Trial Outcomes & Findings for Additive Homeopathy in Cancer Patients (NCT NCT01509612)

Results Overview

Quality of life was evaluated by using the Global Health Status assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30), which was completed by participants throughout the study. The score of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

150 participants

Primary outcome timeframe

baseline and at 18 weeks

Results posted on

2021-06-16

Participant Flow

Patients were recruited from February 2012 to July 2017

Screened participants were excluded from participation in the study when mutations had been observed, these were treated as screening failures and not included in the trial (= not randomized, n=8).

Participant milestones

Participant milestones
Measure	Homeopathic Placebo Globules Cancer patients received homeopathic placebo remedies	Additive Classical Homeopathy in Cancer Patients Lung cancer patients receive additive classical homeopathy with homeopathic remedies	No Intervention Group The patients in this group received no intervention
Overall Study STARTED	47	51	52
Overall Study COMPLETED	47	51	52
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Additive Homeopathy in Cancer Patients n=51 Participants Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules Additive classical homeopathy: Homeopathic remedies every 2 to 3 months	Additive Homeopathic Placebo Globules n=47 Participants Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules Homeopathic Placebo globules: Homeopathic placebo globules every 2 to 3 months	No Intervention n=52 Participants Lung cancer patients receiving conventional chemo- and/or radiation therapy but neither homeopathic remedies nor homeopathic placebo globules, these patients served as a non-intervention control group	Total n=150 Participants Total of all reporting groups
Age, Continuous	63.2 years STANDARD_DEVIATION 8.8 • n=51 Participants	62.5 years STANDARD_DEVIATION 8.9 • n=47 Participants	63.9 years STANDARD_DEVIATION 9.1 • n=52 Participants	63.2 years STANDARD_DEVIATION 8.9 • n=150 Participants
Sex: Female, Male Female	25 Participants n=51 Participants	20 Participants n=47 Participants	24 Participants n=52 Participants	69 Participants n=150 Participants
Sex: Female, Male Male	26 Participants n=51 Participants	27 Participants n=47 Participants	28 Participants n=52 Participants	81 Participants n=150 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Austria	51 participants n=51 Participants	47 participants n=47 Participants	52 participants n=52 Participants	150 participants n=150 Participants
EORTC-QLQ-C30	46.6 units on a scale from 1 to 4 STANDARD_DEVIATION 25.8 • n=51 Participants • The quality of life assessment was done in the two intervention groups (homeopathy or placebo), but was not done in control patients who received no intervention. Therefore, no data are presented for the "No Intervention" group.	51.2 units on a scale from 1 to 4 STANDARD_DEVIATION 28.0 • n=47 Participants • The quality of life assessment was done in the two intervention groups (homeopathy or placebo), but was not done in control patients who received no intervention. Therefore, no data are presented for the "No Intervention" group.	—	48.8 units on a scale from 1 to 4 STANDARD_DEVIATION 26.8 • n=98 Participants • The quality of life assessment was done in the two intervention groups (homeopathy or placebo), but was not done in control patients who received no intervention. Therefore, no data are presented for the "No Intervention" group.

PRIMARY outcome

Timeframe: baseline and at 18 weeks

Population: Data not collected for the no Intervention Group

Quality of life was evaluated by using the Global Health Status assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30), which was completed by participants throughout the study. The score of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status.

Outcome measures

Outcome measures
Measure	Homeopathic Placebo Globules n=47 Participants Cancer patients received homeopathic placebo remedies	Additive Classical Homeopathy in Cancer Patients n=51 Participants Lung cancer patients receive additive classical homeopathy with homeopathic remedies	No Intervention Group Lung cancer patients received conventional anti-cancer therapy, but neither homeopathic remedies nor homeopathic placebo globules. Data not collected for the no Intervention Group.
EORTC-QLQ-C30 Score	51.2 score on a scale Standard Deviation 28.0	46.6 score on a scale Standard Deviation 25.8	—

SECONDARY outcome

Timeframe: 2 years for the individual patient (=whole study duration)

Survival was assessed by chart review, at every study visit (every 9 weeks throughout the trial), and by information of the central mortality registry of Austria

Outcome measures

Outcome measures
Measure	Homeopathic Placebo Globules n=51 Participants Cancer patients received homeopathic placebo remedies	Additive Classical Homeopathy in Cancer Patients n=47 Participants Lung cancer patients receive additive classical homeopathy with homeopathic remedies	No Intervention Group n=52 Participants Lung cancer patients received conventional anti-cancer therapy, but neither homeopathic remedies nor homeopathic placebo globules. Data not collected for the no Intervention Group.
Survival	23 participants	11 participants	7 participants

Adverse Events

Homeopathic Placebo Globules

Serious events: 0 serious events

Other events: 0 other events

Deaths: 11 deaths

Additive Classical Homeopathy in Cancer Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 23 deaths

No Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Frass, MD

Medical University of Vienna

Phone: +436645453040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place