Safety Of Chinese Herbs Research Articles

Effects of TCM on polycystic ovary syndrome and its cellular endocrine mechanism.

Polycystic ovary syndrome (PCOS) is a reproductive endocrine disease characterized by menstrual disorders, infertility, and obesity, often accompanied by insulin resistance and metabolic disorders. The pathogenesis of PCOS is relatively complex and has a certain relationship with endocrine disorders. The increase of androgen and luteinizing hormone (LH) is the main cause of a series of symptoms. Traditional Chinese medicine (TCM) has obvious advantages and significant curative effects in the treatment of this disease. It can effectively reduce the insulin level of PCOS patients, regulate lipid metabolism, and increase ovulation rate and pregnancy rate and has fewer side effects. This article reviews the efficacy and safety of Chinese herbs and other TCM (such as acupuncture) in the treatment of PCOS and its complications in recent years, as well as the effect and mechanism on cellular endocrine, in order to provide a new clinical idea for the treatment of PCOS.

The effects of sulfur fumigation processing on Panacis Quinquefolii Radix in chemical profile, immunoregulation and liver and kidney injury.

The influence of sulfur fumigation processing on chemical profile, pharmacological activity and safety of Chinese herbs has attracted great attention. Panacis Quinquefolii Radix (PQR) was more widely used as edible and medicinal than Ginseng because of its tonifying effect and characteristic of not getting inflamed. The disadvantage of sulfur fumigated (SF) Ginseng has been reported, but the systematic study of SF-PQR is deficient and urgently needed. To systematically describe the influence of sulfur fumigation on chemical profile, characteristic products, immunoregulation and liver and kidney injury of PQR. ICP-MS and HPLC-DAD were used to detect 11 inorganic elements and 3 ginsenosides, respectively. Principal component analysis (PCA) was used to distinguish SF-PQR from non-sulfur fumigated (NSF)-PQR by combining the content changes of inorganic elements and ginsenosides. UPLC/Orbitrap-MS was applied to screen the characteristic products (m/z) after sulfur fumigation. For the effectiveness and safety, male KM mice were used to compare the immunomodulatory effects of NSF-PQR or SF-PQR under both healty and cyclophosphamide induced immunosuppressive conditions by net growth rate of body weight, thymus and spleen indices, serum IL-6, SOD, BUN, AST levels, and HE staining of liver and kidney. Sulfur fumigation processing significantly reduced the contents of ginsenosides Rb1, Re and Rg1 with the elevation of inorganic elements in 20 batches PQR. Based on the scatter distribution of PCA, SF-PQR and NSF-PQR can be distinguished. According to the Rt, Precursor ion (m/z) and Product ion (m/z) produced by UPLC/Orbit trap-MS, R1-SO3 (m/z, 1059.53), Re-SO3 (m/z, 1025.55), Rg1-SO3 (m/z, 878.47), Ro-SO3 (m/z, 1035.32), Rb1-SO3 (m/z, 1179.58), and Rk3-SO3 (m/z, 745.40) could be confirmed as important markers for identifying SF-PQR. The effect of SF-PQR on reversing immunosuppression induced by cyclophosphamide was significantly reduced (P < 0.05) evidenced by the inhibition of net growth rate of body weight, immune organ index, IL-6 level and SOD activity. For healthy mice, SF-PQR not only failed to maintain the normal indexes, but also reduced the indexes to lower levels. After 2 weeks of continuous gastric administration, the abnormal liver and kidney functions in healthy mice were damaged and manifested by the increasing of BUN and AST levels, which was consistent with hepatic lesion area and renal tubular injury observed by HE staining. Sulfur fumigation processing not only reduced the immunomodulatory effect of PQR, but also brought the hidden danger in liver and kidney injury. The sulfonated products provided in this paper can be applied for the identification of SF-PQR accurately.

