Pleo Alb Albicansan

Pleo Alb Albicansan

Statistical Evaluation of an Application Study with the Preparation Series Pleo Alb Albicansan in the administration forms: capsules, drops, suppositories and sips by Dr. Reiner Heidl February 2003 Semmelweis-Institut GmbH Verlag für experimentelle Onkologie GmbH • 27316 Hoya • Germany

Introduction Between August 1991 and February 2001, a total number of 285 patients in three medical practices, one specialising in internal medicine and two in general medicine, participated in an In line with the study’s set-up, only descriptive statistical methods were used. The application of inductive methods was not indicated. An "intention-to-treat“ evaluation was carried out, i.e. that all those patients who had at least received one dose of the medicament were Height varied between 102 and 195 cm with an average height of 157.1 ± 23.6 cm and weight was between 15 and 100 kg with an average weight of 56.6 ± 22.0 kg.

2.1 Diagnoses and Secondary Diseases application study with the preparation series Pleo Alb ALBICANSAN included in the study. The diagnosis leading to the in the administration forms of capsules, drops, suppositories and injections. The homoeopathic test preparation, Pleo Alb ALBICANSAN, consists (with respect to the different administration forms) of Candida albicans in the 3rd, 4th or 5th decimal potency. Pleo Alb ALBICANSAN D5 drops 10 ml contain: 10 ml Candida albicans D5 dil. in accordance with provision 5a, HAB. Pleo Alb ALBICANSAN D5 dilution for injection 1 ml contains: 1 ml Candida albicans D5 aqueous dilution in accordance with provision 5b and 11, HAB. Pleo Alb ALBICANSAN D4 capsules 1 capsule contains: 330 mg Candida albicans D4 trit. in accordance with provision 6, HAB. Pleo Alb ALBICANSAN D3 suppositories 2 Participating Patients 285 patients participated in the study which comprised of 124 males (43.5%) and 161 females (56.5%). The age of the patients varied between 4 and 91 years, with an average age of 30.5 and a standard deviation of 20.6 years. The largest age group was that of patients under 12 years (28.8% of all patients) and the second largest group was the one between 41 and 50 (17.2%). Almost of the same size were the groups between 13 and 20 (14.4%), 21 and 30 (10.5%) and 31 and 40 years (11.9%). 7.7% of all patients were between 51 and 60 and 7.7% between 61 and 70, whilst only 1.8% were over 70 years.

Regarding age structure, the males with an average age between 36.0 ± 21.2 were on average 10 prescription was to be entered in the study protocol. It showed that Pleo Alb ALBICANSAN, according to Isopathy, was used in a very wide application range. The preferred application was independent of the patient’s age.

The main indications were stomatitis, Perlèche as well as intestinal and skin mykoses. Vaginal mykoses were also indications in the adult age group. A diagnosis was made before the start and end of the therapy. Accompanying therapies were to be documented in the evaluation form. In order to obtain a measure of chronic diseases, the patients were asked in the study protocol how long they had suffered from the disease or complaints.

Time frames were given of less than six months, up to one year, up to three years 1 suppository contains: 0.2 g    years older than the females with and more than three years. Candida albicans D3 trit. in accordance with provision 6, HAB. The aim of this application study was to determine the actual application of the preparation as well as its tolerance under the day-to- day conditions of a normal practice. It was also of importance to determine the acceptance of the preparation on the market, especially amongst children. 26.3 ± 19.0 years.

46% of the patients suffered for less than six months, 12.6% between six and 12 months, 13.3% between one and three years and 28.1% for more than three years. In the patient group over 12 years, 37.1% suffered from acute and 34.5% from chronic complaints. Almost of the same size was the group of patients who suffered for less than 12 months (15.2%) and between 12 and 36 months (13.2%). In the children group under 12 years, acute complaints of less than six months Duration of Complaints (67.9%) were predominant. Only 6.2% suffered for 12 months, 13.6% up to 36 and 12.3% for more than 36 months.

