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

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.

Cerumen removal: comparison of cerumenolytic agents and effect on cognition among the elderly.

Cerumen impaction may affect hearing and decrease hearing acuity, thus decreasing cognitive functions among the elderly. The objective of this study was to compare the safety and the efficacy of three cerumenolytic agents and to assess the effect of cerumen removal on cognition. Thirty eight elderly subjects (mean age: 78 years, total 76 ears) were treated with either Auro®, Cerumol® or the newer CleanEars®, and the change in the degree of ear canal occlusion was examined after a week. In addition, a change in cognition following cerumen removal was evaluated using Raven's standard progressive matrices (RSPM) test. There was no difference regarding the eventual degree of occlusion between the three treatment groups. Only in the CleanEars® group a complete resolution of obstruction in both ears was achieved. A statistically significant difference between the RSPM score before and after the removal of cerumen was found. Using CleanEars® is as effective and safe as other agents and may be advantageous due to its spray application. Removal of cerumen significantly improves the well-being of elderly patients.

Complementary medicine regulations.

There is a need for regulations in applying complementary and alternative medicine methods, especially in the case of oncology patients.

Cognitive orientation as predictor of pain relief following acupuncture.

The study investigated the role of beliefs concerning pain relief after treatment. Following the cognitive orientation theory, we hypothesized that beliefs concerning goals, norms, oneself, and general beliefs would predict the extent of improvement following acupuncture. Subjects were 30 Israeli chronic-pain patients (22 women, 8 men; mean age 41.6 years). They were administered a questionnaire assessing the 4 belief types, and control measures assessing personality traits, demographic variables, and pain characteristics. All underwent 4-6 acupuncture sessions. Improvement was determined by patient and physician ratings, and an index based on medication, subjective evaluations, and duration of resting. There were two follow-ups. Three improvement groups were defined: none (n = 8), slight (n = 12), and high (n = 10). These groups did not differ on any of the variables tested except the 4 belief types. A discriminant analysis with belief types as predictors enabled correct classification of the patients in 83% of the cases. A stepwise regression analysis showed that beliefs accounted for 85% of the variance. Discussion focuses on the nature of pain relief and the role of beliefs in disease.