Integrative Medicine Research最新文献

In any meta-analysis it is important to report not only the mean effect size but also how the effect size varies across studies. A treatment that has a moderate clinical impact in all studies is very different than a treatment where the impact is moderate on average, but in some studies is large and in others is trivial (or even harmful). A treatment that has no impact in any studies is very different than a treatment that has no impact on average because it is helpful in some studies but harmful in others. The majority of meta-analyses use the I-squared index to quantify heterogeneity. While this practice is common it is nevertheless incorrect. I-squared does not tell us how much the effect size varies (except when I-squared is zero percent). The statistic that does convey this information is the prediction interval. It allows us to report, for example, that a treatment has a clinically trivial or moderate effect in roughly 10 % of studies, a large effect in roughly 50 %, and a very large effect in roughly 40 %. This is the information that researchers or clinicians have in mind when they ask about heterogeneity. It is the information that researchers believe (incorrectly) is provided by I-squared.

Background

Herbal medicine Oryeongsan (ORS), also known as Wulingsan in Chinesehas been used for the treatment of impaired body fluid balance. However, the mechanisms involved are not clearly defined. The purpose of the present study was to identify the actions of ORS on the renal excretory function and blood pressure (BP) and to define the mechanisms involved in association with renin-angiotensin system (RAS) and natriuretic peptide system (NPS) in spontaneously hypertensive rats (SHR), an animal model of human essential hypertension.

Methods

Changes in urine volume (UV), excretion of electrolytes including Na⁺ (urinary excretion of Na⁺ (U_NaV)) were measured. RT-PCR was performed to trace the changes in expression of RAS, NPS and sodium (Na⁺)-hydrogen (H⁺) exchanger 3 (NHE3) in the renal cortex.

Results

In the SHR treated with vehicle (SHR-V) group, UV and U_NaV were suppressed and the Na⁺ balance was maintained at the higher levels leading to an increase in BP compared to WKY-V group. These were accompanied by an increase in NHE3 expression with an accentuation of angiotensin I converting enzyme-angiotensin II type 1 (ACE-AT₁) receptor and concurrent suppression of angiotensin II type 2 (AT₂) receptor/ACE2-Mas receptor expression in the renal cortex. Chronic treatment with ORS increased UV and U_NaV, and decreased the Na⁺ and water balance with a decrease in BP in the ORS-treated SHR-ORS group compared to SHR-V. These were accompanied by a decrease in NHE3 expression with a suppression of ACE-AT₁ receptor and concurrent accentuation of AT₂/ACE2-Mas receptor.

Conclusion

The present study shows that ORS reduced BP with a decrease in Na⁺ and water retention by a suppression of NHE3 expression via modulation of RAS and NPS in SHR. The present study provides pharmacological rationale for the treatment of hypertension with ORS in SHR.

Background

Our previous studies proved that neurogenic inflammatory spots (or neurogenic spots) have the same physiological features as acupuncture points and that neurogenic spot stimulation generates therapeutic effects in various animal models. However, it is unclear how deeply the neurogenic spots should be stimulated to generate therapeutic effects.

Methods

The effects of acupuncture at various needle depths below the neurogenic spot were examined in a rat immobilization stress-induced hypertension (IMH) model. Electroacupuncture was applied to a neurogenic spot at depths of 1, 2, or 3 mm using a concentric bipolar electrode.

Results

Electrical stimulation of the neurogenic spot at a 3-mm depth most effectively lowered blood pressure compared with controls and stimulation at 1- and 2-mm depths, which was inhibited by pretreatment with a local anesthetic lidocaine. Electrical stimulation of the neurogenic spot or injection of substance P (SP) at a 3-mm depth significantly excited the rostral ventrolateral medulla (rVLM) compared with superficial stimulation. Electrical stimulation applied at a 3-mm depth on neurogenic spots dominantly caused c-fos expression from rVLM and ventrolateral periaqueductal gray (vlPAG) in IMH rats. Pretreatment with resiniferatoxin (RTX) injection into the neurogenic spot to ablate SP or calcitonin gene-related peptide (CGRP) prevented the effects of 3-mm neurogenic spot stimulation on blood pressure in IMH rats. Conversely, artificial injection of SP or CGRP generated anti-hypertensive effects in IMH rats.

Conclusion

Our data suggest that neurogenic spot stimulation at a 3-mm depth generated anti-hypertensive effects through the local release of SP and CGRP and activation of rVLM and vlPAG.

Background

Current endometriosis treatments do not always provide symptom relief, with many using complementary approaches. This study examined the effectiveness of acupuncture on pain and quality of life in people with endometriosis.

