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Biomedical subjects

H Kiene

Publications and source records attributed to H Kiene.

11 recordsLinked to original sources
PubMed2003

Mistletoe in cancer - a systematic review on controlled clinical trials.

BACKGROUND: Mistletoe preparations are among the most widely used unconventional cancer therapies in Central Europe. Their clinical effectiveness, however, is controversial. OBJECTIVE: To investigate whether prospective controlled clinical trials provide evidence for efficacy of mistletoe therapy in cancer. DESIGN: Systematic review. MATERIAL AND METHODS: Search of 11 electronic databases, reference lists and expert consultations. Criteria based analysis was performed to assess methodological quality of the studies. RESULTS: Twenty-three studies were identified: 16 randomized, 2 quasi-randomized and 5 non-randomized. Cancer sites included breast, lung, stomach, colon, rectum, head and neck, kidney, bladder, melanoma, glioma, and genital. Among these studies, statistically significant positive outcomes were reported for survival (n = 8), tumor remission (n = 1), overall quality of life (QOL) (n = 3), and QOL in relation to side effects during cytoreductive therapy (n = 3). Further, positive trends were reported for survival (n = 8), disease-free-survival (n = 1), and tumor remission (n = 2). Several studies reported no effect on survival (n = 4), disease-free-survival (n = 1), recurrence (n = 2), remission (n = 3), and QOL (n = 1). One study showed a negative trend for disease-free-survival. However, methodological quality of the studies was sometimes far below the standard that is today regarded as optimal or necessary. In view of substantial heterogeneity of the studies and potential positive and negative biases, we considered effect size estimation by quantitative synthesis to be unreliable and decided on a non-quantitative synthesis and discussion. Mistletoe therapy was well tolerated, and no major side effects were noted. CONCLUSIONS: Among 23 identified studies evaluated for clinically relevant outcome measures, 12 studies showed one or more statistically significant, positive results, another 7 studies showed at least one positive trend, 3 showed no effect and 1 had a negative trend. All studies, however, suffered from methodological shortcomings to some degree, and many of the studies are not conclusive. As several reasonably well conducted studies indicate beneficial effects, further properly designed trials should be encouraged. Future controlled studies should take into account the methodological limitations and potential biases of these past mistletoe trials.

Antineoplastic Agents↗
PubMed1999

[Does the study "Complementary medicine in health insurance" provide a basis for scientifically valid conclusions?].

In Switzerland public attention was caught by a health economic analysis of health insurance's reimbursement of complementary medical procedures. Objectives of the study were 1) cost development, 2) health status development of insured citizens, 3) substitutional/additional use of complementary medical procedures. However, several conceptual, methodical and statistical flaws limit the conclusions that can be drawn from this study: The analysis claimed to be based on a large randomized trial. However, the attempt to achieve an unbiased equality in experimental and control group through stratified sampling grossly failed. Effects of complementary medical procedures on health status were inappropriately assessed and only based on 10 patients. The question whether complementary medicine is being used as a substitution or addition to conventional medicine was not even explored (the published result is based on a misleading interpretation of the health insurance's database). Finally, statements on cost developments were not based on estimations, but resulted from methodical and statistical artifacts. Furthermore, the study suffered from several other weaknesses, like a 50% dropout rate, an inadequate description of statistical procedures, an extremely reduced statistical power, and a lack of clear distinction between experimental and retrospective analyses. Therefore, no valid conclusions can be drawn from this study.

Complementary Therapies↗
PubMed1998

Single-case causality assessment as a basis for clinical judgment.

Current methodology of therapeutic causality assessment can be traced back to four underlying paradigms: (1) empirical scientific judgment relies on experimentation (paradigm of experiment), (2) causality assessment requires repeated observations (paradigm of large numbers), (3) observed results must be compared with results of control observations (paradigm of comparison), and (4) observed objects or patients must be distributed to verum and control group by chance (paradigm of randomization). Problematic aspects of conventional methodology and the historical evolution of contemporary causality assessment illustrate the necessity and possibility of methodological alternatives. A fundamental alternative is offered by figural correspondence and figural experiments, which allow valid causality assessments in single-case situations without blinding, randomization, comparison, or large numbers of observations. The epistemological foundation of such single-case causality assessment is explained. Examples from clinical judgment are presented. Single-case causality assessment may be particularly appropriate for therapy judgment in complementary medicine.

Complementary Therapies↗
PubMed1997

The powerful placebo effect: fact or fiction?