Evaluation on Effectiveness and Safety of Chinese Herbs in Treatment of Sub-health: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

To evaluate the effectiveness and safety of Chinese herbs in the treatment of sub-health systematically. Nine databases were systematically and extensively searched to collect randomized controlled trials (RCTs) about Chinese herbs in the treatment of sub-health. The outcomes included overall effective rate, main symptoms, quality of life, etc. Literature screening, data extraction and quality assessment were conducted according to Cochrane Handbook 5.1. Meta-analysis was conducted to the included literature with Review Manager Software. Seventy-two studies involving 9,296 patients with sub-health were included with 4,908 patients in experimental groups and 4,387 patients in control groups. The overall quality of included clinical research was not high. In the aspect of improving overall effective rate, relieving main symptoms, Pittsburgh sleep quality index (PSQI) score, Athens Insomnia Scale (AIS) score, Fatigue Scale-14 (FS-14), Cornell Medical Index (CMI) score and discontinuation rate, the effects of experimental groups were better than that of control groups. According to available research reports, adverse reactions in Chinese herb groups were mainly mild gastrointestinal symptoms, which did not affect the treatment. Chinese herbs have a curative effect in the treatment of sub-health. However, there are no clear criteria for diagnosis and curative effectiveness judgment globally, which would affect the accuracy of curative effect evaluation.

A systematic review on Chinese herbal treatment for radiotherapy-induced xerostomia in head and neck cancer patients

BackgroundOver 80% of head and neck cancer patients suffer from radiotherapy-induced xerostomia (dry mouth). Xerostomia affects cancer patients' quality of life, and xerostomia sometimes persists throughout the patients' lifetime. This review aimed to evaluate the effectiveness and safety of Chinese herbs in relieving radiotherapy induced xerostomia. MethodsSystematic searches were conducted on 6 databases (English and Chinese). Studies published up till May 2017 were considered for inclusion. ResultsA final 14 RCTs (total 994 head and neck cancer patients undergoing radiotherapy) compared Chinese herbs with no herbs, were included in analysis. Very low to moderate quality of evidence found Chinese herbal treatment may relief radiotherapy-induced xerostomia and other related complications (such as oral mucositis and loss of appetite) in head and neck cancer patients. ConclusionThere is limited evidence that Chinese herbal treatment may relief radiotherapy-induced xerostomia and other related complications in head and neck cancer patients.

Efficacy and safety of HL301 in the treatment of acute bronchitis and acute exacerbation of chronic bronchitis: a phase 2, randomized, double-blind, placebo-controlled, multicenter study

Purpose: The efficacy and safety of Chinese herbs for symptomatic treatment of bronchitis is not well established. We evaluated the efficacy and safety of a combination product of seven herbs (HL301) for the treatment of acute bronchitis (AB) and acute exacerbation of chronic bronchitis (AECB) using a randomized, double-blind, placebo-controlled, multicenter trial design.Methods: A total of 160 patients with AB or with AECB were randomized to receive placebo or one of three doses of HL301 (0.6 g/day, 1.2 g/day, or 1.8 g/day) for a total of 7 days. The primary study endpoint was the change in bronchitis severity score (BSS) from the baseline visit (visit 2) to the end of treatment visit (visit 3). Other efficacy variables were percentage BSS systemic sign efficacy after treatment and change in individual BSS parameters after treatment.Findings: Changes in BSS from visit 2 to visit 3 in the three treatment groups (4.63 ± 2.24, 4.08 ± 1.63, and 4.15 ± 1.74 in the HL301 0.6 g/day, 1.2 g/day, and 1.8 g/day groups, respectively) were higher than that of the placebo group (2.88 ± 2.57) in the per protocol set (PPS) (P < .05), and it was also valid in the full analysis set (FAS). The number of participants whose symptoms (measured by BSS) improved at least 30% after treatment was higher in all three treatment groups compared to the placebo group in both the FAS and the PPS (P < .05, for all).Implications: Three different doses of HL301 (0.6 g/day, 1.2 g/day, and 1.8 g/day) were effective in decreasing the BSS index compared to placebo. HL301 may be effective for symptomatic treatment of both AB and AECB.Limitations: Essential components of HL301 have not been delineated in the study and patients with AB and AECB were indiscriminately enrolled in the present study. Respective evaluation of the efficacy of HL301 for AB and AECB will be necessary in the future.

