Integrative Medicine Research最新文献

Background

Post-viral olfactory dysfunction (PVOD) is the common symptoms of long COVID, lacking of effective treatments. Traditional Chinese medicine (TCM) is claimed to be effective in treating olfactory dysfunction, but the evidence has not yet been critically appraised. We conducted a systematic review to evaluate the effectiveness and safety of TCM for PVOD.

Methods

We searched eight databases to identified clinical controlled studies about TCM for PVOD. The Cochrane risk of bias tools and GRADE were used to evaluate the quality of evidence. Risk ratio (RR), mean differences (MD), and 95 % confidence interval (CI), were used for effect estimation and RevMan 5.4.1 was used for data analysis.

Results

Six randomized controlled trials (RCTs) (545 participants), two non-randomized controlled trials (non-RCTs) (112 participants), and one retrospective cohort study (30 participants) were included. The overall quality of included studies was low. Acupuncture (n = 8) and acupoint injection (n = 3) were the mainly used TCM therapies. Five RCTs showed a better effect in TCM group. Four trials used acupuncture, and three trials used acupoint injection. The results of two non-RCTs and one cohort study were not statistically significant. Two trials reported mild to moderate adverse events (pain and brief syncope caused by acupuncture or acupoint injection).

Conclusions

Limited evidence focus on acupuncture and acupoint injection for PVOD and suggests that acupuncture and acupoint injection may be effective in improving PVOD. More well-designed trials should focus on acupuncture to confirm the benefit.

Protocol registration

The protocol of this review was registered at PROSPERO: CRD42022366776.

Background

Hominis placental (HPP) extract has been approved by the Ministry of Food and Drug Safety in Korea for treating chronic liver diseases and postmenopausal syndrome. However, its efficacy and safety for treating chronic temporomandibular disorder (TMD) remains unclear. We aimed to assess the effectiveness and safety of HPP for treating chronic TMD compared with physical therapy (PT).

Methods

This study is a 2-arm parallel, multi-center, randomized controlled trial. We enrolled 82 chronic TMD patients from 2 Korean medicine hospitals between December 2019 and January 2021. We included patients with chronic TMD and randomly assigned them to undergo HPP or PT. The primary outcome was the difference in the scores for temporomandibular joint (TMJ) pain at baseline and week 6. The secondary outcomes were the scores for TMJ pain and bothersomeness, TMJ range of motion, the Korean version of Beck's depression index-Ⅱ, jaw functional limitation scale (JFLS) score, patient global impression of change (PGIC) scores, EuroQoL 5-dimension 5-level score, and short form-12 health survey (SF-12) scores.

Results

Compared with PT, HPP showed significantly superior effects on TMJ pain and bothersomeness, protrusive movement pain, JFLS (verbal, emotional, and global), SF-12, and PGIC scores at week 6 (P < 0.05). Compared with the PT group, the HPP group showed a significantly higher recovery rate (≥50 % reduction in the scores for TMJ pain at the 24-week follow-up).

Conclusion

HPP was more effective than PT managing pain and improving function and quality of life. Our findings demonstrate the effectiveness and safety of HPP for TMD treatment.

Trial registration

This study has been registered at clinicalTrials.gov (NCT04087005), Clinical Research Information Service (CRIS) (KCT0004437), and Ministry of Food and Drug Safety (No. 31886).

Background

The effectiveness of acupuncture for chronic low back pain (cLBP) has not been studied specifically in the 65-and-older population. To inform the validity and generalizability of future acupuncture studies among older adults, we characterized elderly participants’ prior experience with and views toward acupuncture and tested for clinical and sociodemographic differences between acupuncture-naïve and non-naïve participants.

Methods

Data for this study were collected during the baseline telephone interview from the participants enrolled in the Kaiser Permanente Northern California site of an NIH-funded, multicenter clinical trial of acupuncture for cLBP in older adults.

Results

Nearly two-thirds (65.6 %) of participants surveyed reported they had previously received acupuncture treatment with the vast majority seeking acupuncture treatment for pain-related issues (84.8 %). The majority of these participants reported relatively modest levels of exposure to acupuncture with most participants (63.1 %) reporting fewer than 10 treatment sessions over their lifetimes. There were no significant differences in age, sex, race, ethnicity, disability scores, income levels, or pain levels between the acupuncture-naïve and non-naïve groups.

Conclusion

Contextual consideration for prior acupuncture utilization rates is warranted and may be higher than expected or previously reported. We found few differences in baseline characteristics between participants who were acupuncture-naïve and those with prior acupuncture experience; thus, future pragmatic clinical trials might relax previous acupuncture-use considerations in their recruitment criteria. For trials focused on acupuncture-naive patients, it may be more feasible to expand the definition of "acupuncture-naive" based on lifetime acupuncture visits or time since last treatment.

Trial registration

The protocol was registered at clinicaltrials.gov (#NCT04982315).

Background

This study aimed to investigate whether placebo control is differently disclosed in drug and non-drug randomised clinical trial (RCT) participant information leaflets (PILs) and how this might affect participant blinding and direction of study outcomes.

