Efficacy and Safety of Chuanxiong Qingnao Granule in Patients with Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial

Objective. To evaluate the efficacy and safety of Chuanxiong Qingnao Granule (CQG) to treat migraine. Method. This study was a randomized, double-blind, placebo-controlled trial. All migraineurs were recruited and randomly assigned into a treatment group treated with CQG and a control group treated with a placebo. The whole research process included a 4-week baseline, 12-week intervention, and 12-week follow-up. The primary outcome was responder rate, defined as the percentage of migraineurs with 50% or more reduction in the frequency of migraine attack during treatment and posttreatment period compared with the baseline. The secondary outcomes were the number of migraine days, migraine attack frequency, visual analogue scale (VAS), Fatigue Severity Scale (FSS), Hamilton Depression Scale (HAMD), and Migraine Disability Assessment (MIDAS). Results. A total of 346 migraineurs completed the research and were included in the intention-treatment analyses. The response rates differed significantly between the treatment group and the control group (71.5% vs. 12.1% at week 12 and 83.1% vs. 3.4% at week 24). Attack frequency, days of headache attack, VAS, FSS, HAMD, and MIDAS decreased at week 12 in both groups with more reduction in the treatment group ( P < 0.001 ). No severe adverse events were observed in this trial. Conclusion. Chuanxiong Qingnao Granule can significantly improve headache symptoms in patients with migraine while improving disability, fatigue, and depression with a good safety profile.

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Intravenous methylcobalamin effectively ameliorated painful diabetic neuropathy: A randomized double-blind placebo controlled trial

Romanian Journal of Neurology ◽

10.37897/rjn.2021.3.12 ◽

2021 ◽

Vol 20 (3) ◽

pp. 335-341

Author(s):

Thomas Eko Purwata ◽

◽

I Putu Eka Widyadharma ◽

Made Rudy ◽

Andreas Soejitno ◽

...

Keyword(s):

Treatment Group ◽

Diabetic Neuropathy ◽

Rating Scale ◽

Controlled Trial ◽

Control Group ◽

Painful Diabetic Neuropathy ◽

Double Blind ◽

Entire Study ◽

Double Blind Placebo ◽

And Control

Objective. Painful diabetic neuropathy (PDN) is a prevalent debilitating consequence of diabetes mellitus with lack of satisfactory therapeutic options. Methylcobalamin (MeCbl) is one of vitamin B12 analogs with known neurotrophic effects. We aimed to determine if MeCbl can relieve PDN. Materials and methods. This was a randomized (1:1) double-blind placebo-controlled trial involving PDN patients. Treatment and control group received daily 12.5 mg oral amitriptyline bid with either 500 µg of intravenous MeCbl or saline injection given on alternating days, respectively, for a 9-consecutive day period. PDN was assessed with douleur neuropathique 4 (DN4) questionnaire. Numeric pain rating scale (NPRS) was used to monitor pain intensity and treatment response. All investigators and patients were kept blinded throughout the study period. Outcomes. 42 patients, 21 on each arm had completed the study. The NPRS reduction can already be observed as early as day 2 post-intervention. Both the treatment and control group demonstrated sustained reduction of NPRS by almost one point per each time point of evaluation in the first three days (p<0.001). NPRS reduction remained until the end of the study period. The treatment group had a significantly lower NPRS score by 1.29 than that of the control group during the entire study period (95% CI -1.84 – -0.75; p < 0.001). Treatment group experienced significantly higher NPRS reduction when compared with control (4.19±1.54 vs. 2.1± 0.83; 95% CI 1.32-2.87; p < 0.001), i.e. 62.6% from baseline. Conclusions. MeCbl significantly and safely relieved PDN in a relatively rapid onset.

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Efficacy and Safety of Cordyceps militaris as an Adjuvant to Duloxetine in the Treatment of Insomnia in Patients With Depression: A 6-Week Double- Blind, Randomized, Placebo-Controlled Trial

Frontiers in Psychiatry ◽

10.3389/fpsyt.2021.754921 ◽

2021 ◽

Vol 12 ◽

Author(s):

Jiaojiao Zhou ◽

Xu Chen ◽

Le Xiao ◽

Jingjing Zhou ◽

Lei Feng ◽

...

