at day 7, 15, 30, 60, 90 and day 120 for study of cytogenetical endpoints like chromosome aberrations (CA), micronuclei (MN), mitotic index (MI) and sperm head anomaly (SHA) and biochemical toxicity parameters like aspartate amino transferase (AST), alanine amino transferase (ALT), acid (AcP) and alkaline (AlkP) phosphatases, lipid peroxidation (LPO) and reduced glutathione (GSH) content. Less number of liver tumors were observed in Gr. V (drug fed) mice. Administration of Nat Sulph 200 reduced genomic damage, activities of AcP, AlkP, AST, ALT, LPO and increased GSH content. Therefore, independent replication of the study by others is encouraged.

BACKGROUND: Homeopathy is a complementary medicine widely used around the world. Despite extensive use of homeopathy for cancer and other serious conditions with reported success, clinical and laboratory research has been equivocal, and no rigorous research has been done on cancer. In 1999, the US National Cancer Institute evaluated the effects of homeopathic treatment of cancer from a clinic in India and has released a request for protocols to conduct further research into this treatment. Therefore, the authors conducted a series of carefully controlled laboratory studies evaluating the effects of commonly used homeopathic remedies in cell and animal models of prostate cancer. STUDY DESIGN: One hundred male Copenhagen rats were randomly assigned to either treatment or control groups after inoculation with prostate tumor cells. METHODS: Prostate tumor cells DU-145, LNCaP, and MAT-LyLu were exposed to 5 homeopathic remedies. Male Copenhagen rats were injected with MAT-LyLu cells and exposed to the same homeopathic remedies for 5 weeks. In vitro outcomes included tumor cell viability and apoptosis gene expression. In vivo outcomes included tumor incidence, volume, weight, total mortality, proliferating cell nuclear antigen (PCNA) expression, apoptotic cell death (terminal deoxynucleotidyl transferase mediated d-uridine triphosphate nick end labeling), and gene expression (rAPO-multiprobe). RESULTS: There were no effects on cell viability or gene expression in 3 prostate cell lines with any remedies at any exposure time. There was a 23% reduction in tumor incidence (P<.0001), and for animals with tumors, there was a 38% reduction in tumor volume in homeopathy-treated animals versus controls (P<.02). At time of killing, experimental animals with tumors had a 13% lower average tumor weight (P<.05). Tumors in these treated animals showed a 19% increase in apoptotic cell death (P<.05) and reduced PCNA-positive cells. CONCLUSIONS: The findings indicate that selected homeopathic remedies for the present study have no direct cellular anticancer effects but appear to significantly slow the progression of cancer and reduce cancer incidence and mortality in Copenhagen rats injected with MAT-LyLu prostate cancer cells.

INTRODUCTION: Homeopathy is a popular form of complementary and alternative medicine and is used to treat for certain liver ailments. AIM: To analyze the efficacy of homeopathic Chelidonium majus (Chel) 30C and 200C in amelioration of experimentally induced hepato-toxicity in rats. METHODS: Rats were randomized into six sub-groups: negative control; negative control+EtOH; positive control; positive control+EtOH group; Chel 30; Chel 200. Rats were sacrificed at day 30, 60, 90 and 120; various toxicity biomarkers and pathological parameters were evaluated. Gelatin zymography for determination of metalloproteinases activity and Western blot of p53 and Bcl-2 proteins were also employed. All analyses were observer blind. RESULTS: Chronic feeding of p-dimethyl amino azo benzene (p-DAB) and phenobarbital (PB) elevated the levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), lactate dehydrogenase (LDH), triglyceride, cholesterol, creatinine and bilirubin and lowered the levels of glutathione (GSH), glucose-6-phosphate dehydrogenase (G-6-PD), catalase and HDL-cholesterol. There were statistically significant modulations of these parameters in the treated animals, compared to positive controls. In both treated groups, there was downregulation of metalloproteinases, p53 and Bcl-2 proteins compared to over-expression in the positive control groups. CONCLUSION: Both the potencies of Chel exhibited anti-tumor and anti-oxidative stress potential against artificially induced hepatic tumors and hepato-toxicity in rats. More studies are warranted.

