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A randomized, placebo-controlled clinical trial on the efficacy of chiropractic therapy on premenstrual syndrome |
Walsh MJ, Polus BI |
Journal of Manipulative and Physiological Therapeutics 1999 Nov-Dec;22(9):582-585 |
clinical trial |
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To evaluate the efficacy of chiropractic therapy on the treatment of symptoms associated with premenstrual syndrome. DESIGN: A prospective, randomized, placebo-controlled, crossover clinical trial. SETTING: Multicenter private clinics. SUBJECTS: Twenty-five subjects with diagnosed premenstrual syndrome (with a Moos premenstrual syndrome questionnaire plus daily symptom monitoring). INTERVENTION: After randomization, 16 of the subjects received high-velocity, low-amplitude spinal manipulation plus soft tissue therapy 2 to 3 times in the week before menses for at least 3 cycles. The remaining 9 subjects received a placebo treatment with a spring-loaded adjusting instrument wound down for minimum force. After a I-cycle washout, the 3 groups changed over. Outcome Measure: Daily rating of symptom level, comparing total scores for premenstrual week with baseline for treatment and placebo phases. Data Analysis: The data were analyzed with paired Student t tests and Wilcoxon signed rank tests, with the statistical significance set at p < 0.05. RESULTS: There was a significant decrease in scores after treatment compared with baseline scores (p = 0.00001) and a statistically significant decrease in scores for the treatment phase compared with the placebo (p = 0.006). For group 1 (n = 16), there was a significant decrease in scores after treatment compared with baseline scores (p = 0.0001) and a statistically significant decrease in scores for the treatment phase compared with the placebo (p = 0.041). For group 2 (n = 9), there was a significant decrease in scores during treatment compared with the baseline (p = 0.01); however, there was no difference at the p = 0.05 level between treatment and placebo scores. CONCLUSIONS: Within the limitations of the study, the results support the hypothesis that the symptoms associated with PMS ran generally be reduced by chiropractic treatment consisting of adjustments and soft-tissue therapy. However, the role of a placebo effect needs further elucidation, given that the group receiving the placebo first, although improving over the baseline, showed no further improvement when they had actual treatment.
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