Keyword(s):

Placebo Group ◽

Controlled Trial ◽

Depression Scale ◽

Cordyceps Militaris ◽

Secondary Outcome ◽

Controlled Study ◽

Depression Symptom ◽

Hamilton Depression Scale ◽

Efficacy And Safety ◽

Double Blind

Background: Insomnia is a common clinical manifestation in patients with depression. Insomnia is not only a depression symptom but also an independent risk factor for recurrence. Cordyceps militaris (C. militaris) is thought to have the potential to treat insomnia. This study aimed to examine the efficacy and safety of duloxetine with C. militaris in improving sleep symptoms in patients with depression.Methods: This study was a single-center, randomized, double-blind, placebo-controlled study that recruited outpatients admitted to Beijing Anding hospital from January 2018 to January 2019. Major depressive disorder (MDD) with insomnia was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and Mini-International Neuropsychiatric Interview (M.I.N.I.). Eligible subjects will be randomly assigned to two treatment groups in a 1:1 ratio, and receive treatment and follow-up of about 6 weeks of duloxetine plus Cordyceps militaris or placebo, respectively. The severity of depression and insomnia was evaluated at baseline and at 1, 2, 4, and 6 weeks using the 17-item Hamilton Depression Scale (HAMD-17) and Athens Insomnia Scale (AIS).Results: A total of 59 subjects were included in the study (31 in the placebo group and 28 in the C. militaris group). 11 (18.6%) participants withdrew during the study period, 5 (17.9%) in the C. militaris group, and 6 (19.3%) in the placebo group. Depressive and sleep symptoms in all patients reduced over time. We found that the total scores of AIS and its subscales decreased more in the placebo group compared to the C. militaris group (p < 0.05). Secondary outcome revealed that there were no significant differences between the two groups in total HAMD-17 and its sleep factor scores (p > 0.05) at 1, 2, 4, and 6 weeks after treatment initiation. The incidences of adverse events were not significantly different between the two groups (all p > 0.05).Conclusion:C. militaris at the current dose and duration did not improve sleep symptoms in patients with depression, but it is safe with rare side effects.

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Efficacy and safety of Qu Xie capsule in metastatic colorectal cancer: A double-blind, randomized, placebo-controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e15069 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e15069-e15069

Author(s):

Tong Zhang ◽

Yufei Yang

Keyword(s):

Colorectal Cancer ◽

Clinical Trial ◽

Treatment Group ◽

Metastatic Colorectal Cancer ◽

Ming Dynasty ◽

Conventional Therapy ◽

Controlled Trial ◽

Control Group ◽

Efficacy And Safety ◽

Double Blind

e15069 Background:Qu Xie capsule was discovered by Li Zhongzi, a traditional Chinese Medicine doctor in the Ming Dynasty. Doctor Yang Yufei improved Qu Xie capsule and used it clinically for more than 10 years. In a previous study, we found that Qu Xie capsule reduces the risk of stage II–III colorectal cancer postoperative recurrence and metastasis and prolongs the survival of patients with metastatic colorectal cancer (mCRC). The present clinical trial was designed to verify the efficacy and safety of Qu Xie capsule in patients with mCRC. Methods: The present study was a randomized, double-blind, placebo-controlled trial. Sixty patients with mCRC were randomized into two groups at a 1:1 ratio. The treatment group received conventional therapy combined with Qu Xie capsule. The control group was treated with conventional therapy combined with placebo. Main outcome measures were overall survival (OS) and progression-free survival (PFS). Results: A total of 121 patients were enrolled and 60 patients were eligible; 54 patients were analyzed. The median OS was 23 months in the treatment group [95% confidence interval (CI) 15–not calculated] vs. 14 months in the control group (95% CI 11–22) (Kaplan–Meier, Log-rank p = 0.060). The OS of the treatment group tended to be longer than that of the control group, although the difference was not significant. This may have been related to the small sample size. In the subgroups of patients < 65 years old, left-sided colon, and ≥second-line therapy, the treatment group showed a significant survival benefit compared with the control group ( p = 0.006, 0.038, 0.013). There were no significant differences between the two groups in PFS. Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group. In the treatment group, one patient had 'abdominal pain' once, which may have been related to the Qu Xie capsule. No other related adverse events were reported. Conclusions:Qu Xie capsule showed good safety and efficacy, and can prolong the OS of patients with mCRC. Clinical trial information: ChiCTR-IOR-16009733.

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