Methods

PILs were obtained from trials registered in the International Standard Randomised Controlled Trial Number database via email. Placebo descriptions in PILs were categorised as Full Disclosure (FD), Partial Disclosure (PD), or Missing Information (MI). Associations between intervention type (drug or non-drug)/placebo disclosure (FD or PD/MI) and participant blinding success/trial outcome direction (positive or non-positive) were examined using a two-sided Fisher's exact test.

Results

Of 116 collected PILs, 56 % were for drug trials and 44 % were for non-drug trials. Among them, 88 PILs had the corresponding publications available and 68 reports specified primary outcomes. Drug trials were more likely to fully disclose placebo information than non-drug trials (92.3 % vs. 74.5 %, p < 0.05). However, the success rate of blinding was only reported in 3 out of 88 trial publications (3.4 %), precluding further analysis. Furthermore, there was no significant association between the direction of trial results and the type of intervention or placebo disclosure.

Conclusion

Our study findings suggest that drug and non-drug RCTs might differ in the way they reveal placebo control information. Further research is warranted to understand what leads to more common PD of placebo information in non-drug trials than drug trials and to determine the optimal placebo control disclosure in specific trial context.

Background

Outcome expectancy is an important component of non-specific effect that may play an important role in pain research and clinical care. We sought to evaluate whether pretreatment expectancy predicts pain reduction in cancer survivors receiving electroacupuncture (EA) or battlefield acupuncture (BFA).

Methods

We analyzed data from a randomized clinical trial that compared EA and BFA versus wait list control (WLC) for chronic musculoskeletal pain in cancer survivors. Expectancy was measured by the Acupuncture Expectancy Scale (AES) at baseline. Pain severity was assessed using the Brief Pain Inventory (BPI) at baseline and week 12. For each treatment arm, multivariable regression models were used to evaluate the association between pretreatment expectancy and week 12 pain severity, controlling for baseline pain severity, age, sex, race, and education.

Results

Among 360 participants enrolled, the mean age was 62.1 years (SD 12.7), with 251 (69.7 %) women and 88 (24.4 %) non-white survivors. Pretreatment expectancy was similar for all groups at baseline (EA: 13.9 ± 3.6; BFA: 13.2 ± 3.7, WLC:12.8 ± 3.3, p = 0.14). Greater pretreatment expectancy was not significantly associated with greater pain reduction in any group, after adjusting for co-variates (EA: Coef. = -0.05, 95 % CI = -0.14 – 0.04, p = 0.28; BFA: Coef. = -0.07, 95 % CI = -0.16 – 0.02, p = 0.15; WLC: Coef. = -0.09, 95 % CI = -0.25 – 0.06, p = 0.23).

Conclusions

Pretreatment expectancy did not predict pain reduction for either EA or BFA in cancer survivors. Our study contributes to the interpretation of analgesic effects of EA or BFA, beyond the notion of a mere 'placebo effect'.

Background

Chronic fatigue is a predominant symptom of post COVID-19 condition, or long COVID. We aimed to evaluate the efficacy and safety of Traditional, Complementary and Integrative Medicine (TCIM) for fatigue post COVID-19 infection.

Methods

Ten English and Chinese language databases and grey literature were searched up to 12 April 2023 for randomized controlled trials (RCTs). Cochrane “Risk of bias” (RoB) tool was applied. Evidence certainty was assessed using Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Effect estimates were presented as risk ratio (RR) or mean difference (MD) with 95% confidence interval (CI).

Results

Thirteen RCTs with 1632 participants were included. One RCT showed that Bufei Huoxue herbal capsules reduced fatigue (n=129, MD -14.90, 95%CI -24.53 to -5.27), one RCT reported that Ludangshen herbal liquid lowered fatigue (n=184, MD -1.90, 95%CI -2.38 to -1.42), and the other one RCT shown that fatigue disappearance rate was higher with Ludangshen herbal liquid (n=184, RR 4.19, 95%CI 2.06 to 8.53). Compared to traditional Chinese medicine rehabilitation (TCM-rahab) alone, one RCT showed that fatigue symptoms were lower following Qingjin Yiqi granules plus TCM-rehab (n=388, MD -0.48, 95%CI -0.50 to -0.46). Due to concerns with RoB and/or imprecision, the certainty in this evidence was low to very low. No serious adverse events was reported.

Conclusions

Limited evidence suggests that various TCIM interventions might reduce post COVID-19 fatigue. Larger, high quality RCTs of longer duration are required to confirm these preliminary findings.

Study Registration

The protocol of this review has been registered at PROSPERO: CRD42022384136.

Background

Tagetes erecta Linn, popularly known as Marigold, has various pharmacological effects. It is used as a dietary supplement, especially for the posterior segment of the eye. However, the effect of T. erecta Linn on ocular disorders is still unknown. The purpose of this study was to investigate the effect of oral administration of ethanol extract of T. erecta Linn flower (TE) for dry eye syndrome (DED) in a murine model.

