After the pilot study that exhibited good results, we repeated the study on a grander scale - this time with about participants - with the same favorable results and even more details. In both trials, a novel approach was applied for the purpose of determination of the efficacy and reproducibility of classical homeopathic treatment in Premenstrual Syndrome (PMS). Findings: 96 women, with evident PMS completed the study. Significantly higher improvement of PMS symptoms (mean MDQ scores) occurred in the homeopathically treated group compared to the controls (0.35 vs. 0.2, p=0.05). Marked reduction (90%) in number of sick days, (p=0.007). Significant reduction in medication intake (75% vs. 36%, p=0.03). Better self assessment (p=0.043) and more.
Michal yakir, MSc.*# S. Kreitler**, Prof A.Brzezinski, MD#,G. Vithoulkas^. Z. Bentwitch, Prof MD#
# Hadassah Medical School, Hebrew University, Jerusalem, Israel **Department of Psychology, Tel Aviv University, Israel. ! Sharey Tzedek hospital, Jerusalem, Israel. ^International Homeopathic Academy, Allonisos, Greece.
Describing and understanding reality is the main goal of science. To understand the reality of health and illness, one needs to confiscate illness from the narrow context of the physical, and decipher it as a simultaneous event of both body and mind, with individual and environmental aspects. Alternative or holistic medicine is by definition oriented that way, and the validity of its clinical researches should be obtained with results describing multiple variables and points of view regarding the curative process. Referenced that way it may draw nearer to the possibility of describing reality - which is the person as a whole - essentially the goal of our treatments.
to convey diverse aspects of the efficacy of homeopathic treatment in premenstrual syndrome (PMS).
Randomized, Controlled, double-blind clinical study of classical homeopathy with individualized treatment versus placebo.
Participants: women volunteers, suffering from PMS, otherwise healthy.
Intervention: A single dose of homeopathic medication, prescribed on the basis of a protocol of symptom clusters, with reference to the key symptoms that indicates one of 14 predefined medications in 200c, administered randomly with its parallel masked placebo, on the seventh day of the menses.
Setting: A university hospital outpatient obstetric clinic, Jerusalem, Israel.
Outcome Measures: (a) Evaluation of a daily menstrual distress questionnaire (MDQ) two months before and three months following treatment (1); (b) sick days (c) external medication usage; (d) self-assessments; (e) changes in Psychological traits.
96 women completed the treatment. The results, similar to those found in the pilot study preceding this one (2), are summarized as follows: After the end of 3 months follow-up, more women in the Active treatment group - compared to the Controls - perceived themselves as suffering less (44% vs. 34%), in less need of treatment (1.8 vs. 2.37, p=0.03 1-tailed,) and generally felt that they improved more (1.4 vs. 1.1, p=0.0035). 47% vs. 22% felt that they don’t need further treatment. The homeopathically treated group improved significantly in PMS scores: 0.35 vs. 0.2, (ANOVA p=0.05); reduced sick days by 90% (no change in the Controls, p=0.007); Reduced Significantly concomitant medications intake (75% vs. 36%, t-test p=0.03); and displayed greater general improvement in health during the rest of the month - the non-PMS period (0.21 vs. 0.08, p=0.05). In addition, Social desirability and Defensivity (Marlow-Crowne`s Social desirability scale (3)) Increased in Active treatment group and not in Controls (non-sig.) and as it was correlated with high improvement (r=0.44, p=0.005), that meaning, improved women could stand up for themselves more – an important quality for PMS sufferers.
The attributes of the improved women were different: In the Active treatment group the women suffering most were the ones to improve the most, (see figure) in Controls, this group did not improve. In general, women who suffered greatly from PMS were highly anxious (Taylor`s Manifest Anxiety Scale (3)). In the Active group, highly suffering women displayed lower Anxiety levels after treatment (decrease from 11.7 to 9.9); while in Controls they remained the same. The combined test: Weinberger Repressibility index (3,4) tended to be in the Active treatment in reverse correlation with improvement: that is, women who improve became less repressive and thus more "open”. (Pearson Correlation. r. changes from -0.05 to -0.28, p=0.09). In Controls – no "opening” occurred. (r. did not change: 0.1 to 0.09).
The study has demonstrated repeatedly effectiveness of homeopathic treatment over placebo, associated with amelioration of PMS symptoms but also with improved general well-being, reduced Sick-days and medications. Those were met with the women self assessments and psychological measurements. The results demonstrate the limit of placebo to generate deep changes in many aspects of life - in comparison to homeopathic treatment: The placebo effect was shown to be ineffective in reaching deeply into the body or mind: High suffering and fundamental emotional traits were hardly altered by placebo. Using mean changes of the PMS outcome measure was not sufficient in revealing such differences. Further wide-ranged aspects trials are called for.
1) Moos RH. The development of a menstrual distress questionnaire. Psychsom Med 1989;30:853- 67.
2) Yakir M. et al. Effects of homeopathic treatment in women with premenstrual syndrome: a pilot study: Br Hom J. 2001 90; 148-153
3) Weinberger D.A. et Al. Low anxious, high anxious and repressive coping styles: Psychometric patterns and behavioral physiological responses to stress. J. Abnorm. Psycol. 1979, 88; 369-380
4) Halbreich U. Endicott J. Methodological issues in studies of PMS changes. Psychoneuroendo. 1985 10: 15-32
* Correspondence: Michal Yakir, email@example.com