| Objective: The present study was conducted to assess the safety and efficacy of “Gouteng Powder” in treating tension-type headache caused by wind-phlegm-fire stagnation and deficiency of qi and yin,and to explore its mechanism of action.The study aimed to provide novel clinical ideas and treatment methods for the management of tension-type headache.Methods: Between November 2021 and June 2022,a randomized controlled trial was carried out to gather 70 patients with tension-type headaches who met the inclusion criteria and did not meet the exclusion criteria from the outpatient clinics and wards of the Department of Encephalopathy,Affiliated Hospital of Shandong University of Traditional Chinese Medicine.The patients were then randomly assigned to treatment and control groups.Gouteng Powder and Eperisone Hydrochloride Tablets were given to 35 patients in the treatment group,while 35 patients in the control group received just Eperisone Hydrochloride Tablets(at the same dose as the treatment group).Both treatment groups received care for a total of 4weeks.Before and after treatment,the two groups’ variations in the headache index scores,HAMA scores,HAMD scores and TCM syndrome scores were noted.SPSS 26.0 statistical software was used for statistical analysis to compare the two treatment plans’ efficacy as well as safety.Results: Both the treatment group and the control group had one lost case throughout the course of the study,and one patient in the control group stopped taking the medication on his own.These are the observations’ findings: 1.In terms of demographic information(gender,age,sickness duration),headache index score,HAMA score,HAMD score and TCM evidence score,there was no statistically significant difference between the two groups prior to therapy(P>0.05).2.The headache index scores,overall HAMA scores,HAMD scores and TCM evidence scores of both groups improved after 4 weeks of therapy in comparison to those before treatment,and the difference between the two was statistically meaningful before and after treatment(P<0.05).3.In regards to improvements in headache index score,overall HAMA scores,HAMD scores and TCM symptom scores after 4 weeks of therapy,the treatment group beat the control group,and the difference was statistically meaningful(P<0.05).In the experimental group,there was a substantial difference(P<0.05)in the increase in quality of headache,head heaviness and dizziness,restlessness,little sleep and dreaminess,fatigue and tiredness,and dry stools,but not in the improved performance of chest tightness and abdominal stuffiness,bitterness and dryness of the mouth and throat,and lack of appetite in the control group(P > 0.05).4.Headache index efficacy: After 4 weeks of medication,the treatment group’s effective rate was 91.18%,whereas the effective rate for the control group was 84.85%.This discrepancy was significant(P<0.05).5.The effectiveness of Chinese medicine is demonstrated by the following data: after 4 weeks of therapy,the effective rate of the treatment group was 94.12% and that of the control group was 78.79%.This distinction was statistically significant(P<0.05).6.Safety analysis:The treatment group did not have any notable side effects or adverse reactions,but the control group included two patients who experienced nausea,one who had mild diarrhoea,and two who had tiredness,none of which interfered with the usual course of therapy.Conclusions:Gouteng Powder can convincingly lower the headache index,headache severity,headache duration,and average frequency of attacks per month in patients with tension-type headaches brought on by stagnation of wind-phlegm-fire,qi and yin Deficiency,as well as relieve patients’ anxiety,depression,and other negative emotions.Also,it has the potential to significantly alleviate TCM clinical symptoms while showing no substantial side effects when administered.It has been shown that Gouteng Powder is an excellent remedy for tension-type headaches brought on by stagnation of wind-phlegm-fire,qi and yin deficiency,and it is deserving of therapeutic promotion and usage. |