Methods

Twenty-four mice were subjected to desiccation stress (DS) to induce DED and subcutaneous injection of scopolamine hydrobromide was administered 4 times a day for 21 days. TE and cyclosporine A (CsA) were administered for an additional 14 days under DS conditions. Mice were randomly divided into four groups: control, TE200, TE400, and CsA. Changes in tear production and corneal fluorescein staining were measured at baseline, after 7 days of DS, and after treatment for 7 and 14 days.

Results

DS significantly decreased tear production and increased corneal fluorescein score; the parameters were significantly reversed in the TE400 (oral administration of 400 mg TE/kg body weight) group. TE markedly improved DS-induced changes including corneal epithelial detachment and lacrimal gland inflammation. The anti-inflammatory effect of TE 400 supplementation was similar to that of CsA.

Conclusions

Our findings suggest that oral administration of TE may protect against DS-induced DED via stabilization of the tear film and suppression of inflammation. This study provides an experimental basis for further studies on the potential clinical use of TE in preventing DED.

Acupuncture treatment can be defined as a medical procedure with an acupuncture needle at acupoints. Establishing suitable control settings is essential, based on the target elements of the acupuncture therapy. In order to properly design a clinical trial or an experiment, a control group must be established. Here, we overview the significance of the control group and its limitations in acupuncture research. Clinical trials have employed a variety of study designs and controls for acupuncture treatment in order to compare the effects of actual treatments with control groups that include no treatment or treatment as usual, sham acupuncture at true acupoints, real acupuncture at non-acupoints, and sham acupuncture at non-acupoints. In order to determine the point-specificity of acupuncture, real acupuncture at non-acupoints should be taken into consideration, whereas sham acupuncture at the same true acupoints should be used to determine the needling-specific effect of acupuncture. It is crucial to choose the optimum control for acupuncture treatments depending on the study's main goal and to interpret the results in accordance with the research design.

Background

Gongjin-dan (GJD, also known as Gongchen-dan) and Ssanghwa-tang (SHT, also known as Shuanghe-tang or Souwa-to) are herbal medicines that are widely used in Korea for treating fatigue. However, few studies have evaluated the efficacy and safety of GJD and SHT in the treatment of chronic fatigue.

Methods

In this randomized, double-blind, placebo-controlled clinical trial, 90 individuals with persistent (≥6 months) chronic fatigue of unknown cause and a Fatigue Severity Scale (FSS) score of ≥4 were randomly assigned to GJD group, SHT group, and control group in a 1:1:1 ratio. Outcomes were the changes in the self-reported fatigue questionnaire scores, levels of fatigue-related biomarkers and safety assessment.

Results

Out of 103 patients recruited, 90 were included in the analysis. A significant improvement in the Social Functioning (SF) score of Short-Form 36 Health Survey (SF-36) at week 4 was observed in the GJD group; similarly, a significant improvement compared with that in the Control group was observed in the Role Emotional (RE) score of SF-36 at weeks 4 and 6 and the Physical Functioning (PF) score of SF-36 at week 6 in the SHT group. Laboratory tests revealed no abnormalities, and serious intervention-related adverse events were not reported.

Conclusions

It is suggested that SHT can effectively treat chronic mental and physical fatigue, whereas GJD can effectively treat chronic mental and social fatigue. Furthermore, this study presents evidence supporting the safety of the long-term use of GJD and SHT (up to 4 weeks).

Trial registration

This study was registered at Clinical Research Information Service (CRIS) of Korea with the registration number KCT0007515.

The convergence of traditional, complementary, and integrative medicine (TCIM) with artificial intelligence (AI) is a promising frontier in healthcare. TCIM is a patient-centric approach that combines conventional medicine with complementary therapies, emphasizing holistic well-being. AI can revolutionize healthcare through data-driven decision-making and personalized treatment plans. This article explores how AI technologies can complement and enhance TCIM, aligning with the shared objectives of researchers from both fields in improving patient outcomes, enhancing care quality, and promoting holistic wellness. This integration of TCIM and AI introduces exciting opportunities but also noteworthy challenges. AI may augment TCIM by assisting in early disease detection, providing personalized treatment plans, predicting health trends, and enhancing patient engagement. Challenges at the intersection of AI and TCIM include data privacy and security, regulatory complexities, maintaining the human touch in patient-provider relationships, and mitigating bias in AI algorithms. Patients' trust, informed consent, and legal accountability are all essential considerations. Future directions in AI-enhanced TCIM include advanced personalized medicine, understanding the efficacy of herbal remedies, and studying patient-provider interactions. Research on bias mitigation, patient acceptance, and trust in AI-driven TCIM healthcare is crucial. In this article, we outlined that the merging of TCIM and AI holds great promise in enhancing healthcare delivery, personalizing treatment plans, preventive care, and patient engagement. Addressing challenges and fostering collaboration between AI experts, TCIM practitioners, and policymakers, however, is vital to harnessing the full potential of this integration.