Dosage and Therapy Duration 3.1. Consultation Times, Therapy Duration According to the nature of an application study, the physicians were not given a preset time limit for the final patient assessment. The final examinations were conducted after a period of 1 to 1100 days, with an average of 72.2 ± 83.2 days. The therapy duration amongst the children (< 12 years) was on average 59.2 ± 46.5 days and was approx. 25% shorter than in the adult group with 77.5 ± 93.7 days. In both age groups, the therapy 80,0 70,0 60,0 50,0 40,0 30,0 20,0 10,0 0,0 > 150 125-150 101-125 76-100 51-75 25-50 < 25 <6 < 12 < 36 > 36 Months Therapy Duration 0 10 20 30 40 50 60 70 Percent < 12 years > 12 years All patients >12 years <12 years duration between 25 and 50 days was predominant, i.e. 67.5% of the patients under 12 and 59.2% of the patients over 12 years.

Dosage: The dosage was set as follows, according to the patient information leaflet: Pleo Alb ALBICANSAN drops Oral application: 1 - 8 drops daily before a meal. Topical application: 2x weekly, 5 - 10 drops on the affected area or in the cubital fossa. Pleo Alb ALBICANSAN injections 2x weekly 1.0 ml i.m., i.v., i.c. or s.c. Pleo Alb ALBICANSAN capsules 1 - 3 capsules daily with some liquid before breakfast or in the evenings at bedtime. Pleo Alb ALBICANSANsuppositories 1x daily, insert 1 suppository rectally at bedtime.

Concerning the administration forms, 178 patients took capsules, 192 patients were treated orally, 68 patients topically (daily), 46 patients topically (weekly), 157 patients with suppositories and 22 patients with injections (weekly). Multiple counts were necessary, if various application forms were combined. Only 24% of the patients were treated with a monotherapy. The most common combination (27.6%) was that of capsules, drops and suppositories.

11.3% of the patients were treated with drops for oral intake, drops for topical application and suppositories. The combination of capsules, drops for oral intake and topical application was used in 7.4% of the patients, whilst only 2.8% were treated with drops for oral intake and topical application. 7.1% were treated with capsules and drops for topical application and 4.2% with a combination of capsules and drops for oral intake. 6.4% were treated with a combination of drops for topical application and suppositories and 4.6% with injections. Other combinations are to be neglected, such as capsules with suppositories (1.4%), capsules with injections (0.7%), drops for oral intake with suppositories (1.8%) and suppositories with injections (0.7%). There was no significant difference between the age groups under 12 and over 12 years with respect to the frequency of combinations of the application forms. The tables above show the average dosage of the administration forms.

Efficacy and tolerance 4.1 Evaluation of Efficacy by Physician and Patient:
In a closing assessment, physicians and patients were asked to evaluate efficacy and tolerance. Efficacy 4 Combination of application forms could be assessed with, "very good," "good," "moderate" or "no effect."  The physicians were also requested to evaluate patient compliance with "very good“, "good“, "moderate" 3 2 Mono 0 10 20 30 40 50 Percent

All patients >12 years <12 years or „non-compliant“. The evaluation of efficacy showed that 74.1% of the patients assessed efficacy with „very good“ and „good“, whilst 25.9% assessed efficacy with "moderate." No patient assessed efficacy with "no effect." The results of the physicians’ evaluation for efficacy were almost identical to that Semmelweis-Institut GmbH Verlag für experimentelle Onkologie GmbH.

Patient´s Evaluation of Efficacy Compliance (N = 280) was assessed by the physicians to be "very good" for 131 patients, "good" for 109 patients, "moderate" for 37 and "non- compliant" for 3 patients. Hence 30 25 20 15 10 5 0 45 40 35 30 25 20 15 10 5 0 Very Good Good Moderate No effect Physician's Evaluation of Efficacy Very Good Good Moderate No Effect < 12 years > 12 years All patients < 12 years > 12 years All patients 84.2% of all patients participating in the study were given a "good“ or "very good“ compliance rating. 4.2 Evaluation of Tolerance by Physician and Patient At the conclusion of the study, an evaluation of tolerance was submitted by the physicians and patients whereby an assessment of "very good", "good“, "moderate" and "no effect" could be chosen. 77.5% of patients and 78.2% of physicians rated tolerance to be "very good", whilst 20.7% of patients and 21.8% of physicians gave Pleo Alb ALBICANSAN a "good" tolerance rating. 1,8% of the patients rated with "moderate" and neither patient nor physician with "no effect". In the age group under 12 years, patients and physicians rated tolerance to be approximately 20% better with regard to the very of the patients.

