Validation Studies Of Zhu Jiangui’s Experiences In Syndrome Differentiation And Treatment Of Menopausal Hot Flashes

1. Purposes(?) To analyze Zhu Jiangui’s syndrome differentiation methods in treating geriatrics Fiery-Hot syndrome and establish dialectical models by information technology.(?) To validate the curative effect of the menopausal hot flashes treatment by using the above described models and to explore the syndrome regularity of the disease.(?) To validate the curative effect of Zhu Jiangui’s self-drafted formula, Zi Shen Qing Xin Formula in all menopausal hot flashes treatment.(?) To analyze the advantages and disadvantages of the Zi Shen Qing Xin Formula in substituting the syndrome typing dialectical treatment.2. MethodsUsing data mining work for Zhu Jiangui’s cases in2007to design information operated Fiery-Hot syndrome differentiation models and thus developing computer software. This belongs to the category of the current status of research in descriptive studies of the clinical epidemiology. The technical application adopted is data mining.(Refer to part2of the thesis)Two groups each of30patients were devised as clinical observation objects:one group referred as the syndrome typing group, diagnosed and treated as the above described models in the outpatient clinic set up for the menopause topic in the second outpatient department of the Guanganmen Hospital; the other group was the prescription-agreed group that utilized the Zi Shen Qing Xin Formula to treat all patients collected from the Geriatrics Department of the Guanganmen Hospital. In the light of the data collected from the two groups, statistical methods were employed to evaluate the curative effect of the individual group and also to compare the curative effect between the two groups on hot flashes and insomnia treatments. In this clinical observation research, using the cluster randomized method to establish two independent serial samples, belongs to cluster randomized controlled clinical study.(Refer to part4of the thesis)3. ResultsAnalysis of Zhu Jiangui’s experiences in syndrome differentiation of the geriatrics Fiery-Hot treatment.In the Fiery-Hot syndrome differentiation, Zhu Jiangui practices the concept of internal heat due to yin deficiency, heat derived from phlegm-dampness, heat derived from liver-Qi stagnation for syndrome typing, while the remaining syndrome typing can be ignored. (1) Symptom classification index (Based on the results of data mining):(a) Internal heat due to yin deficiency type:lumbago, shortness of breath.(b) Heat derived from phlegm-dampness type:sputum, unsmooth defecation.(c) Heat derived from liver-Qi stagnation type:hypochondrium flatulence, eructation.(2) Tongue and pulse classification index (According to expert opinion)(a) Internal heat due to yin deficiency type:deep red, tender, cracked tongue with little or no coating, thready pulse, weak pulse.(b) Heat derived from phlegm-dampness type:greasy or watery tongue coating, slippery pulse.(c) Heat derived from liver-Qi stagnation type:dark color at the lingual sides, stringy pulse, unsmooth pulse.Analysis within the syndrome typing groupThe coincidence rate between the3syndrome types showed only the internal heat due to yin deficiency type and heat derived from phlegm-dampness type was negatively correlated (r=-0.454, p=0.012), while there was no significant correlation between the rest of the syndrome types. Tracking the full treatment course of the syndrome conversion pattern had revealed that after drug intervention, internal heat due to yin deficiency type and heat derived from phlegm-dampness type exhibited reciprocal conversion, but neither was converted to heat derived from Qi stagnation type.In terms of comprehensive efficacy, at the end of treatment, based on Kupperman scale,28cases displayed KI reduction,2cases displayed no changes, indicating94%total efficiency. After the treatment,86%of the patients with varying degrees of menopausal syndrome had improved to atypical symptoms (KI<15)Analysis within the prescription-agreed groupThe curative effect of hot flashes symptom, after1week of treatment,24cases showed hot flashes score reduction,6cases showed no changes; after the treatment,28cases indicated reduction in the final hot flashes score,2cases indicated no changes, the total efficacy was94%. After reviewing the cases, it was discovered that in the2ineffective cases, both displayed greasy tongue coating.After a week of treatment, insomnia score decreased in19cases, while11cases showed no changes (including4asymptomatic cases); after the treatment, the final insomnia score decreased in22cases,8cases indicated no changes (including4asymptomatic cases), the total efficacy was84%. Comparison of the efficacy between the two groupsThe baselines of the two groups were basically the same, the ultimate curative effect comparison between the2groups demonstrated that there is no significant statistical difference be it for hot flashes (p=0.696), or insomnia (p=0.215) treatment.4. ConclusionsBe it categorizing into3syndrome types or non-typing, both were equally effective in treating the disease. The study also revealed that the efficiency of the2treatment regimens was on par with each other. But in actual operation, non-typing is better at reducing the wrong treatment probability caused by the clinical disagreement. Review of the ineffective cases in the hot flashes treatment, the2ineffective cases from the prescription-agreed group both presented greasy tongue coating and this suggested that although Zi Shen Qing Xin Formula showed stable curative effect for the menopausal hot flashes treatment, it is prohibited for patients with obvious damp-heat syndrome.Yin deficiency syndrome and phlegm-dampness syndrome showed a significant negative correlation; suggesting that these two syndromes are mutually exclusive and thus treatment is irreplaceable. Therefore the syndrome typing for menopausal hot flashes treatment should at least include the yin deficiency and phlegm-dampness syndromes. Thus could consider simplifying the models into2syndrome types, the internal heat due to yin deficiency type and heat derived from phlegm-dampness type. And change the prescription to Zi Shen Qing Xin Formula that treats the yin deficiency syndrome and the other group that uses prescriptions capable of eliminating phlegm-dampness such as the Huang Lian Wen Dan Decoction, Hao Qin Qing Dan Decoction, Long Dan Xie Gan Decoction and Xiao Chai Hu Decoction can be taken into consideration. It is more suitable for clinical operation after simplification and improving the curative effect concurrently.In summary, the design scheme of this study is to compare the treatment regimens between a single syndrome type and3syndrome types. But the results suggest that2syndrome types (internal heat due to yin deficiency and heat derived from phlegm-dampness), with2sets of prescriptions (Zi Shen Qing Xin Formula and prescriptions that eliminate phlegm-dampness) is the optimized direction. The validation work relies on the future clinical observation to verify. The syndrome typing outcomes derived from the research showed regularity, and is consistent with the basic theory, indicating that the dialectical models used have a certain degree of accuracy.