Methods

Searches were conducted on Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Allied and Complementary Medicine Database (AMED) and Embase (Ovid), Epistemonikos, and Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCOhost) on 20 March 2023. Trials were included if they used penetrating acupuncture. Risk of bias was assessed with Cochrane RoB2 and GRADE for overall evidence certainty. Random-effects meta-analyses were undertaken, using Hedges’ g or mean difference (MD) both with 95 % confidence intervals (CI).

Results

Six studies involving a total of 331 participants were included. Evidence for benefit was found for acupuncture compared to non-specific acupuncture on overall pelvic pain (g = 1.54, 95 % CI 0.92 to 2.16, 3 RCTs, n = 231, low certainty evidence, p<0.001), menstrual pain (g = 1.67, 95 % CI 1.23 to 2.12, 1 RCT, n = 106, moderate certainty evidence, p<0.001), and non-specified pelvic pain (MD -2.77, 95 % CI 2.15 to 3.38, 2 RCTs, n = 125, low certainty evidence, p<0.001), and compared to usual care on menstrual pain (g = 0.9, 95 % CI 0.15 to 1.64, 1 RCT, n = 19, very low certainty evidence, p = 0.02). Most studies reported low rates of adverse events.

Conclusion

Acupuncture treatment for endometriosis demonstrated clinically relevant improvements in pelvic pain and should be considered as a potential treatment intervention.

Study registration

PROSPERO ID: CRD42023408700.

Background

Advanced pancreatic cancer (APC) is a fatal disease with limited treatment options. This study aims to evaluate the effectiveness and safety of different Chinese herbal injections (CHIs) as adjuvants for radiotherapy (RT) in APC and compare their treatment potentials using network meta-analysis.

Methods

We systematically searched three English and four Chinese databases for randomized controlled trials (RCTs) from inception to July 25, 2023. The primary outcome was the objective response rate (ORR). Secondary outcomes included Karnofsky performance status (KPS) score, overall survival (OS), and adverse events (AEs). The treatment potentials of different CHIs were ranked using the surface under the cumulative ranking curve (SUCRA). The Cochrane RoB 2 tool and CINeMA were used for quality assessment and evidence grading.

Results

Eighteen RCTs involving 1199 patients were included. Five CHIs were evaluated. Compound Kushen injection (CKI) combined with RT significantly improved ORR compared to RT alone (RR 1.49, 95 % CrI 1.21–1.86). Kanglaite (KLT) plus RT (RR 1.58, 95 % CrI 1.20–2.16) and CKI plus RT (RR 1.49, 95 % CrI 1.16–1.95) were associated with improved KPS score compared to radiation monotherapy, with KLT+RT being the highest rank (SUCRA 72.28 %). Regarding AEs, CKI plus RT was the most favorable in reducing the incidence of leukopenia (SUCRA 90.37 %) and nausea/vomiting (SUCRA 85.79 %).

Conclusions

CKI may be the optimal choice of CHIs to combine with RT for APC as it may improve clinical response, quality of life, and reduce AEs. High-quality trials are necessary to establish a robust body of evidence.

Protocol registration

PROSPERO, CRD42023396828.

Background

Eunkyosan (EKS) and Samsoeum (SSE), which are called Yin qiao san and Shen su yin in Chinese, are commonly used herbal medicines for the common cold in East Asian countries. This study aimed to evaluate the effectiveness and safety of EKS and SSE for treating the common cold.

Methods

A randomized, patient-assessor-blind, placebo-controlled, parallel, and multicenter clinical trial was conducted. Adult participants who had one or more cold within 48 h before screening, were randomly allocated to EKS, SSE, or placebo groups. The recruitment goal was planned to be 375 participants. They took an EKS, SSE, or placebo, thrice daily for up to 8 days. The primary outcome was the change in the total score of the Wisconsin Upper Respiratory Symptom Scale-21-Korean version (WURSS-21-K) on day 6 compared to the baseline. The secondary outcomes included visual analog scale (VAS) scores and the duration of symptoms was assessed throughout the trial.

Results

A total of 128 participants were enrolled and 44, 42, and 42 were allocated to the EKS, SSE, and placebo groups, respectively. This study was prematurely terminated due to the COVID-19 pandemic, and we were unable to recruit all the planned participants (n = 375). EKS showed significant clinical effectiveness over the placebo group in the treatment of the common cold, as assessed by the total, symptom, and quality of life scores of WURSS-21-K and VAS, whereas SSE showed significant improvement over the placebo group in terms of WURSS-21-K symptom score. No severe adverse events were reported.

