Study design:
This randomized controlled clinical trial was conducted on patients with a recent stroke in the Acupuncture Clinic of Imam Reza Hospital, affiliated to Mashhad University of Medical Sciences, Mashhad, Iran, from July 2017 to September 2018. Data were collected via convenience sampling.
Sample size calculation method:
Randomization and blinding:
The neurologist and statistician were blind to the study groups. The randomization process was performed through permuted block randomization with varying block sizes of 3, 6, and 9.
Data collection:
The participants were selected via convenience sampling among patients admitted to the Emergency Neurology Department of Ghaem Hospital, Mashhad, Iran. Ischemic stroke was diagnosed based on clinical examinations and brain computed tomography (CT) scans. Patients were screened for the eligibility criteria, and written informed consent were obtained from the patients and their relatives under the neurologist's supervision. Patients who met the inclusion criteria were interviewed. The interventions were explained to the patients and their families, and those who were willing to participate were included.
Inclusion and exclusion criteria:
The patients were randomly assigned to three groups (A, B, and C). All of the groups received the conventional standard treatment (325 mg of aspirin, 20 mg of atorvastatin, and medications for hypertension and diabetes) plus physiotherapy. The patients in group A receive acupuncture in addition to standard therapy, while patients in group B received Dorema ammoniacum. Group C, as the control group, only received the conventional treatment and physiotherapy.
Interventions and comparisons:
Acupuncture group:
The selection of points was selected based on acupuncture reference books and acupuncture therapist experience. Acupuncture performed by an acupuncturist clinician with a Ph. D. in Acupuncture from Beijing Chinese Medical University follows this method:
- After a random selection of the acupuncture group, according to the research method's standards, patients were introduced to the acupuncture clinic of Imam Reza Hospital in Mashhad, affiliated to Mashhad University of Medical Sciences.
- The therapist first explained the method of acupuncture for patients.
- The therapist used the reducing method in the corresponding points entered the body bilaterally to reach the sense of de qi. The exception points were CV6-GV23-GV24, Which are in the center of the body.
4.needles were kept in the patient's body for 30 minutes and then removed from the patient's body. Participants in the acupuncture group (group A) received acupuncture in addition to standard therapy. Acupuncture was performed every other day for 12 sessions (three times per week for four weeks), each session lasting 30 minutes. An acupuncturist performed acupuncture on GV20, GB20, GV24, GV23, CV6, LI15, TW5, SP10, ST36, ST40, LV3, and KI1 points (Table 1). Table 2 showed Revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA).
Dorema ammoniacumgroup:
The participants in group B received 1 g of Dorema ammoniacum (two 500 mg capsules per day) from ammoniacum gum, in addition to standard therapy. It should be noted that all patients in the three groups received standard therapy for stroke. The treatment duration was one month. By monitoring all possible aspects, drugs were provided for the intervention group receiving Dorema ammoniacum.
Outcome measurements:
The patients in the three groups did not have any contact with each other. The symptoms were recorded at the beginning and end of treatment in a questionnaire, regardless of the patient’s group. The extent of improvement in motor functioning and mitigation of motor disability were evaluated in patients with ischemic stroke immediately before the intervention and at the end of the intervention (one month after the intervention), based on the Modified Rankin Scale (mRS) and mNIHSS. During the study, the patients had access to their physician, either in person or through phone calls, and their drug consumption was monitored. If any possible side effects occurred during the intervention, they were recorded, and the patient was excluded from the study and treated based on the medical ethics principles.
The mRS and mNIHSS were completed for the evaluation of patients. At baseline, the patients were examined by mRS and mNIHSS. In almost all acute stroke trials, mRS and mNIHSS are used as primary outcome scales in acute stroke [14-16]. The mRS is rated from 0 to 6, running from “perfect health without symptoms” to “death” [16]. On the other hand, the mNIHSS contains eight items, including the level of consciousness, best gaze, visual field, motor arm, motor leg, sensory abilities, best language, and neglect. This scale has been widely used as a standard part of the assessment in clinical trials. Its scores range from 0 to 31, with scores above 20 indicating severe neurological impairment, 4-20 suggesting moderate impairment, and scores below 4 indicating mild impairment [17]. In this study, the mRS and mNIHSS were completed at baseline and the end of treatments. The primary and secondary outcomes and their differences (pre-treatment and post-treatment differences), based on mNIHSS and mRS, were compared in the study groups.
Hemoglobin A1c (HBA1c), fasting blood sugar (FBS), triglyceride (TG), cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), aspartate aminotransferase (AST), alanine aminotransferase (ALT), plasma creatinine concentration (Cr), and blood urea nitrogen (BUN) levels were measured before the intervention and after 30 days (end of the intervention) for the primary assessment of patients and investigating the possible side effects.
Statistical method:
The baseline characteristics are expressed as mean ± standard deviation for continuous variables or percentages for categorical variables. A Chi-square test was used for the comparison of categorical data. Between-group differences in primary and secondary outcomes are expressed as mean ± standard deviation and examined by the Kruskal-Wallis test. For within-group comparisons, Wilcoxon signed-rank test was used. In order to control for the confounding factors, analysis of covariance was used, and the Bonferroni test was performed for multiple comparisons. A P-value of less than 0.05 was considered statistically significant. All statistical analyses were carried out in SPSS for Windows Version 19.