Effect of Qizhitongluo capsule on lower limb rehabilitation after stroke: A randomized clinical trial.

BACKGROUND: An individual's level of lower limb motor function is associated with his or her disability level after stroke, and motor improvement may lead to a better prognosis and quality of life. Data from animal models show that Qizhitongluo (QZTL) capsule facilitates recovery after focal brain injury. We aimed to validate the efficacy and safety of the QZTL capsule for promoting lower limb motor recovery in poststroke patients. METHODS: In this randomized, multicenter, double-blind, placebo- and active-controlled trial from 13 sites in China, participants with ischemic stroke and Fugl-Meyer motor scale (FMMS) scores of <95 were eligible for inclusion. Patients were randomly assigned in a 2:1:1 ratio to the QZTL group, Naoxintong (NXT) group or placebo group for 12 weeks at 15-28 days after the onset of stroke. The primary outcome was the change in the Lower Limb FMMS (FMMS-LL) score from baseline over the 12-week intervention period. RESULTS: 622 participants were randomly assigned to the QZTL group (309), NXT group (159), or placebo group (154). The FMMS-LL score increased by 4.81 points (95 % CI, 4.27-5.35) in the QZTL group, by 3.77 points (95 % CI, 3.03-4.51) in the NXT group and by 3.00 points (95 % CI, 3.03-4.51) in the placebo group at week 12. The QZTL group showed significantly larger improvements compared with the placebo group at each interview from weeks 4-12 (difference, 0.89 [0.30,1.49] at week 4, P = 0.0032; difference, 1.83[1.01,2.66] at 90 days poststroke, P < 0.0001; difference, 1.81[0.88,2.74] at week 12, P = 0.0001). CONCLUSION: The QZTL capsule is an effective treatment for lower limb motor impairment. The finding indicates that the QZTL capsule may be used as a potential new strategy for stroke rehabilitation.

The effectiveness and safety of acupuncture for the treatment of myasthenia gravis: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: No systematic reviews of acupuncture as a treatment for myasthenia gravis (MG) have been published in English. The aim of our study is to evaluate the efficacy and safety of acupuncture as a treatment for MG. METHODS: We searched for randomized controlled trials (RCTs) in seven main electronic databases. Unpublished articles, including conference papers and Chinese doctoral and master's theses, were also included as supplementary sources. The primary outcome was the relative clinical score (RCS) response rate. We performed a meta-analysis using RR and MD with 95% CI. RESULTS: Thirteen RCTs involving a total of 775 participants were included. Most included trials had a high risk of bias in allocation concealment and blinding. Eleven RCTs used acupuncture as an adjuvant to medication, and this treatment showed a significant improvement in the RCS response rate compared to medication alone (RR: 1.42; 95% CI: 1.06-1.91; P=0.02). The subgroup analysis based on the treatment duration showed a significant effect on the RCS response rate when the treatment duration was longer than 12 weeks (RR: 2.02; 95% CI: 1.31-3.12; P=0.001). In contrast, there was no significant effect of treatment with a duration less than 8 weeks (RR: 1.14; 95% CI: 0.91-1.44; P=0.26). Four RCTs showed a significant difference in the absolute clinical score (ACS) (RR: 3.42; 95% CI: 1.23-5.61; P=0.002). The acupuncture group reported better outcomes. No severe adverse events corresponding to acupuncture were reported. CONCLUSIONS: This meta-analysis suggests that acupuncture as an integrative therapy has a significant positive effect in treating MG. Acupuncture may enhance the efficacy of medication in MG patients. The safety of acupuncture requires further investigation. The clinical significance of these changes needs to be investigated by further studies using rigorous designs and longer follow-up times.

Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial.

BACKGROUND: Tianshu capsule (TSC), a formula of traditional Chinese medicine, has been widely used in clinical practice for prophylactic treatment of headaches in China. However, former clinical trials of TSC were small, and lack of a standard set of diagnostic criteria to enroll patients. The study was conducted to re-evaluate the efficacy and safety of TSC post-marketing in an extending number of migraineurs who have diagnosed migraine with the International Classification of Headache Disorders, 3rd edition (beta version, ICHD-3ß). METHODS: The study was a double-blind, randomized, placebo-controlled clinical trial that conducted at 20 clinical centers in China. At enrollment, patients between 18 and 65 years of age diagnosed with migraine were assigned to receive either TSC (4.08 g, three times daily) or a matched placebo according to a randomization protocol. The primary endpoint was a relative reduction of 50% or more in the frequency of headache attacks. The secondary outcomes included a reduction in the incidence of headache, the visual analogue scale of headache attacks, days of acute analgesic usage, and percentage of patients with a decrease of 50% or more in headache severity. Accompanying symptoms were also assessed. RESULTS: One thousand migraine patients were initially enrolled in the study, and 919 of them completed the trial. Following the 12-week treatment, significant improvement was observed in the TSC group concerning both primary and secondary outcomes. After therapy discontinuation, the gap between the TSC group and the placebo group in efficacy outcomes continued to increase. There were no severe adverse effects. CONCLUSIONS: TSC is an effective, well-tolerated medicine for prophylactic treatment of migraine, and still have prophylactic effect after medicine discontinuation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02035111; Data of registration: 2014-01-10.

Efficacy and safety of acupuncture at a single BL1 acupoint in the treatment of moderate to severe dry eye disease: Protocol for a randomized, controlled trial.

