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Introduction to Placebo? Complementary and Homeopathic Medicines - PDF document

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8/30/2020 Introduction to Placebo? Complementary and Homeopathic Medicines Alternative medicine? Holis tic? Evidence-based? Empirical? Homeopathy Home Remedies? Alternative? Disclosure: FDA-Regulated? Organic? Richard Mudd, National

  1. 8/30/2020 Introduction to Placebo? Complementary and Homeopathic Medicines Alternative medicine? Holis tic? Evidence-based? Empirical? Homeopathy Home Remedies? Alternative? Disclosure: FDA-Regulated? Organic? Richard Mudd, National Pharmacy Educator and Christophe Merville, Natural Herbs? D.Pharm, Director of Education and Pharmacy Development. are employees of Boiron. What should pharmacists know, and why? V2 10/14 1 2 ACPE#: 0104-0000-20-020-L01-P Contact Hours: 1.0 CEU Initial Release Date: 9/12/20 Homeopathic medicines have been regulated as drugs since 1938. (Food, Drug and Cosmetic Act) Following this knowledge-based presentation, the pharmacist participants will be able to: 1) Answer basic questions about homeopathic medicines (safety, The FDA regulates the manufacturing process manufacturing, dosage) from your patients; and distribution of homeopathic medicines. 2) List the limits and advantages of homeopathic medicines and 3) List the indications of four homeopathic medicines (Belladonna, Gelsemium, Apis mellifica, Nux vomica). The official compendium is the Homeopathic Pharmacopoeia of the ACPE#: 0104-0000-20-020-L01-T United States (HPUS), referenced in the United States Pharmacopoeia, Following this Knowledge-based presentation, the pharmacy technician and recognized by the FDA. participants will be able to: 1) Identify a homeopathic medicine; About 1280 strains are described: origin, preparation, 2) Answer basic questions about homeopathic medicines (safety, control, OTC and Rx levels. guidelines, dosage) from your patients and General pharmacy: guideline for manufacturing and control. 3) List the limits and advantages of homeopathic medicines. 3 4 Generics Brand-named medicines Most homeopathic medicines are sold over the counter (OTC) But a few require a prescription : 1 medicine Single or multiple ingredients Some strains are toxic: low dilutions are Rx only. ( Arsenicum, Mercurius ) targeting a set of symptoms Usually pellets or tablets A few strains are controlled substances for all dilutions ( Opium, Coca, Any form (syrups, topicals, drops, Morphinum ) eye drops, suppositories, etc.) The indications must fall into OTC categories ( FDA regulation ) Look at the samples of homeopathic medicines, read the packaging, open them! 5 6 1

  2. 8/30/2020 3 steps STRAINS: Plants Alcohol + ultra Minerals pure Water IDENTIFICATION – QUALITY Tincture or Homeopathic Final product Animals Lactose CONTROL liquid solution dilution Microbes The process is described MACERATION in the HPUS TRITURATIONS (16 to 21 days) and must comply to QUALITY QUALITY cGMP CONTROL CONTROL Alcohol + Inactive MOTHER TINCTURE FIRST DILUTION Purified water Ingredients 7 8 Succussion or dynamization: vigorous shaking: 150 times in C scale: 1% dilutions 7.5 seconds on Solid forms for sublingual absorption: calibrated device 10% 1% 1% 1C 2C 3C 30C 1X Succussion Succussion Succussion Mother tincture X scale: 10% dilutions 10% 10% 10% 2X 3X 30X 1X 4X Multi-dose tube Unit-dose tube Tablets 80 large pellets 1 g small pellets lactose-based Succussion Succussion Succussion 85% sucrose 15% lactose Mother tincture 9 10 Liquid forms: Arnica montana 6C HPUS Syrups Drops :20% alcohol Stiffness from trauma, Swelling and bruising Liquid Lot#: 12568 Exp. Date : June 2016 oral unit-doses or sterile eye drops Gels, UPC #: 321 5132 5115 2 lotions, ointments NDC #: 227-585-9 and creams Other forms: Drug Facts Suppositories 11 12 2