INTRODUCTION: Chronic primary insomnia is defined as difficulty in initiating or maintaining sleep or of non-restorative sleep that lasts for at least 1 month and causes significant distress or impairment in social, occupational or other important areas of functioning. The homeopathic simillimum is that remedy which most closely corresponds to the totality of symptoms; remedy selection is based on a full evaluation of the patient's physical, emotional and mental characteristics. AIM/PURPOSE: The purpose of this randomised, double-blind, placebo-controlled study was to evaluate the efficacy of homeopathic simillimum in the treatment of chronic primary insomnia. METHOD: 30 participants were selected in accordance with DSM-IV TR (2000)(1) criterion 307.42 Primary Insomnia and then randomly divided between treatment and placebo groups. The measurement tools used were a Sleep Diary (SD) and the Sleep Impairment Index (SII).(2) After an initial consultation, 2 follow-up consultations at 2-week intervals took place. Homeopathic medication was prescribed at the first and second consultations. The SII was completed at each consultation and participants were instructed at the first consultation to start the SD. RESULTS: SD data revealed that verum treatment resulted in a significant increase in duration of sleep throughout the study, compared to the placebo treatment which resulted in no significant increase in duration of sleep. A significant improvement in SII summary scores and number of improved individual questions were found in the verum group, responses to all 11 questions having improved significantly upon completion of the study. An initial improvement occurred in the placebo group, but was not sustained. Comparison of results between the groups revealed a statistically significant difference. CONCLUSION: The homeopathic simillimum treatment of primary insomnia was effective, compared to placebo. Homeopathy is a viable treatment modality for this condition and further research is justified.

ABSTRACT: BACKGROUND: Many cancer patients seek homeopathy as a complementary therapy. It has rarely been studied systematically, whether homeopathic care is of benefit for cancer patients. METHODS: We conducted a prospective observational study with cancer patients in two differently treated cohorts: one cohort with patients under complementary homeopathic treatment (HG; n=259), and one cohort with conventionally treated cancer patients (CG; n=380). For a direct comparison, matched pairs with patients of the same tumour entity and comparable prognosis were to be formed. Main outcome parameter: change of quality of life (FACT-G, FACIT-Sp) after 3 months. Secondary outcome parameters: change of quality of life (FACT-G, FACIT-Sp) after a year, as well as impairment by fatigue (MFI) and by anxiety and depression (HADS). RESULTS: HG: FACT-G, or FACIT-Sp, respectively improved statistically significantly in the first three months, from 75.6 (SD 14.6) to 81.1 (SD 16.9), or from 32.1 (SD 8.2) to 34.9 (SD 8.32), respectively. After 12 months, a further increase to 84.1 (SD 15.5) or 35.2 (SD 8.6) was found. Fatigue (MFI) decreased; anxiety and depression (HADS) did not change. CG: FACT-G remained constant in the first three months: 75.3 (SD 17.3) at t0, and 76.6 (SD 16.6) at t1. After 12 months, there was a slight increase to 78.9 (SD 18.1). FACIT-Sp scores improved significantly from t0 (31.0 - SD 8.9) to t1 (32.1 - SD 8.9) and declined again after a year (31.6 - SD 9.4). For fatigue, anxiety, and depression, no relevant changes were found. 120 patients of HG and 206 patients of CG met our criteria for matched-pairs selection. Due to large differences between the two patient populations, however, only 11 matched pairs could be formed. This is not sufficient for a comparative study. CONCLUSION: In our prospective study, we observed an improvement of quality of life as well as a tendency of fatigue symptoms to decrease in cancer patients under complementary homeopathic treatment. It would take considerably larger samples to find matched pairs suitable for comparison in order to establish a definite causal relation between these effects and homeopathic treatment.

