Article

A Placebo-Controlled Double-Blind Randomized Trial with Individualized Homeopathic Treatment Using a Symptom Cluster Approach in Women with Premenstrual Syndrome

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  • At present: free lance at the Louis Bolk Institute, Driebergen, the Netherlands
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Abstract

Background: In a double-blind placebo-controlled randomized trial with parallel groups, the efficacy of individually prescribed homeopathic medicines was evaluated in women with premenstrual syndrome (PMS). Methods: In an outpatient department of a university clinic in Jerusalem, Israel (1996-1999), women with PMS, aged 18 to 50 years, entered a 2-month screening phase with prospective daily recording of premenstrual symptoms by the Menstrual Distress Questionnaire (MDQ). They were included after being diagnosed with PMS. A reproducible treatment protocol was used: women received a homeopathic prescription based on symptom clusters identified in a questionnaire. The symptoms were verified during a complementary, structured, interview. Only women whose symptoms matched the symptom profile of one of 14 pre-selected homeopathic medicines were included. Each participant was administered active medicine or placebo via random allocation. Primary outcome measures were differences in changes in mean daily premenstrual symptom (PM) scores by the MDQ. Analysis was by intention-to-treat. Results: A total of 105 women were included: 49 were randomized to active medicine and 56 to placebo. Forty-three women in the active medicine group and 53 in the placebo group received the allocated intervention with at least one follow-up measurement and their data were analyzed. Significantly greater improvement of mean PM scores was measured in the active medicine group (0.443 [standard deviation, SD, 0.32] to 0.287 [SD, 0.20]) compared to placebo (0.426 [SD, 0.34] to 0.340 [SD, 0.39]); p = 0.043. Conclusions: Individually prescribed homeopathic medicines were associated with significantly greater improvement of PM scores in women with PMS, compared to placebo. Replication, with larger sample size and other refinements, is recommended to confirm the efficacy of this treatment in other settings.

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Placebo effects have an ambiguous reputation, as they are associated with sham treatment and deceit on the one hand and as interesting phenomena, which might be clinically relevant on the other. The goal of this paper is to demonstrate that placebo effects are relevant and can be used as an effective part of many treatments by using communication targeting placebo effect mechanisms. We examined the history of placebos and the placebo effect, addressing common misconceptions and disentangling ambiguities. We then reviewed whether the placebo effect can be robustly shown in the current literature, and zoomed in on the plausible mechanisms (conditioning, expectancies and affect manipulation) through which the placebo effect might be produced. Observing the link with the doctor-patient communication literature, and pleading for a better integration of the two research traditions we conclude by setting out a research agenda for testing the role of communication in placebo effects.
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Systematic assessment of the in vitro research on high potency effects. Publications of experiments were collected through databases, experts, previous reviews, citation tracking. Inclusion criteria: stepwise agitated dilutions <10(-23); cells or molecules from human or animal. Experiments were assessed with the modified SAPEH score. From 75 publications, 67 experiments (1/3 of them replications) were evaluated. Nearly 3/4 of them found a high potency effect, and 2/3 of those 18 that scored 6 points or more and controlled contamination. Nearly 3/4 of all replications were positive. Design and experimental models of the reviewed experiments were inhomogenous, most were performed on basophiles. Even experiments with a high methodological standard could demonstrate an effect of high potencies. No positive result was stable enough to be reproduced by all investigators. A general adoption of succussed controls, randomization and blinding would strengthen the evidence of future experiments.
Article
Most women of reproductive age have some physical discomfort or dysphoria in the weeks before menstruation. Symptoms are often mild, but can be severe enough to substantially affect daily activities. About 5-8% of women thus suffer from severe premenstrual syndrome (PMS); most of these women also meet criteria for premenstrual dysphoric disorder (PMDD). Mood and behavioural symptoms, including irritability, tension, depressed mood, tearfulness, and mood swings, are the most distressing, but somatic complaints, such as breast tenderness and bloating, can also be problematic. We outline theories for the underlying causes of severe PMS, and describe two main methods of treating it: one targeting the hypothalamus-pituitary-ovary axis, and the other targeting brain serotonergic synapses. Fluctuations in gonadal hormone levels trigger the symptoms, and thus interventions that abolish ovarian cyclicity, including long-acting analogues of gonadotropin-releasing hormone (GnRH) or oestradiol (administered as patches or implants), effectively reduce the symptoms, as can some oral contraceptives. The effectiveness of serotonin reuptake inhibitors, taken throughout the cycle or during luteal phases only, is also well established.
Dutch translation 3rd edition by
  • Homeotherapy
Homeotherapy, paragraph 24-25 and The Simile, paragraph 26-34. In: Hahnemann S. Organon der Heilkunst (1810). Dutch translation 3rd edition by O.E.A. Goetze. Alkmaar, Homeovisie 1996:14-19
Evaluating Homeopathic medicine: Clinical and Social Research with Premenstrual Syndrome (PMS) as a Case Study
  • M Yakir
Yakir M. Evaluating Homeopathic medicine: Clinical and Social Research with Premenstrual Syndrome (PMS) as a Case Study [PhD Dissertation, English version], Hebrew University, Jerusalem, 2002
The cognitive orientation of suggestibility. A tool for predicting who will respond to suggestion (unpublished)
  • S Kreitler
  • H Kreitler
Kreitler S, Kreitler H. The cognitive orientation of suggestibility. A tool for predicting who will respond to suggestion (unpublished). Dept. of Psychology, Tel Aviv University; 1990
A qualitative study to determine the efficacy of the homeopathic simillimum in the treatment of premenstrual syndrome
  • T Komar
  • K S Peck
  • J R Torline
  • M Deroukakis
Komar T, Peck KS, Torline JR, Deroukakis M. A qualitative study to determine the efficacy of the homeopathic simillimum in the treatment of premenstrual syndrome. Am J Hom Med 2006; 99:196-204