BACKGROUND: Dry eye disease (DED) is a very common disease. Although several current treatments offer some symptomatic relief, moderate to severe DED is still difficult to cure at present. Acupuncture may be effective for DED via its promotion of tear secretion and ability to improve symptoms, but evidence of its effectiveness is limited. The aim of this study is to evaluate the effect of acupuncture versus artificial tears in moderate to severe DED. METHODS/DESIGN: A total of 120 participants with moderate to severe DED will be randomly assigned to either an acupuncture group or an artificial tear group at a ratio of 1:1. Participants in the acupuncture group will undergo treatments on a single BL1 acupuncture point 3 times per week for 8 weeks. Participants in the control group will use artificial tears 4 times per day for 8 weeks. The primary outcome will be the change from baseline in a mean Schirmer-I test (SIT) at week 8. The secondary outcomes will include the visual analog score (VAS) for the improvement of ocular symptoms, the ocular surface disease index (OSDI), the tear film break-up time (TBUT), and corneal fluorescein staining (CFS) at weeks 4, 8, and 32. Acupuncture acceptance will be evaluated at week 8. Adverse events will also be monitored and documented. A follow-up assessment will be conducted 24 weeks after the treatment. DISCUSSION: We expect to verify that acupuncture is better than artificial tears toward improving the mean SIT values of patients with moderate to severe DED.

Engineering microbial cell factories for the production of plant natural products: from design principles to industrial-scale production.

Plant natural products (PNPs) are widely used as pharmaceuticals, nutraceuticals, seasonings, pigments, etc., with a huge commercial value on the global market. However, most of these PNPs are still being extracted from plants. A resource-conserving and environment-friendly synthesis route for PNPs that utilizes microbial cell factories has attracted increasing attention since the 1940s. However, at the present only a handful of PNPs are being produced by microbial cell factories at an industrial scale, and there are still many challenges in their large-scale application. One of the challenges is that most biosynthetic pathways of PNPs are still unknown, which largely limits the number of candidate PNPs for heterologous microbial production. Another challenge is that the metabolic fluxes toward the target products in microbial hosts are often hindered by poor precursor supply, low catalytic activity of enzymes and obstructed product transport. Consequently, despite intensive studies on the metabolic engineering of microbial hosts, the fermentation costs of most heterologously produced PNPs are still too high for industrial-scale production. In this paper, we review several aspects of PNP production in microbial cell factories, including important design principles and recent progress in pathway mining and metabolic engineering. In addition, implemented cases of industrial-scale production of PNPs in microbial cell factories are also highlighted.

A Randomized Clinical Trial Comparing the Effectiveness of Electroacupuncture versus Medium-Frequency Electrotherapy for Discogenic Sciatica.

Objective. To investigate the short- and long-term effects of electroacupuncture (EA) compared with medium-frequency electrotherapy (MFE) on chronic discogenic sciatica. Methods. One hundred participants were randomized into two groups to receive EA (n = 50) or MFE (n = 50) for 4 weeks. A 28-week follow-up of the two groups was performed. The primary outcome measure was the average leg pain intensity. The secondary outcome measures were the low back pain intensity, Oswestry Disability Index (ODI), patient global impression (PGI), drug use frequency, and EA acceptance. Results. The mean changes in the average leg pain numerical rating scale (NRS) scores were 2.30 (1.86-2.57) and 1.06 (0.62-1.51) in the EA and MFE groups at week 4, respectively. The difference was significant (P < 0.001). The long-term follow-up resulted in significant differences. The average leg pain NRS scores decreased by 2.12 (1.70-2.53) and 0.36 (-0.05-0.78) from baseline in the EA and MFE groups, respectively, at week 28. However, low back pain intensity and PGI did not differ significantly at week 4. No serious adverse events occurred. Conclusions. EA showed greater short-term and long-term benefits for chronic discogenic sciatica than MFE, and the effect of EA was superior to that of MFE. The study findings warrant verification. This trial was registered under identifier ChiCTR-IPR-15006370.

[Comparison effects of acupuncture at distal acupoints and local acupoints on treatment of xerophthalmia].

OBJECTIVE: To compare the clinical efficacy differences between acupuncture at distal acupoints and local acupoints on treatment of xerophthalmia. METHODS: A total of 40 patients of xerophthalmia were randomly divided into a distal group and a local group, 20 cases in each one. One patient in local group lost contact, and finally 20 cases in the distal group and 19 cases in the local group finished treatment. The patients in the distal group were treated with acupuncture at Guangming (GB 37) and Diwuhui (GB 42), while those in the local group were treated with acupuncture at Cuanzhu (BL 2), Tongziliao (GB 1) and Taiyang (EX-HN 5). Patients in both groups were treated once a day, five times per week, and totally 2-week treatment were given. The subjective symptom based on visual analogue scale (VAS), tear secretion, ocular surface disease index (OSDI) and breakup time (BUT) were evaluated before treatment, after two-week treatment (end of treatment) and two weeks after end of treatment (follow-up visit) in the two groups. RESULTS: After treatment and follow-up visit, the VAS, tear secretion, OSDI and BUT were all improved (P<0.05, P<0.01), but the differences of VAS and OSDI between the two groups were not significant (both P>0.05). At follow-up visit, the differences of tear secretion and BUT between the two groups were significant (both P<0.05). CONCLUSION: The acupuncture at distal acupoints could relieve xerophthalmia symptoms, improve quality of life, increase tear secretion and prolong BUT, which is superior to local acupoints in long term.