BACKGROUND:Homeopathic medicine is a branch of integrative medicine that has been gaining increasing popularity. However, its clinical application remains controversial. To improve the understanding of homeopathy, observational studies-which monitor the effects of homeopathy in real-life clinical settings-are a helpful adjunct to randomized controlled trials. The goal of this controlled observational study was to investigate the role of the homeopathic medicine in preventing respiratory tract infections (RTIs).

METHODS:This retrospective analysis of patients' medical records focused on a single centre from 2002 to 2011, and examined 459 patients, out of whom 248 were treated with homeopathic medicine (specific extract of duck liver and heart) and 211 were not treated. All patients were followed-up for at least 1 year, and up to a maximum of 10 years.

RESULTS:A significant reduction in the frequency of onset of RTIs was found in both the homeopathic medicine and untreated groups. The reduction in the mean number of RTI episodes during the period of observation vs. the year before inclusion in the study was significantly greater in the homeopathic-treated group than in untreated patients (-4.76 ± 1.45 vs. -3.36 ± 1.30; p = 0.001). The beneficial effect of the homeopathic medicine was not significantly related to gender, age, smoking habits or concomitant respiratory diseases when compared to the effect observed in untreated patients.

CONCLUSION:These results suggest that homeopathic medicine may have a positive effect in preventing RTIs. However, randomized studies are needed before any firm conclusion can be reached.

OBJECTIVES:To design a model for performing reproducible, objective analyses of skin color changes and to apply this model to evaluate the efficacy of homeopathic Arnica montana as an antiecchymotic agent when taken perioperatively.

METHODS:Twenty-nine patients undergoing rhytidectomy at a tertiary care center were treated perioperatively with either homeopathic A. montana or placebo in a double-blind fashion. Postoperative photographs were analyzed using a novel computer model for color changes, and subjective assessments of postoperative ecchymosis were obtained.

RESULTS:No subjective differences were noted between the treatment group and the control group, either by the patients or by the professional staff. No objective difference in the degree of color change was found. Patients receiving homeopathic A. montana were found to have a smaller area of ecchymosis on postoperative days 1, 5, 7, and 10. These differences were statistically significant (P<.05) only on postoperative days 1 (P<.005) and 7 (P<.001).

CONCLUSIONS:This computer model provides an efficient, objective, and reproducible means with which to assess perioperative color changes, both in terms of area and degree. Patients taking perioperative homeopathic A. montana exhibited less ecchymosis, and that difference was statistically significant (P<.05) on 2 of the 4 postoperative data points evaluated.

BACKGROUND:The homeopathic drug combination Lymphdiaral Basistropfen is established in the treatment of edema and swellings. This is the first time the effectiveness and safety was investigated in the treatment of chronic low back pain.

METHODS:The study is a randomized, double-blind, placebo-controlled trial. From December 2003 to May 2007 248 patients aged 18 to 75 years were screened, 228 were randomized, 221 started therapy, in 192 the progress was measured (103 verum vs. 89 placebo), 137 completed the study (72 verum vs. 65 placebo). They received 10 drops of verum or placebo solution three times daily for 105 days additionally to an inpatient complex naturopathic treatment.

RESULTS:The hannover functional ability questionnaire score (primary outcome measure) tends to increase in the intention-to-treat-analysis (verum: 6.6 vs. placebo: 3.4; p = 0.11) and increases significantly in the per-protocol-analysis (verum: 9.4 vs. placebo: 4.1; p = 0.029). The treatment was well tolerated (92.9% vs. 95.4%). The incidence of adverse reactions and serious adverse reactions was similar in both treatment groups.

CONCLUSIONS:This first randomized, double-blind, placebo-controlled trial shows, that the homeopathic drug combination can improve the treatment of chronic low back pain.

INTRODUCTION:The Health Technology Assessment report on effectiveness, cost-effectiveness and appropriateness of homeopathy was compiled on behalf of the Swiss Federal Office for Public Health (BAG) within the framework of the 'Program of Evaluation of Complementary Medicine (PEK)'.