In 75.4% of the cases physicians assessed efficacy with "very good“ and "good“ and 24.6% with "moderate". In comparison with the adult and the children groups under 12 years, according to tendency, the evaluation of the physicians and patients shifted to "good" assessment. With regard to quality and quantity, the assessments of physicians and patients alike were of equal value in total.

The homoeopathic test 60 50 40 30 20 10 0 100 90 80 70 60 50 40 30 20 10 0 Very Good Good Moderate No effect Physician´s Evaluation of Tolerance Very Good Good Moderate No effect < 12 years > 12 years All patients < 12 years > 12 years All patients preparation, Pleo Alb ALBICANSAN, consists (with respect to the different administration forms) of Candida albicans in the 3rd, 4th or 5th decimal potency. The age of the patients varied between four and 91 years with an average age of 30.5 years.

Pleo Alb ALBICANSAN, according to Isopathy, was mainly used in a very wide application range, independent from the patients’ age. The main indications were stomatitis, Perlèche and intestinal and skin mycoses. Vaginal mycoses were also indications in the adult group. Accompanying therapies were to be documented in the evaluation form. 46% of the patients suffered for less than six months. The second largest group (28.1%) suffered for more than 36 months. In the age group 4.3 Side Effects and Termination of Therapy No therapy with Pleo Alb ALBICANSAN was discontinued and no side effects were reported.

Summary Between August 1991 and February 2001, a total number of 285 patients in three medical practices (two specialising in general medicine and one in under 12 years, acute complaints of less than six months were predominant with 67.9% of the patients. Only 6.2% suffered for 12 months, whilst 13.6% suffered between 12 and 36 months and 12.3% for more than 36 months.

 Amongst the children (< 12 years) the therapy lasted on average 59.2 ± 46.5 days and was approximately 25% shorter than in the adult group with 77.5 + 93.7 days. The therapy duration for both age groups between 25 and 50 days was predominant in 67.5% of the patients under 12 and in 59.2% of the patients over 12 years. Concerning the administration forms, 178 patients took capsules, 192 patients were treated orally, 68 patients topically (daily), 46 patients topically (weekly), 157 patients with suppositories and 22 patients with injections (weekly).

Multiple counts were necessary, if various application forms were combined. Only 24% of the patients were treated with a monotherapy with only one administration form. The The therapeutic progress was determined by evaluations conducted at the beginning and the end of the therapy. In both age groups, there was no difference regarding the extent of combinations of the administration forms. The evaluation of efficacy showed that 74.1% of the patients assessed efficacy with "very good“ and "good“, whilst 25.9% assessed with "moderate“.

No patient assessed efficacy with "no effect". The results of the physicians’ evaluation for efficacy were almost identical to that of the patients. In 75.4% of the cases, physicians assessed efficacy with "very good“ and "good“ and 24.6% with „moderate“. Comparing the adult and children groups under 12 years, according to tendency, the evaluation of the 84.2% of all patients participating in the study were given a "good“ or "very good“ compliance rating. 77.5% of patients and 78.2% of physicians rated tolerance to be "very good“ whilst 20.7% of patients and 21.8% of physicians gave Pleo Alb ALBICANSAN a "good" tolerance rating. 1.8% of the patients rated with "moderate" and neither patient nor physician with "no effect". In the age group under 12 years, patients and physicians rated tolerance to be approximately 20% better with regard to the assessment "very good".

Concerning quality and quantity, the assessments of physicians and patients alike were overall of equal value. No therapy with ALBICANSAN was discontinued and no side effects were reproted. most common combination (27.6%) was that of capsules, drops and suppositories. physicians and patients shifted to "good". Compliance (N = 280) was Werdorf, 7 February 2003 There was no significant difference between the age groups under 12 and over 12 years with respect to the dosage and the frequency of combinations of the application forms. assessed by the physicians to be „very good“ for 131 patients, „good“ for 109 patients, „moderate“ for 37 and „non- compliant“ for 3 patients, hence Dr. Reiner Heidl © Copyright 2006 by Semmelweis- Institut GmbH, 27318 Hoya, Weser Germany All Rights Reserved