Improved quality of life and prolonged survival with add-on homeopathic treatment in patients with non-small cell lung cancer: a prospective, randomized, placebo-controlled, double-blind, three-arm, multicenter study.

چکیده اصلی

BACKGROUND: Alongside conventional anticancer treatment, add-on homeopathy might help to alleviate adverse effects of conventional therapy. AIM: The aim of this study was to replicate previous studies on the effect of adjunctive homeopathy on quality of life (QoL) and survival in non-small cell lung cancer (NSCLC) patients. METHOD: In this prospective, randomized, placebo-controlled, double-blind, three-arm multicenter phase III study with quadruple-checked data analysis, we investigated the potential effects of an add-on homeopathic treatment compared to placebo in patients with stage IV NSCLC in terms of QoL. Ninety-eight received either individualized homeopathic medicinal products (HMPs; n = 51) or placebo (n = 47) in a double-blinded fashion. Fifty-two control patients without homeopathic treatment were only observed in terms of their survival rate. The ingredients of the various HMPs were mainly prepared of plant, mineral, or animal origin. The data entry and statistical analysis were subject to an exceptional quadruple-checked data analysis process. The analysis presented in this article was inspired by our earlier report of this trial published in The Oncologist in 2020, which was retracted by that journal in November 2025 after two corrections; a majority of the co-authors disagreed with this decision. The present article is based on the same trial dataset but was deliberately designed to highlight the unique research methodology: design and preparation by a lead statistician, data entry, data clearing and independent statistical evaluation were performed in four mutually independent steps, reporting follows the CONSORT statement, and the interpretation of the findings has been reframed conservatively. RESULTS: Global health status (QoL) was higher in the homeopathy group than in the placebo group after 9 weeks and after 18 weeks (p < 0.001). With the exception of cognitive functioning at 9 weeks and of pain, diarrhea and financial difficulties at 9 weeks, all functional and symptom scales of the EORTC QLQ-C30 favored the homeopathy group (p < 0.001 for the multivariate comparisons), with between-group differences exceeding the threshold of 10 points that is generally regarded as clinically meaningful. Median survival time over the 730-day observation period was 435 days in the homeopathy group, 257 days in the placebo group (p = 0.010), and 228 days in the non-randomized control group (p < 0.001); the corresponding 2-year survival rates were 45.1%, 23.4%, and 13.5% (homeopathy vs. placebo p = 0.020; homeopathy vs. control p < 0.001). The difference between the placebo group and the non-randomized control group was not statistically significant (p = 0.154). CONCLUSION: In this trial, add-on homeopathy was associated with better quality of life across most functional and symptom domains, with clinically meaningful effect sizes congruently to a previous open study. Survival time was significantly longer in the homeopathy group compared to both the placebo and control groups. Independent replication, ideally within contemporary immuno-oncological treatment regimens is required. TRIALS REGISTRATION: ClinicalTrials.gov; No.: NCT01509612; January 7, 2012.

ترجمه فارسی چکیده

زمینه: به عنوان درمان همراه درمان‌های ضدسرطان کلاسیک، هموپاتی ممکن است به کاهش عوارض جانبی کمک کند. هدف: بررسی اثر هموپاتی همراه بر کیفیت زندگی (QoL) و بقا در بیماران سرطان ریه غیرکوچک سلولی (NSCLC). روش: این مطالعه بالینی تصادفی، کنترل شده با پلاسیبو، دو چشمی، سه شاخه و چندمرکزی مرحله سوم با تحلیل داده‌های چهارگانه بررسی شد. ۹۸ بیمار مرحله IV NSCLC دریافتند یا محصولات دارویی هموپاتی شخصی‌سازی شده (n=51) یا پلاسیبو (n=47) به صورت دو چشمی. ۵۲ بیمار کنترل بدون درمان هموپاتی فقط از نظر نرخ بقا مشاهده شدند. نتایج: کیفیت زندگی کلی در گروه هموپاتی پس از ۹ و ۱۸ هفته بالاتر از گروه پلاسیبو بود (p<0.001). تمام مقیاس‌های عملکردی و عارضه‌ای EORTC QLQ-C30 به نفع گروه هموپاتی بودند (p<0.001). میانگین زمان بقا در طول ۷۳۰ روز ۴۳۵ روز در گروه هموپاتی، ۲۵۷ روز در گروه پلاسیبو (p=0.010) و ۲۲۸ روز در گروه کنترل غیرتصادفی (p<0.001) بود. نتیجه‌گیری: هموپاتی همراه با کیفیت زندگی بهتر و زمان بقا طولانی‌تر همراه بود.

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