MATERIALS AND METHODS:Databases accessible by Internet were systematically searched, complemented by manual search and contacts with experts, and evaluated according to internal and external validity criteria.

RESULTS:Many high-quality investigations of pre-clinical basic research proved homeopathic high-potencies inducing regulative and specific changes in cells or living organisms. 20 of 22 systematic reviews detected at least a trend in favor of homeopathy. In our estimation 5 studies yielded results indicating clear evidence for homeopathic therapy. The evaluation of 29 studies in the domain 'Upper Respiratory Tract Infections/Allergic Reactions' showed a positive overall result in favor of homeopathy. 6 out of 7 controlled studies were at least equivalent to conventional medical interventions. 8 out of 16 placebo-controlled studies were significant in favor of homeopathy. Swiss regulations grant a high degree of safety due to product and training requirements for homeopathic physicians. Applied properly, classical homeopathy has few side-effects and the use of high-potencies is free of toxic effects. A general health-economic statement about homeopathy cannot be made from the available data.

CONCLUSION:Taking internal and external validity criteria into account, effectiveness of homeopathy can be supported by clinical evidence and professional and adequate application be regarded as safe. Reliable statements of cost-effectiveness are not available at the moment. External and model validity will have to be taken more strongly into consideration in future studies.

Alternative therapies in general, and homeopathy in particular, lack clear scientific evaluation of efficacy. Controlled clinical trials are urgently needed, especially for conditions that are not helped by conventional methods. The objective of this work was to assess the efficacy of homeopathic treatment in relieving symptoms associated with premenstrual syndrome (PMS). It was a randomised controlled double-blind clinical trial. Two months baseline assessment with post-intervention follow-up for 3 months was conducted at Hadassah Hospital outpatient gynaecology clinic in Jerusalem in Israel 1992-1994. The subjects were 20 women, aged 20-48, suffering from PMS. Homeopathic intervention was chosen individually for each patient, according to a model of symptom clusters. Recruited volunteers with PMS were treated randomly with one oral dose of a homeopathic medication or placebo. The main outcome measure was scores of a daily menstrual distress questionnaire (MDQ) before and after treatment. Psychological tests for suggestibility were used to examine the possible effects of suggestion. Mean MDQ scores fell from 0.44 to 0.13 (P<0.05) with active treatment, and from 0.38 to 0.34 with placebo (NS). (Between group P=0.057). Improvement>30% was observed in 90% of patients receiving active treatment and 37.5% receiving placebo (P=0.048). Homeopathic treatment was found to be effective in alleviating the symptoms of PMS in comparison to placebo. The use of symptom clusters in this trial may offer a novel approach that will facilitate clinical trials in homeopathy. Further research is in progress.

Twenty-eight patients with xerostomia participated in a blind, placebo-controlled longitudinal study of the possible effects of homeopathic medicines on oral discomfort. All patients were first divided in two groups according to their medication. After that the two groups were randomly assigned according to a coin-toss to the experimental or control group. Most patients had systemic diseases, such as rheumatoid arthritis and/or Sjögren's syndrome, and frequent daily medications. The randomly selected experimental group (n=15) got an individually prescribed homeopathic medicine and the control group (n=13) a placebo substance (sugar granules), both for 6 weeks. Neither group knew of the nature of the medicine. Oral dryness was evaluated by measurement of unstimulated and wax-stimulated salivary flow rates and visual analogue scale. With only two exceptions, the experimental group experienced a significant relief of xerostomia whereas no such effect was found in the placebo group. Stimulated salivary flow rate was slightly higher with homeopathy than placebo but no consistent changes occurred in salivary immunoglobulin (IgA, IgG) levels. In an open follow-up period those receiving homeopathic medicine continued treatment and the placebo group patients were treated with individually prescribed homeopathic medicines. The symptoms of xerostomia improved in both groups. Our results suggest that individually prescribed homeopathic medicine could be a valuable adjunct to the treatment of oral discomfort and xerostomic symptoms.

