Three days ago, I reported a new study of homeopathy. At the time, I had not seen the full paper. Now, thanks to a kind reader sending it to me, I can report more details.
In this double-blind, cluster-randomized, placebo-controlled, four parallel arms, community-based, clinical trial, a 20,000-person sample of the population residing in Ward Number 57 of the Tangra area, Kolkata, was randomized in a 1:1:1:1 ratio of clusters to receive one of three homeopathic medicines:
- Bryonia alba 30cH,
- Gelsemium sempervirens 30cH,
- Phosphorus 30cH,
- or an identical-looking placebo.
The treatment period lasted for 3 (children) or 6 (adults) days. All the participants, who were aged 5 to 75 years, received ascorbic acid (vitamin C) tablets of 500 mg, once per day for 6 days. In addition, instructions on a healthy diet and general hygienic measures, including handwashing, social distancing, and proper use of facemasks and gloves, were given to all the participants.
No new confirmed COVID-19 cases were diagnosed in the target population during the follow-up timeframe of 1 month-December 20, 2020 to January 19, 2021-thus making the trial inconclusive.
The Phosphorus group had the least exposure to COVID-19 compared with the other groups. In comparison with placebo, the occurrence of unconfirmed COVID-19 cases was significantly less in the Phosphorus group (week 1: odds ratio [OR], 0.1; 95% confidence interval [CI], 0.06 to 0.16; week 2: OR, 0.004; 95% CI, 0.0002 to 0.06; week 3: OR, 0.007; 95% CI, 0.0004 to 0.11; week 4: OR, 0.009; 95% CI, 0.0006 to 0.14), but not in the Bryonia or Gelsemium groups.
The authors concluded that the trial was inconclusive. The possible effect exerted by Phosphorus necessitates further investigation.
When I first blogged about this, I commented with this question: If you conduct a COVID prevention trial, would you not make sure that rigorous testing for COVID of all participants is implemented? Having seen the full paper, The question remains unanswered. Here is all that the authors write about the outcome measures:
(a) Primary outcome—Occurrence of newly diagnosed (confirmed by detection of the SARS-CoV-2 RNA in nasopharyngeal swab by real-time reverse transcription polymerase chain reaction (RT-PCR) or rapid antigen test) COVID-19 infections as per Government of India records.
(b) Secondary outcome—Occurrence of unconfirmed COVID19 cases as assessed clinically during home visits. It was defined as abrupt onset (within the last 10 days) of fever (100.4°F or 38°C body temperature) with two or more of the following: loss of taste or smell, dry cough, shortness of breath, sore throat, congestion or runny nose, headache, malaise, fatigue, myalgia, limb or joint pain, chest pain or pressure, conjunctivitis, diarrhea, nausea or vomiting, skin rashes, discoloration of fingers or toes.
The timeline was up to 30 days after completing the recommended dosage or once the person reported COVID-19 positive, whichever was earlier. Data were collected weekly by teams of homeopaths from home visits and/or via telephone, whenever required.
I am not entirely sure what this means but I think “as per Government of India records” indicates that they did not bother to systematically measure the primary endpoint of their study. Instead, they relied on the data from occasional unsystematic testing. My suspicion is further confirmed by the authors’ statement in their discussion section: “a manual search of the Government records during the trial phase could not identify a single confirmed COVID-19 positive case belonging to the study population … Enhanced numbers of testing could have changed the outcome of the trial“.
If my suspicion is true, the study is a joke – and not a good one at that. It would mean that considerable funds and efforts have been wasted. It would also mean that the conclusion drawn by the authors “the trial was inconclusive” is inaccurate. It was not inconclusive but it was fatally flawed from its outset.