In 1955, Henry K. Beecher published the classic work entitled "The Powerful Placebo." Since that time, 40 years ago, the placebo effect has been considered a scientific fact. Beecher was the first scientist to quantify the placebo effect. He claimed that in 15 trials with different diseases, 35% of 1082 patients were satisfactorily relieved by a placebo alone. This publication is still the most frequently cited placebo reference. Recently Beecher's article was reanalyzed with surprising results: In contrast to his claim, no evidence was found of any placebo effect in any of the studies cited by him. There were many other factors that could account for the reported improvements in patients in these trials, but most likely there was no placebo effect whatsoever. False impressions of placebo effects can be produced in various ways. Spontaneous improvement, fluctuation of symptoms, regression to the mean, additional treatment, conditional switching of placebo treatment, scaling bias, irrelevant response variables, answers of politeness, experimental subordination, conditioned answers, neurotic or psychotic misjudgment, psychosomatic phenomena, misquotation, etc. These factors are still prevalent in modern placebo literature. The placebo topic seems to invite sloppy methodological thinking. Therefore awareness of Beecher's mistakes and misinterpretations is essential for an appropriate interpretation of current placebo literature.

Controlled Clinical Trials as Topic↗
PubMed1996

A critique of the double-blind clinical trial. Part 1.

The randomized, double-blind study is generally regarded as the gold standard of clinical drug trials. Bias can occur as a result of the blinding procedure itself, but discussions of this type of bias have been few and far between. This article presents a detailed discussion of such blinding errors, which can obscure genuine drug effects and be of a sufficient magnitude as to generate false-negative results. Uncritical blinding in clinical studies should therefore be questioned.

Bias↗
PubMed1996

A critique of the double-blind clinical trial. Part 2.

The randomized, double-blind study is generally regarded as the gold standard of clinical drug trials. Bias can occur as a result of the blinding procedure itself, but discussions of this type of bias have been few and far between. This article continues with a detailed discussion of such blinding errors, which can obscure genuine drug effects and be of a sufficient magnitude as to generate false-negative results. Uncritical blinding in clinical studies should therefore be questioned.

Clinical Trials as Topic↗
PubMed1996

Placebo effect and placebo concept: a critical methodological and conceptual analysis of reports on the magnitude of the placebo effect.

Since 1955, when HK Beecher published his classic "The Powerful Placebo," it generally has been accepted that 35% of patients with any of a wide variety of disorders can be treated with placebos alone. In recent years, average cure rates of 70%, and up to 100%, also have been quoted. Like pharmacological preparations, placebos are credited with possessing time-effect curves; cumulation and carry-over effects; differentiated actions depending on color, size, or packaging; even toxic effects. It has been postulated that placebos can prolong life, that their effects occur in surgery as well as in medicine, and that they are mediated by endorphins. In this article source material that forms the scientific basis for such claims is examined. Analysis shows that the studies on which such ideas are based, except perhaps in bronchial asthma, do not in any way justify the conclusions drawn from them. The truth is that the placebo effect is counterfeited by a variety of factors including the natural history of the disease, regression to the mean, concomitant treatments, obliging reports, experimental subordination, severe methodological defects in the studies, misquotations, etc; even, on occasion, by the fact that the supposed placebo is actually not a placebo, but has to be acknowledged as having a specific action on the condition for which it is being given. A further reason for misjudgment is the lack of clarity of the placebo concept itself. Experimental subordination and conditioning are other areas of insufficient conceptual differentiation. The authors conclude that the literature relating to the magnitude and frequency of the placebo effect is unfounded and grossly overrated, if not entirely false. They pose the question whether the existence of the so-called placebo effect is itself not largely-or indeed totally-illusory.

Asthma↗
PubMedDate not supplied

Use of Iscador, an extract of European mistletoe (Viscum album), in cancer treatment: prospective nonrandomized and randomized matched-pair studies nested within a cohort study.

CONTEXT: In anthroposophical medicine, total extracts of Viscum album (mistletoe) have been developed to treat cancer patients. The oldest such product is Iscador. Although Iscador is regarded as a complementary cancer therapy, it is the most commonly used oncological drug in Germany. OBJECTIVE: To determine whether Iscador treatment prolongs survival time of patients with carcinoma of the colon, rectum, or stomach; breast carcinoma with or without axillary or remote metastases; or small cell or non-small-cell bronchogenic carcinoma; and to explore synergies between Iscador treatment and psychosomatic self-regulation. DESIGN: Prospective nonrandomized and randomized matched-pair studies nested within a cohort study. SETTING: General community in Germany. PARTICIPANTS: 10,226 cancer patients involved in a prospective long-term epidemiological cohort study, including 1668 patients treated with Iscador and 8475 who had taken neither Iscador nor any other mistletoe product (control patients). INTERVENTION: Iscador. MAIN OUTCOME MEASURE: Survival time. RESULTS: In the nonrandomized matched-pair study, survival time of patients treated with Iscador was longer for all types of cancer studied. In the pool of 396 matched pairs, mean survival time in the Iscador groups (4.23 years) was roughly 40% longer than in the control groups (3.05 years; P < .001). Synergies between Iscador treatment and self-regulation manifested in a longer survival advantage for Iscador patients with good self-regulation (56% relative to control group; P = .03) than for patients with poor self-regulation. Results of the 2 randomized matched-pair studies largely confirmed the results of the non-randomized studies. CONCLUSION: Iscador treatment can achieve a clinically relevant prolongation of survival time of cancer patients and appears to stimulate self-regulation.

Antineoplastic Agents, Phytogenic↗