BACKGROUND:There is a demand for clinical trials that demonstrate homeopathic medications to be effective and safe in the treatment of acute maxillary sinusitis (AMS).

OBJECTIVE:The objective of this clinical trial was to demonstrate the efficacy of a complex homeopathic medication (Sinfrontal) compared with placebo in patients with AMS confirmed by sinus radiography.

DESIGN:A prospective, randomized, double-blind, placebo-controlled, phase III clinical trial was conducted for a treatment period of 22 days, followed by an eight-week posttreatment observational phase.

SETTING:The clinical trial was conducted at six trial sites in the Ukraine.

PARTICIPANTS:One hundred thirteen patients with radiography-confirmed AMS participated in the trial.

INTERVENTIONS:Fifty-seven patients received Sinfrontal and 56 patients received placebo. Additionally, patients were allowed saline inhalations, paracetamol, and over-the-counter medications, but treatment with antibiotics or other treatment for sinusitis was not permitted.

MAIN OUTCOME MEASURES:Primary outcome criterion was change of the sinusitis severity score (SSS) from day zero to day seven. Other efficacy assessments included radiographic and clinical cure, improvement in health state, ability to work or to follow usual activities, and treatment outcome.

RESULTS:From day zero to day seven, Sinfrontal caused a significant reduction in the SSS total score compared with placebo (5.8 +/- 2.3 [6.0] points vs 2.3 +/- 1.8 [2.0] points; P<.0001). On day 21, 39 (68.4%) patients on active medication had a complete remission of AMS symptoms compared with five (8.9%) placebo patients. All secondary outcome criteria displayed similar trends. Eight adverse events were reported that were assessed as being mild or moderate in intensity. No recurrence of AMS symptoms occurred by the end of the eight-week posttreatment observational phase.

CONCLUSION:This complex homeopathic medication is safe and appears to be an effective treatment for acute maxillary sinusitis.

INTRODUCTION: In homeopathy ARNICA is widely used as a woundhealing medication and for the treatment of hematomas. OBJECTIVE: In this pilot study the efficacy and safety of ARNICA D12 in patients following varicose vein surgery were investigated. DESIGN: Prospective, randomized, double-blind, placebo-controlled pilot trial according to ICH GCP guidelines. SETTING: The study was conducted by a surgeon at the Angiosurgical Clinic, Berlin- Buch. INTERVENTION: After randomized allocation, 60 patients received either ARNICA D12 or placebo. Start of medication occurred the evening before operation with 5 globules. On the operation day one preoperative and hourly postoperative dosages after awakening were given. On days 2-14 of the study 5 globules 3 times a day were given. OUTCOME CRITERIA: Surface (in cm(2) and using a three-point verbal rating scale) and intensity of hematomas induced by operation, complications of wound healing, and intensity of pain (five-point verbal rating scale) as well as efficacy and safety of the study medication were assessed. RESULTS: Hematoma surface was reduced (from day 7 to day 14) under ARNICA by 75.5% and under placebo by 71.5% (p = 0.4726). The comparison of hematoma surface (small, medium, large) using the verbal rating scale yielded a value of p = 0.1260. Pain score decreased by 1.0 +/- 2.2 points under ARNICA and 0.3 +/- 0.8 points under placebo (p = 0.1977). Remission or improvement of pain was observed in 43.3% of patients in the ARNICA group and in 27.6% of patients in the placebo group. Tolerability was rated as very good in all cases. CONCLUSION: The results of this pilot study showed a trend towards a beneficial effect of ARNICA D12 with regard to reduction of hematoma and pain during the postoperative course. For a statistically significant proof of efficacy of ARNICA D12 in patients following varicose vein surgery a larger sample size is necessary. Copyright 2003 S. Karger GmbH, Freiburg