  3. 8/30/2020 Examples of conditions that can be relieved by homeopathic preparations of Atropa belladonna (Solanaceae) Belladonna : On mucous membranes: On mucous membranes: Pharmaco-toxicological properties - intense dryness - intense dryness Congestive headaches: (Pathogenesis) - sunstrokes, hot flushes On cardio-vascular system: On cardio-vascular system: - congestive headache - congestive headache - vasodilation of face - vasodilation of face Inflammation (skin and mucous membranes): On nervous system: On nervous system: - red, hot, painful, swollen - hyperesthesia - hyperesthesia (sunburns, …) - hallucinations, convulsions - hallucinations, convulsions - mydriasis - mydriasis Fever: Generally: Generally: - sudden onset, high fever - high fever of sudden onset - high fever of sudden onset - profuse sweating - profuse sweating - red face, sweating - inflammatory syndrome - inflammatory syndrome - dry mouth, thirst 13 14 Examples of conditions that can be relieved by Apis mellifica Honeybee (homeopathic preparations of the entire insect) Pharmaco-toxicological properties (Pathogenesis) Insect stings: - pink edema On skin and mucous membranes: - stinging, burning pain - pink edema - stinging, burning pain Inflammation: - relieved by cold compresses - conjunctivitis With edema, stinging, - sore throat burning pain relieved by - sunburn cold applications Generally: - joint pains - fever without thirst - warm skin Allergies: - sudden inflammatory syndrome - hives, hay fever 15 16 Homeopathic treatments can be used: Homeopathy is a therapeutic method using homeopathic medicines. Alone, in first intent: - Viral pathologies, stress, anxiety, premenstrual syndrome Selecting a homeopathic medicine - When a pre-existing condition or treatment precludes is based on: the use of another medicine. In association with other medicines: The patient’s set of symptoms (functional, etiological, clinical, biological, and factors of aggravation or improvement ). - Treatment of the allergic terrain, - Treatment of the recurrences of ENT or urinary infections. The existence of a pharmacologically active substance As a palliative therapy: that causes similar symptoms in high doses. (Principle of - Treatment of nausea during chemotherapy Similars) The treatment must always make ethical sense! Homeo: same Pathos: suffering 17 18 3

  4. 8/30/2020 Belladonna High High Low Low similarity similarity similarity similarity Restlessness Local Fever, profuse Local Local, General and Behavioral Local and General Hypersensitivity to noise inflammation sweating symptoms symptoms symptoms High fever- Profuse sweating 6C 9C 12C 15C 30C 6C 9C 12C 15C 30C The level of similarity (between the patient’s set of symptoms and the The level of similarity (between the patient’s set of symptoms and the drug’s pathogenesis) determines the choice of the dilution. drug’s pathogenesis) determines the choice of the dilution. 19 20 Symptom’s intensity • Start as soon as possible. • Adjust frequency according to intensity of symptoms and decrease frequency with improvement. • Dose is not body-weight dependent: children receive the same dose. 5 pellets 5 pellets 5 pellets 5 pellets every 3 times a every 2 3 times a hour day hours day • Brand-named drugs: dosage is in the drug facts. 21 22 Research Study on Kali bichromicum 30C in COPD Frass M., et al Influence of Potassium dichromate More than 5.000 references in PubMed on Tracheal Secretions in Critically Ill Patients. Chest. 2005; 127; 936-941 Physical studies Biological studies • Prospective, double-blind, placebo-controlled randomized study on 50 patients affected with Chronic Obstructive Pulmonary Disease. Clinical studies • Patients receive 5 pellets Potassium dichromate 30C twice daily or an identical Observational studies placebo. Pharmaco-economical studies • In treated group, tracheal secretions were significantly reduced (p<0.001) Pharmaco-epidemiolocigal studies • Length of stay was significantly reduced (4.2 ± 1.61 days vs 7.68 ±3.60 days, Meta-analysis p<0.001) 23 24 4

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