Chinese medicinal herbs for acute bronchitis.

Acute bronchitis is one of the most common diagnoses made by primary care physicians. It is traditionally treated with antibiotics (although the evidence for their effectiveness is weak, and modest at best) and other even less effective treatments. Chinese medicinal herbs have also been used as a treatment. This review aimed to summarise the existing evidence on the comparative effectiveness and safety of Chinese medicinal herbs for treating uncomplicated acute bronchitis. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 4) which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1966 to 19 September 19, 2011), EMBASE (1988 to 19 September 2011) and CNKI and the Chinese Biomedical Database (CBM) (1980 to 19 September, 2011). Randomised controlled trials (RCTs) comparing Chinese medicinal herbs with placebo, antibiotics or other Western medicines for the treatment of uncomplicated acute bronchitis. At least two review authors independently extracted data and assessed trial quality. In this updated review, 74 studies involving 6877 participants were reported as RCTs by the study authors. None of them met the inclusion criteria for this review. Out of the 74 trials, we identified 39 as non-RCTs and 35 compared different Chinese herbal medicines in the intervention and control groups. There is insufficient quality data to recommend the routine use of Chinese herbs for acute bronchitis. Trial design limitations of the individual studies meant that we could not draw any conclusions about the benefits of Chinese herbs for acute bronchitis. In addition, the safety of Chinese herbs is unknown due to the lack of toxicological evidence for these herbs, although adverse events were reported in some case reports.

Safety in Chinese Medicine Research

Safety of drugs is a common concern, regardless of traditional Chinese medicine or Western medicine. Historical experiences tell us that ignored drug safety evaluation would lead to serious consequences. Although Chinese medicine has been used for thousands of years, reevaluation of the safety is still very important. The criteria for safety of Chinese herbal medicines should be the same as those for chemical drugs. Many Chinese herbal medicines have a long history of traditional use. However, many of them do not possess proven safety and efficacy by today’s standards. Well- designed randomized controlled trials and comprehensive pre-clinical toxicological studies were not done. Although the lack of such evidence does not absolutely count against the efficacy and safety of Chinese herbs, laboratory and clinical investigations are still needed before the herbs could be considered safe. This paper reviews the evaluation on the safety of Traditional Chinese Medicine.

A Systematic Review of Chinese Medicinal Herbs for Acute Bronchitis

To assess the effectiveness and safety of Chinese medicinal herbs for treating uncomplicated acute bronchitis. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which includes the Cochrane Acute Respiratory Infections Group's specialized register; The Chinese Cochrane Centre's Controlled Trials Register; MEDLINE; EMBASE; and the Chinese Biomedical Database (CBM). We only included randomized controlled trials. At least two authors extracted data and assessed trial quality. Four trials reported the time to improvement of cough, fever, and rales associated with bronchitis and showed that patients treated with Chinese herbs had a shorter duration of signs and symptoms. Two trials reported the proportion of patients with improved signs and symptoms at follow-up and showed that Chinese herbs were beneficial in terms of relief of signs and symptoms. Thirteen (13) trials analyzed the data on physician global assessment of improvement at follow-up. Nine (9) of 13 trials showed that Chinese herbs were superior to routine treatment and the other four trials showed a similar effect to routine treatment. In general, Chinese herbs appeared beneficial. Only one trial reported adverse effects during treatment. There are insufficient quality data to recommend the routine use of Chinese herbs for acute bronchitis. The benefit found in this systematic review could be due to publication bias and study-design limitations of the individual studies. In addition, the safety of Chinese herbs is unknown due to the lack of toxicological evidence on these Chinese herbs, though adverse events are rarely reported.