Conclusions

Although EKS and SSE demonstrated statistically significant clinical effectiveness and safety in patients with the common cold, we failed to recruit our pre-planned number of participants. Future definitive full-scale studies are needed to confirm these results.

Trial registration

ClinicalTrials. gov, registration number: NCT04073511. Registered on 29 August 2019.

Background

Patients with coronavirus disease 2019 (COVID-19) usually complain of fever, cough, and sore throat. This study examined the effects of aromatherapy on sore throat, nasal symptoms, stress, fatigue, and sleep quality by administering it to adults with post-COVID-19 condition.

Methods

This study was conducted in a randomised controlled design. Its target population were adults who were released from COVID-19 quarantine treatment within 45 days from infection onset and capable of performing daily activities after isolation treatment. The participants were randomised into aromatherapy group (AG) and control group (CG). To test experimental treatment effects, the levels of sore throat, nasal symptoms, stress, fatigue and sleep quality were measured at the baseline (pre-test) and after the trial (post-test), using the numerical rating scale for sore throat, stress and fatigue, the Total Nasal Symptoms Score for nasal symptoms, and the Korean Version of Modified Leeds Sleep Evaluation Questionnaire for quality of sleep.

Results

After experimental treatment, there was a significant difference in sore throat in AG compared to CG on the 3rd day (t=-2.022 p=0.048) and 4th day (t=-2.450, p=0.017) of treatment. There was also a significant difference in fatigue between AG and CG on the 2nd day(t=-2.748, p=0.008), 3rd day (t=-2.948, p=0.005) and 4th day (t=-3.084, p=0.003) of treatment. There was no significant difference in TNSS, stress, and sleep quality between the two groups after the experimental treatment.

Conclusion

Inhaling aroma essential oils reduced sore throat and fatigue in adults with post-COVID-19 condition, demonstrating the feasibility of aromatherapy as an effective treatment.

Trial registration

The study was registered with Clinical Research Information Service (KCT0008029).

Background

Peripheral hypersensitivities develop in the face and hindpaws of mice with nitroglycerin (NTG)-induced migraine. We evaluated whether diluted bee venom (DBV) injections at acupoints prevented these peripheral hypersensitivities and c-Fos expression in the trigeminal nucleus caudalis (TNC).

Methods

NTG (10 mg/kg, intraperitoneal, i.p.) was administered every other day for nine days. DBV (0.1 mg/kg) was subcutaneously injected into the ST36 (Zusanli), LI4 (Hegu), or GV16 (Fengfu) acupoints 75 min after each NTG injection. Mice were pretreated with naloxone (5 mg/kg, i.p.) or yohimbine (5 mg/kg, i.p.) 30 min before the DBV injections.

Results

NTG injection caused facial cold allodynia, hindpaw mechanical allodynia, and increased c-Fos-immunoreactive (ir) cells in the TNC. Repetitive DBV injections at GV16, but not the ST36, or LI4 acupoints, suppressed NTG-induced hindpaw mechanical allodynia and facial cold allodynia. The number of c-Fos-ir cells also decreased in response to DBV injections at the GV16 acupoint. Remarkably, pretreatment with yohimbine reversed the anti-allodynic effects of DBV injections and attenuated the decreased c-Fos expression in response to GV16 DBV treatment. Naloxone did not block the effects of GV16 DBV stimulation.

Conclusion

These findings demonstrate that repetitive DBV treatment at the GV16 acupoint relieves NTG-induced facial and hindpaw hypersensitivities and decreases in c-Fos expression in the TNC via activation of the alpha-2 adrenoceptors, but not the opioid receptors.

Real world data (RWD) is increasingly used to investigate health outcomes and treatment efficacy in the field of integrative medicine. Due to the fact that the majority of RWDs are not intended for research, their secondary use in research necessitates complex study designs to account for bias and confounding. To conduct a robust analysis of RWD in integrative medicine, a comprehensive study design process that reflects the characteristics of integrative therapies is necessary. In this paper, we present a guide for designing comparative effectiveness RWE research in integrative medicine. We discuss key factors to consider when selecting RWDs for research on integrative medicine. We provide practical steps for developing a research question, formulating the PICOT objectives (population, intervention, comparator, outcome, and time horizon), and selecting and defining covariates with a summary table. Specific study designs are depicted with corresponding diagrams. Finally, data analysis procedures are introduced. We hope this article clarifies the importance of RWE research design and related processes in order to improve the rigor of RWD studies in the field of integrative medicine research.